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norethindrone and ethinyl estradiol and ferrous fumarate

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Overview

What is GENERESS Fe?

GENERESS Fe provides an oral contraceptive regimen consisting of 24 tablets that contain the active ingredients specified below, followed by four non-hormonal placebo tablets:

Each light green tablet also contains the following inactive ingredients: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Yellow No. 6 aluminum lake, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, spearmint flavor, sucralose and vitamin E.

Each brown, round tablet contains ferrous fumarate, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, spearmint flavor and sucralose. The ferrous fumarate chewable tablets do not serve any therapeutic purpose. Ferrous fumarate chewable tablets are not USP for dissolution and assay.

The empirical formula of ethinyl estradiol is CHOand the chemical structure is:

                   

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

The empirical formula of norethindrone is CHOand the chemical structure is:

                   

The chemical name of norethindrone is [17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one]



What does GENERESS Fe look like?



What are the available doses of GENERESS Fe?

GENERESS Fe consists of 28 tablets in the following order ():

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

How should I use GENERESS Fe?

GENERESS Fe is indicated for use by women to prevent pregnancy.

The efficacy of GENERESS Fe in women with a body mass index (BMI) of > 35 kg/m has not been evaluated.

To achieve maximum contraceptive effectiveness, GENERESS Fe must be taken exactly as directed.  Chew and swallow one tablet without water at the same time every day.  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 pills, see . GENERESS Fe may be administered without regard to meals .


What interacts with GENERESS Fe?

Sorry No Records found


What are the warnings of GENERESS Fe?

Sorry No Records found


What are the precautions of GENERESS Fe?

Sorry No Records found


What are the side effects of GENERESS Fe?

Sorry No records found


What should I look out for while using GENERESS Fe?

Do not prescribe GENERESS Fe to women who are known to have the following:

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

[see Contraindications 

(

)]

. 


What might happen if I take too much GENERESS Fe?

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


How should I store and handle GENERESS Fe?

