HYDROCHLOROTHIAZIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Direct_Rx

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 ut

Product summary:

Hydrochlorothiazide capsules USP, 12.5 mg are available as hard gelatin capsules with opaque white cap and opaque white body imprinted with "U" on cap and "130" on the body in grey ink along the horizontal axis Bottle of 100: Bottle of 500: Bottle of 1000: Store at 200 to 250C (680 to 770F) [see USP Controlled Room Temperature]. Protect from light, moisture, freezing, -200C (-40F). Keep container tightly closed. Rx only Please address medical inquiries to Unichem's toll free # 1-866-562-4616.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE CAPSULE
DIRECT_RX
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HYDROCHLOROTHIAZIDE
Hydrochlorothiazide, USP 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 C7H8ClN3O4S2; its molecular weight is 297.74; and
its structural
formula is:
[Structure of Hydrochlorothiazide]
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: microcrystalline cellulose, pregelatinized
starch, colloidal silicon
dioxide, magnesium stearate, gelatin, titanium dioxide, sodium lauryl
sulfate and black
iron oxide.
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 dosing,
and range from
70 to 490 ng/mL following oral doses of 12.5 to 100 mg. Plasma
concentrations are
linearly related to the administered dose. Concentrations of
hydrochlorothiazide are 1.6
to 1.8 time