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|Valproate Sodium

VALPROIC ACID (Systemic)

Some commonly used brand names are:

In the U.S.—

• Depacon ²
• Depakene ³
• Depakote ¹
• Depakote Sprinkle ¹

In Canada—

• Alti-Valproic ³
• Depakene ³
• Deproic ³
• Dom-Valproic ³
• Epival ¹
• Med Valproic ³
• Novo-Valproic ³
• Nu-Valproic ³
• Penta-Valproic ³
• pms-Valproic Acid ³
• pms-Valproic Acid E.C. ³

Category

• Anticonvulsant—Divalproex; Valproate Sodium; Valproic Acid
• Antimanic—Divalproex
• Migraine headache prophylactic—Divalproex

Description

Valproic acid, valproate sodium, and divalproex belong to the group of medicines called anticonvulsants. They are used to control certain types of seizures in the treatment of epilepsy. Valproic acid, valproate sodium, and divalproex may be used alone or with other seizure medicine. Divalproex is also used to treat the manic phase of bipolar disorder (manic-depressive illness), and to help prevent migraine headaches.

Divalproex and valproate sodium form valproic acid in the body. Therefore, the following information applies to all of these medicines.

These medicines are available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Divalproex
  • Delayed-release capsules (U.S.)
  • Delayed-release tablets (U.S. and Canada)
• Valproic Acid
  • Capsules (U.S. and Canada)
  • Syrup (U.S. and Canada)

• Parenteral
• Valproate Sodium
  • Injection (U.S.)

Before Using This Medicine

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 valproic acid, valproate sodium, and divalproex, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to valproic acid, valproate sodium, or divalproex. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Valproic acid, valproate sodium, and divalproex have been reported to cause birth defects when taken by the mother during the first 3 months of pregnancy. Also, animal studies have shown that valproic acid, valproate sodium, and divalproex cause birth defects when taken in doses several times greater than doses used in humans. However, these medicines may be necessary to control seizures in some pregnant patients. Be sure you have discussed this with your doctor.

Breast-feeding—Valproic acid, valproate sodium, and divalproex pass into the breast milk, but their effect on the nursing baby is not known. It may be necessary for you to take another medicine or to stop breast-feeding during treatment with valproic acid, valproate sodium, or divalproex. Be sure you have discussed the risks and benefits of this medicine with your doctor.

Children—Abdominal or stomach cramps, nausea or vomiting, tiredness or weakness, and yellow eyes or skin may be especially likely to occur in children, who are usually more sensitive to the effects of these medicines. Children up to 2 years of age, those taking more than one medicine for seizure control, and children with certain other medical problems may be more likely to develop serious side effects.

Older adults—Elderly people are especially sensitive to the effects of these medicines. This may increase the chance of side effects during treatment. The dose of this medicine may be lower for older adults.

Other 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 valproic acid, valproate sodium, or divalproex, it is especially important that your health care professional knows if you are taking any of the following:

• Acetaminophen (e.g., Tylenol) (with long-term, high-dose use) or
• Amiodarone (e.g., Cordarone) or
• Amitriptyline and nortriptyline
• Anabolic steroids (nandrolone [e.g., Anabolin], oxandrolone [e.g., Anavar], oxymetholone [e.g., Anadrol], stanozolol [e.g., Winstrol]) or
• Androgens (male hormones) or
• Anticoagulants
• Aspirin
• Barbiturates or
• Carbamazepine (e.g., Tegretol) or
• Carmustine (e.g., BiCNU) or
• Dantrolene (e.g., Dantrium) or
• Daunorubicin (e.g., Cerubidine) or
• Disulfiram (e.g., Antabuse) or
• Estrogens (female hormones) or
• Ethosuximide
• Etretinate (e.g., Tegison) or
• Gold salts (medicine for arthritis) or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Mexate) or
• Methyldopa (e.g., Aldomet) or
• Naltrexone (e.g., Trexan) (with long-term, high-dose use) or
• Phenothiazines (acetophenazine [e.g., Tindal], chlorpromazine [e.g., Thorazine], fluphenazine [e.g., Prolixin], mesoridazine [e.g., Serentil], perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], promazine [e.g., Sparine], promethazine [e.g., Phenergan], thioridazine [e.g., Mellaril], trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin], trimeprazine [e.g., Temaril]) or
• Plicamycin (e.g., Mithracin)—There is an increased risk of serious side effects to the liver

• Central nervous system (CNS) depressants (medicines that cause drowsiness) or
• Tricyclic antidepressants (medicine for depression)—There may be an increase in CNS depressant effects

• Carbenicillin by injection (e.g., Geopen) or
• Dipyridamole (e.g., Persantine) or
• Inflammation or pain medicine, except narcotics, or
• Pentoxifylline (e.g., Trental) or
• Sulfinpyrazone (e.g., Anturane) or
• Ticarcillin (e.g., Ticar)—Valproic acid, valproate sodium, or divalproex may increase the chance of bleeding because of decreased blood clotting ability; the potential of aspirin, medicine for inflammation or pain, or sulfinpyrazone to cause stomach ulcer and bleeding may also increase the chance of bleeding in patients taking valproic acid, valproate sodium, or divalproex

