Rubex
30/06/10
Generic Name: doxorubicin hydrochloride
Dosage Form: injection
FOR INTRAVENOUS USE ONLY
- Severe local tissue necrosis will occur if there is extravasation during administration (see DOSAGE AND ADMINISTRATION). Doxorubicin must not be given by the intramuscular or subcutaneous route.
- Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after termination of therapy. The probability of developing impaired myocardial function based on a combined index of signs, symptoms and decline in left ventricular ejection fraction (LVEF) is estimated to be 1 to 2% at a total cumulative dose of 300 mg/m2 of doxorubicin, 3 to 5% at a dose of 400 mg/m2, 5 to 8% at 450 mg/m2 and 6 to 20% at 500 mg/m2*. The risk of developing CHF increases rapidly with increasing total cumulative doses of doxorubicin in excess of 450 mg/m2. This toxicity may occur at lower cumulative doses in patients with prior mediastinal irradiation or on concurrent cyclophosphamide therapy or with pre-existing heart disease. Pediatric patients are at increased risk for developing delayed cardiotoxicity.
- Dosage should be reduced in patients with impaired hepatic function.
- Severe myelosuppression may occur.
- Doxorubicin should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.
* Data on file at Pharmacia & Upjohn.
Rubex Description
Doxorubicin is a cytotoxic anthracycline antibiotic isolated from cultures of Streptomyces peucetius var. caesius. Doxorubicin consists of a naphthacenequinone nucleus linked through a glycosidic bond at ring atom 7 to an amino sugar, daunosamine.
Chemically, doxorubicin hydrochloride is: (8S,10S) – 10 – [(3 - Amino - 2,3,6 - trideoxy - α - L - lyxo - hexopyranosyl) - oxy] – 8 – glycoloyl – 7,8,9,10 – tetrahydro – 6,8,11 – trihydroxy – 1 – methoxy – 5,12 – naphthacenedione hydrochloride [25316-40-9].
The structural formula is as follows:
Doxorubicin binds to nucleic acids, presumably by specific intercalation of the planar anthracycline nucleus with the DNA double helix. The anthracycline ring is lipophilic but the saturated end of the ring system contains abundant hydroxyl groups adjacent to the amino sugar, producing a hydrophilic center. The molecule is amphoteric, containing acidic functions in the ring phenolic groups and a basic function in the sugar amino group. It binds to cell membranes as well as plasma proteins. Rubex (doxorubicin hydrochloride for injection, USP) is for intravenous use only. It is available in 50 mg and 100 mg single dose vials as a red-orange lyophilized, sterile powder with added lactose (anhydrous), 250 mg and 500 mg, respectively.
Rubex – Clinical Pharmacology
The cytotoxic effect of doxorubicin on malignant cells and its toxic effects on various organs are thought to be related to nucleotide base intercalation and cell membrane lipid binding activities of doxorubicin. Intercalation inhibits nucleotide replication and action of DNA and RNA polymerases. The interaction of doxorubicin with topoisomerase II to form DNA-cleavable complexes appears to be an important mechanism of doxorubicin cytocidal activity. Doxorubicin cellular membrane binding may effect a variety of cellular functions. Enzymatic electron reduction of doxorubicin by a variety of oxidases, reductases and dehydrogenases generate highly reactive species including the hydroxyl free radical OH-. Free radical formation has been implicated in doxorubicin cardiotoxicity by means of Cu (II) and Fe (III) reduction at the cellular level. Cells treated with doxorubicin have been shown to manifest the characteristic morphologic changes associated with apoptosis or programmed cell death. Doxorubicin-induced apoptosis may be an integral component of the cellular mechanism of action relating to therapeutic effects, toxicities, or both.
Animal studies have shown activity in a spectrum of experimental tumors, immunosuppression, carcinogenic properties in rodents, induction of a variety of toxic effects, including delayed and progressive cardiac toxicity, myelosuppression in all species and atrophy to testes in rats and dogs.
Pharmacokinetic studies, determined in patients with various types of tumors undergoing either single or multi-agent therapy have shown that doxorubicin follows a multiphasic disposition after intravenous injection. The initial distributive half-life of approximately 5.0 minutes suggests rapid tissue uptake of doxorubicin, while its slow elimination from tissues is reflected by a terminal half-life of 20 to 48 hours. Steady-state distribution volumes exceed 20 to 30 L/kg and are indicative of extensive drug uptake into tissues. Plasma clearance is in the range of 8 to 20 mL/min/kg and is predominately by metabolism and biliary excretion. Approximately 40% of the dose appears in the bile in 5 days while only 5 to 12% of the drug and its metabolites appear in the urine during the same time period. Binding of doxorubicin and its major metabolite, doxorubicinol to plasma proteins is about 74 to 76% and is independent of plasma concentration of doxorubicin up to 2 µM. Enzymatic reduction at the 7 position and cleavage of the daunosamine sugar yields aglycones which are accompanied by free radical formation, the local production of which may contribute to the cardiotoxic activity of doxorubicin. Disposition of doxorubicinol (DOX-OL) in patients is formation rate limited. The terminal half-life of DOX-OL is similar to doxorubicin. The relative exposure of DOX-OL, compared to doxorubicin ranges between 0.4 to 0.6. In urine, <3% of the dose was recovered as DOX-OL over 7 days.
A published clinical study involving 6 men and 21 women with no prior anthracycline therapy reported a significantly higher median doxorubicin clearance in the men compared to the women (113 versus 44 L/hr). However, the terminal half-life of doxorubicin was longer in men compared to the women (54 versus 35 hrs).
In four patients dose-independent pharmacokinetics have been shown for doxorubicin in the dose range of 30 to 70 mg/m2. Systemic clearance of doxorubicin is significantly reduced in obese women with ideal body weight greater than 130%. There was a significant reduction in clearance without any change in volume of distribution in obese patients when compared with normal patients with less than 115% ideal body weight. The clearance of doxorubicin and doxorubicinol was also reduced in patients with impaired hepatic function. Doxorubicin was excreted in the milk of one lactating patient, with peak milk concentration at 24 hours after treatment being approximately 4.4-fold greater than the corresponding plasma concentration. Doxorubicin was detectable in the milk up to 72 hours after therapy with 70 mg/m2 of doxorubicin given as a 15 minute intravenous infusion and 100 mg/m2 of cisplatin as a 26 hour intravenous infusion. The peak concentration of doxorubicinol in milk at 24 hours was 0.2 µM and AUC up to 24 hours was 16.5 µM.hr while the AUC for doxorubicin was 9.9 µM.hr.
Following administration of 10 to 75-mg/m2 doses of doxorubicin to 60 children and adolescents ranging from 2 months to 20 years of age, doxorubicin clearance averaged 1443 +/- 114 mL/min/m2. Further analysis demonstrated that clearance in 52 children greater than 2 years of age (1540 mL/min/m2) was increased compared with adults. However, clearance in infants younger than 2 years of age (813 mL/min/m2) was decreased compared with older children and approached the range of clearance values determined in adults.
Doxorubicin does not cross the blood brain barrier.
Indications and Usage for Rubex
Rubex (doxorubicin hydrochloride for injection, USP) has been used successfully to produce regression in disseminated neoplastic conditions such as acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms’ tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin’s disease, malignant lymphoma and bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types.
Contraindications
Doxorubicin therapy should not be started in patients who have marked myelosuppression induced by previous treatment with other antitumor agents or by radiotherapy. Doxorubicin treatment is contraindicated in patients who received previous treatment with complete cumulative doses of doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenes.
Warnings
Special attention must be given to the cardiotoxicity induced by doxorubicin. Irreversible myocardial toxicity, manifested in its most severe form by life-threatening or fatal congestive heart failure, may occur either during therapy or months to years after termination of therapy. The probability of developing impaired myocardial function, based on a combined index of signs, symptoms and decline in left ventricular ejection fraction (LVEF) is estimated to be 1 to 2% at a total cumulative dose of 300 mg/m2 of doxorubicin, 3 to 5% at a dose of 400 mg/m2, 5 to 8% at a dose of 450 mg/m2 and 6 to 20% at a dose of 500 mg/m2 given in a schedule of a bolus injection once every 3 weeks (data on file at Pharmacia & Upjohn). In a retrospective review by Von Hoff et al, the probability of developing congestive heart failure was reported to be 5/168 (3%) at a cumulative dose of 430 mg/m2 of doxorubicin, 8/110 (7%) at 575 mg/m2 and 3/14 (21%) at 728 mg/m2. The cumulative incidence of CHF was 2.2%. In a prospective study of doxorubicin in combination with cyclophosphamide, fluorouracil and/or vincristine in patients with breast cancer or small cell lung cancer, the cumulative incidence of congestive heart failure was 5 to 6%. The probability of CHF at various cumulative doses of doxorubicin was 1.5% at 300 mg/m2, 4.9% at 400 mg/m2, 7.7% at 450 mg/m2 and 20.5% at 500 mg/m2.
Cardiotoxicity may occur at lower doses in patients with prior mediastinal irradiation, concurrent cyclophosphamide therapy exposure at an early age and advanced age. Data also suggest that pre-existing heart disease is a co-factor for increased risk of doxorubicin cardiotoxicity. In such cases, cardiac toxicity may occur at doses lower than the respective recommended cumulative dose of doxorubicin. Studies have suggested that concomitant administration of doxorubicin and calcium channel entry blockers may increase the risk of doxorubicin cardiotoxicity. The total dose of doxorubicin administered to the individual patient should also take into account previous or concomitant therapy with related compounds such as daunorubicin, idarubicin and mitoxantrone. Cardiomyopathy and/or congestive heart failure may be encountered several months or years after discontinuation of doxorubicin therapy.
