SPIRONOLACTONE- spironolactone tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Spironolactone (UNII: 27O7W4T232) (Spironolactone - UNII:27O7W4T232)

Commercializzato da:

Preferred Pharmaceuticals Inc.

INN (Nome Internazionale):

Spironolactone

Composizione:

Spironolactone 25 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Spironolactone is indicated in the management of: Primary hyperaldosteronism for: Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). 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. Spironolactone is also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate. Cirrhosis of the liver accompanied by edema and/or ascites: Aldosterone levels may be exceptionally high in this condition. Spi

Dettagli prodotto:

Spironolactone tablets, USP are supplied as follows: Spironolactone tablets 25 mg, white, round, unscored, debossed MP 35 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

SPIRONOLACTONE- SPIRONOLACTONE TABLET
PREFERRED PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
[ENTER DRUG NAME] SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR [ENTER DRUG NAME].
INITIAL U.S. APPROVAL: [ENTER YEAR]
RECENT MAJOR CHANGES
Click here to enter Recent Major Changes
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING
1 INDICATIONS AND USAGE
Hypokalemia
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
9.2 Abuse
9.3 Dependence
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*
Sections or subsections omitted from the full prescribing information
are not listed.
FULL PRESCRIBING INFORMATION
WARNING
Spironolactone has been shown to be a tumorigen in chronic toxicity
studies in rats (see
_Precautions_). Spironolactone should be used only in those conditions
described under _Indications_
_and Usage_. Unnecessary use of this drug should be avoided.
1 INDICATIONS AND USAGE
Spironolactone is indicated in the management of:
PRIMARY HYPERALDOSTERONISM for:
Establishing the diagnosis of primary hyperaldosteronism by
therapeutic trial.
Short-term preoperative treatment of patients with primary
hyperaldosteronism.
Long-term maintenance therapy for patients with discrete
aldosterone-producing adrenal adenomas who
are judged to be poor operative risks or who decline surgery.
Long