ALDACTAZIDE (Page 4 of 4)

Spironolactone

Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting.

Reproductive: Gynecomastia (see Precautions), inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, breast pain. Carcinoma of the breast has been reported in patients taking spironolactone but a cause and effect relationship has not been established.

Hematologic: Leukopenia (including agranulocytosis), thrombocytopenia.

Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis.

Metabolism: Hyperkalemia, electrolyte disturbances (see Warnings and Precautions).

Musculoskeletal: Leg cramps.

Nervous system/psychiatric: Lethargy, mental confusion, ataxia, dizziness, headache, drowsiness.

Liver/biliary: A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration.

Renal: Renal dysfunction (including renal failure).

Skin: Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, pruritus.

Post Marketing Experience

Non-melanoma Skin Cancer

Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses. The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥50,000 mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year.

OVERDOSAGE

The oral LD50 of spironolactone is greater than 1000 mg/kg in mice, rats, and rabbits. The oral LD50 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.

Treatment

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.

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 ALDACTAZIDE 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 ALDACTONE (spironolactone) or hydrochlorothiazide in addition to ALDACTAZIDE in order to provide optimal individual therapy.

The onset of diuresis with ALDACTAZIDE occurs promptly and, due to prolonged effect of the spironolactone component, persists for two to three days after ALDACTAZIDE is 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 hydrochlorothiazide daily, given in a single dose or in divided doses.

Concurrent potassium supplementation is not recommended when ALDACTAZIDE is used in the long-term management of hypertension or in the treatment of most edematous conditions, since the spironolactone content of ALDACTAZIDE is usually sufficient to minimize loss induced by the hydrochlorothiazide component.

HOW SUPPLIED

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 Number Size

0025-1011-31 bottle 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 Number Size

0025-1021-31 bottle of 100

Store below 77°F (25°C).

Pfizer Logo
(click image for full-size original)

LAB-0233-15.0
Revised: March 2021

PRINCIPAL DISPLAY PANEL — 100 Tablet Bottle Label — 1011

Pfizer

NDC 0025-1011-31

Aldactazide®
spironolactone and
hydrochlorothiazide
tablets

25 mg / 25 mg

100 Tablets
Rx only

PRINCIPAL DISPLAY PANEL -- 100 Tablet Bottle Label -- 1011
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 Tablet Bottle Label — 1021

Pfizer

NDC 0025-1021-31

Aldactazide®
spironolactone and
hydrochlorothiazide
tablets

50 mg / 50 mg

100 Tablets
Rx only

PRINCIPAL DISPLAY PANEL -- 100 Tablet Bottle Label -- 1021
(click image for full-size original)
ALDACTAZIDE
spironolactone and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0025-1011
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SPIRONOLACTONE (SPIRONOLACTONE) SPIRONOLACTONE 25 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE, UNSPECIFIED FORM
STARCH, CORN
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
FERRIC OXIDE RED
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color BROWN (tan) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code ALDACTAZIDE;25;SEARLE;1011
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0025-1011-31 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA012616 01/01/1978
ALDACTAZIDE
spironolactone and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0025-1021
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SPIRONOLACTONE (SPIRONOLACTONE) SPIRONOLACTONE 50 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE, UNSPECIFIED FORM
STARCH, CORN
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
FERRIC OXIDE RED
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color BROWN (tan) Score 2 pieces
Shape OVAL (oblong) Size 16mm
Flavor Imprint Code ALDACTAZIDE;50;SEARLE;1021
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0025-1021-31 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA012616 01/01/1978
Labeler — Pfizer Laboratories Div Pfizer Inc (134489525)
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC 829084545 ANALYSIS (0025-1011), ANALYSIS (0025-1021), MANUFACTURE (0025-1011), MANUFACTURE (0025-1021)
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC 829084552 PACK (0025-1011), PACK (0025-1021), LABEL (0025-1011), LABEL (0025-1021)
Establishment
Name Address ID/FEI Operations
Pfizer Inc 943955690 ANALYSIS (0025-1011), ANALYSIS (0025-1021)

Revised: 03/2021 Pfizer Laboratories Div Pfizer Inc

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