No

Contraceptive

Prevention of pregnancy. The net cumulative 5-year pregnancy rate for levonorgestrel implant use has been reported to be from 1.5-3.9 pregnancies/100 users. Norplant® is a very efficient, yet reversible, method of contraception. The long duration of action may be particularly advantageous in women who desire an extended period of contraceptive protection without sacrificing the possibility of future fertility.

X

Women with undiagnosed abnormal uterine bleeding, hemorrhagic diathesis, known or suspected pregnancy, active hepatic disease, active thrombophlebitis, thromboembolic disorders, or known or suspected carcinoma of the breast

Patients presenting with lower abdominal pain should be evaluated for follicular atresia and ectopic pregnancy

>10%: Hormonal: Prolonged menstrual flow, spotting

1% to 10%:

Central nervous system: Headache, nervousness, dizziness

Dermatologic: Dermatitis, acne

Endocrine & metabolic: Amenorrhea, irregular menstrual cycles, scanty bleeding, breast discharge

Gastrointestinal: Nausea, change in appetite, weight gain

Genitourinary: Vaginitis, leukorrhea

Local: Pain or itching at implant site

Neuromuscular & skeletal: Myalgia

<1%: Infection at implant site, induration, bruising, nerve injury, phlebitis

Can result if >6 capsules are in situ; symptoms include uterine bleeding irregularities and fluid retention

Treatment includes removal of all implanted capsules

Decreased effect: Carbamazepine/phenytoin

First, ovulation is inhibited in about 50% to 60% of implant users from a negative feedback mechanism on the hypothalamus, leading to reduced secretion of follicle stimulating hormone (FSH) and luteinizing hormone (LH). An insufficient luteal phase has also been demonstrated with levonorgestrel administration and may result from defective gonadotropin stimulation of the ovary or from a direct effect of the drug on progesterone synthesis by the corpora lutea.

Protein binding: Following release from the implant, levonorgestrel enters the bloodstream highly bound to sex hormone binding globulin (SHBG), albumin, and alpha₁ glycoprotein

Metabolism: In the liver

Half-life, terminal: 11-45 hours

Elimination: In urine primarily as conjugates of sulfate and glucuronide

Total administration doses (implanted): 216 mg in 6 capsules which should be implanted during the first 7 days of onset of menses subdermally in the upper arm; each Norplant® silastic capsule releases 80 mcg of drug/day for 6-18 months, following which a rate of release of 25-30 mcg/day is maintained for less than or equal to 5 years; capsules should be removed by end of 5th year

May cause nervousness or dizziness

Carbamazepine may decrease the effects of levonorgestrel

No information available to require special precautions

Progestins may predispose the patient to gingival bleeding

Do not attempt to remove implants - see prescriber. You may experience photosensitivity (use sunscreen, wear protective clothing and eyewear, and avoid direct sunlight); dizziness or sleeplessness (use caution when driving or engaging in hazardous tasks until response to drug is known); skin rash, change in skin color, loss of hair, or unusual menses (breakthrough bleeding, irregularity, excessive bleeding - these should resolve after the first month). Report swelling, pain, or excessive feelings of warmth in calves, sudden acute headache, or visual disturbance, unusual nausea or vomiting, and any loss of feeling in arms or legs, unusual menses (if they persist past first month), and irritation at insertion site. Pregnancy/breast-feeding precautions: Inform prescriber if pregnant. Consult prescriber if breast-feeding.

The net cumulative 5-year pregnancy rate for levonorgestrel implant use has been reported to be from 1.5-3.9 pregnancies/100 users. This compares to a cumulative rate of 4.9 pregnancies/100 women with an IUD after 5 years. At the end of the first year of use, the pregnancy rate with levonorgestrel implants has been reported to be from 0.2-0.6 pregnancies/100 users. This compares quite favorably with the 2.3 pregnancies/100 users of oral contraceptives during the first year of use and 2.4 pregnancies/100 women with an IUD during the first year. Norplant® is a very efficient, yet reversible, method of contraception. The long duration of action may be particularly advantageous in women who desire an extended period of contraceptive protection without sacrificing the possibility of future fertility.

Capsule, subdermal implantation: 36 mg (6s)

Tablet: 0.75 mg