Azulfidine Entabs
29/06/10
Generic Name: sulfasalazine (Oral route, Rectal route)
sul-fa-SAL-a-zeen
Commonly used brand name(s):
In the U.S.
- Azulfidine
- Azulfidine Entabs
- Sulfazine
- Sulfazine EC
In Canada
- Alti-Sulfasalazine
- Salazopyrin
Available Dosage Forms:
- Suppository
- Enema
- Tablet
- Tablet, Enteric Coated
Therapeutic Class: Gastrointestinal Agent
Chemical Class: Sulfonamide
Uses For Azulfidine Entabs
Sulfasalazine , a sulfa medicine, is used to prevent and treat inflammatory bowel disease, such as ulcerative colitis. It works inside the bowel by helping to reduce the inflammation and other symptoms of the disease. Sulfasalazine is sometimes given with other medicines to treat inflammatory bowel disease.
Sulfasalazine is also used to treat rheumatoid arthritis in patients who have not been helped by or who cannot tolerate other medicines for rheumatoid arthritis.
Sulfasalazine is available only with your doctor’s prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, sulfasalazine is used in certain patients with the following medical conditions:
- Ankylosing spondylitis
Before Using Azulfidine Entabs
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
Sulfasalazine should not be used in children up to 2 years of age because it may cause brain problems. However, sulfasalazine has not been shown to cause different side effects or problems in children over the age of 2 years than it does in adults.
Geriatric
This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | B | Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. |
Breast Feeding
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
Using this medicine 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.
- Riluzole
Using this medicine 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.
- Cyclosporine
- Digoxin
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:
- Allergies, severe or
- Asthma, bronchial—The risk of an allergic reaction to sulfasalazine may be increased
- Blood problems or
- Glucose-6-phosphate dehydrogenase deficiency (lack of G6PD enzyme)—Patients with these problems may have an increase in side effects affecting the blood
- Intestinal blockage—Sulfasalazine will not reach the site of action in the bowel
- Kidney disease or
- Liver disease—Patients with kidney disease or liver disease may have an increased chance of side effects
- Porphyria—Use of sulfasalazine may cause an attack of porphyria
- Urinary blockage—Sulfasalazine may not be eliminated properly, causing an increased risk of side effects
Proper Use of sulfasalazine
This section provides information on the proper use of a number of products that contain sulfasalazine. It may not be specific to Azulfidine Entabs. Please read with care.
Do not give sulfasalazine to infants and children up to 2 years of age, unless otherwise directed by your doctor. It may cause brain problems.
Sulfasalazine is best taken right after meals or with food to lessen stomach upset. If stomach upset continues or is bothersome, check with your doctor.
Each dose of sulfasalazine should also be taken with a full glass (8 ounces) of water. Several additional glasses of water should be taken every day, unless otherwise directed by your doctor. Drinking extra water will help to prevent some unwanted effects of the sulfa medicine.
For patients taking the enteric-coated tablet form of this medicine:
- Swallow tablets whole. Do not break or crush.
Keep taking this medicine for the full time of treatment , even if you begin to feel better after a few days. 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 prevention or treatment of inflammatory bowel disease:
- For oral dosage forms (tablets, enteric-coated tablets):
- Adults and teenagers—To start, 500 milligrams (mg) to 1000 mg (1 gram) every six to eight hours. Your doctor may then decrease the dose to 500 mg every six hours. Later, your doctor may change your dose as needed.
- Children 2 years of age and over—Dose is based on body weight and must be determined by your doctor.
- To start, the dose is usually:
- 6.7 to 10 mg per kilogram (kg) (3.05 to 4.55 mg per pound) of body weight every four hours or
- 10 to 15 mg per kg (4.55 to 6.82 mg per pound) of body weight every six hours or
- 13.3 to 20 mg per kg (6.05 to 9.09 mg per pound) of body weight every eight hours.
- Then, the dose is usually 7.5 mg per kg (3.41 mg per pound) of body weight every six hours.
- To start, the dose is usually:
- Infants and children up to 2 years of age—Use is not recommended.
- For rectal dosage form (enema):
- Adults and teenagers—3 grams (1 unit), used rectally as directed, every night.
- Children 2 years of age and over—Dose must be determined by your doctor.
- Infants and children up to 2 years of age—Use is not recommended.
- For oral dosage forms (tablets, enteric-coated tablets):
- For treatment of rheumatoid arthritis:
- For oral dosage forms (tablets, enteric-coated tablets):
- Adults and teenagers—To start, 500 mg to 1000 mg (1 gram) daily. Your doctor may increase your dose as needed, but the dose is generally not more than 3000 mg (3 grams) a day.
- For children ages 6 and over—30 to 50 mg per kg of body weight daily, divided into two doses. The medicine is usually started at a lower amount and gradually increased to the actual amount over a month. Typically the amount that is needed does not exceed 2 grams per day. The dose must be determined by your doctor.
- Infants and children up to 2 years of age—Use is not recommended.
- For oral dosage forms (tablets, enteric-coated tablets):
Missed Dose
If you miss a dose of this medicine, take 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. Do not double doses.
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 Azulfidine Entabs
It is very important that your doctor check your progress at regular visits. This medicine may cause blood problems, especially if it is taken for a long time.
If your symptoms (including diarrhea) do not improve within 1 or 2 months, or if they become worse, check with your doctor.
Sulfasalazine may cause blood problems. These problems may result in a greater chance of certain infections, slow healing, and bleeding of the gums. Therefore, you should be careful when using regular toothbrushes, dental floss, and toothpicks. Dental work should be delayed until your blood counts have returned to normal. Check with your medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment.
Sulfasalazine may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:
- Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
- Wear protective clothing, including a hat. Also, wear sunglasses.
- Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
- Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
- Do not use a sunlamp or tanning bed or booth.
If you have a severe reaction from the sun, check with your doctor.
This medicine may also cause some people to become dizzy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy. If this reaction is especially bothersome, check with your doctor.
Before you have any medical tests, tell the doctor in charge that you are taking this medicine. The results of the bentiromide (e.g., Chymex) test for pancreas function are affected by this medicine.
Azulfidine Entabs 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:
More common
- Aching of joints
- fever
- headache (continuing)
- itching
- skin rash
- vomiting
Less common or rare
- Aching of joints and muscles
- back, leg, or stomach pains
- bloody diarrhea
- bluish fingernails, lips, or skin
- chest pain
- cough
- difficult breathing
- difficulty in swallowing
- chills, or sore throat
- general feeling of discomfort or illness
- loss of appetite
- pale skin
- redness, blistering, peeling, or loosening of skin
- unusual bleeding or bruising
- unusual tiredness or weakness
- yellow eyes or skin
Check with your doctor as soon as possible if any of the following side effects occur:
More common
- Increased sensitivity of skin to sunlight
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
- Abdominal or stomach pain or upset
- diarrhea
- loss of appetite
- nausea
In some patients this medicine may also cause the urine or skin to become orange-yellow. This side effect does not need medical attention.
