HYDROCHLOROTHIAZIDE capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

REMEDYREPACK INC.

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 capsules, USP 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 treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases a short course of diuretics may provide relief and may be appropriate. Hydrochlorothiazide is contraindicated in patients with anuria. Hypersensitivity to this product or other sulfonamide derived drugs is also contraindicated.

Περίληψη προϊόντος:

Hydrochlorothiazide Capsules, USP contain a white to off white powder filled in size “4” hard gelatin capsules with opaque light blue colored cap and opaque light blue colored body imprinted “SG” on cap and “146” on body with black ink. They are supplied in NDC: 70518-2550-00 NDC: 70518-2550-01 NDC: 70518-2550-02 NDC: 70518-2550-03 NDC: 70518-2550-04 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 60 in 1 BLISTER PACK PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH Dispense in a tight, light-resistant container as defined in the USP. Keep out of reach of children. 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. Rx only Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE CAPSULE
REMEDYREPACK INC.
----------
HYDROCHLOROTHIAZIDE CAPSULES, USP
RX ONLY
DESCRIPTION
Hydrochlorothiazide (hydrochlorothiazide, 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 capsules, USP are supplied as 12.5 mg capsules for
oral use.
_Inactive ingredients:_ colloidal silicon dioxide, corn starch,
lactose monohydrate,
magnesium stearate. The hard gelatin shell consists of gelatin,
titanium dioxide, sodium
lauryl sulfate, FD&C Blue #1, FD&C Red #3. The capsules are printed
with black ink
containing shellac, dehydrated alcohol, isopropyl alcohol, butyl
alcohol, propylene glycol,
strong ammonia solution, black iron oxide, and potassium hydroxide.
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 redu