HYDROCHLOROTHIAZIDE- hydrochlorothiazide capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Available from:

West-ward Pharmaceutical Corp

INN (International Name):

HYDROCHLOROTHIAZIDE

Composition:

HYDROCHLOROTHIAZIDE 12.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrochlorothiazide capsules are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazide capsules may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly tre

Product summary:

Hydrochlorothiazide Capsules 12.5 mg are supplied as a #4 teal blue opaque hard gelatin capsules printed “West-ward 3125” in black ink and are available in: Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light, moisture and freezing. Dispense in a tight, light resistant container as defined in the USP using a child-resistant closure. Manufactured By: West-ward Pharmaceutical Corp. Eatontown, N.J. 07724 Revised May 2011

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE CAPSULE
WEST-WARD PHARMACEUTICAL CORP
----------
HYDROCHLOROTHIAZIDE CAPSULES
REV. 05/11
RX ONLY
DESCRIPTION
Hydrochlorothiazide is the 3,4-dihydro derivative of chlorothiazide.
Its chemical name is 6-Chloro-
3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfon-amide 1,1-dioxide.
Its empirical formula is
C H CIN O S ; its molecular weight is 297.74; and its structural
formula is:
It is a white, or practically white, crystalline powder which is
slightly soluble in water, but freely
soluble in sodium hydroxide solution.
Each capsule, for oral administration, contains 12.5 mg
hydrochlorothiazide and the following inactive
ingredients: colloidal silicon dioxide, corn starch, lactose
monohydrate, magnesium stearate,
microcrystalline cellulose and sodium starch glycolate.
Capsule Shell contains: D&C Red #28, D&C Yellow #10, FD&C Blue #1,
Gelatin and Titanium
Dioxide. The printing ink contains D&C Yellow #10, FD&C Blue #1, FD&C
Blue #2, FD&C Red #40,
n-Butyl Alcohol, Pharmaceutical Glaze, Propylene Glycol, SDA-3A
Alcohol and Synthetic Black Iron
Oxide.
CLINICAL PHARMACOLOGY
Hydrochlorothiazide blocks the reabsorption of sodium and chloride
ions, and it thereby increases the
quantity of sodium traversing the distal tubule and the volume of
water excreted. A portion of the
additional sodium presented to the distal tubule is exchanged there
for potassium and hydrogen ions.
With continued use of hydrochlorothiazide and depletion of sodium,
compensatory mechanisms tend to
increase this exchange and may produce excessive loss of potassium,
hydrogen and chloride ions.
Hydrochlorothiazide also decreases the excretion of calcium and uric
acid, may increase the excretion
of iodide and may reduce glomerular filtration rate. Metabolic
toxicities associated with excessive
electrolyte changes caused by hydrochlorothiazide have been shown to
be dose-related.
PHARMACOKINETICS AND METABOLISM:
Hydrochlorothiazide is well absorbed (65% to 75%) following oral
administration. Absorption of
hydrochlorothi