The risk of congestive heart failure and other acute manifestations of doxorubicin cardiotoxicity in pediatric patients may be as much or lower than in adults. Pediatric patients appear to be at particular risk for developing delayed cardiac toxicity in that doxorubicin induced cardiomyopathy impairs myocardial growth as pediatric patients mature, subsequently leading to possible development of congestive heart failure during early adulthood. As many as 40% of pediatric patients may have subclinical cardiac dysfunction and 5 to 10% of pediatric patients may develop congestive heart failure on long term follow-up. This late cardiac toxicity may be related to the dose of doxorubicin. The longer the length of follow-up the greater the increase in the detection rate.
Treatment of doxorubicin induced congestive heart failure includes the use of digitalis, diuretics, after load reducers such as angiotensin I converting enzyme (ACE) inhibitors, low salt diet, and bed rest. Such intervention may relieve symptoms and improve the functional status of the patient.
Monitoring Cardiac Function
In adult patients severe cardiac toxicity may occur precipitously without antecedent ECG changes. Cardiomyopathy induced by anthracyclines is usually associated with very characteristic histopathologic changes on an endomyocardial biopsy (EM biopsy), and a decrease of left ventricular ejection fraction (LVEF), as measured by multi-gated radionuclide angiography (MUGA scans) and/or echocardiogram (ECHO), from pretreatment baseline values. However, it has not been demonstrated that monitoring of the ejection fraction will predict when individual patients are approaching their maximally tolerated cumulative dose of doxorubicin. Cardiac function should be carefully monitored during treatment to minimize the risk of cardiac toxicity. A baseline cardiac evaluation with an ECG, LVEF, and/or an echocardiogram (ECHO) is recommended especially in patients with risk factors for increased cardiac toxicity (pre-existing heart disease, mediastinal irradiation, or concurrent cyclophosphamide therapy). Subsequent evaluations should be obtained at a cumulative dose of doxorubicin of at least 400 mg/m2 and periodically thereafter during the course of therapy. Pediatric patients are at increased risk for developing delayed cardiotoxicity following doxorubicin administration and therefore a follow-up cardiac evaluation is recommended periodically to monitor for this delayed cardiotoxicity.
In adults, a 10% decline in LVEF to below the lower limit of normal or an absolute LVEF of 45%, or a 20% decline in LVEF at any level is indicative of deterioration in cardiac function. In pediatric patients, deterioration in cardiac function during or after the completion of therapy with doxorubicin is indicated by a drop in fractional shortening (FS) by an absolute value of ≥10 percentile units or below 29%, and a decline in LVEF of 10 percentile units or an LVEF below 55%. In general, if test results indicate deterioration in cardiac function associated with doxorubicin, the benefit of continued therapy should be carefully evaluated against the risk of producing irreversible cardiac damage.
Acute life-threatening arrhythmias have been reported to occur during or within a few hours after doxorubicin administration.
There is a high incidence of bone marrow depression, primarily of leukocytes, requiring careful hematologic monitoring. With the recommended dose schedule, leukopenia is usually transient, reaching its nadir 10 to 14 days after treatment with recovery usually occurring by the 21st day. White blood counts as low as 1000/mm3 are to be expected during treatment with appropriate doses of doxorubicin. Red blood cell and platelet levels should also be monitored since they may also be depressed. Hematologic toxicity may require dose reduction or suspension or delay of doxorubicin therapy. Persistent severe myelosuppression may result in superinfection or hemorrhage.
Doxorubicin may potentiate the toxicity of other anticancer therapies. Exacerbation of cyclophosphamide induced hemorrhagic cystitis and enhancement of the hepatotoxicity of 6-mercaptopurine have been reported. Radiation induced toxicity to the myocardium, mucosae, skin and liver have been reported to be increased by the administration of doxorubicin. Pediatric patients receiving concomitant doxorubicin and actinomycin-D have manifested acute “recall” pneumonitis at variable times after local radiation therapy.
Since metabolism and excretion of doxorubicin occurs predominantly by the hepatobiliary route, toxicity to recommended doses of doxorubicin can be enhanced by hepatic impairment; therefore, prior to the individual dosing, evaluation of hepatic function is recommended using conventional laboratory tests such as SGOT, SGPT, alkaline phosphatase and bilirubin. (See DOSAGE AND ADMINISTRATION.)
Necrotizing colitis manifested by typhlitis (cecal inflammation), bloody stools and severe and sometimes fatal infections have been associated with a combination of doxorubicin given by I.V. push daily for 3 days and cytarabine given by continuous infusion daily for 7 or more days.
On intravenous administration of doxorubicin, extravasation may occur with or without an accompanying stinging or burning sensation, even if blood returns well on aspiration of the infusion needle (see DOSAGE AND ADMINISTRATION). If any signs or symptoms of extravasation have occurred, the injection or infusion should be immediately terminated and restarted in another vein.
Pregnancy Category D
Safe use of doxorubicin in pregnancy has not been established. Doxorubicin is embryotoxic and teratogenic in rats and embryotoxic and abortifacient in rabbits. There are no adequate and well-controlled studies in pregnant women. If doxorubicin is to be used during pregnancy, or if the patient becomes pregnant during therapy, the patient should be apprised of the potential hazard to the fetus. Women of childbearing age should be advised to avoid becoming pregnant.
Precautions
General
Doxorubicin is not an anti-microbial agent.
Information for Patients
Rubex (doxorubicin hydrochloride for injection, USP) imparts a red coloration to the urine for 1 to 2 days after administration, and patients should be advised to expect this during active therapy.
Drug Interactions
Paclitaxel: Two published studies report that initial administration of paclitaxel infused over 24 hours followed by doxorubicin administered over 48 hours resulted in a significant decrease in doxorubicin clearance with more profound neutropenic and stomatitis episodes than the reverse sequence of administration.
Progesterone: In a published study, progesterone was given intravenously to patients with advanced malignancies (ECOG PS <2) at high doses (up to 10 g over 24 hours) concomitantly with a fixed doxorubicin dose (60 mg/m2) via bolus. Enhanced doxorubicin-induced neutropenia and thrombocytopenia were observed.
Verapamil: A study of the effects of verapamil on the acute toxicity of doxorubicin in mice revealed higher initial peak concentrations of doxorubicin in the heart with a higher incidence and severity of degenerative changes in cardiac tissue resulting in a shorter survival.
Cyclosporine: The addition of cyclosporine to doxorubicin may result in increases in AUC for both doxorubicin and doxorubicinol possibly due to a decrease in clearance of parent drug and a decrease in metabolism of doxorubicinol. Literature reports suggest that adding cyclosporine to doxorubicin results in more profound and prolonged hematologic toxicity than doxorubicin alone. Coma and/or seizures have also been described.
Literature reports have also described the following drug interactions: phenobarbital increases the elimination of doxorubicin, phenytoin levels may be decreased by doxorubicin, streptozocin (Zanosar®) may inhibit hepatic metabolism of doxorubicin, and administration of live vaccines to immunosuppressed patients including those undergoing cytotoxic chemotherapy may be hazardous.
Laboratory Tests
Initial treatment with doxorubicin requires observation of the patient and periodic monitoring of complete blood counts, hepatic function tests, and radionuclide left ventricular ejection fraction (see WARNINGS).
Like other cytotoxic drugs, doxorubicin may induce “tumor lysis syndrome” and hyperuricemia in patients with rapidly growing tumors. Appropriate supportive and pharmacologic measures may prevent or alleviate this complication.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Formal long-term carcinogenicity studies have not been conducted with doxorubicin. Doxorubicin and related compounds have been shown to have mutagenic and carcinogenic properties when tested in experimental models (including bacterial systems, mammalian cells in culture, and female Sprague-Dawley rats).
The possible adverse effect on fertility in males and females in humans or experimental animals have not been adequately evaluated. Testicular atrophy was observed in rats and dogs.
A variant of chemotherapy-related acute non-lymphocytic leukemia has been reported to occur infrequently a few years after multiple drug treatment of some neoplasms, which sometimes included doxorubicin. The exact role of doxorubicin has not been elucidated.
Pediatric patients treated with doxorubicin or other topoisomerase II inhibitors are at a risk for developing acute myelogenous leukemia and other neoplasms. The extent of increased risk associated with doxorubicin has not been precisely quantified.
Pregnancy Category D
(See WARNINGS.)
Nursing Mothers
Because of the potential for serious adverse reactions in nursing infants from doxorubicin, mothers should be advised to discontinue nursing during doxorubicin therapy.
Pediatric Use
Pediatric patients are at increased risk for developing delayed cardiotoxicity. Follow-up cardiac evaluations are recommended periodically to monitor for the delayed cardiotoxicity (see WARNINGS).
Doxorubicin, as a component of intensive chemotherapy regimens administered to pediatric patients, may contribute to prepubertal growth failure. It may also contribute to gonadal impairment, which is usually temporary.
Adverse Reactions
Dose limiting toxicities of therapy are myelosuppression and cardiotoxicity. Other reactions reported are:
Cardiotoxicity – (See WARNINGS.)
Cutaneous– Reversible complete alopecia occurs in most cases. Hyperpigmentation of nailbeds and dermal creases, primarily in pediatric patients, and onycholysis have been reported in a few cases. Recall of skin reaction due to prior radiotherapy has occurred with doxorubicin administration.
Gastrointestinal– Acute nausea and vomiting occurs frequently and may be severe. This may be alleviated by antiemetic therapy. Mucositis (stomatitis and esophagitis) may occur 5 to 10 days after administration. The effect may be severe leading to ulceration and represents a site of origin for severe infections. The dosage regimen consisting of administration of doxorubicin on three successive days results in greater incidence and severity of mucositis. Ulceration and necrosis of the colon, especially the cecum, may occur leading to bleeding or severe infections which can be fatal. This reaction has been reported in patients with acute non-lymphocytic leukemia treated with a 3-day course of doxorubicin combined with cytarabine. Anorexia and diarrhea have been occasionally reported.
Vascular– Phlebosclerosis has been reported especially when small veins are used or a single vein is used for repeated administration. Facial flushing may occur if the injection is given too rapidly.
Local – Severe cellulitis, vesication and tissue necrosis will occur if extravasation of doxorubicin occurs during administration. Erythematous streaking along the vein proximal to the site of the injection has been reported (see DOSAGE AND ADMINISTRATION).
