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Equetro (Carbamazepine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Acute 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.

The efficacy of EQUETRO in acute mania was established in 2 randomized, double-blind, placebo-controlled, 3-week studies in adult patients meeting DSM-IV criteria for bipolar I disorder who had an acute manic or mixed episode [see Clinical Studies]. The effectiveness of EQUETRO for longer-term use and for prophylactic use in mania has not been systematically evaluated in controlled clinical trials. Therefore, physicians who elect to use EQUETRO for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.

DOSAGE AND ADMINISTRATION

Dosing Information

The recommended initial dose of EQUETRO is 200 mg administered twice daily. The dose may be increased by 200 mg per day to achieve optimal clinical response. Doses higher than 1600 mg per day have not been studied in mania associated with bipolar disorder.

When discontinuing treatment, reduce the dose gradually and avoid abrupt discontinuation in order to decrease the risk of seizure [see Warnings and Precautions ].

Monitoring Serum Carbamazepine Concentration

Monitoring serum carbamazepine concentrations may be useful for dose selection, minimizing toxicity, and verifying drug compliance, especially in clinical conditions in which alterations in EQUETRO metabolism can occur (e.g., drug interactions) [see Drug Interactions (7)].

Laboratory Testing Prior to Dosing

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 ].

Prior to initiating EQUETRO in all patients, obtain a pre-treatment complete blood count including platelets and differential. Monitor CBC periodically [see Warnings and Precautions].

Administration Instructions

The EQUETRO capsules may be taken orally or may be opened and the beads sprinkled over food, such as a teaspoon of applesauce. Do not crush or chew EQUETRO capsules. EQUETRO can be taken with or without meals.

DOSAGE FORMS AND STRENGTHS

EQUETRO (carbamazepine) extended-release capsules for oral administration is supplied in three dosage strengths:

  • 100 mg - Two-piece hard gelatin capsule yellow opaque cap with bluish green opaque body printed with SPD417 on one end and SPD417 and 100 mg on the other in white ink
  • 200 mg - Two-piece hard gelatin capsule yellow opaque cap with blue opaque body printed with SPD417 on one end and SPD417 and 200 mg on the other in white ink.
  • 300 mg - Two-piece hard gelatin capsule yellow opaque cap with blue body printed with SPD417 on one end and SPD417 and 300 mg on the other in white ink.

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

EQUETRO (carbamazepine) extended-release capsules are supplied in three dosage strengths.

  • 100 mg - Two-piece hard gelatin capsule yellow opaque cap with bluish green opaque body printed with SPD417 on one end and SPD417 and 100 mg on the other in white ink: Supplied in bottles of 120   NDC 30698-419-12
  • 200 mg - Two-piece hard gelatin capsule yellow opaque cap with blue opaque body printed with SPD417 on one end and SPD417 and 200 mg on the other in white ink: Supplied in bottles of 120   NDC 30698-421-12
  • 300 mg - Two-piece hard gelatin capsule yellow opaque cap with blue body printed with SPD417 on one end and SPD417 and 300 mg on the other in white ink: Supplied in bottles of 120   NDC 30698-423-12

Storage

Store at 25° C (77° F); excursions permitted to 15-30° C (59-86° F) [see USP controlled room temperature].

Protect from light and moisture

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