Pregaben CR(Pregabalin)
Therapeutic Group: Drugs of Nervous System
Presentation
Pregaben CR 82.5: Each film coated tablet contains Pregabalin BP 82.5 mg.
Pregaben CR 165: Each film coated tablet contains Pregabalin BP 165 mg.
Pregaben CR 330: Each film coated tablet contains Pregabalin BP 330 mg.
Description
Pregabalin is a structural derivative of gamma-amino butyric acid (GABA). It does not bind directly to GABA-A, GABA-B, or benzodiazepine receptors. It binds with high affinity to the alpha 2-delta site (an auxilliary subunit of voltage-gated calcium channels) in central nervous system tissues. Oral bioavailability of pregabalin is 90%. Pregabalin is eliminated largely by renal excretion and has an elimination half-life of about 6 hours. Pregabalin can be taken with or without food.
Indications
Pregabalin CR is indicated for the management of-
• Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
• Postherpetic neuralgia (PHN)
Dosage & Administration
Neuropathic Pain Associated with Diabetic Peripheral Neuropathy: The initial dose is 165 mg once daily and will increase to 330 mg once daily within 1 week based on individual patient response and tolerability. The maximum recommended dose of Pregabalin CR is 330 mg once daily.
Postherpetic Neuralgia: Initial dose is 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. The maximum recommended dose of Pregabalin CR is 330 mg once daily.
Pregabalin CR should be administered once daily after an evening meal. It should be swallowed whole and should not be split, crushed, or chewed. When discontinuing Pregabalin CR, taper gradually over a minimum of 1 week.
Side Effects
Most common side-effects treated with Pregabalin CR are dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, and weight gain.
Precautions
Discontinue Pregabalin CR immediately in patients with these symptoms:
• Angioedema
• Hypersensitivity reactions
• Seizure disorders
Pregabalin CR may increase the risk of suicidal thoughts or behaviors; it may also cause peripheral edema, dizziness, and somnolence and impair the patient’s ability to operate machinery.
Use in Pregnancy & Lactation
Pregnancy: May cause fetal harm. Advise of the potential risk to the fetus.
Lactation: Breastfeeding is not recommended.
Pediatric patients: The safety and effectiveness of Pregabalin CR in pediatric patients have not been established.
Patient with renal impairment: Use of Pregabalin CR is not recommended for patients with creatinine clearance (CLcr) less than 30 mL/min or who are undergoing hemodialysis. Those patients should receive Pregabalin.
Drug Interaction
The interactions of pregabalin CR with the co-administration of other drugs have not been systematically evaluated. Co-administration of the prokinetic drug erythromycin with Pregabalin CR did not result in any clinically important changes in the pharmacokinetics of Pregabalin CR.
Over Dose
Overdosage of up to 8000 mg has been reported. The symptoms consist of dizziness, somnolence, blurred vision, and mild diarrhoea. Pregabalin can be removed by emesis or gastric lavage.
Storage
Do not store above 30 ºC. Keep away from light and out of the reach of children.
Commercial Pack
Pregaben CR 82.5: Each box contains 3 blister strips of 10 tablets.
Pregaben CR 165: Each box contains 3 blister strips of 10 tablets.
Pregaben CR 330: Each box contains 5 blister strips of 6 tablets.