HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Hydrochlorothiazide (UNII: 0J48LPH2TH) (Hydrochlorothiazide - UNII:0J48LPH2TH)

Available from:

Oxford Pharmaceuticals, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CONTRAINDICATIONS Anuria. Hypersensitivity to this product or to other sulfonamide-derived drugs

Product summary:

HOW SUPPLIED Hydrochlorothiazide Tablets, USP are supplied as follows: 25 mg - Peach, Round scored tablets, upper debossed with "361" above bisect and lower debossed                     "O".  Available in bottles of:                      100,   NDC 69584-361-10                      1000, NDC 69584-361-90                      5000, NDC 69584-361-95 50 mg - Peach, Round scored tablets, upper debossed with "362" above bisect and lower debossed                       "O".  Available in bottles of:                       100,   NDC 69584-362-10                       1000, NDC 69584-362-90. Store at: 20-25°C (68-77°F). [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured by: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211 8200020 Revised: 08/2020 R00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE TABLET
OXFORD PHARMACEUTICALS, LLC
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HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
DESCRIPTION
Hydrochlorothiazide is a diuretic and antihypertensive. It is the
3,4-dihydro derivative of
chlorothiazide. Its chemical name is
6-chloro-3,4-dihyrdo-2_H_-1,2,4-benzothiadiazine-7-
sulfonamide1,1-dioxide, and its structural formula is
Hydrochlorothiazide is a white, or practically white, crystalline
powder, which is slightly soluble in
water, but freely soluble in sodium hydroxide solution.
Each tablet, for oral administration, contains 25 mg or 50 mg
hydrochlorothiazide. In addition. each
tablet contains the following inactive ingredients: Anhydrous Lactose,
Pregelatinized Starch from Corn,
Magnesium Stearate, Microcrystalline Cellulose, and FD&C Yellow #6.
CLINICAL PHARMACOLOGY
The mechanism of the antihypertensive effect of thiazides is unknown.
Hydrochlorothiazide does not
usually affect normal blood pressure.
Hydrochlorothiazide affects the distal renal tubular mechanism of
electrolyte reabsorption. At maximal
therapeutic dosage all thiazides are approximately equal in their
diuretic efficacy.
Hydrochlorothiazide increases excretion of sodium and chloride in
approximately equivalent amounts.
Natriuresis may be accompanied by some loss of potassium and
bicarbonate.
After oral use diuresis begins within 2 hours. peaks in about 4 hours
and lasts about 6 to 12 hours.
PHARMACOKINETICS AND METABOLISM
Hydrochlorothiazide is not metabolized but is eliminated rapidly by
the kidney. When plasma levels
have been followed for at least 24 hours, the plasma half- life has
been observed to vary between 5.6
and 14.8 hours. At least 61 percent of the oral dose is eliminated
unchanged within 24 hours.
Hydrochlorothiazide crosses the placental but not the blood-brain
barrier and is excreted in breast milk.
INDICATIONS AND USAGE
Hydrochlorothiazide tablets are indicated as adjunctive therapy in
edema associated with congestive
heart failure, hepatic cirrhosis, and corticosteroid and estroge