Generic Name: cytomegalovirus immune globulin (CMV IG) (injectable) (sye toe MEH gah loe vye rus ih MUNE GLAW byoo lin)
Brand Names: Cytogam
What is CMV IG?
Cytomegalovirus immune globulin (CMV IG) is a sterilized solution obtained from pooled human blood. It contains the immunoglobulins (or antibodies) to protect against infection from cytomegalovirus. Antibodies are substances in the blood that fight infections.
CMV IG is used to help prevent infection by cytomegalovirus in people who receive an organ transplant.
CMV IG may also be used for purposes other than those listed here.
What is the most important information I should know about CMV IG?
CMV IG is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although CMV IG is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using CMV IG.
Treatment with immune globulin products such as CMV IG has been associated with the development of kidney problems, sometimes resulting in kidney failure and/or death. Notify your doctor immediately if you develop decreased urination, sudden weight gain, fluid retention or swelling, or shortness of breath. These may be signs of kidney problems. Rare cases of aseptic meningitis syndrome (AMS) have been associated with the use of immune globulin products such as CMV IG. Notify your doctor immediately if you experience severe headache, neck stiffness, drowsiness, fever, eye sensitivity to light, painful eye movements, and nausea or vomiting. These may be signs of AMS. Stopping treatment with the immune globulin has resulted in resolution of AMS without any lasting problems.
What should I discuss with my healthcare provider before taking CMV IG?
Do not use CMV IG without first talking to your doctor if you have
kidney disease;
diabetes;
IgA deficiency; or
a previous allergic reaction to another immune globulin product.
You may not be able to use CMV IG, or you may require a dosage adjustment or special monitoring during treatment.
CMV IG is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use CMV IG without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether CMV IG passes into breast milk. Do not use CMV IG without first talking to your doctor if you are breast-feeding a baby. Individuals over the age of 65 years may have an increased risk of kidney problems with the use of CMV IG. Your doctor may prescribe a lower dose of the medication or special monitoring during treatment.
How should I take CMV IG?
CMV IG will be administered by intravenous (into a vein) injection by a healthcare provider in a hospital or clinic setting.
Your doctor may want you to have blood tests or other forms of monitoring during treatment with CMV IG to monitor progress and side effects.
Your healthcare provider will store CMV IG as directed by the manufacturer. If you are storing CMV IG at home, your healthcare provider will provide storage instructions.
Contact your healthcare provider if a dose of CMV IG is missed.
What happens if I overdose?
Seek emergency medical attention or contact your healthcare provider if an overdose of CMV IG is suspected.
No information is available regarding an overdose of CMV IG.
What should I avoid while taking CMV IG?
Do not receive vaccines that use live strains of the virus (e.g., measles, mumps, and rubella or MMR) during and for approximately three months following treatment with CMV IG. These vaccines may not work properly when CMV IG has been recently administered.
CMV IG side effects
CMV IG is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although CMV IG is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using CMV IG.
Treatment with immune globulin products such as CMV IG has been associated with the development of kidney problems, sometimes resulting in kidney failure and/or death. Notify your doctor immediately if you develop decreased urination, sudden weight gain, fluid retention or swelling, or shortness of breath. These may be signs of kidney problems. Rare cases of aseptic meningitis syndrome (AMS) have been associated with the use of immune globulin products such as CMV IG. Notify your doctor immediately if you experience severe headache, neck stiffness, drowsiness, fever, eye sensitivity to light, painful eye movements, and nausea or vomiting. These may be signs of AMS. Stopping treatment with the immune globulin has resulted in resolution of AMS without any lasting problems. Notify your doctor immediately if you experience a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to CMV IG.
Other less serious side effects may also occur. Upon injection of the medication, some patients experience the following side effects:
flushing or sweating;
wheezing;
muscle cramps;
joint pain;
nausea or vomiting; or
fever or chills.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Cytomegalovirus immune globulin (CMV IG) Dosing Information
Usual Adult Dose for CMV Prophylaxis:
Kidney transplant: Within 72 hours of transplant: 150 mg/kg 2 to 8 weeks post transplant: 100 mg/kg 12 to 16 weeks post transplant: 50 mg/kg
Liver, pancreas, lung, heart transplant: Within 72 hours of transplant: 150 mg/kg 2 to 8 weeks post transplant: 150 mg/kg 12 to 16 weeks post transplant: 100 mg/kg
Administer IV at 15 mg/kg/hour. If no adverse reactions occur after 30 minutes, the rate may be increased to 30 mg/kg/hour for 15 minutes before increasing to a maximum rate of 60 mg/kg/hour. Maximum volume not to exceed 75 mL/hr.
The maximum recommended total dosage per infusion is 150 mg/kg.
Usual Pediatric Dose for CMV Prophylaxis:
Kidney transplant: Within 72 hours of transplant: 150 mg/kg 2 to 8 weeks post transplant: 100 mg/kg 12 to 16 weeks post transplant: 50 mg/kg
Liver, pancreas, lung, heart transplant: Within 72 hours of transplant: 150 mg/kg 2 to 8 weeks post transplant: 150 mg/kg 12 to 16 weeks post transplant: 100 mg/kg
Administer IV at 15 mg/kg/hour. If no adverse reactions occur after 30 minutes, the rate may be increased to 30 mg/kg/hour for 15 minutes before increasing to a maximum rate of 60 mg/kg/hour.
The maximum recommended total dosage per infusion is 150 mg/kg.
What other drugs will affect CMV IG?
Do not receive vaccines that use live strains of the virus (e.g., measles, mumps, and rubella or MMR) during and for approximately three months following treatment with CMV IG. These vaccines may not work properly when CMV IG has been recently administered.
