depo-subQ provera 104 contains medroxyprogesterone acetate (MPA), a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate is active by the parenteral and oral routes of administration. It is a white to off-white, odorless crystalline powder that is stable in air and that melts between 205°and 209°C. It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is 17-hydroxy-6α-methylpregn-4ene-3,20-dione 17-acetate. The structural formula is as follows: depo-subQ provera (medroxyprogesterone acetate) 104 for subcutaneous (SC) injection is available in pre-filled syringes (160 mg/mL), each containing 0.65 mL (104 mg) of medroxyprogesterone acetate sterile aqueous suspension. Each 0.65 mL contains: Medroxyprogesterone acetate 104 mg Methylparaben 1.040 mg Propylparaben 0.098 mg Sodium Chloride 5.200 mg Polyethylene Glycol 18.688 mg Polysorbate 80 1.950 mg Monobasic Sodium Phosphate. H2O 0.451 mg Dibasic Sodium Phosphate . 12H2O 0.382 mg Methionine 0.975 mg Povidone 3.250 mg Water for Injection qs When necessary, the pH is adjusted with sodium hydroxide or hydrochloric acid, or both.

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In five clinical studies of depo-subQ provera (medroxyprogesterone acetate) 104 involving 2,325 women (282 treated for up to 6 months, 1,780 treated for up to 1 year and 263 treated for up to 2 years), 9% of women discontinued treatment for adverse reactions. Among these 212 women, the most common reasons for discontinuation were:

• Uterine bleeding irregularities (35%, n=75)
• Increased weight (18%, n=39)
• Decreased libido (11%, n=23)
• Acne (10%, n=21)
• Injection site reactions (6%, n=12)

Adverse reactions reported by 5% or more of all women in these clinical trials included:

• Headache (9%)
• Intermenstrual bleeding (7%)
• Increased weight (6%)
• Amenorrhea (6%)
• Injection site reactions (5%)

Adverse reactions reported by 1% to < 5% of all women in these clinical trials included: General disorders: fatigue, injection site pain Gastrointestinal disorders: abdominal distention, abdominal pain, diarrhea, nausea Infections: bronchitis, influenza, nasopharyngitis, pharyngitis, sinusitis, upper respiratory tract infection, urinary tract infection, vaginal candidiasis, vaginitis, vaginitis bacterial Investigations: abnormal cervix smear Musculoskeletal, connective tissue, and bone disorders: arthralgia, back pain, limb pain Nervous system disorders: dizziness, insomnia Psychiatric disorders: anxiety, depression, irritability, decreased libido Reproductive system and breast disorders: breast pain, breast tenderness, menometrorrhagia, menorrhagia, menstruation irregular, uterine hemorrhage, vaginal hemorrhage Skin disorders: acne Vascular disorders: hot flushes Postmarketing Experience There have been rare cases of osteoporosis including osteoporotic fractures reported postmarketing in patients taking DEPO-PROVERA Contraceptive Injection. In addition, infrequent voluntary reports of anaphylaxis and anaphylactoid reaction have been received associated with use of Depo-Provera CI (150 mg). The following additional reactions have been reported with Depo-Provera Contraceptive Injection and may occur with use of depo-subQ provera 104: General disorders: asthenia, axillary swelling, chills, chest pain, fever, excessive thirst Blood and lymphatic system disorders: anemia, blood dyscrasia Cardiac disorders: tachycardia Gastrointestinal disorders: gastrointestinal disturbances, rectal bleeding Hepato-biliary disorders: jaundice Immune system disorders: allergic reaction Infections:genitourinary infections Investigations: decreased glucose tolerance Musculoskeletal, connective tissue, and bone disorders: loss of bone mineral density, scleroderma Neoplasms: breast cancer, cervical cancer Nervous system disorders: convulsions, facial palsy, fainting, paralysis, paresthesia, somnolence Psychiatric disorders: increased libido, nervousness Reproductive system and breast disorders: breast lumps, galactorrhea, nipple discharge or bleeding, oligomenorrhea, prevention of lactation, prolonged anovulation, unexpected pregnancy, uterine hyperplasia, vaginal cyst Respiratory disorders: asthma, dyspnea, hoarseness Skin disorders: angioedema, dry skin, increased body odor, melasma, pruritus, urticaria Vascular disorders: deep vein thrombosis, pulmonary embolus, thrombophlebitis Read the Depo-SubQ Provera (medroxyprogesterone acetate) Side Effects Center for a complete guide to possible side effectsLearn More »

