r stop INNOPRAN XL.
5.7 Reduced Effectiveness of Epinephrine in Treating Anaphylaxis
Beta adrenergic blocker- treated patients treated with epinephrine for a severe anaphylactic reaction may be less responsive to the typical doses of epinephrine. In these patients, consider other medications (e.g., intravenous fluids, glucagon).
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions occurring at a rate of ≥3%, excluding those reported more commonly in placebo, encountered in the INNOPRAN XL placebo-controlled hypertension trials and plausibly related to treatment are shown in Table 1.
Table 1. Treatment-Emergent Adverse Reactions Reported In ≥3% of Subjects
INNOPRAN XL
Placebo 80 mg 120 mg
Body System (N=88) (N=89) (N=85)
Fatigue 3 (3%) 4 (5%) 6 (7%)
Dizziness (except vertigo) 2 (2%) 6 (7%) 3 (4%)
Constipation 0 3 (3%) 1 (1%)
6.2 Postmarketing Experience
In addition to adverse reactions reported from clinical trials, the following reactions have been identified during post-marketing use of INNOPRAN XL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions were observed and have been reported with use of formulations of sustained- or immediate-release propranolol.
Allergic: Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions; pharyngitis and agranulocytosis; erythematous rash, fever combined with aching and sore throat, laryngospasm, and respiratory distress.
Autoimmune: Systemic lupus erythematosus (SLE).
Cardiovascular: exacerbation of peripheral arterial disease, arterial insufficiency, usually of the Raynaud type.
Central Nervous System: Light-headedness, mental depression, insomnia, lassitude, weakness, fatigue, visual disturbances, hallucinations, vivid dreams, short-term memory loss, emotional lability, slightly clouded sensorium, paresthesia of hands.
Gastrointestinal: Nausea, vomiting, epigastric distress, abdominal cramping, diarrhea, mesenteric arterial thrombosis, ischemic colitis.
Genitourinary: Male impotence; Peyronie’s disease.
Hematologic: Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura.
Musculoskeletal: Myopathy, myotonia.
Skin and mucous membranes: Stevens-Johnson syndrome, toxic epidermal necrolysis, dry eyes, exfoliative dermatitis, erythema multiforme, urticaria, alopecia, SLE-like reactions, and psoriasisiform rashes.
7 DRUG INTERACTIONS
7.1 Pharmacokinetic Drug-Drug Interactions
Impact of Propranolol on Other Drugs
Warfarin: Warfarin concentrations are increased when administered with propranolol. Monitor prothrombin time accordingly [see Clinical Pharmacolog |
