Taro-Phenytoin (Taro Pharmaceuticals, 100 mg): Uses, Side Effects and Dosage

What the medication is used for:

Taro-Phenytoin has been prescribed to you by your doctor to control seizures. It is specifically used for:

• the control of generalized tonic-clonic seizures, and psychomotor seizures.
• the prevention and treatment of seizures that may begin during or after surgery to the brain or nervous system.

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What it does:

Taro-Phenytoin Capsules belong to the family of medicines called anticonvulsant. It acts in the brain to block the spread of seizure activity.

When it should not be used:

• If you are allergic to phenytoin or other medicines of the hydantoin family, including fosphenytoin (CEREBRYX), or to any of the nonmedicinal ingredients in the formulations (see what the nonmedicinal ingredients are).
• If you take Delavirdine (drug used to treat HIV infection).
• If you have slow heart rate (bradycardia), heart block, or other heart problems.

What the medicinal ingredient is:

Phenytoin sodium.

What the nonmedicinal ingredients are:

The non-medicinal ingredients are: lactitol monohydrate, magnesium stearate, sodium lauryl sulphate, talc.

Capsule shells: black iron oxide, erythrosine, gelatin, potassium hydroxide, propylene glycol, quinoline yellow, shellac, and titanium dioxide.

For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.

What dosage forms it comes in:

Extended Phenytoin Sodium Capsules (100 mg).

Do not stop your treatment with Taro-Phenytoin without first checking with your doctor as that could cause sudden worsening of your seizure. If you/your child are experiencing any side effects please see “Side Effects and What To Do About Them” section for guidance.

BEFORE you use Taro-Phenytoin talk to your doctor or pharmacist if:

• You/your child are diabetic,
• You/your child are anemic.
• You/your child have low bone density,
• You/your child have or have had any kidney or liver disease, or blood disorders (including porphyria),
• You/your child have had an allergy to this drug, or other drugs used to treat your condition,
• You/your child have slow heart rate (bradycardia), fast heart rate (tachycardia), heart block, or a history of cardiac arrest (asystole). Regardless of your cardiac history, tell your doctor if you experience any of the adverse events listed above when taking Taro-Phenytoin.,

• You are pregnant or thinking about becoming pregnant. If you take Taro-Phenytoin during pregnancy your baby is at risk for serious birth defects, such as cleft lip or cleft palate. Birth defects may happen even in children born to women who are not taking any medicines and do not have any other risk factors. All women of child-bearing age who are being treated for epilepsy should talk to their healthcare providers about using other possible treatments instead of Taro-Phenytoin. If the decision is made to use Taro-Phenytoin, you should use effective birth control (contraception) unless you are planning to become pregnant. You should talk to your doctor about the best kind of birth control to use while you are taking Taro-Phenytoin.

• You are breast-feeding.
• You/your child are taking other drugs (prescription and over-the-counter medicines), dietary or herbal supplements.

• You consume alcohol on a regular or occasional basis.

• Certain individuals of Asian and /or of black origin may be at an increased risk of developing serious skin reactions during treatment with Taro-Phenytoin.

ABOUT THIS MEDICATION

WARNINGS AND PRECAUTIONS

• You/your child have experienced in the past or have a family history of anticonvulsant hypersensitivity syndrome. This may occur rarely in patients treated with anticonvulsant medications and includes symptoms such as fever, rash, hepatitis (such as yellowing of skin and eyes) and lymph node swelling, among other symptoms.
• You/your child are currently being treated with cranial irradiation and corticosteroids.
• You/your child suffer from absence seizures (petit mal) or seizures caused by low blood sugar (hypoglycemia) or other metabolic causes, as Taro-Phenytoin is not effective in controlling these types of seizures.
• You/your child have or have had depression, mood problems, or suicidal thoughts or behaviour.
• You/your child have lactose intolerance or have hereditary galactose intolerance or glucose-galactose malabsorption, because Taro-Phenytoin capsules contain lactitol monohydrate.

When taking Taro-Phenytoin:

• Always take Taro-Phenytoin as your doctor has prescribed. If it is not possible for you to take Taro-Phenytoin as prescribed, tell your doctor.
• Tell your doctor if you develop a skin rash while taking Taro-Phenytoin.
• Tell your doctor right away if you develop serious skin reactions such as rash, red skin, blistering of the lips, eyes or mouth, skin peeling that may be accompanied by fever. These reactions may be more frequent in patients of Asian origin. Reports of these reactions have been highest in patients from Taiwan, Malaysia and the Philippines.