Hematologic– The occurrence of secondary acute myeloid leukemia with or without a preleukemic phase has been reported rarely in patients concurrently treated with doxorubicin in association with DNA-damaging antineoplastic agents. Such cases could have a short (1-3 years) latency period. Pediatric patients are also at risk of developing secondary acute myeloid leukemia.
Hypersensitivity– Fever, chills and urticaria have been reported occasionally. Anaphylaxis may occur. A case of apparent cross sensitivity to lincomycin has been reported.
Neurological – Peripheral neurotoxicity in the form of local-regional sensory and/or motor disturbances have been reported in patients treated intra-arterially with doxorubicin, mostly in combination with cisplatin. Seizures were reported in one patient receiving a very high dose of doxorubicin (2 to 3 times the approved dosage) in combination with high-dose cyclophosphamide.
Other– Conjunctivitis and lacrimation occur rarely.
Overdosage
Acute overdosage with doxorubicin enhances the toxic effects of mucositis, leukopenia and thrombocytopenia. Treatment of acute overdosage consists of treatment of the severely myelosuppressed patient with hospitalization, antimicrobials, platelet transfusions and symptomatic treatment of mucositis. Use of hemopoietic growth factor (G-CSF, GM-CSF) may be considered.
Cumulative dosage with doxorubicin increases the risk of cardiomyopathy and resultant congestive heart failure (see WARNINGS). Treatment consists of vigorous management of congestive heart failure with digitalis preparations, diuretics, and after load reducers such as ACE inhibitors.
Rubex Dosage and Administration
Care in the administration of Rubex will reduce the chance of perivenous infiltration (see WARNINGS). It may also decrease the chance of local reactions such as urticaria and erythematous streaking. On intravenous administration of doxorubicin, extravasation may occur with or without an accompanying burning or stinging sensation, even if blood returns well on aspiration of the infusion needle. If any signs or symptoms of extravasation have occurred, the injection or infusion should be immediately terminated and restarted in another vein. If extravasation is suspected, intermittent application of ice to the site for 15 min, q.i.d. x 3 days may be useful. The benefit of local administration of drugs has not been clearly established. Because of the progressive nature of extravasation reactions, close observation and plastic surgery consultation is recommended. Blistering, ulceration and/or persistent pain are indications for wide excision surgery, followed by split-thickness skin grafting.
The most commonly used dose schedule when used as a single agent is 60 to 75 mg/m2 as a single intravenous injection administered at 21-day intervals. The lower dosage should be given to patients with inadequate marrow reserves due to old age, or prior therapy, or neoplastic marrow infiltration. Rubex has been used concurrently with other approved chemotherapeutic agents. Evidence is available that in some types of neoplastic disease combination chemotherapy is superior to single agents. The benefits and risks of such therapy continue to be elucidated. When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m2 given as a single intravenous injection every 21 to 28 days. Doxorubicin dosage must be reduced in case of hyperbilirubinemia as follows:
| Plasma bilirubin concentration (mg/dL) | Dosage reduction (%) |
| 1.2 – 3 | 50 |
| 3.1 – 5 | 75 |
Reconstitution Directions: Rubex 50 mg and 100 mg vials should be reconstituted with 25 mL and 50 mL, respectively, of Sodium Chloride Injection, USP (0.9%) to give a final concentration of 2 mg/mL of doxorubicin hydrochloride. An appropriate volume of air should be withdrawn from the vial during reconstitution to avoid excessive pressure buildup. Bacteriostatic diluents are not recommended.
After adding the diluent, the vial should be shaken and the contents allowed to dissolve. The reconstituted solution is stable for 7 days at room temperature and under normal room light (100 foot-candles) and 15 days under refrigeration 2°-8° C (36°-46° F). It should be protected from exposure to sunlight and any unused solution should be discarded.
It is recommended that Rubex be slowly administered into the tubing of a freely running intravenous infusion of Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP. The tubing should be attached to a Butterfly® needle inserted preferably into a large vein. If possible, avoid veins over joints or in extremities with compromised venous or lymphatic drainage. The rate of administration is dependent on the size of the vein, and the dosage. However, the dose should be administered in not less than 3 to 5 minutes. Local erythematous streaking along the vein as well as facial flushing may be indicative of too rapid an administration. A burning or stinging sensation may be indicative of perivenous infiltration and the infusion should be immediately terminated and restarted in another vein. Perivenous infiltration may occur painlessly.
Doxorubicin should not be mixed with heparin or fluorouracil since it has been reported that these drugs are incompatible to the extent that a precipitate may form. Until specific compatibility data are available, it is not recommended that doxorubicin be mixed with other drugs.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Handling and Disposal — Skin reactions associated with doxorubicin have been reported. Skin accidently exposed to doxorubicin should be rinsed copiously with soap and warm water, and if the eyes are involved, standard irrigation techniques should be used immediately. The use of goggles, gloves, and protective gowns is recommended during preparation and administration of the drug.
Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published1-7. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
Caregivers of pediatric patients receiving doxorubicin should be counseled to take precautions (such as wearing latex gloves) to prevent contact with the patient’s urine and other body fluids for at least 5 days after each treatment.
How is Rubex Supplied
Rubex® (doxorubicin hydrochloride for injection, USP) is available as follows:
| 50 mg — | Each single-dose vial contains 50 mg of doxorubicin HCl, USP as a sterile red-orange lyophilized powder, NDC 0015-3352-22. Available as one individually cartoned vial. |
| 100 mg — | Each single-dose vial contains 100 mg of doxorubicin HCl, USP as a sterile red-orange lyophilized powder, NDC 0015-3353-22. Available as one individually cartoned vial. |
Storage
Store dry powder at controlled room temperature 15°-30° C (59°-86° F) (see USP). Protect from light.
The reconstituted solution is stable for 7 days at room temperature or 15 days under refrigeration 2°-8° C (36°-46° F).
Protect from exposure to sunlight. Retain in carton until time of use.
Contains no preservative. Discard unused portion.
REFERENCES
- Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621. For sale by the Superintendent of Documents, US Government Printing Office, Washington, DC 20402.
- AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA, 1985;253 (11):1590-1592.
- National Study Commission on Cytotoxic Exposure — Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, ScD, Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.
- Clinical Oncological Society of Australia. Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia 1983;1:426-428.
- Jones RB, et al: Safe Handling of Chemotherapeutic Agents:A Report from the Mount Sinai Medical Center. CA —A Cancer Journal for Clinicians 1983; (Sept/Oct) 258-263.
- American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm 1990;47:1033-1049.
- Controlling occupational exposure to hazardous drugs. (OSHA WORK PRACTICE GUIDELINES). Am J Health-Syst Pharm 1996;53:1669-1685.
3351DIM-08
51-004726-04
1085217A2
Revised: May 2001
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Revised: 06/2007Bristol-Myers Squibb Company
Rubramin PC
30/06/10
Rubramin PC (Cyanocobalamin Injection) contains cyanocobalamin (vitamin B12) in a clear, red, sterile, nonpyrogenic, aqueous solution in a potency of 1000 mcg/mL (cobalt: 40 mcg/mL) for intramuscular use. Each mL of solution also contains 10 mg benzyl alcohol as a preservative and sodium chloride for isotonicity; pH has been adjusted between 4.5 and 7.0 with sodium hydroxide or hydrochloric acid.
Cyanocobalamin is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). The vitamin B12 coenzymes are very unstable in light.
Cyanocobalamin may be chemically designated as 5,6-dimethyl-benzimidazolyl cyanocobamide. The structural formula is represented below:
Rubramin PC – Clinical Pharmacology
Vitamin B12 is essential to growth, cell reproduction, hematopoiesis, and nucleoprotein and myelin synthesis.
Cyanocobalamin is quantitatively and rapidly absorbed from intramuscular sites of injection; the plasma level of the compound reaches its peak within one hour after intramuscular injection. Absorbed vitamin B12 is transported via specific B12 binding proteins, transcobalamin I and II to the various tissues. The liver is the main organ for vitamin B12 storage.
Within 48 hours after injection of 1000 mcg of vitamin B12, 50 to 98 percent of the injected dose may appear in the urine. The major portion is excreted within the first eight hours.
Gastrointestinal absorption of vitamin B12 depends on the presence of sufficient intrinsic factor and calcium ions. Intrinsic factor deficiency causes pernicious anemia, which may be associated with subacute combined degeneration of the spinal cord. Prompt parenteral administration of vitamin B12 prevents progression of neurologic damage.
The average diet supplies about 5 to 15 mcg/day of vitamin B12 in a protein-bound form that is available for absorption after normal digestion. Vitamin B12 is not present in foods of plant origin, but is abundant in foods of animal origin. In people with normal absorption, deficiencies have been reported only in strict vegetarians who consume no products of animal origin (including milk products or eggs).
Vitamin B12 is bound to intrinsic factor during transit through the stomach; separation occurs in the terminal ileum in the presence of calcium, and vitamin B12 enters the mucosal cell for absorption. It is then transported by the transcobalamin binding proteins. A small amount (approximately 1 percent of the total amount ingested) is absorbed by simple diffusion, but this mechanism is adequate only with very large doses. Oral absorption is considered too unreliable in patients with pernicious anemia or other conditions resulting in malabsorption of vitamin B12.
Cyanocobalamin is the most widely used form of vitamin B12, and has hematopoietic activity apparently identical to that of the anti-anemia factor in purified liver extract. Hydroxycobalamin is equally as effective as cyanocobalamin, and they share the cobalamin molecular structure.
Indications and Usage for Rubramin PC
Rubramin PC is indicated for use as the flushing dose in the Schilling (vitamin B12 absorption) Test for pernicious anemia.
Contraindications
This preparation is contraindicated in patients who are sensitive to cobalt and/or vitamin B12.
Warnings
Patients who have early Leber’s disease (hereditary optic nerve atrophy) have been found to suffer severe and swift optic atrophy when treated with vitamin B12.
