Aranelle B 341 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?
Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptive products which contain 50 mcg of estrogen, should not be used unless medically indicated. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception.1 The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of.
What should I know before taking it?
Oral contraceptives should not be used in women who have the following conditions: Thrombophlebitis or thromboembolic disordersA past history of deep vein thrombophlebitis or thromboembolic disordersCerebral vascular or coronary artery diseaseCurrent diagnosis of, or history of, breast cancer, which may be hormone-sensitive Undiagnosed abnormal genital bleedingCholestatic jaundice of pregnancy or jaundice with prior pill useHepatic adenomas, carcinomas or benign liver tumorsKnown or suspected pregnancyAre receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see WARNINGS, Risk of Liver Enzyme.
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?
To achieve maximum contraceptive effectiveness, oral contraceptives must be taken exactly as directed and at intervals not exceeding 24 hours. For a DAY 1 START, count the first day of menstrual flow as Day 1 and the first light yellow tablet is then taken on Day 1. For a SUNDAY START when menstrual flow begins on or before Sunday, the first light yellow tablet is taken on that day. With either a DAY 1 START or SUNDAY START, 1 light yellow tablet is taken for 7 days, then 1 white tablet for 9 days, then 1 light yellow tablet for 5 days, then 1 peach tablet (inert) for 7 days, whether bleeding has stopped or not. With either a DAY 1 START or SUNDAY START 1 tablet is taken each day at the.
What side effects are listed?
Post Marketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 to 1.12 (Figure 1). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 to 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer.
What interactions are listed?
Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin sodium, and possibly with griseofulvin, ampicillin and tetracyclines.76 Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation Do not coadminister Aranelle® with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see WARNINGS, Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment ).
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0beef9d3-8326-48cf-b89a-fa794902c6c1
⚠️ 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.