D-Vi-Sol

Generic Name: vitamin d and related compounds (Oral route, Parenteral route)

Commonly used brand name(s)

In the U.S.

• Calciferol


• Delta D3


• DHT


• DHT Intensol


• Drisdol


• Hectorol


• Rocaltrol


• Vitamin D


• Zemplar

In Canada

• D-Vi-Sol


• Radiostol Forte

Available Dosage Forms:

• Capsule, Liquid Filled


• Capsule


• Solution


• Tablet


• Oil


• Liquid


• Tablet, Chewable

Uses For D-Vi-Sol

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are available in the foods that you eat. Vitamin D is necessary for strong bones and teeth.

Lack of vitamin D may lead to a condition called rickets, especially in children, in which bones and teeth are weak. In adults it may cause a condition called osteomalacia, in which calcium is lost from bones so that they become weak. Your doctor may treat these problems by prescribing vitamin D for you. Vitamin D is also sometimes used to treat other diseases in which calcium is not used properly by the body.

Ergocalciferol is the form of vitamin D used in vitamin supplements.

Some conditions may increase your need for vitamin D. These include:

• Alcoholism


• Intestine diseases


• Kidney disease


• Liver disease


• Overactivity of the parathyroid glands with kidney failure


• Pancreas disease


• Surgical removal of stomach

In addition, individuals and breast-fed infants who lack exposure to sunlight, as well as dark-skinned individuals, may be more likely to have a vitamin D deficiency. Increased need for vitamin D should be determined by your health care professional.

Alfacalcidol, calcifediol, calcitriol, and dihydrotachysterol are forms of vitamin D used to treat hypocalcemia (not enough calcium in the blood). Alfacalcidol, calcifediol, and calcitriol are also used to treat certain types of bone disease that may occur with kidney disease in patients who are undergoing kidney dialysis.

Claims that vitamin D is effective for treatment of arthritis and prevention of nearsightedness or nerve problems have not been proven. Some psoriasis patients may benefit from vitamin D supplements; however, controlled studies have not been performed.

Injectable vitamin D is given by or under the supervision of a health care professional. Some strengths of ergocalciferol and all strengths of alfacalcidol, calcifediol, calcitriol, and dihydrotachysterol are available only with your doctor's prescription. Other strengths of ergocalciferol are available without a prescription. However, it may be a good idea to check with your health care professional before taking vitamin D on your own. Taking large amounts over long periods may cause serious unwanted effects.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Vitamin D is found naturally only in fish and fish-liver oils. However, it is also found in milk (vitamin D–fortified). Cooking does not affect the vitamin D in foods. Vitamin D is sometimes called the "sunshine vitamin" since it is made in your skin when you are exposed to sunlight. If you eat a balanced diet and get outside in the sunshine at least 1.5 to 2 hours a week, you should be getting all the vitamin D you need.

Vitamins alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods. For example, fat is needed so that vitamin D can be absorbed into the body.

The daily amount of vitamin D needed is defined in several different ways.

• For U.S.—


• Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).


• Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

• For Canada—


• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

In the past, the RDA and RNI for vitamin D have been expressed in Units (U). This term has been replaced by micrograms (mcg) of vitamin D.

Normal daily recommended intakes in mcg and Units are generally defined as follows:

Persons	U.S.		Canada
	mcg	Units	mcg	Units
Infants and children birth to 3 years of age	7.5-10	300-400	5–10	200–400
Children 4 to 6 years of age	10	400	5	200
Children 7 to 10 years of age	10	400	2.5–5	100–200
Adolescents and adults	5–10	200–400	2.5–5	100–200
Pregnant and breast-feeding females	10	400	5–7.5	200–300

Remember:

• The total amount of each vitamin that you get every day includes what you get from the foods that you eat and what you may take as a supplement.


• Your total amount should not be greater than the RDA or RNI, unless ordered by your doctor. Taking too much vitamin D over a period of time may cause harmful effects

Before Using D-Vi-Sol

If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Problems in children have not been reported with intake of normal daily recommended amounts. Some studies have shown that infants who are totally breast-fed, especially with dark-skinned mothers, and have little exposure to sunlight may be at risk of vitamin D deficiency. Your health care professional may prescribe a vitamin/mineral supplement that contains vitamin D. Some infants may be sensitive to even small amounts of alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, or ergocalciferol. Also, children may show slowed growth when receiving large doses of alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, or ergocalciferol for a long time.

Studies on doxercalciferol or paricalcitol have been done only in adult patients, and there is no specific information comparing the use of doxercalciferol or paricalcitol in children with use in other age groups.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts. Studies have shown that older adults may have lower blood levels of vitamin D than younger adults, especially those who have little exposure to sunlight. Your health care professional may recommend that you take a vitamin supplement that contains vitamin D.

Pregnancy

It is especially important that you are receiving enough vitamin D when you become pregnant and that you continue to receive the right amounts of vitamins throughout your pregnancy. The healthy growth and development of the fetus depend on a steady supply of nutrients from the mother.

You may need vitamin D supplements if you are a strict vegetarian (vegan-vegetarian) and/or have little exposure to sunlight and do not drink vitamin D-fortified milk.

Taking too much alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, or ergocalciferol can also be harmful to the fetus. Taking more than your health care professional has recommended can cause your baby to be more sensitive than usual to its effects, can cause problems with a gland called the parathyroid, and can cause a defect in the baby's heart.

Doxercalciferol or paricalcitol have not been studied in pregnant women. However, studies in animals have shown that paricalcitol causes problems in newborns. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast Feeding

It is especially important that you receive the right amounts of vitamins so that your baby will also get the vitamins needed to grow properly. Infants who are totally breast-fed and have little exposure to the sun may require vitamin D supplementation. However, taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or baby and should be avoided.