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Contraception And Endometriosis Indications Route of Administration depo-subQ provera (medroxyprogesterone acetate) 104 must be given by subcutaneous injection into the anterior thigh or abdomen, once every 3 months (12 to 14 weeks). depo-subQ provera (medroxyprogesterone acetate) 104 is not formulated for intramuscular injection. Dosage does not need to be adjusted for body weight. The pre-filled syringe of depo-subQ provera (medroxyprogesterone acetate) 104 must be vigorously shaken just before use to create a uniform suspension. First Injection Ensure that the patient is not pregnant at the time of the first injection. For women who are sexually active and having regular menses, the first injection should be given only during the first 5 days of a normal menstrual period. Women who are breast-feeding may have their first injection during or after their sixth postpartum week. Second and Subsequent Injections Dosing is every 12 to 14 weeks. If more than 14 weeks elapse between injections, pregnancy should be ruled out before the next injection. If Using For Contraception And Switching From Another Method When switching from other contraceptive methods, depo-subQ provera 104 should be given in a manner that ensures continuous contraceptive coverage. For example, patients switching from combined (estrogen plus progestin) contraceptives should have their first injection of depo-subQ provera (medroxyprogesterone acetate) 104 within 7 days after the last day of using that method (7 days after taking the last active pill, removing the patch or ring). Similarly, contraceptive coverage will be maintained in switching from Depo-Provera CI (150 mg) to depo-subQ provera (medroxyprogesterone acetate) 104, provided the next injection is given within the prescribed dosing period for Depo-Provera CI (150 mg). If Using For Treatment Of Endometriosis Treatment for longer than two years is not recommended, due to the impact of long-term depo-subQ provera (medroxyprogesterone acetate) 104 on bone mineral density. If symptoms return after discontinuation of treatment, bone mineral density should be evaluated prior to retreatment. Instructions for Use of depo-subQ provera (medroxyprogesterone acetate) 104 FOR SUBCUTANEOUS ADMINISTRATION ONLY. Please read these instructions carefully. It is very important that the entire dose of deposubQ provera 104 is given. Getting ready Ensure that the medication is at room temperature. Make sure the following components are available. depo-subQ provera (medroxyprogesterone acetate) 104, as with other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration. Step 1: Choosing & preparing Choose the injection area.

• Avoid boney areas and the umbilicus
• The upper thigh & abdomen are preferred injection sites. See shaded areas in diagram

Use an alcohol pad to wipe the skin in the injection area you have chosen.

• Allow the skin to dry

Preferred injection areas: Step 2: Syringe preparation Carefully remove the needle and syringe from the packaging. Hold the syringe firmly by the barrel, with the barrel pointing upward.

• Shake it forcefully for at least 1 minute to thoroughly mix the medication

Hold the syringe barrel firmly.

• Unscrew the protective cap from the tip of the syringe barrel

Hold the syringe barrel firmly.

• Attach the needle to the barrel of the syringe by pushing down firmly with a slight twist

• Move the safety shield away from the needle and toward the syringe barrel. The safety shield will remain in an open 45 to 90 degree position

• While holding the syringe barrel firmly, remove the plastic cover from the needle without twisting, ensuring the needle is still firmly attached to the syringe

• While holding the syringe with the needle pointing upward, gently push in the plunger until the medicine is up to the top of the syringe. There should be no air within the barrel

Step 3: Injecting the dose Gently grasp and squeeze a large area of skin in the chosen injection area between the thumb and forefinger, pulling it away from the body. Insert the needle at a 45 degree angle so that most of the needle is in the fatty tissue.

• The plastic hub of the needle should be nearly or almost touching the skin

Inject the medication slowly until the syringe is empty.

• It is important that the entire dose of deposubQ provera 104 is given
• This should take about 5–7 seconds

Step 4: Disposing the needle and syringe After completing the injection, remove the needle from the skin and activate the safety shield. Position shield about 40°- 45°. With a firm quick motion, press down against a flat surface until a click is heard or felt. If uncertain that the safety shield is fully engaged, repeat this step. Use a clean cotton pad to press lightly on the injection area for a few seconds.

• Do NOT rub the area

Following the administration of each dose, the used syringe should be discarded in a safe and proper manner. Keep away from children.

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No drug-drug interaction studies have been conducted with depo-subQ provera (medroxyprogesterone acetate) 104. Aminoglutethimide administered concomitantly with depo-subQ provera (medroxyprogesterone acetate) 104 may significantly decrease the serum concentrations of MPA. Read the Depo-SubQ Provera Drug Interactions Center for a complete guide to possible interactions Learn More »

