Emkit

How should I use Emkit?

Use Emkit as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Emkit. Talk to your pharmacist if you have questions about this information.
• Take Emkit as soon as possible after suspected birth control failure or after you have unprotected sexual intercourse. The first dose must be taken within 72 hours. Take the second tablet 12 hours after the first tablet. However, your doctor may instruct you to take Emkit in a different way. Follow the directions provided by your doctor.
• Emkit can be used any time during the menstrual cycle.
• If vomiting occurs within 1 hour after taking either tablet of Emkit, talk with your health care provider to discuss whether to repeat that dose.
• A physical exam is not needed before taking Emkit. If you are unsure about your general health or pregnancy status, a follow-up physical or pelvic exam may be needed after taking Emkit.
• If you miss a dose of Emkit, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Emkit.

Uses of Emkit in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

Emkit, is an emergency hormonal contraceptive used to help prevent a pregnancy when taken within 72 hours (3 days) of having had unprotected sex or if usual method of contraception has failed. It is also i available as a T-shaped intrauterine delivery system (IUD) which is used for the prevention of pregnancy (contraception) for up to three years.

Emkit description

A synthetic progestational hormone with actions similar to those of progesterone and about twice as potent as its racemic or (+-)-isomer (norgestrel). It is used for contraception, control of menstrual disorders, and treatment of endometriosis. It is usually supplied in a racemic mixture (Norgestrel, 6533-00-2). Only the Emkit isomer is active. Emkit is marketed mostly as a combination oral contraceptive under several brand names such as Alesse, Triphasil, and Min-Ovral.

Emkit dosage

Emkit® (Emkit implants (unavailable in us)) implants are a set of two flexible cylindrical implants, each containing 75 mg of the progestin Emkit. The total administered (implanted) dose is 150 mg. Insertion of the two implants should be performed during the first 7 days following the onset of menses by a health-care professional familiar with the Emkit implant insertion technique. It is strongly recommended that all health-care providers receive instruction in the proper insertion and removal procedures. Insertion is subdermal in the midportion of the inner surface of the upper arm about 8 to 10 cm above the medial epicondyle. The two implants should be placed in a "V" shape about 30 degrees apart. Proper insertion will facilitate removal.

How supplied

Emkit® implants are supplied in a sterile package containing a set of two Emkit-containing implants.

Store at room temperature, 15-30° C (59-86°F)

References available upon request.

Instructions For Insertion And Removal

Emkit® implants are a set of two cylindrical Emkit-releasing implants that are inserted subdermally in the medial aspect of the upper arm.

Emkit® (Emkit implants (unavailable in us)) implants provide up to 5 years of effective contraceptive protection.

The basis for successful use and subsequent removal of Emkit® (Emkit implants (unavailable in us)) implants is a correct and carefully performed subdermal insertion of the two implants. It is recommended that health-care professionals performing insertions or removals of Emkit® (Emkit implants (unavailable in us)) implants be instructed and supervised in proper techniques prior to attempting these procedures independently. During insertion, special attention should be given to the following:

-aseptic technique

-correct subdermal placement of the implants

-careful technique to minimize tissue trauma.

This will help to avoid infections and excessive scarring at the insertion area and will help keep the implants from being inserted too deeply in the tissue. If the implants are placed too deeply, they will be more difficult to remove than correctly placed subdermal implants.

Insertion Procedure

Insertion should be performed within 7 days from the onset of menses. However, Emkit® (Emkit implants (unavailable in us)) implants may be inserted at any time during the cycle provided that the possibility of ovulation and conception has been considered, pregnancy has been excluded, and a nonhormonal contraceptive method is used for at least 7 days. If ovulation and conception have already occurred, pregnancy may be established in the month of insertion. It is recommended that a complete history and physical examination, including a gynecologic examination, be performed before the insertion of Emkit® (Emkit implants (unavailable in us)) implants. Determine if the subject has any allergies to the antiseptic or anesthetic to be used or any contraindications to the use of Emkit or any of the components of the implants. If none are found, the implants are inserted using the procedure outlined below.

One Emkit® unit consists of two Emkit implants in a sterile pouch. The insertion is performed under aseptic conditions using a trocar to place the implants under the skin.

