Cormax

clobetasol propionate

Dosage Form: ointment

Cormax® Ointment 0.05% (Clobetasol Propionate Ointment, USP)

Rx only

For Dermatologic Use Only - Not for Ophthalmic Use.

Cormax Description

Cormax Ointment contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.


Chemically, clobetasol propionate is 21-Chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione,17-propionate and it has the following structural formula:

Clobetasol propionate has the molecular formula C25H32ClF05 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.

Each gram of Cormax Ointment contains 0.5 mg clobetasol propionate in a base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum.

Cormax - Clinical Pharmacology

The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects. Topical corticosteroids such as clobetasol propionate are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain.


Clobetasol propionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids, including clobetasol propionate, is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings (see DOSAGE AND ADMINISTRATION).


As with all topical corticosteroids, clobetasol propionate can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see DOSAGE AND ADMINISTRATION).


Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similarly to systemically administered corticosteroids.


Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids, including clobetasol propionate and its metabolites, are also excreted into the bile.


Clobetasol propionate ointment has been shown to depress the plasma levels of adrenal cortical hormones following repeated nonocclusive application to diseased skin in patients with psoriasis and eczematous dermatitis. These effects have been shown to be transient and reversible upon completion of a two-week course of treatment.

Indications and Usage for Cormax

Cormax Ointment is indicated for short-term treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.


This product is not recommended for use in pediatric patients under 12 years of age.

Contraindications

Cormax Ointment is contraindicated in patients who are hypersensitive to clobetasol propionate, to other corticosteroids, or to any ingredient in th is preparation.

Precautions

General: Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 g per day.

Systemic absorption of topical corticosteroids has resulted in reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.


Conditions that augment systemic absorption include the application of more potent corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an allempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.


Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.


Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS: Pediatric Use).


If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.


In the presence of dermatologic infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued unti l the infection has been adequately controlled.


Certain areas of the body, such as the face, groin, and axillae, are more prone to atrophic changes than other areas of the body following treatment with corticosteroids. Frequent observation of the patient is important if these areas are to be treated.


As with other potent topical corticosteroids, Cormax Ointment should not be used in the treatment of rosacea and perioral dermatitis. Topical corticosteroids in general should not be used in the treatment of acne or as sole therapy in widespread plaque psoriasis.

Information for Patients

Patients using Cormax Ointment should receive the following information and instructions:

1. This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. It is for external use only Avoid contact with the eyes.


2. This medication should not be used for any disorder other than that for which it is prescribed.


3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive.


4. Patients should report any signs of local adverse reactions to the physician.

Laboratory Tests

The following tests may be helpful in evaluating HPA axis suppression:

    Urinary free cortisol test

    ACTH stimulation test

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.


Studies to determine mutagenicity with prednisolone have revealed negative results.

Pregnancy

Teratogenic Effects: Pregnancy Category C: The more potent corticosteroids have been shown to be teratogenic in animals after dermal application. Clobetasol propionate has not been tested for teratogenicity by this route; however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and the mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent.


There are no adequate and well-controlled studies of the teratogenic effects of topically applied corticosteroids, including clobetasol, in pregnant women. Therefore, clobetasol and other topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and they should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk.

Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are prescribed for a nursing woman.

Pediatric Use

Use of Cormax Ointment in pediatric patients under 12 years of age is not recommended.


Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.


HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use

Clinical studies of clobetasol propionate scalp application, 0.05% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported ctinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious.

Adverse Reactions

Cormax Ointment is generally well tolerated when used for two-week treatment periods. The most frequent adverse reactions reported for clobetasol propionate ointment have been local and have included burning sensation, irritation, and itching. These occured in approximately 0.5% of the patients. Less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of  fingers, skin atrophy, and telangiectasia, which occurred in approximately 0.3% of the patients.


The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions are listed in an approximately decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatifis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. In rare instances, treatment (or withdrawal of treatment) of psoriasis with corticosteroids is thought to have exacerbated the disease or provoked the pustular form of the disease, so careful patient supervision is recommended.

Overdosage

Topically applied Cormax Ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Cormax Dosage and Administration

A thin layer of Cormax Ointment should be applied with gentle rubbing to the affected skin area twice daily, once in the morning and once at night.


Cormax Ointment is potent; therefore, treatment must be limited to two consecutive weeks, and amounts greater than 50 g per week should not be used, Cormax Ointment is not to be used with occlusive dressings.

How is Cormax Supplied

Cormax Ointment, 0.05% is supplied in

15 g (NDC 52544-048-86), and

45 g (NDC 52544-048-89) tubes. Store at controlled room temperature 20-25°C (68-77°F). Do not refrigerate. Rx only


Keep out of reach of children.


Manufactured for:

Watson Pharmaceuticals, Inc.

Corona, CA 92880 USA


Manufactured by:

DPT Laboratories, Lid.

