Pregavalex

 Each Capsule contains:

Pharmacological Actions:

• Pregabalin is a structural derivative of gamma-amino butyric acid (GABA)  indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN), it  acts through binding to calcium channels thereby modulating calcium influx, it also has some influence on GABA transport.
• Pregabalin does not bind to GABA or benzodiazepine receptors, does not inhibit dopamine, serotonin or adrenaline reuptake, does not block Sodium channels and does not alter cycloxygenase enzyme activity.

• For the treatment of neuropathic pain associated with diabetic peripheral neuropathy and herpes zoster (post herpetic neuralgia).
• An adjunctive therapy in adults with partial seizures with or without secondary generalization.

Known hypersensitivity to Pregabalin or any of the components.

Most common adverse effects are dry mouth, constipation, vomiting, flatulence edema, dizziness, drowsiness, attention disturbance, disturbances in muscle control and movement, speech disorder, parasthesia, euphoria, confusion, fatigue, appetite change, weight gain, changes in sexual function, visual disturbance and ocular disorders.

• Pregavalex may be administered with or without food intake.
• The usual dose range is 150 mg to 600 mg per day in two or three divided doses.
• In neuropathic pain: Treatment may be initiated at a dose of 150 mg per day. After an interval period of 3 to 7 days, the dosage may then be increased to 300 mg per day based on individual patient response and tolerability. If further needed,  a maximum dose of 600 mg daily may be administered after 7 days of initial therapy.
• In epilepsy: The initial dose is 150 mg per day. After one week interval,  the dosage may then be increased to 300 mg per day based on individual patient response and tolerability. The maximum dosage of 600 mg per day may be administered after an additional week.

Pregavalex is unlikely to be affected by other antiepileptic drugs or hypoglycemics, diuretics through metabolic interactions or protein binding displacement.

Pregnancy and lactation:

• In pregnancy, benefit achieved from treatment with Pregabalin should outweigh the possible risk to fetus.
• Pregavalex is excreted in human milk, therefore nursing should be discontinued during medication administration.

• Pregavalex administration may be associated with symptoms of dizziness and somnolence, therefore patients under treatment should be advised to exercise caution while driving or operating hazardous machinery until familiar with the potential effects of medication.
• Pregavalex should not be withdrawn rapidly or abruptly to avoid symptoms of nausea, headache and diarrhea.
• In patients with renal impairment or reduced function, the dosage should be adjusted based on the patient's creatinine clearance.
• Patients should be informed that if changes in vision occur, they should notify their physician.
• As Pregavalex causes weight gain and may also cause edema, concomitant use of Pregavalex with thiazolidinedione should be avoided in patients with pre-existing cardiac conditions.

• Store in dry place, at a temperature not exceeding 30 °C.

Boxes of one or two AL/PVC/PE/PVDC strips, each of 10 capsules.