It is not known whether other medications will interact with CMV IG. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products during treatment with CMV IG.
Where can I get more information?
Your pharmacist has additional information about CMV IG written for health professionals that you may read.
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.
Liothyronine is a man-made form of a hormone that is normally produced by your thyroid gland to regulate the body’s energy and metabolism. Liothyronine is given when the thyroid does not produce enough of this hormone on its own.
Liothyronine treats hypothyroidism (low thyroid hormone). Liothyronine is also used to treat or prevent goiter (enlarged thyroid gland), and is also given as part of a medical tests for thyroid disorders.
Liothyronine should not be used to treat obesity or weight problems.
Liothyronine may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about Cytomel (liothyronine)?
Since thyroid hormone occurs naturally in the body, almost anyone can take liothyronine. You should not use this medication if you have a thyroid disorder called thyrotoxicosis, or an adrenal gland problem that is not controlled by treatment.
Before taking liothyronine, tell your doctor if you have heart disease, angina (chest pain), coronary artery disease, congestive heart failure, diabetes, or problems with your pituitary or adrenal glands.
Tell your doctor if you are pregnant or breast-feeding.
To be sure this medication is helping your condition, your blood may need to be tested on a regular basis. Do not miss any follow-up visits to your doctor.
Keep using this medicine as directed, even if you feel well. You may need to use this medication for the rest of your life.
Call your doctor if you notice any signs of thyroid toxicity, such as chest pain, fast or pounding heartbeats, feeling hot or nervous, or sweating more than usual.
What should I discuss with my healthcare provider before taking Cytomel (liothyronine)?
Since thyroid hormone occurs naturally in the body, almost anyone can take liothyronine. You should not use this medication if you have a thyroid disorder called thyrotoxicosis, or an adrenal gland problem that is not controlled by treatment.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:
heart disease, angina (chest pain);
coronary artery disease;
congestive heart failure;
diabetes; or
problems with your pituitary or adrenal gland.
FDA pregnancy category A. Liothyronine is not expected to be harmful to an unborn baby. However, tell your doctor if you become pregnant, since your dose needs may change. Small amounts of liothyronine can pass into breast milk, but this is not expected to harm a nursing baby. However, do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I take Cytomel (liothyronine)?
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
Your doctor may occasionally change your dose to make sure you get the best results from this medication.
To be sure this medication is helping your condition, your blood may need to be tested on a regular basis. Do not miss any follow-up visits to your doctor.
Keep using this medicine as directed, even if you feel well. You may need to use this medication for the rest of your life.
Call your doctor if you notice any signs of thyroid toxicity, such as chest pain, fast or pounding heartbeats, feeling hot or nervous, or sweating more than usual.
If you need to have any type of surgery, tell the surgeon ahead of time that you are using liothyronine.
Store liothyronine at room temperature away from moisture and heat.
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 the 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 headache, sweating, diarrhea, irregular menstrual periods, feeling restless or irritable, confusion, weakness, swelling in your hands or feet, fast heart rate, chest pain, feeling short of breath, or fainting.
What should I avoid while taking Cytomel (liothyronine)?
If you also take cholestyramine (Prevalite, Questran) or colestipol (Colestid), avoid taking these medications within 4 hours before or after you take liothyronine.
Cytomel (liothyronine) side effects
Stop using liothyronine and 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.
Less serious side effects may include temporary hair loss (especially in children).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Cytomel (liothyronine)?
The following drugs can interact with liothyronine. Tell your doctor if you are using any of these:
birth control pills or hormone replacement therapy;
a blood thinner such as warfarin (Coumadin);
digoxin (digitalis, Lanoxin);
insulin or diabetes medication you take by mouth;
medications that contain iodine (such as I-131);
an antidepressant such as amitriptyline (Elavil, Etrafon), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others;
salicylates such as aspirin, Backache Relief Extra Strength, Novasal, Nuprin Backache Caplet, Doan’s Pills Extra Strength, Tricosal, and others; or
steroids such as prednisone and others.
This list is not complete and there may be other drugs that can interact with liothyronine. 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 liothyronine.
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.
Generic Name: cytarabine (sye TAR a been)
Brand Names: Cytosar-U, Tarabine PFS
What is Cytosar-U (cytarabine)?
Cytarabine is a cancer medication. Cytarabine interferes with the growth of cancer cells and slows their growth and spread in the body.
Cytarabine is used to treat certain types of leukemia (blood cancers). Cytarabine is also used to treat leukemia associated with meningitis.
Cytarabine may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about Cytosar-U (cytarabine)?
Do not receive this medication without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.
Before receiving cytarabine, tell your doctor if you are allergic to any drugs, or if you have a breathing disorder such as asthma, or a history of stomach ulcer or bleeding.
Cytarabine can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.
Do not receive a “live” vaccine while you are being treated with cytarabine. The live vaccine may not work as well during this time, and may not fully protect you from disease.
What should I discuss with my healthcare provider before receiving Cytosar-U (cytarabine)?
You should not use this medication if you are allergic to cytarabine.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use cytarabine:
asthma or other breathing disorder; or
a history of stomach ulcer or bleeding.
FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not receive cytarabine without telling your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. It is not known whether cytarabine 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 is cytarabine given?
Cytarabine is given as an injection through a needle placed into a vein, under the skin, or into the space around the spinal cord. You will receive this injection in a clinic or hospital setting.
Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.
Cytarabine can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.
What happens if I miss a dose?
Contact your doctor for instructions if you miss an appointment for your cytarabine injection.
What happens if I overdose?
Seek emergency medical attention if you think you have received too much of this medicine.
