PMS-Gabapentin

PMS-Gabapentin

gabapentin

Manufacturer:

Pharmascience

Distributor:

Medicell Pharma
Concise Prescribing Info
Contents
Gabapentin
Indications/Uses
Adjunctive therapy for management of patients w/ epilepsy who are not satisfactorily controlled by conventional therapy.
Dosage/Direction for Use
Adult 900-1,800 mg daily. Initially 300 mg tds, may be increased up to 1,800 mg daily. Daily maintenance dose: To be given in 3 equally divided doses & max time of 12 hr between doses. Renal impairment CrCl ≥60 mL/min Total daily dose range: 900-3,600 mg in 3 divided doses, >30-59 mL/min Total daily dose range: 400-1,400 mg in 2 divided doses, >15-29 mL/min Total daily dose range: 200-700 mg once daily, 15 mL/min Total daily dose range: 100-300 mg once daily. Hemodialysis Total daily dose range: 125-350 mg post-hemodialysis supplemental dose administered after each 4 hr of hemodialysis.
Administration
May be taken with or without food.
Special Precautions
Severe life-threatening systemic hypersensitivity reactions (eg, DRESS). Discontinue use immediately if signs & symptoms suggest SJS or erythema multiforme; anaphylaxis. Patients who have mixed seizure disorders including absence seizures. Possible increased seizure frequency w/ abrupt w/drawal of therapy. Increased occurrence of accidental injury (fall) due to dizziness & somnolence. Higher risk of CNS depression including sedation, somnolence, loss of consciousness, serious cases of resp depression in patients w/ compromised resp function, resp or neurological disease, renal impairment & elderly. Advise patients to refrain from activities requiring mental alertness or physical coordination until they are sure that PMS-Gabapentin does not affect them adversely. Carefully evaluate patients for history of drug abuse & closely observe for signs of abuse or misuse (eg, tolerance development, self-dose escalation & drug-seeking behavior). Consider appropriate treatment & monitor for signs of suicidal ideation & behaviour. Concomitant use w/ opioids may result in resp depression, profound sedation, syncope & death; CNS depressants. May impair ability to drive or handle potentially dangerous machinery. Pregnancy & lactation. Childn <18 yr. Elderly >65 yr.
Adverse Reactions
Somnolence, dizziness, ataxia, fatigue, nystagmus & tremor.
Drug Interactions
Decreased Cmax & AUC values of hydrocodone. Increased AUC w/ morphine. Reduced bioavailability w/ Al- & Mg-based antacid. Slight decreased in renal excretion when co-administered w/ cimetidine. Additive in the impairment of cognitive & gross motor function w/ opioids, benzodiazepines & alcohol. False +ve readings w/ Ames N-Multistix SG dipstick test when gabapentin or placebo was added to other anticonvulsants; sulfosalicylic acid precipitation procedure is recommended for urinary protein determination.
MIMS Class
Anticonvulsants / Drugs for Neuropathic Pain
ATC Classification
N02BF01 - gabapentin ; Belongs to the class of gabapentinoids. Used to relieve pain and other conditions.
Presentation/Packing
Form
PMS-Gabapentin cap 100 mg
Packing/Price
100's
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