Only small amounts of alfacalcidol, calcifediol, calcitriol, or dihydrotachysterol pass into breast milk and these amounts have not been reported to cause problems in nursing babies.

It is not known whether doxercalciferol or paricalcitol passes into breast milk. Be sure you have discussed the risks and benefits of the supplement with your doctor.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of dietary supplements in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart or blood vessel disease—Alfacalcidol, calcifediol, calcitriol, or dihydrotachysterol may cause hypercalcemia (high blood levels of calcium), which may make these conditions worse.

• Kidney disease—High blood levels of alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, or ergocalciferol may result, which may increase the chance of side effects.

• Sarcoidosis—May increase sensitivity to alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, or ergocalciferol and increase the chance of side effects

Proper Use of vitamin d and related compounds

This section provides information on the proper use of a number of products that contain vitamin d and related compounds. It may not be specific to D-Vi-Sol. Please read with care.

For use as a dietary supplement:

• Do not take more than the recommended daily amount. Vitamin D is stored in the body, and taking too much over a period of time can cause poisoning and even death.

If you have any questions about this, check with your health care professional.

For individuals taking the oral liquid form of this dietary supplement:

• This preparation should be taken by mouth even though it comes in a dropper bottle.


• This dietary supplement may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food.

While you are taking alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, doxercalciferol or paricalcitol , your health care professional may want you to follow a special diet or take a calcium supplement. Be sure to follow instructions carefully. If you are already taking a calcium supplement or any medicine containing calcium, make sure your health care professional knows.

Dosing

The dose medicines in this class 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 these medicines. 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 alfacalcidol


• To treat bone disease in kidney patients undergoing kidney dialysis:
  
  • For oral dosage form (capsules):
    
    • Adults and teenagers—At first, 1 microgram (mcg) a day. Your doctor may change your dose if needed. However, most people will take not more than 3 mcg a day.
    
    
  
  
  • For oral dosage form (drops):
    
    • Adults and teenagers—At first, 1 microgram (mcg) a day. Your doctor may change your dose if needed. However, most people will take not more than 3 mcg a day.
    
    
  
  
  • For oral dosage form (solution):
    
    • Adults and teenagers—At first, 1 mcg a day. Your doctor may change your dose if needed. However, most people will take not more than 3 mcg a day.
    
    
  
  
  • For parenteral dosage form (injection):
    
    • Adults and teenagers—At first, 1 mcg a day. Your doctor may change your dose if needed. However, most people will take not more than 12 mcg a week.
    
    
  
  


• To treat diseases in which calcium is not used properly by the body:
  
  • For oral dosage form (capsules):
    
    • Adults and teenagers—At first, 0.25 microgram (mcg) a day. Your doctor may change your dose if needed. However, most people will take not more than 1 mcg a day.
    
    
  
  
  • For oral dosage form (drops):
    
    • Adults and teenagers—At first, 0.25 microgram (mcg) a day. Your doctor may change your dose if needed. However, most people will take not more than 1 mcg a day.
    
    
  
  
  • For oral dosage form (solution):
    
    • Adults and teenagers—At first, 0.25 mcg a day. Your doctor may change your dose if needed. However, most people will take not more than 1 mcg a day.
    
    
  
  

• For calcifediol


• To treat diseases in which calcium is not used properly by the body or to treat bone disease in kidney patients undergoing kidney dialysis:
  
  • For oral dosage form (capsules):
    
    • Adults, teenagers, and children over 10 years of age—At first, 300 to 350 micrograms (mcg) a week, taken in divided doses either once a day or every other day. Your doctor may change your dose if needed.
    
    
    • Children 2 to 10 years of age—50 mcg a day.
    
    
    • Children up to 2 years of age—20 to 50 mcg a day.
    
    
  
  


• To treat diseases in which calcium is not used properly by the body or to treat bone disease in kidney patients undergoing kidney dialysis:
  
  • For oral dosage forms (capsules and solution):
    
    • Adults, teenagers, and children—At first, 0.25 micrograms (mcg) a day. Your doctor may change your dose if needed.
    
    
  
  
  • For parenteral dosage forms (injection):
    
    • Adults and teenagers—At first, 0.5 mcg injected into a vein three times a week. Your doctor may change your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

• For dihydrotachysterol


• To treat diseases in which calcium is not used properly by the body:
  
  • For oral dosage forms (capsules, solution, or tablets):
    
    • Adults and teenagers—At first, 100 micrograms (mcg) to 2.5 milligrams (mg) a day. Your doctor may change your dose if needed.
    
    
    • Children—At first, 1 to 5 mg a day. Your doctor may change your dose if needed.
    
    
  
  

• For doxercalciferol


• To treat an overactive parathyroid gland in patients with kidney failure:
  
  • For oral dosage form (capsules):
    
    • Adults—10 micrograms (mcg) three times weekly at dialysis. The doctor may change your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

• For ergocalciferol


• The amount of vitamin D to meet normal daily recommended intakes will be different for different individuals. The following information includes only the average amounts of vitamin D.


• To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
  
  • For oral dosage form (capsules):
    
    • For the U.S.
    
    
    • Adults and teenagers—5 to 10 micrograms (mcg) (200 to 400 Units) per day.
    
    
    • Pregnant and breast-feeding females—10 mcg (400 Units) per day.
    
    
    • Children 4 to 10 years of age—10 mcg (400 Units) per day.
    
    
    • Children birth to 3 years of age—7.5 to 10 mcg (300 to 400 Units) per day.
    
    
    • For Canada
    
    
    • Adults and teenagers—2.5 to 5 mcg (100 to 200 Units) per day.
    
    
    • Pregnant and breast-feeding females—5 to 7.5 mcg (200 to 300 Units) per day.
    
    
    • Children 7 to 10 years of age—2.5 to 5 mcg (100 to 200 Units) per day.
    
    
    • Children 4 to 6 years of age—5 mcg (200 Units) per day.
    