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.
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Azulfidine Tablets
29/06/10
Generic Name: sulfasalazine
Dosage Form: tablet
Azulfidine®
sulfasalazine tablets, USP
Azulfidine Tablets Description
Azulfidine Tablets contain sulfasalazine, 500 mg, for oral administration.
Therapeutic Classification: Anti-inflammatory agent.
Chemical Designation: 5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid.
Chemical Structure:

Molecular Formula: C18H14N4O5S
Azulfidine Tablets – Clinical Pharmacology
Pharmacodynamics
The mode of action of sulfasalazine (SSZ) or its metabolites, 5-aminosalicylic acid (5-ASA) and sulfapyridine (SP), is still under investigation, but may be related to the anti-inflammatory and/or immunomodulatory properties that have been observed in animal and in vitro models, to its affinity for connective tissue, and/or to the relatively high concentration it reaches in serous fluids, the liver and intestinal walls, as demonstrated in autoradiographic studies in animals. In ulcerative colitis, clinical studies utilizing rectal administration of SSZ, SP, and 5-ASA have indicated that the major therapeutic action may reside in the 5-ASA moiety.
Pharmacokinetics
In vivo studies have indicated that the absolute bioavailability of orally administered SSZ is less than 15% for parent drug. In the intestine, SSZ is metabolized by intestinal bacteria to SP and 5-ASA. Of the two species, SP is relatively well absorbed from the intestine and highly metabolized, while 5-ASA is much less well absorbed.
Following oral administration of 1 g of SSZ to 9 healthy males, less than 15% of a dose of SSZ is absorbed as parent drug. Detectable serum concentrations of SSZ have been found in healthy subjects within 90 minutes after the ingestion. Maximum concentrations of SSZ occur between 3 and 12 hours post-ingestion, with the mean peak concentration (6 µg/mL) occurring at 6 hours.
In comparison, peak plasma levels of both SP and 5-ASA occur approximately 10 hours after dosing. This longer time to peak is indicative of gastrointestinal transit to the lower intestine where bacteria mediated metabolism occurs. SP apparently is well absorbed from the colon with an estimated bioavailability of 60%. In this same study, 5-ASA is much less well absorbed from the gastrointestinal tract with an estimated bioavailability of from 10 to 30%.
Following intravenous injection, the calculated volume of distribution (Vdss) for SSZ was 7.5 ± 1.6 L. SSZ is highly bound to albumin (>99.3%) while SP is only about 70% bound to albumin. Acetylsulfapyridine (AcSP), the principal metabolite of SP, is approximately 90% bound to plasma proteins.
As mentioned above, SSZ is metabolized by intestinal bacteria to SP and 5-ASA. Approximately 15% of a dose of SSZ is absorbed as parent and is metabolized to some extent in the liver to the same two species. The observed plasma half-life for intravenous sulfasalazine is 7.6 ± 3.4 hours. The primary route of metabolism of SP is via acetylation to form AcSP. The rate of metabolism of SP to AcSP is dependent upon acetylator phenotype. In fast acetylators, the mean plasma half-life of SP is 10.4 hours while in slow acetylators, it is 14.8 hours. SP can also be metabolized to 5-hydroxy-sulfapyridine (SPOH) and N-acetyl-5-hydroxy-sulfapyridine. 5-ASA is primarily metabolized in both the liver and intestine to N-acetyl-5-aminosalicylic acid via a non-acetylation phenotype dependent route. Due to low plasma levels produced by 5-ASA after oral administration, reliable estimates of plasma half-life are not possible.
Absorbed SP and 5-ASA and their metabolites are primarily eliminated in the urine either as free metabolites or as glucuronide conjugates. The majority of 5-ASA stays within the colonic lumen and is excreted as 5-ASA and acetyl-5-ASA with the feces. The calculated clearance of SSZ following intravenous administration was 1 L/hr. Renal clearance was estimated to account for 37% of total clearance.
Special Populations
Elderly patients with rheumatoid arthritis showed a prolonged plasma half-life for SSZ, SP, and their metabolites. The clinical impact of this is unknown.
Small studies have been reported in the literature in children down to the age of 4 years with ulcerative colitis and inflammatory bowel disease. In these populations, relative to adults, the pharmacokinetics of SSZ and SP correlated poorly with either age or dose.
The metabolism of SP to AcSP is mediated by polymorphic enzymes such that two distinct populations of slow and fast metabolizers exist. Approximately 60% of the Caucasian population can be classified as belonging to the slow acetylator phenotype. These subjects will display a prolonged plasma half-life for SP (14.8 hours vs 10.4 hours) and an accumulation of higher plasma levels of SP than fast acetylators. The clinical implication of this is unclear; however, in a small pharmacokinetic trial where acetylator status was determined, subjects who were slow acetylators of SP showed a higher incidence of adverse events.
Gender appears not to have an effect on either the rate or the pattern of metabolites of SSZ, SP, or 5-ASA.
Indications and Usage for Azulfidine Tablets
Azulfidine Tablets are indicated:
- a)
- in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and
- b)
- for the prolongation of the remission period between acute attacks of ulcerative colitis.
Contraindications
Azulfidine Tablets are contraindicated in:
- Patients with intestinal or urinary obstruction,
- Patients with porphyria as sulfonamides have been reported to precipitate an acute attack,
- Patients hypersensitive to sulfasalazine, its metabolites, sulfonamides, or salicylates.
Warnings
Only after critical appraisal should Azulfidine Tablets be given to patients with hepatic or renal damage or blood dyscrasias. Deaths associated with the administration of sulfasalazine have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia, other blood dyscrasias, renal and liver damage, irreversible neuromuscular and central nervous system changes, and fibrosing alveolitis. The presence of clinical signs such as sore throat, fever, pallor, purpura, or jaundice may be indications of serious blood disorders or hepatotoxicity. Complete blood counts, as well as urinalysis with careful microscopic examination, should be done frequently in patients receiving AZULFIDINE (see PRECAUTIONS, Laboratory Tests). Discontinue treatment with sulfasalazine while awaiting the results of blood tests. Oligospermia and infertility have been observed in men treated with sulfasalazine; however, withdrawal of the drug appears to reverse these effects.
Precautions
General
Azulfidine Tablets should be given with caution to patients with severe allergy or bronchial asthma. Adequate fluid intake must be maintained in order to prevent crystalluria and stone formation. Patients with glucose-6 phosphate dehydrogenase deficiency should be observed closely for signs of hemolytic anemia. This reaction is frequently dose related. If toxic or hypersensitivity reactions occur, the drug should be discontinued immediately.
