Label Changes for:
Innopran XL (propranolol hydrochloride) capsules
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
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.
- Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery.
- 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.
- Plasma propranolol hydrochloride levels may increase with acute alcohol consumption and decrease upon chronic alcohol use.
- small placentas, and congenital abnormalities have been reported
- Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions; pharyngitis and agranulocytosis; erythematous rash, fever combined with aching and sore throat, laryngospasm, and respiratory distress.
- Stevens-Johnson syndrome; toxic epidermal necrolysis; exfoliative dermatitis; Erythemamultiforme; urticaria.
- Myopathy, myotonia.