Minastrin 24 Fe
"Despite the potential for adverse maternal and fetal outcomes, contraceptive use in women with certain medical conditions is suboptimal, according to a new study.
Steven W. Champaloux, PhD, MPH, a scientist in the Division of Reproduc"...
Minastrin 24 Fe
Minastrin 24 Fe Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Minastrin 24 Fe (norethindrone acetate and ethinyl estradiol/ferrous fumarate) is a combination of female hormones and the mineral iron used as an oral contraceptive to prevent pregnancy. Minastrin 24 Fe is available in generic form. Common side effects of Minastrin 24 Fe are headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain.
Minastrin 24 Fe consists of 28 soft gelatin capsules in the following order:
- 24 yellow capsules (active), each containing 1 mg norethindrone acetate and 20 mcg ethinyl estradiol
- 4 maroon capsules (non-hormonal placebo) each containing 75 mg ferrous fumarate which does not serve any therapeutic purpose
Each capsule should be taken by mouth at the same time every day, with or without meals. Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of Minastrin 24 Fe or increase breakthrough bleeding. Patients should use a back-up method or alternative method of contraception when taking enzyme inducers.
There is no reason for pregnant women to use Minastrin 24 Fe. Minastrin 24 Fe may decrease the production of breast milk and should not be used by nursing mothers.
Minastrin 24 Fe (norethindrone acetate and ethinyl estradiol/ferrous fumarate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Minastrin 24 Fe FDA Prescribing Information: Side Effects
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]
- Vascular events [see WARNINGS AND PRECAUTIONS]
- Liver disease [see WARNINGS AND PRECAUTIONS]
Adverse reactions commonly reported by COC users are:
- Irregular uterine bleeding
- Breast tenderness
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data presented in Section 6.1 are from a clinical trial conducted with a 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 0.020 mg tablets. Minastrin 24 Fe is bioequivalent to these norethindrone acetate/ethinyl estradiol tablets.
Common Adverse Reactions ( ≥ 2% of all Treated Subjects): The most common adverse reactions reported by at least 2% of the 743 women using norethindrone acetate/ethinyl estradiol tablets were the following, in order of decreasing incidence: headache (6.3%), vaginal candidiasis (6.1%), nausea (4.6%), menstrual cramps (4.4%), breast tenderness (3.4%), bacterial vaginitis (3.1%), abnormal cervical smear (3.1%), acne (2.7%), mood swings (2.2%), and weight gain (2.0%).
Adverse Reactions Leading to Study Discontinuation: Among the 743 women using norethindrone acetate/ethinyl estradiol tablets, 46 women (6.2%) withdrew because of an adverse event. Adverse events occurring in 3 or more subjects leading to discontinuation of treatment were, in decreasing order: abnormal or irregular bleeding (1.3%), nausea (0.8%), menstrual cramps (0.5%), and increased blood pressure (0.4%).
The following adverse reactions have been identified during post approval use of a 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 0.020 mg tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or evaluate a causal relationship to drug exposure.
Adverse reactions are grouped into System Organ Classes.
Immune system disorders: hypersensitivity reaction.
GI disorders: nausea, vomiting, abdominal pain.
Musculoskeletal and connective tissue disorders: myalgia.
Eye disorders: blurred vision, visual impairment, corneal thinning, change in corneal curvature (steepening).
Infections and infestations: fungal infection, vaginal infection.
Nervous system disorders: headache, dizziness, migraine, loss of consciousness.
Psychiatric disorders: mood swings, depression, insomnia, anxiety, suicidal ideation, panic attack, changes in libido.
Renal and urinary disorders: cystitis-like syndrome.
Reproductive system and breast disorders: breast changes (tenderness, pain, enlargement, and secretion), premenstrual syndrome, dysmenorrhea.
Read the entire FDA prescribing information for Minastrin 24 Fe (Norethindrone Acetate and Ethinyl Estradiol/Ferrous Fumarate Capsules)
Additional Minastrin 24 Fe Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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