Information for Patients
Patients should be informed of the possibility of adverse reactions and of the need for careful medical supervision. The occurrence of sore throat, fever, pallor, purpura, or jaundice may indicate a serious blood disorder. Should any of these occur, the patient should seek medical advice. They should also be made aware that ulcerative colitis rarely remits completely, and that the risk of relapse can be reduced by continued administration of AZULFIDINE at a maintenance dosage. Patients should be instructed to take AZULFIDINE in evenly divided doses preferably after meals. Additionally, patients should be advised that sulfasalazine may produce an orange-yellow discoloration of the urine or skin.
Laboratory Tests
Complete blood counts, including differential white cell count and liver function tests, should be performed before starting AZULFIDINE and every second week during the first three months of therapy. During the second three months, the same tests should be done once monthly and thereafter once every three months, and as clinically indicated. Urinalysis and an assessment of renal function should also be done periodically during treatment with AZULFIDINE.
The determination of serum sulfapyridine levels may be useful since concentrations greater than 50 µg/mL appear to be associated with an increased incidence of adverse reactions.
Drug Interactions
Reduced absorption of folic acid and digoxin have been reported when those agents were administered concomitantly with sulfasalazine.
Drug/Laboratory Test Interactions
The presence of sulfasalazine or its metabolites in body fluids has not been reported to interfere with laboratory test procedures.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Two-year oral carcinogenicity studies were conducted in male and female F344/N rats and B6C3F1 mice. Sulfasalazine was tested at 84 (496 mg/m2), 168 (991 mg/m2), and 337.5 (1991 mg/m2) mg/kg/day doses in rats. A statistically significant increase in the incidence of urinary bladder transitional cell papillomas was observed in male rats. In female rats, two (4%) of the 337.5 mg/kg rats had transitional cell papilloma of the kidney. The increased incidence of neoplasms in the urinary bladder and kidney of rats was also associated with an increase in the renal calculi formation and hyperplasia of transitional cell epithelium. For the mouse study, sulfasalazine was tested at 675 (2025 mg/m2), 1350 (4050 mg/m2), and 2700 (8100 mg/m2) mg/kg/day. The incidence of hepatocellular adenoma or carcinoma in male and female mice was significantly greater than the control at all doses tested.
Sulfasalazine did not show mutagenicity in the bacterial reverse mutation assay (Ames test) and in L51784 mouse lymphoma cell assay at the HGPRT gene. However, sulfasalazine showed equivocal mutagenic response in the micronucleus assay of mouse and rat bone marrow and mouse peripheral RBC and in the sister chromatid exchange, chromosomal aberration, and micronucleus assays in lymphocytes obtained from humans.
Impairment of male fertility was observed in reproductive studies performed in rats at a dose of 800 mg/kg/day (4800 mg/m2). Oligospermia and infertility have been described in men treated with sulfasalazine. Withdrawal of the drug appears to reverse these effects.
Pregnancy
Pregnancy Category B
Reproduction studies have been performed in rats and rabbits at doses up to 6 times the human dose and have revealed no evidence of impaired female fertility or harm to the fetus due to sulfasalazine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
A national survey evaluated the outcome of pregnancies associated with inflammatory bowel disease (IBD). In a group of 186 women treated with sulfasalazine alone or sulfasalazine and concomitant steroid therapy, the incidence of fetal morbidity and mortality was comparable to that for 245 untreated IBD pregnancies as well as to pregnancies in the general population.1 A study of 1,455 pregnancies associated with exposure to sulfonamides indicated that this group of drugs, including sulfasalazine, did not appear to be associated with fetal malformation.2 A review of the medical literature covering 1,155 pregnancies in women with ulcerative colitis suggested that the outcome was similar to that expected in the general population.3
No clinical studies have been performed to evaluate the effect of sulfasalazine on the growth development and functional maturation of children whose mothers received the drug during pregnancy.
Sulfasalazine and sulfapyridine pass the placental barrier. Although sulfapyridine has been shown to have a poor bilirubin-displacing capacity, the potential for kernicterus in newborns should be kept in mind.
A case of agranulocytosis has been reported in an infant whose mother was taking both sulfasalazine and prednisone throughout pregnancy.
Nursing Mothers
Caution should be exercised when AZULFIDINE is administered to a nursing woman. Sulfonamides are excreted in the milk. In the newborn, they compete with bilirubin for binding sites on the plasma proteins and may thus cause kernicterus. Insignificant amounts of uncleaved sulfasalazine have been found in milk, whereas the sulfapyridine levels in milk are about 30 to 60 percent of those in the maternal serum. Sulfapyridine has been shown to have a poor bilirubin-displacing capacity.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of two years have not been established.
Adverse Reactions
The most common adverse reactions associated with sulfasalazine are anorexia, headache, nausea, vomiting, gastric distress, and apparently reversible oligospermia. These occur in about one-third of the patients. Less frequent adverse reactions are skin rash, pruritus, urticaria, fever, Heinz body anemia, hemolytic anemia, and cyanosis, which may occur at a frequency of one in every thirty patients or less. Experience suggests that with a daily dosage of 4 g or more, or total serum sulfapyridine levels above 50 µg/mL, the incidence of adverse reactions tends to increase.
Although the listing which follows includes a few adverse reactions which have not been reported with this specific drug, the pharmacological similarities among the sulfonamides require that each of these reactions be considered when Azulfidine Tablets are administered. Less common or rare adverse reactions include:
Blood dyscrasias: aplastic anemia, agranulocytosis, leukopenia, megaloblastic (macrocytic) anemia, purpura, thrombocytopenia, hypoprothrombinemia, methemoglobinemia, congenital neutropenia, and myelodysplastic syndrome.
Hypersensitivity reactions: erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, epidermal necrolysis (Lyell’s syndrome) with corneal damage, drug rash with eosinophilia and systemic symptoms (DRESS), anaphylaxis, serum sickness syndrome, interstitial lung disease, pneumonitis with or without eosinophilia, vasculitis, fibrosing alveolitis, pleuritis, pericarditis with or without tamponade, allergic myocarditis, polyarteritis nodosa, lupus erythematosus-like syndrome, hepatitis and hepatic necrosis with or without immune complexes, fulminant hepatitis, sometimes leading to liver transplantation, parapsoriasis varioliformis acuta (Mucha-Haberman syndrome), rhabdomyolysis, photosensitization, arthralgia, periorbital edema, conjunctival and scleral injection, and alopecia.
Gastrointestinal reactions: hepatitis, hepatic failure, pancreatitis, bloody diarrhea, impaired folic acid absorption, impaired digoxin absorption, stomatitis, diarrhea, abdominal pains, and neutropenic enterocolitis.
Central nervous system reactions: transverse myelitis, convulsions, meningitis, transient lesions of the posterior spinal column, cauda equina syndrome, Guillian-Barre syndrome, peripheral neuropathy, mental depression, vertigo, hearing loss, insomnia, ataxia, hallucinations, tinnitus, and drowsiness.
