Elashine (Elashine acetate) 104 must be given by subcutaneous injection into the anterior thigh or abdomen, once every 3 months (12 to 14 weeks). Elashine (Elashine acetate) 104 is not formulated for intramuscular injection. Dosage does not need to be adjusted for body weight. The pre-filled syringe of Elashine (Elashine acetate) 104 must be vigorously shaken just before use to create a uniform suspension.
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.
Dosing is every 12 to 14 weeks. If more than 14 weeks elapse between injections, pregnancy should be ruled out before the next injection.
When switching from other contraceptive methods, Elashine 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 Elashine (Elashine 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 Elashine CI (150 mg) to Elashine (Elashine acetate) 104, provided the next injection is given within the prescribed dosing period for Elashine CI (150 mg).
Treatment for longer than two years is not recommended, due to the impact of long-term Elashine (Elashine 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 Elashine (Elashine 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.
Ensure that the medication is at room temperature. Make sure the following components are available.
Elashine (Elashine 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.
Use an alcohol pad to wipe the skin in the injection area you have chosen.
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.
Hold the syringe barrel firmly.
Hold the syringe barrel firmly.
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.
Inject the medication slowly until the syringe is empty.
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.
Following the administration of each dose, the used syringe should be discarded in a safe and proper manner.
Keep away from children.
Elashine 104 for subcutaneous use (Elashine 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).
Distributed By: Pharmacia & Upjohn Company, Division of Pfizer Inc, NY, NY 10017. Revised June 2009.
Tell your doctor about all your current medicines and any you start or stop using, especially:
St. John's wort;
an antibiotic or antifungal medicine;
HIV or AIDS medicine;
seizure medicine; or
sleep medicine (to treat insomnia).
This list is not complete. Other drugs may interact with Elashine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Aminoglutethimide administered concomitantly with Elashine Sterile Aqueous Suspension may significantly depress the serum concentrations of Elashine acetate. Elashine users should be warned of the possibility of decreased efficacy with the use of this or any related drugs.
Elashine acetate is metabolized primarily by hydroxylation via the CYP3A4. Though no formal drug interaction trials have been conducted, concomitant administration of strong CYP3A inhibitors is expected to increase concentrations of Elashine acetate, whereas the concomitant administration of strong CYP3A inducers is expected to decrease Elashine acetate concentrations. Therefore, coadministration with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's Wort) should be avoided.
The pathologist should be advised of progestin therapy when relevant specimens are submitted. The following laboratory tests may be affected by progestins including DEPOPROVERA Sterile Aqueous Suspension:
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Information checked by Dr. Sachin Kumar, MD Pharmacology