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Acode 50

Acode 50

lacosamide

Manufacturer:

Torrent Pharmaceuticals

Distributor:

Torrent
Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing
Concise Prescribing Info
Contents
Lacosamide
Indications/Uses
Monotherapy of partial-onset seizures in patients ≥16 yr w/ epilepsy. Adjunctive therapy in the treatment of partial onset seizures w/ or w/o secondary generalization in patients ≥16 yr w/ epilepsy.
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Dosage/Direction for Use
Adult ≥16 yr As monotherapy Initially 100 mg bid increased to 150 mg bid after 1 wk. Can be further increased at wkly interval by 50 mg bid depending on response & tolerability up to max recommended maintenance daily dose 200 mg bid. As adjunctive therapy Initially 50 mg bid increased to 100 mg bid after 1 wk. Maintenance dose can be further increased by 50 mg bid every wk up to max 400 mg daily (200 mg bid). Initiation w/ loading dose 200 mg loading dose followed by 100 mg bid maintenance dose approx 12 hr later. Maintenance dose can be further increased by 50 mg bid every wk up to max 400 mg daily (200 mg bid). Patient w/ severe renal impairment (CrCl ≤30 mL/min), ESRD or mild to moderate hepatic impairment Max dose: 300 mg/day. Patient requiring haemodialysis Consider a supplement up to 50% of the divided daily dose directly after end of haemodialysis.
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Overdosage
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Administration
May be taken with or without food.
Contraindications
Hypersensitivity.
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Special Precautions
May cause dizziness. PR interval prolongations have been observed in clinical studies; caution in patients w/ known conduction problems or severe cardiac disease eg, history of MI or heart failure. Post-marketing reports of 2nd degree or higher AV block. Reports of suicidal ideation & behavior. Monitor for signs of suicidal ideation & behaviors & consider appropriate treatment. Minor to moderate influence on the ability to drive & use machines. Patients w/ severe renal impairment (CrCl ≤30 mL/min), ESRD; hepatic impairment. Pregnancy. Decide whether to discontinue nursing or discontinue therapy taking into account the drug's importance to the mother. Not recommended in childn & adolescents <16 yr.
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Use In Pregnancy & Lactation
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Adverse Reactions
Dizziness, headache; diplopia; nausea. Depression, confusional state, insomnia; cognitive disorder, nystagmus, balance disorder, abnormal coordination, memory impairment, tremor, somnolence, dysarthria, disturbance in attention, hypoesthesia, paresthesia; blurred vision; vertigo, tinnitus; vomiting, constipation, flatulence, dyspepsia, dry mouth, diarrhea; pruritus; muscle spasms; gait disturbance, asthenia, fatigue, irritability, feeling drunk; fall, skin laceration, confusion.
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Drug Interactions
Concomitant use w/ medicinal products associated w/ PR prolongation (eg, carbamazepine, lamotrigine, pregabalin) or class I antiarrhythmic drugs. Decreased overall systemic exposure w/ other anti-epileptics known to be enzyme inducers (carbamazepine, phenytoin, phenobarb, in various doses).
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Storage
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Description
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Action
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MIMS Class
Anticonvulsants
ATC Classification
N03AX18 - lacosamide ; Belongs to the class of other antiepileptics.
Regulatory Classification
Rx
Presentation/Packing
Form
Acode 50 FC tab 50 mg
Packing/Price
30's (P960/box)