HYDROCHLOROTHIAZIDE capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Alembic Pharmaceuticals Limited

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 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 exp

Περίληψη προϊόντος:

Hydrochlorothiazide capsules USP, 12.5 mg are supplied in Teal Blue opaque/Teal Blue opaque size ‘4’ hard gelatin capsules radially imprinted ‘A129’ on cap and ‘12.5 mg’ on body in black ink, filled with white to off-white powder. NDC 46708-438-30            bottle of 30 capsules NDC 46708-438-31            bottle of 100 capsules NDC 46708-438-71            bottle of 500 capsules NDC 46708-438-91            bottle of 1000 capsules NDC 46708-438-10           carton of 100 (10 x 10) unit-dose capsules Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature.] Protect from light, moisture, freezing, -20°C (-4°F). Keep container tightly closed. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Village Panelav, P. O. Tajpura, Near Baska, Taluka-Halol, Panchmahal, Gujarat, India. Revised: 02/2017

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE CAPSULE
ALEMBIC PHARMACEUTICALS LIMITED
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HYDROCHLOROTHIAZIDE CAPSULES USP, 12.5 MG
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 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, pregelatinized starch, lactose monohydrate,
magnesium
stearate. Gelatin capsules contain D&C Red # 28, D&C Yellow # 10, FD&C
Blue # 1,
gelatin, titanium dioxide. The capsules are printed with edible ink
containing black iron
oxide and pharmaceutical glaze.
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
7
8
3
4 2
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