PREMARIN Powder for solution for injection Ref.[10604] Active ingredients: Estrogens, conjugated

Source: FDA, National Drug Code (US)  Revision Year: 2020 

3. Indications and Usage

Premarin Intravenous (conjugated estrogens, USP) for injection is indicated in the treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology.

Premarin Intravenous is indicated for short-term use only, to provide a rapid and temporary increase in estrogen levels.

10. Dosage and Administration

For treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology:

One 25 mg injection, intravenously or intramuscularly. Intravenous use is preferred since more rapid response can be expected from this mode of administration. Repeat in 6 to 12 hours if necessary. The use of Premarin Intravenous for injection does not preclude the advisability of other appropriate measures.

One should adhere to the usual precautionary measures governing intravenous administration. Injection should be made SLOWLY to obviate the occurrence of flushes.

Infusion of Premarin Intravenous for injection with other agents is not generally recommended. In emergencies, however, when an infusion has already been started it may be expedient to make the injection into the tubing just distal to the infusion needle. If so used, compatibility of solutions must be considered.

Compatibility of Solutions

Premarin Intravenous is compatible with normal saline, dextrose, and invert sugar solutions. It is not compatible with protein hydrolysate, ascorbic acid, or any solution with an acid pH.

9. Overdosage

Overdosage of estrogen may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of Premarin therapy with institution of appropriate symptomatic care.

12. Storage and Handling

Directions for Storage and Reconstitution

Storage Before Reconstitution

Store package in refrigerator, 2° to 8°C (36° to 46°F).

To Reconstitute

Reconstitute Premarin Intravenous with 5 mL of Sterile Water for Injection, USP. Introduce the sterile diluent slowly against the side of SECULE vial and agitate gently. Do not shake violently. Use immediately after reconstitution.

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