Fatal hypokalemia may occur when severe megaloblastic anemia is treated intensively with vitamin B12, as a result of increased erythrocyte potassium requirements (see PRECAUTIONS, Laboratory Tests).
Anaphylactic shock and death have been reported after parenteral vitamin B12 administration. An intradermal test dose is recommended before cyanocobalamin is administered to patients suspected of being sensitive to this drug.
This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal “Gasping Syndrome” in premature infants.
Precautions
General
Doses of vitamin B12 exceeding 10 mcg daily may produce a hematologic response in patients who have a folate deficiency. Indiscriminate administration of vitamin B12 may mask the true diagnosis of pernicious anemia.
Vitamin B12 deficiency that is allowed to progress for longer than three months may produce permanent degenerative lesions of the spinal cord. Doses of folic acid greater than 0.1 mg per day may result in hematologic remission in patients with vitamin B12 deficiency. Neurologic manifestations will not be prevented with folic acid, and if not treated with vitamin B12, irreversible damage will result.
Laboratory Tests
Patients with pernicious anemia have about three times the incidence of carcinoma of the stomach as the general population, so appropriate tests for this condition should be carried out when indicated.
Drug Interactions
Neomycin, colchicine, para-aminosalicylic acid, or excessive alcohol intake longer than two weeks may cause malabsorption of vitamin B12. Chloramphenicol and other drugs having bone marrow suppressant properties may cause a lack of therapeutic response to vitamin B12; this effect may be due to interference with erythrocyte maturation.
Drug/Laboratory Test Interactions
Most antibiotics, methotrexate, and pyrimethamine invalidate folic acid and vitamin B12 diagnostic microbiological blood assays.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals to evaluate carcinogenic potential have not been done. There is no evidence from long-term use in patients with pernicious anemia that cyanocobalamin is carcinogenic. Pernicious anemia is associated with an increased incidence of carcinoma of the stomach, but this is believed to be related to the underlying pathology and not to treatment with cyanocobalamin.
Pregnancy
Pregnancy Category C. Adequate and well-controlled studies have not been done in pregnant women. However, vitamin B12 is an essential vitamin and requirements are increased during pregnancy. Amounts of vitamin B12 that are recommended by the Food and Nutrition Board, National Academy of Science-National Research Council for pregnant women (4 mcg daily) should be consumed during pregnancy.
Nursing Mothers
Vitamin B12 is known to be excreted in human milk. Amounts of vitamin B12 that are recommended by the Food and Nutrition Board, National Academy of Science-National Research Council for lactating women (4 mcg daily) should be consumed during lactation.
Vitamin B12 appears in the milk of nursing mothers in concentrations that approximate the mother’s vitamin B12 blood level.
Pediatric Use
Safety and effectiveness in pediatric patients has not been established.
Adverse Reactions
No serious toxic reactions have been reported following the intramuscular administration of cyanocobalamin. The following allergic-type reactions have been reported rarely; the relationship of these reactions to cyanocobalamin or other components in the preparation is unknown.
Generalized—anaphylactic shock and death have been reported with administration of parenteral vitamin B12 (see WARNINGS)
Cardiovascular—pulmonary edema and congestive heart failure early in treatment, peripheral vascular thrombosis
Hematologic—polycythemia vera
Gastrointestinal—mild transient diarrhea
Dermatologic—itching, transitory exanthema, urticaria
Miscellaneous—feeling of swelling of entire body
Overdosage
No overdosage has been reported with this drug.
Rubramin PC Dosage and Administration
Rubramin PC (Cyanocobalamin Injection) should be visually inspected for particulate matter and color prior to administration; the solution is clear red.
Do not administer intravenously.
Schilling Test*
The flushing dose is 1000 mcg injected intramuscularly. For procedure see the insert packaged with Rubratope®-57 (Cyanocobalamin Co 57) capsules or diagnostic kit (see the DOSAGE AND ADMINISTRATION section).
How is Rubramin PC Supplied
Rubramin PC (Cyanocobalamin Injection USP)
Unimatic® Single Dose Syringes
The syringes are supplied with sterile disposable 22-gauge, 1-1/4-inch needles.
1000 mcg (1 mL): NDC 0270-0519-16
Storage
Protect from light (keep syringes in carton). Store at controlled room temperature; avoid freezing.
Directions for Use of
UNIMATIC® single dose syringe
- 1)
- Screw the threaded tip of the plunger rod clockwise into the cartridge plunger and push forward a few millimeters to break any friction between the cartridge plunger and syringe barrel.
- 2)
- Holding syringe erect, aseptically remove the rubber cap from the tip of the syringe and attach the sterile, disposable needle using a push-twist action.
- 3)
- Remove the needle guard, hold the syringe erect, and push plunger forward until a drop appears at tip of needle and all of the air is evacuated. Following the usual aspiration procedure complete the injection.
- 4)
- Destroy the needle and syringe immediately after use.
Manufactured for
Bracco Diagnostics Inc.
Princeton, N.J. 08543
by E.R. Squibb & Sons Inc.
New Brunswick, N.J. 08903
J3-662G
Printed in USA
May 1995
| Rubramin PC cyanocobalamin injection, solution |
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Revised: 10/2006Bristol-Myers Squibb Company
Rubratope-57
30/06/10
DESCRIPTION Rubratrope-57 diagnostic capsules for oral administration provide radioactive cyanocobalamin in which a portion of the molecules contain Co 57 in the molecular structure vitamin B12-57Co. The chemical structure of cyanocobalamin is given below:
Each Rubratope-57 capsule contains approximately 18.5 to 37 kBq (0.5 to 1.0 microcurie) of cyanocobalamin Co 57; the cyanocobalamin content of each capsule will vary with the specific activity of the cyanocobalamin Co 57 used. Complete assay data are provided on the vial label.
PHYSICAL CHARACTERISTICS
Cobalt 57 decays by electron capture with a physical half-life of 270.9 days.1 Photons that are useful for detection and imaging studies are listed in Table 1.
| Principal Radiation Emission Data | ||
| Radiation | Mean % per Disintegration |
Mean Energy (keV) |
| Gamma-2 | 85.5 | 122.1 |
| Gamma-3 | 10.6 | 136.5 |
- 1
- Kocher, David C., “Radioactive Decay Data Tables”, DOE/TIC-11026, (1981) p.77.
External Radiation
The specific gamma ray constant for Co 57 is 0.96 R/hour-millicurie at 1 cm. The first half-value thickness of Pb (lead) for Co 57 is 0.006 cm. To facilitate control of the radiation exposure, a range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. For example, the use of 1.6 cm of Pb will decrease the external radiation exposure by a factor of about 1,000.
| Radiation Attenuation by Lead Shielding | |
| Shield Thickness (Pb) cm |
Attenuation Factor |
| To correct for physical decay of Co 57, the fractions that remain at selected intervals before and after calibration time are shown in Table 3. | |
| 0.006 | 0.5 |
| 0.05 | 10-1 |
| 0.14 | 10-2 |
| 1.6 | 10-3 |
| 3.5 | 10-4 |
| Physical Decay Chart: Co 57 half-life 270.9 days | |||
| Days | Fraction Remaining |
Days | Fraction Remaining |
| *Calibration time | |||
| 0* | 1.000 | 75 | 0.825 |
| 5 | 0.987 | 90 | 0.794 |
| 10 | 0.975 | 105 | 0.764 |
| 15 | 0.962 | 120 | 0.736 |
| 30 | 0.926 | 135 | 0.708 |
| 45 | 0.891 | 150 | 0.681 |
| 60 | 0.858 | 165 | 0.656 |
| 180 | 0.631 | ||
Rubratope-57 – Clinical Pharmacology
After oral administration, cyanocobalamin is normally bound by intrinsic factor and absorbed by the distal ileum. It is then bound to plasma proteins, stored in the liver, and slowly released when needed to carry out normal cellular metabolic functions. Absorbed cyanocobalamin is ultimately excreted in the urine; any cyanocobalamin not bound by intrinsic factor is excreted in the stool.
Indications and Usage for Rubratope-57
Rubratope-57 (Cyanocobalamin Co 57 Capsules) is intended for the diagnosis of pernicious anemia and as a diagnostic adjunct in other defects of intestinal vitamin B12 absorption.
Contraindications
None known.
Warnings
None.
Precautions
General
In the use of any radioactive material, care should be taken to insure minimum radiation exposure to the patient and occupational workers consistent with proper patient management.
Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
Because a large parenteral dose of vitamin B12 may temporarily affect subsequent intestinal absorption and excretion of the vitamin, tests employing radioactive vitamin B12 should not be performed for at least 24 hours after either a flushing dose for the Schilling test or a therapeutic injection (1000 micrograms) of vitamin B12.
Drug Interactions
Most antibiotics, methotrexate, pyrimethamine, colchicine, para-aminosalicylic acid, or excessive alcohol intake for longer than two weeks may result in malabsorption of vitamin B12.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate carcinogenic potential or whether this agent affects fertility in males or females.
Pregnancy: Teratogenic Effects
Category C
Animal reproduction studies have not been conducted with Cyanocobalamin Co 57 Capsules. It is also not known whether this agent can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Since vitamin B12-57Co is taken up by the fetus, radiocyanocobalamin absorption tests in pregnant women should be postponed until after delivery unless the potential benefit justifies the potential risk to the fetus.
Ideally, examinations using radiopharmaceuticals, especially those elective in nature, in women of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.
Nursing Mothers
Since vitamin B12-57Co is excreted in human milk during lactation, formula feedings should be substituted for breast feedings.
Pediatric Use
Safety and effectiveness in children have not been established.
Adverse Reactions
No adverse reactions specifically attributable to Cyanocobalamin Co 57 Capsules have been reported.
The following adverse reactions have been reported with nonradioactive cyanocobalamin: mild transient diarrhea, polycythemia vera, peripheral vascular thrombosis, itching, transitory exanthema, feeling of swelling of the entire body, congestive heart failure and pulmonary edema, anaphylactic shock, and death.
