Carbamazepin 200 mg/1
Carbamazepine · TABLET, EXTENDED RELEASE · Upsher-Smith Laboratories, LLC
Carbamazepine is a mood stabilizer tablet taken by mouth that is used to treat seizures, nerve pain, and bipolar disorder. The extended-release formulation allows for once or twice daily dosing.
Key Facts
- Brand Name
- Carbamazepin
- Generic Name
- Carbamazepine
- NDC Code (Product)
0832-6023- Manufacturer
- Upsher-Smith Laboratories, LLC
- Strength
- 200 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA213311
- Drug Class
- Mood Stabilizer [EPC]
- Marketing Start
- 04/13/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Epilepsy Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. Generalized tonic-clonic seizures (grand mal). Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine [see PRECAUTIONS, General ] . Trigeminal Neuralgia Carbamazepine is indicated in the treatment of the pain associated with true trigeminal neuralgia. Beneficial results have also been reported in glossopharyngeal neuralgia. This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.
Dosage & Administration
DOSAGE AND ADMINISTRATION (SEE TABLE BELOW) Monitoring of blood levels has increased the efficacy and safety of anticonvulsants [see PRECAUTIONS, Laboratory Tests ] . Dosage should be adjusted to the needs of the individual patient. A low initial daily dosage with a gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level. Medication should be taken with meals. Conversion of patients from oral carbamazepine tablets to carbamazepine suspension: Patients should be converted by administering the same number of mg per day in smaller, more frequent doses (i.e., twice a day tablets to three times a day suspension). Carbamazepine extended-release tablets are an extended-release formulation for twice a day administration. When converting patients from carbamazepine conventional tablets to carbamazepine extended-release tablets, the same total daily mg dose of carbamazepine extended-release tablets should be administered. Carbamazepine extended-release tablets must be swallowed whole and never crushed or chewed. Carbamazepine extended-release tablets should be inspected for chips or cracks. Damaged tablets,…
Warnings
WARNINGS Serious Dermatologic Reactions Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported with carbamazepine treatment. The risk of these events is estimated to be about 1 to 6 per 10,000 new users in countries with mainly Caucasian populations. However, the risk in some Asian countries is estimated to be about 10 times higher. Carbamazepine should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered. SJS/TEN and HLA-B*1502 Allele Retrospective case-control studies have found that in patients of Chinese ancestry there is a strong association between the risk of developing SJS/TEN with carbamazepine treatment and the presence of an inherited variant of the HLA-B gene, HLA-B*1502. The occurrence of higher rates of these reactions in countries with higher frequencies of this allele suggests that the risk may be increased in allele-positive individuals of any ethnicity. Across Asian populations, notable variation exists in the prev…
Contraindications
CONTRAINDICATIONS Carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc. Likewise, on theoretical grounds its use with monoamine oxidase (MAO) inhibitors is not recommended. Before administration of carbamazepine, MAO inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits. Coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Coadministration of carbamazepine with nefazodone is contraindicated.
Adverse Reactions
ADVERSE REACTIONS If adverse reactions are of such severity that the drug must be discontinued, the physician must be aware that abrupt discontinuation of any anticonvulsant drug in a responsive epileptic patient may lead to seizures or even status epilepticus with its life-threatening hazards. The most severe adverse reactions have been observed in the hemopoietic system and skin [see BOXED WARNING ] , the liver, and the cardiovascular system. The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the lowest dosage recommended. The following additional adverse reactions have been reported: Hemopoietic System: Aplastic anemia, agranulocytosis, pancytopenia, bone marrow depression, thrombocytopenia, leukopenia, leukocytosis, eosinophilia, acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda. Skin: Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) [see BOXED WARNING ] , Acute Generalized Exanthematous Pustulosis (AGEP), pruritic and erythematous rashes, urticaria…
Frequently Asked Questions
What is Carbamazepin used for?
Carbamazepine is a mood stabilizer tablet taken by mouth that is used to treat seizures, nerve pain, and bipolar disorder. The extended-release formulation allows for once or twice daily dosing.
Is Carbamazepin a controlled substance?
Carbamazepin is not classified as a controlled substance by the DEA.
What is the generic name for Carbamazepin?
The generic name for Carbamazepin is Carbamazepine. There are 12 other brand versions of Carbamazepine.
What is the NDC code for Carbamazepin 200 mg/1?
The NDC (National Drug Code) for Carbamazepin 200 mg/1 is 0832-6023, listed by Upsher-Smith Laboratories, LLC.