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Depakote ER (Generic Valproic Acid)

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WARNING

The damage to the liver from valproic acid may be serious or even fatal, and it is most likely to happen during the first six months of treatment. Children under the age of 2 who take more than one medication to prevent seizures, have certain inherited diseases that may prevent the body from converting food to energy normally, or who have any condition that impairs thinking, learning, or understanding are more likely to experience liver damage. If you have liver illness, urea cycle disorder (an hereditary disorder that affects the ability to metabolise protein), or a condition that affects the brain, muscles, nerves, or liver, let your doctor know. You won’t want to take valproic acid, your doctor will probably advise you. Call your doctor right away if you have any of the following symptoms or find that your seizures are becoming more severe or frequent: Excessive fatigue, a lack of energy, a feeling of weakness, right stomach ache, nausea, vomiting, dark urine, a yellowing of the skin or the whites of your eyes, or facial swelling.

Valproic acid exposure before birth can result in major birth abnormalities (physical issues that exist at birth), particularly in the brain and spinal cord. It can also result in lower IQ, issues with movement and coordination, learning, communication, emotions, and behaviour in infants. If you are pregnant or want to become pregnant, let your doctor know. Valproic acid for migraine prevention should not be taken by women who are pregnant, capable of becoming pregnant, or who are not using an effective method of birth control. Valproic acid should only be used by pregnant women if other medications have failed to control their symptoms or they are unable to use them for the treatment of seizures or bipolar disorder (also known as manic-depressive disorder; a condition that causes episodes of depression, episodes of mania, and other abnormal moods). Discuss the dangers of valproic acid use during pregnancy with your doctor. If you are a woman of childbearing age, including girls who have begun puberty, discuss utilising alternative therapies in place of valproic acid with your doctor. If it is decided to utilise valproic acid, you must use reliable birth control while receiving medication. Discuss effective birth control options with your doctor. Call your doctor right away if you become pregnant while taking valproic acid. The foetus could suffer from valproic acid.

The pancreas may suffer severe or potentially fatal damage as a result of valproic acid. Throughout your treatment, this could happen at any time. Call your doctor right away if you have any of the following symptoms: Constant pain that starts in the stomach but can move to the back, along with nausea, vomiting, or an appetite loss.

Keep all of your appointments with your physician and the lab. To determine how you are responding to valproic acid, your doctor will request a number of lab tests.

Consult your doctor regarding the dangers of valproic acid use or administration to a kid.

The manufacturer’s patient information sheet (Medication Guide) will be sent to you by your doctor or pharmacist when you start taking valproic acid and each time you refill your prescription. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Why is this medication prescribed?

Some forms of seizures are treated with valproic acid alone or in combination with other drugs. Moreover, mania (periods of frenzied, unusually exuberant mood) is treated with valproic acid in bipolar disorder sufferers (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). In contrast to relieving already-started headaches, it is also utilised to prevent migraines. The drug valproic acid belongs to the anticonvulsant drug class. It functions by raising the brain’s concentration of a specific natural chemical.

How should this medicine be used?

Valproic acid is available as a capsule, a tablet with a long half-life (extended release), a tablet with a delayed release (releases the medication in the intestine to prevent stomach damage), a sprinkle capsule (contains tiny beads of medication that can be sprinkled on food), and a syrup (liquid) for oral consumption. Typically, two or more times a day are required for the syrup, capsules, delayed-release tablets, and sprinkle capsules. Typically, one daily dose of the extended-release tablets is required. Take valproic acid every day at around the same time(s). To reduce the likelihood of the drug upsetting your stomach, take valproic acid with food. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Use valproic acid as prescribed by your doctor. Never take it in quantities or frequencies other than those recommended by your doctor.

Do not split, chew, or crush the standard capsules, delayed-release capsules, or extended-release tablets; instead, swallow them whole.

You can either open the sprinkle capsules and sprinkle the beads inside them on a teaspoonful of soft food, such applesauce or pudding, or you can take the capsules whole. As soon as you prepare the mixture of food and drug beads, swallow it. Don’t eat the beads, please. Do not keep leftover food and drug combinations.

Never add the syrup to any carbonated beverage.

Products containing divalproex sodium, valproate sodium, and valproic acid are absorbed by the body in various ways and cannot be interchanged. Your doctor might need to change your dosage if you need to transition from one product to another. Verify that you have received the medication prescribed for you each time you receive a prescription. If you are unsure if you were given the correct medication, speak with your pharmacist.

Your physician might prescribe you a modest dose of valproic acid and then gradually increase it.

Your problem won’t be cured by valproic acid, but it might help you manage it. Valproic acid should still be used even if you feel OK. Even if you have side effects including odd changes in behaviour or mood or if you learn that you are pregnant, do not discontinue taking valproic acid without first consulting your doctor. You might have a severe, protracted, and possibly fatal seizure if you abruptly stop taking valproic acid. Your dose will likely be gradually reduced by your doctor.

Other uses for this medicine

Moreover, valproic acid is occasionally used to manage violent outbursts in young patients with ADHD (ADHD; more difficulty focusing or remaining still or quiet than other people who are the same age). Discuss the potential dangers of using this medicine for your illness with your doctor.

