EQUETRO 100 mg/1
Carbamazepine · CAPSULE, EXTENDED RELEASE · Validus Pharmaceuticals LLC
EQUETRO is a capsule, extended release containing carbamazepine at 100 mg/1, taken oral. Manufactured by Validus Pharmaceuticals LLC.
Key Facts
- Brand Name
- EQUETRO
- Generic Name
- Carbamazepine
- NDC Code (Product)
30698-419- Manufacturer
- Validus Pharmaceuticals LLC
- Strength
- 100 mg/1
- Dosage Form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA021710
- Drug Class
- Mood Stabilizer [EPC]
- Marketing Start
- 12/10/2004
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1INDICATIONS AND USAGE EQUETRO is: A mood stabilizer indicated for the treatment of acute manic or mixed episodes associated with bipolar I disorder ( 1.1 ) Indicated for the treatment of the pain associated with trigeminal neuralgia ( 1.2 ) An anti-epileptic drug (AED) indicated for the treatment of partial seizures with complex symptomatology, generalized tonic-clonic seizures, and mixed seizures ( 1.3 ) 1.1Acute Manic or Mixed Episodes associated with Bipolar I Disorder EQUETRO is indicated for treatment of patients with acute manic or mixed episodes associated with bipolar I disorder [see Clinical Studies ( 14.1 ) ] . 1.2 Pain of Trigeminal Neuralgia EQUETRO is indicated in the treatment of the pain associated with 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. 1.3 Epilepsy EQUETRO is indicated for the treatment of partial seizures with complex symptomatology (e.g., psychomotor, temporal lobe), generalized tonic-clonic seizures (grand mal), and mixed seizure patterns, which include the seizure types listed here or other partial or…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION SEE DOSAGE FOR BIPOLAR DISORDER, TRIGEMINAL NEURALGIA, AND EPILEPSY ( 2.2 , 2.3 , 2.4 ) When discontinuing treatment, reduce dose gradually ( 2.6 , 5.6 ) Monitoring serum carbamazepine concentrations may be useful in dose selection and minimizing risk of toxicity ( 2.7 ) Swallow capsules whole or open capsules and sprinkle beads over food ( 2.8 ) Do not crush or chew the capsule or beads ( 2.8 ) 2.1 Pretreatment Screening Prior to initiating treatment with EQUETRO, test patients with ancestry in genetically at-risk populations for the presence of the HLA-B*1502 allele. The high resolution genotype test is positive if one or two HLA-B*1502 alleles are present. Avoid use of EQUETRO in patients testing positive for the allele, unless the benefit clearly outweighs the risk [see Boxed Warning , Warnings and Precautions ( 5.1 )] . Complete pretreatment blood counts, including platelets and possibly reticulocytes and serum iron, 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. Discontinuation of EQUETRO should be considered if any evi…
Contraindications
4 CONTRAINDICATIONS Bone marrow depression [see Warnings and Precautions ( 5.2 ) ] . Known hypersensitivity to carbamazepine, such as anaphylaxis or serious hypersensitivity reaction [see Warnings and Precautions ( 5.3 ) ] . Known hypersensitivity to any of the tricyclic compounds (e.g., amitriptyline, desipramine, imipramine, protriptyline, and nortriptyline.) Hypersensitivity reactions include anaphylaxis and serious rash. Concomitant use of delavirdine or other non-nucleoside reverse transcriptase inhibitors that are substrates for CYP3A4. EQUETRO can substantially reduce the concentrations of these drugs through induction of CYP3A4. This can lead to loss of virologic response and possible resistance to these medications [see Warnings and Precautions ( 5.9 ) and Drug Interactions ( 7.2 ) ] . Concomitant use of monoamine oxidase inhibitors (MAOIs). Before beginning treatment with EQUETRO, MAOIs should be discontinued for a minimum of 14 days. Concomitant use can cause serotonin syndrome. Concomitant use of nefazodone. This may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Bone marrow depression ( 4 ) Known hy…
Drug Interactions
7 DRUG INTERACTIONS Cytochrome (CYP) 3A4 inhibitors, epoxide hydrolase inhibitors, CYP3A4 inducers, drugs metabolized by CYP1A2 or CYP3A4 (oral contraceptives, delavirdine, nefazodone), phenytoin, CNS depressants, lithium, chloroquine, mefloquine ( 7.1 , 7.2 , 7.3 ) Equetro may decrease the effectiveness of hormonal contraceptives. Use alternative form of birth control ( 7.2 ) 7.1 Pharmacokinetic Effect s of other Drugs on EQ U ETRO Drugs that Inhibit Cytochrome P450 3A4 (CYP3A4) EQUETRO is metabolized primarily by CYP3A4 to the active carbamazepine-10,11-epoxide, which is further metabolized to the trans-diol by epoxide hydrolase. Inhibitors of CYP 3A4 and/or epoxide hydrolase can increase plasma levels of EQUETRO and its active metabolites, increasing plasma concentrations of EQUETRO and the risk of adverse reactions. It may be necessary to reduce the EQUETRO dose if used concomitantly with inhibitors of CYP3A4 and/or epoxide hydrolase. The following drugs are CYP3A4 inhibitors: Acetazolamide, aprepitant, azole antifungals (e.g., ketoconazole, itraconazole, fluconazole, voriconazole ) , cimetidine, ciprofloxacin, clarithromycin, dalfopristin, danazol, dantrolene, delavirdine, dil…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail in other sections of the labeling: Serious Dermatologic Reactions: Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome [see Warnings and Precautions ( 5.1 ) Aplastic anemia/agranulocytosis [see Warnings and Precautions ( 5.2 )] Drug Reaction with Eosinophilia and Systemic Symptoms/Multiorgan Hypersensitivity [see Warnings and Precautions ( 5.3 )] Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.4 )] Embryofetal Toxicity [see Warnings and Precautions ( 5.5 )] Abrupt Discontinuation and Seizure Risk [see Warnings and Precautions ( 5.6 )] Hyponatremia [see Warnings and Precautions ( 5.7 )] Cognitive and Motor Impairment [see Warnings and Precautions ( 5.8 )] Drug Interaction with Non-Nucleoside Reverse Transcriptase Inhibitors [see Warnings and Precautions ( 5.9 )] Liver Damage [see Warnings and Precautions ( 5.10 )] AV Heart Block [see Warnings and Precautions ( 5.11 )] Hepatic Porphyria [see Warnings and Precautions ( 5.12 )] Increased Intraocular Pressure [see Warnings and Precautions ( 5.13 )] Most common ( > 5% and 2 times placebo) adverse reactions were dizziness, somnole…
Frequently Asked Questions
What is EQUETRO used for?
EQUETRO contains Carbamazepine. It is a capsule, extended release taken oral. Consult your doctor for specific uses.
Is EQUETRO a controlled substance?
EQUETRO is not classified as a controlled substance by the DEA.
What is the generic name for EQUETRO?
The generic name for EQUETRO is Carbamazepine. There are 12 other brand versions of Carbamazepine.
What is the NDC code for EQUETRO 100 mg/1?
The NDC (National Drug Code) for EQUETRO 100 mg/1 is 30698-419, listed by Validus Pharmaceuticals LLC.