San Antonio, TX 78215 USA


Revised: June 2008

128717-0608

S0608

Principal Display Panel

New NDC#

NDC 52544-048-89      45g Tube

Cormax Ointment 0.05%

(Clobetasol Propionate Ointment, USP)

Watson      Rx Only

Cormax  clobetasol propionate  ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63094-0048 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOBETASOL PROPIONATE (CLOBETASOL) CLOBETASOL PROPIONATE 0.5 mg  in 1 g

Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL   PETROLATUM

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63094-0048-6 1 TUBE In 1 CARTON contains a TUBE 1 15 g In 1 TUBE This package is contained within the CARTON (63094-0048-6) 2 63094-0048-9 1 TUBE In 1 CARTON contains a TUBE 2 45 g In 1 TUBE This package is contained within the CARTON (63094-0048-9)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074221	09/18/2008	01/27/2010

Labeler - DPT Laboratories, Ltd. (832224526)

Registrant - DPT Laboratories, Ltd. (832224526)

Establishment
Name	Address	ID/FEI	Operations
DPT Laboratories, Ltd.		832224526	manufacture

Revised: 01/2010DPT Laboratories, Ltd.

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• Cormax Drug Interactions
• Cormax Support Group
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• Cormax Concise Consumer Information (Cerner Multum)


• Cormax Advanced Consumer (Micromedex) - Includes Dosage Information


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Sudafed Cold/Cough

Pronunciation: a-seet-a-MIN-oh-fen/dex-troe-meth-OR-fan/gwye-FEN-e-sin/sue-doe-eh-FED-rin
Generic Name: Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine
Brand Name: Examples include Robitussin Cold/Cough/Flu and Sudafed Cold/Cough

Sudafed Cold/Cough is used for:

Relieving pain, congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Sudafed Cold/Cough is an analgesic, decongestant, cough suppressant, and expectorant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, loosening mucus and lung secretions in the chest, and making coughs more productive. The analgesic and cough suppressant works in the brain to decrease pain and to help decrease the cough reflex to reduce a dry cough.

Do NOT use Sudafed Cold/Cough if:

• you are allergic to any ingredient in Sudafed Cold/Cough


• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)


• you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sudafed Cold/Cough:

Some medical conditions may interact with Sudafed Cold/Cough. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of glaucoma, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, seizures, stroke, or liver problems, or if you consume more than 3 alcohol-containing drinks per day


• if you have a chronic cough, lung problems (eg, asthma, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with Sudafed Cold/Cough. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects from Sudafed Cold/Cough may be increased


• Anticoagulants (eg, warfarin), digoxin, or droxidopa because the risk of side effects such as bleeding, irregular heartbeat or heart attack may be increased


• Bromocriptine because the risk of side effects may be increased by Sudafed Cold/Cough


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Sudafed Cold/Cough

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sudafed Cold/Cough 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 Sudafed Cold/Cough:

Use Sudafed Cold/Cough as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Sudafed Cold/Cough may be taken with or without food.


• Drink plenty of water while taking Sudafed Cold/Cough.


• If you miss a dose of Sudafed Cold/Cough, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Sudafed Cold/Cough.

Important safety information:

• Sudafed Cold/Cough may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Sudafed Cold/Cough. Using Sudafed Cold/Cough alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Do not take appetite suppressants while you are taking Sudafed Cold/Cough without checking with your doctor.


• Sudafed Cold/Cough contains acetaminophen and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.


• Do NOT exceed the recommended dose or take Sudafed Cold/Cough for longer than prescribed without checking with your doctor.


• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.


• Sudafed Cold/Cough may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Sudafed Cold/Cough or other pain relievers/fever reducers. Alcohol use combined with Sudafed Cold/Cough may increase your risk for liver damage.


• Sudafed Cold/Cough may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Sudafed Cold/Cough.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Sudafed Cold/Cough.


• Use Sudafed Cold/Cough with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using Sudafed Cold/Cough in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Sudafed Cold/Cough, discuss with your doctor the benefits and risks of using Sudafed Cold/Cough during pregnancy. It is unknown if Sudafed Cold/Cough is excreted in breast milk. Do not breast-feed while taking Sudafed Cold/Cough.

Possible side effects of Sudafed Cold/Cough:

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:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; yellowing of skin or eyes.

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Sudafed Cold/Cough side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; stomach pain; unusually fast, slow, or irregular heartbeat; vomiting; yellowing of skin or eyes.

Proper storage of Sudafed Cold/Cough:

Store Sudafed Cold/Cough at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sudafed Cold/Cough out of the reach of children and away from pets.

General information:

• If you have any questions about Sudafed Cold/Cough, please talk with your doctor, pharmacist, or other health care provider.


• Sudafed Cold/Cough 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.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Sudafed Cold/Cough. 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.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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Furadantin

Generic Name: nitrofurantoin (NYE troe fue RAN toin)

Brand Names: Furadantin, Macrobid, Macrodantin

What is Furadantin (nitrofurantoin)?

Nitrofurantoin is an antibiotic that fights bacteria in the body.

Nitrofurantoin is used to treat urinary tract infections.

Nitrofurantoin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Furadantin (nitrofurantoin)?

You should not take nitrofurantoin if you are allergic to it, or if you have severe kidney disease, urination problems, or a history of jaundice or liver problems caused by nitrofurantoin. Do not take nitrofurantoin if you are in the last 2 to 4 weeks of pregnancy.

Before you take nitrofurantoin, tell your doctor if you have kidney disease, anemia, diabetes, an electrolyte imbalance or vitamin B deficiency, a genetic enzyme deficiency, or any type of debilitating disease.