Rubratope-57 Dosage and Administration
The suggested oral dose range for the average patient (70 kg) when performing a Schilling urinary excretion test is between 18.5 to 37 kBq (0.5 to 1 microcurie) of cyanocobalamin Co 57.
The patient dose in each Cyanocobalamin Co 57 Capsule should be measured by a suitable radioacttivity calibration system immediately prior to administration.
Schilling Urinary Excretion Test1,2
Test Procedure
The patient should be instructed to fast (patient may have water) for 12 hours prior to the test. Vitamin B12 should not be administered orally or parenterally during the preceding 24 hours. It is important to establish the absence of any potentially interfering gamma-emitting radioisotopes in the patient’s urine prior to starting the study.
After the patient voids, administer one Rubratope- 57 (Cyanocobalamin Co 57) capsule. Inject 1000 µg non-radioactive Cyanocobalamin Injection USP intramuscularly as a flushing dose two hours following administration of the capsule. Collect and pool all urine for 24 hours and mix thoroughly. Collect an additional 24 hour sample separately if renal function is impaired or if urinary excretion is delayed.
Determine 10-minute net radioactivity counts for a 4 mL sample of urine from each excretion period, and a 4 mL sample of diluted Cobatope-57 (Cobaltous Chloride Co 57 Reference Standard Solution). The working standard is prepared by diluting 0.5 mL Cobatope-57, which contains the equivalent of 1 percent of the total radioactivity in the oral dose, with 3.5 mL of water. Calculate as follows:
counts per volume
minute x of urine
per mL of urine(a) collected of
———————————————— x 100 = % administered
counts per dose
minute x 100(c)
of standard(b)
- (a)
- The measurement of radioactivity of the urine sample was a 10-minute count on a 4 mL sample. To convert to counts per minute per mL, divide by 40 (10 minutes x 4 mL).
- (b)
- The count rate of the 4 mL standard is divided by 10 in order to obtain the counts per minute.
- (c)
- 1% standard, so dilution factor is 100.
Results
Values of 9 percent or more for samples excreted during either the first 24 hour period or first and second 24 hour periods combined, are generally considered to represent a normal state for vitamin B12 absorption. The test should be repeated if a lower result is obtained.
Retest Procedure
The need for repeating a test should be carefully evaluated, especially in younger patients. A retest can be conducted four or five days following the primary test. Administer one Intrinsic Factor Concentrate capsule with a Rubratope-57 (Cyanocobalamin Co 57) capsule. Repeat all other steps of the primary procedure. Retest values greater than 9 percent are indicative of pernicious anemia; values of less than 9 percent are indicative of bacterial interference, malabsorption or ileal lesion.
An additional retest can be conducted to determine malabsorption or bacterial interference. Administer antibiotics, in lieu of Intrinsic Factor, 10 to 14 days prior to the second retest. Repeat all other steps of the primary procedure. Values greater than 9 percent are indicactive of bacterial interference; values of less than 9 percent are indicative of lack of ileal absorption sites.
Radiation Dosimetry
The estimated absorbed radiation doses to an average patient (70 kg) from an oral dose of 37 kBq (1 microcurie) of vitamin B12-57 Co are shown in Table 4.
| Estimated Absorbed Radiation Doses | ||||
| Tissue | mGy/37kBq | Co57 (rads/uCi) | ||
| Normal | Pernicious Anemia |
|||
| Liver | 1.3* | (0.13*) | 0.26 | (0.026) |
| Stomach | 0.00081 | (0.000081) | 0.0011 | (0.00011) |
| Small Intestine | 0.0013 | (0.00013) | 0.0040 | (0.00040) |
| Upper Large Intestine |
0.0025 | (0.00025) | 0.0076 | (0.00076) |
| Lower Large Intestine |
0.0060 | (0.00060) | 0.018 | (0.0018) |
| Testes | 0.052 | (0.0052) | 0.0012 | (0.00012) |
| Ovaries | 0.065 | (0.0065) | 0.0057 | (0.00057) |
| Whole-body | 0.099 | (0.0099) | 0.013 | (0.0013) |
Method of Calculation: “S” Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11 (1975).
*The administration of a flushing dose of nonradioactive vitamin B12 will decrease the dose to the liver, gonads, and whole-body from Co 57 by about 30 percent.
How is Rubratope-57 Supplied
Rubratope-57 (Cyanocobalamin Co 57 Capsules) is available in bottles of 5 and 10 capsules. Each two-piece blue/red capsule contains approximately 18.5 to 37 kBq (0.5 to 1 microcurie) at the time of calibration. Complete assay data are provided on the container.
Also Available
Cobatope-57 (Cobaltous Chloride Co 57 Reference Standard Solution), supplied in 10 mL vials, is manufactured in companion lots to the diagnostic capsules. Cobatope-57 is intended for laboratory use only as a standard of comparison to the diagnostic capsules. Each mL of aqueous solution provides activity equivalent to 2 percent of the total radioactivity in each capsule bearing the same lot number as the reference standard solution. No decay corrections are necessary when the capsules are used with a companion vial of Cobatope-57 (Cobaltous Chloride Co 57 Reference Standard Solution).
Rubratope-57 Diagnostic Kit (Cyanocobalamin Co 57 Diagnostic Kit) provides material for primary and initial retesting (Schilling test) for two patients.
Storage
Rubratope-57 (Cyanocobalamin Co 57) capsules should be stored at 20-25°C (68-77°F) [See USP].
REFERENCES
- McIntyre PA: “Use of Radioisotope Techniques in the Clinical Evaluation of Patients with Megaloblastic Anemia”, Semin in Nucl. Med. 5:1 (1975), 79-94.
- Nickoloff EL: “Alternatives to Vitamin B12 Radioassays: The Schilling Test”, The Ligand Quart 2: (1979), 27-29.
“This package conforms to the conditions and limitations specified in 49 CFR 173.421 for exempted radioactive material, limited quantity, N.O.S. UN 2910”.
Receipt, transfer, handling, possession or use of this product is subject to the radioactive materials regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreements States or Licensing States as appropriate.
Manufactured for
Bracco Diagnostics Inc.
Princeton, NJ 08543
by Amersham plc Little Chalfont England
L/4734/04/04
Revised April 2004
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Revised: 03/2007Bracco Diagnostics Inc.
rufinamide
30/06/10
Generic Name: rufinamide (roo FIN a mide)
Brand Names: Banzel
What is rufinamide?
Rufinamide is an anti-epileptic medication, also called an anticonvulsant.
Rufinamide is used in combination with other medications to treat children with Lennox-Gastaut syndrome, a severe form of childhood epilepsy that also causes developmental and behavior problems.
Rufinamide may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about rufinamide?
You should not use this medication if you are allergic to rufinamide, or if you have a genetic heart rhythm disorder called “Short QT syndrome.”
If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before taking rufinamide, tell your doctor if you have liver disease, kidney disease, or if you are on dialysis.
You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.
Take rufinamide with food.
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Do not stop taking rufinamide without first talking to your doctor, even if you feel better. You may have increased seizures if you stop taking rufinamide suddenly. You will need to use less and less before you stop the medication completely.
Contact your doctor if your seizures get worse or you have them more often while taking rufinamide.
What should I discuss with my healthcare provider before taking rufinamide?
You should not use this medication if you are allergic to rufinamide, or if you have a genetic heart rhythm disorder called “Short QT syndrome.”
If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before taking rufinamide, tell your doctor if you have:
-
liver disease;
-
kidney disease; or
-
if you are on dialysis.
You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.
Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.
FDA pregnancy category C. It is not known whether rufinamide is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Rufinamide can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking rufinamide. Rufinamide may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Rufinamide is not for use in children younger than 4 years old.
How should I take rufinamide?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Your doctor may occasionally change your dose to make sure you get the best results from this medication.
Take rufinamide with food.
Do not stop taking rufinamide without first talking to your doctor, even if you feel better. You may have increased seizures if you stop taking rufinamide suddenly. You will need to use less and less before you stop the medication completely.
Contact your doctor if your seizures get worse or you have them more often while taking rufinamide.
Carry an ID card or wear a medical alert bracelet stating that you have seizures, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.
It is important to use rufinamide regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Store rufinamide at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.
See also: Rufinamide dosage in more detail
What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
Symptoms of a rufinamide overdose are not known.
What should I avoid while taking rufinamide?
Avoid drinking alcohol. It can increase some of the side effects of rufinamide. Rufinamide can cause side effects that may impair your vision or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.
Rufinamide side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; fever; swollen glands; painful sores in or around your eyes or mouth; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, panic, or if you feel hyperactive, talkative, restless, agitated, aggressive, angry, impulsive, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have any of these serious side effects:
-
fever with a skin rash;
-
trouble walking;
-
loss of balance or coordination;
-
swollen glands, pale skin, easy bruising or bleeding;
-
nausea, pain in your upper stomach, jaundice (yellowing of your skin or eyes);
-
severe tingling, numbness, pain, muscle weakness;
-
lower back pain, bloody urine, urinating less than usual; or
-
worsening of seizures.
Less serious side effects may include:
-
dizziness, drowsiness, tired feeling;
-
loss of balance or coordination;
-
vomiting;
-
increased or decreased appetite;
-
stuffy nose, sore throat;
-
headache; or
-
blurred vision.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Rufinamide Dosing Information
Usual Adult Dose for Lennox-Gastaut Syndrome:
Initial dose: 400 to 800 mg/day administered in two equally divided doses.
The dose should be increased by 400 to 800 mg/day every 2 days until a maximum daily dose of 3200 mg/day, administered in two equally divided doses is reached. It is not known whether doses lower than 3200 mg are effective.
Usual Pediatric Dose for Lennox-Gastaut Syndrome:
4 years or older:
Initial dose: daily dose of approximately 10 mg/kg/day administered in two equally divided doses.
The dose should be increased by approximately 10 mg/kg increments every other day to a target dose of 45 mg/kg/day or 3200 mg/day, whichever is less, administered in two equally divided doses. It is not known whether doses lower than the target doses are effective.
