What Depakene is used for and how to use it
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Depakene - Consumer Medicine Information

Manufacture: Abbott
Country: Canada
Condition: Epilepsy, Mania, Migraine Prevention (Migraine Prophylaxis), Schizoaffective Disorder, Seizure Prevention (Seizure Prophylaxis), Seizures (Convulsions)
Class: Fatty acid derivative anticonvulsants
Form: Capsules
Ingredients: valproic acid, corn oil, gelatin mass, ink (Light Redwood), lecithin, medium chain triglycerides, nitrogen

DEPAKENE capsules

valproic acid

About This Medication

What the medication is used for

  • DEPAKENE has been prescribed to you to control your epilepsy. Please follow your doctor’s recommendations carefully.

What it does

DEPAKENE has anticonvulsant properties. The mechanism of action has not yet been established. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid (GABA).

When it should not be used

DEPAKENE should not be taken by

  • patients with liver disease or significant liver dysfunction
  • patients with mitochondrial diseases (e.g., Alpers or Alpers-Huttenlocher disease)
  • patients who are allergic to the drug
  • patients with known urea cycle disorders (a genetic disorder)
  • patients with known porphyria (a genetic disorder)

What the medicinal ingredient is

valproic acid.

What the non-medicinal ingredients are

DEPAKENE 250 mg capsules contain the following nonmedicinal ingredients: Corn oil, gelatin mass, ink (Light Redwood), lecithin, medium chain triglycerides, nitrogen.

What dosage forms it comes in

DEPAKENE is available as a capsule containing 250 mg of valproic acid.

DEPAKENE is also available as an oral solution containing 250 mg of valproic acid for every 5 mL.

Warnings and Precautions

Serious Warnings and Precautions

  • Hepatotoxicity:liver failure resulting in death has occurred in patients receiving DEPAKENE. These incidents usually occurred during the first 6 months of treatment with DEPAKENE. Patients taking several anticonvulsant drugs, children, those with a history of liver disease, metabolic disorders, severe seizure disorders accompanied by mental retardation, and those with brain disease may be at particular risk. Experience has indicated that children under the age of 2 years are at a considerably increased risk of developing fatal hepatotoxicity, especially those on multiple anticonvulsants.
  • Teratogenicity:DEPAKENE can produce birth defects to an unborn baby. Accordingly, the use of DEPAKENE in women of childbearing potential requires that the benefits of its use be weighed against the risk of injury to the fetus.
  • Pancreatitis: cases of life threatening pancreas disorder have been reported in both children and adults receiving DEPAKENE. Some cases have occurred shortly after first use as well as after several years of use. Abdominal pain, nausea, vomiting and/or anorexia can be symptoms of pancreatitis that require immediate medical evaluation.

BEFORE you use DEPAKENE talk to your doctor or pharmacist if:

  • you have a history of, or suffer from a liver disease, such as jaundice (yellowing of the skin and eyes);
  • you have ever had an unusual or allergic reaction to DEPAKENE (including fever or rash);
  • you are allergic to any component of DEPAKENE capsules or oral solution;
  • you are pregnant or are planning to become pregnant;
  • you are breast-feeding (nursing); DEPAKENE passes into breast milk;
  • you are taking any other prescription or over the counter medicine;
  • you have kidney disease;
  • you have other medical conditions including a history of unexplained coma, intellectual disability or any type of brain dysfunction;
  • you have a psychiatric disorder or have thoughts of suicide;
  • you consume alcohol on a regular basis.

Precautions while taking DEPAKENE

  • Your doctor will monitor your response to DEPAKENE on a regular basis. However, if your seizures get worse, you should tell your doctor immediately.
  • Since DEPAKENE may cause poor coordination and/or drowsiness, you should not engage in hazardous activities, such as driving and operating machinery, until you know that you don’t become drowsy from the drug.
  • You should not stop taking your medication unless directed by your doctor. You should always check that you have an adequate supply of DEPAKENE®. You should remember that this medicine was prescribed only for you; it should never be given to anyone else.

Women of Childbearing Potential

  • All women of childbearing age who are being treated with DEPAKENE should talk to their healthcare providers about using other possible treatments instead of DEPAKENE. If the decision is made to use DEPAKENE, you must use an effective method of birth control (contraception). You should talk to your doctor about the best kind of birth control to use while you are taking DEPAKENE.

Pregnant Women

  • If you take DEPAKENE during pregnancy, your child has a higher risk for birth defects and adverse effects on IQ and brain development, which can begin early in the pregnancy, even before you know that you are pregnant.
  • There may be other medications to treat your condition that have a lower chance of birth defects.
  • If you are planning to become pregnant, or if you become pregnant while taking DEPAKENE, you should promptly inform your doctor. Do not suddenly stop taking the drug. Appropriate treatment options will need to be discussed with your physician to ensure the benefits outweigh the risks.
  • Pregnancy Registry: If you become pregnant while taking DEPAKENE, talk to your doctor about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy. Information on the registry can also be found at the following website: http://www.aedpregnancyregistry.org/.

