البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
REMEDYREPACK INC.
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE 12.5 mg
ORAL
PRESCRIPTION DRUG
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. 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 capsules are contraindicated in patients with anuria. Hypersensitivity to this product or other sulfonamide derived drugs is also contraindicated.
Hydrochlorothiazide capsules USP, 12.5 mg are available as hard gelatin capsules with opaque white cap and opaque white body imprinted with "U" on cap and "130" on the body in grey ink along the horizontal axis NDC: 70518-0335-00 NDC: 70518-0335-01 NDC: 70518-0335-02 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 60 in 1 BLISTER PACK Store at 200 to 250C (680 to 770F) [see USP Controlled Room Temperature]. Protect from light, moisture, freezing, -200C (-40F). Keep container tightly closed. Rx only Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Abbreviated New Drug Application
HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE CAPSULE REMEDYREPACK INC. ---------- HYDROCHLOROTHIAZIDE CAPSULES USP, 12.5 MG DESCRIPTION Hydrochlorothiazide, USP 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. _Inactive ingredients_: Black iron oxide, colloidal silicon dioxide, gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and titanium dioxide. FDA approved dissolution test specifications differ from USP. 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 Hydrochlorothiazide is well absorbed (65% to 75%) following oral administration. 7 8 3 4 2 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 doses of 12.5 to 100 mg. Plasma concentration اقرأ الوثيقة كاملة