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Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate

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Overview

What is Melodetta 24 Fe?

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

Each white active chewable tablet also contains the following inactive ingredients: acacia, confectioner’s sugar, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc.

Each brown placebo tablet contains ferrous fumarate, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, povidone, spearmint flavor and sucralose. The ferrous fumarate tablets do not serve any therapeutic purpose.

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

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

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

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



What does Melodetta 24 Fe look like?



What are the available doses of Melodetta 24 Fe?

Melodetta 24 Fe consists of 28 tablets in the following order :

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

How should I use Melodetta 24 Fe?

Melodetta™ 24 Fe is indicated for use by females of reproductive age to prevent pregnancy .

The efficacy of Melodetta 24 Fe in women with a body mass index (BMI) of more than 35 kg/m has not been evaluated.

To achieve maximum contraceptive effectiveness, Melodetta 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, . Melodetta 24 Fe may be administered without regard to meals .


What interacts with Melodetta 24 Fe?

Sorry No Records found


What are the warnings of Melodetta 24 Fe?

Sorry No Records found


What are the precautions of Melodetta 24 Fe?

Sorry No Records found


What are the side effects of Melodetta 24 Fe?

Sorry No records found


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

Do not prescribe Melodetta 24 Fe to women who are known to have the following conditions:

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 should not be used by women who are over 35 years of age and smoke .


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

Store at 20° to 25° C (68° to 77° F); excursions permitted between 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature]. Keep this drug and all drugs out of the reach of children. Store at 20° to 25° C (68° to 77° F); excursions permitted between 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature]. Keep this drug and all drugs out of the reach of children. Prior to dispensing, tap vial until all powder flows freely. Add indicated amount of room temperature 70% ethyl alcohol to vial (to the mark) and immediately shake to completely dissolve erythromycin.NOTE: store at room temperature between 15°C to 30°C (59°F to 86°F).After reconstitution,Do not freeze. Keep tightly closed. Keep out of reach of children.Rx onlyPrior to dispensing, tap vial until all powder flows freely. Add indicated amount of room temperature 70% ethyl alcohol to vial (to the mark) and immediately shake to completely dissolve erythromycin.NOTE: store at room temperature between 15°C to 30°C (59°F to 86°F).After reconstitution,Do not freeze. Keep tightly closed. Keep out of reach of children.Rx onlyPrior to dispensing, tap vial until all powder flows freely. Add indicated amount of room temperature 70% ethyl alcohol to vial (to the mark) and immediately shake to completely dissolve erythromycin.NOTE: store at room temperature between 15°C to 30°C (59°F to 86°F).After reconstitution,Do not freeze. Keep tightly closed. Keep out of reach of children.Rx onlyPrior to dispensing, tap vial until all powder flows freely. Add indicated amount of room temperature 70% ethyl alcohol to vial (to the mark) and immediately shake to completely dissolve erythromycin.NOTE: store at room temperature between 15°C to 30°C (59°F to 86°F).After reconstitution,Do not freeze. Keep tightly closed. Keep out of reach of children.Rx onlyPrior to dispensing, tap vial until all powder flows freely. Add indicated amount of room temperature 70% ethyl alcohol to vial (to the mark) and immediately shake to completely dissolve erythromycin.NOTE: store at room temperature between 15°C to 30°C (59°F to 86°F).After reconstitution,Do not freeze. Keep tightly closed. Keep out of reach of children.Rx only


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Clinical Information

Chemical Structure

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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
Do not prescribe Melodetta 24 Fe to women who are known to have the following conditions:

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 should not be used by women who are over 35 years of age and smoke .

Due to the potential for additive effects, caution and careful titration are warranted in patients receiving diltiazem hydrochloride concomitantly with any agents known to affect cardiac contractility and/or conduction (see ). Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with diltiazem hydrochloride (see ). As with all drugs, care should be exercised when treating patients with multiple medications. Diltiazem hydrochloride undergoes biotransformation by cytochrome P-450 mixed function oxidase. Coadministration of diltiazem hydrochloride with other agents which follow the same route of biotransformation may result in the competitive inhibition of metabolism. Especially in patients with renal and/or hepatic impairment, dosages of similarly metabolized drugs, particularly those of low therapeutic ratio such as cyclosporine, may require adjustment when starting or stopping concomitantly administered diltiazem hydrochloride to maintain optimum therapeutic blood levels. Concomitant administration of diltiazem with carbamazepine has been reported to result in elevated plasma levels of carbamazepine, resulting in toxicity in some cases.

Stop Melodetta 24 Fe if an arterial or deep venous thrombotic event (VTE) occurs. Stop Melodetta 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 Melodetta 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 Melodetta 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 thrombosis 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.

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

Adverse reactions commonly reported by COC users are:

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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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Tips

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Interactions

Interactions

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