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NORETHINDRONE ACETATE, ETHINYL ESTRADIOL AND FERROUS FUMARATE

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Overview

What is Mibelas 24 Fe?

Mibelas 24 Fe provides an oral contraceptive regimen consisting of 24 white to off white active chewable tablets that contain the active ingredients, followed by 4 brown mottled non-hormonal placebo tablets as specified below:

Each white to off white active chewable tablet also contains the following inactive ingredients: acacia, confectioner's sugar, corn starch, lactose monohydrate, magnesium stearate and talc.

Each brown mottled placebo tablet contains ferrous fumarate, magnesium stereate, microcrystalline cellulose, povidone, sodium starch glycolate, and sucrose. The ferrous fumarate tablets do not serve any therapeutic purpose.

The empirical formula of ethinyl estradiol is CHO and the structural formula is:

The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The molecular weight of ethinyl estradiol is 296.40.

The empirical formula of norethindrone acetate is CHO and the structural formula is:

The chemical name of norethindrone acetate is [19-Norpregn-4-en-20-yn-3-one, 17(acetyloxy)-, (17α)-]. The molecular weight of norethindrone acetate is 340.46.



What does Mibelas 24 Fe look like?



What are the available doses of Mibelas 24 Fe?

Mibelas 24 Fe is available in carton (NDC 68180-911-13) containing three pouches, each pouch containing a wallet of 28 tablets (NDC 68180-911-11).

Each wallet contains 28 tablets in the following order:

What should I talk to my health care provider before I take Mibelas 24 Fe?

How should I use 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 wallet pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed tablets, Mibelas 24 Fe may be administered without regard to meals


What interacts with Mibelas 24 Fe?

Sorry No Records found


What are the warnings of Mibelas 24 Fe?

Sorry No Records found


What are the precautions of Mibelas 24 Fe?

Sorry No Records found


What are the side effects of Mibelas 24 Fe?

Sorry No records found


What should I look out for while using Mibelas 24 Fe?

  A high risk of arterial or venous thrombotic diseases ()

  Breast cancer or other estrogen- or progestin-sensitive cancer ()

  Liver tumors or liver disease ()

  Undiagnosed abnormal uterine bleeding ()

  Pregnancy ()

  Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ()


What might happen if I take too much Mibelas 24 Fe?

There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.


How should I store and handle Mibelas 24 Fe?

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].CABOMETYX tablets are supplied as follows:60 mg tables are yellow film-coated, oval shaped with no score, debossed with "XL" on one side and "60" on the other side of the tablet; available in bottles of 30 tablets: NDC 42388-023-2640 mg tablets are yellow film-coated, triangle shaped with no score, debossed with "XL" on one side and "40" on the other side of the tablet; available in bottles of 30 tablets: NDC 42388-025-2620 mg tablets are yellow film-coated, round shaped with no score, debossed with "XL" on one side and "20" on the other side of the tablet; available in bottles of 30 tablets: NDC 42388-024-26Store CABOMETYX at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].CABOMETYX tablets are supplied as follows:60 mg tables are yellow film-coated, oval shaped with no score, debossed with "XL" on one side and "60" on the other side of the tablet; available in bottles of 30 tablets: NDC 42388-023-2640 mg tablets are yellow film-coated, triangle shaped with no score, debossed with "XL" on one side and "40" on the other side of the tablet; available in bottles of 30 tablets: NDC 42388-025-2620 mg tablets are yellow film-coated, round shaped with no score, debossed with "XL" on one side and "20" on the other side of the tablet; available in bottles of 30 tablets: NDC 42388-024-26Store CABOMETYX at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].CABOMETYX tablets are supplied as follows:60 mg tables are yellow film-coated, oval shaped with no score, debossed with "XL" on one side and "60" on the other side of the tablet; available in bottles of 30 tablets: NDC 42388-023-2640 mg tablets are yellow film-coated, triangle shaped with no score, debossed with "XL" on one side and "40" on the other side of the tablet; available in bottles of 30 tablets: NDC 42388-025-2620 mg tablets are yellow film-coated, round shaped with no score, debossed with "XL" on one side and "20" on the other side of the tablet; available in bottles of 30 tablets: NDC 42388-024-26Store CABOMETYX at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].CABOMETYX tablets are supplied as follows:60 mg tables are yellow film-coated, oval shaped with no score, debossed with "XL" on one side and "60" on the other side of the tablet; available in bottles of 30 tablets: NDC 42388-023-2640 mg tablets are yellow film-coated, triangle shaped with no score, debossed with "XL" on one side and "40" on the other side of the tablet; available in bottles of 30 tablets: NDC 42388-025-2620 mg tablets are yellow film-coated, round shaped with no score, debossed with "XL" on one side and "20" on the other side of the tablet; available in bottles of 30 tablets: NDC 42388-024-26Store CABOMETYX at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].CABOMETYX tablets are supplied as follows:60 mg tables are yellow film-coated, oval shaped with no score, debossed with "XL" on one side and "60" on the other side of the tablet; available in bottles of 30 tablets: NDC 42388-023-2640 mg tablets are yellow film-coated, triangle shaped with no score, debossed with "XL" on one side and "40" on the other side of the tablet; available in bottles of 30 tablets: NDC 42388-025-2620 mg tablets are yellow film-coated, round shaped with no score, debossed with "XL" on one side and "20" on the other side of the tablet; available in bottles of 30 tablets: NDC 42388-024-26Store CABOMETYX at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

Non-Clinical Toxicology
  A high risk of arterial or venous thrombotic diseases ()

  Breast cancer or other estrogen- or progestin-sensitive cancer ()

  Liver tumors or liver disease ()

  Undiagnosed abnormal uterine bleeding ()

  Pregnancy ()

  Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ()

When administered concurrently, the following drugs may interact with adrenal corticosteroids.





Digitalis glycosides

Oral anticoagulants

Antidiabetic drugs





Barbiturates, phenytoin, or rifampin—

Anabolic steroids





Estrogen

Stop Mibelas 24 Fe if an arterial or deep venous thrombotic event (VTE) occurs. Stop Mibelas 24 Fe if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.

If feasible, stop Mibelas 24 Fe at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE.

Start Mibelas 24 Fe no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.

The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use of a COC. The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC use is discontinued.

Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest in older (greater than 35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with underlying risk factors.

Use COCs with caution in women with cardiovascular disease risk factors.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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