Contraindications
Known, suspected or history of breast or progestin-sensitive cancers; current or history of thrombosis or thromboembolic disorders; undiagnosed abnormal vaginal bleeding. Hepatic impairment, active or history of hepatic tumour (benign or malignant), active hepatic disease. Pregnancy.
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Special Precautions
Patient with hypertension, diabetes or prediabetes, hypercholesterolaemia, hyperlipidaemia; diseases which aggravates fluid retention; gallbladder disease; history of depressed mood or chloasma gravidarum. Smokers and overweight patients. May consider removal of implant during prolonged immobilisation due to illness or surgery. Renal impairment. Lactation. Monitoring Parameters Rule out pregnancy prior to implant insertion. Monitor blood pressure at baseline then yearly; weight at baseline and during therapy; signs and symptoms of thromboembolic disorders, visual changes, and depression. Perform diagnostic measures to rule out malignancy in all cases of undiagnosed abnormal vaginal bleeding. Instruct the patient to regularly palpate the implant.
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Adverse Reactions
Significant: Ovarian cyst, increased risk of breast or cervical cancer; retinal vein thrombosis, thromboembolism (e.g. DVT), other vascular events (e.g. MI, stroke); changes in menstrual bleeding patterns, weight gain, increased risk of gall bladder disease, increased LDL concentration, sustained hypertension, fluid retention; depressed mood, depression; chloasma. Rarely, ectopic pregnancy, hepatic adenomas.
Gastrointestinal disorders: Abdominal pain, nausea, flatulence.
General disorders and administration site conditions: Implant site pain and reactions, fatigue, pain, influenza-like illness.
Immune system disorders: Hypersensitivity reactions.
Investigations: Weight decreased.
Metabolism and nutrition disorders: Increased appetite.
Musculoskeletal and connective tissue disorders: Back pain.
Nervous system disorders: Headache, dizziness.
Psychiatric disorders: Nervousness, affect lability.
Reproductive system and breast disorders: Vaginal infection, vaginitis, breast tenderness, breast pain, decreased libido, dysmenorrhoea, leucorrhoea, amenorrhoea.
Respiratory, thoracic and mediastinal disorders: Pharyngitis.
Skin and subcutaneous tissue disorders: Acne, alopecia.
Vascular disorders: Hot flushes.
Potentially Fatal: Pulmonary embolism. |
Drug Interactions
May decrease plasma concentration and efficacy with efavirenz, phenytoin, barbiturates, rifampicin, carbamazepine, nelfinavir, ritonavir, boceprevir, telaprevir, nevirapine, griseofulvin. May increase the plasma concentration with moderate to strong CYP3A4 inhibitors (e.g. fluconazole, diltiazem, erythromycin, itraconazole, clarithromycin), indinavir and atazanavir/ritonavir, etravirine. Plasma and tissue levels of ciclosporin may be increased, while lamotrigine may be decreased.
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CIMS Class
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ATC Classification
G03AC08 - etonogestrel ; Belongs to the class of progestogens. Used as systemic contraceptives.
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