PAMIDRONATE DISODIUM injection solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

American Regent, Inc.

SNN (starptautisko nepatentēto nosaukumu):

PAMIDRONATE DISODIUM

Kompozīcija:

PAMIDRONATE DISODIUM 3 mg in 1 mL

Receptes veids:

PRESCRIPTION DRUG

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

PAMIDRONATE DISODIUM- PAMIDRONATE DISODIUM INJECTION, SOLUTION
AMERICAN REGENT, INC.
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PAMIDRONATE DISODIUM INJECTION
FOR INTRAVENOUS INFUSION
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Pamidronate disodium injection is a bisphosphonate available in 30 mg
or 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 and 90 mg
vial contains, respectively, 3 mg and 9 mg of pamidronate disodium, 47
mg and 37.5 mg of mannitol,
water for injection q.s., and phosphoric acid to adjust pH.
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, 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
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 recommended for the treatment
of h