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Depakote

Depakote (divalproex sodium) is utilized in the treatment of various types of seizure disorders. Depakote is also used to treat manic episodes that can occur with bipolar disorder, and to prevent migraine headaches.

Generic Depakote Quantity Consultation Request This Medication
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Generic Depakote ER 250mg 120 Tablets Included Click Here
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Depakote ER 250mg (brand) 30 Tablets Included Click Here
Depakote ER 250mg (brand) 60 Tablets Included Click Here
Depakote ER 250mg (brand) 90 Tablets Included Click Here
Depakote ER 250mg (brand) 120 Tablets Included Click Here
Depakote ER 500mg (brand) 30 Tablets Included Click Here
Depakote ER 500mg (brand) 60 Tablets Included Click Here
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DEPAKOTE MEDICATION INFO


PLEASE NOTE: The following information is intended as a supplement, but not as a substitution for the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be assumed that use of the drug is safe, appropriate, or effective for your condition. Consult your healthcare professional before using this drug.

Do not use Depakote to prevent migraine headaches if you are pregnant.

If you utilize Depakote for seizures or manic episodes: Do not start or stop taking the medicine during pregnancy without your doctor's advice. Divalproex sodium may result in problems with an unborn baby, but having a seizure during pregnancy could harm both the mother and the baby.

You should not use Depakote if you have liver disease, a urea cycle disorder, or a genetic disorder such as Alpers' disease or Alpers-Huttenlocher syndrome (especially in a child younger than 2 years old).

Contact your physician immeditately if the person taking this medicine has early signs of liver damage, such as: loss of appetite, upper stomach pain, ongoing nausea or vomiting, dark urine, swelling in the face, or jaundice (yellowing of the skin or eyes).

Depakote can also cause serious harm to the pancreas, which may get worse quickly. Call your doctor at once if you have symptoms such as: severe pain in your upper stomach spreading to your back, or ongoing nausea or vomiting.

DEPAKOTE ER (also known as divalproex sodium)

COMMON BRAND NAME(S): Depakote, Depakote ER

USES: Mania - Depakote (divalproex sodium) is a valproate and is used in the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritation. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility.

Epilepsy - Depakote is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Depakote is also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.

Migraine - Depakote is indicated for prophylaxis of migraine headaches. DDepakote tablets are administered orally. The recommended starting dose is 250 mg twice daily. In the clinical trials, there was no evidence that higher doses led to greater efficacy. Read and follow your doctor's instructions carefully.

HOW TO USE: Consume this med by mouth or as directed by your doctor. You may take it with food if stomach upset occurs. Swallow the tablet whole. Do not crush or chew the tablet, which can irritate the mouth or throat.

Dosage is based on your age, weight, medical condition, and response to therapy. Use Depakote regularly in order to get the most benefit from it. Remember to use it at the same time each day to keep the amount of Depakote in your blood constant.

If Depakote ER is used for seizures, do not stop taking it without consulting your doctor. Your condition may become worse if Depakote ER is suddenly stopped. Your dose may need to be gradually decreased.

POSSIBLE SIDE EFFECTS: Get emergency medical help if you have any of these signs of an allergic reaction: to Depakote hives; fever, swollen glands, mouth sores, difficulty breathing; swelling of your face, lips, tongue, or throat.

Contact your doctor imediately if the person taking this medicine has early signs of liver damage, such as: loss of appetite, upper stomach pain, ongoing nausea or vomiting, dark urine, swelling in the face, or jaundice (yellowing of the skin or eyes).

Depakote can also cause serious harm to the pancreas, which may get worse quickly. Call your doctor at once if you have symptoms such as: severe pain in your upper stomach spreading to your back, or ongoing nausea or vomiting.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Contact your doctor at once if you have any of these other side effects: confusion, tiredness, cold feeling, vomiting, change in your mental state; easy bruising, unusual bleeding (nose, mouth, or gums), purple or red pinpoint spots under your skin; severe drowsiness; worsening seizures; or severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Depakote side effects may include: mild nausea or vomiting, mild stomach pain, diarrhea; headache, mild dizziness, weakness, tremors; problems with balance or walking; blurred vision, double vision; or changes in appetite, weight gain.

This is not a complete list of side effects, and others may occur. Contact your doctor for medical advice about side effects.

PRECAUTIONS:

Pancreatitis - Patients and guardians should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis.

Hyperammonemia - Patients should be informed of the signs and symptoms associated with hyperammonemic encephalopathy and be told to inform the prescriber if any of these symptoms occur.

CMS Depression - Since DEPAKOTE may produce CMS depression, especially when in combination with another CMS depressant (e.g., alcohol), patients should be advised not to engage in hazardous activities, such as driving an automobile or operating dangerous machinery, until it is known that they do not become drowsy from the drug.

Birth Defects - Since DEPAKOTE (divalproex sodium delayed release tablets) has been associated with certain types of birth defects, female patients of child-bearing age considering the use of DEPAKOTE (divalproex sodium delayed release tablets) should be advised of the risk and of alternative therapeutic options and to read the Patient Information Leaflet, which appears as the last section of the labeling. This is especially important when the treatment of a spontaneously reversible condition not ordinarily associated with permanent injury or risk of death (e.g., migraine) is considered.

