Valproic Acid and Derivatives Drug Information

Type of Drug:

Anticonvulsant; drug used to treat epilepsy, seizures, and other conditions.

How the Drug Works:

Valproic acid prevents or reduces the number of seizures by controlling the abnormal activity of nerve impulses in the brain and central nervous system. Sodium valproate and divalproex sodium are converted to valproic acid in the body.

Uses:

Used alone or in combination with other anticonvulsants to control simple and complex absence seizures (petit mal).

Used alone or in combination with other anticonvulsants to control isolated complex partial seizures or complex partial seizures associated with other types of seizures.

Delayed-release tablets: To treat manic episodes associated with bipolar disorder.

Delayed-release, extended-release tablets: For the prevention of migraine headaches.

Unlabeled Uses: May be effective as an adjunct to antipsychotic drugs in the symptomatic management of schizophrenia in patients who fail to respond to an adequate trial of the antipsychotic agent alone. Also may be a useful adjunct in schizophrenic patients with EEG abnormalities suggestive of seizure activity, or in those patients with agitated or violent behavior. May be effective in relieving tardive dyskinesia in patient receiving long-term antipsychotic drug therapy. For the treatment of aggressive outbursts in children with attention deficit hyperactivity disorder. Has been shown to be effective in a limited number of nations with organic brain syndrome.

Precautions:

Liver disease: Liver failure resulting in death has occurred in patients receiving valproic acid and its derivatives. Children younger than 2 years of age are at an increased risk of developing fatal liver toxicity, especially if they are taking several anticonvulsant medications or have birthA­related metabolic disorders, severe seizure disorders accompanied by mental retardation, or brain damage. Liver problems usually occur during the first 6 months of treatment. Loss of seizure control, general feeling of ill health, weakness, drowsiness, facial swelling, appetite loss, yellowing of skin and eyes, or persistent or unexplained vomiting may be warning signs of possible liver problems.

Pancreatitis: Cases of life-threatening pancreatitis have been reported in children and adults receiving valproate. Pancreatitis can occur at any time while using valproic acid. Abdominal pain, nausea, vomiting, or anorexia can be symptoms of pancreatitis that require prompt medical evaluation.

Pregnancy: Studies have shown a potential risk to the fetus. Using these drugs during pregnancy may result in birth defects. If you are pregnant or are planning to become pregnant, discuss with your doctor the possible risks to the unborn infant. Use only if clearly needed and the potential benefits outweigh the possible risks.

Breastfeeding: Valproic acid appears in breast milk. Consult your doctor before you begin breastfeeding.

Children: Children younger than 2 years of age may be particularly sensitive to the possible liver damage caused by valproic acid, especially if taking other anticonvulsant drugs at the same time. Safety and effectiveness have not been established in children younger than 18 years of age for treatment of acute mania. Safety and efficacy of divalproex sodium for the prevention of migraines has not been established in children younger than 16 years of age. Safety and effectiveness of divalproex sodium extended-release tablets for the prevention of migraine headache and treatment of epilepsy have not been established in children younger than 18 years of age. Sprinkle capsules me for adults and children 10 years of age and older. Consult your doctor See Liver disease.

Elderly: Elderly patients may be at an increased risk of drowsiness and tremor. Lower doses are usually used when starting therapy.

Lab Tests: Lab tests will be required during treatment. Tests may include liver function, blood cell counts, blood-clotting tests, and valproic acid blood levels.

Drug Interactions:

Tell your doctor or pharmacist if you are taking or planning to take any over-the-counter or prescription medications or dietary supplements with this drug. Drug doses may need to be modified or a different drug prescribed. The following drugs and drug classes interact with this drug:

Carbamazepine (eg, Tegretol)

Diazepam (eg, Valium)

Ethosuximide (eg, Zarontin)

Felbamate (Felbatol)

Hydantoins (eg, phenytoin)

Lamotrigine (Lamictal)

Phenobarbital (eg, Solfoton)

Primidone (eg, Mysoline)

Salicylates (eg, aspirin)

Side Effects:

Every drug is capable of producing side effects. Many patients experience no, or minor, side effects. The frequency and severity of side effects depend on many factors including dose, duration of therapy, and individual susceptibility. Possible side effects include:

Senses: Abnormal vision; eye redness or pain; blurred or double vision; spots before the eyes; unusual eye movements; dry eyes; hearing loss; ear pain or disorder; ringing in the ears; taste perversion.

