देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
ETIDRONATE DISODIUM (UNII: M16PXG993G) (ETIDRONIC ACID - UNII:M2F465ROXU)
Carilion Materials Management
ETIDRONATE DISODIUM
ETIDRONATE DISODIUM 200 mg
ORAL
PRESCRIPTION DRUG
Etidronate disodium tablets, USP are indicated for the treatment of symptomatic Paget’s disease of bone and in the prevention and treatment of heterotopic ossification following total hip replacement or due to spinal cord injury. Etidronate disodium tablets are not approved for the treatment of osteoporosis. Etidronate disodium tablets are indicated for the treatment of symptomatic Paget’s disease of bone. Etidronate disodium therapy usually arrests or significantly impedes the disease process as evidenced by: In addition, reductions in pagetically elevated cardiac output and skin temperature have been observed in some patients. In many patients, the disease process will be suppressed for a period of at least one year following cessation of therapy. The upper limit of this period has not been determined. The effects of the etidronate disodium treatment in patients with asymptomatic Paget’s disease have not been studied. However, etidronate disodium treatment of such patients may be warranted if extensive invo
Product: 68151-1521 NDC: 68151-1521-9 1 TABLET in a PACKAGE
Abbreviated New Drug Application
ETIDRONATE DISODIUM- ETIDRONATE DISODIUM TABLET CARILION MATERIALS MANAGEMENT ---------- DESCRIPTION Etidronate disodium tablets, USP contain either 200 mg or 400 mg of etidronate disodium, the disodium salt of (1-hydroxyethylidene) diphosphonic acid, for oral administration. This compound, also known as EHDP, regulates bone metabolism. Etidronate disodium, USP is a white powder, highly soluble in water, with a molecular weight of 250 and the following structural formula: Inactive ingredients: Each tablet contains magnesium stearate, microcrystalline cellulose, pregelatinized starch and starch (corn). CLINICAL PHARMACOLOGY Etidronate disodium acts primarily on bone. It can inhibit the formation, growth, and dissolution of hydroxyapatite crystals and their amorphous precursors by chemisorption to calcium phosphate surfaces. Inhibition of crystal resorption occurs at lower doses than are required to inhibit crystal growth. Both effects increase as the dose increases. Etidronate disodium is not metabolized. The amount of drug absorbed after an oral dose is approximately 3%. In normal subjects, plasma half-life (t ) of etidronate, based on non-compartmental pharmacokinetics is 1 to 6 hours. Within 24 hours, approximately half the absorbed dose is excreted in urine; the remainder is distributed to bone compartments from which it is slowly eliminated. Animal studies have yielded bone clearance estimates up to 165 days. In humans, the residence time on bone may vary due to such factors as specific metabolic condition and bone type. Unabsorbed drug is excreted intact in the feces. Preclinical studies indicate etidronate disodium does not cross the blood- brain barrier. Etidronate disodium therapy does not adversely affect serum levels of parathyroid hormone or calcium. PAGET’S DISEASE Paget’s disease of bone (osteitis deformans) is an idiopathic, progressive disease characterized by abnormal and accelerated bone metabolism in one or more bones. Signs and symptoms may include bone pain and/or deformity, neurologic dis पूरा दस्तावेज़ पढ़ें