• Heparin—There is an increased risk of side effects that may cause bleeding

• Mefloquine—The amount of valproic acid, valproate sodium, or divalproex that you need to take may change

• Other anticonvulsants (medicine for seizures)—There is an increased risk of seizures or other unwanted effects

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

• Blood disease or
• Brain disease or
• Kidney disease—There is an increased risk of serious side effects

• Liver disease—Valproic acid, valproate sodium, or divalproex may make the condition worse

• Pancreatitis—may be life threatening, stop using valproate if you have this condition

• Urea cycle disorders—my lead to serious side effects or death

Proper Use of This Medicine

For patients taking the capsule form of valproic acid:

• Swallow the capsule whole without chewing, crushing, or breaking. This is to prevent irritation of the mouth or throat.

For patients taking the delayed-release capsule form of divalproex:

• Swallow the capsule whole, or sprinkle the contents on a small amount of soft food, such as applesauce or pudding, and swallow without chewing.

For patients taking the delayed-release tablet form of divalproex:

• Swallow the tablet whole without chewing, breaking, or crushing. This is to prevent damage to the special coating that helps lessen irritation of the stomach.

For patients taking the syrup form of valproic acid:

• The syrup may be mixed with any liquid or added to food for a better taste.

For patients taking the oral dosage forms of valproic acid and divalproex:

• These medicines may be taken with meals or snacks to reduce stomach upset.

This medicine must be taken exactly as directed by your doctor to prevent seizures and lessen the possibility of side effects.

Dosing—The dose of valproic acid, valproate sodium, or divalproex 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 valproic acid, valproate sodium, or divalproex. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules or tablets or teaspoonfuls of syrup that you take or the number of injections you receive 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 valproic acid, valproate sodium, or divalproex .

• If valproic acid or divalproex is the only medicine you are taking for seizures:
  • Adults and adolescents: Dose is based on body weight. The usual dose is 5 to 15 milligrams (mg) per kilogram (kg) (2.3 to 6.9 mg per pound) of body weight to start. Your doctor may increase your dose gradually every week by 5 to 10 mg per kg of body weight if needed. However, the dose is usually not more than 60 mg per kg of body weight a day. If the total dose a day is greater than 250 mg, it is usually divided into smaller doses and taken two or more times during the day.
  • Children 1 to 12 years of age: Dose is based on body weight. The usual dose is 15 to 45 mg per kg (6.9 to 20.7 mg per pound) of body weight to start. The doctor may increase the dose gradually every week by 5 to 10 mg per kg of body weight if needed.
• If you are taking more than one medicine for seizures:
  • Adults and adolescents: Dose is based on body weight. The usual dose is 10 to 30 mg per kg (4.6 to 13.8 mg per pound) of body weight to start. Your doctor may increase your dose gradually every week by 5 to 10 mg per kg of body weight if needed. If the total dose a day is greater than 250 mg, it is usually divided into smaller doses and taken two or more times during the day.
  • Children 1 to 12 years of age: Dose is based on body weight. The usual dose is 30 to 100 mg per kg (13.8 to 45.5 mg per pound) of body weight.
• If you are using valproate sodium for seizures because you temporarily cannot take oral medication:
  • Adults, adolescents, and children: Dose is based on body weight, and will be determined by your doctor. The dose is injected into a vein.
• If you are taking divalproex for treatment of mania:
  • Adults: At first, 750 mg a day, usually divided into smaller doses and taken two or more times during the day. Your doctor may increase your dose if needed.
  • Children: Use and dose must be determined by your doctor.
• If you are taking divalproex for prevention of migraine headaches:
  • Adults: At first, 250 mg two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1000 mg a day.
  • Children: Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, and your dosing schedule is:

• One dose a day—Take the missed dose as soon as possible. However, if you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• Two or more doses a day—If you remember within 6 hours of the missed dose, take it right away. Then take the rest of the doses for that day at equally spaced times. Do not double doses.

If you have any questions about this, check with your doctor.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the capsule or tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the syrup form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Your doctor should check your progress at regular visits , especially for the first few months that you take this medicine. This is necessary to allow dose adjustments and to reduce any unwanted effects.

Do not stop taking this medicine without first checking with your doctor . Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

Before you have any medical tests, tell the doctor in charge that you are taking this medicine. The results of the metyrapone and thyroid function tests may be affected by this medicine.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine . Valproic acid, valproate sodium, or divalproex may change the time it takes your blood to clot, which may increase the chance of bleeding. Also, taking valproic acid, valproate sodium, or divalproex together with medicines that are used during surgery or dental or emergency treatments may increase the CNS depressant effects.

Valproic acid, valproate sodium, and divalproex will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine .

For diabetic patients:

• This medicine may interfere with urine tests for ketones and give false-positive results.

Your doctor may want you to carry a medical identification card or bracelet stating that you are taking this medicine.

This medicine may cause some people to become drowsy or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are drowsy or not alert .

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

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

Revised: 11/11/2003

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