PAMIDRONATE DISODIUM injection

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

PAMIDRONATE DISODIUM (UNII: 8742T8ZQZA) (PAMIDRONIC ACID - UNII:OYY3447OMC)

제공처:

Mylan Institutional LLC

INN (International Name):

PAMIDRONATE DISODIUM

구성:

PAMIDRONATE DISODIUM 3 mg in 1 mL

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Pamidronate disodium, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. Patients who have either epidermoid or non-epidermoid tumors respond to treatment with pamidronate disodium. Vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 L/day throughout treatment. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics). Patients should be hydrated adequately throughout the treatment, but overhydration, especially in those patients who have cardiac failure, must be avoided. Diuretic therapy should not be employed prior to correction of hypovolemia. The safety and efficacy of pamidronate disodium in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions h

제품 요약:

Pamidronate Disodium Injection is available as follows: Vials – 3 mg/mL, 10 mL vial - each contains 30 mg of Pamidronate Disodium and 470 mg of Mannitol, USP in 10 mL Water for Injection, USP. Carton of 1 vial. NDC 67457-430-10. Vials – 9 mg/mL, 10 mL vial - each contains 90 mg of Pamidronate Disodium and 375 mg of Mannitol, USP in 10 mL Water for Injection, USP. Carton of 1 vial. NDC 67457-446-10. Storage: Store at 20° to 25°C (68°  to 77°F.) [See USP Controlled Room Temperature.] Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Steriscience Specialties Private Limited Bangalore, India 1033247 1200005570 July 2022

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

PAMIDRONATE DISODIUM- PAMIDRONATE DISODIUM INJECTION
MYLAN INSTITUTIONAL LLC
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PAMIDRONATE DISODIUM INJECTION
FOR INTRAVENOUS INFUSION
RX ONLY
DESCRIPTION
Pamidronate Disodium is a sterile bone-resorption inhibitor available
in 30 mg and 90 mg
vials for intravenous administration. The pamidronate disodium
obtained by combining
pamidronic acid and sodium hydroxide is provided in a sterile, ready
to use solution for
injection. Each mL of the 30 mg vial contains, 3 mg Pamidronate
Disodium, 47 mg
Mannitol, USP; Water for Injection, USP, q.s.; Phosphoric acid to
adjust pH. Each mL of
the 90 mg vial contains, 9 mg Pamidronate Disodium, 37.5 mg Mannitol,
USP; Water for
Injection, USP, q.s.; Phosphoric acid to adjust pH. The pH of a 1%
solution of
pamidronate disodium in distilled water is approximately 8.3.
Pamidronate, a member of
the group of chemical compounds known as bisphosphonates, is an analog
of
pyrophosphate. Pamidronate disodium is designated chemically as
phosphonic acid (3-
amino-1-hydroxypropylidene) bis-, disodium salt, and its structural
formula is:
Pamidronate disodium is soluble in water and in 2N sodium hydroxide,
sparingly soluble
in 0.1N hydrochloric acid and in 0.1N acetic acid, and practically
insoluble in organic
solvents. Its molecular formula is C H NO P Na and its molecular
weight is 279.1
(calculated as the anhydrous form).
_Inactive Ingredients: _Mannitol, Phosphoric acid (for adjustment to
pH range of 6.0 to
7.0) and Water for Injection.
CLINICAL PHARMACOLOGY
The principal pharmacologic action of pamidronate disodium is
inhibition of bone
resorption. Although the mechanism of antiresorptive action is not
completely
understood, several factors are thought to contribute to this action.
Pamidronate
disodium adsorbs to calcium phosphate (hydroxyapatite) crystals in
bone and may
directly block dissolution of this mineral component of bone. _In
vitro _studies also
suggest that inhibition of osteoclast activity contributes to
inhibition of bone resorption.
In animal studies, at doses reco