Ethinylestradiol + levonorgestrel

Current or history of venous thromboembolism (e.g. DVT, pulmonary embolism), hereditary or acquired predisposition for venous thromboembolism (e.g. factor V Leiden mutation, activated protein C [APC] resistance, antithrombin-III-deficiency, protein C and S deficiency), current or history of arterial thromboembolism (e.g. MI) or prodromal condition (e.g. angina pectoris), hereditary or acquired predisposition for arterial thromboembolism (e.g. hyperhomocysteinaemia, antiphospholipid-antibodies), high risk of arterial thromboembolism due to multiple risk factors or the presence of 1 serious risk factor (e.g. severe dyslipoproteinaemia, diabetes mellitus with vascular symptoms); cerebrovascular disease, coronary artery disease, thrombogenic valvular or rhythm disorders, severe or uncontrolled hypertension; history of migraine with focal neurological symptoms (e.g. aura); current or history of pancreatitis associated with severe hypertriglyceridemia, severe hepatic disease (e.g. active viral hepatitis, severe cirrhosis), benign or malignant liver tumours; known or suspected sex-steroid dependent malignancies (e.g. breast or endometrial cancer), undiagnosed vaginal bleeding; SLE with positive or unknown antiphospholipid antibodies. Women >35 years who smoke; obese (BMI ≥30 kg/m²). Major surgery with prolonged immobilisation. Concomitant use with ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir. Pregnancy.

Patient with CV disease, diabetes mellitus with mild vascular disease or mild nephropathy, adequately controlled hypertension, migraine; history of chloasma gravidarum; history of cholestatic jaundice of pregnancy or jaundice with previous hormonal contraceptive use; current or family history of hypertriglyceridemia, risk factors for coronary artery disease (e.g. high LDL or triglycerides, low HDL), depression; hereditary angioedema, SLE. Discontinue treatment at least 4 weeks before an elective major operation; do not restart until 2 weeks after full ambulation. Not recommended for use in women with complicated organ transplants. Renal impairment. Lactation. Monitoring Parameters Assess pregnancy status prior to therapy and during missed menstrual period. Monitor blood pressure, BMI (baseline and during therapy); lipid profile in patients with hyperlipidaemias and glycaemic control in diabetic patients. Monitor for signs and symptoms of depression, thromboembolic disorders, bleeding irregularities, and vision changes. Perform adequate diagnostic measures to rule out malignancy in all cases of undiagnosed abnormal vaginal bleeding.

Significant: New onset or exacerbation of migraines or unusually frequent or severe headaches, jaundice, hepatitis, significant increase in blood pressure, severe upper abdominal pain or liver enlargement, increased risk of breast and cervical cancer; chloasma, breakthrough bleeding or spotting, cholestasis, pancreatitis, gallbladder disease; changes in lipid levels, persistent hypertriglyceridaemia, glucose intolerance; retinal vascular thrombosis; depression; exacerbated symptoms of hereditary or acquired angioedema; acute or chronic disturbances of liver function. Gastrointestinal disorders: Nausea, vomiting, abdominal pain, diarrhoea. General disorders and administration site conditions: Fatigue; application site reaction (patch). Investigations: Weight gain. Metabolism and nutrition disorders: Fluid retention. Nervous system disorders: Dizziness, nervousness. Reproductive system and breast disorders: Metrorrhagia, menorrhagia, dysmenorrhoea; breast tenderness, pain, and hypertrophy; decreased libido, vaginitis, candidiasis. Skin and subcutaneous tissue disorders: Acne, rash, urticaria.
Potentially Fatal: Venous thromboembolism (e.g. DVT, pulmonary embolism), arterial thromboembolism (e.g. MI), CVA (e.g. TIA, stroke). Rarely, benign and malignant liver tumours leading to intra-abdominal haemorrhage.

Decreased serum concentration with CYP3A4 inducers (e.g. phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate, barbiturates, primidone, bosentan, rifampicin, griseofulvin, ritonavir, nevirapine). Increased serum concentration with moderate and strong CYP3A4 inhibitors (e.g. voriconazole, erythromycin, verapamil, diltiazem). May decrease the serum concentration of lamotrigine. May increase the serum concentration of ciclosporin. Ethinylestradiol: May increase the serum concentration of tizanidine and theophylline. Increased serum concentration with etoricoxib and ascorbic acid.

Oestrogens & Progesterones & Related Synthetic Drugs

G03AC03 - levonorgestrel ; Belongs to the class of progestogens. Used as systemic contraceptives.
G03CA01 - ethinylestradiol ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.
L02AA03 - ethinylestradiol ; Belongs to the class of estrogens.
G03AD01 - levonorgestrel ; Belongs to the class of emergency contraceptives. Used as systemic contraceptives.