Overdose symptoms may include extreme drowsiness, or changes in personality or behavior.
What should I avoid while receiving Cytosar-U (cytarabine)?
Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.
Do not receive a “live” vaccine while you are being treated with cytarabine. The live vaccine may not work as well during this time, and may not fully protect you from disease.
Cytosar-U (cytarabine) 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 a serious side effect such as:
easy bruising or bleeding, unusual weakness;
eye pain or redness, problems with your vision;
sudden shortness of breath, dry cough;
unusual thoughts or behavior;
problems with urination;
black, bloody, or tarry stools;
coughing up blood or vomit that looks like coffee grounds;
nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
fever, chest pain, muscle or bone pain, skin rash, tired feeling, and redness of the eyes (may occur 6 to 12 hours after your injection).
Less serious side effects may include:
nausea, vomiting, diarrhea, stomach pain;
mouth sores;
drowsiness, dizziness;
loss of appetite;
sores or swelling around your mouth or rectum;
sore throat;
hair loss; or
headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Cytosar-U (cytarabine)?
Tell your doctor if you take digoxin (Lanoxin).
This list is not complete and there may be other drugs that can interact with cytarabine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
Where can I get more information?
Your pharmacist can provide more information about cytarabine.
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.
Cysteine Hydrochloride Injection, USP 0.5 gram is a sterile, nonpyrogenic solution containing 0.5 gram of Cysteine Hydrochloride, monohydrate in 10 mL of water for injection. The pH is 1.3 (1.0 to 2.5). Specific gravity is 1.02; contains 0.285 mMol cysteine/mL. Cysteine is a sulfur-containing amino acid. In premixed solutions of crystalline amino acids, cysteine is relatively unstable over time, eventually converting to insoluble cystine. To avoid such precipitation, Cysteine Hydrochloride Injection, USP is provided as an additive for use with crystalline amino acid solutions immediately prior to administration to the patient.
Cysteine Hydrochloride, USP, monohydrate is chemically designated C3H7NO2S• HCI • H2O, a white crystalline powder soluble in water.
It has the following structural formula:
Cysteine Hydrochloride – Clinical Pharmacology
Cysteine is synthesized from methionine via the trans-sulfuration pathway in the adult, but newborn infants lack the enzyme, cystathionase, necessary to effect this conversion. Therefore, Cysteine Hydrochloride Injection, USP is generally considered to be an essential amino acid in infants.
Metabolism of cysteine produces pyruvate and inorganic sulfate as end products. Cysteine is introduced directly into the pathway of carbohydrate metabolism at the pyruvate stage with all three carbons convertible to glucose. The sulfur is primarily transformed to inorganic sulfate, which is introduced into complex polysaccharides among other structural components.
Indications and Usage for Cysteine Hydrochloride
Cysteine Hydrochloride Injection, USP 0.5 gram is indicated for use only after dilution as an additive to Aminosyn (a crystalline amino acid solution) to meet the intravenous amino acid nutritional requirements of infants receiving total parenteral nutrition.
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND ADVERSE REACTIONS
The contraindications, warnings, precautions and adverse reactions associated with Cysteine Hydrochloride Injection, USP additive are the same as those cited for Aminosyn 5%, given as part of a total parenteral nutrition program, as defined in the accompanying Aminosyn package insert.
Pregnancy Category C.
Animal reproduction studies have not been conducted with Cysteine Hydrochloride Injection, USP 0.5 gram. It is also not known whether this additive can cause fetal harm when administered to pregnant women or can affect reproductive capacity. This additive should be given to a pregnant woman only if clearly indicated.
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Overdosage
In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. SEE WARNINGS and PRECAUTIONS appearing in accompanying Aminosyn package insert.
Cysteine Hydrochloride Dosage and Administration
Cysteine Hydrochloride Injection, USP 0.5 gram is intended for use only after dilution in Aminosyn (a crystalline amino acid solution). Each 10 mL of Cysteine Hydrochloride Injection, USP 0.5 gram should be combined aseptically with 12.5 grams of amino acids, such as that present in 250 mL of Aminosyn 5%. The admixture is then diluted with 250 mL of dextrose 50% or such lesser volume as indicated. Equal volumes of Aminosyn 5% and dextrose 50% produce a final solution which contains Aminosyn 2.5% in dextrose 25%, which is suitable for administration by central venous infusion. Administration of the final admixture should begin within one hour of mixing due to the oxidative degradation of cysteine in the higher pH environment of the amino acid and dextrose admixture. Otherwise, the admixture should be refrigerated immediately and used within 12 hours of the time of mixing. For the recommended rate of administration, see the Aminosyn package insert.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
How is Cysteine Hydrochloride Supplied
Cysteine Hydrochloride Injection, USP 0.5 gram (50 mg/mL) is supplied as follows:
List No.
Container
8975
10 mL Glass Abboject® Needleless
Unit of Use Syringe
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing.
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Abboject® is a trademark of the Abbott group of companies.
Cysto-Conray II is a sterile aqueous solution intended for instillation as a diagnostic radiopaque medium. Cysto-Conray II contains 17.2% w/v iothalamate meglumine which is 1-Deoxy-1-(methylamino)-D-glucitol 5-acetamido-2,4,6-triiodo-N-methylisophthalamate (salt) and has the following structural formula:
Each milliliter of Cysto-Conray II contains 172 mg of iothalamate meglumine, equivalent to 81 mg (8.1% w/v) of organically bound iodine, 0.110 mg edetate calcium disodium as a stabilizer and 0.115 mg of monobasic sodium phosphate as a buffer.
Cysto-Conray II is hypertonic under conditions of use and is supplied in containers from which the air has been displaced by nitrogen. The pH of Cysto-Conray II is 6.6-7.6.