What other drugs will affect rufinamide?
Before taking rufinamide, tell your doctor about all other seizure medications you use, especially:
-
carbamazepine (Carbatrol, Tegretol);
-
phenobarbital (Luminal, Solfoton);
-
phenytoin (Dilantin); or
-
valproic acid (Depakene).
This list is not complete and there may be other drugs that can interact with rufinamide. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Where can I get more information?
- Your pharmacist can provide more information about rufinamide.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 1.02. Revision Date: 4/12/2009 4:46:21 PM.
Generic Name: Chlorpheniramine/Phenylephrine/Pyrilamine (klor-fen-IHR-ah-meen/fen-ill-EF-rin/peer-IL-a-meen)
Brand Name: Examples include Poly Hist Forte and Ru-Hist Forte
Ru-Hist Forte Controlled-Release Tablets are used for:
Relieving symptoms of sinus congestion, pressure, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.
Ru-Hist Forte Controlled-Release Tablets are an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, which relieves congestion and pressure.
Do NOT use Ru-Hist Forte Controlled-Release Tablets if:
- you are allergic to any ingredient in Ru-Hist Forte Controlled-Release Tablets
- you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
- you take sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using Ru-Hist Forte Controlled-Release Tablets:
Some medical conditions may interact with Ru-Hist Forte Controlled-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, plan to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a fast, slow, or irregular heartbeat
- if you have a history of asthma; lung problems (eg, emphysema); adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate; seizures; or an overactive thyroid
Some MEDICINES MAY INTERACT with Ru-Hist Forte Controlled-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, monoamine oxidase (MAO)inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Ru-Hist Forte Controlled-Release Tablets may be increased
- Digoxin or droxidopa because risk of irregular heartbeat or heart attack may be increased
- Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Ru-Hist Forte Controlled-Release Tablets
- Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Ru-Hist Forte Controlled-Release Tablets
This may not be a complete list of all interactions that may occur. Ask your health care provider if Ru-Hist Forte Controlled-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Ru-Hist Forte Controlled-Release Tablets:
Use Ru-Hist Forte Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Ru-Hist Forte Controlled-Release Tablets may be taken with or without food.
- Swallow Ru-Hist Forte Controlled-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Ru-Hist Forte Controlled-Release Tablets may be broken in half before they are taken. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand may be broken in half.
- If you miss a dose of Ru-Hist Forte Controlled-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Ru-Hist Forte Controlled-Release Tablets.
Important safety information:
- Ru-Hist Forte Controlled-Release Tablets may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Ru-Hist Forte Controlled-Release Tablets. Using Ru-Hist Forte Controlled-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
- Do not take diet or appetite control medicines while you are taking Ru-Hist Forte Controlled-Release Tablets without checking with your doctor.
- Ru-Hist Forte Controlled-Release Tablets contains phenylephrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains phenylephrine. If it does or if you are uncertain, contact your doctor or pharmacist.
- Do NOT exceed the recommended dose or take Ru-Hist Forte Controlled-Release Tablets for longer than prescribed without checking with your doctor.
- If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.
- Ru-Hist Forte Controlled-Release Tablets may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Ru-Hist Forte Controlled-Release Tablets. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
- If you are scheduled for allergy skin testing, do not take Ru-Hist Forte Controlled-Release Tablets for several days before the test because it may decrease your response to the skin tests.
- Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Ru-Hist Forte Controlled-Release Tablets.
- Use Ru-Hist Forte Controlled-Release Tablets with caution in the ELDERLY because they may be more sensitive to its effects.
- Caution is advised when using Ru-Hist Forte Controlled-Release Tablets in CHILDREN because they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Ru-Hist Forte Controlled-Release Tablets, discuss with your doctor the benefits and risks of using Ru-Hist Forte Controlled-Release Tablets during pregnancy. It is unknown if Ru-Hist Forte Controlled-Release Tablets are excreted in breast milk. Do not breast-feed while taking Ru-Hist Forte Controlled-Release Tablets.
Possible side effects of Ru-Hist Forte Controlled-Release Tablets:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.
Proper storage of Ru-Hist Forte Controlled-Release Tablets:
Store Ru-Hist Forte Controlled-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ru-Hist Forte Controlled-Release Tablets out of the reach of children and away from pets.
General information:
- If you have any questions about Ru-Hist Forte Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
- Ru-Hist Forte Controlled-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Ru-Hist Forte Controlled-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Ru-Tuss Sustained-Release Tablets
30/06/10
Generic Name: Belladonna Alkaloids/Chlorpheniramine/Pseudoephedrine (bell-a-DON-a AL-ka-loids/klor-fen-EER-a-meen/sue-do-eh-FED-rin)
Brand Name: Examples include Respa-AR and Ru-Tuss
Ru-Tuss Sustained-Release Tablets are used for:
Relieving congestion, sneezing, runny nose, and itchy, watery eyes due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.
Ru-Tuss Sustained-Release Tablets are an antihistamine, decongestant, and anticholinergic combination. It works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. It also relieves nasal congestion by shrinking the nasal mucous membranes, which promotes nasal drainage, and dries the chest by decreasing lung secretions.
Do NOT use Ru-Tuss Sustained-Release Tablets if:
- you are allergic to any ingredient in Ru-Tuss Sustained-Release Tablets
- you are pregnant or breast-feeding
- you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days
- you have severe heart blood vessel disease, severe high blood pressure, narrow-angle glaucoma, severe bleeding, severe irritation of the esophagus or other serious problems with the esophagus (eg, esophageal achalasia), peptic ulcer, a blockage of your stomach or bowel, bowel motility problems, severe bowel inflammation (eg, ulcerative colitis), certain muscle problems (eg, myasthenia gravis), or uncontrolled bleeding
- you are unable to urinate or are having an asthma attack
Contact your doctor or health care provider right away if any of these apply to you.
Before using Ru-Tuss Sustained-Release Tablets:
Some medical conditions may interact with Ru-Tuss Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are planning to become pregnant
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of diabetes, an enlarged prostate, bladder or kidney problems, high blood pressure, diarrhea, asthma, nerve problems, heart problems, blood clots, a hiatal hernia, an adrenal gland tumor, glaucoma, breathing problems during sleep, seizures, myasthenia gravis (muscle weakness), or an overactive thyroid
Some MEDICINES MAY INTERACT with Ru-Tuss Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Alpha-blockers (eg, prazosin, guanethidine, methyldopa), beta-blockers (eg, atenolol), diuretics (eg, furosemide, hydrochlorothiazide), furazolidone, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline)
- Alkalizers (eg, calcium or magnesium antacids), anticholinergics (eg, atropine, benztropine, dicyclomine), carbonic anhydrase inhibitors (eg, acetazolamide), ergotamine, or sodium bicarbonate because the side effects of Ru-Tuss Sustained-Release Tablets may be increased
- Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), certain stimulants (eg, doxapram, pseudoephedrine), cocaine, digoxin, droxidopa, potassium chloride, or sodium oxybate (GHB) because side effects may be increased by Ru-Tuss Sustained-Release Tablets
- Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Ru-Tuss Sustained-Release Tablets
This may not be a complete list of all interactions that may occur. Ask your health care provider if Ru-Tuss Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Ru-Tuss Sustained-Release Tablets:
Use Ru-Tuss Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Ru-Tuss Sustained-Release Tablets may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Do not take Ru-Tuss Sustained-Release Tablets at the same time as an antacid, certain medicines for diarrhea (eg, kaolin, pectin, attapulgite, bismuth), or ketoconazole. Take these medicines 2 or 3 hours before or after taking Ru-Tuss Sustained-Release Tablets.
- Swallow whole. Do not crush or chew before swallowing. Some brands of Ru-Tuss Sustained-Release Tablets may be broken in half before they are taken. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand may be broken in half.
- If you miss a dose of Ru-Tuss Sustained-Release Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Ru-Tuss Sustained-Release Tablets.
Important safety information:
- Ru-Tuss Sustained-Release Tablets may cause drowsiness, dizziness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Ru-Tuss Sustained-Release Tablets. Using Ru-Tuss Sustained-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
- If your symptoms do not improve within 7 days or if you develop a high fever or persistent headache, check with your doctor.
- Ru-Tuss Sustained-Release Tablets may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.
- Ru-Tuss Sustained-Release Tablets may cause your eyes to become sensitive to sunlight. Wearing sunglasses may help.
- Ru-Tuss Sustained-Release Tablets may reduce sweating. Do not become overheated in hot weather or during exercise or other activities; heatstroke may occur.
- Do not take diet or appetite control medicines while you are taking Ru-Tuss Sustained-Release Tablets without checking with your doctor.
- Ru-Tuss Sustained-Release Tablets contains pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.
- If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take Ru-Tuss Sustained-Release Tablets.
- Ru-Tuss Sustained-Release Tablets may interfere with certain lab test results. Be sure your doctors and lab personnel know that you are taking Ru-Tuss Sustained-Release Tablets.
- Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Ru-Tuss Sustained-Release Tablets.
- Diabetes patients – Ru-Tuss Sustained-Release Tablets may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
- Caution is advised when using Ru-Tuss Sustained-Release Tablets the ELDERLY because they may be more sensitive to its effects.
- Caution is advised when using Ru-Tuss Sustained-Release Tablets in CHILDREN because they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: It is unknown if Ru-Tuss Sustained-Release Tablets can cause harm to the fetus. If you become pregnant while taking Ru-Tuss Sustained-Release Tablets, discuss with your doctor the benefits and risks of using Ru-Tuss Sustained-Release Tablets during pregnancy. Ru-Tuss Sustained-Release Tablets are excreted in breast milk. Do not breast-feed while taking Ru-Tuss Sustained-Release Tablets.
Possible side effects of Ru-Tuss Sustained-Release Tablets:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mental or mood changes; seizures; severe dizziness, lightheadedness, or headache; tremor; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include deep sleep or loss of consciousness; hot or cool skin; irregular heartbeat; irritability, anxiety, or panic; large pupils; numbness or tingling in the arms or legs; seizures; slowed or shallow breathing.
