InnoPran XL

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 8/27/2021
InnoPran XL Side Effects Center

What Is InnoPran XL?

Innopran XL (propranolol hydrochloride) is a beta-blocker used to treat tremors, angina (chest pain), hypertension (high blood pressure), heart rhythm disorders, and other heart or circulatory conditions. Innopran XL is also used to treat or prevent heart attack, and to reduce the severity and frequency of migraine headaches.

What Are Side Effects of InnoPran XL?

Common side effects of Innopran XL include:

  • dizziness,
  • lightheadedness, or
  • tiredness as the body adjusts to the medication

Other side effects of Innopran XL include:

Dosage for InnoPran XL

The starting dose of Innopran XL is 80 mg but adjustment may be needed to a dose of 120 mg. Take once daily at bedtime, consistently either on an empty stomach or with food.

What Drugs, Substances, or Supplements Interact with InnoPran XL?

Innopran XL may interact with clonidine, digitalis, dobutamine, haloperidol, isoproterenol, blood thinners, antidepressants, MAO inhibitors, aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs), doxazosin, prazosin, terazosin, heart medications, amiodarone, propafenone, quinidine, or ACE inhibitors. Tell your doctor all medications and supplements you use.

InnoPran XL During Pregnancy or Breastfeeding

During pregnancy, Innopran XL should be used only when prescribed. Infants exposed to this medication during pregnancy may have low birth weight, low blood sugar, or slow breathing/heartbeat. Discuss the risks and benefits with your doctor. This drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Innopran XL (propranolol hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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InnoPran XL Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • slow or uneven heartbeats;
  • a light-headed feeling, like you might pass out;
  • wheezing or trouble breathing;
  • shortness of breath (even with mild exertion), swelling, rapid weight gain;
  • sudden weakness, vision problems, or loss of coordination (especially in a child with hemangioma that affects the face or head);
  • cold feeling in your hands and feet;
  • depression, confusion, hallucinations;
  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery;
  • low blood sugar in a baby--pale skin, blue or purple skin, sweating, fussiness, crying, not wanting to eat, feeling cold, drowsiness, weak or shallow breathing (breathing may stop for short periods), seizure (convulsions), or loss of consciousness; or
  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • nausea, vomiting, diarrhea, constipation, stomach cramps;
  • decreased sex drive, impotence, or difficulty having an orgasm;
  • sleep problems (insomnia); or
  • tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for InnoPran XL (Propranolol Hydrochloride)

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InnoPran XL Professional Information

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 Placebo
(N=88)
INNOPRAN XL
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 followingreactions 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.

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 propranololresulting 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 entire FDA prescribing information for InnoPran XL (Propranolol Hydrochloride)

© InnoPran XL Patient Information is supplied by Cerner Multum, Inc. and InnoPran XL Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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