Carmapine Suspension

Carmapine Suspension is used for: Epilepsy, Schizophrenia, Bipolar disorder, Trigeminal neuralgia

Oral Epilepsy Indicated for the treatment of partial seizures with complex symptomatology (eg, psychomotor, temporal lobe), generalized tonic-clonic seizures (grand mal), and mixed seizure patterns, which include the seizure types listed here or other partial or generalized seizures Maintenance dose range: 800-1200 mg/day PO in divided doses Therapeutic range: 4-12 mg/L (16.9-50.8 micromoles/L) Maximum dose of 1600 mg/day recommended Tablet (immediate-release) Initial: 200 mg PO twice daily Increase weekly by 200 mg/day divided PO 6-8 hourly Tablet/capsule (extended-release) Initial: 200 mg PO twice daily Increase weekly by 200 mg/day PO divided by 12 hourly Oral suspension Initial: 10 mL (200 mg) PO by 6 hourly Increase weekly by up to 200 mg/day PO divided 6-8 hourly Trigeminal neuralgia Adult: Initial: On the first day, start with one 200 mg capsule. This daily dose may be increased by up to 200 mg/day every 12 hours only as needed to achieve freedom from pain. Do not exceed 1200 mg daily. Maintenance: Control of pain can be maintained in most patients with 400-800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. Prophylaxis of bipolar disorder Indicated for treatment of patients with acute manic or mixed episodes associated with bipolar I disorder Adult: Initially, 400 mg daily in divided doses, increased gradually as necessary. Maintenance: 400-600 mg daily in divided doses. Max: 1.6 g daily. Postherpetic Neuralgia 100-200 mg PO once daily; may increase slowly to 1200 mg/day

Epilepsy <6 Years Initial (oral suspension): 10-20 mg/kg/day PO q6hr Initial (tablet): 10-20 mg/kg/day PO q8-12hr Maintenance: For tablets or suspension may divide frequency into 3-4 times daily not to exceed 35 mg/kg/day 6-12 Years Initial (oral suspension): 50 mg PO q6hr Initial (tablet, immediate- or extended-release): 100 mg PO q12hr; may increase qWeek by 100 mg/day Maintenance: 400-800 mg/day PO q6-8hr (immediate-release); q12hr (extended-release) Not to exceed 1000 mg/day >12 Years Initial (oral suspension): 10 mL (200 mg) PO q6hr Initial (tablet, immediate- or extended-release): 200 mg PO q12hr May increase by up to 200 mg/day qWeek; q12hr (extended-release tablet); q6-8hr (other formulations) 12-15 years: Dose not to exceed 1000 mg/day >15 years: Dose not to exceed 1200 mg/day

Renal impairment Glomerular filtration rate <10 mL/min: Administer 75% of dose and monitor Peritoneal dialysis and hemodialysis: Administer 75% of dose and monitor

Should be taken with food. Avoid grapefruit juice.

Documented hypersensitivity History of bone marrow suppression Administration of MAO inhibitors within the last 14 days Coadministration with nefazodone; carbamazepine decreases plasma levels of nefazodone and its active metabolite Coadministration with NNRTIs (eg, delavirdine, efavirenz, etravirine, nevirapine, rilpivirine); carbamazepine induces CYP3A4 and may substantially reduce NNRTI serum concentration Jaundice, hepatitis Pregnancy (especially first trimester: risk of fetal carbamazepine syndrome)

Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported during treatment with carbamazepine; studies in patients of Chinese ancestry found a strong association between the risk of developing SJS/TEN and the presence of HLA-B*1502, an inherited allelic variant of the HLA-B gene; HLA-B*1502 is found almost exclusively in patients of Asian ancestry, with populations across broad areas of Asia producing such descendants; patients testing positive for the allele should not be treated with carbamazepine unless the benefit clearly outweighs the risk; patients with ancestry in genetically at-risk populations should be screened for the presence of HLA-B*1502 prior to initiation of treatment with carbamazepine Aplastic anemia and agranulocytosis were reported; patients with a previous history of adverse hematologic reaction to any drug may be at increased risk Complete pretreatment hematological testing should be obtained as a baseline; if a patient in the course of treatment exhibits low or decreased white blood cell or platelet counts, the patient should be monitored closely; consider discontinuation of therapy if significant bone marrow depression develops MONITORING PARAMETERS Plasma concentration for optimum response 4–12 mg/litre (20–50 micromol/litre) measured after 1–2 weeks.

