Label Changes for:

Innopran XL (propranolol hydrochloride) capsules

December 2010

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2010

 

WARNINGS

Hypersensitivity and Skin Reactions:
  • Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, have been associated with the administration of propranolol hydrochloride. Cutaneous reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis,exfoliative dermatitis, erythema multiforme, and urticaria, have been reported with use of propranolol hydrochloride.

Major Surgery

  • Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery.

PRECAUTIONS

Myopathy
  • Caution should be exercised when administering propranolol Hydrochloride to patients with underlying skeletal muscle disease. Isolated cases of exacerbation of myopathy and myotonia have been reported.
Drug Interactions
  • Plasma propranolol hydrochloride levels may increase with acute alcohol consumption and decrease upon chronic alcohol use.
Pregnancy
  • small placentas, and congenital abnormalities have been reported

ADVERSE REACTIONS

Allergic
  • Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions; pharyngitis and agranulocytosis; erythematous rash, fever combined with aching and sore throat, laryngospasm, and respiratory distress.
Skin
  • Stevens-Johnson syndrome; toxic epidermal necrolysis; exfoliative dermatitis; Erythemamultiforme; urticaria.
Musculoskeletal
  • Myopathy, myotonia.
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