Afalino 25mg Tablet 10pcs

Composition of Afalino 25

Cenobamate

Uses of Afalino 25

Anti-epileptic drugs

Side Effects of Afalino 25

• Common: Somnolence, fatigue, dizziness, nausea, constipation, double vision, decreased appetite, diarrhea, or weakness may occur.
• Rare: Serious allergic reactions to Afalino are uncommon.

How does Afalino 25 work?

The inhibition of voltage-gated sodium channels increases the threshold for generating action potentials and decreases the number of action potentials.1

Pharmacology

Cenobamate functions as a positive modulator of the GABA-A receptor and inhibits voltage-gated sodium channels. This inhibition raises the threshold for action potential generation, thereby reducing the frequency of action potentials. The combination of these two mechanisms may enhance its effectiveness in controlling seizures.

Overdose Effects of Afalino 25

In the case of an overdose, Afalino should be discontinued, and general supportive care should be provided until the clinical toxicity subsides or resolves.

Dosage & Administration of Afalino 25

Cenobamate can be administered with or without food, or as directed by a physician. The recommended dosage for partial-onset seizures in adults is as follows:

Initial Dosage:

• Weeks 1 and 2: 12.5 mg once daily.

Titration Regimen:

• Weeks 3 and 4: 25 mg once daily.
• Weeks 5 and 6: 50 mg once daily.
• Weeks 7 and 8: 100 mg once daily.
• Weeks 9 and 10: 150 mg once daily.

Maintenance Dosage:

• From Week 11 onward: 200 mg once daily.

Maximum Dosage:

• If clinically necessary and well-tolerated, the dose may be increased beyond 200 mg in increments of 50 mg once daily every two weeks, up to a maximum of 400 mg once daily.
  Medication should be taken according to the advice of a registered healthcare provider.

• Pediatric Use: The safety and efficacy of Afalino in children under 18 years have not been established.
• Geriatric Use: Treatment should begin at the lower end of the dosing range.
• Renal Impairment: Use with caution; dosage reduction may be necessary for patients with mild to moderate (creatinine clearance 30 to <90 ml/min) or severe (creatinine clearance <30 ml/min) renal impairment. The maximum recommended dose for these patients is 300 mg/day. It is contraindicated in patients with end-stage renal disease or those undergoing hemodialysis.
• Hepatic Impairment: Caution is advised in patients with mild to moderate hepatic impairment; consider lowering the maximum dose. The use of Afalino in severe hepatic impairment is not recommended.

Interaction

• Phenytoin: Gradually reduce the dosage of phenytoin by up to 50%.
• Phenobarbital and Clobazam: Adjust dosages as necessary when taken alongside Afalino.
• Lamotrigine and Carbamazepine: Increase dosages as needed when used with Afalino.
• CYP2B6 and CYP3A Substrates: Adjust dosages as required when taken with Afalino.
• CYP2C19 Substrates: Reduce dosages as necessary when used alongside Afalino.
• Oral Contraceptives: The effectiveness of hormonal oral contraceptives may be reduced when taken with Afalino; additional or alternative non-hormonal birth control methods should be considered.

Cenobamate is contraindicated in patients with known:

• Hypersensitivity to Cenobamate or its excipients.
• Familial Short QT syndrome.

Pregnancy & Lactation

There are no sufficient studies on the use of Cenobamate in pregnant women, but it may pose risks to the fetus. It should be used during pregnancy only if the potential benefits outweigh the risks. There is no information available regarding the presence of Cenobamate in breast milk, its effects on breastfed infants, or its impact on milk production.

Patients should be monitored for potential adverse effects, including:

• Multiorgan Hypersensitivity Reaction: Discontinue if no other cause is identified.
• QT Shortening: Exercise caution when combining Afalino with other medications that shorten the QT interval.
• Suicidal Thoughts: Monitor for any signs of suicidal behavior or ideation.
• Neurological Adverse Reactions: Regularly assess somnolence and fatigue, advising against driving or operating machinery until they have adjusted to Afalino. Caution is advised when used alongside other CNS depressants or alcohol due to the potential for additive effects.
• Withdrawal of Antiepileptic Drugs: Afalino should be tapered off gradually to avoid increasing seizure frequency.

Storage:

Store below 30 degrees Celsius, protected from light, and out of reach of children.