Sabril
About Sabril:
- Sabril is a prescription medicine used as an adjunctive treatment in adults and children (2 years of age and older) with refractory complex partial seizures who have not responded well to several other treatments and where the possible benefits outweigh the risk of vision loss.
- Vigabatrin is not indicated as a first-line agent.
- It is used in infantile spasms where the potential benefits outweigh the potential risk of vision loss.
Strength:
- Sabril tablet: 500 mg
- Sabril powder for oral solution: 500 mg
Recommended Dosage:
For refractory complex partial seizures:
- Adults (17 years of age and older): Initiate at 1000 mg/day (500 mg twice daily); increase total daily dose weekly in 500 mg/day increments, to the recommended dose of 3000 mg/day (1500 mg twice daily).
- Pediatric (10 to 16 years of age): Initiate at 500 mg/day (250 mg twice daily); increase total daily dose weekly in 500 mg/day increments, to recommended maintenance dose of 2000 mg/day (1000 mg twice daily); dose patients weighing more than 60 kg according to adult recommendations.
For infantile spasms:
- Initiate at a daily dose of 50 mg/kg (25 mg/kg twice daily); increase total daily dose every 3 days, in increments of 25 mg/kg/day to 50 mg/kg/day, up to a maximum daily dose of 150 mg/kg (75 mg/kg twice daily).
- Renal Impairment: Dose adjustment recommended.
Warnings & Precautions:
- Some infants with infantile spasms receiving Sabril have shown abnormal MRI signal changes.
- Sabril induces the risk of suicidal thoughts and behavior.
- Withdrawal can occur so the Sabril dose should be tapered to avoid withdrawal seizures
- Symptoms of anemia should be monitored.
- Advise patients not to drive or operate machinery until they have gained sufficient control with Sabril as it can cause somnolence.
Common Sabril Side Effects
For Refractory complex partial seizures:
- Permanent vision loss
- Fatigue
- Somnolence
- Nystagmus
- Tremor
- Blurred vision
- Memory impairment
- Weight gain
- Arthralgia
- Abnormal coordination
- Confusional state
For pediatric patients (10 to 16 years of age):
- Weight gain
- Upper respiratory tract
- Infection
- Tremor
- Fatigue
- Aggression
- Diplopia
For infantile spasms:
- Somnolence
- Bronchitis
- Ear infection
- Acute otitis media
Use in Specific Population
Pregnancy: It may cause fetal harm as per animal data and Sabril is excreted in human milk in lactating mothers.
Storage and Handling
- Sabril must be stored at 20 to 25°C (68 to 77°F).
For the medicine procurement, we follow a simple four-step process.
- Enquiry about the medicine: When you request information about the medication you require, we will handle your data. Our Named Access Program Support team will contact you within 24 hours to assist.
- Verification Process: In our mission to help patients access medications that may not be approved or readily accessible in their home countries, Sansfro ensures the verification of medicine availability and approval. Additionally, we thoroughly review the patient’s prescription and medical information for accuracy and compliance.
- Sourcing the Medicine: Upon successfully completing the verification process, our team will initiate contact with our network of suppliers to source the required medication for you. Subsequently, our team works diligently to obtain the most favorable quotes for your medicines and oversees the processing of your order.
- Safe Delivery: We will coordinate the secure delivery of your consignment upon approval of the final quote. Our team of logistics specialists is available to provide consignment tracking assistance. Acknowledging that the Named Access Program industry is susceptible to unauthorized channels is essential. To uphold the safe and legal provision of medications, we rigorously adhere to Standard Operating Procedures.
For the importation of medication, we will require the following documents from the patient:
- An authentic prescription copy.
- A proof of identity document.
- Information about the healthcare provider in charge.
- A current residential address.
Once all these documents are provided, the Sansfro team will begin the import license application process. This license is a crucial requirement to facilitate the procurement of the necessary medication upon receiving government approval.
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About Sansfro
Sansfro is committed to bridging the healthcare gap. Our purpose is to bring hope and healing to patients suffering from rare diseases by linking them with life-saving treatments through our Named Patient Program. Join us in our quest for a better and healthier world.
Know More...FAQ'S
What are the serious side effects of Sabril?
Sabril can cause some serious life-threatening side effects including:
- Permanent vision loss
- Magnetic resonance imaging (MRI) changes in babies with infantile spasms
- Risk of suicidal thoughts or actions
How Sabril is stored
Sabril must be stored at 20 to 25°C (68 to 77°F).
What should I tell my doctor before starting Vigabatrin for children having complex partial seizures?
The doctor should be informed about:
- depression, mood problems, or suicidal thoughts and behavior
- any allergic reaction
- any vision problems
- any kidney problems
- anemia
- any nervous or mental illnesses
- any other medical conditions
- if breastfeeding or planning to breastfeed
- patients who are pregnant or plan to become pregnant
What should I avoid while starting Sabril?
Sabril causes sleepiness and tiredness so patients should not drive, operate machinery, or perform any hazardous task unless instructed by a healthcare provider.
What are the ingredients of Sabril?
Sabril contains Vigabatrin as an active ingredient and inactive ingredients such as hydroxy propyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone, sodium starch glycolate, and titanium dioxide, povidone.
What are the drug interactions associated with Sabril?
Sabril intake can cause a decrease in phenytoin plasma levels, therefore dosage adjustment may be needed.
Are there any precautions to be considered while having Sabril treatment?
Sabril can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability.
Dr Anchal Aryan
Medical counselor
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