HYDROCHLOROTHIAZIDE- hydrochlorothiazide capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Heritage Pharmaceuticals Inc.

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. Usage in Pregnancy: 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 u

Product summary:

Hydrochlorothiazide capsules USP 12.5 mg are: Teal/Teal colored size '4' hard gelatin capsules with 'HP45' imprinted in black on Cap and Body, filled with white to off-white powder. They are supplied in the following package sizes: Bottles of 30 Capsules       (NDC 23155-045-03) Bottles of 100 Capsules     (NDC 23155-045-01) Bottles of 500 Capsules     (NDC 23155-045-05) Bottles of 1000 Capsules   (NDC 23155-045-10) 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 and freezing, -20°C (-4°F) Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Manufactured by: Ipca Laboratories Limited 48, Kandivli Ind. Estate, Mumbai 400 067, India. Iss.05/18

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE CAPSULE
HERITAGE PHARMACEUTICALS INC.
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HYDROCHLOROTHIAZIDE CAPSULES USP 12.5 MG
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
empirical 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.
_Inactive ingredients:_ Lactose monohydrate, corn starch, sodium
starch glycolate, colloidal silicon
dioxide and magnesium stearate. The hard gelatin capsule shell
consists of gelatin, FD & C Blue No.1,
D&C Red No. 28, D&C Yellow No. 10, titanium dioxide and sodium lauryl
sulfate. The imprinting ink
on the capsules contains 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
hydrochlorothiazide is reduced in patients with congestive heart
failure.
Peak plasma concentrations are observed within 1 to 5 hours of do