Renal reactions: toxic nephrosis with oliguria and anuria, nephritis, nephrotic syndrome, urinary tract infections, hematuria, crystalluria, proteinuria, and hemolytic-uremic syndrome.
Other reactions: urine discoloration and skin discoloration.
The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides), and oral hypoglycemic agents. Goiter production, diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides. Cross-sensitivity may exist with these agents. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides and long-term administration has produced thyroid malignancies in this species.
Postmarketing Reports
The following events have been identified during post-approval use of products which contain (or are metabolized to) mesalamine in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to mesalamine:
Reports of hepatotoxicity, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, and possible hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal. One case of Kawasaki-like syndrome, which included hepatic function changes, was also reported.
Drug Abuse and Dependence
None reported.
Overdosage
There is evidence that the incidence and severity of toxicity following overdosage are directly related to the total serum sulfapyridine concentration. Symptoms of overdosage may include nausea, vomiting, gastric distress, and abdominal pains. In more advanced cases, central nervous system symptoms such as drowsiness, convulsions, etc., may be observed. Serum sulfapyridine concentrations may be used to monitor the progress of recovery from overdosage.
There are no documented reports of deaths due to ingestion of large single doses of sulfasalazine.
Doses of Azulfidine Tablets of 16 g per day have been given to patients without mortality. A single oral dose of 12 g/kg was not lethal to mice.
Instructions for Overdosage
Gastric lavage or emesis plus catharsis as indicated. Alkalinize urine. If kidney function is normal, force fluids. If anuria is present, restrict fluids and salt, and treat appropriately. Catheterization of the ureters may be indicated for complete renal blockage by crystals. The low molecular weight of sulfasalazine and its metabolites may facilitate their removal by dialysis.
Azulfidine Tablets Dosage and Administration
The dosage of Azulfidine Tablets should be adjusted to each individual’s response and tolerance.
Initial Therapy
Adults: 3 to 4 g daily in evenly divided doses with dosage intervals not exceeding eight hours. In some cases, it is advisable to initiate therapy with a smaller dosage, e.g., 1 to 2 g daily, to reduce possible gastrointestinal intolerance. If daily doses exceeding 4 g are required to achieve desired effects, the increased risk of toxicity should be kept in mind.
Children, six years of age and older: 40 to 60 mg/kg body weight in each 24-hour period, divided into 3 to 6 doses.
Maintenance Therapy
Adults: 2 g daily.
Children, six years of age and older: 30 mg/kg body weight in each 24-hour period, divided into 4 doses.
The response of acute ulcerative colitis to Azulfidine Tablets can be evaluated by clinical criteria, including the presence of fever, weight changes, and degree and frequency of diarrhea and bleeding, as well as by sigmoidoscopy and the evaluation of biopsy samples. It is often necessary to continue medication even when clinical symptoms, including diarrhea, have been controlled. When endoscopic examination confirms satisfactory improvement, the dosage of AZULFIDINE should be reduced to a maintenance level. If diarrhea recurs, the dosage should be increased to previously effective levels. If symptoms of gastric intolerance (anorexia, nausea, vomiting, etc.) occur after the first few doses of AZULFIDINE, they are probably due to increased serum levels of total sulfapyridine and may be alleviated by halving the daily dose of AZULFIDINE and subsequently increasing it gradually over several days. If gastric intolerance continues, the drug should be stopped for 5 to 7 days, then reintroduced at a lower daily dose.
Some patients may be sensitive to treatment with sulfasalazine. Various desensitization-like regimens have been reported to be effective in 34 of 53 patients,4 7 of 8 patients,5 and 19 of 20 patients.6 These regimens suggest starting with a total daily dose of 50 to 250 mg sulfasalazine initially, and doubling it every 4 to 7 days until the desired therapeutic level is achieved. If the symptoms of sensitivity recur, AZULFIDINE should be discontinued. Desensitization should not be attempted in patients who have a history of agranulocytosis, or who have experienced an anaphylactoid reaction while previously receiving sulfasalazine.
How is Azulfidine Tablets Supplied
Azulfidine Tablets, 500 mg, are round, gold-colored, scored tablets, monogrammed “101″ on one side and “KPh” on the other. They are available in the following package sizes:
Bottles of 100 NDC 0013-0101-01
Bottles of 300 NDC 0013-0101-20
Unit Dose (100) NDC 0013-0101-11
Store at 25° C (77° F); excursions permitted to 15–30° C (59–86° F) [see USP Controlled Room Temperature].
Sulfasalazine is also available as AZULFIDINE EN-tabs® brand of sulfasalazine delayed release tablets, USP, 500 mg, in the following package sizes:
Bottles of 100 NDC 0013-0102-01
Bottles of 300 NDC 0013-0102-20
REFERENCES
- Mogadam M, et al. Pregnancy in inflammatory bowel disease: effect of sulfasalazine and corticosteroids on fetal outcome. Gastroenterology 1981;80:72–6.
- Kaufman DW, editor. Birth defects and drugs during pregnancy. Littleton, MA: Publishing Sciences Group, Inc, 1977: 296–313.
- Jarnerot G. Fertility, sterility and pregnancy in chronic inflammatory bowel disease. Scand J Gastroenterol 1982;17:1–4.
- Korelitz B, et al. Desensitization to sulfasalazine in allergic patients with IBD: an important therapeutic modality. Gastroenterology 1982;82:1104.
- Holdworth CG. Sulphasalazine desensitization. Br Med J 1981;282:110.
- Taffet SL, Das KM. Desensitization of patients with inflammatory bowel disease to sulfasalazine. Am J Med 1982;73:520–4.
Rx only

LAB-0241-3.0
September 2009
PRINCIPAL DISPLAY PANEL – 500 mg tablet bottle
NDC 0013-0101-01
100 Tablets
Rx only
Azulfidine®
sulfasalazine tablets, USP
500 mg
Pfizer
Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017

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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA021243 | 08/18/2000 | |
| Labeler - Pharmacia and Upjohn Company (829076566) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Kemwell AB | 774341221 | MANUFACTURE | |
Revised: 12/2009Pharmacia and Upjohn Company
Azithromycin Tablets
29/06/10
Azmacort
29/06/10
Generic Name: triamcinolone inhalation (trye am SIH no lone)
Brand Names: Azmacort
What is triamcinolone inhalation?
Triamcinolone is a steroid. It prevents the release of substances in the body that cause inflammation.
Triamcinolone inhalation is used to prevent asthma attacks. It will not treat an asthma attack that has already begun.
Triamcinolone may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about triamcinolone inhalation?
Do not use triamcinolone inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, faster-acting inhalation medication to treat an asthma attack.
Contact your doctor if your asthma symptoms do not improve after using triamcinolone inhalation for 2 weeks.
Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. Your dosage needs may also change if you have surgery, are ill, are under stress, or have recently had an asthma attack. If you were switched from an oral (taken by mouth) steroid to triamcinolone inhalation, you may need to go back to taking the oral medicine if you are under stress or have an asthma attack or other medical emergency. Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency.
