HYDROCHLOROTHIAZIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rising Health, LLC

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

Product summary:

Hydrochlorothiazide Capsules USP 12.5 mg are blue/blue size ‘4’ hard gelatin capsules, imprinted with ‘D’ on blue cap and ‘26’ on blue body with black edible ink, filled with white to off-white powder.          Bottles of 100               NDC 57237-002-01           Bottles of 500               NDC 57237-002-05          Bottles of 1,000             NDC 57237-002-99 Dispense in a tight, light-resistant container as defined in the USP.   Keep out of reach of children. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light, moisture, freezing, -20°C (-4°F). Keep container tightly closed. Distributed by: Rising Health, LLC Saddle Brook, NJ 07663 Made in India Code: TS/DRUGS/19/1993 Revised: 09/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE CAPSULE
RISING HEALTH, LLC
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HYDROCHLOROTHIAZIDE CAPSULES USP
RX ONLY
DESCRIPTION
Hydrochlorothiazide is the 3,4-dihydro derivative of chlorothiazide.
Its chemical name is 6-chloro-
3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its
molecular formula is
C H ClN 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.
Hydrochlorothiazide is supplied as 12.5 mg capsules for oral use. Each
capsule contains the following
inactive ingredients: colloidal silicon dioxide, corn starch, lactose
monohydrate, and magnesium
stearate. The hard gelatin shell consists of gelatin, titanium
dioxide, sodium lauryl sulphate, FD&C
Blue #1, D&C Red #28, D&C Yellow #10, black iron oxide and shellac.
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
7
8
3
4
2
hydrochlorothiazide is reduced in patients with congestive heart
failure.
Peak plasma concentrations are observed within 1 to 5 hours of dosing
and range from 70 to 490 ng/mL
following oral dose