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Protropin

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Protropin

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Indications
Dosage
How Supplied

INDICATIONS

Protropin® (somatrem for injection) is indicated only for the long- term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion. Other etiologies of short stature should be excluded.

DOSAGE AND ADMINISTRATION

A weekly dosage of 0.30 mg/kg (approximately 0.90 IU/kg) of body weight administered by daily intramuscular or subcutaneous injection is recommended.

The Protropin® (somatrem for injection) dosage and administration schedule should be individualized for each patient. Therapy should not be continued if final height is achieved or epiphyseal fusion occurs. Patients who fail to respond adequately while on Protropin (somatrem) therapy should be evaluated to determine the cause of unresponsiveness.

After the dose has been determined, reconstitute as follows: each 5 mg vial should be reconstituted with 1-5 mL of Bacteriostatic Water for Injection, USP (benzyl alcohol preserved); or each 10 mg vial should be reconstituted with 1-10 mL Bacteriostatic Water for Injection, USP (benzyl alcohol preserved) only. For use in newborns see WARNINGS. The pH of Protropin (somatrem) after reconstitution with Bacteriostatic Water for Injection, USP (benzyl alcohol preserved) is approximately 7.8.

To prepare the Protropin (somatrem) solution, inject the Bacteriostatic Water for Injection, USP (benzyl alcohol preserved) into the Protropin (somatrem) vial, aiming the stream of liquid against the glass wall. Then swirl the product vial with a GENTLE rotary motion until the contents are completely dissolved. DO NOT SHAKE. Because Protropin (somatrem) is a protein, shaking can result in a cloudy solution. The Protropin (somatrem) solution should be clear immediately after reconstitution. Occasionally, after refrigeration, you may notice that small colorless particles of protein are present in the Protropin (somatrem) solution. This is not unusual for solutions containing proteins. If the solution is cloudy immediately after reconstitution or refrigeration, the contents MUST NOT be injected.

Before needle insertion, wipe the septum of both the Protropin (somatrem) and diluent vials with rubbing alcohol or an antiseptic solution to prevent contamination of the contents by microorganisms that may be introduced by repeated needle insertions. It is recommended that Protropin (somatrem) be administered using sterile, disposable syringes and needles. The syringes should be of small enough volume that the prescribed dose can be drawn from the vial with reasonable accuracy.

HOW SUPPLIED

Protropin® (somatrem for injection) is supplied as 5 mg (approximately 15 IU) or 10 mg (approximately 30 IU) of lyophilized, sterile, somatrem per vial.

Each 5 mg carton contains two vials of Protropin® (somatrem for injection) (5 mg per vial) and one 10 mL multiple dose vial of Bacteriostatic Water for Injection, USP (benzyl alcohol preserved). NDC 50242-015-02

Each 10 mg carton contains two vials of Protropin® (somatrem for injection) (10 mg per vial) and two 10 mL multiple dose vials of Bacteriostatic Water for Injection, USP (benzyl alcohol preserved). NDC 50242-016-20

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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