What should I discuss with my healthcare provider before using triamcinolone inhalation?
Before using this medication, tell your doctor if you have been sick or had an infection of any kind (especially tuberculosis). You may not be able to use triamcinolone inhalation until you are well.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether triamcinolone passes into breast milk or if it could harm a nursing baby. Do not use triamcinolone inhalation without telling your doctor if you are breast-feeding a baby.
Triamcinolone can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.
Do not give this medicine to a child younger than 5 years old.
Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk of osteoporosis.
How should I use triamcinolone inhalation?
Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Triamcinolone comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Do not use triamcinolone inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, faster-acting inhalation medication to treat an asthma attack.
To reduce the chance of developing a yeast infection in your mouth, rinse with water after using triamcinolone inhalation. Do not swallow.
Asthma is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor.
It is important to use triamcinolone inhalation regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Contact your doctor if your asthma symptoms do not improve after using triamcinolone inhalation for 2 weeks.
Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. Your dosage needs may also change if you have surgery, are ill, are under stress, or have recently had an asthma attack. If you were switched from an oral (taken by mouth) steroid to triamcinolone inhalation, you may need to go back to taking the oral medicine if you are under stress or have an asthma attack or other medical emergency. Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency. Store triamcinolone inhalation at room temperature away from moisture and heat. Keep the medicine canister away from high heat, such as open flame or in a car on a hot day. The canister may explode if it gets too hot.
What happens if I miss a dose?
Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use 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.
An overdose of triamcinolone inhalation is not expected to produce life-threatening symptoms.
What should I avoid while using triamcinolone inhalation?
Steroid medication can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. Avoid being near people who are sick or have infections. Contact your doctor if you have been exposed to someone with measles or chicken pox.
Triamcinolone inhalation 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. Call your doctor at once if you have any of these serious side effects:
-
weakness, tired feeling, nausea, loss of appetite, weight loss;
-
wheezing or breathing problems after using this medication;
-
skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
-
pain or burning when you urinate;
-
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);
-
worsening asthma symptoms.
Less serious side effects may include:
-
nausea, diarrhea, stomach pain;
-
joint or muscle pain;
-
dryness in your mouth, nose, or throat;
-
white patches or sores inside your mouth or on your lips;
-
stuffy nose, sinus pain, sore throat, cough; or
-
hoarseness or deepened voice.
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 triamcinolone inhalation?
There may be other drugs that can interact with triamcinolone inhalation. 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 triamcinolone inhalation.
- 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: 5.05. Revision Date: 4/12/2009 4:37:49 PM.
Azmacort Aerosol
29/06/10
Generic Name: Triamcinolone (TRYE-am-SIHN-oh lohn)
Brand Name: Azmacort
Azmacort Aerosol is used for:
Preventing or reducing the frequency and severity of bronchial asthma attacks. It will not stop an asthma attack once it has started. It may also be used for other conditions as determined by your doctor.
Azmacort Aerosol is a corticosteroid. It works by decreasing the irritation and swelling of the airways of the lung. This helps to control or prevent asthma symptoms.
Do NOT use Azmacort Aerosol if:
- you are allergic to any ingredient in Azmacort Aerosol
- you are currently taking mifepristone
- you are having an asthma attack
Contact your doctor or health care provider right away if any of these apply to you.
Before using Azmacort Aerosol:
Some medical conditions may interact with Azmacort Aerosol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning 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 or have been recently exposed to a bacterial, fungal, parasitic, or viral infection, especially measles, chickenpox, tuberculosis (TB), or herpes simplex of the eye
- if you have been recently vaccinated with a live or inactivated vaccine, or have had a positive TB skin test
- if you are having an attack of bronchospasm (tightening of the airway, difficulty breathing), or have diarrhea
Some MEDICINES MAY INTERACT with Azmacort Aerosol. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Barbiturates (eg, phenobarbital), carbamazepine, fluconazole, hydantoins (eg, phenytoin), lithium, rifampin, or thioamines (eg, propylthiouracil) because they may decrease Azmacort Aerosol’s effectiveness
- Clarithromycin, itraconazole, oral contraceptives (birth control pills), or midazolam because the risk of side effects, such as nervous system or adrenal gland problems, may be increased
- Anticholinesterases (eg, pyridostigmine), anticoagulants (eg, warfarin), mifepristone, nondepolarizing muscle relaxants (eg, vecuronium), ritodrine, sympathomimetics (eg, albuterol, amphetamine, pseudoephedrine), or live vaccines because the risk of their side effects may be increased by Azmacort Aerosol
- Anticholinesterases (eg, pyridostigmine), anticoagulants (eg, warfarin), interleukin-2, or nondepolarizing muscle relaxants (eg, vecuronium) because their effectiveness may be decreased by Azmacort Aerosol
This may not be a complete list of all interactions that may occur. Ask your health care provider if Azmacort Aerosol 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 Azmacort Aerosol:
Use Azmacort Aerosol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Azmacort Aerosol. Talk to your pharmacist if you have questions about this information.
- Before using Azmacort Aerosol, be sure that the canister is properly placed in the inhaler unit. Shake well. Breathe out slowly and completely. Place the mouthpiece between your lips and try to rest your tongue flat, unless your doctor has told you otherwise. Your doctor may have told you to hold the inhaler 1 or 2 inches (2 or 3 centimeters) away from the open mouth or to use a special spacing device. As you start to take a slow deep breath, press the canister and mouthpiece together at exactly the same time. This will release a dose of Azmacort Aerosol. Continue breathing in slowly and deeply and hold for as long as comfortable, then breathe out slowly through pursed lips or your nose. If more than 1 inhalation is to be used, wait a few minutes and repeat the above steps. Keep the spray away from your eyes.
- Rinse your mouth or gargle with water after using Azmacort Aerosol to prevent mouth sores or bad taste.
- Each time a new inhaler is used, turn the canister away from the face and press down into the mouthpiece to release test sprays into the air. This process is called priming and will allow you to be sure the inhaler is working properly and will provide a full dose of medicine.
- Keep track of the number of sprays you use and subtract this number from the number of doses in the container. This will help you know when the container is becoming empty.
- If you miss a dose of Azmacort Aerosol, use 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 use 2 doses at once.
Ask your health care provider any questions you may have about how to use Azmacort Aerosol.
Important safety information:
- Azmacort Aerosol will not stop an asthma attack once it has started
- If you are also using a bronchodilator inhaler, be sure to always carry the inhaler with you to use during asthma attacks.
- After you begin using Azmacort Aerosol, a few weeks may pass before the full benefit is obtained. Continue to use it as directed during this time.
- Use caution if you switch from an oral steroid (eg, prednisone) to Azmacort Aerosol. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.
