Gabapentin Sandoz

Gabapentin

Neuropathic pain in adults ≥18 yr. Peripheral neuropathic pain eg, painful diabetic neuropathy & post-herpetic neuralgia in adults >18 yr. Monotherapy in treatment of partial seizures w/ & w/o secondary generalization in adults & adolescents ≥12 yr. Adjunctive therapy in treatment of partial seizures w/ & w/o secondary generalization in adults & childn ≥3 yr.

Adult & adolescent ≥12 yr Initial titration for all indications: 300 mg once daily on day 1, 300 mg bid on day 2, 300 mg tid on day 3. Epilepsy Total daily dose: Divided in 3 single doses. Max time interval between doses: Not to exceed 12 hr. Adult & adolescent ≥12 yr 900-3,600 mg daily. Initiate therapy as above or w/ 300 mg tid on day 1, thereafter may further increase in 300 mg daily increments every 2-3 days up to max 3,600 mg daily. Childn 3-12 yr Start w/ 10-15 mg/kg daily in 3 divided doses & upward titration to reach the effective dose over a period of approx 3 days. Effective dose: Childn 5-12 yr 25-35 mg/kg daily, 3-4 yr 40 mg/kg daily. Neuropathic pain Adult Initiate therapy as above, or w/ 900 mg daily as 3 equally divided doses. May further increase in 300 mg daily increments every 2-3 days up to max 3,600 mg daily. Max duration: 5 mth. Renal impairment CrCl ≥80 mL/min 900-3,600 mg, 50-79 mL/min 600-1,800 mg, 30-49 mL/min 300-900 mg, 15-29 mL/min 150-600 mg (300 mg every other day), <15 mL/min 150-300 mg (reduce daily dose in proportion to CrCl eg, patients w/ CrCl 7.5 mL/min: ½ daily dose that patients w/ CrCl <15 mL/min). Total daily dose: 3 divided doses. Anuric patients undergoing haemodialysis 300-400 mg, then 200-300 mg following each 4 hr of haemodialysis. Renally impaired patients undergoing haemodialysis Maintenance dose: 200-300 mg following each 4 hr of haemodialysis.

May be taken with or without food: Swallow whole, do not chew/crush.

Hypersensitivity.

Discontinue if signs or symptoms of anaphylaxis occurs; acute pancreatitis develops. Not effective against primary generalised seizures eg, absences. Severe, life-threatening, systemic hypersensitivity reactions eg, DRESS. Monitor for signs of suicidal ideation & behaviours. Carefully evaluate patients for a history of drug abuse & observe for possible signs of abuse eg, drug-seeking behaviour, dose escalation, development of tolerance. Increased occurrence of accidental injury (fall). Patients w/ mixed seizures including absences; compromised resp function, resp or neurological disease. Abrupt w/drawal may precipitate status epilepticus. False +ve readings in semi-quantitative determination of total urine protein. Concomitant use w/ opioids; CNS depressants. May affect ability to drive & use machines. Renal impairment. Not to be used during pregnancy. Increased risk of congenital malformations. Lactation. Childn during long term therapy >36 wk. Elderly ≥65 yr.

Viral infection; somnolence, dizziness, ataxia; fatigue, fever. Pneumonia, resp infection, UTI, otitis media; leucopenia; anorexia, increased appetite; hostility, confusion & emotional lability, depression, anxiety, nervousness, abnormal thinking; convulsions, hyperkinesias, dysarthria, amnesia, tremor, insomnia, headache, sensations eg, paresthesia, hypesthesia, abnormal coordination, nystagmus, increased/decreased or absent reflexes; visual disturbances eg, amblyopia, diplopia; HTN, vasodilatation; dyspnoea, bronchitis. pharyngitis, cough, rhinitis; vomiting, nausea, dental abnormalities, gingivitis, diarrhoea, abdominal pain, dyspepsia, constipation, dry mouth or throat, flatulence; facial oedema, purpura most often described as bruises resulting from physical trauma, rash, pruritus, acne; arthralgia, myalgia, back pain, twitching; incontinence; impotence; peripheral oedema, abnormal gait, asthenia, pain, malaise, flu syndrome; decreased WBC, wt gain; accidental injury, fracture, abrasion.

Increased mean AUC w/ morphine. Reduced bioavailability w/ Al- & Mg-containing antacids. Slight decreased in renal excretion w/ cimetidine.

Drugs for Neuropathic Pain / Anticonvulsants

N02BF01 - gabapentin ; Belongs to the class of gabapentinoids. Used to relieve pain and other conditions.

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