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InnoPran XL

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InnoPran XL

Side Effects
Interactions

SIDE EFFECTS

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
Placebo
(N=88)
80 mg
(N=89)
120 mg
(N=85)
Fatigue 3 (3%) 4 (5%) 6 (7%)
Dizziness (except vertigo) 2 (2%) 6 (7%) 3 (4%)
Constipation 0 3 (3%) 1 (1%)

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.

Read the InnoPran XL (propranolol hydrochloride) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

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 PHARMACOLOGY].

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

Alpha Blockers: Co-administration of beta-blockers with alpha blocker (e.g., prazosin) has been associated with prolongation of first dose hypotension and syncope.

Dobutamine: Propranolol may reduce sensitivity to dobutamine stress echocardiography in patients undergoing evaluation for myocardial ischemia.

Antidepressants: The hypotensive effect of MAO inhibitors or tricyclic antidepressants may be exacerbated when administered with beta-blockers. Monitor patients for postural hypotension.

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
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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InnoPran XL - User Reviews

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