Sometimes, this drug is prescribed for other purposes. For more information, consult your physician or pharmacist.

What special precautions should I follow?

Before taking valproic acid,

  • If you have any allergies, including to valproic acid, other medicines, or any of the substances in the brand of valproic acid your doctor has prescribed, let your doctor and pharmacist know right once. Get a list of the components from your pharmacist.
  • Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Incorporate any of the following: Anticoagulants, also known as “blood thinners,” include acyclovir (Zovirax), amitriptyline, aspirin, and carbamazepine (Tegretol), medications for anxiety or mental illness, meropenem, cholestyramine (Prevalite), clonazepam (Klonopin), diazepam (Valium), ertapenem (Invanz), doripenem (Doribax), ethosuximide (Zarontin), felbamate (Felbatol), some hormonal contraceptives (birth control pills, rings, patches, implants, injections, and intrauterine devices), imi (Merrem), sedatives, sleeping pills, tolbutamide, topiramate (Topamax), tranquillizers, zidovudine, phenobarbital, phenytoin (Dilantin), primidone (Mysoline), rifampin (Rifadin), rufinamide (Banzel), and rifampin (Retrovir). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Inform your doctor if you currently have or have ever had comas (losses of consciousness for a period of time), trouble coordinating your movements, episodes of confusion and loss of cognitive and verbal abilities, especially during pregnancy or childbirth, human immunodeficiency virus (HIV), or cytomegalovirus (CMV; a virus that can cause symptoms in people who have weak immune systems).
  • If you are breastfeeding, let your doctor know.
  • Inform your doctor or dentist that you are taking valproic acid if you are having surgery, including dental surgery.
  • You ought to be aware that valproic acid might make you sleepy. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
  • Keep in mind that drinking alcohol can worsen the drowsiness brought on by this drug.
  • You should be aware that, particularly if you are senior, valproic acid can make you feel extremely sleepy and may cause you to eat or drink less than usual. If you find it difficult to eat or drink as you normally would, let your doctor know.
  • You should be aware that while taking valproic acid for the treatment of epilepsy, mental illness, or other illnesses, your mental health may alter in unexpected ways and you may become suicidal (thinking about injuring or killing oneself, preparing to do so, or trying to do so). In clinical studies, a small proportion of patients using anticonvulsants like valproic acid to treat various conditions about 1 in 500 adults and children aged 5 and older became suicidal while receiving medication. Some of these individuals started exhibiting suicidal thoughts and actions as little as one week after beginning the medicine. If you take an anticonvulsant drug like valproic acid, there is a chance that you could experience changes in your mental state. Nevertheless, there is also a chance that if your condition is left untreated, those changes could happen to you as well. If taking an anticonvulsant medicine has more dangers than it is worth, you and your doctor will decide that taking the medication is the better option. Any of the following symptoms should prompt you, your family, or your carer to call your doctor immediately away: panic attacks, restlessness or agitation, increased or new irritation, anxiety, or depression, acting on risky impulses, trouble falling or keeping asleep, and aggressive, irate, or violent behaviour; Mania (an irrationally frantic and ecstatic state); talking about hurting yourself or wanting to end your life; cutting off relationships with loved ones; obsessing about death and dying; parting with priceless possessions; or exhibiting any other unexpected changes in behaviour or mood. Make sure your family or carer is aware of any symptoms that could be significant so they can contact the doctor on your behalf if you are unable to call for help.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If your next dose is approaching, skip the missed one and carry on with your regular dosing regimen. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Valproic acid could have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Drowsiness
  • Dizziness
  • Headache
  • Diarrhea
  • Constipation
  • Alterations in appetite
  • Weight variations
  • Back ache
  • Agitation
  • Mood changes
  • Abnormal thought
  • Body part shaking that is uncontrollable
  • Issues with coordination or walking
  • Eye motions that are erratic
  • Double or blurry vision
  • An earache that ringers
  • Hair fall

Some adverse effects may be severe. Call your doctor right away if any of the following symptoms occur, in addition to those in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections:

  • Significant bruising or bleeding
  • Little red or purple patches on the skin
  • Fever
  • Rash
  • Bruising
  • Hives
  • Breathing or swallowing challenges
  • Enlarged glands
  • Face, eyes, lips, tongue, or throat swelling
  • Blistered or flaking skin
  • Confusion
  • Tiredness
  • Vomiting
  • Body temperature decline
  • Joint weakness or enlargement

Further negative effects of valproic acid are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it at room temperature and away from moisture and excessive heat (not in the bathroom).

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Sleepiness
  • Abnormal heartbeat
  • Coma (loss of consciousness for a period of time)

What other information should I know?

You might find the drug beads in your stool if you’re taking sprinkle capsules. This is typical and does not indicate that you did not take the entire drug dose.

Inform your doctor that you are taking valproic acid if you have diabetes and they have instructed you to check your urine for ketones. Ketones in urine tests may give false positives if valproic acid is present.

Inform the lab staff and your doctor that you are taking valproic acid prior to any laboratory test.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Depakene®
  • Depakote®
  • Depakote® ER
  • Depakote® Sprinkle
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