INNOPRAN XL- propranolol hydrochloride capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ)

Available from:

ANI Pharmaceuticals, Inc.

INN (International Name):

PROPRANOLOL HYDROCHLORIDE

Composition:

PROPRANOLOL HYDROCHLORIDE 80 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INNOPRAN XL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including beta-blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. INNOPRAN XL is contraindicated in patients with: Risk Summary Prolonged experience with propranolol in pregnant women over several decades, based on published interventional and observational studies, has not identified a drug associated risk of major birth defects, miscarriage, or other adverse maternal outcomes. Bradycardia, hypoglycemia, and respiratory depression have been observed with use of beta-blockers, including propranolol, in utero near the time of delivery. There are inconsistent reports of intrauterine growth restriction with beta-blocker use, including propranolol, during pregnancy. Untreated hypertension during pregnancy can lead to serious adverse outcomes for the mother and the fetus (see Clinical Considerations and Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage) Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Propranolol crosses the placenta. Neonates born to mothers who are receiving propranolol during pregnancy, may be at risk for bradycardia, hypoglycemia, and respiratory depression. Monitor neonates exposed to propranolol during pregnancy and manage accordingly. Data Animal Data In a series of reproductive and developmental toxicology studies, propranolol was given to rats by gavage or in the diet throughout pregnancy and lactation. At doses of 150 mg/kg/day, but not at doses of 80 mg/kg/day (equivalent to the maximum recommended human oral daily dose (MRHD) on a body surface area basis), treatment was associated with embryotoxicity (reduced litter size and increased resorption rates) as well as neonatal toxicity (deaths). Propranolol HCl was also administered (in the feed) to rabbits (throughout pregnancy and lactation) at doses as high as 150 mg/kg/day (about 5 times the MRHD). No evidence of embryo or neonatal toxicity was noted. Risk Summary Propranolol is present in human milk at low levels, but the related risk to a breastfed infant is unknown. There are no data on the effects of propranolol on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for INNOPRAN XL and any potential adverse effects on the breastfed child from INNOPRAN XL or from the underlying maternal condition. Infertility Males Based on the published literature, beta-blockers, including propranolol, may cause erectile dysfunction. In rats, propranolol inhibits spermatogenesis [see Nonclinical Toxicology (13.1)] . Safety and effectiveness of propranolol in pediatric patients have not been established. Clinical studies of INNOPRAN XL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. The exposure to propranolol is increased in patients with renal impairment. Initiate INNOPRAN XL therapy in patients with impaired renal function at the lowest dose (80 mg) once daily and monitor patients for marked bradycardia and hypotension [see Clinical Pharmacology (12.6)] . The exposure to propranolol is increased in patients with hepatic impairment. Initiate INNOPRAN XL therapy in patients with impaired hepatic function at the lowest dose (80 mg) once daily and monitor patients for marked bradycardia and hypotension [see Clinical Pharmacology (12.6)] .

Product summary:

INNOPRAN XL (propranolol hydrochloride) Extended Release Capsules are supplied as capsules and are available as follows: Each gray/white capsule, imprinted with ‘InnoPran XL’, ‘80’, and 2 segmented bands, contains 80 mg of propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol) and are available as follows: Bottles of 30          NDC 62559-590-30 Bottles of 7            NDC 62559-590-77 (professional sample) Bottles of 14          NDC 62559-590-14 (professional sample). Each gray/off-white capsule, imprinted with ‘InnoPran XL’, ‘120’, and 3 segmented bands, contains 120 mg of propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol) and are available as follows: Bottles of 30          NDC 62559-591-30 Bottles of 7            NDC 62559-591-77 (professional sample) Bottles of 14          NDC 62559-591-14 (professional sample). Storage: Store at 25ºC (77ºF); excursions permitted to 15º and 30ºC (59º and 86ºF) [see USP Controlled Room Temperature] in a tightly closed container.

Authorization status:

New Drug Application

Summary of Product characteristics

INNOPRAN XL- PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
ANI PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INNOPRAN XL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR INNOPRAN XL.
INNOPRAN XL (PROPRANOLOL HYDROCHLORIDE) EXTENDED RELEASE CAPSULES, FOR
ORAL USE
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Warnings and Precautions, Hypoglycemia (5.4) 5/2023
INDICATIONS AND USAGE
INNOPRAN XL is a beta-adrenergic blocker indicated for the treatment
of hypertension, to lower blood
pressure. Lowering blood pressure reduces the risk of fatal and
nonfatal cardiovascular events, primarily
strokes and myocardial infarctions. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Capsules: 80 mg, 120 mg. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most commonly reported adverse reactions (≥3% and greater than
placebo) included the following:
fatigue, dizziness, and constipation. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ANI PHARMACEUTICALS,
INC. AT 1-800-308-
6755 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 6/2023
®
Administer once daily at bedtime consistently either on an empty
stomach or with food. (2)
Initiate dosage at 80 mg and titrate up to 120 mg if needed. (2)
Cardiogenic shock and decompensated heart failure. (4)
Sinus bradycardia, sick sinus syndrome, and greater than first-degree
block unless a permanent
pacemaker is in place. (4)
Bronchial asthma. (4)
Hypersensitivity to propranolol or any of the components of INNOPRAN
XL. (4)
Abrupt cessation may exacerbate myocardial ischemia. (5.1)
May worsen congestive heart failure. (5.2)
Avoid discontinuing therapy prior to major surgery. (5.3)
Diabetes: May mask symptoms of hypoglycemia, and alter glucose levels;
monitor. (5.4)
Bradycardia. (5.6)
CYP2D6, 1A