ethinylestradiol + drospirenone




International Med
Concise Prescribing Info
Drospirenone 3 mg, ethinylestradiol 0.03 mg
Dosage/Direction for Use
1 tab daily for 21 consecutive days. Each subsequent pack is started after a 7-day tablet-free interval.
May be taken with or without food.
Hypersensitivity. Presence or risk of venous thromboembolism or arterial thromboembolism. Presence or history of severe hepatic disease as long as liver function values have not returned to normal. Severe renal impairment or acute renal failure. Presence or history of liver tumours (benign or malignant). Known or suspected sex-steroid influenced malignancies (eg, of the genital organs or the breasts). Undiagnosed vag bleeding.
Special Precautions
Increased risk of venous thromboembolism; arterial thromboembolism or CVA. Risk of cervical cancer upon long-term use; benign liver tumours (rare cases); breast cancer. Check serum K during the 1st treatment cycle in patients w/ renal insufficiency, particularly during concomitant use of K-sparing medicinal products. Increased risk of pancreatitis in women w/ hypertriglyceridemia or a family history thereof. W/draw combined OC in patients w/ pre-existing HTN if constantly elevated BP values or a significant increase in BP do not adequately respond to antihypertensive treatment. Reports of jaundice &/or pruritus related to cholestasis; gallstones; porphyria; SLE; haemolytic uremic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss; worsening of endogenous depression, epilepsy, Crohn's disease & of ulcerative colitis. Induced or exacerbated symptoms of angioedema in women w/ hereditary angioedema. Acute or chronic disturbances of liver function may necessitate discontinuation of combined OC. Carefully observe diabetic women, particularly in the early stage of combined OC use. Chloasma may occur especially in women w/ a history of chloasma gravidarum. Rare hereditary problems of galactose intolerance, lactose intolerance or glucose-galactose malabsorption. May influence results of certain laboratory tests (eg, biochemical parameters of liver, thyroid, adrenal & renal function, plasma levels of (carrier) proteins eg, corticosteroid-binding globulin & lipid/lipoprotein fractions, parameters of carbohydrate metabolism & parameters of coagulation & fibrinolysis). Drospirenone causes an increase in plasma renin activity & plasma aldosterone. Not indicated during pregnancy. Consider increased risk of venous thromboembolism during post-partum period when re-starting Gveza. Lactation. Childn <18 yr.
Adverse Reactions
Depressive mood; headache; migraine; nausea; menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness, vag discharge, vulvovaginal candidiasis.
Drug Interactions
Increased clearance w/ enzyme inducers (eg, barbiturates, bosentan, carbamazepine, phenytoin, primidone, rifampicin, & HIV medication ritonavir, nevirapine & efavirenz & possibly also felbamate, griseofulvin, oxcarbazepine, topiramate & products containing the St. John's Wort). Increased or decreased conc w/ HIV PIs & NNRTIs including HCV inhibitors. Decreased clearance w/ strong CYP3A4 inhibitors eg, ketoconazole, etoricoxib. Increased plasma & tissue conc of ciclosporin. Decreased plasma & tissue conc of lamotrigine. Increased plasma conc of CYP1A2 substrates eg, theophylline (weak increases), tizanidine (moderate increases).
MIMS Class
ATC Classification
G03AA12 - drospirenone and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Gveza FC tab
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