Xil
ANTI NEUROPATHICS: Pregabalin
Indication
Xil Capsules is indicated for:
1. Management of neuropathic pain (diabetic neuropathy, postherpetic neuralgia etc.)
2. Management of fibromyalgia
3. Adjunctive therapy for partial onset of seizures/epilepsyGAD (Generalized anxiety disorder)
Xil-CR is indicated for:
1. Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
2. Postherpetic Neuralgia (PHN)
Contraindication
Pregabalin is contraindicated in patients with known hypersensitivity to pregabalin or any of its components.
Dosage & Administration
Dosing recommendation for Xil Capsules:
1. Neuropathic pain: Initially 150 mg daily in 2-3 divided doses, increased if necessary after 3-7 days to 300 mg daily in 2-3 divided doses, increased further if necessary after 7 days to max. 600 mg daily in 2-3 divided doses. Use in child and adolescents under 18 years are not recommended.
2. Fibromyalgia: The recommended dose is 300 to 450 mg daily. Dosing should begin at 150 mg daily in two divided doses and may be increased to 300 mg daily in two divided doses within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg daily may be further increased 450 mg daily in two divided doses.
3. Epilepsy: Initially 150 mg daily in 2-3 divided doses, increased if necessary after 7 days to 300 mg daily in 2-3 divided doses, increased further if necessary after 7 days to max. 600 mg daily in 2-3 divided doses. Use in child and adolescents under 18 years are not recommended.
4. Generalized anxiety disorder: Initially 150 mg daily in 2-3 divided doses, increased if necessary at 7 days intervals in steps of 150 mg daily; max. 600 mg daily in 2-3 divided doses. Use in child and adolescents under 18 years are not recommended.
Dosing recommendation for Xil ®-CR Tablets:
Xil- CR tablet should be administered once daily after an meal. It should be swallowed whole and should not be split, crushed or chewed.
| Indication | Dosing Regimen | Initial Dose | Maximum Dose |
| DPN Pain | Single dose per day | 165 mg/day | 330 mg/day within 1 week |
| PHN | Single dose per day | 165 mg/day | 330 mg/day within 1 week Maximum dose of 660 mg/day. |
Side Effect
Pregabalin is well tolerated but a few side effects like dizziness, somnolence and blurred vision may occur.
Drug Interaction
There are no pharmacokinetic interaction between Pregabalin and the following antiepileptic drugs: Carbamazepine, Valproic Acid, Lamotrigine, Phenytoin, Phenobarbitol and Topiramate. Important pharmacokinetic interactions would also not be expected to occur between Pregabalin and commonly used antiepileptic drugs.
Precaution
Abrupt or rapid discontinuation of Pregabalin may produce some symptoms including insomnia, nausea, headache and diarrhoea. So Pregabalin should be tapered gradually over a minimum of 1 week rather than discontinued abruptly. Pregabalin treatment may associate with creatine kinase elevations. It should be discontinued if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur.
Use Pregnancy Lactation
Pregnancy: Pregabalin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation: Pregabalin may be secreted through the breast milk like other drugs, so it should be used in nursing women only if the benefits clearly overweigh the risks.
Packaging
Xil ®- 25 Capsule: Each box containing 3×10’s capsules in blister pack.
Xil ®- 50 Capsule: Each box containing 3×10’s capsules in blister pack.
Xil – 75 Capsule: Each box containing 3×10’s capsules in blister pack.
Storage
Store below 30°C. Protect from light and moisture. Keep all medicines out of the reach of children.
Xil – CR 82.5 Tablet: Each Box Containing 3×10’s Tablets in blister pack
