Levonorgestrel And Ethinyl Estradiol And Ferrous Bisglycinate
Generic Name: levonorgestrel and ethinyl estradiol and ferrous bisglycinate
Brand Names:
Minzoya
11 DESCRIPTION Minzoya (levonorgestrel and ethinyl estradiol tablets USP and ferrous bisglycinate tablets) provides an oral contraceptive regimen consisting of 21 white to off-white active tablets and 7 blue inactive tablets.
Overview
11 DESCRIPTION Minzoya (levonorgestrel and ethinyl estradiol tablets USP and ferrous bisglycinate tablets) provides an oral contraceptive regimen consisting of 21 white to off-white active tablets and 7 blue inactive tablets.
Uses
1 INDICATIONS AND USAGE Minzoya™ is indicated for use by females of reproductive potential to prevent pregnancy. Minzoya is a progestin/estrogen COC indicated for use by females of reproductive potential to prevent pregnancy.
Dosage
2 DOSAGE AND ADMINISTRATION Take one tablet by mouth at the same time every day. ( 2.1 ) Take tablets in the order directed on the blister pack. ( 2.1 ) 2.1 How to Start Minzoya Minzoya is dispensed in a blister card [see How Supplied/Storage and Handling ( 16 )] . Minzoya may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration. 2.2 How to Take Minzoya Minzoya (white to off-white active tablets, and blue placebo tablets) is swallowed whole once a day.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ( 5.1 )] Vascular events [see Warnings and Precautions ( 5.1 )] Liver disease [see Warnings and Precautions ( 5.2 )] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache Common adverse reactions (≥2% of women): headache (14%), metrorrhagia (8%), dysmenorrhea and nausea (7% each), abdominal pain and breast pain (4% each), emotional lability and acne (3% each), and depression, amenorrhea, and vaginal moniliasis (2% each) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc.
Interactions
7 DRUG INTERACTIONS Consult the labeling of concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with COCs ( 7.1 ).
Warnings
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see Contraindications ( 4 )] . 5 WARNINGS AND PRECAUTIONS Thrombotic Disorders and Other Vascular Problems : Stop Minzoya if a thrombotic event occurs. Stop at least 4 weeks before through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding ( 5.1 ) Liver disease : Discontinue Minzoya if jaundice occurs ( 5.2 ) High Blood Pressure : If used in women with well- controlled hypertension, monitor blood pressure and stop Minzoya if blood pressure rises significantly. ( 5.4 ) Carbohydrate and Lipid Metabolic Effects : Monitor prediabetic and diabetic women taking Minzoya. 4 CONTRAINDICATIONS Minzoya is contraindicated in females who are known to have or develop the following conditions: • A high risk of arterial or venous thrombotic disease. Examples include women who are known to: - Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ( 5.1 )] .
Pregnancy
8.1 Pregnancy Risk Summary Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets are contraindicated in pregnancy because there is no reason to use combined hormonal contraceptives (CHCs) in pregnancy. Discontinue levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets if pregnancy occurs. Based on epidemiologic studies and meta-analyses, there is little or no increased risk of birth defects in the children of females who inadvertently use COCs during early pregnancy (See Data) . In the U.S.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Minzoya is available in a blister pack containing 28 tablets arranged in 3 rows of 7 active tablets and 1 row of inactive tablets, as follows: 21 active tablets: White to off-white round biconvex tablets, debossed with "J3" on one side and plain on other side; and each containing levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg 7 inactive t...
Frequently Asked Questions
What is Levonorgestrel And Ethinyl Estradiol And Ferrous Bisglycinate used for?▼
1 INDICATIONS AND USAGE Minzoya™ is indicated for use by females of reproductive potential to prevent pregnancy. Minzoya is a progestin/estrogen COC indicated for use by females of reproductive potential to prevent pregnancy.
What are the side effects of Levonorgestrel And Ethinyl Estradiol And Ferrous Bisglycinate?▼
6 ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ( 5.1 )] Vascular events [see Warnings and Precautions ( 5.1 )] Liver disease [see Warnings and Precautions ( 5.2 )] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache Common adverse reactions (≥2% of women): headache (14%), metrorrhagia (8%), dysmenorrhea and nausea (7% each), abdominal pain and breast pain (4% each), emotional lability and acne (3% each), and depression, amenorrhea, and vaginal moniliasis (2% each) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc.
Can I take Levonorgestrel And Ethinyl Estradiol And Ferrous Bisglycinate during pregnancy?▼
8.1 Pregnancy Risk Summary Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets are contraindicated in pregnancy because there is no reason to use combined hormonal contraceptives (CHCs) in pregnancy. Discontinue levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets if pregnancy occurs. Based on epidemiologic studies and meta-analyses, there is little or no increased risk of birth defects in the children of females who inadvertently use COCs during early pregnancy (See Data) . In the U.S.
What are the important warnings for Levonorgestrel And Ethinyl Estradiol And Ferrous Bisglycinate?▼
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see Contraindications ( 4 )] . 5 WARNINGS AND PRECAUTIONS Thrombotic Disorders and Other Vascular Problems : Stop Minzoya if a thrombotic event occurs. Stop at least 4 weeks before through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding ( 5.1 ) Liver disease : Discontinue Minzoya if jaundice occurs ( 5.2 ) High Blood Pressure : If used in women with well- controlled hypertension, monitor blood pressure and stop Minzoya if blood pressure rises significantly. ( 5.4 ) Carbohydrate and Lipid Metabolic Effects : Monitor prediabetic and diabetic women taking Minzoya. 4 CONTRAINDICATIONS Minzoya is contraindicated in females who are known to have or develop the following conditions: • A high risk of arterial or venous thrombotic disease. Examples include women who are known to: - Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ( 5.1 )] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.