Elashine Dosage

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• Dosage of Elashine in details
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Dosage of Elashine in details

Contraception And Endometriosis Indications

Route of Administration

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.

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, 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).

If Using For Treatment Of Endometriosis

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.

Getting ready

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.

• 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.

How supplied

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.

What other drugs will affect Elashine?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• bosentan;

• griseofulvin;

• 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.

Elashine interactions

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.

In vitro

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.

Laboratory Test Interactions

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:

1. Plasma and urinary steroid levels are decreased (e.g. progesterone, estradiol, pregnanediol, testosterone, cortisol).
2. Gonadotropin levels are decreased.
3. Sex-hormone binding globulin concentrations are decreased.
4. Protein bound iodine and butanol extractable protein bound iodine may increase. T3 uptake values may decrease.
5. Coagulation test values for prothrombin (Factor II), and Factors VII, VIII, IX, and X may increase.
6. Sulfobromophthalein and other liver function test values may be increased.
7. The effects of Elashine acetate on lipid metabolism are inconsistent. Both increases and decreases in total cholesterol, triglycerides, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol have been observed in studies.

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Information checked by Dr. Sachin Kumar, MD Pharmacology