Digestive Tract: Appetite changes; nausea; vomiting; stomach cramps or pain; indigestion; diarrhea; fecal incontinence; constipation; gas; tongue inflammation; vomiting of blood; belching; pancreatitis.

Nervous System: Weakness; tiredness; nervousness; forgetfulness; clumsiness; drowsiness; behavior changes; depression; headache; tremors; hallucinations; dizziness; slurred speech; abnormal dreams; abnormal thinking; agitation; abnormal gait; twitching; abnormal skin sensations (eg, burning, prickling, tingling); feeling of whirling motion; exaggerated sense of well-being; decreased sense of stimulation; difficulty moving; increased reflexes; confusion; sleeplessness; behavioral deterioration; anxiety.

Circulatory System: Changes in blood pressure; pounding in the chest (eg pitations); dizziness or light-headedness when rising from a sitting or lying position (postural hypotension); fast heartbeat; flushing; chest pain

Skin: Yellowing of skin or eyes; unusual bleeding or bruising; sensitivity 10 sunlight; rash; itching; dry or oily skin; skin redness; hair follicle infection; hair loss.

Other: Swelling of the face, hands, or feet; weight changes; abscessed teeth; muscle, joint, and back pain; leg cramps; tight muscles; difficulty breathing; increased cough; runny nose; frequent, painful, or difficult urination; loss of bladder control; chills; fever; neck pain or stiffness; changes in menstrual periods; painful menstruation; injection site reactions; sore throat; flu-like syndrome; sweating; general body discomfort; vaginal infection; bronchitis; respiratory infection; muscle weakness; nosebleed; sinus infection; difficulty speaking.

Guidelines for Use:

Dosage is individualized. Take exactly as prescribed.

Do not stop taking or change the dose, unless instructed by your doctor. If you stop taking this medicine suddenly, your seizures may suddenly begin again.

May cause stomach upset. Take with food.

Tablets, capsules - Swallow whole; do not chew or crush. Chewing or crushing may cause irritation in the mouth or throat.

Sprinkle capsules - May be swallowed whole or taken by opening the capsule and sprinkling the contents on a small amount (teaspoonful) of soft foods such as applesauce or pudding. Swallow quickly without chewing. Do not store drug/food mixture for future use. Some of the specially coated sprinkles may be seen in the stool. This is normal and no cause for concern.

May cause dizziness, drowsiness, or sleepiness. Use caution when driving or performing other tasks requiring alertness, coordination, or physical dexterity until tolerance is determined. Taking at bedtime may help decrease drowsiness.

Contact your doctor immediately if you experience loss of seizure control, weakness, swelling of the face, unusual bleeding or bruising, skin reactions, lethargy, general body discomfort, appetite loss, yellowing of skin or eyes, vomiting, nausea, or stomach pain.

If dose is missed, take as soon as possible. If several hours have passed or it is nearing time for the next dose, do not double the dose to catch up, unless instructed by your doctor. If more than one dose if missed or it is necessary to establish a new dosage schedule, conA­tact your doctor or pharmacist.

When you first begin taking this medicine, see your doctor regularly. Your doctor may want to adjust the dose you are taking to make sure it is the best dose to control your condition and minimize side effects. Checkups are particularly important if you are taking other anticonvulsant drugs with valproic acid.

Inform your doctor if you are pregnant, become pregnant, are planning to become pregnant, or are breastfeeding.

Diabetes - These drugs may interfere with urine tests for ketones and may give inaccurate test results.

Using these drugs with alcohol or other central nervous system depressants (eg, narcotic pain relievers, sedatives) may cause additional drowsiness.

Carry Medic Alert identification indicating that you are taking these drugs and have epilepsy.

May cause sensitivity to sunlight. Avoid prolonged exposure to the sun and other ultraviolet light. Use sunscreens and wear protective clothing until tolerance is determined.

Store capsules at 59A° to 77A°F. Store tablets and syrup below 86A°F.