Take nitrofurantoin with food. Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb nitrofurantoin. Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Nitrofurantoin will not treat a viral infection such as the common cold or flu. Stop taking this medication and call your doctor at once if you have sudden chest pain, dry cough, or breathing problems.

What should I discuss with my healthcare provider before taking Furadantin (nitrofurantoin)?

You should not take nitrofurantoin if you are allergic to it, or if you have:

• severe kidney disease;


• 
  

  a history of jaundice or liver problems caused by taking nitrofurantoin;

  
  


• 
  

  if you are urinating less than usual or not at all; or

  
  


• 
  

  if you are in the last 2 to 4 weeks of pregnancy.

  
  

To make sure you can safely take nitrofurantoin, tell your doctor if you have any of these other conditions:

• 
  

  kidney disease;

  
  


• 
  

  anemia;

  
  


• 
  

  diabetes;

  
  


• 
  

  an electrolyte imbalance or vitamin B deficiency;

  
  


• 
  

  glucose-6-phosphate dehydrogenase (G6PD) deficiency; or

  
  


• 
  

  any type of debilitating disease.

  
  

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby, unless it is used during the last 2 to 4 weeks of pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Nitrofurantoin can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking nitrofurantoin.

How should I take Furadantin (nitrofurantoin)?

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.

Take each dose with a full glass of water. Take nitrofurantoin with food. Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

You may mix your liquid dose with water, milk, or fruit juice to make it easier to swallow. Drink the entire mixture right away.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Nitrofurantoin is usually given for up to 1 week after lab tests show that the infection has cleared. Nitrofurantoin will not treat a viral infection such as the common cold or flu.

If you use this medication long-term, your kidney, liver, and lung function will need to be tested often. Visit your doctor regularly.

This medication can cause you to have unusual results with certain urine glucose (sugar) tests. Tell any doctor who treats you that you are using nitrofurantoin.

Store at room temperature away from moisture, heat, and light. Do not freeze.

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.

What should I avoid while taking Furadantin (nitrofurantoin)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb nitrofurantoin.

Furadantin (nitrofurantoin) 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 nitrofurantoin and call your doctor at once if you have a serious side effect such as:

• 
  

  diarrhea that is watery or bloody;

  
  


• 
  

  shortness of breath, running out of breath easily;

  
  


• 
  

  sudden chest pain or discomfort, wheezing, dry cough or hack;

  
  


• 
  

  fever, chills, body aches, unexplained weight loss;

  
  


• 
  

  peripheral neuropathy - numbness, tingling, or pain in your hands or feet;

  
  


• 
  

  nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  pale skin, easy bruising, confusion or weakness;

  
  


• 
  

  patchy skin color, red spots, or a severe blistering, peeling, and red skin rash; or

  
  


• 
  

  severe headache, ringing in your ears, dizziness, vision problems, pain behind your eyes.

  
  

Less serious side effects may include:

• 
  

  upset stomach, vomiting;

  
  


• 
  

  mild diarrhea;

  
  


• 
  

  rust-colored or brownish urine; or

  
  


• 
  

  vaginal itching or discharge.

  
  

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 Furadantin (nitrofurantoin)?

Tell your doctor about all other medicines you use, especially:

• 
  

  magnesium salicylate (Nuprin Backache, Doan's Pills);

  
  


• 
  

  choline magnesium salicylate (Tricosal, Trilisate); or

  
  


• 
  

  probenecid (Benemid) or other gout medications.

  
  

This list is not complete and other drugs may interact with nitrofurantoin. 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.

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• Furadantin Side Effects (in more detail)
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• Furadantin Prescribing Information (FDA)


• Furadantin Advanced Consumer (Micromedex) - Includes Dosage Information


• Furadantin Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Nitrofurantoin Professional Patient Advice (Wolters Kluwer)


• Nitrofurantoin Monograph (AHFS DI)


• Macrobid Prescribing Information (FDA)


• Macrobid MedFacts Consumer Leaflet (Wolters Kluwer)


• Macrobid Consumer Overview


• Macrodantin Prescribing Information (FDA)


• Macrodantin MedFacts Consumer Leaflet (Wolters Kluwer)

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Where can I get more information?

• Your pharmacist can provide more information about nitrofurantoin.

See also: Furadantin side effects (in more detail)

Multi-Nate 30 Prenatal Multivitamin and Minerals

Multi-Nate 30

Other Ingredients

Other Ingredients: Mono and Diglycerides, Croscarmellose Sodium, Microcrystalline Cellulose, Crospovidone, Maltodextrin, Stearic Acid, Magnesium Stearate, Silicon Dioxide, Acacia, Sodium Alginate, Polyethylene Glycol, Arabic Gum, Gelatin, Sucrose, Pea Starch, Cornstarch, Partially Hydrogenated Soybean Oil, Hydroxypropyl Methylcelluslose, Dicalcium Phosphate, dI-alpha Tocopherol, Titanium Dioxide, Triacetin, Carmine Powder, Polysorbate, Riboflaving.

Contains Soy.

May contain Povidone and Polydextrose.


