Drugplain

Spironolactone and Hydrochlorothiazide 25 mg/1

Spironolactone and Hydrochlorothiazide · TABLET · Bryant Ranch Prepack

No Recall HistoryCurrently in Shortage
Plain English

Spironolactone and Hydrochlorothiazide is a tablet containing spironolactone and hydrochlorothiazide at 25 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.

Key Facts

Brand Name
Spironolactone and Hydrochlorothiazide
Generic Name
Spironolactone and Hydrochlorothiazide
NDC Code (Product)
63629-1068
Manufacturer
Bryant Ranch Prepack
Strength
25 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA089534
Drug Class
Thiazide Diuretic [EPC]; Aldosterone Antagonist [EPC]
Marketing Start
07/02/1987

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea94 reports
fatigue70 reports
nausea68 reports
diarrhoea65 reports
headache65 reports
dizziness49 reports
cough45 reports
pain41 reports
infusion site pain39 reports
off label use38 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Spironolactone, an ingredient of spironolactone and hydrochlorothiazide tablets, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions section). Spironolactone and hydrochlorothiazide tablets should be used only in those conditions described below. Unnecessary use of this drug should be avoided. Spironolactone and hydrochlorothiazide tablets are 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. Spironolactone and hydrochlorothiazide tablets are indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium. The nephroti…

Dosage & Administration

DOSAGE AND ADMINISTRATION Optimal dosage should be established by individual titration of the components. Edema in adults ( congestive heart failure, hepatic cirrhosis, or nephrotic syndrome) The usual maintenance dose of spironolactone and hydrochlorothiazide tablets is 100 mg each of spironolactone and hydrochlorothiazide daily, administered in a single dose or in divided doses, but may range from 25 mg to 200 mg of each component daily depending on the response to the initial titration. In some instances it may be desirable to administer separate tablets of either spironolactone or hydrochlorothiazide in addition to spironolactone and hydrochlorothiazide tablets in order to provide optimal individual therapy. The onset of diuresis with spironolactone and hydrochlorothiazide tablets occurs promptly and, due to prolonged effect of the spironolactone component, persists for two to three days after spironolactone and hydrochlorothiazide tablets are discontinued. Essential hypertension Although the dosage will vary depending on the results of titration of the individual ingredients, many patients will be found to have an optimal response to 50 mg to 100 mg each of spironolactone and …

Warnings

WARNINGS Potassium supplementation, either in the form of medication or as a diet rich in potassium, should not ordinarily be given in association with spironolactone and hydrochlorothiazide therapy. Excessive potassium intake may cause hyperkalemia in patients receiving spironolactone and hydrochlorothiazide (see Precautions: General ). Concomitant administration of spironolactone and hydrochlorothiazide with the following drugs or potassium sources may lead to severe hyperkalemia: • other potassium-sparing diuretics • ACE inhibitors • angiotensin II receptor antagonists • aldosterone blockers • non-steroidal anti-inflammatory drugs (NSAIDs), e.g., indomethacin • heparin and low molecular weight heparin • other drugs or conditions known to cause hyperkalemia • potassium supplements • diet rich in potassium • salt substitutes containing potassium Spironolactone and hydrochlorothiazide 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 spironolactone and hydrochlorothiazi…

Contraindications

CONTRAINDICATIONS Spironolactone and hydrochlorothiazide tablets are 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. Spironolactone and hydrochlorothiazide may also be contraindicated in acute or severe hepatic failure.

Drug Interactions

Drug interactions ACE inhibitors, Angiotensin II receptor antagonists, aldosterone blockers, potassium supplements, heparin, low molecular weight heparin, and other drugs known to cause hyperkalemia Concomitant administration may lead to severe hyperkalemia. Alcohol, barbiturates, or narcotics Potentiation of orthostatic hypotension may occur. Antidiabetic drugs (e.g., oral agents, insulin) Dosage adjustment of the antidiabetic drug may be required (see Precautions ). Corticosteroids, ACTH Intensified electrolyte depletion, particularly hypokalemia, may occur. Pressor amines (e.g., norepinephrine) Both spironolactone and hydrochlorothiazide reduce the vascular responsiveness to norepinephrine. Therefore, caution should be exercised in the management of patients subjected to regional or general anesthesia while they are being treated with spironolactone and hydrochlorothiazide. Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine) Possible increased responsiveness to the muscle relaxant may result. Lithium Lithium generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity. Nonsteroidal anti-in…

Adverse Reactions

ADVERSE REACTIONS 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. Eye Disorders: Acute myopia and acute angle-closure glaucoma (see Warnings ). 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 ). Ski…

Frequently Asked Questions

What is Spironolactone and Hydrochlorothiazide used for?

Spironolactone and Hydrochlorothiazide contains Spironolactone and Hydrochlorothiazide. It is a tablet taken oral. Consult your doctor for specific uses.

Is Spironolactone and Hydrochlorothiazide a controlled substance?

Spironolactone and Hydrochlorothiazide is not classified as a controlled substance by the DEA.

What is the generic name for Spironolactone and Hydrochlorothiazide?

The generic name for Spironolactone and Hydrochlorothiazide is Spironolactone and Hydrochlorothiazide. There are no other listed brand versions of Spironolactone and Hydrochlorothiazide.

What is the NDC code for Spironolactone and Hydrochlorothiazide 25 mg/1?

The NDC (National Drug Code) for Spironolactone and Hydrochlorothiazide 25 mg/1 is 63629-1068, listed by Bryant Ranch Prepack.

Product NDC

63629-1068

Package NDC

63629-1068-1

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)