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Spironolactone-Hctz 25-25 Mg Tabs 500 By Mylan Pharma

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Spironolactone-Hctz 25-25 Mg Tabs 500 By Mylan Pharma

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Spironolactone-Hctz 25-25 Mg Tabs 500 By Mylan Pharma This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD1271006/RXB10032802
Size : 500
Selling UoM : EA
NDC: 00378-0141-05
UPC Barcode : 303780141056Supplier: 0050000337 MYLAN PHARM
Supplier Material : 014105
Generic Code : 006813 SPIRONOLACT/HYDROCHLOROTHIAZID ORAL TABL
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GRX Generic RX

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Product Description.:

M 41
tablet , off-white , scored , round round
Biconvex

WARNING

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

Fixed-dose combination drugs are not indicated for initial therapy of edema or hypertension. Edema or 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. The treatment of hypertension and edema is not static but must be reevaluated as conditions in each patient warrant.

DRUG DESCRIPTION
Aldactazide oral tablets contain:

spironolactone......................................25 mg
hydrochlorothiazide......................................25 mg

or

spironolactone......................................50 mg
hydrochlorothiazide......................................50 mg

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.

INDICATIONS

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

Aldactazide is indicated for:

Edematous conditions for patients with:

Congestive heart failure: For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures. The treatment of diuretic-induced hypokalemia in patients with congestive heart failure when other measures are considered inappropriate. The treatment of patients with congestive heart failure taking digitalis when other therapies are considered inadequate or inappropriate.

Cirrhosis of the liver accompanied by edema and/or ascites: Aldosterone levels may be exceptionally high in this condition. Aldactazide is indicated for maintenance therapy together with bed rest and the restriction of f.The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developing toxemia.

Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Aldactazide is indicated in pregnancy when edema is due to pathologic causes just as it is in the absence of pregnancy (however, see PRECAUTIONS: Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose use of diuretics to lower intravascular volume in this case is unsupported and unnecessary. There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.

SIDE EFFECTS

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

Body as a whole: Weakness.

Cardiovascular: Hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs).

Digestive: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialoadenitis, cramping, constipation, gastric irritation, nausea, anorexia.

Hematologic:Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia.

Hypersensitivity: Anaphylactic reactions, necrotizing angitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura.

Metabolic:Electrolyte imbalance (see PRECAUTIONS), hyperglycemia, glycosuria, hyperuricemia.

Musculoskeletal:Muscle spasm.

Nervous system/psychiatric:Vertigo, paresthesias, dizziness, headache, restlessness.

Renal: Renal failure, renal dysfunction, interstitial nephritis (see WARNINGS).

Skin: Erythema multiforme, pruritus.

Special senses: Transient blurre