Contains No artificial flavors or preservatives, yeast, wheat (gluten), nuts or milk based by-products.

Indications and Usage for Multi-Nate 30 Prenatal Multivitamin and Minerals

Multi-Nate 30 is indicated to provide vitamin and mineral supplementation throughout pregnancy and during postnatal period for the lactating and non-lactating mother. It is also useful for improving the nutritional status prior to conception.


Multi-Nate 30: Contains 1 mg folic acid, which is very important in the development of the baby’s spinal column during a specific period of time. Women are advised to start taking folate supplementation several weeks before conception and to continue taking them through the first 12 weeks of pregnancy, or longer. It is recommended that all women of childbearing years take supplements containing folic acid.

Contraindications

Folic acid (pteroylglutamic acid) is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.


WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or a poison control center immediately.

Warnings

Pernicious anemia should be ruled out before starting treatment. While folic acid corrects the blood picture pernicious anemia, it does not ameliorate the attendant neurologic involvement.

Resistance to treatment may be due to depressed hematopoiesis alcoholism, the presence of anti-metabolic drugs, and to deficiencies of vitamins.

Precautions

Folic acid (pteroylglutamic acid) and Vitamin B12 microbiological blood assays are invalidated by the administration of most antibiotics, methotrexate, and pyrimethamine. Folic acid (pteroylglutamic acid) is not effective reversing the toxic effects of methotrexate. Folinic acid (5-formyltetrahydrofolic acid) must be used in that situation. Black tarry stools may be due to either occult GI bleeding or iron therapy or both.


Folic acid may partially correct the hematological damage due to Vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses. In rare instances allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Adverse Reactions

Allergic sensitivity reactions and gastrointestinal disturbances may occur.

Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088.

Multi-Nate 30 Prenatal Multivitamin and Minerals Dosage and Administration

Before, during and after pregnancy, take one tablet by mouth daily, or as directed by a physician.

How is Multi-Nate 30 Prenatal Multivitamin and Minerals Supplied

Multi-Nate 30 is available as a dark pink tablet imprinted “RE 316”: bottles of 100 tablets NDC 68032-444-10. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Store a controlled room temperature 15-30C (59-86F).

Keep in a cool, dry place.


WARNING: Keep this and all drugs out of reach of children.

Caution: Rx Only

PACKAGING

MULTI-NATE 30   beta carotene, ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68032-444 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETA CAROTENE (BETA CAROTENE) BETA CAROTENE 3000 [iU] ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU] ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 30 mg THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE 1.8 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 4 mg NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug CALCIUM CARBONATE (CALCIUM) CALCIUM CARBONATE 200 mg IRON (IRON) IRON 29 mg MAGNESIUM OXIDE (MAGNESIUM) MAGNESIUM OXIDE 25 mg ZINC OXIDE (ZINC) ZINC OXIDE 25 mg CUPRIC OXIDE (CUPRIC CATION) CUPRIC OXIDE 2 mg

Inactive Ingredients Ingredient Name Strength CAPRYLIC/CAPRIC MONO/DIGLYCERIDES   CROSCARMELLOSE SODIUM   CELLULOSE, MICROCRYSTALLINE   CROSPOVIDONE   MALTODEXTRIN   STEARIC ACID   MAGNESIUM STEARATE   SILICON DIOXIDE   ACACIA   SODIUM ALGINATE   POLYETHYLENE GLYCOL   SUCROSE   STARCH, CORN   HYDROGENATED SOYBEAN OIL   HYPROMELLOSE 2208 (100 MPA.S)   ANHYDROUS DIBASIC CALCIUM PHOSPHATE   ALPHA-TOCOPHEROL, DL-   TITANIUM DIOXIDE   TRIACETIN   POLYSORBATE 20   RIBOFLAVIN

Product Characteristics Color pink Score no score Shape CAPSULE Size 20mm Flavor Imprint Code RE;316 Contains

Packaging # NDC Package Description Multilevel Packaging 1 68032-444-10 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/01/2009	11/30/2011

Labeler - River's Edge Pharmaceuticals, LLC (133879135)

Revised: 12/2010River's Edge Pharmaceuticals, LLC

More Multi-Nate 30 Prenatal Multivitamin and Minerals resources

• Multi-Nate 30 Prenatal Multivitamin and Minerals Use in Pregnancy & Breastfeeding
• Drug Images
• Multi-Nate 30 Prenatal Multivitamin and Minerals Drug Interactions
• Multi-Nate 30 Prenatal Multivitamin and Minerals Support Group
• 21 Reviews for Multi-Nate 30 Prenatal Multivitamin and Minerals - Add your own review/rating

Compare Multi-Nate 30 Prenatal Multivitamin and Minerals with other medications

• Vitamin/Mineral Supplementation during Pregnancy/Lactation

chlorpropamide

klor-PROE-pa-mide

Commonly used brand name(s)

In the U.S.

• Diabinese

Available Dosage Forms:

• Tablet

Therapeutic Class: Hypoglycemic

Chemical Class: 1st Generation Sulfonylurea

Uses For chlorpropamide

Chlorpropamide is used to treat high blood sugar levels caused by a type of diabetes mellitus called type 2 diabetes. In type 2 diabetes, your body does not work properly to store excess sugar and the sugar remains in your blood. High blood sugar over a long time can lead to serious health problems.