Proper storage of Ru-Tuss Sustained-Release Tablets:
Store Ru-Tuss Sustained-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ru-Tuss Sustained-Release Tablets out of the reach of children and away from pets.
General information:
- If you have any questions about Ru-Tuss Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
- Ru-Tuss Sustained-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Ru-Tuss Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Ru-Tuss Jr.
30/06/10
Generic Name: guaifenesin and pseudoephedrine (gwye FEN e sin, soo doe e FED rin)
Brand Names: Altarussin PE, Ambifed, Biotuss PE, D-Feda II, Despec-SR, Dynex, ExeFen, Guiatex II SR, Maxifed, Maxifed-G, Medent LD, Medent-LDI, Mucinex D, Nasabid SR, Nasatab LA, Nomuc-PE, Poly-Vent IR, Poly-Vent, Jr., Pseudatex, Pseudo GG, Pseudo GG TR, Pseudo Max, Q-Tussin PE, Respaire-120 SR, Robitussin Severe Congestion, Ru-Tuss Jr., Sudafed Non Drying Sinus, SudaTex-G, Touro LA-LD, Triaminic Softchews Chest Congestion, We Mist II LA, We Mist LA
What is Ru-Tuss Jr. (guaifenesin and pseudoephedrine)?
Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of guaifenesin and pseudoephedrine is used to treat nasal and sinus congestion, and to reduce chest congestion caused by the common cold, infections, or allergies.
Guaifenesin and pseudoephedrine may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about Ru-Tuss Jr. (guaifenesin and pseudoephedrine)?
Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains a decongestant or expectorant.
What should I discuss with my healthcare provider before taking Ru-Tuss Jr. (guaifenesin and pseudoephedrine)?
Do not use this medication if you are allergic to guaifenesin or pseudoephedrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.
Before taking guaifenesin and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:
-
heart disease or high blood pressure;
-
diabetes; or
-
a thyroid disorder.
If you have any of these conditions, you may not be able to use this medication, or you may need a dosage adjustment or special tests during treatment.
This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.
How should I take Ru-Tuss Jr. (guaifenesin and pseudoephedrine)?
Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.
Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Do not crush, chew, break, or open a controlled-release, delayed-release, or extended-release tablet or capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.
Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Take guaifenesin and pseudoephedrine with food if it upsets your stomach. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.
If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.
Store this medicine at room temperature, away from heat, light, and moisture.
What happens if I miss a dose?
Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, dizziness, and feeling restless or nervous.
What should I avoid while taking Ru-Tuss Jr. (guaifenesin and pseudoephedrine)?
This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol while you are taking this medicine.
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.
Do not use any other over-the-counter cold, allergy, or cough medicine without first asking your doctor or pharmacist. Guaifenesin and pseudoephedrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains guaifenesin or pseudoephedrine.
Ru-Tuss Jr. (guaifenesin and pseudoephedrine) side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medication and call your doctor at once if you have any of these serious side effects:
-
fast, pounding, or uneven heartbeat;
-
severe dizziness, anxiety, restless feeling, or nervousness;
-
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
-
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).
Keep taking guaifenesin and pseudoephedrine and talk to your doctor if you have any of these less serious side effects:
-
dizziness or headache;
-
feeling excited or restless;
-
sleep problems (insomnia);
-
nausea, vomiting, or stomach upset;
-
mild loss of appetite;
-
warmth, tingling, or redness under your skin; or
-
skin rash or itching.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Ru-Tuss Jr. (guaifenesin and pseudoephedrine)?
Before taking guaifenesin and pseudoephedrine, tell your doctor if you are using any of the following drugs:
-
methyldopa (Aldomet);
-
medicines to treat high blood pressure;
-
a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or
-
antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.
This is not a complete list and there may be other drugs that can affect guaifenesin and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Where can I get more information?
- Your pharmacist can provide more information about guaifenesin and pseudoephedrine.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 8.02. Revision Date: 4/12/2009 4:40:58 PM.
roo-BELL-a VYE-rus VAX-een, lyve, mumps VYE-rus VAX-een, lyve
Available Dosage Forms:
- Powder for Solution
Therapeutic Class: Vaccine
Uses For rubella and mumps virus vaccine live
Rubella and mumps virus vaccine live is an active immunizing agent used to prevent infection by the rubella and mumps viruses. It works by causing your body to produce its own protection (antibodies) against the virus.
Rubella (also known as German measles) is a serious infection that causes miscarriages, stillbirths, or birth defects in unborn babies when pregnant women get the disease.
Mumps is an infection that can cause serious problems, such as encephalitis and meningitis, which affect the brain. In addition, adolescent boys and men are very susceptible to a condition called orchitis, which causes pain and swelling in the testicles and scrotum and, in rare cases, sterility. Also, mumps infection can cause spontaneous abortion in women during the first 3 months of pregnancy.
While immunization against rubella and mumps is recommended for all persons 12 months of age and older, it is especially important for women of childbearing age and persons traveling outside the U.S.
If rubella and mumps virus vaccine live is to be given to a child, the child should be at least 12 months of age. This is to make sure the vaccine is effective. In a child less than 12 months of age, antibodies from the mother may prevent the vaccine from working.
This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.
Before Using rubella and mumps virus vaccine live
In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to rubella and mumps virus vaccine live or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Use of this vaccine is not recommended for infants younger than 12 months of age. Children who received the vaccine when younger than 12 months of age should receive another dose of vaccine at 12 to 15 months of age.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
Breast Feeding
Mumps Virus Vaccine, Live
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Rubella Virus Vaccine, Live
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aclarubicin
- Adalimumab
- Aldesleukin
- Alemtuzumab
- Altretamine
- Amonafide
- Amsacrine
- Asparaginase
- Azacitidine
- Azathioprine
- Bleomycin
- Broxuridine
- Busulfan
- Capecitabine
- Carboplatin
- Carmustine
- Certolizumab Pegol
- Chlorambucil
- Cisplatin
- Cladribine
- Cyclophosphamide
- Cytarabine
- Cytarabine Liposome
- Dacarbazine
- Dactinomycin
- Daunorubicin
- Daunorubicin Citrate Liposome
- Decitabine
- Docetaxel
- Doxifluridine
- Doxorubicin Hydrochloride
- Doxorubicin Hydrochloride Liposome
- Edatrexate
- Eflornithine
- Epirubicin
- Estramustine
- Etanercept
- Etoposide
- Floxuridine
- Fludarabine
- Fluorouracil
- Fotemustine
- Gallium Nitrate
- Gemcitabine
- Golimumab
- Hydroxyurea
- Idarubicin
- Ifosfamide
- Irinotecan
- Lomustine
- Mechlorethamine
- Melphalan
- Mercaptopurine
- Methotrexate
- Mitolactol
- Mitomycin
- Mitotane
- Mitoxantrone
- Mycophenolic Acid
- Oxaliplatin
- Paclitaxel
- Pegaspargase
- Pentostatin
- Pipobroman
- Pirarubicin
- Plicamycin
- Procarbazine
- Raltitrexed
- Rilonacept
- Rituximab
- Sirolimus
- Streptozocin
- Tacrolimus
- Teceleukin
- Tegafur
- Temsirolimus
- Teniposide
- Thioguanine
- Thiotepa
- Topotecan
- Treosulfan
- Trimetrexate
- Trofosfamide
- Uracil Mustard
- Vinblastine
- Vincristine
- Vincristine Liposome
- Vindesine
- Vinorelbine
Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abatacept
- Leflunomide
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:
- Immune deficiency condition (or family history of)—Condition may increase the chance and severity of side effects of the vaccine and/or may decrease the useful effects of the vaccine
- Severe illness with fever—The symptoms of the condition may be confused with the possible side effects of the vaccine
Proper Use of rubella and mumps virus vaccine live
Dosing
The dose of rubella and mumps virus vaccine live will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of rubella and mumps virus vaccine live. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form:
- For prevention of rubella and mumps:
- Adults and children 12 months of age and older—One dose injected under the skin.
- Children up to 12 months of age—Use is not recommended.
- For prevention of rubella and mumps:
Precautions While Using rubella and mumps virus vaccine live
Do not become pregnant for 3 months after receiving rubella and mumps virus vaccine live without first checking with your doctor . There may be a chance that this vaccine can cause birth defects.
Tell your doctor that you have received this vaccine:
- If you are to receive blood products or immune globulins within 14 days of receiving this vaccine
- If you are to receive this vaccine within 3 months of receiving blood products or immune globulin
- If you are to receive a tuberculin skin test within 4 to 6 weeks after receiving this vaccine. The results of the test may be affected by this vaccine.
rubella and mumps virus vaccine live Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Symptoms of allergic reaction – rare
- Difficulty in breathing or swallowing
- hives
- itching, especially of feet or hands
- reddening of skin, especially around ears
- swelling of eyes, face, or inside of nose
- unusual tiredness or weakness (sudden and severe)
Check with your doctor as soon as possible if any of the following side effects occur:
Less common
- Pain or tenderness of eyes
Rare
- Bruising or purple spots on skin
- confusion
- fever over 103 °F (39.4 °C)
- headache (severe or continuing)
- irritability
- pain, numbness, or tingling of hands, arms, legs, or feet
- pain, tenderness, or swelling in testicles and scrotum
- stiff neck
- vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Burning or stinging at place of injection
- skin rash
- swelling of glands in neck
Less common
- Aches or pain in joints
- headache (mild)
- itching, swelling, redness, tenderness, or hard lump at place of injection
- nausea
- runny nose
- sore throat
- vague feeling of bodily discomfort
The above side effects (especially aches or pain in joints) are more likely to occur in adults, particularly women.
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
rubella virus vaccine
30/06/10
Generic Name: rubella virus vaccine (roo BEL a VYE rus vax EEN)
Brand Names: Meruvax II
What is rubella virus vaccine?
Rubella is a serious disease caused by a virus. It is spread from person to person through the air.
