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Convuliz

Convuliz

pregabalin

Manufacturer:

Saga Lifesciences

Distributor:

Trumed
Full Prescribing Info
Contents
Pregabalin.
Description
Two coloured, maroon and white, capsule with printed "P3" on top and bottom.
Each capsule contains: Pregabalin 75 mg.
Action
Antiepileptic.
Pharmacology: Pharmacokinetics: Pregabalin is rapidly absorbed after oral doses and peak plasma concentrations are achieved within 1.5 hours. Oral bioavailability is about 90%. The rate but not the extent of absorption is reduced if given with food but this is not clinically significant. Steady state is achieved after 1 to 2 days. Pregabalin is not bound to plasma proteins and undergoes negligible metabolism. About 98% of a dose is excreted in the urine as unchanged drug. The mean elimination half-life is 6.3 hours. Pregabalin is removed by haemodialysis. Distribution into milk has been found in studies in rats.
Indications/Uses
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, neuropathic pain, and fibromyalgia.
Dosage/Direction for Use
Route of Administration: Oral.
Dosage: Pregabalin is given orally in 2 or 3 divided doses daily.
For the treatment of Epilepsy: 150 mg daily increased after 1 week according to response to 300 mg daily and then to 600 mg daily after another week.
For the treatment of Generalized Anxiety Disorder: The initial dose is 150 mg daily; this may be increased at weekly intervals in steps of 150 mg, to a maximum of 600 mg daily.
For the treatment Neuropathic Pain: The initial dose is 150 mg daily increased after 3 to 7 days to 300 mg daily and then to 600 mg daily after another 7 days. Maximum daily dose of 300 mg is recommended in diabetic neuropathy.
For the treatment of Fibromyalgia: The initial dose is 150 mg daily increased after 1 week according to response to 300 mg daily and then to 450 mg daily if necessary.
Dosage of pregabalin should be reduced in patients with renal impairment.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Special Precautions
Withdrawal of pregabalin therapy in epilepsy or transition to or from another type of antiepileptic therapy should be made gradually to avoid precipitating an increase in frequency of seizures.
Adverse Reactions
The most common adverse effect reported during therapy with pregabalin are dizziness and somnolence. Other common adverse effects include blurred vision, diplopia, increase appetite and weight gain, dry mouth, constipation, vomiting, flatulence, euphoria, confusion, reduced libido, erectile dysfunction, irritability, vertigo, ataxia, tremor, dysarthria, paraesthesia, fatigue, and oedema. Disturbances of attention, memory, coordination, and gait also occur frequently. Syncope and congestive heart failure have been reported less frequently. Reversible renal failure, elevation of creatine kinase concentration, and rhabdomyolysis have been reported rarely. Hypersensitivity reactions have occurred shortly after starting pregabalin therapy; symptoms include rash, blisters, urticaria, dyspnoea, and wheezing. Stevens-Johnson syndrome has also been reported. An increased incidence of haemangiosarcoma was observed in mice that had been given high doses of pregabalin.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Anticonvulsants / Drugs for Neuropathic Pain
ATC Classification
N02BF02 - pregabalin ; Belongs to the class of gabapentinoids. Used to relieve pain and other conditions.
Presentation/Packing
Form
Convuliz cap 75 mg
Packing/Price
28's
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