Proper diet is the first step in managing type 2 diabetes, but often medicines are needed. Chlorpropamide belongs to a class of drugs called sulfonylureas. It increases the release of insulin from the pancreas, which helps your body store sugar. This also lowers the level of sugar in the blood and restores the way you use food to make energy.

chlorpropamide is available only with your doctor's prescription.

Before Using chlorpropamide

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 chlorpropamide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to chlorpropamide 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

Appropriate studies have not been performed on the relationship of age to the effects of chlorpropamide in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of chlorpropamide have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of chlorpropamide in the elderly. However, elderly patients are more likely to have age-related liver or kidney problems, which may require an adjustment in the dose for patients receiving chlorpropamide.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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. When you are taking chlorpropamide, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using chlorpropamide 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.

• Acarbose


• Alatrofloxacin


• Balofloxacin


• Ciprofloxacin


• Clinafloxacin


• Disopyramide


• Enoxacin


• Fleroxacin


• Flumequine


• Gatifloxacin


• Gemifloxacin


• Grepafloxacin


• Levofloxacin


• Lomefloxacin


• Moxifloxacin


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Prulifloxacin


• Rufloxacin


• Sparfloxacin


• Temafloxacin


• Tosufloxacin


• Trovafloxacin Mesylate

Using chlorpropamide 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.

• Acebutolol


• Aceclofenac


• Acemetacin


• Alclofenac


• Alprenolol


• Apazone


• Aspirin


• Atenolol


• Benoxaprofen


• Betaxolol


• Bevantolol


• Bisoprolol


• Bitter Melon


• Bromfenac


• Bucindolol


• Bufexamac


• Carprofen


• Carteolol


• Carvedilol


• Celiprolol


• Chloramphenicol


• Chlorthalidone


• Clofibrate


• Clometacin


• Clonixin


• Clorgyline


• Dexketoprofen


• Diclofenac


• Diflunisal


• Dilevalol


• Dipyrone


• Droxicam


• Esmolol


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Fenugreek


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Garlic


• Glucomannan


• Guar Gum


• Hydrochlorothiazide


• Ibuprofen


• Indomethacin


• Indoprofen


• Iproniazid


• Isocarboxazid


• Isoxicam


• Ketoprofen


• Ketorolac


• Labetalol


• Levobunolol


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Mepindolol


• Metipranolol


• Metoprolol


• Moclobemide


• Nabumetone


• Nadolol


• Naproxen


• Nebivolol


• Nialamide


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxprenolol


• Oxyphenbutazone


• Pargyline


• Penbutolol


• Phenelzine


• Phenylbutazone


• Pindolol


• Pirazolac


• Piroxicam


• Pirprofen


• Procarbazine


• Propranolol


• Propyphenazone


• Proquazone


• Psyllium


• Rifampin


• Rifapentine


• Selegiline


• Sotalol


• Sulfadiazine


• Sulfamethoxazole


• Sulindac


• Suprofen


• Talinolol


• Tenidap


• Tenoxicam


• Tertatolol


• Tiaprofenic Acid


• Timolol


• Tolmetin


• Toloxatone


• Tranylcypromine


• Zomepirac

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using chlorpropamide with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use chlorpropamide, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of chlorpropamide. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol intoxication or


• Underactive adrenal glands or


• Underactive pituitary gland or


• Undernourished condition or


• Weakened physical condition—May cause side effects to become worse.

• Diabetic ketoacidosis (ketones in the blood) or


• Type I diabetes—Should not be used in patients with these conditions.

• Glucose 6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem)—Use with caution. May cause hemolytic anemia (blood disorder) in patients with this condition.

• Heart or blood vessel disease—Use with caution. May make this condition worse.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of chlorpropamide

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

You should take your medicine each morning with breakfast.

Dosing

The dose of chlorpropamide 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 chlorpropamide. 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 type 2 diabetes:
    
    • Adults—At first, 250 milligrams (mg) once a day. Your doctor may adjust your dose as needed. The dose is usually not more than 750 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of chlorpropamide, 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using chlorpropamide

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide whether you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

It is very important to carefully follow any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.


• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.


• Travel—Keep your recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.


• In case of an emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes and a list of all of your medicines.

Check with your doctor right away if you start having chest pain or discomfort; nausea; pain or discomfort in arms, jaw, back, or neck; shortness of breath; sweating; or vomiting while you are using chlorpropamide. These may be symptoms of a serious heart problem, including a heart attack.

Chlorpropamide can cause hypoglycemia (low blood sugar). However, this can also occur if you delay or miss a meal or snack, drink alcohol, exercise more than usual, cannot eat because of nausea or vomiting, take certain medicines, or take chlorpropamide with another type of diabetes medicine. The symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have, so you can treat it quickly.

Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty with thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drink, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. Members of your household also should know how to use it.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

chlorpropamide 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:

Rare

• Abdominal or stomach pain


• agitation


• black, tarry stools


• chills


• clay-colored stools


• coma


• confusion


• continuing diarrhea


• continuing stomach pain


• convulsions


• dark urine


• decreased urine output


• depression


• diarrhea


• dizziness


• fast or irregular heartbeat


• fever


• headache


• hostility


• increased thirst


• irritability


• itching


• lethargy


• loss of appetite


• muscle pain or cramps


• muscle twitching


• nausea or vomiting


• rapid weight gain


• rash


• seizures


• shortness of breath


• stupor


• swelling of the face, ankles, or hands


• unpleasant breath odor


• unusual tiredness or weakness


• vomiting of blood


• yellow eyes or skin

Incidence not known

• Anxiety


• back, leg, or stomach pains


• bleeding gums


• blood in the urine or stools


• blurred vision


• chest pain


• cold sweats


• cool, pale skin


• cough or hoarseness


• depression


• difficulty with breathing


• fever with or without chills


• fluid-filled skin blisters


• general body swelling


• general feeling of tiredness or weakness


• headache


• high fever


• increased hunger


• lower back or side pain


• nervousness


• nightmares


• nosebleeds


• painful or difficult urination


• pinpoint red spots on the skin


• sensitivity to the sun


• shakiness


• skin thinness


• slurred speech


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• swollen or painful glands


• tightness in the chest


• unusual bleeding or bruising


• wheezing

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

• Indigestion


• passing of gas

Less common

• Hives or welts


• redness of the skin


• weight loss

Rare

• Blistering, peeling, or loosening of the skin


• cracks in the skin


• loss of heat from the body


• red, irritated eyes


• red, swollen skin


• scaly skin

Incidence not known

• Increased sensitivity of the skin to sunlight


• redness or other discoloration of the skin


• severe sunburn

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.

See also: chlorpropamide side effects (in more detail)

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.

More chlorpropamide resources

• Chlorpropamide Side Effects (in more detail)
• Chlorpropamide Dosage
• Chlorpropamide Use in Pregnancy & Breastfeeding
• Drug Images
• Chlorpropamide Drug Interactions
• Chlorpropamide Support Group
• 0 Reviews for Chlorpropamide - Add your own review/rating

• chlorpropamide Concise Consumer Information (Cerner Multum)


• Chlorpropamide Prescribing Information (FDA)


• Chlorpropamide Monograph (AHFS DI)


• Chlorpropamide Professional Patient Advice (Wolters Kluwer)


• Chlorpropamide MedFacts Consumer Leaflet (Wolters Kluwer)


• Diabinese Prescribing Information (FDA)

Compare chlorpropamide with other medications

• Diabetes, Type 2

cyclosporine

Generic Name: cyclosporine (SYE kloe SPOR een)

Brand Names: Gengraf, Neoral, SandIMMUNE

What is cyclosporine?

Cyclosporine lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.

Cyclosporine is used to prevent organ rejection after a kidney, liver, or heart transplant.

Cyclosporine is also used to treat severe psoriasis or severe rheumatoid arthritis.

Cyclosporine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about cyclosporine?

You may not be able to use this medication if you have kidney disease, untreated or uncontrolled hypertension (high blood pressure), or any type of cancer.

If you are being treated for psoriasis, you should not receive light therapy (PUVA or UVB) or radiation treatments while you are receiving cyclosporine. Make sure all doctors involved in your care know you are taking cyclosporine.

You may take cyclosporine with or without food, but take it the same way each time. Cyclosporine should be given in two separate doses each day. Try to take the medication at the same dosing times each day.

If there are any changes in the brand or form of cyclosporine you use, your dosage needs may change. Always check your refills to make sure you have received the correct brand and type of medicine prescribed by your doctor. Call your doctor at once if you have any signs of kidney failure, such as urinating less than usual or not at all, drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting, swelling, weight gain, or feeling short of breath. Do not receive a "live" vaccine while you are being treated with cyclosporine. The live vaccine may not work as well during this time, and may not fully protect you from disease. There are many other medicines that can cause serious medical problems if you take them together with cyclosporine. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

What should I discuss with my health care provider before taking cyclosporine?

You should not use this medication if you are allergic to cyclosporine. You may not be able to use cyclosporine if you have:

• 
  

  kidney disease;

  
  


• 
  

  untreated or uncontrolled high blood pressure; or

  
  


• 
  

  any type of cancer.

  
  

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take cyclosporine:

• 
  

  psoriasis that has been treated with PUVA, UVB, radiation, methotrexate (Trexall), or coal tar; or

  
  


• 
  

  if you are also taking an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), etodolac (Lodine), indomethacin (Indocin), and others.

  
  

FDA pregnancy category C. It is not known whether cyclosporine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Cyclosporine 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 cyclosporine?

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.

You may take cyclosporine with or without food, but take it the same way each time. Cyclosporine should be given in two separate doses each day. Try to take the medication at the same dosing times each day.

If there are any changes in the brand or form of cyclosporine you use, your dosage needs may change. Always check your refills to make sure you have received the correct brand and type of medicine prescribed by your doctor.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Sandimmune oral solution may be mixed with milk, chocolate milk, or orange juice at room temperature to make the medicine taste better. Neoral "modified" (microemulsion) oral solution should be mixed with orange juice or apple juice that is at room temperature.

Cyclosporine 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. Your blood pressure and kidney function may also need to be checked. Do not miss any scheduled appointments.

