Sabril: A Comprehensive Guide to Its Uses, Risks, and Precautions

Sabril (Vigabatrin) is a prescription medication used to treat infantile spasms, a rare and serious form of epilepsy that occurs in infants. It is also used to treat refractory complex partial seizures in adults who have not responded to other medications. Sabril works by inhibiting GABA transaminase, an enzyme that helps to break down GABA, a neurotransmitter that has calming effects on the brain.

FDA Details

Approval Date: August 21, 2009

Drug Class: Anticonvulsant

Generic Name: Vigabatrin

Brand Name: Sabril

Manufacturer: Patheon

Strength: 500 mg tablets

Indication and Usage

• Sabril, an anticonvulsant, is employed in conjunction with other medications to address complex partial seizures in individuals aged 10 years and older who have not responded to other medications.
• Additionally, the powder for oral solution is utilized to manage infantile spasms in infants and children between 1 month and 2 years of age.

Dosage and Administration

Sabril, is offered in two forms and strengths. The tablet variant is provided at 500 mg, while the Powder for Oral Solution is also available at 500 mg.

• Refractory complex partial seizures in adults: Adults (17 years of age and older): Initiate treatment with Sabril at a daily dose of 1000 mg (Sabril 500 mg tablet twice daily). Increase the total daily dose weekly by 500 mg increments, aiming for the recommended maintenance dose of 3000 mg per day (1500 mg twice daily).

• Pediatric (10 to 16 years of age): Start pediatric patients at a daily dose of Sabril 500 mg (250 mg twice daily). Weekly increments of 500 mg can be added to the total daily dose to achieve the recommended maintenance dose of 2000 mg per day (1000 mg twice daily). Adjust dosing for patients weighing more than 60 kg according to adult recommendations.

• Infantile spasms: Begin treatment with Sabril at a daily dose of 50 mg/kg (25 mg/kg twice daily). Increase the total daily dose every 3 days, ranging from 25 mg/kg/day to 50 mg/kg/day, with a maximum daily dose of 150 mg/kg (75 mg/kg twice daily).

• Renal Impairment: For patients with renal impairment, dose adjustment is recommended.

Warnings and Precautions

• Vision loss: Sabril can cause progressive and permanent bilateral concentric visual field constriction. The risk of vision loss increases with the length of treatment and the total dose of Sabril. Patients should have regular eye exams while taking Sabril.
• Suicide: Sabril has been associated with an increased risk of suicide ideation and behavior. Patients taking Sabril should be monitored closely for signs of suicide.
• Neurologic toxicity: Sabril can cause neurologic toxicity, such as encephalopathy, tremors, and ataxia.
• Status epilepticus: Avoid suddenly discontinuing SABRIL, as it may lead to severe complications. Stopping SABRIL or any antiepileptic medication suddenly can trigger seizures, including those that persist and do not stop (status epilepticus), especially in individuals undergoing seizure treatment. It is crucial to adhere to the guidance provided by your healthcare provider regarding the gradual cessation of SABRIL. 
• Teratogenicity: Sabril is a pregnancy Category D drug, which means that it can cause birth defects. Sabril should not be used by pregnant women or women who are planning to become pregnant.
• Withdrawal of AEDs: It is crucial to gradually reduce the dose to avoid withdrawal seizures.
• Anemia: Regular monitoring for symptoms of anemia is recommended
• Somnolence and Fatigue: Patients should be advised not to drive or operate machinery until they have gained sufficient experience with SABRIL.

Additionally, it is necessary to inform healthcare providers about relevant medical conditions, ongoing medications, and any changes in health status. 

Contraindications

Sabril is contraindicated in patients with a history of hypersensitivity to Vigabatrin or any of the other ingredients in the medication.

Use in Specific Populations:

• Children: Sabril is considered safe and effective for use in children. However, parents or caregivers should inform their healthcare providers about the child’s condition, especially if there is a possibility of pregnancy.

• Adults: Sabril is safe and effective for use in adults. Individuals should communicate any relevant medical information, including pregnancy or breastfeeding plans, with their healthcare providers before starting the medication.

• Geriatrics: Sabril is deemed safe and effective for use in geriatric patients. Elderly individuals should discuss their overall health and any specific concerns with their healthcare providers.

• Pregnant women: Sabril should not be used by pregnant women or those planning to become pregnant. It is essential for women to inform their physicians about their pregnancy status before starting the medication.

• Breastfeeding women: Sabril is not recommended for use by women who are breastfeeding. Breastfeeding individuals should inform their healthcare providers about their nursing status, and alternative options will be discussed.

It is crucial for patients to provide comprehensive information about their health and circumstances to their healthcare providers before initiating any medication. This ensures appropriate guidance and consideration of individual factors.

Common Side Effects Of Sabril

Adults may experience permanent vision loss, fatigue, somnolence, nystagmus, tremor, blurred vision, memory impairment, weight gain, arthralgia, abnormal coordination, and confusional state. 

Pediatric patients (10 to 16 years of age) may experience weight gain, upper respiratory tract infection, tremor, fatigue, aggression, and diplopia.

For infantile Spasms condition few adverse reactions may include somnolence, bronchitis, ear infection, and acute otitis media.

How to Buy Sabril Online?

Explore simplified online purchasing options for Sabril through the SANSFRO team or specialized companies facilitating medicine importation, particularly from the US and Europe. The cost of Sabril is influenced by various factors and product specifications. For precise and up-to-date Sabril 500mg price information tailored to the Indian market, contact our dedicated Patient Support Team at (+91) 9315705373 or via email at help@sansfro.com. They can provide accurate details based on your specific requirements

Conclusion

Sabril is a safe and effective medication for the treatment of infantile spasms and refractory complex partial seizures in adults. However, it is important to be aware of the potential risks and side effects of Sabril before taking it. Patients should talk to their doctor about the risks and benefits of Sabril to determine if it is right for them.

Reference: 

1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022006s020,020427s018lbl.pdf
2. https://reference.medscape.com/drug/sabril-vigadrone-vigabatrin-343008
3. https://www.drugs.com/sabril.html