ETIDRONATE DISODIUM- etidronate disodium tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

ETIDRONATE DISODIUM (UNII: M16PXG993G) (ETIDRONIC ACID - UNII:M2F465ROXU)

제공처:

Mylan Pharmaceuticals Inc.

INN (국제 이름):

ETIDRONATE DISODIUM

구성:

ETIDRONATE DISODIUM 200 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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

제품 요약:

Etidronate Disodium Tablets, USP are available containing 200 mg or 400 mg of etidronate disodium, USP. The 200 mg tablets are white, rectangular-shaped tablets with ED 200 on one side and G on the other side. They are available as follows: NDC 0378-3286-91 bottles of 60 The 400 mg tablets are white, capsule-shaped tablets with ED 400 on one side and G on the other side. They are available as follows: NDC 0378-3288-91 bottles of 60 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat (over 104°F or 40°C) . Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by: ALPHAPHARM PTY LTD 15 Garnet Street Carole Park QLD 4300 Australia ALP:ETDN:R8 Revised: 3/2017

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

ETIDRONATE DISODIUM- ETIDRONATE DISODIUM TABLET
MYLAN PHARMACEUTICALS INC.
----------
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 disord