Cysto-Conray II – Clinical Pharmacology
The most important characteristic of contrast media is the iodine content. The relatively high atomic weight of iodine contributes sufficient radiodensity for radiographic contrast.
Following instillation by sterile catheter, Cysto-Conray II provides for visualization of the lower urinary tract. Clinical literature reports indicate that routinely less than 1 percent of a retrograde urographic radiopaque is absorbed systemically, however, as much as 12 percent absorption was observed with pyelorenal back flow and may produce iodine medicated thyrotropic effects described under PRECAUTIONS.
Indications and Usage for Cysto-Conray II
Cysto-Conray II is indicated for use in retrograde cystography and cystourethrography.
Contraindications
See WARNINGS concerning inadvertant intrathecal administration.
Warnings
SEVERE ADVERSE EVENTS – INADVERTENT INTRATHECAL ADMINISTRATION: Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to insure that this drug product is not administered intrathecally.
Precautions
General
Diagnostic procedures which involve the use of radiopaque diagnostic agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed. Appropriate facilities should be available for coping with any complication of the procedure, as well as for emergency treatment of severe reactions to the contrast agent itself. After administration of the radiocontrast agent, competent personnel and emergency facilities should be available for at least 30 to 60 minutes since delayed reactions have occurred (See ADVERSE REACTIONS).
The possibility of an idiosyncratic reaction in susceptible patients should always be considered (See ADVERSE REACTIONS). The susceptible population includes patients with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine per se and patients with a known clinical hypersensitivity: bronchial asthma, hay fever and food allergies.
A positive history of allergies or hypersensitivity does not arbitrarily contraindicate the use of a contrast agent where a diagnostic procedure is thought essential, but caution should be exercised (See ADVERSE REACTIONS). Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions in such patients should be considered. Recent reports indicate that such pre-treatment does not prevent serious life-threatening reactions, but may reduce both their incidence and severity.
Since these procedures require instrumentation, special precautions should be observed in those patients known to have an acute urinary tract infection.
Filling of the bladder should be done at a steady rate, exercising caution to avoid excessive pressure. Sterile procedures should be employed in administration.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential or whether this drug affects fertility in males or females.
Use in Pregnancy
Category C. Animal reproduction studies have not been conducted with Cysto-Conray II. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cysto-Conray II should be used in pregnant women only if clearly needed.
Nursing Mothers
Iothalamate salts are excreted unchanged in human milk. Although it has not been established that serious adverse reactions occur in nursing infants, because of the potential for adverse reactions, caution should be exercised when Cysto-Conray II is administered to a nursing woman.
Information for the Patient
Patients receiving diagnostic agents for instillation urography should be instructed to:
Inform your physician if you are pregnant.
Inform your physician if you are allergic to any food, drugs or dyes used for x-ray procedures (See PRECAUTIONS – General).
Consult with your physician if, at some future date, any thyroid tests are planned. The iodine in this agent may interfere with later thyroid tests.
Inform your physician about any other medications you are currently taking.
Drug/Laboratory Test Interaction
Thyroid Function Tests: If indicated, these tests generally should be performed prior to the administration of any iodinated agent. However, thyroid function can be evaluated after use of these agents by using T3 resin uptake or free thyroxine assays.
Adverse Reactions
Irritation of the bladder or ureter, common to some degree to all contrast media administered for retrograde urographic procedures, may occasionally occur.
As with all contrast media, intravasation may lead to hypersensitivity reactions such as a sense of warmth, flushing, sneezing, sweating, chills, fever, urticaria, laryngeal edema, bronchospasm, hypertension, hypotension, cardiac arrhythmias and cardiac arrest.
Adverse reactions associated with procedural technique include injury to the urethra, bladder, ureter, and introduction of infection.
In the event of serious or anaphylactoid reactions, it should be kept in mind that the reactions known to occur with intravenous administration of radiopaque contrast materials are possible.
Cysto-Conray II Dosage and Administration
Patient Preparation
Unless contraindicated, an appropriate laxative is given the night before the examination.
Radiographic Technique
The radiographic procedure normally employed for cystography and cystourethrography should be employed. A preliminary radiograph is recommended before the contrast agent is administered.
Administration
Sterile catherization is essential. Cysto-Conray II may be introduced by gravity flow using an appropriate venoclysis set or by syringe. Excessive pressure should be avoided with any method of administration.
Usual Dosage
Cystography and Cystourethrography– Either Conray 43 supplied at 43% w/v or Cysto-Conray II supplied at a 17.2% w/v concentration may be used for these procedures. The desired concentration will vary depending upon the patient’s size and age and also with the technique and equipment used. (SEE CONRAY 43 PACKAGE INSERT FOR SPECIFIC INFORMATION ABOUT THE USE OF THIS PRODUCT.) Sufficient volume of contrast medium is administered to adequately fill the urinary bladder. The volume of solution required will vary depending upon the individual patient. Adults usually require a volume in the range of 200-400 mL. Children require a volume in proportion to their body size. The usual dose ranges from 30 to 300 mL.
How is Cysto-Conray II Supplied
Cysto-CONRAY® II Glass Bottles
NDC Number
12×250 mL single dose bottles
0019-0862-07
12×500 mL single dose bottles
0019-0862-09
Storage
Store below 30°C (86°F). Exposing this product to very cold temperatures may result in crystallization of the salt. If this occurs, the containers should be brought to room temperature. Shake vigorously to assure complete dissolution of any crystals. The speed of dissolution may be increased by heating with circulating warm air. Before use, examine the product to assure that all solids are redissolved and that the container and closure have not been damaged.