    
    • Children birth to 3 years of age—5 to 10 mcg (200 to 400 Units) per day.
    
    
  
  


• To treat deficiency:
  
  • Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on severity of deficiency.
  
  


• To treat diseases in which calcium and phosphate are not used properly by the body:
  
  • Adults and teenagers—At first, 1000 to 500,000 Units a day. The doctor may change your dose if needed.
  
  
  • Children—At first, 1000 to 200,000 Units a day. The doctor may change your dose if needed.
  
  

• For paricalcitol


• To treat an overactive parathyroid gland in patients with kidney failure:
  
  • For oral dosage form (capsules):
    
    • Adults—1 to 2 micrograms (mcg) one time per day or 2 to 4 mcg three times a week (not more often than every other day). The doctor may change your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For parenteral dosage form (injection):
    
    • Adults—0.04 to 0.1 micrograms (mcg) per kg no more than every other day during dialysis. The doctor may change your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

For use as a dietary supplement: If you miss taking a dietary supplement for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in vitamins. However, if your health care professional has recommended that you take this dietary supplement, try to remember to take it as directed every day.

If you are taking this medicine for a reason other than as a dietary supplement and you miss a dose and your dosing schedule is:

• One dose every other day—Take the missed dose as soon as possible if you remember it on the day it should be taken. However, if you do not remember the missed dose until the next day, take it at that time. Then skip a day and start your dosing schedule again. Do not double doses


• One dose a day—Take the missed dose as soon as possible. Then go back to your regular dosing schedule. However, if you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


• More than one dose a day—Take the missed dose as soon as possible. Then go back to your regular dosing schedule. 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.

If you have any questions about this, check with your health care professional.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using D-Vi-Sol

For individuals taking vitamin D without a prescription:

• Vitamin D is stored in the body; therefore, when you take more than the body needs, it will build up in the body. This may lead to poisoning. Problems are more likely to occur in:
  
  • Adults taking 20,000 to 80,000 Units a day and more for several weeks or months.
  
  
  • Children taking 2,000 to 4,000 Units a day for several months.
  
  

If you are taking this medicine for a reason other than as a dietary supplement, your doctor should check your progress at regular visits to make sure that it does not cause unwanted effects.

Do not take any nonprescription (over-the-counter [OTC]) medicine or dietary supplement that contains calcium, phosphorus, or vitamin D while you are taking any of these dietary supplements unless you have been told to do so by your health care professional. The extra calcium, phosphorus, or vitamin D may increase the chance of side effects.

Do not take antacids or other medicines containing magnesium while you are taking any of these medicines. Taking these medicines together may cause unwanted effects.

D-Vi-Sol Side Effects

Along with its needed effects, a dietary supplement may cause some unwanted effects. Alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, and ergocalciferol do not usually cause any side effects when taken as directed. However, taking large amounts over a period of time may cause some unwanted effects that can be serious.

Check with your doctor immediately if any of the following side effects occur:

Late symptoms of severe overdose

• High blood pressure


• high fever


• irregular heartbeat


• stomach pain (severe)

Check with your doctor as soon as possible if any of the following side effects occur:

Early symptoms of overdose

• Bone pain


• constipation (especially in children or adolescents)


• diarrhea


• drowsiness


• dryness of mouth


• headache (continuing)


• increased thirst


• increase in frequency of urination, especially at night, or in amount of urine


• irregular heartbeat


• itching skin


• loss of appetite


• metallic taste


• muscle pain


• nausea or vomiting (especially in children or adolescents)


• unusual tiredness or weakness

Late symptoms of overdose

• Bone pain


• calcium deposits (hard lumps) in tissues outside of the bone


• cloudy urine


• drowsiness


• increased sensitivity of eyes to light or irritation of eyes


• itching of skin


• loss of appetite


• loss of sex drive


• mood or mental changes


• muscle pain


• nausea or vomiting


• protein in the urine


• redness or discharge of the eye, eyelid, or lining of the eyelid


• runny nose


• weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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• Qatar


• Saudi Arabia


• Slovakia


• Switzerland


• United Arab Emirates


• United Kingdom

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Doxef

Doxef may be available in the countries listed below.

Ingredient matches for Doxef

Cefadroxil

Cefadroxil monohydrate (a derivative of Cefadroxil) is reported as an ingredient of Doxef in the following countries:

• Indonesia

International Drug Name Search

Otocalmine

Otocalmine may be available in the countries listed below.

Ingredient matches for Otocalmine

Lidocaine

Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Otocalmine in the following countries:

• Belgium

Phenazone

Phenazone is reported as an ingredient of Otocalmine in the following countries:

• Belgium

International Drug Name Search

Unitop

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Unitop

Cuprimyxin

Cuprimyxin is reported as an ingredient of Unitop in the following countries:

• United States

International Drug Name Search

Encorate

Encorate may be available in the countries listed below.

Ingredient matches for Encorate

Valproic Acid

Valproic Acid sodium (a derivative of Valproic Acid) is reported as an ingredient of Encorate in the following countries:

• Bangladesh


• Myanmar


• Russian Federation


• Sri Lanka

International Drug Name Search

Nicarbazin

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Nicarbazin

Nicarbazin

Nicarbazin (BAN) is also known as Nicarbazin (BAN)

Bacitracin

Bacitracin methylene disalicylate (a derivative of Bacitracin) is reported as an ingredient of Nicarbazin in the following countries:

• United States

International Drug Name Search

Glossary

BAN	British Approved Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Oksamen-L

Oksamen-L may be available in the countries listed below.

Ingredient matches for Oksamen-L

Tenoxicam

Tenoxicam is reported as an ingredient of Oksamen-L in the following countries:

• Turkey

International Drug Name Search

Oncovin

In some countries, this medicine may only be approved for veterinary use.

