MedPath

DIURIL

DIURIL® (chlorothiazide) Oral Suspension

Approved
Approval ID

bd936e35-1af8-42da-bcc0-f22489d68574

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 1, 2021

Manufacturers
FDA

Salix Pharmaceuticals, Inc

DUNS: 793108036

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

CHLOROTHIAZIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65649-311
Application NumberNDA011870
Product Classification
M
Marketing Category
C73594
G
Generic Name
CHLOROTHIAZIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2021
FDA Product Classification

INGREDIENTS (10)

ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
CHLOROTHIAZIDEActive
Quantity: 250 mg in 5 mL
Code: 77W477J15H
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TRAGACANTHInactive
Code: 2944357O2O
Classification: IACT

Drug Labeling Information

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 11/1/2021

DOSAGE AND ADMINISTRATION

Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response.

Adults

For Edema

The usual adult dosage is 500 mg to 1,000 mg (10 mL to 20 mL) once or twice a day. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on three to five days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.

For Control of Hypertension

The usual adult starting dosage is 500 mg or 1,000 mg (10 mL to 20 mL) a day as a single or divided dose. Dosage is increased or decreased according to blood pressure response. Rarely some patients may require up to 2,000 mg (40 mL) a day in divided doses.

Infants and Children

For Diuresis and For Control of Hypertension

The usual pediatric dosage is 5 mg to 10 mg per pound (10 mg/kg to 20 mg/kg) per day in single or two divided doses, not to exceed 375 mg per day (2.5 mL to 7.5 mL or ½ to 1½ teaspoonfuls of the oral suspension daily) in infants up to 2 years of age or 1,000 mg per day in children 2 to 12 years of age. In infants less than 6 months of age, doses up to 15 mg per pound (30 mg/kg) per day in two divided doses may be required (see PRECAUTIONS, Pediatric Use).

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DIURIL - FDA Drug Approval Details