PAMIDRONATE DISODIUM injection, solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Hospira, Inc.

DCI (Denominação Comum Internacional):

PAMIDRONATE DISODIUM

Composição:

PAMIDRONATE DISODIUM 6 mg in 1 mL

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Hypercalcemia of Malignancy   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 has not been established. Paget’s Disease   Pamidronate disodium is indicated for the treatment of patients with moderate to severe Paget’s disease of bone. The effectiveness of pamidronate disodium was demonstrated primarily in patients with serum alkaline phosphatase ≥ 3 times the upper limit of normal. Pamidronate disodium therapy in patients with Paget’s disease has been effective in reducing serum alkaline phosphatase and urinary hydroxyproline levels by ≥ 50% in at least 50% of patients, and by ≥ 30% in at least 80% of patients. Pamidronate disodium therapy has also been effective in reducing these biochemical markers in patients with Paget’s disease who failed to respond, or no longer responded to other treatments. Osteolytic Bone Metastases of Breast Cancer and Osteolytic Lesions of Multiple Myeloma Pamidronate disodium is indicated, in conjunction with standard antineoplastic therapy, for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma. The pamidronate disodium treatment effect appeared to be smaller in the study of breast cancer patients receiving hormonal therapy than in the study of those receiving chemotherapy, however, overall evidence of clinical benefit has been demonstrated (see CLINICAL PHARMACOLOGY, Osteolytic Bone Metastases of Breast Cancer and Osteolytic Lesions of Multiple Myeloma, Clinical Trials section). Pamidronate disodium is contraindicated in patients with clinically significant hypersensitivity to pamidronate disodium or other bisphosphonates.

Resumo do produto:

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. NDC 61703-324-18 Carton of 1 Single-dose vial 30 mg/10 mL (3 mg/mL) Vials – 6 mg/mL, 10 mL vial - each contains 60 mg of Pamidronate Disodium and 400 mg of Mannitol, USP in 10 mL Water for Injection, USP. NDC 61703-325-18 Carton of 1 Single-dose vial 60 mg/10 mL (6 mg/mL) 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. NDC 61703-326-18 Carton of 1 Single-dose vial 90 mg/10 mL (9 mg/mL) Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1156-3.0 Revised: 4/2021

Status de autorização:

Abbreviated New Drug Application

Características técnicas

PAMIDRONATE DISODIUM- PAMIDRONATE DISODIUM INJECTION, SOLUTION
HOSPIRA, INC.
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PAMIDRONATE DISODIUM INJECTION
FOR INTRAVENOUS INFUSION
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Pamidronate disodium is a bisphosphonate available in 30 mg, 60 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 vial contains: 3 mg Pamidronate
Disodium; 47 mg
Mannitol, USP; Water for Injection, USP, q.s.; Phosphoric Acid and/or
Sodium Hydroxide,
as necessary to adjust pH. Each mL of the 60 mg vial contains: 6 mg
Pamidronate
Disodium; 40 mg Mannitol, USP; Water for Injection, USP, q.s.;
Phosphoric Acid and/or
Sodium Hydroxide, as necessary 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 and/or Sodium Hydroxide, as necessary 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, USP, Phosphoric Acid and/or Sodium
Hydroxide, as
necessary (for adjustment to pH range of 6.0 - 7.0) and Water for
Injection, USP.
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 t