In the US, Oncovin (vincristine systemic) is a member of the drug class mitotic inhibitors and is used to treat Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Anaplastic Oligodendroglioma, Cancer, Evan's Syndrome, Hodgkin's Lymphoma, Multiple Myeloma, Neuroblastoma, Non-Hodgkin's Lymphoma, Rhabdomyosarcoma and Wilms' Tumor.

US matches:

• Oncovin

Ingredient matches for Oncovin

Vincristine

Vincristine sulfate (a derivative of Vincristine) is reported as an ingredient of Oncovin in the following countries:

• Austria


• Denmark


• France


• Greece


• Ireland


• Japan


• Kenya


• Luxembourg


• Mexico


• Nigeria


• Oman


• Peru


• Serbia


• Sweden


• Switzerland


• Tanzania


• Uganda


• United Kingdom

International Drug Name Search

Furosémide Winthrop

Furosémide Winthrop may be available in the countries listed below.

Ingredient matches for Furosémide Winthrop

Furosemide

Furosemide is reported as an ingredient of Furosémide Winthrop in the following countries:

• France

International Drug Name Search

Pektolin

Pektolin may be available in the countries listed below.

Ingredient matches for Pektolin

Diphenhydramine

Diphenhydramine is reported as an ingredient of Pektolin in the following countries:

• Iceland

International Drug Name Search

Pantemon

Pantemon may be available in the countries listed below.

Ingredient matches for Pantemon

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Pantemon in the following countries:

• Japan

International Drug Name Search

Unibios Simple

Unibios Simple may be available in the countries listed below.

Ingredient matches for Unibios Simple

Metamizole

Metamizole sodium anhydrous (a derivative of Metamizole) is reported as an ingredient of Unibios Simple in the following countries:

• Argentina

International Drug Name Search

Frommicillin

Frommicillin may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Frommicillin

Ampicillin

Ampicillin trihydrate (a derivative of Ampicillin) is reported as an ingredient of Frommicillin in the following countries:

• Germany

International Drug Name Search

Amantadine Quality Pharm

Amantadine Quality Pharm may be available in the countries listed below.

Ingredient matches for Amantadine Quality Pharm

Amantadine

Amantadine hydrochloride (a derivative of Amantadine) is reported as an ingredient of Amantadine Quality Pharm in the following countries:

• Hong Kong

International Drug Name Search

Aspen Nevirapine

Aspen Nevirapine may be available in the countries listed below.

Ingredient matches for Aspen Nevirapine

Nevirapine

Nevirapine is reported as an ingredient of Aspen Nevirapine in the following countries:

• South Africa

International Drug Name Search

Seloken L

Seloken L may be available in the countries listed below.

Ingredient matches for Seloken L

Metoprolol

Metoprolol tartrate (a derivative of Metoprolol) is reported as an ingredient of Seloken L in the following countries:

• Japan

International Drug Name Search

Amfetamine

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

N06BA01

CAS registry number (Chemical Abstracts Service)

0000300-62-9

Chemical Formula

C9-H13-N

Molecular Weight

135

Therapeutic Category

Central stimulant

Chemical Name

Benzeneethanamine, α-methyl-, (±)-

Foreign Names

• Amfetaminum (Latin)
• Amfetamin (German)
• Amfétamine (French)
• Anfetamina (Spanish)

Generic Names

• Amfetamina (OS: DCIT)
• Amfetamine (OS: BAN)
• Amphetamine (OS: BAN)
• Amphétamine (OS: DCF)
• Benzpropamin (IS)
• CERM 1767 (IS)
• Phenylisopropylamin (IS)
• Racemic Desoxynorephedrine (IS)
• Amfetamine Sulphate (OS: BANM)
• Amphetamine Sulfate (IS)
• Amphetamine Sulphate (IS)
• Phenaminum (IS: USSRP)
• Phenylaminopropanum racemicum sulfuricum (IS)
• Amfetamine Sulphate (PH: BP 2010, Ph. Eur. 6)
• Amfetaminsulfat (PH: Ph. Eur. 6)
• Amphétamine (sulfate d') (PH: Ph. Eur. 6)
• Amphetamine Sulfate (PH: USP 32)
• Amphetamini sulfas (PH: Ph. Eur. 6, Ph. Eur. 6)

Brand Names

• Almetamin
  Dae Hwa Pharmaceuticals, Ethiopia



• Ampetamin
  Tablets, Ethiopia



• Anfetamina L.CH.
  Chile, Chile



• Epipropane (Amfetamine and Phenobarbital)
  Medgenix, Luxembourg



• Adderall XR (Amfetamine and Dexamfetamine)
  Shire, United States



• Amfetamin Actavis
  Actavis, Iceland

International Drug Name Search

Glossary

BAN	British Approved Name
BANM	British Approved Name (Modified)
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Apo-Raloxifene

Apo-Raloxifene may be available in the countries listed below.

Ingredient matches for Apo-Raloxifene

Raloxifene

Raloxifene hydrochloride (a derivative of Raloxifene) is reported as an ingredient of Apo-Raloxifene in the following countries:

• Canada

International Drug Name Search

Albezon

Albezon may be available in the countries listed below.

Ingredient matches for Albezon

Beclometasone

Beclometasone 17α,21-dipropionate (a derivative of Beclometasone) is reported as an ingredient of Albezon in the following countries:

• Japan

International Drug Name Search

Avrazor

Avrazor may be available in the countries listed below.

Ingredient matches for Avrazor

Ornidazole

Ornidazole is reported as an ingredient of Avrazor in the following countries:

• Czech Republic


• Slovakia

International Drug Name Search

Bactirom

Bactirom may be available in the countries listed below.

Ingredient matches for Bactirom

Cefpirome

Cefpirome sulfate (a derivative of Cefpirome) is reported as an ingredient of Bactirom in the following countries:

• Indonesia

International Drug Name Search

Ritemed Tetracycline

Ritemed Tetracycline may be available in the countries listed below.

