Product Description.:
MYLAN 347
tablet , white , scored , round round
Propranolol hydrochloride and hydrochlorothiazide tablets, USP for oral administration combine two antihypertensive agents: propranolol hydrochloride, USP, a beta-adrenergic blocking agent, and hydrochlorothiazide, USP, a thiazide diuretic-antihypertensive. Propranolol hydrochloride and hydrochlorothiazide tablets, 40/25 contain 40 mg propranolol hydrochloride and 25 mg hydrochlorothiazide propranolol hydrochloride and hydrochlorothiazide tablets, 80/25 contain 80 mg propranolol hydrochloride and 25 mg hydrochlorothiazide.
Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.81.
Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water freely soluble in sodium hydroxide solution sparingly soluble in methanol insoluble in ether, chloroform, benzene, and dilute mineral acids. Its chemical name is: 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its structural formula is:
Propranolol hydrochloride and hydrochlorothiazide tablets, 40 mg/25 mg and 80 mg/25 mg are for oral administration and contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized cornstarch and sodium lauryl sulfate.
INDICATIONS AND USAGE
Propranolol hydrochloride and hydrochlorothiazide tablets are indicated in the management of hypertension.
This fixed combination is not indicated for initial therapy of hypertension. Hypertension requires therapy titrated to the individual patient. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management.
CONTRAINDICATIONS
Propranolol hydrochloride
Propranolol is contraindicated in 1) cardiogenic shock 2) sinus bradycardia and greater than first-degree block 3) bronchial asthma 4) congestive heart failure (see WARNINGS) unless the failure is secondary to a tachyarrhythmia treatable with propranolol.
Hydrochlorothiazide
Hydrochlorothiazide is contraindicated in patients with anuria or hypersensitivity to this or other sulfonamide-derived drugs.
WARNINGS
Propranolol hydrochloride
Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, have been associated with the administration of propranolol (see ADVERSE REACTIONS).
Hydrochlorothiazide
Thiazides should be used with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. In patients with impaired renal function, cumulative effects of the drug may develop.
Thiazides should also be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Thiazides may add to or potentiate the action of other antihypertensive drugs. Potentiation occurs with ganglionic or peripheral adrenergic-blocking drugs.
Sensitivity reactions may occur in patients with a history of allergy or bronchial asthma. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.
PRECAUTIONS
General
Propranolol hydrochloride
Propranolol should be used with caution in patients with impaired hepatic or renal function. Propranolol hydrochloride and hydrochlorothiazide tablets are not indicated for the treatment of hypertensive emergencies.
Information for Patients
Beta-adrenoreceptor blockade can cause reduction of intraocular pressure. Patients should be told that propranolol hydrochloride and hydrochlorothiazide may interfere with the glaucoma screening test. Withdrawal may lead to a return of increased intraocular pressure.