Your condition may need to be treated with a combination of different drugs. For best treatment results, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. Every person taking cyclosporine should remain under the care of a doctor.

Store cyclosporine at room temperature away from moisture and heat.

See also: Cyclosporine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. 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 can cause nausea, vomiting, pain in your upper stomach, loss of appetite, jaundice (yellowing of the skin or eyes), and urinating less than usual or not at all.

What should I avoid while taking cyclosporine?

Avoid exposure to sunlight, sunlamps, or tanning beds. Cyclosporine can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing and use sunscreen (SPF 15 or higher) when you are outdoors.

If you are being treated for psoriasis, you should not receive light therapy (PUVA or UVB) or radiation treatments while you are receiving cyclosporine. Make sure all doctors involved in your care know you are taking cyclosporine.

Do not receive a "live" vaccine while you are being treated with cyclosporine. The live vaccine may not work as well during this time, and may not fully protect you from disease.

Avoid eating grapefruit or drinking grapefruit juice. Grapefruit may interact with cyclosporine and increase your blood levels of this medication.

Cyclosporine 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:

• 
  

  urinating less than usual or not at all;

  
  


• 
  

  drowsiness, confusion, mood changes, increased thirst;

  
  


• 
  

  swelling, weight gain, feeling short of breath;

  
  


• 
  

  blurred vision, headache or pain behind your eyes, sometimes with vomiting;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  muscle pain or weakness, fast heart rate, feeling light-headed;

  
  


• 
  

  signs of infection such as fever, chills, sore throat, flu symptoms;

  
  


• 
  

  pale skin, easy bruising or bleeding, unusual weakness; or

  
  


• 
  

  nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  tremors or shaking;

  
  


• 
  

  increased hair growth;

  
  


• 
  

  headache or body pain;

  
  


• 
  

  diarrhea, constipation, vomiting; or

  
  


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  numbness or tingly feeling.

  
  

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.

Cyclosporine Dosing Information

Usual Adult Dose for Organ Transplant -- Rejection Prophylaxis:

IV: 2 to 4 mg/kg/day IV infusion once a day over 4 to 6 hours or
1 to 2 mg/kg IV infusion twice a day over 4 to 6 hours or
2 to 4 mg/kg/day as a continuous IV infusion over 24 hours.
Capsules: 8 to 12 mg/kg/day orally in 2 divided doses.
Solution: 8 to 12 mg/kg orally once a day.
Doses are usually titrated downward with time to maintenance doses as low as 3 to 5 mg/kg/day. All doses should be adjusted to achieve the desired therapeutic concentration.

Usual Adult Dose for Rheumatoid Arthritis:

cyclosporine formulation for emulsion: 5 mg/kg/day orally divided in 2 doses. If possible, anti-inflammatory drugs should be discontinued to help avoid renal toxicity. A maximum dose of 5 mg/kg/day and a maximal increase in serum creatinine levels no more than 30% above baseline values are recommended to minimize renal toxic effects.

Cyclosporine capsules USP modified - Initial dose: 1.25 mg/kg orally twice a day.
Salicylates, nonsteroidal anti-inflammatory agents, and oral corticosteroids may be continued. Onset of action generally occurs between 4 and 8 weeks. If insufficient clinical benefit is seen and tolerability is good (including serum creatinine less than 30% above baseline), the dose may be increased by 0.5 to 0.75 mg/kg/day after 8 weeks and again after 12 weeks to a maximum of 4 mg/kg/day. If no benefit is seen by 16 weeks of therapy, cyclosporine capsules USP modified therapy should be discontinued. Dose decreases by 25% to 50% should be made at any time to control adverse events, e.g., hypertension elevations in serum creatinine (30% above the patient's pretreatment level) or clinically significant laboratory abnormalities.
If dose reduction is not effective in controlling abnormalities or if the adverse event or abnormality is severe, cyclosporine capsules USP modified should be discontinued. The same initial dose and dosage range should be used if cyclosporine capsules USP modified is combined with the recommended dose of methotrexate. Most patients can be treated with cyclosporine capsules USP modified doses of 3 mg/kg/day or below when combined with methotrexate doses of up to 15 mg/week.
There is limited long-term treatment data. Recurrence of rheumatoid arthritis disease activity is generally apparent within 4 weeks after stopping cyclosporine.

Usual Adult Dose for Ulcerative Colitis -- Active:

When refractory to corticosteroids: 4 mg/kg/day via continuous IV infusion. The dose should be titrated gradually to achieve clinical efficacy while avoiding unacceptable toxicity. Therapy should be continued for 7 to 14 days. In successful treatments, oral therapy should be instituted after 14 days of IV therapy and continued for 3 to 6 months.

Some clinicians have found a dose of 2 mg/kg/day via continuous IV infusion to be equally effective to the 4 mg/kg/day dosage regimen.

Usual Adult Dose for Psoriasis:

Refractory plaque-type psoriasis: cyclosporine formulation for emulsion: 2.5 mg/kg/day orally in 2 equally divided doses. The dose should be titrated gradually to achieve clinical efficacy while avoiding excessive toxicity. The incidence of serious toxicity increases with time thus limiting the duration of therapy. Disease relapse may occur after discontinuation or reduction in dose. A maximum dose of 5 mg/kg/day and a maximal increase in serum creatinine levels no more than 30% above baseline values are recommended to minimize renal toxic effects.