- Tell your doctor or dentist that you take Azmacort Aerosol before you receive any medical or dental care, emergency care, or surgery.
- If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does.
- Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Azmacort Aerosol.
- Use Azmacort Aerosol with extreme caution in CHILDREN. Azmacort Aerosol should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Azmacort Aerosol while you are pregnant. It is not known if Azmacort Aerosol is found in breast milk. If you are or will be breast-feeding while you use Azmacort Aerosol, check with your doctor. Discuss any possible risks to your baby.
You may experience WITHDRAWAL when switching from an oral steroid medicine to an inhaled one. Contact your health care provider at once if the following symptoms occur: muscle and joint pain, exhaustion, depression.
Possible side effects of Azmacort Aerosol:
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:
Back pain; dry mouth; flu-like symptoms; headache, hoarseness; irritated or sore throat; sinus inflammation.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest congestion; depression; exhaustion; fainting; muscle and joint pain; severe dizziness; sudden weight loss; unusual weakness; white, curd-like patches in mouth.
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.
Proper storage of Azmacort Aerosol:
Store Azmacort Aerosol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Store away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Azmacort Aerosol out of the reach of children and away from pets.
General information:
- If you have any questions about Azmacort Aerosol, please talk with your doctor, pharmacist, or other health care provider.
- Azmacort Aerosol is 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 Azmacort Aerosol. 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.
Azo-Cranberry
29/06/10
Generic Name: cranberry (KRAN ber ee)
Brand Names: Azo-Cranberry, Cranberry
What is Azo-Cranberry (cranberry)?
Cranberry is produced from the berry fruit of a North American evergreen shrub.
Cranberry has been used in alternative medicine to prevent bladder symptoms such as pain or burning with urination. Cranberry will not treat the bacteria that causes a bladder infection.
Cranberry has also been used to reduce the odor of urine and to improve the quality of life in people who have urinary incontinence.
Cranberry has not been approved by the FDA to treat any disease, and it should not be substituted for prescription medications.
Cranberry has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of cranberry may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. Some marketed herbal supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.
Cranberry may also have other uses not listed in this medication guide.
What is the most important information I should know about Azo-Cranberry (cranberry)?
Cranberry has not been approved by the FDA to treat any disease, and it should not be substituted for prescription medications. Do not take cranberry if you are allergic to it.
Before taking cranberry, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use this product if you have ever had a kidney stone or if you take a blood thinner such as warfarin (Coumadin).
Cranberry will not treat bacteria that causes a bladder infection.
Cranberry has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of cranberry may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. Some marketed herbal supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.
Stop using cranberry and call your doctor at once if you have any symptoms of a bladder infection, such as pain or burning when you urinate, blood in your urine, severe stomach pain, or urinating less than usual or not at all.
Less serious side effects are more likely to occur, and you may have none at all. Tell your doctor, pharmacist, or healthcare provider about any unusual or bothersome side effect.
What should I discuss with my healthcare provider before taking Azo-Cranberry (cranberry)?
Do not take cranberry if you are allergic to it.
Before taking cranberry, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use this product if you have ever had a kidney stone.
Do not take cranberry without telling your doctor if you are pregnant or plan to become pregnant during treatment. Cranberry may be harmful to an unborn baby. It is not known whether cranberry passes into breast milk or if it could harm a nursing baby. Do not use this product without telling your doctor if you are breast-feeding a baby. Do not give any herbal/health supplement to a child without the advice of a doctor.
Liquid forms of cranberry may contain sugar or alcohol. Talk to your doctor before using this form of cranberry if you have diabetes or liver disease, or if you otherwise need to avoid alcohol.
How should I take Azo-Cranberry (cranberry)?
When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.
If you choose to take cranberry, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of this product than is recommended on the label.
Cranberry is available in a capsule or tablet formulation.
Other forms of cranberry may also be available, such as teas, tinctures, or liquids. Do not use many different forms of cranberry together at the same time, unless your healthcare provider instructs you to. Using different forms together may increase your risk of an overdose of cranberry.
Store cranberry in a sealed container as directed on the product label, away from moisture, heat, and light.
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, wait until then to take this product and skip the missed dose. Do not take extra cranberry to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include stomach pain or diarrhea.
What should I avoid while taking Azo-Cranberry (cranberry)?
Follow your healthcare provider’s instructions about any restrictions on food, beverages, or activity while you are taking cranberry.
Azo-Cranberry (cranberry) 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 using cranberry and call your doctor at once if you have any symptoms of a bladder infection, such as:
-
pain or burning when you urinate;
-
blood in your urine;
-
severe stomach pain; or
-
urinating less than usual or not at all.
Less serious side effects are more likely to occur, and you may have none at all.
Other side effects may also occur with the use of cranberry. Tell your doctor, pharmacist, herbalist, or other healthcare provider about any unusual or bothersome side effect.
What other drugs will affect Azo-Cranberry (cranberry)?
Do not take cranberry without the advice of a doctor if you are also taking a blood thinner such as warfarin (Coumadin).
There may be other drugs that can interact with cranberry. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Where can I get more information?
- Consult with a licensed healthcare professional before using any herbal/health supplement. Whether you are treated by a medical doctor or a practitioner trained in the use of natural medicines/supplements, make sure all your healthcare providers know about all of your medical conditions and treatments.
- Consultation with a licensed healthcare professional is advisable before using any herbal/health supplement. Additionally, consultation with a practitioner trained in the uses of herbal/health supplements may be beneficial and coordination of treatment among all healthcare providers involved may be advantageous. Remember, keep this and all other prescription drug products, over-the-counter drug products, and herbal/health supplements out of the reach of children.
- 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: 1.05. Revision Date: 02/26/2010 3:13:15 PM.
Azo-Gesic
29/06/10
Generic Name: phenazopyridine (fen AY zoe PIR i deen)
Brand Names: Azo-Gesic, Azo-Standard, Baridium, Phenazo, Prodium, Pyridiate, Pyridium, Re-Azo, Uricalm, Uristat
What is Azo-Gesic (phenazopyridine)?
Phenazopyridine is a pain reliever that affects the lower part of your urinary tract (bladder and urethra).
Phenazopyridine is used to treat pain, burning, increased urination, and increased urge to urinate. These symptoms are usually caused by infection, injury, surgery, catheter, or other conditions that irritate the lower urinary tract.
Phenazopyridine will treat the symptoms of a urinary tract infection, but this medication does not treat the actual infection. Take any antibiotic that your doctor prescribes to treat your infection.
Phenazopyridine may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about Azo-Gesic (phenazopyridine)?
Do not take this medication if you are allergic to phenazopyridine, or if you have kidney disease. Phenazopyridine will treat the symptoms of a urinary tract infection, but this medication does not treat the actual infection. Take any antibiotic that your doctor prescribes to treat your infection. To avoid stomach upset, take phenazopyridine with food.