Interactions With This Medication

Serious Drug Interactions

  • Rare cases of coma have been reported in patients receiving DEPAKENE alone or when taken with phenobarbital.
  • Serious skin reactions (such as conditions called Stevens-Johnson syndrome and Toxic Epidermal Necrolysis) have been reported when DEPAKENE and lamotrigine were taken together.

Drugs that may interact with DEPAKENE include

  • anticonvulsants such as carbamazepine, lamotrigine, primidone, topiramate, felbamate, phenytoin, ethosuximide, phenobarbital;
  • anticoagulants such as acetylsalicylic acid, warfarin, dicumarol;
  • benzodiazepines such as diazepam, lorazepam, clonazepam;
  • some medicines used to treat infections such as rifampin;
  • some medicines used to treat diabetes such as tolbutamide;
  • some HIV-antiviral medication such as zidovudine;
  • any of the group of antibiotics in the carbapenem class such as doripenem, ertapenem, imipenem, meropenem;
  • some medicines used to treat heartburn and peptic ulcers such as cimetidine;
  • medicines used to treat depression such as Selective Serotonin Re-Uptake Inhibitors (SSRIs), Monoamine Oxidase Inhibitors (MAOIs), Tricyclic antidepressants such as amitriptyline, nortriptyline;
  • antipsychotics.

Proper Use of This Medication

Please consult your doctor before taking any other medication, including over-the-counter medicines. Some drugs can produce various side effects when they are used in combination with DEPAKENE.

It is important to keep your appointments for medical checkups.

The doctor may need to take blood tests to measure the amount of DEPAKENE in your blood when adjusting your medications.

Usual dose

It is very important to take DEPAKENE exactly as instructed by your doctor.

The recommended starting dose of DEPAKENE will be decided by your doctor based on your weight, your seizures or manic episodes and your concomitant medications. Be sure to tell your doctor all the prescription and over the counter medications that you are currently taking. Your doctor will gradually increase the dosage until your condition is well controlled without experiencing side effects. You should carefully follow the instructions that were given to you and not change your dose without consulting with your doctor.

DEPAKENE may be taken with or without food.

Overdose

If you accidentally take an overdose of DEPAKENE, you should contact your doctor or nearest hospital emergency, or your Regional Poison Control Centre, even though you may not feel sick.

Missed Dose

Do not suddenly stop taking your medicine because of the risk of increasing your epileptic seizures.

If you miss a dose, you should not try to make up for it by doubling up on your next dose. You should take your next regularly scheduled dose and try not to miss any more doses.

Side Effects and What to Do About Them

You should check with your doctor or pharmacist right away if you notice any bothersome or unusual effects while taking DEPAKENE.

The most commonly reported adverse reactions include nausea, vomiting, indigestion sleepiness, headache, diarrhea, weakness, tremor and dizziness. Changes in hair are also reported, such as hair loss or in increase in hair on face, chest and back. If any of these affect you severely, contact your doctor or pharmacist.

You should know that this does not mean that you will experience such effects, because people can react in different ways to the same medicine.

Serious Side Effects, How Often They Happen and What to Do About Them

Symptom/effectTalk with your doctor or pharmacist right away Seek Emergency medical attention
Only if severeIn all cases
CommonHallucinations: seeing or hearing something that is not thereT
UncommonBrain dysfunction from high ammonia levels in the blood (tiredness, vomiting, abnormal walking, extreme irritability, combative/bizarre behaviour↑↑, refusal to eat meat or high protein products↑↑)T
Decreased number of platelets in the blood (may result in easy bruising and bleeding from the skin or other areas)T
Liver disorder (weakness, tiredness, abdominal pain, diarrhea, facial swelling, loss of appetite, yellowing of the skin or eyes, dark urine, nausea, and vomiting)T
Pancreas disorder (abdominal pain, nausea, vomiting, and/or loss of appetite)T
Thoughts of suicide or hurting yourself, symptoms of depression or unusual changes in mood or behaviourT
RareMuscle disorder (unexplained muscle pain or tenderness, with a fever or “teacoloured” urine, or reduced urination)T

In young children
↑↑In older children or adults

This is not a complete list of side effects. For any unexpected effects while taking DEPAKENE, contact your doctor or pharmacist.

How to Store It

Store DEPAKENE capsules between 15 and 25°C.

DEPAKENE should be kept out of reach of children.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report on line at:
www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701D
      Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at

http://www.healthcanada.gc.ca/medeffect

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

The most recent version of this document plus the full Product Monograph, prepared for health professionals can be found at:


http://www.abbott.ca

or by contacting the sponsor, BGP Pharma ULC, Saint-Laurent, Qc H4S 1Z1 at:
1-800-699-9948