Ratio-Valproic-Cap 250mg: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for;

• RATIO-VALPROIC has been prescribed to you to

  control your epilepsy. Please follow your doctor’s recommendations carefully.

What it does;

RATIO-VALPROIC 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 garnma-aminobutyric acid (GABA).

When it should not be used;

RATIO-VALPROIC should not be taken by:

• patients with liver disease or significant liver

  dysfunction

• patients who are allergic to the drug

• patients with known urea cycle disorders (a genetic

  disorder)

What the medicinal ingredient is:

valproic acid

What the non-medicinal ingredients are:

250 mg: Corn oil, FD&C yellow #6, gelatin, glycerin, sorbitol, titanium dioxide, parabens and purified water.

500 mg: Eudragit, D&C Yellow #10, FD&C Yellow #6, gelatin, glycerin, hydropropylmethylcellulose, isopropyl alcohol, methyl paraben, mineral oil, propyl paraben, purified water, simethicone, sodium hydroxide, talc, titanium dioxide and triethyl citrate.

What dosage forms it comes in:

RATIO-VALPROIC is available as a capsule containing 250 mg or 500 mg of valproic acid.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• Hepatotoxicity: liver failure resulting in death has occurred in patients receiving valproic acid. These incidents usually occurred during the first 6 months of treatment with valproic acid. 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: RATIO-VALPROIC can produce birth defects to an unborn baby. Accordingly, the use of RATIO-VALPROIC 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 valproic acid. 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 RATIO-VALPROIC 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 ever had an unusual or allergic reaction to

  RATIO-VALPROIC (including fever or rash);

• you are allergic to any component of RATIO-

  VALPROIC capsules;

• you are pregnant or are planning to become pregnant;

• you are breast-feeding (nursing); RATIO-VALPROIC 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, mental retardation 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 RATIO-VALPROIC:

• Your doctor will monitor your response to RATIO-

  VALPROIC on a regular basis. However, if your seizures get worse, you should tell your doctor immediately. Since RATIO-VALPROIC® 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 RATIO-VALPROIC. You should remember that this medicine was prescribed only for you; it should never be given to anyone else.

INTERACTIONS WITH THIS MEDICATION

Serious Drug Interactions

• Rare cases of coma have been reported in patients

  receiving valproic acid alone or when taken with phenobarbital.

• Serious skin reactions (such as conditions called

  Stevens-Johnson syndrome and Toxic Epidermal Necrolysis) have been reported when valproic acid and lamotrigine were taken together.

Drugs that may interact with RATIO-VALPROIC 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 RATIO-VALPROIC.

It is important to keep your appointments for medical checkups.

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

Usual dose:

It is very important to take RATIO-VALPROIC exactly as instructed by your doctor.

The recommended starting dose of RATIO-VALPROIC 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.

RATIO-VALPROIC may be taken with or without food.

Overdose:

If you accidentally take an overdose of RATIO-VALPROIC, 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 abruptly 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 RATIO-VALPROIC.

Different side effects have been reported by patients taking RATIO-VALPROIC. The most commonly reported adverse reactions are nausea, vomiting and indigestion. 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.

^† In young children

^†† In older children or adults

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

HOW TO STORE IT

RATIO-VALPROIC capsules should be stored between 15 and 30°C.

RATIO-VALPROIC should be kept out of reach of children.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, ratiopharm Inc., at: 1-800-337-2584

Last Revised: March 8, 2012