Phenazopyridine will most likely darken the color of your urine to an orange or red color. This is a normal effect and is not cause for alarm unless you have other symptoms such as pale or yellowed skin, fever, stomach pain, nausea, and vomiting. Darkened urine may also cause stains to your underwear, which may or may not be removed by laundering.
Phenazopyridine can also permanently stain soft contact lenses, and you should not wear them while taking this medicine.
Do not use phenazopyridine for longer than 2 days unless your doctor has told you to.
Stop taking this medication and call your doctor at once if you have pale skin, fever, confusion, yellowing of your skin or eyes, increased thirst, swelling, or if you urinate less than usual or not at all.
What should I discuss with my health care provider before taking Azo-Gesic (phenazopyridine)?
Do not take this medication if you are allergic to phenazopyridine, or if you have kidney disease.
Before using phenazopyridine, tell your doctor if you are allergic to any drugs, or if you have:
-
liver disease;
-
diabetes; or
-
a condition called G6PD (glucose-6-phosphate dehydrogenase) deficiency.
If you have any of these conditions, you may need a dose adjustment or special tests to safely take phenazopyridine.
FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether phenazopyridine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I take Azo-Gesic (phenazopyridine)?
Take phenazopyridine 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.
Take this medicine with a full glass of water. To avoid stomach upset, take phenazopyridine with food.
Phenazopyridine will most likely darken the color of your urine to an orange or red color. This is a normal effect and is not cause for alarm unless you have other symptoms such as pale or yellowed skin, fever, stomach pain, nausea, and vomiting. Darkened urine may also cause stains to your underwear, which may or may not be removed by laundering.
Phenazopyridine can also permanently stain soft contact lenses, and you should not wear them while taking this medicine.
Do not use phenazopyridine for longer than 2 days unless your doctor has told you to.
This medication can cause you to have false results with glucose or ketone urine tests. Tell any doctor who treats you that you are using phenazopyridine.
Store this medication at room temperature away from moisture and heat.
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.
Overdose symptoms may include yellowed skin, fever, confusion, weakness, urinating less than usual, nausea, vomiting, swelling, numbness, or blue-colored skin.
What should I avoid while taking Azo-Gesic (phenazopyridine)?
Avoid wearing soft contact lenses while you are taking phenazopyridine. The medication can cause permanent staining of soft contact lenses.
Azo-Gesic (phenazopyridine) 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 using phenazopyridine and call your doctor at once if you have any of these serious side effects:
-
pale skin, fever, confusion or weakness;
-
jaundice (yellowing of your skin or eyes);
-
urinating less than usual or not at all;
-
drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
-
swelling, weight gain, feeling short of breath; or
-
blue or purple coloring in your skin.
Less serious side effects may include:
-
headache;
-
dizziness;
-
stomach pain, upset stomach; or
-
skin 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 Azo-Gesic (phenazopyridine)?
There may be other drugs that can interact with phenazopyridine. 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 phenazopyridine.
- 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: 3.02. Revision Date: 4/12/2009 4:37:06 PM.
Azo-Septic
29/06/10
Generic Name: phenazopyridine (Oral route)
fen-ay-zoe-PIR-i-deen
Commonly used brand name(s):
In the U.S.
- Azo-Gesic
- Azo-Septic
- Azo-Standard
- Baridium
- Phenazo 95
- Prodium
- Pyridiate
- Pyridium
- RE-Azo
- Urinary Pain Relief
- Uristat
- UTI Relief
Available Dosage Forms:
- Tablet
- Kit
Therapeutic Class: Analgesic
Uses For Azo-Septic
Phenazopyridine is used to relieve the pain, burning, and discomfort caused by infection or irritation of the urinary tract. It is not an antibiotic and will not cure the infection itself.
In the U.S., phenazopyridine is available only with your doctor’s prescription.
Before Using Azo-Septic
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
Although there is no specific information comparing use of phenazopyridine in children with use in other age groups, it is not expected to cause different side effects or problems in children than it does in adults.
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. Although there is no specific information comparing use of phenazopyridine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | B | Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. |
Breast Feeding
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
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:
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency or
- Hepatitis or
- Kidney disease—The chance of side effects may be increased.
Proper Use of phenazopyridine
This section provides information on the proper use of a number of products that contain phenazopyridine. It may not be specific to Azo-Septic. Please read with care.
This medicine is best taken with food or after eating a meal or a snack to lessen stomach upset.
Do not use any leftover medicine for future urinary tract problems without first checking with your doctor. An infection may require additional medicine.
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 oral dosage form (tablets):
- For relieving pain, burning, and discomfort in the urinary tract:
- Adults and teenagers—200 milligrams (mg) three times a day.
- Children—The dose is based on body weight and must be determined by your doctor. The usual dose is 4 mg per kilogram (kg) (about 1.8 mg per pound) of body weight three times a day.
- For relieving pain, burning, and discomfort in the urinary tract:
Missed Dose
If you miss a dose of this medicine, take 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. Do not double doses.
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 Azo-Septic
Check with your doctor if symptoms such as bloody urine, difficult or painful urination, frequent urge to urinate, or sudden decrease in the amount of urine appear or become worse while you are taking this medicine .
Phenazopyridine causes the urine to turn reddish orange . This is to be expected while you are using it. This effect is harmless and will go away after you stop taking the medicine. Also, the medicine may stain clothing.
For patients who wear soft contact lenses:
- It is best not to wear soft contact lenses while being treated with this medicine. Phenazopyridine may cause discoloration or staining of contact lenses. It may not be possible to remove the stain.
For diabetic patients:
- This medicine may cause false test results with urine sugar tests and urine ketone tests. If you have any questions about this, check with your health care professional, especially if your diabetes is not well controlled.
Before you have any medical tests, tell the person in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
Azo-Septic 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 as soon as possible if any of the following side effects occur:
Rare
- Blue or blue-purple color of skin
- fever and confusion
- shortness of breath, tightness in chest, wheezing, or troubled breathing
- skin rash
- sudden decrease in the amount of urine
- swelling of face, fingers, feet, and/or lower legs
- unusual tiredness or weakness
- weight gain
- yellow eyes or skin
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 or rare
- Dizziness
- headache
- indigestion
- itching of the skin
- stomach cramps or pain
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.
Azo-Standard
29/06/10
Generic Name: phenazopyridine (fen AY zoe PIR i deen)
Brand Names: Azo-Gesic, Azo-Standard, Baridium, Phenazo, Prodium, Pyridiate, Pyridium, Re-Azo, Uricalm, Uristat
What is Azo-Standard (phenazopyridine)?
Phenazopyridine is a pain reliever that affects the lower part of your urinary tract (bladder and urethra).
Phenazopyridine is used to treat pain, burning, increased urination, and increased urge to urinate. These symptoms are usually caused by infection, injury, surgery, catheter, or other conditions that irritate the lower urinary tract.