This product is sensitive to light and must be protected from strong daylight or direct exposure to the sun.
As with all contrast media, the containers should be inspected prior to use to ensure that breakage or other damage has not occurred during shipping and handling. All containers should be inspected for closure integrity. Damaged containers should not be used.
tyco
Healthcare
MALLINCKRODT
Mallinckrodt Inc.
St. Louis, MO 63042 USA
www.Mallinckrodt.com
MKR 0862302
Revised 3/02 Printed in U.S.A.
Cysto-Conray II
iothalamate meglumine injection
Product Information
Product Type
HUMAN PRESCRIPTION DRUG
NDC Product Code (Source)
0019-0862
Route of Administration
URETHRAL
DEA Schedule
INGREDIENTS
Name (Active Moiety)
Type
Strength
Iothalamate Meglumine (Iothalamic acid)
Active
172 MILLIGRAM In 1 MILLILITER
Edetate Calcium Disodium
Inactive
0.110 MILLIGRAM In 1 MILLILITER
Monobasic Sodium Phosphate
Inactive
0.115 MILLIGRAM In 1 MILLILITER
Product Characteristics
Color
Score
Shape
Size
Flavor
Imprint Code
Contains
Packaging
#
NDC
Package Description
Multilevel Packaging
1
0019-0862-07
12 BOTTLE In 1 BOX
contains a BOTTLE, GLASS
1
250 mL (MILLILITER) In 1 BOTTLE, GLASS
This package is contained within the BOX (0019-0862-07)
2
0019-0862-09
12 BOTTLE In 1 BOX
contains a BOTTLE, GLASS
2
500 mL (MILLILITER) In 1 BOTTLE, GLASS
This package is contained within the BOX (0019-0862-09)
For retrograde cystourethrography
Not intended for intravascular injection
Cystografin Description
Cystografin is a radiopaque contrast agent supplied as a sterile, aqueous solution. Each mL provides 300 mg diatrizoate meglumine with 0.4 mg edetate disodium as a sequestering agent. Each mL of solution also contains approximately 141 mg organically bound iodine. At the time of manufacture, the air in the container is replaced by nitrogen. The preparation should be protected from strong light.
INDICATION
Cystografin is indicated for retrograde cystourethrography.
Contraindications
This preparation is contraindicated in patients with a hypersensitivity to salts of diatrizoic acid.
Warnings
Severe sensitivity reactions are more likely to occur in patients with a personal or family history of bronchial asthma, significant allergies, or previous reactions to contrast agents.
A history of sensitivity to iodine per se or to other contrast agents is not an absolute contraindication to the use of diatrizoate meglumine, but calls for extreme caution in administration.
Precautions
Safe and effective use of this preparation depends upon proper dosage, correct technique, adequate precautions, and readiness for emergencies.
Retrograde cystourethrography should be performed with caution in patients with a known active infectious process of the urinary tract.
Sterile technique should be employed in administration. During administration, care should be taken to avoid excessive pressure, rapid or acute distention of the bladder, and trauma.
Contrast agents may interfere with some chemical determinations made on urine specimens; therefore, urine should be collected before administration of the contrast medium or two or more days afterwards.
Pregnancy—Teratogenic Effects:
Pregnancy Category C
Animal reproduction studies have not been conducted with diatrizoate meglumine injection. It is also not known whether diatrizoate meglumine injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cystografin should be administered to a pregnant woman only if clearly needed.
Adverse Reactions
Retrograde genitourinary procedures may cause such complications as hematuria, perforation of the urethra or bladder, introduction of infection into the genitourinary tract, and oliguria or anuria.
If intravasation of this drug occurs, the reactions which may be associated with intravenous administration may possibly be encountered. Hypersensitivity or anaphylactoid reactions may occur. Severe reactions may be manifested by edema of the face and glottis, respiratory distress, convulsions or shock; such reactions may prove fatal unless promptly controlled by such emergency measures as maintenance of a clear airway and immediate use of oxygen and resuscitative drugs.
Cystografin Dosage and Administration
Preparation of the patient: Appropriate preparation is desirable for optimal results. A laxative the night before the examination and a low residue diet the day before the procedure are recommended.
Dosage: The dose for retrograde use in cystography and voiding cystourethrography ranges from 25 to 300 mL depending on the age of the patient and the degree of bladder irritability; amounts greater than 300 mL may be used if the bladder capacity allows. Best results are obtained when the bladder is filled with the contrast agent. If desired, the preparation may be diluted with sterile water or sterile saline as indicated in the table below.
Administration: After sterile catheterization, the bladder should be filled to capacity with Cystografin using a suitable sterile administration set. Care should be taken to avoid using excessive pressure. The presence of bladder discomfort or reflux and/or spontaneous voiding usually indicates that the bladder is full.
Radiography: The commonly employed radiographic techniques should be used. A scout film is recommended before the contrast agent is administered.
Dilution Table
USE DILUTED SOLUTIONS IMMEDIATELY
100 mL Bottle
Sterile Water or Sterile Saline Added
% Diatrizoate Meglumine w/v
% Organically Bound Iodine w/v
Total Volume
0 mL
30.0
14.1
100 mL
25 mL
24.0
11.3
125 mL
50 mL
20.0
9.4
150 mL
67 mL
18.0
8.5
167 mL
300 mL Bottle
Sterile Water or Sterile Saline Added
0 mL
30.0
14.1
300 mL
50 mL
25.7
12.1
350 mL
How is Cystografin Supplied
Cystografin (Diatrizoate Meglumine Injection USP 30%) is available in 200 mL and 400 mL bottles containing 100 mL and 300 mL of Cystografin respectively with sufficient capacity for dilution up to 167 mL and 350 mL respectively.
