HYDROCHLOROTHIAZIDE capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

NuCare Pharmaceuticals,Inc.

INN (International namn):

HYDROCHLOROTHIAZIDE

Sammansättning:

HYDROCHLOROTHIAZIDE 12.5 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Hydrochloro­thiazide capsules USP 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 USP 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

Produktsammanfattning:

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. NDC 68071-4361-3 BOTTLES OF 30 NDC 68071-4361-6 BOTTLES OF 60 NDC 68071-4361-9 BOTTLES OF 90 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). Distributed by: Citron Pharma LLC Suite -1101 2 Tower Center Blvd East Brunswick NJ 08816 Code No.: DRUGS/AP/19/1993 Made in India Revised: 08/2014

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE CAPSULE
NUCARE PHARMACEUTICALS,INC.
----------
HYDROCHLOROTHIAZIDE CAPSULES USP
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
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
7
8
3
4
2
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