PAMIDRONATE DISODIUM- pamidronate disodium injection, solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Fresenius Kabi USA, LLC

INN (nemzetközi neve):

PAMIDRONATE DISODIUM

Összetétel:

PAMIDRONATE DISODIUM 3 mg in 1 mL

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Pamidronate Disodium Injection, 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 injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-

Termék összefoglaló:

Product No. NDC No. 730410 63323-734-10 Pamidronate Disodium Injection, 30 mg/10 mL (3 mg/mL), in a 10 mL single dose vial, packaged individually. 730510 63323-735-10 Pamidronate Disodium Injection, 90 mg/10 mL (9 mg/mL), in a 10 mL single dose vial, packaged individually. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. This container closure is not made with natural rubber latex.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

PAMIDRONATE DISODIUM- PAMIDRONATE DISODIUM INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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PAMIDRONATE DISODIUM INJECTION
DESCRIPTION
Pamidronate Disodium Injection is a bone-resorption inhibitor
available as a sterile, aqueous solution in
30 mg or 90 mg vials for intravenous administration. 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. 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, and
its structural formula is:
C
H
NO
P
NA M.W. 279.03
_Inactive Ingredients_. Mannitol, USP, and phosphoric acid (for
adjustment of pH to 6.5).
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 hypercalcemia of malignancy is the
finding that pamidronate disodium
inhibits the accelerated bone resorption that results from osteoclast
hyperactivity induced by various
tumors in animal studies.
PHARMACOKINETICS
Cancer patients (n=24) who had minimal or no bony involvement were
given an intravenous infusion of
30, 60, or 9