Gamalix

Gamalix

pregabalin

Manufacturer:

Ifars
Concise Prescribing Info
Contents
Pregabalin
Indications/Uses
Peripheral & central neuropathic pain in adults. As adjunctive therapy in adults w/ partial seizures w/ or w/o secondary generalization. Generalized anxiety disorder in adults. Reduce pain in the management of fibromyalgia.
Dosage/Direction for Use
150-600 mg daily in 2 or 3 divided doses. Neuropathic pain Initially 75 mg twice daily. May be increased to 150 mg twice daily after 3-7 day interval. Max: 300 mg twice daily after an additional wk. Epilepsy Initially 75 mg twice daily. May be increased to 150 mg twice daily after 1 wk. Max: 300 mg twice daily after an additional wk. Generalized anxiety disorder 150-600 mg daily in 2-3 divided doses. Initially 150 mg daily, may be increased to 300 mg daily after 1 wk. Following an additional wk, dose may be increased to 450 mg daily. Max dose: 600 mg daily may be achieved after an additional wk. Fibromyalgia Recommended dose: 300-450 mg daily in 2 divided doses. Initially 75 mg twice daily (150 mg daily), may be increased to 150 mg twice daily (300 mg daily) w/in 1 wk. Patient who do not experience sufficient benefit w/ 300 mg daily dose May be further increased to 225 mg twice daily (450 mg daily). Renal impairment CrCl ≥60 mL/min Initially 150 mg twice daily. Max dose: 600 mg daily; CrCl 30-60 mL/min Initially 75 mg once or twice daily. Max dose: 300 mg daily; CrCl 15-30 mL/min Initially 25-50 mg once or twice daily. Max dose: 150 mg daily; CrCl <15 mL/min Initially 25 mg once daily. Max dose: 75 mg daily. Supplementary dose following haemodialysis Initially 25 mg once daily. Max: 100 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity.
Special Precautions
Patients w/ rare hereditary problems of galactose intolerance, lapp-lactase deficiency or glucose-galactose malabsorption. Adjust hypoglycemic medications in some diabetic patients who gain wt on pregabalin treatment. Discontinue immediately if symptoms of angioedema occur. Associated w/ dizziness & somnolence that may increase accidental injury/fall in elderly. Loss of consciousness, confusion & mental impairment. Transient visual blurring & other changes in visual acuity. W/drawal symptoms. Evaluate patients for history of drug misuse & abuse; observe for signs of pregabalin abuse. CHF patients. Increased CNS adverse events especially somnolence in the treatment of central neuropathic pain due to spinal cord injury. Renal impairment. Do not drive, operate complex machinery or engage in other potentially hazardous activities. Effective contraception must be used in women of childbearing potential. Pregnancy & lactation. Childn. Elderly.
Adverse Reactions
Increased appetite; euphoric mood, confusion, decreased libido, irritability, depression, disorientation, insomnia; dizziness, somnolence; blurred vision, diplopia; vertigo; tachycardia; flushing, hot flushes; dyspnea, dry nose; dry mouth, constipation, flatulence, vomiting; sweating, red papules; muscle twitch, swollen joints, muscle cramps, myalgia, arthralgia, back pain, limb pain, muscle spasm; dysuria, urinary incontinence; erectile dysfunction; fatigue, peripheral oedema, feeling drunk, oedema, abnormal gait; increased wt.
Drug Interactions
May potentiate ethanol & lorazepam effects. Resp failure & coma in patients who have taken pregabalin w/ other CNS depressants. Additive impairment of cognitive & gross motor function w/ oxycodone. Reduced lower GIT function eg, intestinal obstruction, paralytic ileus, constipation w/ opioid analgesics.
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
Gamalix cap 150 mg
Packing/Price
3 × 10's
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