Figure 1: The following equipment is recommended for the insertion:

— an examining table for the patient to lie on.

— sterile surgical drapes, sterile gloves (free of talc), antiseptic solution.

— local anesthetic, needles, and syringe.

— #11 scalpel, #10 trocar, forceps.

— skin closure, sterile gauze, and compresses.

Figure 2: Have the patient lie on her back on the examination table with her nondominant arm flexed at the elbow and externally rotated so that her hand is lying by her head. The implants will be inserted subdermally and positioned in a "V" shape. The optimal insertion area is in the inner surface of the upper arm about 8 to 10 cm above the medial epicondyle.

Figure 3: Clean the patient's upper arm with antiseptic solution and then frame the insertion area with a fenestrated drape.

Figure 4: Open the Emkit® (Emkit implants (unavailable in us)) package carefully by pulling apart the sheets of the pouch, allowing the two implants to fall onto a sterile drape.

Figure 5: After determining the absence of known allergies to the anesthetic agent or related drugs, fill a 5-mL syringe with the local anesthetic. Since blood loss is minimal with this procedure, use of epinephrine-containing anesthetics is not considered necessary.

Anesthetize the insertion area by first inserting the needle under the skin and injecting a small amount of anesthetic. Then anesthetize two areas about 4.5 cm long, to mimic the V shape of the implantation site.

Figure 6: Use the scalpel to make a small incision (about 2 mm) just through the dermis of the skin.

Alternatively, the trocar may be inserted directly through the skin without making an incision with the scalpel. The bevel of the trocar should always face up during the insertion.

Figure 7: The trocar has three marks on it. The mark closest to the hub indicates how far the trocar should be introduced under the skin to place the Emkit® (Emkit implants (unavailable in us)) implants. The middle mark (indicated by the small arrow) is not used with Emkit® (Emkit implants (unavailable in us)) insertions and should be ignored. The mark closest to the tip indicates how much of the trocar should remain under the skin following placement of the first implant.

Figure 8: Insert the tip of the trocar beneath the skin at a shallow angle. Throughout the insertion procedure, the trocar should be oriented with the bevel up. It is important to keep the trocar subdermal by tenting the skin with the trocar, as failure to do so may result in deep placement of the implants and could make removal more difficult. Advance the trocar gently under the skin to the mark nearest the hub of the trocar; be careful to use the appropriate mark. Do not force the trocar, and if resistance is encountered, try another direction.

Figure 9: When the trocar has been inserted the appropriate distance, remove the obturator and load the first implant into the trocar using the thumb and forefinger.

Figure 10: Gently advance the implant with the obturator towards the tip of the trocar until you feel resistance. Never force the obturator.

Figure 11: Then holding the obturator stationary, withdraw the trocar to the mark closest to the trocar tip. It is important to keep the obturator stationary and not to push the implant into the tissue. Do not completely remove the trocar until both implants have been placed. The trocar is withdrawn only to the mark closest to its tip.

Figure 12: The implant should have been released under the skin when the mark closest to the tip of the trocar is visible at the insertion point. Release of the implant can be checked by palpation.

Figure 13a: To place the second implant, align the trocar so that the second implant will be positioned at about a 30-degree angle relative to the first. Fix the position of the previous implant with the forefinger and middle finger of the free hand, and advance the trocar along the tips of the fingers. This will ensure a suitable distance of about 30 degrees between implants and keep the trocar from puncturing the previously inserted implant.

Figure 13b: Leave a distance of about 5 mm between the incision and the tips of the implants. This will help avoid spontaneous expulsions.

Figure 14: After placement of the second implant, a sterile gauze may be used to apply pressure briefly to the insertion site and ensure hemostasis. Palpate the distal ends of the implants to make sure that both have been properly placed.

Figure 15: Press the edges of the incision together, and close the incision with a skin closure. Suturing the incision should not be necessary.

Figure 16: Cover the placement area with a dry compress, and wrap gauze snugly around the arm to ensure hemostasis.

Observe the patient for a few minutes for signs of syncope or bleeding from the insertion site before she is discharged.