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depo-subQ provera (medroxyprogesterone acetate) 104 is indicated for the prevention of pregnancy in women of child bearing potential. depo-subQ provera (medroxyprogesterone acetate) 104 also is indicated for management of endometriosis-associated pain. In considering use for either indication, 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 depo-subQ provera 104 long-term (see WARNINGS). Contraception Studies In three clinical studies, no pregnancies were detected among 2,042 women using deposubQ provera 104 for up to 1 year. The Pearl Index pregnancy rate in women who were less than 36 years old at baseline, based on cycles in which they used no other contraceptive methods, was 0 pregnancies per 100 women-years of use (upper 95% confidence interval = 0.25). Pregnancy rates for various contraceptive methods are typically reported for only the first year of use and are shown in Table 2. Table 2 : Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year: United States
Method % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women
Continuing
Use at 1 Year 3 Typical Use1 Perfect Use2 Chance4 85 85   Spermicides5 26 6 40 Periodic Abstinence 25   63   Calendar   9     Ovulation Method   3     Symptothermal6   2     Post-ovulation   1   Cap7     Parous Women 40 26 42   Nulliparous Women 20 9 56 Sponge         Parous Women 40 20 42   Nulliparous Women 20 9 56 Diaphragm7 20 6 56 Withdrawal 19 4   Condom8     Female (Reality) 21 5 56   Male 14 3 61 Pill 5   71   Progestin only   0.5     Combined   0.1   IUD     Progesterone T 2.0 1.5 81   Copper T 380A 0.8 0.6 78   LNg 20 0.1 0.1 81 Depo-Provera IM 150 mg 0.3 0.3 70 Norplant and Norplant-2 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100 Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10
Source: Hatcher et al., 1998.

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1. Known or suspected pregnancy.
2. Undiagnosed vaginal bleeding.
3. Known or suspected malignancy of breast.
4. Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease.
5. Significant liver disease.
6. Known hypersensitivity to medroxyprogesterone acetate or any of its other ingredients.

Last reviewed on RxList: 7/27/2009
This monograph has been modified to include the generic and brand name in many instances.

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No information provided.

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depo-subQ provera 104 for subcutaneous use (medroxyprogesterone acetate injectable suspension 104 mg/0.65 mL) is available as a pre-filled syringe, packaged with a 26gauge x 3/8 inch Terumo® Surguard™ needle in the following presentation: NDC 0009-4709-13 0.65 mL single-use, disposable syringe Store at controlled room temperature 20°to 25°C (68°to 77°F) [see USP]. Distributed By: Pharmacia & Upjohn Company, Division of Pfizer Inc, NY, NY 10017. Revised June 2009. Last reviewed on RxList: 7/27/2009
This monograph has been modified to include the generic and brand name in many instances.

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Physical Examination It is good medical practice for all women to have annual history and physical examinations, including women using depo-subQ provera (medroxyprogesterone acetate) 104. The physical examination, however, may be deferred until after initiation of depo-subQ provera (medroxyprogesterone acetate) 104 if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care. Fluid Retention Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction, require careful observation. Weight Gain Weight gain is a common occurrence in women using depo-subQ provera 104. In three large clinical trials using depo-subQ provera (medroxyprogesterone acetate) 104, the mean weight gain was 3.5 lb in the first year of use. In a small, two-year study comparing depo-subQ provera (medroxyprogesterone acetate) 104 to Depo-Provera CI (150 mg), the mean weight gain observed for women using depo-subQ provera (medroxyprogesterone acetate) 104 (7.5 lb) was similar to the mean weight gain for women using Depo-Provera CI, 150 mg (7.6 lb). Although there are no data related to weight gain beyond 2 years for depo-subQ provera (medroxyprogesterone acetate) 104, the data on Depo-Provera CI (150 mg) may be relevant. In a clinical study, after five years, 41 women using Depo-Provera CI (150 mg) had a mean weight gain of 11.2 lb, while 114 women using non-hormonal contraception had a mean weight gain of 6.4 lb. Return to Ovulation and Fertility Return to ovulation is likely to be delayed after stopping therapy. Among 15 women who received multiple doses of depo-subQ provera (medroxyprogesterone acetate) 104:

• Median time to ovulation was 10 months after the last injection
• Earliest return to ovulation was 6 months after the last injection
• 12 women (80%) ovulated within 1 year of the last injection

However, ovulation has occurred as early as 14 weeks after a single dose of depo-subQ provera (medroxyprogesterone acetate) 104, and therefore it is important to follow the recommended dosing schedule. Return to fertility also is likely to be delayed after stopping therapy. Among 28 women using depo-subQ provera (medroxyprogesterone acetate) 104 for contraception who stopped treatment to become pregnant, 1 became pregnant within 1 year of her last injection. A second woman became pregnant 443 days after her last injection. Seven women were lost to follow-up. Depression Patients with a history of treatment for clinical depression should be carefully monitored while receiving depo-subQ provera (medroxyprogesterone acetate) 104. Injection Site Reactions In 5 clinical studies of depo-subQ provera (medroxyprogesterone acetate) 104 involving 2,325 women (282 treated for up to 6 months, 1,780 treated for up to 1 year and 263 women treated for up to 2 years), 5% of women reported injection site reactions, and 1% had persistent skin changes, typically described as small areas of induration or atrophy. Carbohydrate/Metabolism Some patients receiving progestins may exhibit a decrease in

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