Levoplant

Levoplant

levonorgestrel

Manufacturer:

Shanghai Dahua Pharma

Distributor:

DKT

Marketer:

DKT
Concise Prescribing Info
Contents
Levonorgestrel
Indications/Uses
Prevention of pregnancy (contraception).
Dosage/Direction for Use
2 implants subdermally. May be inserted at any time during menstrual cycle.
Contraindications
Hypersensitivity. Current/history of breast cancer; other diagnosed or suspected sex hormone-dependent neoplasia; thromboembolic disease; unexplained vag bleeding; SLE w/ +ve or unknown antiphospholipid Abs. Severe liver disease, infection, or tumor.
Special Precautions
Take complete medical & family history before initiating or reinstituting treatment. Perform BP & physical exam. Examine the insertion area at every control visit. Rule out malignancy if undiagnosed, persistent or recurrent vag bleeding occurs. Monitor w/ particular care women w/ family history of breast cancer or who have benign breast nodules or mastopathy. Expulsion of an implant may occur before incision has healed if inserted very near skin surface or too close to incision or when the insertion site is infected. May alter serum lipoprotein levels. Reports of thromboembolic & CV undesirable effects; altered glucose tolerance & insulin sensitivity in oral glucose tests; slightly increased risk of cholelithiasis during use of other levonorgestrel implants of similar type; idiopathic intracranial HTN (rare); irregular, prolonged & intermenstrual bleeding, spotting & amenorrhea; autoimmune diseases eg, scleroderma, lupus erythematosus disseminata or RA. Remove implants in patients who develop thrombotic or embolic disease; if sustained HTN develops during use or significant increase in BP does not adequately respond to antihypertensive therapy; if cholestatic hepatitis or jaundice develops; if idiopathic intracranial HTN is diagnosed. Occurrence of thrombophlebitis & superficial phlebitis. Special caution in patients w/ recognized risk factors for or any predisposition to arterial disease. Carefully assess if patient has history of or develops focal or crescendo type migraine or exhibits worsening of such migraine during use. Contact lens wearers who develop loss of vision or changes in lens tolerance should be assessed by an ophthalmologist. Possible wt gain during use. Carefully monitor women w/ history of depression & consider removal of implant if clear symptoms develop. May cause some degree of fluid retention. Development of follicles. Risk of breast cancer. Levonorgestrel metabolism may be slower in patients w/ impaired liver function. Remove implants if pregnancy occurs. Examine to exclude ectopic pregnancy if a woman presents w/ lower abdominal pain or found to be pregnant.
Adverse Reactions
Headache, nervousness, dizziness; nausea, lower abdominal pain; disturbance of menstrual bleeding patterns eg, frequent, irregular, or prolonged menstrual bleeding, spotting, dysmenorrhea, oligomenorrhoea, or amenorrhea, cervicitis, vag discharge, genital pruritus, pelvic & breast pain; wt gain, breakage of implant during removal, implant site pain; vag infection; back pain. Mood changes, depression, changes in libido, dyspareunia; migraine; palpitation, chest pain; HTN, varicose veins; dyspnea; abdominal discomfort; rise in total serum bilirubin; acne, contact dermatitis, alopecia, hypertrichosis, rash, pruritus, skin discoloration; urinary tract symptoms; vaginitis, ovarian cysts, benign breast nodules, breast discharge; itching near insertion site, general pain, fatigue, wt loss.
Drug Interactions
Increased clearance which may lead to changes in uterine bleeding profile &/or contraceptive failure w/ drugs that induce microsomal enzymes eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin, efavirenz, & possibly oxcarbazepine, topiramate, bosentan, felbamate, griseofulvin & products containing St. John's wort. Increased plasma conc of progestin w/ strong & moderate CYP3A4 inhibitors eg, azole antifungals (eg, itraconazole, voriconazole, fluconazole), verapamil, macrolides (eg, clarithromycin, erythromycin), diltiazem & grapefruit juice. Decreased plasma conc w/ nevirapine, etravirine, efavirenz. Increased plasma conc w/ ritonavir, darunavir/ritonavir, lopinavir/ritonavir, atazanavir/ritonavir, tipranavir/ritonavir, & (fos)amprenavir/ritonavir, indinavir. May increase plasma & tissue conc of ciclosporin or decrease plasma & tissue conc of lamotrigine. May influence results of some endocrine lab tests: Reduce conc of sex hormone binding globulin; decrease thyroxine serum conc & elevate values in triiodothyronine binding test.
MIMS Class
Depot Contraceptives
ATC Classification
G03AC03 - levonorgestrel ; Belongs to the class of progestogens. Used as systemic contraceptives.
Presentation/Packing
Form
Levoplant subdermal implant 75 mg
Packing/Price
10 × 2's