Advise the patient to keep the insertion area dry and avoid heavy lifting for 2 to 3 days. The gauze may be removed after 1 day, and the skin closure as soon as the insertion area has healed, ie, typically in 3 days.

Removal Procedure

Described below is a removal procedure which was used during the clinical trials for NORPLANT® implants and for Emkit® (Emkit implants (unavailable in us)) implants. As with many surgical procedures, variations of the technique have appeared and some have been published. No one particular procedure routinely appears to have advantage over another.

It is recommended that removals be scheduled so that preparations for carrying out the procedure can be facilitated.

Removal of the implants should be performed very gently and will take more time than insertion. Implants are sometimes nicked, cut, or broken during removal. The overall incidence of removal difficulties in the clinical trials, including damage to the implants, was 7.5%. If removal of the implant(s) proves difficult, close the incision and bandage the wound, and have the patient return for another visit. The remaining implant(s) will be easier to remove after the area is healed. It may be appropriate to seek consultation or provide referral for patients in whom initial attempts at implant removal prove difficult. A nonhormonal method of contraception should be used until both implants are completely removed.

The position of the patient and the need for aseptic technique are the same as for insertion.

Figure 17: The following equipment is needed for the removal:

— an examining table for the patient to lie on.

— sterile surgical drapes, sterile gloves (free of talc), antiseptic solution.

— local anesthetic, needles, and syringe.

— #11 scalpel, forceps (straight and curved mosquito).

— skin closure, sterile gauze, and compresses.

Figure 18: Palpate the area to locate both implants. If the implants cannot be palpated, they may be located by ultrasound (7 MHz) or X-ray (soft tissue). Once both implants are located, clean the patient's upper arm with antiseptic solution and then frame the area with a fenestrated drape. You may mark the position of the Emkit® (Emkit implants (unavailable in us)) implants with a sterile marker.

Figure 19: Once both implants are located, apply a small amount of local anesthetic at the skin and under the ends of the implants nearest the original incision site. This will serve to raise the ends of the implants. Anesthetic injected over the implants will obscure them and make removal more difficult. Additional small amounts of the anesthetic can be used for removal of the second implant, if required.

Figure 20: Make a 4-mm incision with the scalpel close to the proximal ends of the implants (below the bottom of the "V"). Do not make a large incision.

Figure 21: Push each implant gently towards the incision with the fingers. When the tip is visible or near to the incision, grasp it with a mosquito forceps.

Figure 22: Use the scalpel, the other forceps, or gauze to very gently open the tissue sheath that has formed around the implant.

Figures 23 and 24: Grasp the proximal end of the implant with the second forceps and gently remove it. Repeat the procedure for the second implant.

Figures 25 and 26: After the procedure is completed, the incision is closed and bandaged as with insertion. The upper arm should be kept dry for a few days.

Following removal, the contraceptive effects reverse quickly and a woman can become pregnant at a rate similar to women who have not used the method. If the patient wishes to continue using the method, a new set of Emkit® (Emkit implants (unavailable in us)) implants can be inserted through the same incision in the same or opposite direction.

Hints

Insertion

- Counselling of the patient on the benefits and side effects of the method and the insertion and removal procedures before insertion will greatly increase patient satisfaction.

- Correct subdermal placement of the implants will facilitate removal.

- Before insertion, apply the anesthetic just beneath the skin so as to raise the dermis above the underlying tissue.

- Never force the trocar.

- To ensure subdermal placement, the trocar should be held with the bevel up and should be supported by the index finger to raise the skin visibly at all times during insertion.

- To avoid damaging the first implant, stabilize it with your forefinger and middle finger and then advance the trocar alongside the fingertips at an angle of about 30 degrees.

-After insertion, make a drawing for the patient's file showing the location of the 2 implants and describe any variations in placement. This will greatly aid removal.

- Emkit® (Emkit implants (unavailable in us)) packaging contains stick-on labels identifying the lot number for both the provider's and the patient's records. Both the provider and the patient should retain these stick-on labels in case a need arises to determine which lot is being used by the woman. The stick-on label for the patient may be affixed to her copy of the patient information materials. Please also be sure to inform the patient on the patient package insert that she is to retain the stick-on label identifying the lot number in case of future problems with the lot.

Removal

- The removal of the implants will take more time than the insertion.

