Macromate

Macromate

topiramate

Manufacturer:

MacroPhar

Distributor:

MacroPhar Lab
Concise Prescribing Info
Contents
Topiramate
Indications/Uses
Initial monotherapy in patients (adult & childn ≥2 yr) for newly diagnosed epilepsy or who received previous anticonvulsant regimen. Adjunct for management in adults & childn ≥2 yr w/ partial onset seizures, generalized tonic-clonic seizures & seizures associated w/ Lennox-Gastaut syndrome. Prophylaxis of migraine headache.
Dosage/Direction for Use
Epilepsy Adult Initially 25-50 mg at night for 1 wk, increased thereafter by increments of 25 or 50 mg at 1-2 wk intervals until effective dose is reached. Daily doses of >25 mg should be taken in 2 divided doses. Monotherapy: Usual dose range: 100-500 mg daily. Adjunctive therapy: Usual daily dose: 200-400 mg. Childn ≥6 yr Monotherapy: Initially 0.5-1 mg/kg at night for the 1st wk, increased thereafter by 0.5-1 mg/kg every 1 or 2 wk daily in 2 divided doses. Childn ≥2 yr Adjunctive therapy: Initially 25 mg given as single dose at night for 1 wk, then increased by 1-3 mg/kg every 1 or 2 wk until effective dose is reached. Higher daily dose are divided & given bid. About 5-9 mg/kg is usually required. Migraine Adult Initially 25 mg at night for 1 wk, increased by 25 mg increments every wk to usual dose of 50 mg bid. Moderate to severe renal impairment (CrCl <70 mL/min/1.73 m2) ½ of usual adult dose. Patient undergoing hemodialysis Supplemental dose equal to about ½ of daily dose given in divided doses (at start & finish of procedure).
Administration
May be taken with or without food: Swallow whole, do not break/chew.
Contraindications
Special Precautions
Discontinue if acute myopia associated w/ secondary angle closure glaucoma, visual problems occur; metabolic acidosis develops & persists. Gradually w/draw therapy in patients w/ or w/o history of seizures or epilepsy. Visual field defects (independent of elevated IOP); acute myopia & secondary angle closure glaucoma; oligohidrosis & hyperthermia; hyperchloremic, non-anion gap; metabolic acidosis; hyperammonemia w/ or w/o encephalopathy; hematologic disorders. Increased risk of suicidal thoughts or behavior; kidney stones. Avoid use in patients on ketogenic diet. Monitor for evidence of decreased sweating & increased body temp especially on ped patients; emergence or worsening of depression, suicidal thoughts or behavior, &/or any unusual changes in mood or behavior. Measure baseline & periodic serum bicarbonate during treatment; ammon level in patients who develop unexplained lethargy, vomiting or changes in mental status. Increase fluid intake. Concomitant use w/ other drugs predisposing heat-related disorders eg, other carbonic anhydrase inhibitor & anticholinergic drugs; valproic acid. Avoid concomitant use w/ any other drug producing metabolic acidosis. Do not take alcohol during therapy. Should not drive or operate machinery during therapy. Hepatic or renal impairment. Pregnancy & lactation.
Adverse Reactions
Oligohydrosis & hyperthermia, hyperammonemia, hyperammonemic encephalopathy, hypothermia; hepatic failure (including fatalities), hepatitis, pancreatitis; bullous skin reaction (including erythema multiforme, SJS, TEN), pemphigus; kidney stones; acute myopia, secondary angle closure glaucoma, maculopathy; decreased INR or prothrombin time.
Drug Interactions
Decreased plasma conc w/ phenytoin or carbamazepine. Hypothermia & hyperammonemia w/ & w/o encephalopathy w/ valproic acid. Concomitant use w/ alcohol or other CNS depressant; pioglitazone. Decreased contraceptive efficacy & increased breakthrough bleeding w/ OCs. Increased systemic exposure of lithium. Increased severity of metabolic acidosis & risk of kidney stone formation w/ other carbonic anhydrase inhibitor (eg, zonisamide or acetazolamide). Increased Cmax & AUC w/ hydrochlorothiazide.
MIMS Class
Anticonvulsants / Antimigraine Preparations
ATC Classification
N03AX11 - topiramate ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Macromate FC tab 100 mg
Packing/Price
6 × 10's
Form
Macromate FC tab 25 mg
Packing/Price
6 × 10's
Form
Macromate FC tab 50 mg
Packing/Price
6 × 10's
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