Label Changes for:

Carbatrol (carbamazepine) Extended Release Capsules

March 2013

Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

March 2013

PRECAUTIONS

Hyponatremia, Syndrome of Inappropriate Antidiuretic Hormone Secretion, and Water Intoxication
  • Hyponatremia can occur as a result of treatment with Carbatrol. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
  • The risk of developing SIADH with Carbatrol treatment may be dose-related. Elderly patients may be at greater risk of developing hyponatremia. Patients treated with diuretics can be at greater risk.
  • Consider discontinuing Carbatrol in patients with symptomatic hyponatremia. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls.

ADVERSE REACTIONS

Metabolism
  • Decreased levels of plasma calcium leading to osteoporosis have been reported.

 

 

January 2011

 

CONTRAINDICATIONS

  • 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.

PRECAUTIONS

Drug Interactions/Agents with Decreased Levels in the Presence of Carbamazepine due to Induction of Cytochrome P450 Enzymes

  • Added ‚Ķnefazodone‚Ķ
  • 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 (see CONTRAINDICATIONS).


MEDICATION GUIDE

Who should not take CARBATROL? Do not take CARBATROL if you:

  • added ... take nefazodone

 

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