Synfonia

Synfonia

ethinylestradiol + drospirenone

Manufacturer:

Exeltis
Concise Prescribing Info
Contents
Drospirenone 3 mg, ethinylestradiol 0.02 mg
Indications/Uses
OC. Symptoms of premenstrual dysphoric disease (PMDD) in women who use OC as method of contraception.
Dosage/Direction for Use
1 tab for 28 consecutive days. Each subsequent pack is started the day after the last tab of the previous pack.
Administration
May be taken with or without food: Take at the same time each day.
Contraindications
Hypersensitivity. Venous or arterial thrombotic/thromboembolic events, prodromi of a thrombosis; migraine w/ focal neurological symptoms; DM w/ vascular involvement; pancreatitis; severe hypertriglyceridemia, severe hepatic disease, renal insufficiency or acute renal failure; liver tumors; known or suspected sex steroid-influenced malignancies; undiagnosed vag bleeding; breast & endometrium carcinoma, estrogen-dependent neoplasia, severe HTN, cholestatic jaundice. Heavy smokers & >35 yr. Pregnancy.
Special Precautions
Circulatory disorders, tumors, renal insufficiency, hypertriglyceridemia or a family history thereof; HTN, jaundice &/or pruritus related to cholestasis, gallstone formation, porphyria, SLE, hemolytic uremic syndrome, Sydenham's chorea, herpes gestationis, otosclerosis-related hearing loss, diabetes, Crohn's disease, ulcerative colitis, chloasma. Pregnancy & lactation.
Adverse Reactions
Nausea, breast pain, unscheduled uterine bleeding, genital tract bleeding not further specified; emotional lability, depression/depressive mood; migraine, headache.
Drug Interactions
Increased hepatic metabolism w/ phenytoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, St. John's wort, ritonavir, nevirapine. Interference w/ enterohepatic circulation w/ penicillins, tetracyclines. Increased plasma & tissue conc of cyclosporin. Decreased plasma & tissue conc of lamotrigine. Increased serum K level w/ AIIA, K-sparing diuretics, aldosterone antagonist.
MIMS Class
Oral Contraceptives
ATC Classification
G03AA12 - drospirenone and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Presentation/Packing
Form
Synfonia FC tab
Packing/Price
1 × 28's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in