- Before initiating removal, the two implants should be located by palpation. If both implants cannot be palpated, they may be located by ultrasound (7 MHz) or X-ray (soft tissue).

- Before removal, apply the anesthetic under the ends of the implants nearest the original insertion site.

- If removal of the implants proves difficult, interrupt the procedure, close the incision and bandage the wound, and have the patient return for another visit. The remaining implant(s) will be easier to remove after the area is healed. It may be appropriate to seek consultation or provide referral for patients in whom initial attempts at implant removal prove difficult.

References provided on request. Manufacturer information: n/a. FDA rev date: n/a

Emkit interactions

See also:
What other drugs will affect Emkit?

Emkit® (Emkit implants (unavailable in us)) implants are not recommended for women who require chronic use of phenytoin, phenobarbital, carbamazepine or oxcarbazepine because Emkit® (Emkit implants (unavailable in us)) is likely to be less effective for these women. Although the large clinical trials of NORPLANT® and of Emkit® (Emkit implants (unavailable in us)) implants excluded women with epilepsy, there are published studies showing decreased Emkit concentrations in women taking these antiepileptic drugs along with Emkit-containing contraceptives. These drugs may increase the metabolism of Emkit through induction of microsomal liver enzymes. For women receiving long-term therapy with hepatic enzyme inducers, a different method of contraception should be considered. Women on short-term therapy with hepatic enzyme inducers should consider using a back-up method of contraception (such as condoms or spermicides) for the duration of therapy.

Rifampicin is known to decrease the effectiveness of combination oral contraceptives; its effect on Emkit concentrations has not been established. Data from clinical trials of NORPLANT® implants, however, indicate low serum concentrations and subsequent pregnancy in one woman using rifampicin.

Herbal products containing St. John's Wort (hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and may reduce the effectiveness of contraceptive steroids.

Laboratory Test Interactions

Certain endocrine tests may be affected by Emkit® (Emkit implants (unavailable in us)) use:

1. SHBG concentrations are decreased.
2. Thyroxine concentrations may be slightly decreased and triiodothyronine uptake increased.

Emkit side effects

See also:
What are the possible side effects of Emkit?

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Emkit tablet was studied in a randomized, double-blinded multicenter clinical trial. In this study, all women who had received at least one dose of study medication were included in the safety analysis: 1,379 women in the Emkit tablet group (1 dose of 1.5 mg Emkit), and 1,377 women in the Emkit tablets group (2 doses of 0.75 mg Emkit taken 12 hours apart). The mean age of women given Emkit tablet was 27 years. The racial demographic of those enrolled was 54% Chinese, 12% Other Asian or Black, and 34% were Caucasian in each treatment group. 1.6% of women in the Emkit tablet group and 1.4% in Emkit tablets group were lost to follow-up.

The most common adverse events (>10%) in the clinical trial for women receiving Emkit tablet included heavier menstrual bleeding (30.9%), nausea (13.7%), lower abdominal pain (13.3%), fatigue (13.3%), and headache (10.3%). Table 1 lists those adverse events that were reported in > 4% of Emkit tablet users.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Emkit tablets (2 doses of 0.75 mg Emkit taken 12 hours apart). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal Disorders

Abdominal Pain, Nausea, Vomiting

General Disorders and Administration Site Conditions

Fatigue

Nervous System Disorders

Dizziness, Headache

Reproductive System and Breast Disorders

Dysmenorrhea, Irregular Menstruation, Oligomenorrhea, Pelvic Pain

Emkit contraindications

See also:
What is the most important information I should know about Emkit?

Emkit should not be given with undiagnosed vaginal bleeding nor to those with history or current high risk of arterial disease.

Emkit should not be used diagnostically for pregnancy testing and should not be given in missed or incomplete abortion.

Use in pregnancy: Emkit should not be given to pregnant women; though if taken, it will not interrupt pregnancy. In the case of failure of emergency contraception, epidemiological studies indicate no adverse effects of progestogens on the foetus. It is generally considered that known teratogens will not produce malformations before organogenesis starts, which is later than 72 hrs after fertilisation.

Active ingredient matches for Emkit:

Levonorgestrel in Peru.