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INNOPRAN-XL (PROPRANOLOL HYDROCHLORIDE): PRESCRIBING INFORMATION (see "References")

DESCRIPTION

InnoPran-XL (Propranolol Hydrochloride) is a nonselective beta blocker. InnoPran-XL is available as 80 mg and 120 mg capsules which contain sustained-release beads. Each of the beads contains Propranolol Hydrochloride and is coated with dual membranes. These membranes are designed to retard release of propranolol hydrochloride for several hours after ingestion followed by the sustained release of propranolol.

The active ingredient in InnoPran-XL is a synthetic beta-adrenergic receptor-blocking agent chemically described as 1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanol hydrochloride.

Propranolol HCl is a stable, white, crystalline solid, which is readily soluble in water and ethanol. Its molecular weight is 295.81. Each capsule for oral administration contains ethylcellulose, sugar spheres, povidone, diethyl phthalate, hypromellose phthalate, hypromellose, gelatin, polyethylene glycol, titanium dioxide, and black iron oxide. In addition, InnoPran-XL 120-mg capsules contain yellow iron oxide.


INDICATIONS AND USAGE

Hypertension

InnoPran-XL (Propranolol HCl) is indicated in the management of hypertension; it may be used alone or in combination with other antihypertensive agents.


CONTRAINDICATIONS

InnoPran-XL (Propranolol HCl) capsules is contraindicated in:

  • cardiogenic shock
  • sinus bradycardia, sick sinus syndrome, and greater than first-degree block unless a permanent pacemaker is in place
  • bronchial asthma
  • in patients with known hypersensitivity to InnoPran-XL (Propranolol Hydrochloride).


    DOSAGE AND ADMINISTRATION

    Propranolol HCl (InnoPran-XL) should be administered once daily at bedtime (approximately 10 p.m.) and should be taken consistently either on an empty stomach or with food. The starting dose is 80 mg but dosage should be individualized and titration may be needed to a dose of 120 mg. In the clinical trial, doses of Propranolol HCl (InnoPran-XL) capsules above 120 mg had no additional effects on blood pressure. The time needed for full antihypertensive response is variable, but is usually achieved within 2 to 3 weeks.


    CLINICAL PHARMACOLOGY

    InnoPran-XL clinical pharmacology


    PHARMACOKINETICS

    InnoPran-XL pharmacokinetics


    SPECIAL POPULATIONS

    InnoPran-XL special populations


    DRUG INTERACTIONS

    InnoPran-XL drug interactions


    WARNINGS

    InnoPran-XL warnings


    PRECAUTIONS

    InnoPran-XL precautions


    DRUG-DRUG INTERACTIONS

    InnoPran-XL drug-drug interactions


    ADVERSE REACTIONS

    InnoPran-XL adverse reactions


    OVERDOSAGE

    InnoPran-XL overdosage


    HOW SUPPLIED

    InnoPran-XL (Propranolol Hydrochloride) Extended Release Capsules

    Each gray/white capsule, imprinted with "80", 2 segmented bands, "InnoPran-XL", and the Reliant logo, contains 80 mg of Propranolol Hydrochloride in bottles.

    Each gray/off-white capsule, imprinted with "120", 3 segmented bands, "InnoPran-XL", and the Reliant logo, contains 120 mg of Propranolol Hydrochloride in bottles.

    Store at 25°C (77°F); excursions permitted to 15 and 30°C (59 and 86°F) [see USP Controlled Room Temperature] in a tightly closed container.

    Manufactured and distributed by AstraZeneca, GlaxoSmithKline, Akrimax Pharmaceuticals companies and their divisions.



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