Ingredient matches for Ritemed Tetracycline

Tetracycline

Tetracycline is reported as an ingredient of Ritemed Tetracycline in the following countries:

• Philippines

International Drug Name Search

Acova

Acova is a brand name of argatroban, approved by the FDA in the following formulation(s):

ACOVA (argatroban - injectable; injection)

• 
  Manufacturer: PFIZER
  
  Approval date: June 30, 2000
  
  Strength(s): 250MG/2.5ML (100MG/ML) ^[RLD][AP]

Has a generic version of Acova been approved?

A generic version of Acova has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Acova and have been approved by the FDA:

argatroban injectable; injection

• 
  Manufacturer: HIKMA PHARM CO LTD
  
  Approval date: January 5, 2012
  
  Strength(s): 250MG/2.5ML (100MG/ML) ^[AP]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Acova. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• 
  Method for dissolving arginineamides and pharmaceutical compositions containing them
  Patent 5,214,052
  Issued: May 25, 1993
  Inventor(s): Ofuchi; Kunihiko & Nomura; Tatsuo
  Assignee(s): Mitsubishi Kasei Corporation
  A method for dissolving an arginineamide of the invention comprising dissolving N.sup.2 -arylsulfonyl-L-arginineamide having the general formula (I) ##STR1## wherein R.sup.1 represents a (2R, 4R)-4-alkyl-2-carboxypiperizino group and R.sup.2 represents a phenyl group or a condensed polycyclic compound residue which may be substituted with one or more substituents selected from lower alkyl groups, lower alkoxy groups and lower alkyl-substituted amino groups, said condensed polycyclic compound residue including a benzene ring which binds to sulfur atom of the sulfonyl group in the general formula (I) and is condensed with one or more other rings which may be heterocyclic and having 7 to 14 carbon atoms as the ring-constituent atoms; and/or its salt in a solvent of alcohol and water is disclosed herein. And, the pharmaceutical composition comprising N.sup.2 -arylsulfonyl-L-arginineamide having the general formula (I), an alcohol and water is disclosed herein.
  
  Patent expiration dates:
  
  
  • June 30, 2014
    
  
  

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

• Exclusivity expiration dates:
  • May 5, 2011 - PROVISION FOR USE OF ARGAGATROBAN IN CERTAIN PEDIATRIC PATIENTS WITH HEPARIN-INDUCED THROMBOCYTOPENIA (HIT) OR HEPARIN-INDUCED THROMBOCYTOPENIA WITH THROMBOSIS (HITTS)
  
  

See also...

• Acova Consumer Information (Cerner Multum)
• Acova AHFS DI Monographs (ASHP)
• Argatroban Consumer Information (Wolters Kluwer)
• Argatroban Consumer Information (Cerner Multum)
• Argatroban Intravenous Advanced Consumer Information (Micromedex)
• Argatroban AHFS DI Monographs (ASHP)

Prelazine

Prelazine may be available in the countries listed below.

Ingredient matches for Prelazine

Cilostazol

Cilostazol is reported as an ingredient of Prelazine in the following countries:

• Japan

International Drug Name Search

Lenchence

Lenchence may be available in the countries listed below.

Ingredient matches for Lenchence

Bifonazole

Bifonazole is reported as an ingredient of Lenchence in the following countries:

• Japan

International Drug Name Search

Genocolan

Genocolan may be available in the countries listed below.

Ingredient matches for Genocolan

Lactulose

Lactulose is reported as an ingredient of Genocolan in the following countries:

• Argentina

International Drug Name Search

Desipramine

Dosage Form: tablet, film coated
Desipramine Hydrochloride Tablets, USP

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Desipramine hydrochloride tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Desipramine hydrochloride is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

Desipramine Description

Desipramine hydrochloride USP is an antidepressant drug of the tricyclic type available as tablets of 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg for oral administration. Its chemical name is 5H-Dibenz[bf]azepine-5-propanamine, 10, 11-dihydro-N-methyl-, monohydrochloride.

Inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch (corn), and titanium dioxide.

Desipramine - Clinical Pharmacology

Mechanism of Action

Available evidence suggests that many depressions have a biochemical basis in the form of a relative deficiency of neurotransmitters such as norepinephrine and serotonin. Norepinephrine deficiency may be associated with relatively low urinary 3-methoxy-4-hydroxyphenyl glycol (MHPG) levels, while serotonin deficiencies may be associated with low spinal fluid levels of 5-hydroxyindoleacetic acid.

While the precise mechanism of action of the tricyclic antidepressants is unknown, a leading theory suggests that they restore normal levels of neurotransmitters by blocking the re-uptake of these substances from the synapse in the central nervous system. Evidence indicates that the secondary amine tricyclic antidepressants, including Desipramine, may have greater activity in blocking the re-uptake of norepinephrine. Tertiary amine tricyclic antidepressants, such as amitriptyline, may have greater effect on serotonin re-uptake.

Desipramine hydrochloride is not a monoamine oxidase (MAO) inhibitor and does not act primarily as a central nervous system stimulant. It has been found in some studies to have a more rapid onset of action than imipramine. Earliest therapeutic effects may occasionally be seen in 2 to 5 days, but full treatment benefit usually requires 2 to 3 weeks to obtain.

Metabolism

Tricyclic antidepressants, such as Desipramine hydrochloride, are rapidly absorbed from the gastrointestinal tract. Tricyclic antidepressants or their metabolites are to some extent excreted through the gastric mucosa and reabsorbed from the gastrointestinal tract. Desipramine is metabolized in the liver, and approximately 70% is excreted in the urine.

The rate of metabolism of tricyclic antidepressants varies widely from individual to individual, chiefly on a genetically determined basis. Up to a 36-fold difference in plasma level may be noted among individuals taking the same oral dose of Desipramine. The ratio of 2-hydroxyDesipramine to Desipramine may be increased in the elderly, most likely due to decreased renal elimination with aging.