Storage
Store at 20-25°C (68-77°F) [See USP].
Protect from light.
Also Available
Cystografin Dilute (Diatrizoate Meglumine Injection USP 18%) is also available, as a 300 mL fill in a 400 mL bottle.
Manufactured for
Bracco Diagnostics Inc.
Princeton, NJ 08543
For retrograde cystourethrography
Not intended for intravascular injection
Cystografin Dilute Description
Cystografin Dilute (Diatrizoate Meglumine Injection USP 18%) is a radiopaque contrast agent supplied as a sterile, aqueous solution. Each mL provides 180 mg diatrizoate meglumine with 0.4 mg edetate disodium as a sequestering agent. Each mL of solution also contains approximately 85 mg organically bound iodine. At the time of manufacture, the air in the container is replaced by nitrogen.
INDICATION
Cystografin Dilute is indicated for retrograde cystourethrography.
Contraindications
This preparation is contraindicated in patients with a hypersensitivity to salts of diatrizoic acid.
Warnings
Severe sensitivity reactions are more likely to occur in patients with a personaI or family history of bronchial asthma, significant allergies, or previous reactions to contrast agents.
A history of sensitivity to iodine per se or to other contrast agents is not an absolute contraindication to the use of diatrizoate meglumine, but calls for extreme caution in administration.
Precautions
Safe and effective use of this preparation depends upon proper dosage, correct technique, adequate precautions, and readiness for emergencies.
Retrograde cystourethrography should be performed with caution in patients with a known active infectious process of the urinary tract.
Sterile technique should be employed in administration. During administration, care should be taken to avoid excessive pressure, rapid or acute distention of the bladder, and trauma.
Contrast agents may interfere with some chemical determinations made on urine specimens; therefore, urine should be collected before administration of the contrast medium or two or more days afterwards.
Pregnancy—Teratogenic Effects:
Pregnancy Category C
Animal reproduction studies have not been conducted with diatrizoate meglumine injection. It is also not known whether diatrizoate meglumine injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cystografin Dilute should be administered to a pregnant woman only if clearly needed.
Adverse Reactions
Retrograde genitourinary procedures may cause such complications as hematuria, perforation of the urethra or bladder, introduction of infection into the genitourinary tract, and oliguria or anuria.
If intravasation of this drug occurs, the reactions which may be associated with intravenous administration may possibly be encountered. Hypersensitivity or anaphylactoid reactions may occur. Severe reactions may be manifested by edema of the face and glottis, respiratory distress, convulsions or shock; such reactions may prove fatal unless promptly controlled by such emergency measures as maintenance of a clear airway and immediate use of oxygen and resuscitative drugs.
Cystografin Dilute Dosage and Administration
Preparation of the patient: Appropriate preparation is desirable for optimal results. A laxative the night before the examination and a low residue diet the day before the procedure are recommended.
Dosage: The dose for retrograde use in cystography and voiding cystourethrography ranges from 25 to 300 mL depending on the age of the patient and the degree of bladder irritability; amounts greater than 300 mL may be used if the bladder capacity allows. Best results are obtained when the bladder is filled with the contrast agent.
Administration: After sterile catheterization, the bladder should be filled to capacity with Cystografin Dilute using a suitable sterile administration set. Care should be taken to avoid using excessive pressure. The presence of bladder discomfort or reflux and/or spontaneous voiding usually indicates that the bladder is full.
Radiography: The commonly employed radiographic techniques should be used. A scout film is recommended before the contrast agent is administered.
How is Cystografin Dilute Supplied
Cystografin Dilute (Diatrizoate Meglumine Injection USP 18%) is available in packages of ten 300 mL bottIes (NDC 0270-1410-30).
Storage
Store at 20–25°C (68–77°F) [See USP]; protect from light.
Manufactured for
Bracco Diagnostics Inc.
Princeton, NJ 08543
Generic Name: gonadorelin diacetate tetrahydrate
Dosage Form: FOR ANIMAL USE ONLY
Cystorelin®
(Gonadorelin Diacetate Tetrahydrate)
FOR INJECTION
For the treatment of cystic ovaries in cattle
CAUTION
Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.
Cystorelin Description
Cystorelin® is a sterile solution containing 50 micrograms of gonadorelin (GnRH) diacetate tetrahydrate per milliliter suitable for intramuscular or intravenous administration. Gonadorelin is a decapeptide composed of the sequence of amino acids–
5-oxoPro-His-Trp-Ser-Tyr-Gly-Leu-Arg-Pro-Gly-NH2–
a molecular weight of 1182.32 and empirical formula C55H75N17O13. The diacetate tetrahydrate ester has a molecular weight of 1374.48 and empirical formula C59H91N17O21.
Gonadorelin is the hypothalamic releasing factor responsible for the release of gonadotropins (e.g., LH, FSH) from the anterior pituitary. Synthetic gonadorelin is physiologically and chemically identical to the endogenous bovine hypothalamic releasing factor.
PHARMACOLOGY AND TOXICOLOGY
Endogenous gonadorelin is synthesized and/or released from the hypothalamus during various stages of the bovine estrus cycle following appropriate neurogenic stimuli. It passes via the hypophyseal portal vessels, to the anterior pituitary to effect the release of gonadotropins (e.g. LH, FSH) Synthetic gonadorelin administered intravenously or intramuscularly also causes the release of endogenous LH or FSH from the anterior pituitary.
Gonadorelin diacetate tetrahydrate has been shown to be safe. The LD50 for mice and rats is greater than 60 mg/kg, and for dogs, greater than 600 mcg/kg, respectively. No untoward effects were noted among rats or dogs administered 120 mcg/kg/day or 72 mcg/kg/day intravenously for 15 days.
