Gianvi 28-Day Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Gianvi is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. Oral contraceptives are highly effective. Table II lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and contraceptive implants and IUDs, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. 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.
What should I know before taking it?
Gianvi should not be used in women who have the following: Renal insufficiencyHepatic dysfunction Adrenal InsufficiencyThrombophlebitis or thromboembolic disordersA past history of deep-vein thrombophlebitis or thromboembolic disordersCerebral-vascular or coronary-artery disease (current or history)Valvular heart disease with thrombogenic complications Severe hypertensionDiabetes with vascular involvementHeadaches with focal neurological symptoms Major surgery with prolonged immobilizationKnown or suspected carcinoma of the breastCarcinoma of the endometrium or other known or suspected estrogen-dependent neoplasiaUndiagnosed abnormal genital bleedingCholestatic jaundice of pregnancy or.
What important warnings are listed?
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
How is this medication usually taken?
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. See "Patient Labeling" printed below.
What side effects are listed?
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS ). ThrombophlebitisArterial thromboembolismPulmonary embolismMyocardial infarctionCerebral hemorrhageCerebral thrombosisHypertensionGallbladder diseaseHepatic adenomas or benign liver tumors There is evidence of an association between the following conditions and the use of oral contraceptives: Mesenteric thrombosisRetinal thrombosis The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: NauseaVomitingGastrointestinal symptoms (such as abdominal cramps and bloating)Breakthrough.
What interactions are listed?
Metabolism of DRSP and potential effects of DRSP on hepatic cytochrome P450 (CYP) enzymes have been investigated in in vitro and in vivo studies (see Metabolism). In in vitro studies DRSP did not affect turnover of model substrates of CYP1A2 and CYP2D6, but had an inhibitory influence on the turnover of model substrates of CYP1A1, CYP2C9, CYP2C19 and CYP3A4 with CYP2C19 being the most sensitive enzyme. The potential effect of DRSP on CYP2C19 activity was investigated in a clinical pharmacokinetic study using omeprazole as a marker substrate. In the study with 24 postmenopausal women [including 12 women with homozygous (wild type) CYP2C19 genotype and 12 women with heterozygous CYP2C19.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b61cdce5-9fb5-4901-a768-4282a684db3f
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.