jasmiel drospirenone and ethinyl estradiol
1 INDICATIONS AND USAGE Jasmiel is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: Prevent pregnancy. ( 1.1 ) Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. ( 1.2 ) Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. ( 1.3 ) 1.1 Oral Contraceptive Jasmiel ® is indicated for use by females of reproductive potential to prevent pregnancy. 1.2 Premenstrual Dysphoric Disorder (PMDD) Jasmiel is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in females of reproductive potential who choose to use an oral contraceptive as their method of contraception. The effectiveness of Jasmiel 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 associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. In this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders. Jasmiel has not been evaluated for the treatment of premenstrual syndrome (PMS). 1.3 Acne Jasmiel is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Jasmiel should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
afaxys pharma, llc
ROUND PINK S 77
S 77 ROUND PINK
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Jasmiel (
DROSPIRENONE AND ETHINYL ESTRADIOL tablets, USP) are available in Blister Pack Containing 28 tablets in the following order. Each blister pack (28 tablets) contains in the following order: 24 active light pink to pink, round, flat faced, beveled-edge tablets, debossed with “S” on one side and “77” on other side 4 inert green, round, mottled, flat faced beveled-edge, uncoated tablets, debossed with “S” on one side and “37” on other side. The blister packs are available in the following packages: The Blister Packs are packed in Pouches and the pouches are packaged in cartons 1 Pouch containing one Blister Pack NDC 50102-240-21 Carton of 3 Pouches NDC 50102-240-23 16.2 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
More pills like ROUND S 77