Cyclosporine capsules USP modified - Initial dose: 1.25 mg/kg twice a day.
Patients should be kept at that dose for at least 4 weeks, barring adverse events. If significant clinical improvement has not occurred in patients by that time, the patient's dosage should be increased at 2 week intervals. Based on patient response, dose increases of approximately 0.5 mg/kg/day should be made to a maximum of 4 mg/kg/day.
Dose decreases by 25% to 50% should be made at any time to control adverse events, e.g., hypertension, elevations in serum creatinine (25% above the patient's pretreatment level), or clinically significant laboratory abnormalities. If dose reduction is not effective in controlling abnormalities, or if the adverse event or abnormality is severe, cyclosporine capsules USP modified should be discontinued.
Patients generally show some improvement in the clinical manifestations of psoriasis in 2 weeks. Satisfactory control and stabilization of the disease may take 12 to 16 weeks to achieve. Treatment should be discontinued if satisfactory response cannot be achieved after 6 weeks at 4 mg/kg/day or the patient's maximum tolerated dose. Once a patient is adequately controlled and appears stable the dose of cyclosporine capsules USP modified should be lowered, and the patient treated with the lowest dose that maintains an adequate response. Doses below 2.5 mg/kg/day may also be equally effective.
Upon stopping treatment with cyclosporine, relapse will occur in approximately 6 weeks (50% of the patients) to 16 weeks (75% of the patients). In the majority of patients rebound does not occur after cessation of treatment with cyclosporine. Long-term experience with cyclosporine capsules USP modified in psoriasis patients is limited and continuous treatment for extended periods greater than one year is not recommended. Alternation with other forms of treatment should be considered in the long-term management of patients with this lifelong disease.

Usual Pediatric Dose for Organ Transplant -- Rejection Prophylaxis:

IV: 2 to 4 mg/kg/day IV infusion once a day over 4 to 6 hours or
1 to 2 mg/kg IV infusion twice a day over 4 to 6 hours or
2 to 4 mg/kg/day as a continuous IV infusion over 24 hours.
Capsules: 8 to 12 mg/kg/day orally in 2 divided doses.
Solution: 8 to 12 mg/kg orally once a day.
Doses are usually titrated downward with time to maintenance doses as low as 3 to 5 mg/kg/day. All doses should be adjusted to achieve the desired therapeutic concentration.

What other drugs will affect cyclosporine?

Many drugs can interact with cyclosporine. Below is just a partial list. Tell your doctor about all other medications you are using, especially:

• 
  

  etoposide (VePesid, Etopophos);

  
  


• 
  

  lithium (Eskalith, Lithobid);

  
  


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  methotrexate (Rheumatrex, Trexall);

  
  


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  nefazodone;

  
  


• 
  

  repaglinide (Prandin);

  
  


• 
  

  St. John's wort;

  
  


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  an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik);

  
  


• 
  

  a heart or blood pressure medication such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro, Avalide), losartan (Cozaar, Hyzaar), valsartan (Diovan), telmisartan (Micardis), or olmesartan (Benicar);

  
  


• 
  

  medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);

  
  


• 
  

  other medicines used to prevent organ transplant rejection, such as sirolimus (Rapamune) or tacrolimus (Prograf);

  
  


• 
  

  pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), naproxen (Aleve, Naprosyn), and others;

  
  


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  IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci-IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);

  
  


• 
  

  antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

  
  


• 
  

  cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid).

  
  

This list is not complete and there are many other medicines that can cause serious medical problems if you take them together with cyclosporine. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More cyclosporine resources

• Cyclosporine Dosage
• Cyclosporine Use in Pregnancy & Breastfeeding
• Drug Images
• Cyclosporine Drug Interactions
• Cyclosporine Support Group
• 5 Reviews for Cyclosporine - Add your own review/rating

• cyclosporine Ophthalmic Advanced Consumer (Micromedex) - Includes Dosage Information


• Cyclosporine Prescribing Information (FDA)


• Cyclosporine MedFacts Consumer Leaflet (Wolters Kluwer)


• Cyclosporine Monograph (AHFS DI)


• Gengraf Advanced Consumer (Micromedex) - Includes Dosage Information


• Gengraf Prescribing Information (FDA)


• Gengraf MedFacts Consumer Leaflet (Wolters Kluwer)


• Neoral Prescribing Information (FDA)


• Sandimmune Prescribing Information (FDA)

Compare cyclosporine with other medications

• Cogan's Syndrome
• Crohn's Disease
• Evan's Syndrome
• Focal Segmental Glomerulosclerosis
• Graft-versus-host disease
• Idiopathic Thrombocytopenic Purpura
• Inflammatory Bowel Disease
• Nephrotic Syndrome
• Organ Transplant, Rejection Prophylaxis
• Organ Transplant, Rejection Reversal
• Pemphigoid
• Pemphigus
• Psoriasis
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Ulcerative Colitis
• Ulcerative Colitis, Active

Where can I get more information?

• Your pharmacist can provide more information about cyclosporine.