Mibelas 24 Fe
NORETHINDRONE ACETATE, ETHINYL ESTRADIOL AND FERROUS FUMARATE · KIT · Lupin Pharmaceuticals, Inc.
Mibelas 24 Fe is a kit containing norethindrone acetate, ethinyl estradiol and ferrous fumarate. Manufactured by Lupin Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Mibelas 24 Fe
- Generic Name
- NORETHINDRONE ACETATE, ETHINYL ESTRADIOL AND FERROUS FUMARATE
- NDC Code (Product)
68180-911- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Dosage Form
- KIT
- Marketing Status
- Application #
- ANDA206287
- Marketing Start
- 03/31/2020
Recall History
Lupin Limited (Unit 1)
Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Mibelas 24 Fe is an estrogen/progestin COC indicated for use by women to prevent pregnancy ( 1 ) The efficacy in women with a body mass index of more than 35 kg/m 2 has not been evaluated ( 1 , 8.8 ) Mibelas™ 24 Fe is indicated for use by females of reproductive age to prevent pregnancy [see CLINICAL STUDIES ( 14 )]. The efficacy of Mibelas 24 Fe in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION One tablet daily chewed and swallowed or swallowed whole taken at the same time of day. Follow with 8 ounces of water ( 2.1 ) Take one tablet by mouth at the same time every day for 28 days ( 2.1 ) Take tablets in the order directed on the blister pack ( 2.1 ) Tablets may be administered without regard to meals ( 12.3 ) 2.1 How to Take Mibelas 24 Fe To achieve maximum contraceptive effectiveness, Mibelas 24 Fe must be taken exactly as directed. Instruct patients to take one tablet by mouth at the same time every day. The tablet may be chewed and swallowed or swallowed whole. The patient should drink a full glass (8 ounces) of water immediately after the white tablets are chewed or swallowed whole. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed tablets, [see FDA-approved patient labeling]. Mibelas 24 Fe may be administered without regard to meals [see CLINICAL PHARMACOLOGY ( 12.3 )]. 2.2 How to Start Mibelas 24 Fe Instruct the patient to begin taking Mibelas 24 Fe either on the first day of her menstrual period (Day 1 Start) or on …
Contraindications
4 CONTRAINDICATIONS A high risk of arterial or venous thrombotic diseases ( 4 ) Breast cancer Liver tumors or liver disease ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 ) Pregnancy ( 4 ) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 ) Mibelas 24 Fe is contraindicated in females who are known to have or develop the following conditions: • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: • Smoke, if over age 35 [see BOXED WARNING and WARNINGS AND PRECAUTIONS ( 5.1 )] • Have deep vein thrombosis or pulmonary embolism, now or in the past [see WARNINGS AND PRECAUTIONS ( 5.1 )] • Have cerebrovascular disease [see WARNINGS AND PRECAUTIONS ( 5.1 )] • Have coronary artery disease [see WARNINGS AND PRECAUTIONS ( 5.1 )] • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS AND PRECAUTIONS ( 5.1 )] • Have inherited or acquired hypercoagulopathies [see WARNINGS AND PRECAUTIONS ( 5.1 )] • Have uncontrolled hypertension [see WARNINGS AND PRE…
Drug Interactions
7 DRUG INTERACTIONS 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 ) Consult the labeling of the concurrently-used drug to obtain further information about interactions with COCs or the potential for enzyme alterations. No drug-drug interaction studies were conducted with Mibelas 24 Fe. 7.1 Effects of Other Drugs on Combined Oral Contraceptives Substances Diminishing the Efficacy of COCs Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate and products containing St. John's wort. Interactions between oral contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative meth…
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions in clinical trials (greater than or equal to 2%) were: headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 6.1 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 c…
Frequently Asked Questions
What is Mibelas 24 Fe used for?
Mibelas 24 Fe contains NORETHINDRONE ACETATE, ETHINYL ESTRADIOL AND FERROUS FUMARATE. It is a kit taken as directed. Consult your doctor for specific uses.
Is Mibelas 24 Fe a controlled substance?
Mibelas 24 Fe is not classified as a controlled substance by the DEA.
What is the generic name for Mibelas 24 Fe?
The generic name for Mibelas 24 Fe is NORETHINDRONE ACETATE, ETHINYL ESTRADIOL AND FERROUS FUMARATE. There are no other listed brand versions of NORETHINDRONE ACETATE, ETHINYL ESTRADIOL AND FERROUS FUMARATE.
What is the NDC code for Mibelas 24 Fe ?
The NDC (National Drug Code) for Mibelas 24 Fe is 68180-911, listed by Lupin Pharmaceuticals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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