Spironolactone And Hydrochlorothiazide (Aldactazide)

Trade Name : ALDACTAZIDE

G.D. Searle LLC Division of Pfizer Inc

TABLET, FILM COATED

Strength 2525 mg/1mg/1

Storage and handling for ALDACTAZIDE

SPIRONOLACTONE; HYDROCHLOROTHIAZIDE Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Spironolactone And Hydrochlorothiazide (Aldactazide) which is also known as ALDACTAZIDE and Manufactured by G.D. Searle LLC Division of Pfizer Inc. It is available in strength of 25; 25 mg/1; mg/1 per ml. Read more

Spironolactone And Hydrochlorothiazide (Aldactazide) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

ALDACTAZIDE oral tablets contain:
spironolactone . . . . . . . . . . . . . . . . . . . . 25 mghydrochlorothiazide . . . . . . . . . . . . . . . . 25 mg
or
spironolactone . . . . . . . . . . . . . . . . . . . . 50 mghydrochlorothiazide . . . . . . . . . . . . . . . . 50 mg
Spironolactone (ALDACTONE), an aldosterone antagonist, is 17-hydroxy-7u03b1-mercapto-3-oxo-17u03b1-pregn-4-ene-21-carboxylic acid u03b3-lactone acetate and has the following structural formula:
Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform.
Hydrochlorothiazide, a diuretic and antihypertensive, is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula:
Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution.
Inactive ingredients include calcium sulfate, corn starch, flavor, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.

No data

Spironolactone, an ingredient of ALDACTAZIDE, has been shown to be a tumorigen in chronic toxicity studies in rats (see section). ALDACTAZIDE should be used only in those conditions described below. Unnecessary use of this drug should be avoided.

ALDACTAZIDE is contraindicated in patients with anuria, acute renal insufficiency, significant impairment of renal excretory function, hypercalcemia, hyperkalemia, Addison's disease, and in patients who are allergic to thiazide diuretics or to other sulfonamide-derived drugs. ALDACTAZIDE may also be contraindicated in acute or severe hepatic failure.

Potassium supplementation, either in the form of medication or as a diet rich in potassium, should not ordinarily be given in association with ALDACTAZIDE therapy. Excessive potassium intake may cause hyperkalemia in patients receiving ALDACTAZIDE (see ).
Concomitant administration of ALDACTAZIDE with the following drugs or potassium sources may lead to severe hyperkalemia:
ALDACTAZIDE should not be administered concurrently with other potassium-sparing diuretics. Spironolactone, when used with ACE inhibitors or indomethacin, even in the presence of a diuretic, has been associated with severe hyperkalemia. Extreme caution should be exercised when ALDACTAZIDE is given concomitantly with these drugs (see ).
ALDACTAZIDE should be used with caution in patients with impaired hepatic function because minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Lithium generally should not be given with diuretics (see ).
Thiazides should be used with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.
Thiazides may add to or potentiate the action of other antihypertensive drugs.
Sensitivity reactions to thiazides may occur in patients with or without a history of allergy or bronchial asthma.
Sulfonamide derivatives, including thiazides, have been reported to exacerbate or activate systemic lupus erythematosus.
Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

No data

The following adverse reactions have been reported and, within each category (body system), are listed in order of decreasing severity.

The oral LD of spironolactone is greater than 1000 mg/kg in mice, rats, and rabbits. The oral LD of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.
Acute overdosage of spironolactone may be manifested by drowsiness, mental confusion, maculopapular or erythematous rash, nausea, vomiting, dizziness, or diarrhea. Rarely, instances of hyponatremia, hyperkalemia (less commonly seen with ALDACTAZIDE because the hydrochlorothiazide component tends to produce hypokalemia), or hepatic coma may occur in patients with severe liver disease, but these are unlikely due to acute overdosage.
However, because ALDACTAZIDE contains both spironolactone and hydrochlorothiazide, the toxic effects may be intensified, and signs of thiazide overdosage may be present. These include electrolyte imbalance such as hypokalemia and/or hyponatremia. The potassium-sparing action of spironolactone may predominate and hyperkalemia may occur, especially in patients with impaired renal function. BUN determinations have been reported to rise transiently with hydrochlorothiazide. There may be CNS depression with lethargy or even coma.
Induce vomiting or evacuate the stomach by lavage. There is no specific antidote. Treatment is supportive to maintain hydration, electrolyte balance, and vital functions.
Patients who have renal impairment may develop spironolactone-induced hyperkalemia. In such cases, ALDACTAZIDE should be discontinued immediately. With severe hyperkalemia, the clinical situation dictates the procedures to be employed. These include the intravenous administration of calcium chloride solution, sodium bicarbonate solution, and/or the oral or parenteral administration of glucose with a rapid-acting insulin preparation. These are temporary measures to be repeated as required. Cationic exchange resins such as sodium polystyrene sulfonate may be orally or rectally administered. Persistent hyperkalemia may require dialysis.

Optimal dosage should be established by individual titration of the components.

ALDACTAZIDE tablets containing 25 mg of spironolactone (ALDACTONE) and 25 mg of hydrochlorothiazide are round, tan, film coated, with SEARLE and 1011 debossed on one side and ALDACTAZIDE and 25 on the other side, supplied as:
NDC Numbern- Size
0025-1011-31u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0bottle of 100
ALDACTAZIDE tablets containing 50 mg of spironolactone (ALDACTONE) and 50 mg of hydrochlorothiazide are oblong, tan, scored, film coated, with SEARLE and 1021 debossed on the scored side and ALDACTAZIDE and 50 on the other side, supplied as:
NDC Numbern- Size
0025-1021-31u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0bottle of 100
Store below 77u00b0F (25u00b0C).

LAB-0233-12.0Revised January 2019

Pfizer
NDC 0025-1011-31
Aldactaziden spironolactone andhydrochlorothiazidetablets
25 mg / 25 mg
100 Tablets Rx only

Pfizer
NDC 0025-1021-31
Aldactaziden spironolactone andhydrochlorothiazidetablets
50 mg / 50 mg
100 Tablets Rx only

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