It has no adverse effects on heart rate, blood pressure, or EKG to unanesthetized dogs at 60 mcg/kg. In anesthetized dogs it did not produce depression of myocardial or system hemodynamics or adversely affect coronary oxygen supply or myocardial oxygen requirements.
The intravenous administration of 60 mcg/kg/day of gonadorelin diacetate tetrahydrate to pregnant rats and rabbits during organogenesis did not cause embryotoxic or teratogenic effects.
The intramuscular administration of 1000 mcg to normally cycling dairy cattle had no effect on hematology or blood chemistry.
Further, Cystorelin does not cause irritation at the site of intramuscular administration in dogs. The dosage administered was 72 mcg/kg/day for seven (7) days.
INDICATIONS AND DOSAGE
Cystorelin® is indicated for the treatment of ovarian follicular cysts in dairy cattle. Ovarian cysts are non-ovulated follicles with incomplete luteinization which result in nymphomania or irregular estrus.
Historically, cystic ovaries have responded to an exogenous source of luteinizing hormone (LH) such as human chorionic gonadotropin. Cystorelin initiates release of endogenous LH to cause ovulation and luteinization.
The recommended intravenous or intramuscular dosage of Cystorelin is 100 mcg (2 mL) per cow.
Each mL of Cystorelin contains:
Gonadorelin diacetate tetrahydrate
50 mcg
Benzyl Alcohol
9 mg
Sodium Chloride
7.47 mg
Water for Injection, U.S.P.
q.s.
pH adjusted with potassium phosphate (monobasic and dibasic).
Precautions
Not for use in humans.
Keep this and all drugs out of reach of children.
The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects in users, to obtain an MSDS, or for assistance call 1-888-637-4251.
KEEP REFRIGERATED: 2–8°C (36–46°F).
Discard remaining product 90 days after first use.
How is Cystorelin Supplied
Cystorelin is available in a concentration of 50 mcg/mL pH adjusted with potassium phosphate (monobasic and dibasic).
Cystorelin is supplied in multi-dose vials containing 10 mL and 30 mL of sterile solution.
Marketed by:
Merial LLC
Duluth, GA 30096-4640 U.S.A.
Hyoscyamine produces many effects in the body, including relief from muscle spasms.
Hyoscyamine also reduces the fluid secretions of many organs and glands in the body, such as the stomach, pancreas, lungs, saliva glands, sweat glands, and nasal passages.
Hyoscyamine is used to treat many different stomach and intestinal disorders, including peptic ulcer and irritable bowel syndrome. It is also used to control muscle spasms in the bladder, kidneys, or digestive tract, and to reduce stomach acid. Hyoscyamine is sometimes used to reduce tremors and rigid muscles in people with symptoms of Parkinson’s disease.
Hyoscyamine is also used as a drying agent to control excessive salivation, runny nose, or excessive sweating.
Hyoscyamine may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about Cystospaz (hyoscyamine)?
Do not take hyoscyamine if you are allergic to it, or if you have kidney disease, a bladder or intestinal obstruction, severe ulcerative colitis, toxic megacolon, glaucoma, or myasthenia gravis.
Before taking hyoscyamine, tell your doctor if you have heart disease, congestive heart failure, a heart rhythm disorder, high blood pressure, overactive thyroid, or hiatal hernia with gastroesophageal reflux disease.
Avoid taking antacids at the same time you take hyoscyamine. Antacids can make it harder for your body to absorb hyoscyamine. If you use an antacid, take it after you have taken hyoscyamine and eaten a meal.
Hyoscyamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase drowsiness and dizziness while you are taking hyoscyamine.
Avoid becoming overheated or dehydrated during exercise and in hot weather. Hyoscyamine can decrease sweating and you may be more prone to heat stroke.
What should I discuss with my healthcare provider before taking Cystospaz (hyoscyamine)?
Do not take hyoscyamine if you are allergic to it, or if you have:
kidney disease;
an enlarged prostate or problems with urination;
intestinal blockage;
severe ulcerative colitis, or toxic megacolon;
glaucoma; or
myasthenia gravis.
If you have any of these other conditions, you may need a hyoscyamine dose adjustment or special tests:
heart disease, congestive heart failure;
a heart rhythm disorder;
high blood pressure;
overactive thyroid; or
hiatal hernia with GERD (gastroesophageal reflux disease).
FDA pregnancy category C. It is not known whether hyoscyamine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Hyoscyamine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I take Cystospaz (hyoscyamine)?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Your medication may come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Do not crush, chew, or open an extended-release tablet or capsule. It is specially made to release medicine slowly in the body. Breaking or crushing the pill would cause too much of the drug to be released at one time. Your doctor may want you to break an extended-release tablet and take only half of it. Follow your doctor’s instructions.
Measure the oral liquid form of hyoscyamine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
The sublingual tablet form of this medication must be placed under the tongue, where it will dissolve. Do not swallow the sublingual tablet whole or wash it down with water. You may drink water after the pill has completely dissolved in your mouth.
Before using hyoscyamine oral spray for the first time, you must prime the spray pump. To do this, spray 3 test sprays into the air and away from your face. Prime the spray pump at least 1 test spray any time you have not used the oral spray for longer than 2 days. Spray until a fine mist appears.
After using the oral spray, try not to swallow right away. Do not rinse your mouth or spit for 5 to 10 minutes after using the oral spray.
Hyoscyamine is usually taken before a meal. Follow your doctor’s instructions.
Store this medication at room temperature away from moisture and heat.
