HYDROCHLOROTHIAZIDE capsule, gelatin coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Blenheim Pharmacal, Inc.

INN (International Name):

HYDROCHLOROTHIAZIDE

Sammensætning:

HYDROCHLOROTHIAZIDE 12.5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Hydrochlorothiazide is 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 properly t

Produkt oversigt:

Hydrochlorothiazide Capsules, USP are #4 Teal Opaque/White Opaque two piece hard gelatin capsules imprinted with WATSON 347 and 12.5 mg in black ink. They are supplied in bottles of 100 and 500. Bottles of 100 are supplied with child resistant closures. Dispense in a tight, light-resistant container as defined in the USP. Keep out of reach of children. Store at 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 For all medical inquiries contact: WATSON Medical Communications Parsippany, NJ 07054 USA 800-272-5525 Manufactured By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed By: Watson Pharma, Inc. Parsippany, NJ 07054 USA Revised: October 2011 174788-3

Autorisation status:

New Drug Application Authorized Generic

Produktets egenskaber

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED
BLENHEIM PHARMACAL, INC.
----------
HYDROCHLOROTHIAZIDE CAPSULES, USP
REVISED: OCTOBER 2011
RX ONLY
174788-3
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 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 times
higher in whole blood than in plasma.
Binding to serum proteins has been reported to be approximately 40% to
68%. The plasma elimination
half-life has been reported to be 6 to 15 hours. Hydrochlorothiazide
is eliminated primarily by renal
pathways. Following oral doses of 12.5 to 100 mg, 55% to 77% of the
administered dose appears in
urine and greater than 95% of the absorbed dose is excreted in urine
as unchanged drug. In patients with
renal disease, plasma concentrations of hydrochlorothiazide are
increased and the elimination half-life
is prolonged.
When hydrochlorothiazide is administ