24 drospirenone 3 MG Ethinyl Estradiol 0.02 MG Oral Tablet 4 Inert Ingredients 1 MG Oral Tablet Pack Gianvi 28Day

1 INDICATIONS AND USAGE Gianvi 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 Gianvi ® is indicated for use by women to prevent pregnancy. 1.2 Premenstrual Dysphoric Disorder (PMDD) Gianvi 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 Gianvi 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. Gianvi has not been evaluated for the treatment of premenstrual syndrome (PMS). 1.3 Acne Gianvi 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. Gianvi should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

Teva Pharmaceuticals USA Inc

FDA Reported Adverse Reactions
[1] fatigue    [2] drug ineffective    [3] pain    [4] nausea    [5] off label use    [6] headache    [7] dyspnoea    [8] arthralgia    [9] diarrhoea    [10] toxicity to various agents