HYDROCHLOROTHIAZIDE capsule, gelatin coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
01-02-2023

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Proficient Rx LP

INN (Jina la Kimataifa):

HYDROCHLOROTHIAZIDE

Tungo:

HYDROCHLOROTHIAZIDE 12.5 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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

Bidhaa muhtasari:

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 07, 30, 60 and 90. 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 Repackaged By: Proficient Rx LP Thousand Oaks, CA 91320 Revised: October 2011 174788-3

Idhini hali ya:

New Drug Application Authorized Generic

Tabia za bidhaa

                                HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED
PROFICIENT RX LP
----------
HYDROCHLOROTHIAZIDE CAPSULES, USP
REVISED: OCTOBER 2011
RX ONLY
DESCRIPTION
Hydrochlorothiazide Capsules, USP, 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.
_Inactive ingredients: _colloidal silicon dioxide, corn starch,
lactose monohydrate,
magnesium stearate. Gelatin capsules contain D&C Red No. 28, D&C
Yellow No. 10,
FD&C Blue No. 1, gelatin, titanium dioxide. The capsules are printed
with edible ink
containing black iron oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C
Blue No. 2,
FD&C Red No. 40.
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.
7
8
3
4 2
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 
                                
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