HYDROCHLOROTHIAZIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lannett Company, 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 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 uterus is

Product summary:

Hydrochlorothiazide Capsules, 12.5 mg are #4 Teal Opaque/Teal Opaque capsules imprinted with Logo “LANNETT” on the cap and “1635” on the body. They are packaged in bottles of 100 (NDC 0527-1635-01), 500 (NDC 0527-1635-05) and 1000 (NDC 0527-1635-10). PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP. Keep out of reach of children. Store at room temperature, 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from light, moisture, freezing, -20°C (-4°F). Keep container tightly closed. Rx Only Manufactured by: LANNETT COMPANY, INC. Philadelphia, PA 19136 Made in the USA Revised: 04/11 10-578

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE CAPSULE
LANNETT COMPANY, INC.
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HYDROCHLOROTHIAZIDE CAPSULES, 12.5 MG
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-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, pregelatinized corn starch, sodium starch glycolate,
magnesium stearate and colloidal
silicon dioxide. Gelatin capsules contain D&C Red #28, D&C Yellow #10,
FD&C Blue #1, gelatin and
titanium dioxide. The capsule imprinting ink contains shellac glaze in
ethanol, black iron oxide, n-butyl
alcohol, propylene glycol, methanol, ethanol, FD&C Blue #2 Aluminum
Lake, FD&C Red #40
Aluminum Lake, FD&C Blue #1 Aluminum Lake and D&C Yellow #10 Aluminum
Lake.
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
h