drospirenone 3 mg ethinyl estradiol 0.02 mg
1 INDICATIONS AND USAGE Loryna (drospirenone and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to: Prevent pregnancy. ( 1.1 ) Treat symptoms of premenstrual dysphoric disorder (PMDD) for women 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 Loryna (drospirenone and ethinyl estradiol tablets) are indicated for use by women to prevent pregnancy. 1.2 Premenstrual Dysphoric Disorder (PMDD) Loryna is 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 Loryna 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. Loryna has not been evaluated for the treatment of premenstrual syndrome (PMS). 1.3 Acne Loryna tablets are 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. Drospirenone and ethinyl estradiol tablets should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
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ROUND ORANGE SZ U2
SZ U2 ROUND ORANGE
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16 HOW SUPPLIED/STORAGE AND HANDLING Loryna (
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS, USP) 3 mg/0.02 mg are available as follows: Each blister card contains 24 active tablets and 4 inactive tablets. The 24 active tablets are peach, round, film-coated, debossed with SZ on one side and U2 on the other side. The 4 inert tablets are white, round, film-coated, debossed with SZ on one side and J1 on the other side. NDC 63629-2336-01, one box containing 3 individual unit cartons.
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