Berlontin

Berlontin

gabapentin

Manufacturer:

Berlin Pharm

Distributor:

Berlin Pharm

Marketer:

Berlin Pharm
Concise Prescribing Info
Contents
Gabapentin
Indications/Uses
Monotherapy for partial seizures w/ & w/o secondary generalization in adults & adolescents ≥12 yr. Peripheral neuropathic pain eg, painful diabetic neuropathy & post-herpetic neuralgia in adults. Adjunctive therapy for partial onset seizures w/ & w/o secondary generalization in adults & childn ≥3 yr.
Dosage/Direction for Use
Epilepsy Adult & adolescent ≥12 yr 900-3,600 mg daily, may be initiated by 300 mg tid on Day 1, or by titrating dose as 300 mg once daily on day 1, 300 mg bid on day 2, 300 mg tid on day 3. Dose may be increased in 3 equally divided doses up to max: 3,600 mg daily. Childn ≥3 yr Initially 10-15 mg/kg daily given in 3 divided doses. Maintenance dose: Childn 5-11 yr 25-35 mg/kg daily given in 3 divided doses, 3-4 yr 40 mg/kg daily given in 3 divided doses. Max time interval between doses: Not to exceed 12 hr. Peripheral neuropathic pain Adult Initially 900 mg daily in 3 equally divided doses, may be initiated by titrating dose as 300 mg once daily on day 1, 300 mg bid on day 2, 300 mg tid on day 3. Max dose: 3,600 mg daily. Renal impairment (including those undergoing haemodialysis) CrCl ≥80 mL/min 900-3,600 mg daily in 3 divided doses, 50-79 mL/min 600-1,800 mg daily in 3 divided doses, 30-49 mL/min 300-900 mg daily in 3 divided doses, 15-29 mL/min 150-600 mg daily in 3 divided doses, <15 mL/min 150-300 mg daily given in 3 divided doses. Anuric patients undergoing haemodialysis who have never received gabapentin Loading dose: 300-400 mg then, 200-300 mg following each 4-hr hemodialysis. Renally impaired patients undergoing haemodialysis Maintenance dose then additional 200-300 mg dose following each 4-hr haemodialysis.
Administration
May be taken with or without food: Swallow whole w/ sufficient fluid (eg, a glass of water).
Contraindications
Special Precautions
Discontinue if acute pancreatitis develops. Not effective for primary generalized seizures eg, patients w/ mixed seizures including absences. Increased in seizure frequency or onset of new types of seizures. Refractory patient on >1 antiepileptic treatment. May precipitate status epilepticus. May cause hematologic disorder eg, leucopenia & rarely, thrombocytopenia. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. False +ve total urine protein test result. May affect ability to drive & use machines. Liver or kidney disease. Women who are likely to become pregnant or of childbearing potential. Not to be used during pregnancy. Lactation. Prolonged therapy effects in childn & adolescents; developmental delay in childn of mothers w/ epilepsy. Elderly ≥65 yr.
Adverse Reactions
Viral infection; somnolence, dizziness, ataxia; fatigue, fever. Pneumonia, resp infection, UTI, infection, 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), hypaesthesia, abnormal coordination, nystagmus, increased/decreased or absent reflexes; visual disturbances eg, amblyopia, diplopia; vertigo; HTN, vasodilatation; dyspnoea, bronchitis, pharyngitis, cough, rhinitis; vomiting, nausea, dental abnormalities, gingivitis, diarrhea, abdominal pain, dyspepsia, constipation, dry mouth or throat, flatulence; facial oedema, purpura as bruises resulting from physical trauma, rash, pruritus, acne; arthralgia, myalgia, back pain, twitching; incontinence; impotence; peripheral or generalized oedema, abnormal gait, asthenia, pain, malaise, flu syndrome; decreased WBC, wt gain; accidental injury, fracture, abrasion. SJS, erythema multiforme.
Drug Interactions
Increased AUC w/ morphine. Reduced bioavailability w/ Al- & Mg-containing antacids. Slightly decreased renal excretion w/ cimetidine.
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
Berlontin FC tab 600 mg
Packing/Price
10 × 10's
Form
Berlontin hard cap 100 mg
Packing/Price
10 × 10's
Form
Berlontin hard cap 300 mg
Packing/Price
10 × 10's
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