Certain drugs, particularly the psychostimulants and the phenothiazines, increase plasma levels of concomitantly administered tricyclic antidepressants through competition for the same metabolic enzyme systems. Concurrent administration of cimetidine and tricyclic antidepressants can produce clinically significant increases in the plasma concentrations of the tricyclic antidepressants. Conversely, decreases in plasma levels of the tricyclic antidepressants have been reported upon discontinuation of cimetidine, which may result in the loss of the therapeutic efficacy of the tricyclic antidepressant. Other substances, particularly barbiturates and alcohol, induce liver enzyme activity and thereby reduce tricyclic antidepressant plasma levels. Similar effects have been reported with tobacco smoke.

Research on the relationship of plasma level to therapeutic response with the tricyclic antidepressants has produced conflicting results. While some studies report no correlation, many studies cite therapeutic levels for most tricyclics in the range of 50 to 300 nanograms per milliliter. The therapeutic range is different for each tricyclic antidepressant. For Desipramine, an optimal range of therapeutic plasma levels has not been established.

Indications and Usage for Desipramine

Desipramine hydrochloride is indicated for the treatment of depression.

Contraindications

Desipramine hydrochloride should not be given in conjunction with, or within 2 weeks of, treatment with an MAO inhibitor drug; hyperpyretic crises, severe convulsions, and death have occurred in patients taking MAO inhibitors and tricyclic antidepressants. When Desipramine hydrochloride is substituted for an MAO inhibitor, at least 2 weeks should elapse between treatments. Desipramine hydrochloride should then be started cautiously and should be increased gradually.

Desipramine hydrochloride is contraindicated in the acute recovery period following myocardial infarction. It should not be used in those who have shown prior hypersensitivity to the drug. Cross-sensitivity between this and other dibenzazepines is a possibility.

Warnings

Clinical Worsening and Suicide Risk

Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.

The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1.

Table 1

Age Range	Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated
	Increases Compared to Placebo
<18	14 additional cases
18-24	5 additional cases
	Decreases Compared to Placebo
25-64	1 fewer case
≥65	6 fewer cases

No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.

It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.

All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.

Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for Desipramine hydrochloride should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Screening Patients for Bipolar Disorder

A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that Desipramine hydrochloride is not approved for use in treating bipolar depression.

General

Extreme caution should be used when this drug is given in the following situations:

a. In patients with cardiovascular disease, because of the possibility of conduction defects, arrhythmias, tachycardias, strokes, and acute myocardial infarction.

b. In patients who have a family history of sudden death, cardiac dysrhythmias, or cardiac conduction disturbances.

c. In patients with a history of urinary retention or glaucoma, because of the anticholinergic properties of the drug.

d. In patients with thyroid disease or those taking thyroid medication, because of the possibility of cardiovascular toxicity, including arrhythmias.

e. In patients with a history of seizure disorder, because this drug has been shown to lower the seizure threshold. Seizures precede cardiac dysrhythmias and death in some patients.

This drug is capable of blocking the antihypertensive effect of guanethidine and similarly acting compounds.

The patient should be cautioned that this drug may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.

In patients who may use alcohol excessively, it should be borne in mind that the potentiation may increase the danger inherent in any suicide attempt or overdosage.

Use in Pregnancy

Safe use of Desipramine hydrochloride during pregnancy and lactation has not been established; therefore, if it is to be given to pregnant patients, nursing mothers, or women of childbearing potential, the possible benefits must be weighed against the possible hazards to mother and child. Animal reproductive studies have been inconclusive.

Geriatric Use

Clinical studies of Desipramine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Lower doses are recommended for elderly patients. (See DOSAGE AND ADMINISTRATION.)

The ratio of 2-hydroxyDesipramine to Desipramine may be increased in the elderly, most likely due to decreased renal elimination with aging.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Desipramine hydrochloride use in the elderly has been associated with a proneness to falling as well as confusional states. (See ADVERSE REACTIONS.)

Precautions

Information for Patients

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Desipramine hydrochloride and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions” is available for Desipramine hydrochloride. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Desipramine hydrochloride.

Clinical Worsening and Suicide Risk

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS: Clinical Worsening and Suicide Risk). Therefore, Desipramine hydrochloride is not recommended for use in children.

Anyone considering the use of Desipramine hydrochloride in a child or adolescent must balance the potential risks with the clinical need (see also ADVERSE REACTIONS: Cardiovascular).

General

It is important that this drug be dispensed in the least possible quantities to depressed outpatients, since suicide has been accomplished with this class of drug (see WARNINGS: Clinical Worsening and Suicide Risk). Ordinary prudence requires that children not have access to this drug or to potent drugs of any kind; if possible, this drug should be dispensed in containers with child-resistant safety closures. Storage of this drug in the home must be supervised responsibly.

If serious adverse effects occur, dosage should be reduced or treatment should be altered. Desipramine hydrochloride therapy in patients with manic-depressive illness may induce a hypomanic state after the depressive phase terminates.

The drug may cause exacerbation of psychosis in schizophrenic patients.

Both elevation and lowering of blood sugar levels have been reported.

Leukocyte and differential counts should be performed in any patient who develops fever and sore throat during therapy; the drug should be discontinued if there is evidence of pathologic neutrophil depression.

Clinical experience in the concurrent administration of ECT and antidepressant drugs is limited. Thus, if such treatment is essential, the possibility of increased risk relative to benefits should be considered.

This drug should be discontinued as soon as possible prior to elective surgery because of possible cardiovascular effects. Hypertensive episodes have been observed during surgery in patients taking Desipramine hydrochloride.

