Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
DROSPIRENONE (UNII: N295J34A25) (DROSPIRENONE - UNII:N295J34A25), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)
Lupin Pharmaceuticals, Inc.
PRESCRIPTION DRUG
Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are indicated for use by women to prevent pregnancy. Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets for PMDD when used for more than three menstrual cycles has not been evaluated. The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associat
Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are available in 28 tablets wallet containing 28 tablets packed in a pouch (NDC 68180-894-11). Such three pouches are packaged in a carton (NDC 68180-894-13). Each Wallet contains 28 film-coated tablets in the following order: Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM - DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM Lupin Pharmaceuticals, Inc. ---------- FDA Approved Patient Labeling Guide for Using Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets WARNING TO WOMEN WHO SMOKE Do not use drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke. Birth control pills help to lower the chances of becoming pregnant when taken as directed. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases. What are Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets? Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are birth control pill. It contains two female hormones, a synthetic estrogen called ethinyl estradiol and a progestin called drospirenone. Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets also contains levomefolate calcium, which is a B vitamin. The progestin drospirenone may increase potassium. Therefore, you should not take drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets if you have kidney, liver or adrenal disease because this could cause serious heart and health problems. Other drugs may also increase potassium. If you are currently on daily, long-term treatment for a chronic condition with any of the medications below, you should consult your healthcare provider about whether drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate Citiți documentul complet
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM - DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM LUPIN PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM TABLETS AND LEVOMEFOLATE CALCIUM TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM TABLETS AND LEVOMEFOLATE CALCIUM TABLETS. DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM TABLETS AND LEVOMEFOLATE CALCIUM TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2010 WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ Women over 35 years old who smoke should not use drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets. (4) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. (4) RECENT MAJOR CHANGES Contraindications (4) 08/2017 Warnings and Precautions (5.5) 08/2017 INDICATIONS AND USAGE Drospirenone, ethinyl estradiol and levomefolate calcium tablet and levomefolate calcium tablet is an estrogen/progestin COC containing a folate, indicated for use by women to: (1) DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day. (2.1) Tablets must be taken in the order directed on the wallet. (2.1) DOSAGE FORMS AND STRENGTHS Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets consist of 28 film-coated, biconvex tablets in the following order (3): 24 pink tablets, each containing 3 mg drospirenone (DRSP), 0.02 mg ethinyl estradiol (EE) and 0.451 mg levomefolate calcium 4 light orange tablets, each containing 0.451 mg levomefolate calcium CONTRAINDICATIONS Renal impairment (4) Adrenal insufficiency (4) A high risk of arterial or venous thromb Citiți documentul complet