Neugalin 25 mg Capsule

Neugalin 25 mg Capsule

Description

Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid (GABA), it does not bind directly to GABAA, GABAB and benzodiazepine receptor. Pregabalin selectively binds to the alpha2delta subunit protein of voltage-gated calcium channels in various regions of central nervous system tissues.

Pregabalin oral bioavailability is approximately 90% and it is well absorbed after oral administration.

Composition

Neugalin 25 : Each capsule contains Pregabalin INN 25 mg.

Neugalin 50 : Each capsule contains Pregabalin INN 50 mg.

Neugalin 75 : Each capsule contains Pregabalin INN 75 mg.

Indications

• Neuropathic pain from diabetic neuropathy.

• Post herpetic neuralgia.

• Fibromyalgia.

• Adjunctive therapy in adults with partial seizures with or without secondary generalization.

• Generalized anxiety disorder.

Dosage and Administration

Neuropathic pain

Initially 150 mg/day in 2-3 divided doses, may be increased if necessary after 3-7 days to 300 mg daily in 2

divided doses, The dose may be increased further if necessary after 7 days to maximum 600 mg daily in two divided doses .

Post herpetic neuralgia

The recommended dose is 75 to 150 mg two times a day, dosing should begin at 75 mg two times a day and may be increased to 300 mg/day within 1 week based on efficacy and tolerability.

Fibromyalgia

The recommended dose of Pregabalin for fibromyalgia is 300 to 450 mg/day in two divided doses.

Epilepsy

Initially 150 mg daily in 2 divided doses, increased if necessary after 7 days to 300 mg daily in 2 divided doses, increased further if necessary after 7 days to maximum 600 mg daily in 2 divided doses.

Generalized anxiety disorder

Initially 150 mg daily in 2 divided doses, increased if necessary after 7 days to 300 mg in 2 divided doses, increased further if necessary after 7 days to maximum 600 mg daily in 2 divided doses.

Or as directed by the physician.

Contraindications

Pregabalin is contraindicated in patients with known hypersensitivity to Pregabalin or any of its components.

Side effects

The most common side effects reported are tiredness, dizziness, headache, dry mouth, nausea, vomiting, constipation.

Precautions

Abrupt or rapid discontinuation may result in insomnia, nausea, headache, or diarrhea. Concomitant treatment with Pregabalin and a antidiabetic agent may lead to an additive effect on edema and weight gain. For patients with preexisting cardiac conditions, this may increase the risk of heart failure.

Use in pregnancy and lactation

Pregnancy category C. It should be used during pregnancy only if the potential benefits justifies the potential risk to the fetus. Breast feeding is not recommended during treatment with Pregabalin. Pediatric use

The safety and efficacy of pregabalin in pediatric patients have not been established.

Drug interactions

Interactions may occur with opioids benzodiazepines, barbiturates, ethanol (alcohol), and other drugs that depress the central nervous system.

Overdosage

Overdose of up to 8000 mg has been reported. The most commonly reported adverse events in overdose are somnolence, confusional state, agitation and restlessness.

Supply

Neugalin 25 : Each box contains 3 x 10 capsules in Alu-Alu blisters.

Neugalin 50 : Each box contains 3 x 10 capsules in Alu-Alu blisters.

Neugalin 75 : Each box contains 3 x 10 capsules in Alu-Alu blisters.