Drug Interactions

Drugs Metabolized by P450 2D6

The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the Caucasian population (about 7% to 10% of Caucasians are so called “poor metabolizers”); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African and other populations are not yet available. Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TCAs) when given usual doses. Depending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small, or quite large (8 fold increase in plasma AUC of the TCA).

In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type IC antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the co-administration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).

Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be co-administered with another drug known to be an inhibitor of P450 2D6.

Close supervision and careful adjustment of dosage are required when this drug is given concomitantly with anticholinergic or sympathomimetic drugs.

Patients should be warned that while taking this drug their response to alcoholic beverages may be exaggerated.

If Desipramine hydrochloride is to be combined with other psychotropic agents such as tranquilizers or sedative/hypnotics, careful consideration should be given to the pharmacology of the agents employed since the sedative effects of Desipramine and benzodiazepines (e.g., chlordiazepoxide or diazepam) are additive. Both the sedative and anticholinergic effects of the major tranquilizers are also additive to those of Desipramine.

Adverse Reactions

Included in the following listing are a few adverse reactions that have not been reported with this specific drug. However, the pharmacologic similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when Desipramine hydrochloride is given.

Cardiovascular

Hypotension, hypertension, palpitations, heart block, myocardial infarction, stroke, arrhythmias, premature ventricular contractions, tachycardia, ventricular tachycardia, ventricular fibrillation, sudden death.

There has been a report of an “acute collapse” and “sudden death” in an 8-year old (18 kg) male, treated for 2 years for hyperactivity.

There have been additional reports of sudden death in children (see PRECAUTIONS: Pediatric Use).

Psychiatric

Confusional states (especially in the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia and nightmares; hypomania; exacerbation of psychosis.

Neurologic

Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures; alterations in EEG patterns; tinnitus.

Symptoms attributed to Neuroleptic Malignant Syndrome have been reported during Desipramine use with and without concomitant neuroleptic therapy.

Anticholinergic

Dry mouth, and rarely associated sublingual adenitis; blurred vision, disturbance of accommodation, mydriasis, increased intraocular pressure; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of urinary tract.

Allergic

Skin rash, petechiae, urticaria, itching, photosensitization (avoid excessive exposure to sunlight), edema (of face and tongue or general), drug fever, cross-sensitivity with other tricyclic drugs.

Hematologic

Bone marrow depressions including agranulocytosis, eosinophilia, purpura, thrombocytopenia.

Gastrointestinal

Anorexia, nausea and vomiting, epigastric distress, peculiar taste, abdominal cramps, diarrhea, stomatitis, black tongue, hepatitis, jaundice (simulating obstructive), altered liver function, elevated liver function tests, increased pancreatic enzymes.

Endocrine

Gynecomastia in the male, breast enlargement and galactorrhea in the female; increased or decreased libido, impotence, painful ejaculation, testicular swelling; elevation or depression of blood sugar levels; syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Other

Weight gain or loss; perspiration, flushing; urinary frequency, nocturia; parotid swelling; drowsiness, dizziness, proneness to falling, weakness and fatigue, headache; fever; alopecia; elevated alkaline phosphatase.

Withdrawal Symptoms

Though not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise.

Overdosage

Deaths may occur from overdosage with this class of drugs. Overdose of Desipramine has resulted in a higher death rate compared to overdoses of other tricyclic antidepressants. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after tricyclic antidepressant overdose; therefore, hospital monitoring is required as soon as possible. There is no specific antidote for Desipramine overdosage.

Oral LD50

The oral LD50 of Desipramine is 290 mg/kg in male mice and 320 mg/kg in female rats.

Manifestations of Overdosage

Critical manifestations of overdose include: cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression, including coma. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity. Early changes in the QRS complex include a widening of the terminal 40 msec with a rightward axis in the frontal plane, recognized by the presence of a terminal S wave in Lead 1 and AVL and an R wave in AVR.

Other signs of overdose may include: confusion, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia, or any of the symptoms listed under ADVERSE REACTIONS.

Management

Aggressive supportive care and serum alkalinization are the mainstays of therapy.

General

Obtain an ECG and immediately initiate cardiac monitoring. Protect the patient’s airway, establish an intravenous line, and initiate gastric decontamination. A minimum of 6 hours of observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary. If signs of toxicity occur at any time during this period, extended monitoring is required. Follow ECG, renal function, CPK, and arterial blood gasses as clinically indicated. There are case reports of patients succumbing to fatal dysrhythmias late after overdose; these patients had clinical evidence of significant poisoning prior to death, and most received inadequate gastrointestinal decontamination. Monitoring of plasma drug levels should not guide management of the patient.

Gastrointestinal Decontamination

Emesis is contraindicated. Activated charcoal should be administered to patients who present early after an overdose.

Cardiovascular

A maximal limb-lead QRS duration widening to greater than 100 msec is a significant indicator of toxicity, specifically for the risk of seizures and, eventually, cardiac dysrhythmias. Serum alkalinization with intravenous sodium bicarbonate and hyperventilation (as needed) should be instituted in patients manifesting significant toxicity such as QRS widening. Dysrhythmias despite adequate alkalemia may respond to overdrive pacing, beta-agonist infusions, and magnesium therapy. Type 1A and 1C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide).

CNS

In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration. Seizures should be controlled with benzodiazepines. If these are ineffective or seizures recur, other anticonvulsants (eg, phenobarbital, propofol) may be used.

Psychiatric Follow-up

Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Psychiatric referral may be appropriate.

Pediatric Management

The principles of management of child and adult overdosages are similar. It is strongly recommended that the physician contact the local poison control center for specific pediatric treatment.

Desipramine Dosage and Administration

Not recommended for use in children (see WARNINGS).

Lower dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients compared to hospitalized patients, who are closely supervised. Dosage should be initiated at a low level and increased according to clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a period of time and should be at the lowest dose that will maintain remission.

