VIGABATRIN – AMNEAL

VIGABATRIN – AMNEAL is the generic version of Sabril and is available as an oral tablet and solution.

VIGABATRIN – AMNEAL is available as a 500 mg oral tablet and 500 mg packets for oral solution.

VIGABATRIN – AMNEAL is an antiepileptic that is used to treat:
Difficult-to-treat complex partial seizures in people age 2 years and older (as add-on therapy to other medications)
Infantile spasms in children age 1 month to 2 years

VIGABATRIN – AMNEAL is an antiepileptic (another name for anti-seizure medication). It’s not exactly clear how it works to treat seizures. But it’s thought to raise the levels of gamma-aminobutyric acid (GABA), a chemical in the brain that calms nerves. This helps control seizures.

VIGABATRIN – AMNEAL is dosed as follows:
The dose is the same for the tablet and powder for liquid.

Complex partial seizures

• Age 17 years or older: The typical dose is 500 mg to 1,500 mg by mouth twice per day
• Age 2 to less than 17 years: The dose is based on your child’s body weight
• 22 to 33 pounds: The typical dose is 175 mg to 525 mg by mouth twice per day
• 33 to 44 pounds: The typical dose is 225 mg to 650 mg by mouth twice per day
• 44 to 55 pounds: The typical dose is 250 mg to 750 mg by mouth twice per day
• 55 to 132 pounds: The typical dose is 250 mg to 1,000 mg by mouth twice per day
• Greater than 132 pounds: The typical dose is 500 mg to 1,500 mg by mouth twice per day
• Infantile spasms: The dose is based on your child’s body weight. The starting dose is 25 mg/kg by mouth twice per day. The maximum dose is 75 mg/kg twice per day

Your provider will change the dose depending on how well the medication is working for you and if you’re having side effects. Your dose might differ if you have kidney problems.

VIGABATRIN – AMNEAL is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of VIGABATRIN – AMNEAL:

• Adults
• Headache
• Dizziness
• Tiredness
• Drowsiness
• Uncontrolled shaking
• Common cold symptoms
• Blurred vision
• Eye twitching
• Diarrhea
• Nausea
• Joint pain
• Abnormal coordination

Children age 3 to 16 years (for complex partial seizures)

• Weight gain
• Upper respiratory tract infection (e.g., cough, common cold)
• Tiredness

Children age 1 month to 2 years (for infantile spasms)

• Upper respiratory tract infection
• Middle ear infection
• Fever
• Irritable behavior
• Vomiting
• Sleepiness

Serious side effects are rare with VIGABATRIN – AMNEAL. Contact your healthcare provider immediately if you experience any of the following.

• Permanent vision loss
• Suicidal thoughts or behaviors

The following medications may interact with VIGABATRIN – AMNEAL:

Amneal Pharmaceuticals

Based on animal data, VIGABATRIN – AMNEAL use in pregnant women may result in fetal harm. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, including vigabatrin, during pregnancy. Encourage women who are taking vigabatrin during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334 or visiting the website, AED pregnancy registry. This must be done by the patient herself.