PAMIDRONATE DISODIUM injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Areva Pharmaceuticals Inc.

INN (International Name):

PAMIDRONATE DISODIUM

Composition:

PAMIDRONATE DISODIUM 3 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pamidronate disodium for Injection USP, 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 for Injection USP. 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 for Injection USP in the treatment of hypercalcemia associated with hyperparat

Product summary:

Pamidronate disodium for Injection USP is available as a white, sterile, lyophilized cake contained in a vial with an externally lacquered, light blue, tear-off, flip-off seal, containing 30 mg pamidronate disodium USP and 470 mg mannitol USP, packaged one vial per carton (NDC No. 59923-601-10). Pamidronate disodium for Injection USP is available as a white, sterile, lyophilized cake contained in a vial with an externally lacquered, white, tear-off, flip-off seal, containing 60 mg pamidronate disodium USP and 400 mg mannitol USP, packaged one vial per carton (NDC No. 59923-602-10). Pamidronate disodium for Injection USP is available as a white, sterile, lyophilized cake contained in a vial with an externally lacquered, dark green, tear-off, flip-off seal, containing 90 mg pamidronate disodium USP and 375 mg mannitol USP, packaged one vial per carton (NDC No. 59923-603-10). Store at 20° - 25° C (68°-77° F) [See USP Controlled Room Temperature]. Areva Manufactured for AREVA Pharmaceuticals, Inc., 7112 Areva Dr. N.E. Georgetown, IN 47122 Mfd. by Cipla Ltd. Made in India © 2011 AREVA Pharmaceuticals, Inc. Toll-free number: 1-855-853-4760 Revised: July 2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PAMIDRONATE DISODIUM- PAMIDRONATE DISODIUM INJECTION, POWDER,
LYOPHILIZED, FOR
SOLUTION
AREVA PHARMACEUTICALS INC.
----------
PAMIDRONATE DISODIUM FOR INJECTION USP
FOR INTRAVENOUS INFUSION
RX ONLY
DESCRIPTION
Pamidronate disodium for Injection USP, is a bisphosphonate available
in 30 mg, 60 mg or 90 mg vials
for intravenous administration. Each 30-mg, 60-mg and 90-mg vial
contains, respectively, 30 mg, 60 mg
and 90 mg of sterile, lyophilized pamidronate disodium and 470 mg, 400
mg and 375 mg of mannitol,
USP. The pH of a 1% solution of pamidronate disodium in distilled
water is approximately 8.3.
Pamidronate disodium, 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, pentahydrate, and its
structural formula is
Pamidronate disodium is a white-to-practically-white powder. It 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
•5H
O and its molecular
weight is 369.1.
_Inactive Ingredients: _mannitol USP and phosphoric acid (for
adjustment to pH 6.5 prior to lyophilization).
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 recommended for the treatment of hypercalcemia,
pamidronate disodium inhibits bone
resorption apparently without inhibiting bone formation and
mineralization. Of relevance to the treatment
of h