In making the diagnosis, care should be taken to rule out other cyclical mood disorders. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. 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. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. 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. The effectiveness of Yaz for PMDD when used for more than three menstrual cycles has not been evaluated. Yaz 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. #YAZ BIRTH CONTROL HOW TO#( 5.10)įULL PRESCRIBING INFORMATION: CONTENTS * WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS 1 INDICATIONS AND USAGE 1.1 Oral Contraceptive 1.2 Premenstrual Dysphoric Disorder (PMDD) 1.3 Acne 2 DOSAGE AND ADMINISTRATION 2.1 How to Take Yaz 2.2 How to Start Yaz 2.3 Advice in Case of Gastrointestinal Disturbances 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Thromboembolic Disorders and Other Vascular Problems 5.2 Hyperkalemia 5.3 Malignant Neoplasms 5.4 Liver Disease 5.5 Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment 5.6 High Blood Pressure 5.7 Gallbladder Disease 5.8 Carbohydrate and Lipid Metabolic Effects 5.9 Headache 5.10 Bleeding Irregularities 5.11 COC Use Before or During Early Pregnancy 5.12 Depression 5.13 Interference with Laboratory Tests 5.14 Monitoring 5.15 Other Conditions 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Effects of Other Drugs on Combined Oral Contraceptives 7.2 Effects of Combined Oral Contraceptives on Other Drugs 7.3 Concomitant Use of HCV Combination Therapy – Liver Enzyme Elevation 7.4 Interference with Laboratory Tests 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Patients with Renal Impairment 8.7 Patients with Hepatic Impairment 8.8 Race 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Oral Contraceptive Clinical Trial 14.2 Premenstrual Dysphoric Disorder Clinical Trials 14.3 Acne Clinical Trials 15 REFERENCES 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.ġ.2 Premenstrual Dysphoric Disorder (PMDD) Uterine bleeding: Evaluate irregular bleeding or amenorrhea.Headache: Evaluate significant change in headaches and discontinue Yaz if indicated.Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking Yaz.High blood pressure: Do not prescribe Yaz for women with uncontrolled hypertension or hypertension with vascular disease.Liver disease: Discontinue Yaz if jaundice occurs.Check serum potassium concentration during the first treatment cycle in women on long-term treatment with medications that may increase serum potassium concentration. Do not use in patients predisposed to hyperkalemia.
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