Rubella virus (also called German Measles) causes skin rash, fever, swollen glands, and joint pain. Becoming infected with rubella during pregnancy can result in a miscarriage or serious birth defects.
The rubella virus vaccine is used to help prevent this disease in adults and children who are at least 12 months old.
This vaccine works by exposing you to a small dose of the virus or a protein from the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.
Rubella virus vaccine is for use in children between the ages of 12 months and 6 years old, and in adults who have never received the vaccine or had the diseases.
Although immunization against rubella virus is available in a single vaccine, it may be best for you to receive a combination measles, mumps, and rubella (MMR) vaccine. Follow your doctor’s instructions.
Like any vaccine, the rubella virus vaccine may not provide protection from disease in every person.
What is the most important information I should know about this vaccine?
Although immunization against rubella virus is available in a single vaccine, it may be best for you to receive a combination measles, mumps, and rubella (MMR) vaccine. Follow your doctor’s instructions. You should not receive a rubella virus vaccine if you are pregnant. Wait until after your child is born to receive the vaccine. Avoid becoming pregnant for at least 3 months after receiving a rubella virus vaccine.
The first rubella virus vaccine is usually given to a child who is 12 to 15 month old. The booster shots are then given between 4 and 6 years of age. A measles, mumps, and rubella (MMR) vaccine should then be given before the child starts elementary school.
Adults born after 1956 should receive at least one measles, mumps, and rubella vaccination if they have never had the diseases or received an MMR vaccine during their lifetime.
Your individual booster schedule may be different from these guidelines. Follow your doctor’s instructions or the schedule recommended by the health department of the state you live in.
Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.
You can still receive a vaccine if you have a minor cold or low fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.
You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Becoming infected with rubella is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
What should I discuss with my healthcare provider before receiving this vaccine?
You should not receive this vaccine if you are allergic to:
-
gelatin;
-
neomycin (Mycifradin, Neo-Fradin, Neo-Tab); or
-
if you have ever had a life-threatening allergic reaction to any vaccine containing rubella.
You should also not receive this vaccine if you have:
-
a blood cell disorder such as anemia;
-
blood or bone marrow cancer such as leukemia, lymphoma, and others;
-
severe active immune suppression caused by disease (such as cancer, HIV, or AIDS), or by receiving chemotherapy or radiation; or
-
if you are pregnant.
Before receiving this vaccine, tell the doctor if you have:
-
thrombocytopenia purpura (easy bruising or bleeding);
-
active or untreated tuberculosis infection;
-
a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or
-
if you have received an immune globulin or other blood product within the past 3 months.
You can still receive a vaccine if you have a minor cold or low fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.
You should not receive a rubella virus vaccine if you are pregnant. Wait until after your child is born to receive the vaccine. Avoid becoming pregnant for at least 3 months after receiving a rubella virus vaccine. Do not receive this vaccine while you are breast-feeding a baby. Small amounts of the rubella virus contained in the vaccine can pass into breast milk and could harm a nursing baby.
Rubella virus vaccine contains albumin (part of the blood) and it may contain viruses and other infectious agents that can cause disease. Although donated human blood is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of receiving this vaccine.
How is this vaccine given?
This vaccine is given as an injection (shot) under your skin. You will receive this injection in a doctor’s office or other clinic setting.
Rubella virus vaccine is recommended for people in the following situations:
-
healthcare workers;
-
college students;
-
military personnel;
-
travelers on cruise ships or to destinations outside the U.S.;
-
a woman who is susceptible to rubella and has just had a baby; and
-
a child who has never been vaccinated against rubella and is in contact with a pregnant woman.
Adults born after 1956 should receive at least one measles, mumps, and rubella (MMR) vaccination if they have never had the diseases or received an MMR vaccine during their lifetime.
The first rubella virus vaccine is usually given to a child who is 12 to 15 month old. The booster shots are then given between 4 and 6 years of age. A measles, mumps, and rubella (MMR) vaccine should then be given before the child starts elementary school.
Your doctor may want you to receive an immune globulin (IG) injection within 3 months after you receive the rubella virus vaccine. Your individual booster schedule may be different from these guidelines. Follow your doctor’s instructions or the schedule recommended by the health department of the state you live in.
Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor’s instructions about how much of this medicine to take.
It is especially important to prevent fever from occurring if you have a seizure disorder such as epilepsy.
This vaccine can cause false results on a skin test for tuberculosis. Tell any doctor who tests you if you have received a rubella virus vaccine within the past 4 to 6 weeks.
What happens if I miss a dose?
Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.
Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.
What happens if I overdose?
An overdose of this vaccine is unlikely to occur.
What should I avoid before or after receiving this vaccine?
An immune globulin (IG) injection should not be given at the same time as the rubella virus vaccine.
Rubella virus vaccines side effects
You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Becoming infected with measles, mumps, or rubella is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
-
high fever (within a few hours or a few days after the vaccine);
-
swollen glands;
-
easy bruising or bleeding, unusual weakness;
-
joint swelling or stiffness that continues for several weeks after vaccination;
-
weakness, severe lower back pain, numbness or tingly feeling in your feet and spreading upward;
-
problems with hearing, vision, speech, swallowing, or bladder and bowel functions;
-
slow heart rate, trouble breathing, feeling like you might pass out;
-
seizure (black-out or convulsions); or
-
severe blistering, peeling, and red skin rash.
Less serious side effects include:
-
low fever, sore throat, cough, runny nose;
-
headache, dizziness, feeling tired or irritable;
-
nausea, vomiting, diarrhea;
-
joint or muscle pain;
-
numbness or tingly feeling; or
-
redness, pain, swelling, or a lump where the shot was given.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.
Rubella virus vaccine Dosing Information
Usual Adult Dose for Rubella Prophylaxis:
0.5 mL subcutaneously into the outer aspect of the upper arm.
Usual Pediatric Dose for Rubella Prophylaxis:
>= 1 year: 0.5 mL subcutaneously into the outer aspect of the upper arm. Primary vaccination is recommended at age 12 to 15 months.
Revaccination with measles/mumps/rubella vaccine is recommended before entry into elementary school.
What other drugs will affect rubella virus vaccine?
Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.
Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:
-
an oral, nasal, inhaled, or injectable steroid medicine;
-
medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or
-
medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).
If you are using any of these medications, you may not be able to receive the vaccine, or may need to wait until the other treatments are finished.
There may be other drugs that can affect this vaccine. Tell your doctor about all the prescription and over-the-counter medications you have received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Where can I get more information?
- Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.
- Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 2.01. Revision Date: 11/19/2009 9:54:07 AM.
Rozex
30/06/10
Generic Name: metronidazole (Topical route)
met-roe-NYE-da-zole
Metronidazole has been shown to be carcinogenic in mice and rats. Unnecessary use of the drug should be avoided .
Metronidazole has been shown to be carcinogenic in mice and rats. Unnecessary use of the drug should be avoided .
Intravenous routeSolution
Metronidazole has been shown to be carcinogenic in mice and rats. Its use, therefore, should be reserved conditions that it is approved for .
Metronidazole has been shown to be carcinogenic in mice and rats. Its use, therefore, should be reserved for conditions that it is approved for .
Commonly used brand name(s):
In the U.S.
- Metrocream
- Metrogel
- Metrolotion
- Noritate
- Rozex
- Vitazol
Available Dosage Forms:
- Cream
- Lotion
- Gel/Jelly
- Emulsion
Therapeutic Class: Antiacne Antibacterial
Chemical Class: Nitroimidazole
Uses For Rozex
Topical metronidazole is applied to the skin in adults to help control rosacea , also known as acne rosacea and “adult acne.” This medicine helps to reduce the redness of the skin and the number of pimples, usually found on the face, in patients with rosacea.
Topical metronidazole is available only with your doctor’s prescription.
Before Using Rozex
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Rosacea is usually considered an adult disease. Therefore, topical metronidazole is not generally used in children.
Geriatric
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of topical metronidazole in the elderly with use in other age groups.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Blood disease or a history of blood disease—Metronidazole may make the condition worse
Proper Use of metronidazole
This section provides information on the proper use of a number of products that contain metronidazole. It may not be specific to Rozex. Please read with care.
Do not use this medicine in or near the eyes. Watering of the eyes may occur when the medicine is used too close to the eyes.
If this medicine does get into your eyes, wash them out immediately, but carefully, with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.
Before applying this medicine, thoroughly wash the affected area(s) with a mild, nonirritating cleanser, rinse well, and gently pat dry.
To use:
- After washing the affected area(s), apply this medicine with your fingertips.
- Apply and rub in a thin film of medicine, using enough to cover the affected area(s) lightly. You should apply the medicine to the whole area usually affected by rosacea, not just to the pimples themselves .
- Wash the medicine off your hands.
To help keep your rosacea under control, keep using this medicine for the full time of treatment. You may have to continue using this medicine every day for 9 weeks or longer. Do not miss any doses.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For topical dosage forms (cream, gel, and lotion):
- For rosacea:
- Adults—Apply to the affected area(s) of skin two times a day, morning and evening, for nine weeks.
- Children—Use and dose must be determined by your doctor.
- For rosacea:
Missed Dose
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Precautions While Using Rozex
If your rosacea does not improve within 3 weeks, or if it becomes worse, check with your doctor. However, treatment of rosacea may take up to 9 weeks or longer before you see full improvement.
Stinging or burning of the skin may be expected after this medicine is applied. These effects may last up to a few minutes or more. If irritation continues, check with your doctor. You may have to use the medicine less often or stop using it altogether. Follow your doctor’s directions.
You may continue to use cosmetics (make-up) while you are using this medicine for rosacea. However, it is best to use only “oil-free” cosmetics. Also, it is best not to use cosmetics too heavily or too often. They may make your rosacea worse. If you have any questions about this, check with your doctor.
Rozex Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Dry skin
- redness or other signs of skin irritation not present before use of this medicine
- stinging or burning of the skin
- watering of eyes
Rare
- Metallic taste in the mouth
- nausea
- tingling or numbness of arms, legs, hands, or feet
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.