"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
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
|Body System||INNOPRAN XL|
|Fatigue||3 (3%)||4 (5%)||6 (7%)|
|Dizziness (except vertigo)||2 (2%)||6 (7%)||3 (4%)|
|Constipation||0||3 (3%)||1 (1%)|
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
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.
Read the InnoPran XL (propranolol hydrochloride) Side Effects Center for a complete guide to possible side effects
Pharmacokinetic Drug-Drug Interactions
Impact of Propranolol on Other Drugs
Propafenone: Co-administration of propranolol increases the plasma concentrations of propafenone. Monitor patients for symptoms of excessive exposure to propafenone including bradycardia and postural hypotension [see CLINICAL PHARMACOLOGY].
Impact of Other Drugs on Propranolol
CYP2D6-, CYP1A2-and CYP2C19 Inhibitors: CYP2D6 inhibitors (e.g. bupropion, fluoxetine, paroxetine, quinidine), CYP1A2 inhibitors (e.g., ciprofloxacin, enoxamine, fluvoxamine) and CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine) increase exposure to propranolol when co-administered with INNOPRAN XL. Monitor patients for bradycardia and hypotension [see CLINICAL PHARMACOLOGY].
CYP1A2 and CYP2C19 Inducers: CYP1A2 inducers (e.g., phenytoin, montelukast, smoking) and CYP2C19 inducers (e.g. rifampin) decrease the plasma levels of propranolol resulting in a loss of efficacy [see CLINICAL PHARMACOLOGY].
Cholestyramine and Colestipol: Co-administered cholestyramine or colestipol significantly reduces the plasma concentrations of co-administered propranolol which may result in loss of efficacy [see CLINICAL PHARMACOLOGY].
Pharmacodynamic Drug-Drug Interactions
Adrenergic Agonists: Beta-blockers may antagonize the antihypertensive effects of clonidine, and rebound hypertension may result if clonidine is withdrawn abruptly. If clonidine and a beta-blocker are co-administered, withdraw the beta-blocker several days before the withdrawal of clonidine
Nonsteroidal Anti-Inflammatory Drugs: Nonsteroidal anti-inflammatory drugs (NSAIDS) may attenuate the antihypertensive effect of beta-adrenoreceptor blocking agents. Monitor blood pressure.
Read the InnoPran XL Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 12/23/2013
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