Pregnancy Females of reproductive potential should be counseled on the consistent use of effective nonhormonal contraception or barrier methods during treatment Therapy can cause fetal harm when administered to a pregnant woman; an association between the use of drugs during pregnancy and congenital malformations, including spina bifida and malformations involving other body systems (e.g., craniofacial defects and cardiovascular malformations) shown; developmental delays reported Women of childbearing potential should be informed of potential risks to the fetus Consideration should be given to discontinuing therapy in women who are pregnant or attempting to become pregnant if the benefits of discontinuation outweigh the risks of recurrent seizures; women with epilepsy should not discontinue therapy abruptly due to the risk of status epilepticus and less severe seizures which may be life-threatening There have been a few cases of neonatal seizures and/or respiratory depression associated with maternal carbamazepine in combination with other antiepileptic drugs; a few cases of neonatal vomiting, diarrhea, and/or decreased feeding have also been reported in association with maternal carbamazepine use; these symptoms may represent a neonatal withdrawal syndrome Tests to detect birth defects using currently accepted procedures should be considered a part of routine prenatal care in childbearing women receiving carbamazepine; evidence suggests that folic acid supplementation prior to conception and during first trimester of pregnancy decreases risk for congenital neural tube defects in general population; not known whether risk of neural tube defects in offspring of women receiving therapy is reduced by folic acid supplementation, but dietary folic acid supplementation both prior to conception and during pregnancy should be recommended for patients in therapy Animal data In animal studies, therapy during pregnancy resulted in developmental toxicity, including increased incidences of fetal malformations Lactation Drug and its epoxide metabolite are excreted in human milk; there are no data to assess the effects of the drug or its metabolites on milk production, or on the breastfed infant, of mothers taking the drug; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for drug and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Increased plasma levels w/ CYP3A4 inhibitors (e.g. cimetidine). Decreased plasma levels w/ CYP3A4 inducers (e.g. cisplatin). Increased risk of neurotoxic side effects w/ lithium. May decrease the effect of hormonal contraceptives. Increased plasma levels of active metabolite carbamazepine-10, 11-epoxide w/ loxapine, quetiapine, primidone, progabide, valproic acid and valpromide. May increase cyclophosphamide levels. May reduce exposure of aripiprazole. May reduce plasma levels of tacrolimus, temsirolimus and lapatinib. May increase risk of isoniazid-induced hepatotoxicity. Risk of symptomatic hyponatraemia w/ diuretics (e.g. hydrochlorothiazide, furosemide). Potentially Fatal: May decrease serum concentrations of nefazodone and its active metabolites. Toxic reactions may develop when taken concurrently w/ MAOIs. Contraindicated (45) apixaban artemether/lumefantrine atazanavir cabotegravir cariprazine cobimetinib darunavir dienogest/estradiol valerate doravirine efavirenz elbasvir/grazoprevir elvitegravir/cobicistat/emtricitabine/tenofovir DF etravirine fostemsavir irinotecan irinotecan liposomal isavuconazonium sulfate isocarboxazid ledipasvir/sofosbuvir lenacapavir linezolid lonafarnib lorlatinib lumacaftor/ivacaftor lumefantrine lurasidone mavacamten naloxegol nefazodone nevirapine nirmatrelvir/ritonavir ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC) panobinostat phenelzine pirfenidone praziquantel procarbazine regorafenib rilpivirine roflumilast selegiline selegiline transdermal tranylcypromine vandetanib voriconazole

Side effects of Carbamazepine : >10% Ataxia (15%),Dizziness (44%),Drowsiness (32%),Nausea (29%),Vomiting (18%) 1-10% Dry mouth (8%) Rare MI,Stevens-Johnson syndrome Hepatic failure,Punctate cortical lens opacities,Syndrome of inappropriate antidiuretic hormone secretion (SIADH) Frequency Not Defined Hemopoietic system: Aplastic anemia, agranulocytosis, pancytopenia, bone marrow depression, thrombocytopenia, leukopenia, leukocytosis, eosinophilia, anemia, acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda Skin: Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) (see Black Box Warnings), pruritic and erythematous rashes, urticaria, photosensitivity reactions, alterations in skin pigmentation, exfoliative dermatitis, erythema multiforme and nodosum, purpura, aggravation of disseminated lupus erythematosus, alopecia, diaphoresis, and onychomadesis Cardiovascular system: Congestive heart failure, edema, aggravation of hypertension, hypotension, syncope and collapse, aggravation of coronary artery disease, arrhythmias and AV block, thrombophlebitis, thromboembolism, and adenopathy or lymphadenopathy Liver: Abnormalities in liver function tests, cholestatic and hepatocellular jaundice, hepatitis; very rare cases of hepatic failure Pancreatic: Pancreatitis Respiratory System: Pulmonary hypersensitivity characterized by fever, dyspnea, pneumonitis, or pneumonia Genitourinary System: Urinary frequency, acute urinary retention, oliguria with elevated blood pressure, azotemia, renal failure, and impotence (rare reports of impaired male fertility and/or abnormal spermatogenesis) Laboratory: Albuminuria, glycosuria, elevated BUN, decreased plasma calcium, and microscopic deposits in the urine Nervous system: Dizziness, drowsiness, disturbances of coordination, confusion, headache, fatigue, blurred vision, visual hallucinations, transient diplopia, oculomotor disturbances, nystagmus, speech disturbances, abnormal involuntary movements, peripheral neuritis and paresthesias, depression with agitation, talkativeness, tinnitus, hyperacusis, neuroleptic malignant syndrome; isolated cases of neuroleptic malignant syndrome Digestive system: Nausea, vomiting, gastric distress and abdominal pain, diarrhea, constipation, anorexia, and dryness of the mouth and pharynx, including glossitis, and stomatitis Eyes: Scattered punctate cortical lens opacities, increased intraocular pressure as well as conjunctivitis Musculoskeletal system: Aching joints and muscles, and leg cramps Metabolism: Fever and chills; SIADH; cases of frank water intoxication, with decreased serum sodium (hyponatremia) and confusion; decreased levels of plasma calcium leading to osteoporosis Potentially Fatal: Agranulocytosis, aplastic anaemia, hepatic failure, severe exfoliative dermatitis and Stevens-Johnson syndrome.

Carbamazepine reduces polysynaptic responses and blocks post-tetanic potentiation. It is effective in partial and generalised convulsions as well as in mixed types but not in petit mal seizures. It reduces or abolishes pain in trigeminal and glossopharyngeal neuralgia.

Carmapine 100mg/5 ml Suspension manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Carbamazepine. Carmapine is availble in Bangladesh. Farmaco BD drug index information on Carmapine Suspension is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.