Melodia

Melodia

ethinylestradiol + drospirenone

Manufacturer:

Exeltis

Distributor:

DKLL

Marketer:

Exeltis
Concise Prescribing Info
Contents
Drospirenone 3 mg, ethinylestradiol 0.03 mg
Indications/Uses
Dosage/Direction for Use
1 tab daily for 21 days followed by 7 tab-free days. Start the next pack after 7 days drug-free interval.
Administration
May be taken with or without food.
Contraindications
Known or suspected breast or endometrium carcinoma & estrogen-dependent neoplasia. History of benign or malignant hepatic tumors. Adrenal insufficiency; cardiac insufficiency; active or history of cerebrovascular disease/CAD; cholestatic jaundice of pregnancy or jaundice prior pill use; cholestatic hepatic disease; thrombophlebitis, thrombosis or thromboembolic disorder; abnormal or undiagnosed uterine bleeding; HTN; DM. Hepatic or renal impairment. Pregnancy.
Special Precautions
Discontinue use if possible signs of thrombosis occur eg, extreme pain &/or inflammation of 1 of patient's legs; intense & sudden chest pain, which may reach patient's left arm; sudden difficulty in breathing & cough w/o clear cause; unusual headache, intense or prolonged, or worsening of a migraine; partial or complete vision loss, or double vision; difficulty or inability to speak; vertigo or fainting; weakness, abnormal sensations, or numbness of any body part; pregnancy is suspected. Not to be used in women w/ higher risk of thrombosis eg, history of thrombophlebitis, obesity, diabetes & HTN; in presence or history of liver tumors, known or suspected sex hormones related cancer eg, breast or genital organs cancer. Presence of thrombosis & hepatic disease. Do regular visits to a physician at least every 6-12 mth. Regularly examine breast & visit a physician if the patient find any lump. Inform physician if patient is taking birth control pills prior to scheduled lab tests eg, blood test. Have physical exam prior refill of an old prescription for OC, especially after pregnancy. Women taking combined contraceptives. Smoking especially in women >35 yr. Not recommended during lactation.
Adverse Reactions
Nausea, abdominal pain; increased wt; headache; depressed or altered mood, breast tenderness & pain.
Drug Interactions
Concomitant use w/ antiepileptics (eg, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate), anti-TB (eg, rifampicin, rifabutin), anti-HIV infections (eg, ritonavir, nevirapine), antibiotics (eg, penicillins, tetracyclines, griseofulvin), St. John's wort. Inhibited metabolism w/ ketoconazole, erythromycin, cyclosporine. Increased plasma & tissue conc w/ cyclosporine. Decreased plasma conc w/ lamotrigine. Increased serum K levels w/ AIIA & diuretics.
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
Melodia FC tab
Packing/Price
1 × 21's
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