InnoGen Pharmaceuticals


InnoGen Pharmaceuticals
Full Prescribing Info
Each capsule contains: Pregabalin 75 mg.
Pregabalin is an antiepileptic drug chemically related to gabapentin. Pregabalin binds to calcium channels on nerves and may modify the release of neurotransmitters (chemicals that nerves use to communicate with each other). Reducing communication between nerves may contribute to pregabalin's effect on pain and seizures.
Pharmacology: Pharmacokinetics: Pregabalin is rapidly absorbed when administered on an empty stomach, with peak plasma concentrations occurring within one hour. Its oral bioavailability is estimated to be greater than or equal to 90% and is independent of dose. The rate of pregabalin absorption is decreased when given with food resulting in a decrease in Cmax by approximately 25 to 30% and a delay in Tmax to approximately 2.5 hours.
Pregabalin has been shown to cross the blood brain barrier in mice, rats and monkeys. It has been shown to cross the placenta in rats and is present in the milk of lactating rats. In humans, the volume of distribution of pregabalin for an orally administered dose is approximately 0.56 L/kg and is not bound to plasma proteins.
Pregabalin undergoes negligible metabolism in humans. Approximately 98% of the radioactivity recovered in the urine was unchanged pregabalin. The N-methyl pregabalin is the major metabolite.
Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. Renal clearance of pregabalin is 73 mL/minute.
Pregabalin is an antiepileptic used as an adjunct in the treatment of partial seizures with or without secondary generalization. It is also used in the treatment of generalized anxiety disorder.
Dosage/Direction for Use
Pregabalin is given by mouth in 2 or 3 divided doses daily.
The initial adult dose in the treatment of epilepsy is 150 mg daily increased after 1 week according to response to 300 mg daily and then to 600 mg daily after another week or as prescribed by the physician.
In the treatment of generalized anxiety disorder, the initial adult dose is 150 mg daily, this may be increased at weekly intervals in steps of 150 mg, to 1 maximum of 600 mg daily or as prescribed by the physician.
Dosage of pregabalin should be reduced in patients with renal impairment.
Special Precautions
Dizziness, somnolence and blurred vision may impair a patient's ability to perform skilled tasks such as driving.
Adverse Reactions
The most common side effects of pregabalin are dizziness, drowsiness, dry mouth, edema (accumulation of fluid), blurred vision, weight gain, and difficulty concentrating. Other side effects include reduced blood platelet counts, and increased blood creatinine kinase levels. Increased creatinine kinase can be a sign of muscle injury, and in clinical trials three patients experienced rhabdomyolysis (severe muscle injury). Therefore, patients should report unexplained muscle pain, tenderness or weakness to their doctors, especially if associated with fever and malaise (reduced well-being). Pregabalin has rarely been associated with angioedema (swelling of the face, tongue, lips, and gums, throat and larynx).
Store at temperatures not exceeding 30°C.
ATC Classification
N03AX16 - pregabalin ; Belongs to the class of other antiepileptics.
Cap 75 mg x 20's.
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