Be on alert for Suicidal Thinking and Behavior - Patients, their caregivers, and families should be counseled that AEDs, including Depakote , may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to the healthcare providers.

Multi-organ Hypersensitivity Reaction - Patients should be instructed that a fever associated with other organ system involvement (rash, lymphadenopathy, etc.) may be drug-related and should be reported to the physician immediately (see PRECAUTIONS - Multi-organ Hypersensitivity Reaction).

Mutagenesis - Valproate was not mutagenic in an in vitro bacterial assay (Ames test), did not produce dominant lethal effects in mice, and did not increase chromosome aberration frequency in an in vivo cytogenetic study in rats. Increased frequencies of sister chromatid exchange (SCE) have been reported in a study of epileptic children taking valproate, but this association was not observed in another study conducted in adults. There is some evidence that increased SCE frequencies may be associated with epilepsy. The biological significance of an increase in SCE frequency is not known.

Fertility - Chronic toxicity studies in juvenile and adult rats and dogs demonstrated reduced spermatogenesis and testicular atrophy at oral doses of 400 mg/kg/day or greater in rats (approximately equivalent to or greater than the maximum human daily dose on a mg/m2 basis) and 150 mg/kg/day or greater in dogs (approximately 1.4 times the maximum human daily dose or greater on a mg/m2 basis). Segment I fertility studies in rats have shown doses up to 350 mg/kg/day (approximately equal to the maximum human daily dose on a mg/m2 basis) for 60 days to have no effect on fertility. THE EFFECT OF VALPROATE ON TESTICULAR DEVELOPMENT AND ON SPERM PRODUCTION AND FERTILITY IN HUMANS IS UNKNOWN.

Pregnancy - VALPROATE CAN PRODUCE TERATOGENIC EFFECTS. DATA SUGGEST THAT THERE IS AN INCREASED INCIDENCE OF CONGENITAL MALFORMATIONS ASSOCIATED WITH THE USE OF VALPROATE BY WOMEN WITH SEIZURE DISORDERS DURING PREGNANCY WHEN COMPARED TO THE INCIDENCE IN WOMEN WITH SEIZURE DISORDERS WHO DO NOT USE ANTIEPILEPTIC DRUGS DURING PREGNANCY. USE ONLY IN THE ESSENTIAL MANAGEMENT OF A MEDICAL CONDITION AND AS DIRECTED BY A DOCTOR. NOTE: Antiepileptic drugs should not be discontinued abruptly in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In individual cases where the severity and frequency of the seizure disorder are such that the removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy, although it cannot be said with any confidence that even minor seizures do not pose some hazard to the developing embryo or fetus.

Nursing Mothers - Valproate is excreted in breast milk. Concentrations in breast milk have been reported to be 1-10% of serum concentrations. It is not known what effect this would have on a nursing infant. Consideration should be given to discontinuing nursing when divalproex sodium is administered to a nursing woman.

Pediatric Use - Experience has indicated that pediatric patients under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those with the aforementioned conditions (see BOXED WARNING). When DEPAKOTE (divalproex sodium delayed release tablets) is used in this patient group, it should be used with extreme caution and as a sole agent. The benefits of therapy should be weighed against the risks. Above the age of 2 years, experience in epilepsy has indicated that the incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups.Younger children, especially those receiving enzyme-inducing drugs, will require larger maintenance doses to attain targeted total and unbound valproic acid concentrations.

*The safety and effectiveness of DEPAKOTE (divalproex sodium delayed release tablets) for the treatment of acute mania has not been studied in individuals below the age of 18 years.

Geriatric Use - A study of elderly patients with dementia revealed drug related somnolence and discontinuation for somnolence. The starting dose should be reduced in these patients, and dosage reductions or discontinuation should be considered in patients with excessive somnolence .

DRUG INTERACTIONS: Before using Depakote, tell your doctor all of the prescription and nonprescription/herbal products you use, especially: certain antidepressants (e.g., amitriptyline, nortriptyline, phenelzine), certain benzodiazepines (e.g., clonazepam, diazepam), certain antibiotics (carbapenems such as doripenem, imipenem), mefloquine, other medications for seizure (e.g., carbamazepine, ethosuximide, felbamate, lamotrigine, phenobarbital, phenytoin, rufinamide, topiramate), rifampin, warfarin, vorinostat, zidovudine.

Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually these dosages are 81-325 milligrams per day), should be continued. Consult your doctor or pharmacist if you are using aspirin for any reason.

Tell your doctor if you also take drugs that cause drowsiness such as: antihistamines that cause drowsiness (e.g., diphenhydramine), medicine for sleep (e.g., sedatives), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine), tranquilizers.

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your doctor about the safe use of those products.

This list does not contain all possible interactions that can occur with this medication. Therefore, before using Depakote ER, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: excessive drowsiness, coma, irregular/slowed/skipped heart beats (heart block).

NOTES: Do not share Depakote ER with others.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

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