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Tonoclone Retard 200 mg C.R. - 10 F.C. Tablets

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Medical Description

Antiseizure agent, anticonvulsant used in the treatment of focal (partial) onset seizures and generalized onset seizures as monotherapy or adjunctive therapy, also used in the management of neuropathic pain.

Indication & Usage

-Focal (partial) onset seizures and generalized onset seizures (monotherapy or adjunctive therapy):Oral: Initial 2 to 3 mg/kg/day (100 to 200 mg/day) or up to 400 mg/day, may gradually increase dose based on seizure control, tolerability, and serum concentrations every ≥5 days in increments of ≤200 mg/day to a usual maintenance dose of ~10 mg/kg/day (800 mg/day to 1.2 g/day). -Neuropathic pain: For use in trigeminal or glossopharyngeal neuralgia. May also be used in critically ill patients with neuropathic pain as a component of multimodal pain control: Oral: Initial: 200 to 400 mg/day, gradually increasing (eg, over several weeks) in increments of 200 mg/day as needed. Usual maintenance dose: 600 to 800 mg/day; maximum dose: 1.2 g/day. -Bipolar disorder, hypomania and mild to moderate mania or episodes with mixed features and bipolar major depression :Acute treatment (monotherapy): Oral: Initial: 100 to 400 mg/day; may increase dose based on response and tolerability in increments of 200 mg/day every 1 to 4 days; usual dose range: 600 mg/day to 1.2 g/day; maximum dose: 1.6 g/day. -Pediatric dosing: Seizure disorder: Dosage must be adjusted according to patient's response and serum concentrations: Oral: Infants and Children <6 years: Immediate-release formulations: Tablets: Initial: 10 to 20 mg/kg/day in divided doses twice or 3 times daily; titrate at weekly intervals until optimal response; maintenance doses administered 3 or 4 times daily; maximum daily dose: 35 mg/kg/day, suspension: Initial: 10 to 20 mg/kg/day in divided doses 4 times daily; titrate at weekly intervals until optimal response; maintenance doses administered 3 or 4 times daily; maximum daily dose: 35 mg/kg/day. Children ≥6 to 12 years: Immediate-release formulations: Tablets: Initial: 100 mg twice daily, titrate by up to 100 mg/day at weekly intervals. Usual maintenance dose range: 400 to 800 mg/day in 3 to 4 divided doses. Maximum daily dose: 1,000 mg/day.

Active Ingredients

Carbamazepine

Recommended Doctors

No Recommended Doctors Found

Dosage & Administration

-Chewable or immediate release tablets: Administer with food. -Suspension: Shake well before administration. -Extended release tablets: Should be administered with meals; swallow whole, do not crush or chew. -Extended release capsule: may be administered with or without food; do not crush or chew capsule or beads inside capsule.

Side Effects

-Anemia, aplastic anemia, leukopenia, neutropenia, thrombocytopenia, eosinophilia, leukocytosis, lymphocytosis, macrocytosis, increase the risk of cardiac failure, increased serum transaminases, hepatocellular hepatitis, cholestatic hepatitis, hypersensitivity reactions, ranging from mild with maculopapular rash to severe cutaneous adverse reactions including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), hyponatremia, ataxia, dizziness, and drowsiness, anxiety and depression, nausea, vomiting, hypertension, pruritus, skin rash, constipation, xerostomia.

Safety Advice

-In chronic therapy, carbamazepine should be withdrawed gradually over 2 to 6 months to minimize the potential of increased seizure frequency (in patients with epilepsy) and other withdrawal symptoms (eg, dysphoria, hallucinations, headache, insomnia, tremor) unless safety concerns require more rapid withdrawal. -Withdrawal of therapy is typically evaluated if patient has been seizure free for 2 years. Abrupt discontinuation is not recommended. Gradual tapers have ranged from 6 weeks to 9 months. The slow discontinuation should be tailored to the patient's preference and needs. -In case of Hepatic Impairment: Use with caution and consider dose reduction; because, carbamazepine is metabolized primarily in the liver. -To convert from immediate-release solid dosage form to suspension: Use the same daily dose and divide into 3 daily doses. -To convert from immediate-release tablets to extended-release formulations: Use the same daily dose and divide into 2 daily doses. -Carbamazepine use has been associated with low serum concentrations of folate, vitamin B2 (riboflavin), B6 (pyridoxine) and B12 (cyanocobalamin) -Carbamazepine may decrease plasma concentrations of hormonal contraceptives; alternate or back-up methods of contraception should be considered. -Incase of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.

Storage

Store at room temperature.

Drug Interactions

-Acetaminophen: carbamazepine may increase the metabolism of Acetaminophen. -Albendazole: carbamazepine may decrease serum concentrations of the active metabolite(s) of Albendazole. -Alfacalcidol: carbamazepine may decrease the serum concentration of Alfacalcidol. -Allopurinol: May increase the serum concentration of carbamazepine. -Amiodarone: carbamazepine may decrease serum concentrations of the active metabolite(s) of Amiodarone. -Amlodipine: carbamazepine may decrease the serum concentration of Amlodipine. -Atorvastatin: carbamazepine may decrease the serum concentration of Atorvastatin. -Bisoprolol: carbamazepine may decrease the serum concentration of Bisoprolol. -Cannabis: May increase the serum concentration of carbamazepine. -Citalopram: carbamazepine may decrease the serum concentration of Citalopram. -Clarithromycin: carbamazepine may increase serum concentrations of the active metabolite(s) of Clarithromycin. -Dexamethasone (Systemic): carbamazepine may decrease the serum concentration of Dexamethasone. -Eplerenone: carbamazepine may decrease the serum concentration of Eplerenone. -Escitalopram: carbamazepine may decrease the serum concentration of Escitalopram. -Estrogen Derivatives: carbamazepine may decrease the serum concentration of Estrogen Derivatives. -Grapefruit Juice: May increase the serum concentration of carbamazepine. -Itraconazole: carbamazepine may decrease serum concentrations of the active metabolite(s) of Itraconazole. -Ivabradine: carbamazepine may decrease the serum concentration of Ivabradine. -Lamotrigine: carbamazepine may enhance the adverse/toxic effect of Lamotrigine. -Levetiracetam: May enhance the adverse/toxic effect of carbamazepine. -Levonorgestrel (intra uterine device): carbamazepine may diminish the therapeutic effect of Levonorgestrel (IUD). -Mebendazole: carbamazepine may decrease the serum concentration of Mebendazole.

Pregnancy & Lactation

-Carbamazepine and its active metabolite cross the placenta, Carbamazepine may be associated with teratogenic effects, including spina bifida, craniofacial defects, and cardiovascular malformations, Carbamazepine is not recommended for the treatment of bipolar disorder in pregnancy. -Carbamazepine and its active epoxide metabolite are present in breast milk. Carbamazepine can also be detected in the serum of breastfed infants, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of exposure to the infant and the benefits of treatment to the mother.

Manufacture

T3A PHARMA

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