DIURIL Solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)

Λέξεις κλειδιά

76478-711

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1. Description

Intravenous Sodium DIURIL (chlorothiazide sodium) is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt and its molecular weight ...

2. Clinical Pharmacology

The mechanism of the antihypertensive effect of thiazides is unknown. DIURIL (chlorothiazide) does not usually affect normal blood pressure. DIURIL (chlorothiazide) affects the distal renal tubular mechanism ...

3. Indications and Usage

Intravenous Sodium DIURIL is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Intravenous Sodium DIURIL has ...

4. Contraindications

Anuria. Hypersensitivity to any component of this product or to other sulfonamide-derived drugs.

5. Warnings

Intravenous use in infants and children has been limited and is not generally recommended. Use with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. ...

6.1. General

All patients receiving diuretic therapy should be observed for evidence of fluid or electrolyte imbalance: namely, hyponatremia, hypochloremic alkalosis, and hypokalemia. Serum and urine electrolyte determinations ...

6.3. Laboratory Tests

Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be done at appropriate intervals.

6.4. Drug Interactions

When given concurrently the following drugs may interact with thiazide diuretics. Alcohol, barbiturates, or narcotics - potentiation of orthostatic hypotension may occur. Antidiabetic drugs - ...

6.5. Drug/Laboratory Test Interactions

Thiazides should be discontinued before carrying out tests for parathyroid function (see PRECAUTIONS, General).

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been conducted with chlorothiazide. Chlorothiazide was not mutagenic in vitro in the Ames microbial mutagen test (using a maximum concentration of 5 mg/plate and ...

6.7. Pregnancy

Teratogenic Effects Although reproduction studies performed with chlorothiazide doses of 50 mg/kg/day in rabbits, 60 mg/kg/day in rats and 500 mg/kg/day in mice revealed no external abnormalities of the ...

6.9. Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from Intravenous Sodium DIURIL, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into ...

6.10. Pediatric Use

Safety and effectiveness of Intravenous Sodium DIURIL in pediatric patients have not been established.

6.11. Geriatric Use

Clinical studies of Intravenous Sodium DIURIL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical ...

7. Adverse Reactions

The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity. Body as a Whole: Weakness. Cardiovascular: Hypotension including ...

9. Overdosage

The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also ...

10. Dosage and Administration

Intravenous Sodium DIURIL should be reserved for patients unable to take oral medication or for emergency situations. Therapy should be individualized according to patient response. Use the smallest dosage ...

11. How Supplied

Intravenous Sodium DIURIL is a dry, sterile lyophilized white powder usually in plug form, supplied in vials containing chlorothiazide sodium equivalent to 0.5 g of chlorothiazide. NDC 76478-711-40 Distributed ...

12. Storage and Handling

Store at 20° to 25°C (68° to 77°F). See USP Controlled Room Temperature. For single dose only. Use solution immediately after reconstitution (see DOSAGE AND ADMINISTRATION, Directions for Reconstitution). ...