Usual Adult Dose

The usual adult dose is 100 to 200 mg per day. In more severely ill patients, dosage may be further increased gradually to 300 mg/day if necessary. Dosages above 300 mg/day are not recommended.

Dosage should be initiated at a lower level and increased according to tolerance and clinical response.

Treatment of patients requiring as much as 300 mg should generally be initiated in hospitals, where regular visits by the physician, skilled nursing care, and frequent electrocardiograms (ECG’s) are available.

The best available evidence of impending toxicity from very high doses of Desipramine is prolongation of the QRS or QT intervals on the ECG. Prolongation of the PR interval is also significant, but less closely correlated with plasma levels. Clinical symptoms of intolerance, especially drowsiness, dizziness, and postural hypotension, should also alert the physician to the need for reduction in dosage.

Initial therapy may be administered in divided doses or a single daily dose.

Maintenance therapy may be given on a once-daily schedule for patient convenience and compliance.

Adolescent and Geriatric Dose

The usual adolescent and geriatric dose is 25 to 100 mg daily.

Dosage should be initiated at a lower level and increased according to tolerance and clinical response to a usual maximum of 100 mg daily. In more severely ill patients, dosage may be further increased to 150 mg/day. Doses above 150 mg/day are not recommended in these age groups.

Initial therapy may be administered in divided doses or a single daily dose.

Maintenance therapy may be given on a once-daily schedule for patient convenience and compliance.

How is Desipramine Supplied

Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:

10 mg: debossed GG 63 on one side and plain on the reverse side, and supplied as:

NDC 0781-1971-01 bottles of 100

NDC 0781-1971-10 bottles of 1000

25 mg: debossed GG 64 on one side and plain on the reverse side, and supplied as:

NDC 0781-1972-01 bottles of 100

NDC 0781-1972-10 bottles of 1000

NDC 0781-1972-13 unit dose packages of 100

50 mg: debossed GG 65 on one side and plain on the reverse side, and supplied as:

NDC 0781-1973-01 bottles of 100

NDC 0781-1973-10 bottles of 1000

NDC 0781-1973-13 unit dose packages of 100

75 mg: debossed GG 166 on one side and plain on the reverse side, and supplied as:

NDC 0781-1974-01 bottles of 100

NDC 0781-1974-10 bottles of 1000

100 mg: debossed GG 167 on one side and plain on the reverse side, and supplied as:

NDC 0781-1975-01 bottles of 100

NDC 0781-1975-10 bottles of 1000

150 mg: debossed GG 168 on one side and plain on the reverse side, and supplied as:

NDC 0781-1976-50 bottles of 50

NDC 0781-1976-10 bottles of 1000

Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).

Dispense in a tight, light-resistant container.

MEDICATION GUIDE

Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Read the Medication Guide that comes with you or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member’s, healthcare provider about:

• all risks and benefits of treatment with antidepressant medicines


• all treatment choices for depression or other serious mental illness

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.


2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.


3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
   
   • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
   
   
   • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
   
   
   • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.
   
   

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying


• attempts to commit suicide


• new or worse depression


• new or worse anxiety


• feeling very agitated or restless


• panic attacks


• trouble sleeping (insomnia)


• new or worse irritability


• acting aggressive, being angry, or violent


• acting on dangerous impulses


• an extreme increase in activity and talking (mania)


• other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

• Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.


• Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.


• Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.


• Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.


• Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

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

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

11-2009M

7359

Sandoz Inc.

Princeton, NJ 08540

mg Label

NDC 0781-1971-01

Desipramine

Hydrochloride

Tablets, USP

10 mg

PHARMACIST: PLEASE

DISPENSE WITH MEDICATION

GUIDE PROVIDED SEPARATELY.

Rx only 100 Tablets

SANDOZ

mg Label

NDC 0781-1972-01

Desipramine

Hydrochloride

Tablets, USP

25 mg

PHARMACIST: PLEASE

DISPENSE WITH MEDICATION

GUIDE PROVIDED SEPARATELY.

Rx only 100 Tablets

SANDOZ

mg Label

NDC 0781-1973-01

Desipramine

Hydrochloride

Tablets, USP

50 mg

PHARMACIST: PLEASE

DISPENSE WITH MEDICATION

GUIDE PROVIDED SEPARATELY.

Rx only 100 Tablets

SANDOZ

mg Label

NDC 0781-1974-01

Desipramine

Hydrochloride

Tablets, USP

75 mg

PHARMACIST: PLEASE

DISPENSE WITH MEDICATION

GUIDE PROVIDED SEPARATELY.

Rx only 100 Tablets

SANDOZ

mg Label

NDC 0781-1975-01

Desipramine

Hydrochloride

Tablets, USP

100 mg

PHARMACIST: PLEASE

DISPENSE WITH MEDICATION

GUIDE PROVIDED SEPARATELY.

Rx only 100 Tablets

SANDOZ

mg Label

NDC 0781-1976-50

Desipramine

Hydrochloride

Tablets, USP

150 mg

PHARMACIST: PLEASE

DISPENSE WITH MEDICATION

GUIDE PROVIDED SEPARATELY.

Rx only 50 Tablets

SANDOZ

Desipramine HYDROCHLORIDE  Desipramine hydrochloride  tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0781-1971 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Desipramine HYDROCHLORIDE (Desipramine) Desipramine HYDROCHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE   HYDROXYPROPYL CELLULOSE   HYPROMELLOSE 2910 (3 MPA.S)   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   POLYETHYLENE GLYCOL   STARCH, CORN   TITANIUM DIOXIDE

Product Characteristics Color WHITE Score no score Shape ROUND Size 6mm Flavor Imprint Code GG63 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0781-1971-10 1000 TABLET In 1 BOTTLE None 2 0781-1971-01 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA072099	05/24/1988

Desipramine HYDROCHLORIDE  Desipramine hydrochloride  tablet, film coated