• Tell your doctor if you become pregnant while taking Taro-Phenytoin. You and your doctor should decide if you will continue to take Taro-Phenytoin while you are pregnant. If you become pregnant while taking Taro-Phenytoin, 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 about the registry can also be found at the website:

  http:// www.aedpregnancyregistry.org/.

• Talk to your doctor about the best way to care for your teeth, gums, and mouth during your treatment with Taro-Phenytoin. It is very important that you care for your mouth properly to decrease the risk of gum damage.
• It is recommended that you do not drink alcohol while taking Taro-Phenytoin, without first talking to your doctor. Drinking alcohol while taking Taro-Phenytoin may change your blood levels of Taro-Phenytoin, which can cause serious problems.

• Do not drive, operate heavy machinery or do other dangerous activities until you know how Taro-Phenytoin affects you. Taro-Phenytoin can slow your thinking and motor skills.

  There are many drugs that may increase or decrease phenytoin levels. Also, Taro-Phenytoin may affect the levels of many drugs. Therefore, tell your doctor or pharmacist about all other prescription and non-prescription medications you are talking, as well as dietary and herbal supplements, enteral feeding preparations or nutritional drinks, as there may be a need to adjust your medication or monitor you more carefully.

  It is very important that you take Taro-Phenytoin exactly as your doctor has prescribed. Never increase or decrease the dose yourself. Do not stop taking it abruptly unless directed by your doctor as your seizures may increase. Tell your doctor if you cannot take the drug as prescribed, for example if you will be having surgery. You should always check that you have an adequate supply of Taro-Phenytoin.

  Do not use capsules that are discoloured.

Usual dose:

Adult:

Starting dose: One capsule (100 mg) three times daily. The dose is adjusted according to your response to treatment. In some cases, blood level assessment may be necessary to adjust the dose optimally.

Maintenance dose: Usually, 3-4 capsules (300-400 mg) in divided doses daily. Some adult patients can be maintained on 300 mg once-a-day (3 capsules of 100 mg, taken together once-a-day).

Pediatrics (<18 years of age):

Taro-Phenytoin is for use in children over 6 years old who are able to swallow capsules. Taro-Phenytoin IS NOT available in any pediatric dosage forms i.e. a 30 mg capsule strength, a 50 mg chewable tablet, or an oral suspension of 30 mg in each 5 mL.

Starting dose: Initially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily. Given that Taro-Phenytoin is available only as a 100 mg capsule, this means that a child must be a minimum of 40 kg to initiate phenytoin using this product. In some cases, blood level assessment may be necessary to adjust the dose optimally.

Maintenance: A recommended daily maintenance dosage is usually 4 to 8 mg/kg/day. Children over 6 years old may require the minimum adult dose (300 mg/day).

Overdose:

Very high doses can cause toxicity or death.

INTERACTIONS WITH THIS MEDICATION

PROPER USE OF THIS MEDICATION

Missed Dose:

If you/your child miss/misses a dose, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Instead, take the next scheduled dose. Do not try to make up for the missed dose by taking a double dose next time.

Like all medicines, Taro-Phenytoin can cause side effects, although not everybody gets them.

Other Side Effects:

If you experience any side effects such as unusual eye movement, changes in muscle movements or co-ordination, slurred speech, dizziness, vertigo, trouble sleeping (insomnia), changes to facial skin, rash, headache, nausea or vomiting, consult your doctor

This is not a complete list of side effects. For any unexpected effects, or effects that worry you while taking Taro-Phenytoin, contact your doctor or pharmacist.

Store at controlled room temperature 15-30°C. Protect from light and moisture.

Keep out of reach and sight of children.

REPORTING SIDE EFFECTS

If you want more information about Taro-Phenytoin:

• Talk to your health care professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website at https://www.canada.ca/en/health-canada.html or at https://www.taro.ca or by contacting the sponsor at toll-free number, 1-800-268-1975

TARO is a registered trademark of Taro Pharmaceuticals Inc.

Last Revised: November 07, 2019

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

HOW TO STORE IT

MORE INFORMATION