MEDROXYPROGESTERONE ACETATE injection, suspension, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Medroxyprogesterone acetate (UNII: C2QI4IOI2G) (medroxyprogesterone - UNII:HSU1C9YRES)

Available from:

Amphastar Pharmaceuticals, Inc.

INN (International Name):

Medroxyprogesterone acetate

Composition:

Medroxyprogesterone acetate 150 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Medroxyprogesterone acetate is indicated only for the prevention of pregnancy. The loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use Medroxyprogesterone acetate long-term [see Warnings and Precautions (5.1)] . The use of Medroxyprogesterone acetate is contraindicated in the following conditions: - Known or suspected pregnancy or as a diagnostic test for pregnancy. - Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [see Warnings and Precautions (5.2)] . - Known or suspected malignancy of breast [see Warnings and Precautions (5.3)]. - Known hypersensitivity to Medroxyprogesterone acetate or any of its other ingredients [see Warnings and Precautions (5.5)] . - Significant liver disease [see Warnings and Precautions (5.6)]. - Undiagnosed vaginal bleeding

Product summary:

Medroxyprogesterone acetate injectable suspension, USP, 150 mg/mL is available as: The 1 mL dose vials are packaged in individual cartons.  The 1 mL dose vials are packaged with 25 vials per carton. The 1 mL dose syringes are packaged in individual cartons. Each syringe is packaged with a 22 gauge × 1 1/2 inch needle with the Needle-Pro® EDGETM Safety Device. Instructions for using the Needle: 1. WARNINGS for use with the Needle-Pro® EDGE™ Safety Device: 1.1   A needle stick with a contaminated needle may cause infectious diseases. 1.2   Intentional disengagement of the Needle-Pro® EDGE™ safety device may result in a needle stick with a contaminated needle. 1.3   Bent or damaged needles can result in breakage or damage to the tissue or accidental needle puncture. If the needle is bent or damaged, no attempt should be made to straighten the needle or engage the Needle-Pro® EDGE™ safety device. Immediately discard into a sharps container. The Needle-Pro® EDGE™ safety device may not properly contain a bent needle and/or the needle could puncture the needle protection device which may result in a needle stick with a contaminated needle. 1.4   Mishandling of this device, including excessive engagement force, may cause the needle to protrude from the needle protection device which may result in a contaminated needle stick. 1.5   Do not use free hand to press sheath over the needle. This may result in a needle stick with a contaminated needle. 2.   CAUTIONS for use with the Needle-Pro® EDGE™ Safety Device: 2.1   Follow standard infection control procedures as specified by the Centers for Disease Control and Prevention (USA) or local equivalent. 2.2   Do Not Reuse: Medical devices require specific material characteristics to perform as intended. These characteristics have been verified for single use only. Any attempt to re-process the device for subsequent reuse may adversely affect the integrity of the device or lead to deterioration in performance. 3.   INSTRUCTIONS for use of the Prefilled Syringe with the Needle-Pro® EDGE™ Safety Device: 3.1   Remove syringe end cap exposing the luer fitting. Peel blister pouch for the Needle-Pro® EDGE™ safety device open half way. Grasp sheath using the plastic peel pouch. To prevent contamination, be careful not to touch the needle’s Luer connector. 3.2   Attach prefilled syringe to the Luer connection of the Needle-Pro® EDGE™ safety device. Insert plunger rod into open end of syringe until it contacts the stopper. Secure with 3 clockwise half turns. Shake vigorously with needle cap in place. 3.3   Pull needle cap (plastic component covering needle) straight away from the needle. Do not twist cap as Needle-Pro® EDGE™ safety device may be loosened from the prefilled syringe. 3.4   For user convenience, the needle is in the “bevel up” position when the safety sheath is located to the right as indicated by the “arrow” on the device. 3.5   Perform injection according to local standard practice using aseptic technique. 3.6   After procedure is completed, actuate needle protection by pressing the sheath against a flat surface using a one-handed technique. An audible click may be heard as an indication that the needle is engaged into the needle protection device. AS THE SHEATH IS PRESSED (FIGURE 1), THE NEEDLE IS FIRMLY ENGAGED INTO THE SHEATH (FIGURE 2). 3.7   Visually confirm that the needle is fully engaged into the needle protection sheath.3.8   After use, place syringe and needle into a sharps container. Dispose of sharps container containing used syringe and needle in a safe manner according to Centers for Disease Control and Prevention, USA and Federal/State/Local regulations (EPA, OSHA) and health care facility guidelines or local equivalent. The Smiths Medical and Jelco design marks; Needle-Pro® EDGE; and the color orange applied to the needle protection device are trademarks of the Smiths Medical family of companies. The symbol ® indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other countries. The products described are covered by one or more of the following: U.S. Patent No. RE37, 110; counterpart foreign patent(s); and other U.S. and/or foreign pending patents. Syringe must be stored in carton at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] until ready for use. Vials MUST be stored upright at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEDROXYPROGESTERONE ACETATE- MEDROXYPROGESTERONE ACETATE INJECTION,
SUSPENSION, EXTENDED RELEASE
AMPHASTAR PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEDROXYPROGESTERONE
ACETATE CONTRACEPTIVE INJECTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
MEDROXYPROGESTERONE ACETATE CONTRACEPTIVE INJECTION.
MEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION, FOR INTRAMUSCULAR
USE
INITIAL U.S. APPROVAL: 1959
WARNING: LOSS OF BONE MINERAL DENSITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WOMEN WHO USE MEDROXYPROGESTERONE ACETATE CONTRACEPTIVE INJECTION MAY
LOSE
SIGNIFICANT BONE MINERAL DENSITY. BONE LOSS IS GREATER WITH INCREASING
DURATION OF
USE AND MAY NOT BE COMPLETELY REVERSIBLE. (5.1)
IT IS UNKNOWN IF USE OF MEDROXYPROGESTERONE ACETATE CONTRACEPTIVE
INJECTION DURING
ADOLESCENCE OR EARLY ADULTHOOD, A CRITICAL PERIOD OF BONE ACCRETION,
WILL REDUCE PEAK
BONE MASS AND INCREASE THE RISK FOR OSTEOPOROTIC FRACTURE IN LATER
LIFE. (5.1)
MEDROXYPROGESTERONE ACETATE CONTRACEPTIVE INJECTION SHOULD NOT BE USED
AS A LONG-
TERM BIRTH CONTROL METHOD (I.E., LONGER THAN 2 YEARS) UNLESS OTHER
BIRTH CONTROL
METHODS ARE CONSIDERED INADEQUATE. (5.1)
RECENT MAJOR CHANGES
Dosage and Administration, Prevention of Pregnancy (2.1) 11/2016
Warnings and Precautions, Injection Site Reactions (5.6) 11/2016
INDICATIONS AND USAGE
Medroxyprogesterone acetate is a progestin indicated only for the
prevention of pregnancy. (1)
DOSAGE AND ADMINISTRATION
The recommended dose is 150 mg of Medroxyprogesterone acetate every 3
months (13 weeks)
administered by deep, intramuscular (IM) injection in the gluteal or
deltoid muscle. (2.1)
DOSAGE FORMS AND STRENGTHS
Vials containing sterile aqueous suspension: 150 mg per mL (3)
Prefilled syringes: prefilled syringes are available packaged with
22-gauge × 1 1/2 inch Needle-Pro
EDGE™ Safety Device (3)
CONTRAINDICATIONS
Known or suspected pregnancy or as a diagnostic test for pregnancy.
(4