HYDROCHLOROTHIAZIDE capsule, gelatin coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

AvKARE

INN (International Name):

HYDROCHLOROTHIAZIDE

Sammensætning:

HYDROCHLOROTHIAZIDE 12.5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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. 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 tre

Produkt oversigt:

Hydrochlorothiazide capsules 12.5 mg are #4 Blue Opaque / White Opaque hard gelatin capsules imprinted with TL382 in black ink and are available in the following package sizes: Storage: Keep container tightly closed. Protect from light, moisture, freezing, -20°C (-4°F) and store at 20°-25°C (68° - 77°F) [See USP Controlled Room temperature]. Keep this and all medication out of the reach of children. Manufactured for: AvKARE, Inc. Pulaski, TN  38478 Mfg. Rev. 03/11 AV 08/16 (P)

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED
AVKARE
----------
HYDROCHLOROTHIAZIDE CAPSULES
RX ONLY
DESCRIPTION
Hydrochlorothiazide capsules 12.5 mg 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. Each
capsule contains
the following inactive ingredients: colloidal silicon dioxide, D&C
Yellow #10, FD&C Blue
#1, FD&C Blue #2, FD&C Red #40, gelatin, iron oxide black, lactose
monohydrate,
magnesium stearate, pregelatinized starch, propylene glycol, shellac,
and titanium
dioxide.
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:
7
8
3
4
2
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 dose