Synfonia

Synfonia

ethinylestradiol + drospirenone

Manufacturer:

Exeltis

Distributor:

DKLL

Marketer:

Exeltis
Concise Prescribing Info
Contents
Drospirenone 3 mg, ethinylestradiol 0.02 mg
Indications/Uses
Symptomatic treatment of premenstrual dysphoric disorder (PMDD). Moderate acne vulgaris in women ≥14 yr who achieved menarche & in patients desiring OC for birth control. Prevention of pregnancy.
Dosage/Direction for Use
Take 1 tab daily at about the same time for 28 consecutive days starting on 1st day of menstruation. Start each subsequent pack the day after the last tab of the previous pack. No preceding hormonal contraceptive use in past mth May start on days 2-5 of cycle but w/ additional contraceptive method (barrier method) for 1st 7 days of tab-taking in 1st cycle. Changing from another combined hormonal contraceptive [combined OC (COC), vag ring or transdermal patch] Start on the day after the last active tab or following usual tab-free or inactive tab of previous COC. Vag ring or transdermal patch: Start preferably on the day of removal, but at the latest when next application is due. Changing from progestogen-only method (progestogen-only pill, inj, implant) or progestogen-releasing intrauterine system (IUS) May switch any day from progestogen-only pill, or when the next inj is due, or from the day implant or IUS is removed, but should use additional barrier method (ie, condom) for 1st 7 days of tab-taking when having intercourse.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Adrenal insufficiency; active or history of deep-vein thrombophlebitis or thromboembolic disorders, & cerebrovascular disease or CAD; valvular heart disease w/ thrombogenic complications; severe HTN; diabetes w/ vascular involvement; current or history of pancreatitis associated w/ high levels of fatty substances in blood; headache w/ focal neurological symptoms; major surgery w/ prolonged immobilization; known or suspected breast or endometrial carcinoma or estrogen-dependent neoplasia; jaundice, cholestatic jaundice of pregnancy or jaundice w/ prior pill use; undiagnosed vag bleeding; benign or malignant liver tumor or active liver disease; cigarette smoking especially in women >35 yr. Renal insufficiency. Hepatic dysfunction. Known or suspected pregnancy.
Special Precautions
Not to be used as protection against HIV infections (AIDS) & others STDs. Discontinue immediately if symptoms of venous or arterial thrombotic/thromboembolic events or CVA occur. Not to be used in women >35 yr who smoke & w/ active or history of ischemic heart disease. Increased risk of thromboembolism, stroke, MI, liver tumor, gallbladder disease, visual disturbances, HTN; VTE; cervical cancer. Heavy cigarette smoking (≥15 cigarettes daily) in women >35 yr. Breast cancer. Benign or malignant liver tumors; severe pain in abdomen. Persistent HPV infection. Take complete medical & family history prior to treatment. Perform physical exam & measure BP. Discontinue treatment during pregnancy. Not recommended during lactation.
Adverse Reactions
Nausea, abdominal pain; increased wt; headache; depressed or altered mood; breast tenderness & pain.
Drug Interactions
Increased clearance w/ hepatic enzyme inducers eg, phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, griseofulvin, rifampicin, HIV-medication (ritonavir, nevirapine), St. John's Wort. May increase plasma & tissue conc of ciclosporin. May decrease plasma & tissue conc of lamotrigine. May influence results of certain lab tests including biochemical parameters of liver, thyroid, adrenal & renal function, & plasma protein levels.
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;10 × 28's;12 × 28's;13 × 28's;2 × 28's;3 × 28's;4 × 28's;5 × 28's;6 × 28's
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