Do not use hyoscyamine oral spray for more than 30 sprays, even if there is medicine still left in the bottle.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine 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 headache, dizziness, dry mouth, trouble swallowing, nausea, vomiting, blurred vision, hot dry skin, and feeling restless or nervous.
What should I avoid while taking Cystospaz (hyoscyamine)?
Avoid taking antacids at the same time you take hyoscyamine. Antacids can make it harder for your body to absorb hyoscyamine. If you use an antacid, take it after you have taken hyoscyamine and eaten a meal.
Hyoscyamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase drowsiness and dizziness while you are taking hyoscyamine.
Avoid becoming overheated or dehydrated during exercise and in hot weather. Hyoscyamine can decrease sweating and you may be more prone to heat stroke.
Cystospaz (hyoscyamine) 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 hyoscyamine and call your doctor at once if you have any of these serious side effects:
diarrhea;
confusion, hallucinations;
unusual thoughts or behavior;
fast, pounding, or uneven heart rate;
rash or flushing (warmth, redness, or tingly feeling); or
eye pain.
Less serious side effects may include:
dizziness, drowsiness, feeling nervous;
blurred vision, headache;
sleep problems (insomnia);
nausea, vomiting, bloating, heartburn, or constipation;
changes in taste;
problems with urination;
decreased sweating;
dry mouth; or
impotence, loss of interest in sex, or trouble having an orgasm.
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 Cystospaz (hyoscyamine)?
Tell your doctor about all other medicines you use, especially:
amantadine (Symmetrel);
haloperidol (Haldol);
an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);
phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril), or trifluoperazine (Stelazine); or
an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.
This list is not complete and other drugs may interact with hyoscyamine. 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?
Your pharmacist can provide more information about hyoscyamine.
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.
Generic Name: aminoglutethimide (ah mee no glue TEH tha mide)
Brand Names: Cytadren
What is Cytadren (aminoglutethimide)?
Aminoglutethimide is an anti-hormone medication. Aminoglutethimide interferes with the body’s production of certain hormones.
Aminoglutethimide is used in the treatment of conditions which cause the body to make too much of certain hormones (Cushing’s syndrome).
Aminoglutethimide may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about Cytadren (aminoglutethimide)?
Aminoglutethimide should only be administered under the supervision of a qualified healthcare provider experienced with its use and hazards. Treatment should usually begin in a hospital.
Use caution when driving, operating machinery, or performing other hazardous activities. Aminoglutethimide may cause drowsiness and dizziness. If you experience drowsiness or dizziness, avoid these activities. Use alcohol cautiously. Alcohol may increase the effects of aminoglutethimide.
Aminoglutethimide may stop your body from responding to conditions of stress, such as surgery, injury, or sudden illness. Talk to your doctor about the possible side effects from treatment with aminoglutethimide.
What should I discuss with my healthcare provider before taking Cytadren (aminoglutethimide)?
Do not use aminoglutethimide without first talking to your doctor if you have recently had:
a serious injury;
surgery; or
a serious illness.
You may not be able to use aminoglutethimide, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Aminoglutethimide is in the FDA pregnancy category D. This means that it is known to be harmful to an unborn baby. Do not use aminoglutethimide without first talking to your doctor if you are pregnant or could become pregnant during treatment. Discuss with your doctor the appropriate use of birth control during treatment. It is not known whether aminoglutethimide passes into breast milk. Do not take aminoglutethimide without first talking to your doctor if you are breast feeding a baby.
How should I use Cytadren (aminoglutethimide)?
Aminoglutethimide should only be administered under the supervision of a qualified healthcare provider experienced with its use and hazards. Treatment should usually begin in a hospital.
Take each oral dose with a full glass of water.
Your doctor will determine the correct amount and frequency of treatment with aminoglutethimide depending upon your condition. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.
Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with aminoglutethimide to monitor progress and side effects.
Store aminoglutethimide at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the dose you missed and take only the next dose as directed. Do not take a double dose. A double dose of this medication could be dangerous.
What happens if I overdose?
Seek emergency medical attention.
Symptoms of a aminoglutethimide overdose may include decreased breathing, dizziness, fainting, sleepiness, poor coordination, weakness, coma, nausea, and vomiting.
What should I avoid while using Cytadren (aminoglutethimide)?
Use caution when driving, operating machinery, or performing other hazardous activities. Aminoglutethimide may cause drowsiness and dizziness. If you experience drowsiness or dizziness, avoid these activities. Use alcohol cautiously. Alcohol may increase the effects of aminoglutethimide.
Cytadren (aminoglutethimide) side effects
If you experience any of the following serious side effects from aminoglutethimide, contact your doctor immediately:
an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or
fainting or dizziness, especially when standing up.
Other, less serious side effects may be more likely to occur. Continue taking aminoglutethimide and talk to your doctor if you experience:
dizziness, drowsiness, poor coordination, or weakness;
nausea, vomiting, or loss of appetite;
headache; or
rash and itching.
Other side effects have also been reported. Discuss with your doctor any side effect that occurs during treatment with aminoglutethimide.
What other drugs will affect Cytadren (aminoglutethimide)?
Before using aminoglutethimide, tell your doctor if you are taking any of the following:
You may not be able to take aminoglutethimide, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the drugs listed above.
Drugs other than those listed here may also interact with aminoglutethimide. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with aminoglutethimide.
Where can I get more information?
Your healthcare provider may have additional information about aminoglutethimide that you may read.
What does my medication look like?
Aminoglutethimide is available with a prescription under the brand name Cytadren. Other brand or generic formulations may also be available. Ask your healthcare provider or pharmacist any questions you have about this medication, especially if it is new to you.
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.