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- Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery.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