Levonorgestrel


Generic Medicine Info
Administration
May be taken with or without food.
Contraindications
Known or suspected sex hormone dependent malignancies (e.g. breast cancer), undiagnosed vaginal bleeding, active or history of thromboembolism (e.g. MI, stroke); acute hepatic disease, hepatic tumours (benign or malignant), severe hepatic disease wherein LFTs have not returned to normal. Oral: Severe diabetes with vascular changes. IUD: Uterine bleeding of unknown aetiology; known or suspected uterine, cervical, or endometrial malignancy; cervical intraepithelial neoplasia (until resolved); untreated acute cervicitis or vaginitis (e.g. bacterial vaginosis, chlamydial or gonococcal cervical infection), other lower genital tract infections (until control of infection), conditions that increase the risk to pelvic infections; congenital or acquired uterine anomaly, including fibroids that impair the uterine activity; history of or active acute pelvic inflammatory disease, postpartum endometriosis or infected abortion (within the past 3 months); postcoital contraception, unremoved IUD. Pregnancy.
Special Precautions
Patient with a predisposition to ectopic pregnancy (e.g. history of ectopic pregnancy, salpingitis, tubal surgery, or pelvic infection) or endometritis, history of symptomatic functional ovarian cysts, bradycardia, syncope, seizure, depression, coagulopathy or use of anticoagulants, migraine, focal migraine with asymmetrical visual loss, or other symptoms indicating TIA, exceptionally severe headache, marked increase of blood pressure, malignancies affecting the blood or leukaemias in remission, jaundice; incomplete involution of the uterus (IUD); diabetes, history of chloasma gravidarum (oral). Obese patients (BMI ≥30 kg/m2). Lactation. Monitoring Parameters Evaluate pregnancy status before administration. Following oral emergency contraception, monitor spontaneous abortion, ectopic pregnancy, delayed (≥1 week) normal menstrual period, development of lower abdominal pain or occurrence of persistent bleeding. Before insertion of IUD, perform a bimanual examination and cervical inspection, obtain weight, and screen for STD. Following insertion, check placement through transvaginal ultrasound. Re-examine patient as necessary (refer to specific product guidelines). Assess thread visibility. Monitor blood pressure, serum glucose (in diabetic patients); significant changes in menstrual bleeding (during prolonged use). Perform Pap smear. Evaluate patients presenting with lower abdominal pain for ovarian cysts or ectopic pregnancy. Monitor for signs and symptoms of infection and thromboembolism (in patients who require surgery with prolonged immobilisation).
Adverse Reactions
Significant: Bleeding pattern alterations (e.g. spotting, irregular bleeding, heavy bleeding, oligomenorrhoea, amenorrhoea), ectopic pregnancy, thromboembolism, hypertension, depression, breast cancer; implant or IUD expulsion. Oral: Carbohydrate intolerance, chloasma, hepatic disease. Rarely, hepatic adenoma. Implant: Cholestatic hepatitis or jaundice. Rarely, idiopathic intracranial hypertension. IUD: intrauterine pregnancy, ovarian cysts, group A streptococcal sepsis, pelvic inflammatory disease, endometritis, actinomycosis, perforation (total or partial), seizure, bradycardia, syncope. Cardiac disorders: Palpitations, chest pain (implant). Gastrointestinal disorders: Nausea, vomiting, lower abdominal pain, diarrhoea, abdominal distention. General disorders and administration site conditions: Fatigue; pain. Itching at insertion site (implant). Immune system disorders: Hypersensitivity reactions (e.g. rash, urticaria, angioedema). Investigations: Weight gain or loss, increase in total serum bilirubin (implant). Musculoskeletal and connective tissue disorders: Back pain (IUD/implant). Nervous system disorders: Headache, dizziness, migraine. Psychiatric disorders: Decreased libido, nervousness, mood changes (IUD/implant). Reproductive system and breast disorders: Dysmenorrhoea, breast pain, pelvic pain (oral/IUD); vulvovaginitis, bacterial vaginosis, vaginal mycosis, genital discharge, upper genital tract infection (IUD); breast discharge, benign breast nodules, vaginitis (implant). Respiratory, thoracic and mediastinal disorders: Dyspnoea (implant). Skin and subcutaneous tissue disorders: Acne, alopecia (IUD/implant); hirsutism (IUD); contact dermatitis, rash, pruritus, skin discolouration, hypertrichosis (implant).
Potentially Fatal: Rarely, intra-abdominal haemorrhage associated with benign or malignant liver tumours (implant).
Drug Interactions
Decreased serum concentration with CYP3A4 enzyme inducers (e.g. rifampicin, phenytoin, carbamazepine, primidone, efavirenz, ritonavir, griseofulvin). Increased serum concentration with strong and moderate CYP3A4 inhibitors (e.g. voriconazole, ketoconazole, itraconazole, verapamil, diltiazem, erythromycin, clarithromycin). May increase the risk of ciclosporin toxicity. Increased or decreased serum concentration with protease inhibitors.
CIMS Class
Depot Contraceptives / Oestrogens & Progesterones & Related Synthetic Drugs / Oral Contraceptives / Other Contraceptives
ATC Classification
G03AC03 - levonorgestrel ; Belongs to the class of progestogens. Used as systemic contraceptives.
G03AD01 - levonorgestrel ; Belongs to the class of emergency contraceptives. Used as systemic contraceptives.
Disclaimer: This information is independently developed by CIMS based on levonorgestrel from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 CIMS. All rights reserved. Powered by CIMSAsia.com
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in