Neugaba

Neugaba

gabapentin

Manufacturer:

Viatris

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Gabapentin
Indications/Uses
Monotherapy in treatment of partial seizures w/ & w/o secondary generalization in adult & childn ≥12 yr. Adjunctive therapy in treatment of partial seizures w/ & w/o secondary generalization in adult & childn ≥3 yr. Neuropathic pain in adult ≥18 yr.
Dosage/Direction for Use
Epilepsy Adult & ped patients >12 yr Dosing range: 900 mg to 3,600 mg/day. Initially 300 mg tid on Day 1 or titrating dose to 300 mg once daily on Day 1, 300 mg bid on Day 2 & 300 mg tid on Day 3. Thereafter, dose may be increased in 3 equally divided doses. Max: 3,600 mg. Max time interval: ≤12 hr. Ped patients 3-12 yr Initially 10-15 mg/kg/day in equally divided doses tid for approx 3 days, ≥5 yr 25-35 mg/kg/day in equally divided doses tid, 3 to <5 yr 40 mg/kg/day in equally divided doses tid. Max time interval: ≤12 hr. Neuropathic pain Adult Initially 900 mg/day in 3 equally divided doses, increased if necessary. Therapy should be initiated by titrating dose from 300 mg once daily on Day 1, to 300 mg bid on Day 2, then 300 mg tid on Day 3. Max dose: 3,600 mg/day. Renal impairment w/ CrCl ≥80 mL/min 900-3,600 mg/day, 50-79 mL/min 600-1,800 mg/day, 30-49 mL/min 300-900 mg/day, 15-29 mL/min 150 mg (administered as 300 mg every other day) to 600 mg/day, <15 mL/min 150 mg (administered as 300 mg every other day) to 300 mg/day. Patients undergoing hemodialysis Loading dose: 300-400 mg, then 200-300 mg following each 4 hr of hemodialysis.
Administration
May be taken with or without food: Swallow whole w/ sufficient fluid.
Contraindications
Special Precautions
Abrupt w/drawal may precipitate status epilepticus. Not for treatment of absence seizures. Concomitant use w/ opioids. DRESS. Discontinue treatment if signs & symptoms of anaphylaxis occur. Evaluate patients for history of drug abuse. False +ve results w/ Ames N-Multistix SG dipstick test in concomitant use w/ other anticonvulsant drugs. May impair ability to drive & use machines. Pregnancy & lactation.
Adverse Reactions
Abdominal pain, back pain, fatigue, fever, headache, viral infection; vasodilation; constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, dry mouth or throat, nausea &/or vomiting; leukopenia, decreased WBC; peripheral edema, increased wt; fracture, myalgia; amnesia, ataxia, confusion, abnormal coordination, depression, dizziness, dysarthria, emotional lability, insomnia, nervousness, nystagmus, somnolence, abnormal thinking, tremor, twitching; coughing, pharyngitis, rhinitis; abrasion, acne, pruritus, rash; ambylopia, diplopia; impotence. Hostility, hyperkinesia; bronchitis, resp infection. Accidental injury, asthenia, flu syndrome, infection, pain; flatulence; abnormal gait, hypesthesia, vertigo, dyspnea.
Drug Interactions
Resp depression &/or sedation may occur w/ opioids. Reduced bioavailability w/ Al- & Mg-containing antacids.
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
Neugaba cap 300 mg
Packing/Price
60's
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