Phenazopyridine will treat the symptoms of a urinary tract infection, but this medication does not treat the actual infection. Take any antibiotic that your doctor prescribes to treat your infection.
Phenazopyridine may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about Azo-Standard (phenazopyridine)?
Do not take this medication if you are allergic to phenazopyridine, or if you have kidney disease. Phenazopyridine will treat the symptoms of a urinary tract infection, but this medication does not treat the actual infection. Take any antibiotic that your doctor prescribes to treat your infection. To avoid stomach upset, take phenazopyridine with food.
Phenazopyridine will most likely darken the color of your urine to an orange or red color. This is a normal effect and is not cause for alarm unless you have other symptoms such as pale or yellowed skin, fever, stomach pain, nausea, and vomiting. Darkened urine may also cause stains to your underwear, which may or may not be removed by laundering.
Phenazopyridine can also permanently stain soft contact lenses, and you should not wear them while taking this medicine.
Do not use phenazopyridine for longer than 2 days unless your doctor has told you to.
Stop taking this medication and call your doctor at once if you have pale skin, fever, confusion, yellowing of your skin or eyes, increased thirst, swelling, or if you urinate less than usual or not at all.
What should I discuss with my health care provider before taking Azo-Standard (phenazopyridine)?
Do not take this medication if you are allergic to phenazopyridine, or if you have kidney disease.
Before using phenazopyridine, tell your doctor if you are allergic to any drugs, or if you have:
-
liver disease;
-
diabetes; or
-
a condition called G6PD (glucose-6-phosphate dehydrogenase) deficiency.
If you have any of these conditions, you may need a dose adjustment or special tests to safely take phenazopyridine.
FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether phenazopyridine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I take Azo-Standard (phenazopyridine)?
Take phenazopyridine 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.
Take this medicine with a full glass of water. To avoid stomach upset, take phenazopyridine with food.
Phenazopyridine will most likely darken the color of your urine to an orange or red color. This is a normal effect and is not cause for alarm unless you have other symptoms such as pale or yellowed skin, fever, stomach pain, nausea, and vomiting. Darkened urine may also cause stains to your underwear, which may or may not be removed by laundering.
Phenazopyridine can also permanently stain soft contact lenses, and you should not wear them while taking this medicine.
Do not use phenazopyridine for longer than 2 days unless your doctor has told you to.
This medication can cause you to have false results with glucose or ketone urine tests. Tell any doctor who treats you that you are using phenazopyridine.
Store this medication at room temperature away from moisture and heat.
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.
Overdose symptoms may include yellowed skin, fever, confusion, weakness, urinating less than usual, nausea, vomiting, swelling, numbness, or blue-colored skin.
What should I avoid while taking Azo-Standard (phenazopyridine)?
Avoid wearing soft contact lenses while you are taking phenazopyridine. The medication can cause permanent staining of soft contact lenses.
Azo-Standard (phenazopyridine) 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 using phenazopyridine and call your doctor at once if you have any of these serious side effects:
-
pale skin, fever, confusion or weakness;
-
jaundice (yellowing of your skin or eyes);
-
urinating less than usual or not at all;
-
drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
-
swelling, weight gain, feeling short of breath; or
-
blue or purple coloring in your skin.
Less serious side effects may include:
-
headache;
-
dizziness;
-
stomach pain, upset stomach; or
-
skin 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 Azo-Standard (phenazopyridine)?
There may be other drugs that can interact with phenazopyridine. 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 phenazopyridine.
- 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: 3.02. Revision Date: 4/12/2009 4:37:06 PM.
Azopt
29/06/10
Generic Name: brinzolamide ophthalmic (brin ZOE la mide off THAL mik)
Brand Names: Azopt
What is Azopt (brinzolamide ophthalmic)?
Brinzolamide reduces the amount of fluid in the eye, which decreases pressure inside the eye.
Brinzolamide ophthalmic (for the eyes) is used to treat certain types of glaucoma and other causes of high pressure inside the eye.
Brinzolamide ophthalmic may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about Azopt (brinzolamide ophthalmic)?
Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using the eye drops before putting your contact lenses in.
Before using this medication, tell your doctor if you are allergic to any drugs, or if you have narrow-angle glaucoma.
Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.
Do not use any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using brinzolamide ophthalmic. Do not use the medications at the same time.
Brinzolamide ophthalmic can cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.
What should I discuss with my healthcare provider before using Azopt (brinzolamide ophthalmic)?
You should not use this medication if you are allergic to brinzolamide.
Before using this medication, tell your doctor if you are allergic to any drugs, or if you have narrow-angle glaucoma.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether brinzolamide ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I use Azopt (brinzolamide ophthalmic)?
Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using the eye drops before putting your contact lenses in.
Use brinzolamide ophthalmic exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.
Wash your hands before using the eye drops.
To apply the eye drops:
-
Tilt your head back slightly and pull down on the lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper. Squeeze out a drop and close your eye. Gently press your finger to the inside corner of the eye (near the nose) for about 1 minute to keep the liquid from draining into your tear duct.
-
If you use the drops in both eyes, repeat the steps above in your other eye. Also wait at least 10 minutes before using any other eye drops that your doctor has prescribed.
Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye. Do not use this medicine if it has changed colors or has particles in it.
Tell your doctor right away if you have an eye infection, injury, or plan to have any type of eye surgery. You may need to stop using the medicine for a short time.
Store this medication at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.
What happens if I miss a dose?
Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use 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.
An overdose of brinzolamide ophthalmic is not expected to produce life-threatening symptoms.
What should I avoid while using Azopt (brinzolamide ophthalmic)?
Brinzolamide ophthalmic can cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.
Do not use any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using brinzolamide ophthalmic. Do not use the medications at the same time.
Azopt (brinzolamide ophthalmic) 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 using this medication and call your doctor at once if you have any of these serious side effects:
-
swelling or redness of your eyelids;
-
eye redness, discomfort, or sensitivity to light;
-
drainage, crusting, or oozing of your eyes or eyelids;
-
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
-
pain in your upper stomach, jaundice (yellowing of your skin or eyes);
-
pale skin, easy bruising or bleeding; or
-
chest pain.
Less serious side effects may include:
-
blurred vision, double vision, drooping eyelid;
-
burning or stinging in your eye;
-
bitter or unusual taste in your mouth;
-
stomach or back pain;
-
dry eyes, feeling that something is in your eye;
-
headache; or
-
nausea, diarrhea.
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 Azopt (brinzolamide ophthalmic)?
Before using brinzolamide ophthalmic, tell your doctor if you are using any of the following drugs:
-
salicylates such as aspirin, Novasal, Doan’s Extra Strength, Salflex, Tricosal, and others;
This list is not complete and there may be other drugs that can interact with brinzolamide ophthalmic. 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 brinzolamide ophthalmic.
- 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: 2.05. Revision Date: 4/12/2009 4:43:19 PM.
