Lydia Implanex II

Lydia Implanex II

levonorgestrel

Manufacturer:

DKT

Distributor:

MCE
Full Prescribing Info
Contents
Levonorgestrel.
Description
Each rod contains 75 mg of levonorgestrel, the active ingredient, for a total of 150 mg. The rods are inserted into tubes composed of a colorless, transparent form of silicone elastomer. Both ends of each tube are sealed with an adhesive.
Action
Pharmacology: Levonorgestrel, a progestin, is a synthetic hormone. It mimics progesterone, a potent inhibitor of sex hormones secreted by the pituitary gland. Like progesterone, levonorgestrel suppresses ovulation. It also thickens cervical mucus, which impedes the migration of sperm. Finally, it thins the endometrium, and this interferes with the implantation of the zygote.
Indications/Uses
Lydia Implant is indicated for women of reproductive age who wish to use a long-acting method of contraception.
Dosage/Direction for Use
The two rods are usually inserted during the first week of a woman's menstrual cycle (starting from the first day of menstruation). A 0.2 cm-long incision is made in the skin of the upper arm or inside of the thigh, and the rods are implanted beneath the skin with a trocar (surgical instrument), under local anesthesia and aseptic conditions. An adhesive bandage is applied to cover the surface of the incision and then the limb is wrapped with gauze. Lydia Implant provides effective contraception for a period of four years.
Contraindications
Lydia Implant is contraindicated for pregnant women and for breastfeeding women during the first six weeks postpartum (Medical Eligibility Criteria for contraceptive use, World Health Organization [WHO], update 2008). Lydia Implant should not be inserted in patients with acute or chronic hepatitis, nephritis, a history of breast cancer, diabetes, hyperthyroidism, high blood pressure, thrombus, sickle cell anemia, unexplained vaginal bleeding, serious liver disease or jaundice, rheumatic disease, or epilepsy.
Women who suspect they may be pregnant should not have Lydia Implant inserted. Women who take anticoagulants should not use this product.
Special Precautions
The following are important considerations for women using or contemplating use of Lydia Implant as their method of contraception: Women with a history of irregular periods, or women over 45 years of age should not use Lydia Implant.
If a patient experiences intolerable side effects from Lydia Implant, she should see a doctor for help in managing them. The implant may be removed, if necessary.
Women who have their implants removed and who use no other form of contraception can expect fertility to return promptly (Medical Eligibility Criteria for Contraceptive Use, WHO, update 2008).
Insertion, follow-up, and removal of Lydia Implant should be conducted in a county-level hospital or a family planning clinic and should be performed by qualified professionals who have received specialized training in the procedures.
Women who receive Lydia Implant should return regularly to the previously-described medical facilities for follow-up visits.
Women who become pregnant while using Lydia Implant should consult with a doctor. Women who plan to carry the pregnancy to term should have their implants removed.
The implants must be removed at the end of 4 years because they become less effective. It can be removed at any time within the 4-year period, however, if a woman wants to stop using the method for any reason.
Care should be taken to avoid damaging the implants during removal.
Side Effects
Irregular menstrual bleeding is the most frequently reported side effect of Lydia Implant. Bleeding irregularities diminish, however, with continuing use of Lydia Implant. Following are some of the undesirable side effects that may occur with the use of Lydia Implant: Nausea; Fatigue, back pain, or generalized pain; Weight loss or gain; Abdominal discomfort; Mood swings; decreased libido; depression; Pain or itching at the insertion site; Inflammation of the cervix; ovarian cysts; Urinary tract infections; Benign breast lumps; breast discharge; Women who already have acne or excess hair on her face or body could experience worsening of these problems, hair loss, rash, itching, or mild skin discoloration.
Rarely reported side effects: High blood pressure; palpitations; chest pain; Varicose veins; Difficulty in breathing; Migraines.
Women should tell their doctors about any undesirable side effects not mentioned previously that they may experience.
Drug Interactions
Even though Lydia Implant is not taken orally, doctors and their patients must consider all medications that the patients may be taking. This is because certain drugs may reduce Lydia Implant contraceptive effectiveness.
Among the medications that interfere with Lydia Implant are barbiturates, phenytoin, carbamazepine, oxcarbazepine, primidone, topiramate, and rifampicin. Herbal products containing St. John's Wort (Hypericum perforatum) may also diminish Lydia Implant effectiveness. If a woman takes any one of these medications, she should supplement Lydia Implant with an additional method of contraception during that period and for 28 days after discontinuing it. Doctors and patients should discuss this matter before combining Lydia Implant with any of these medications.
Storage
Duration of use: 4 years.
ATC Classification
G03AC03 - levonorgestrel ; Belongs to the class of progestogens. Used as systemic contraceptives.
Presentation/Packing
Implant 75 mg (set of two flexible, cylindrical rods made of milky-white, medical-grade silicone elastomer) x 2's.
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