Store at 20° to 25°C (68° to 77°F); see USP controlled room temperature. Protect from light. Do not freeze.Alfentanil HCl Injection, USP for intravenous use is a sterile, aqueous, preservative free solution. Each mL contains: Active: Alfentanil base 500 mcg. Inactives: Sodium Chloride 9 mg and WFI q.s. Alfentanil HCl Injection, USP available as: NDC 17478-067-02, 2 mL Ampule in packages of 10 NDC 17478-067-05, 5 mL Ampule in packages of 10 NDC 17478-067-10, 10 mL Ampule in packages of 5 NDC 17478-067-20, 20 mL Ampule in packages of 5 Alfentanil HCl Injection, USP is supplied in individually sealed dosage forms which pose no known risk to health care providers having incidental contact. Accidental dermal exposure to alfentanil should be treated by rinsing the affected area with water. Store at 20° to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Protect from light. AKORN Manufactured by: Lake Forest, IL 60045AFA0N Rev. 12/16 Alfentanil HCl Injection, USP for intravenous use is a sterile, aqueous, preservative free solution. Each mL contains: Active: Alfentanil base 500 mcg. Inactives: Sodium Chloride 9 mg and WFI q.s. Alfentanil HCl Injection, USP available as: NDC 17478-067-02, 2 mL Ampule in packages of 10 NDC 17478-067-05, 5 mL Ampule in packages of 10 NDC 17478-067-10, 10 mL Ampule in packages of 5 NDC 17478-067-20, 20 mL Ampule in packages of 5 Alfentanil HCl Injection, USP is supplied in individually sealed dosage forms which pose no known risk to health care providers having incidental contact. Accidental dermal exposure to alfentanil should be treated by rinsing the affected area with water. Store at 20° to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Protect from light. AKORN Manufactured by: Lake Forest, IL 60045AFA0N Rev. 12/16 Alfentanil HCl Injection, USP for intravenous use is a sterile, aqueous, preservative free solution. Each mL contains: Active: Alfentanil base 500 mcg. Inactives: Sodium Chloride 9 mg and WFI q.s. Alfentanil HCl Injection, USP available as: NDC 17478-067-02, 2 mL Ampule in packages of 10 NDC 17478-067-05, 5 mL Ampule in packages of 10 NDC 17478-067-10, 10 mL Ampule in packages of 5 NDC 17478-067-20, 20 mL Ampule in packages of 5 Alfentanil HCl Injection, USP is supplied in individually sealed dosage forms which pose no known risk to health care providers having incidental contact. Accidental dermal exposure to alfentanil should be treated by rinsing the affected area with water. Store at 20° to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Protect from light. AKORN Manufactured by: Lake Forest, IL 60045AFA0N Rev. 12/16 Alfentanil HCl Injection, USP for intravenous use is a sterile, aqueous, preservative free solution. Each mL contains: Active: Alfentanil base 500 mcg. Inactives: Sodium Chloride 9 mg and WFI q.s. Alfentanil HCl Injection, USP available as: NDC 17478-067-02, 2 mL Ampule in packages of 10 NDC 17478-067-05, 5 mL Ampule in packages of 10 NDC 17478-067-10, 10 mL Ampule in packages of 5 NDC 17478-067-20, 20 mL Ampule in packages of 5 Alfentanil HCl Injection, USP is supplied in individually sealed dosage forms which pose no known risk to health care providers having incidental contact. Accidental dermal exposure to alfentanil should be treated by rinsing the affected area with water. Store at 20° to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Protect from light. AKORN Manufactured by: Lake Forest, IL 60045AFA0N Rev. 12/16 Alfentanil HCl Injection, USP for intravenous use is a sterile, aqueous, preservative free solution. Each mL contains: Active: Alfentanil base 500 mcg. Inactives: Sodium Chloride 9 mg and WFI q.s. Alfentanil HCl Injection, USP available as: NDC 17478-067-02, 2 mL Ampule in packages of 10 NDC 17478-067-05, 5 mL Ampule in packages of 10 NDC 17478-067-10, 10 mL Ampule in packages of 5 NDC 17478-067-20, 20 mL Ampule in packages of 5 Alfentanil HCl Injection, USP is supplied in individually sealed dosage forms which pose no known risk to health care providers having incidental contact. Accidental dermal exposure to alfentanil should be treated by rinsing the affected area with water. Store at 20° to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Protect from light. AKORN Manufactured by: Lake Forest, IL 60045AFA0N Rev. 12/16 Alfentanil HCl Injection, USP for intravenous use is a sterile, aqueous, preservative free solution. Each mL contains: Active: Alfentanil base 500 mcg. Inactives: Sodium Chloride 9 mg and WFI q.s. Alfentanil HCl Injection, USP available as: NDC 17478-067-02, 2 mL Ampule in packages of 10 NDC 17478-067-05, 5 mL Ampule in packages of 10 NDC 17478-067-10, 10 mL Ampule in packages of 5 NDC 17478-067-20, 20 mL Ampule in packages of 5 Alfentanil HCl Injection, USP is supplied in individually sealed dosage forms which pose no known risk to health care providers having incidental contact. Accidental dermal exposure to alfentanil should be treated by rinsing the affected area with water. Store at 20° to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Protect from light. AKORN Manufactured by: Lake Forest, IL 60045AFA0N Rev. 12/16 Alfentanil HCl Injection, USP for intravenous use is a sterile, aqueous, preservative free solution. Each mL contains: Active: Alfentanil base 500 mcg. Inactives: Sodium Chloride 9 mg and WFI q.s. Alfentanil HCl Injection, USP available as: NDC 17478-067-02, 2 mL Ampule in packages of 10 NDC 17478-067-05, 5 mL Ampule in packages of 10 NDC 17478-067-10, 10 mL Ampule in packages of 5 NDC 17478-067-20, 20 mL Ampule in packages of 5 Alfentanil HCl Injection, USP is supplied in individually sealed dosage forms which pose no known risk to health care providers having incidental contact. Accidental dermal exposure to alfentanil should be treated by rinsing the affected area with water. Store at 20° to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Protect from light. AKORN Manufactured by: Lake Forest, IL 60045AFA0N Rev. 12/16 Alfentanil HCl Injection, USP for intravenous use is a sterile, aqueous, preservative free solution. Each mL contains: Active: Alfentanil base 500 mcg. Inactives: Sodium Chloride 9 mg and WFI q.s. Alfentanil HCl Injection, USP available as: NDC 17478-067-02, 2 mL Ampule in packages of 10 NDC 17478-067-05, 5 mL Ampule in packages of 10 NDC 17478-067-10, 10 mL Ampule in packages of 5 NDC 17478-067-20, 20 mL Ampule in packages of 5 Alfentanil HCl Injection, USP is supplied in individually sealed dosage forms which pose no known risk to health care providers having incidental contact. Accidental dermal exposure to alfentanil should be treated by rinsing the affected area with water. Store at 20° to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Protect from light. AKORN Manufactured by: Lake Forest, IL 60045AFA0N Rev. 12/16 Alfentanil HCl Injection, USP for intravenous use is a sterile, aqueous, preservative free solution. Each mL contains: Active: Alfentanil base 500 mcg. Inactives: Sodium Chloride 9 mg and WFI q.s. Alfentanil HCl Injection, USP available as: NDC 17478-067-02, 2 mL Ampule in packages of 10 NDC 17478-067-05, 5 mL Ampule in packages of 10 NDC 17478-067-10, 10 mL Ampule in packages of 5 NDC 17478-067-20, 20 mL Ampule in packages of 5 Alfentanil HCl Injection, USP is supplied in individually sealed dosage forms which pose no known risk to health care providers having incidental contact. Accidental dermal exposure to alfentanil should be treated by rinsing the affected area with water. Store at 20° to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Protect from light. AKORN Manufactured by: Lake Forest, IL 60045AFA0N Rev. 12/16 Alfentanil HCl Injection, USP for intravenous use is a sterile, aqueous, preservative free solution. Each mL contains: Active: Alfentanil base 500 mcg. Inactives: Sodium Chloride 9 mg and WFI q.s. Alfentanil HCl Injection, USP available as: NDC 17478-067-02, 2 mL Ampule in packages of 10 NDC 17478-067-05, 5 mL Ampule in packages of 10 NDC 17478-067-10, 10 mL Ampule in packages of 5 NDC 17478-067-20, 20 mL Ampule in packages of 5 Alfentanil HCl Injection, USP is supplied in individually sealed dosage forms which pose no known risk to health care providers having incidental contact. Accidental dermal exposure to alfentanil should be treated by rinsing the affected area with water. Store at 20° to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Protect from light. AKORN Manufactured by: Lake Forest, IL 60045AFA0N Rev. 12/16


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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
Do not prescribe GENERESS Fe to women who are known to have the following:

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

[see Contraindications 

(

)]

. 

Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.

Stop GENERESS Fe if an arterial or deep venous thrombotic (VTE) event occurs. Although the use of COCs increases the risk of venous thromboembolism, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of venous thromboembolism in women using COCs is 3 to 9 per 10,000 woman-years. The excess risk is highest during the first year of use of a COC.  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.  The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC use is discontinued.

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

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

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 among older (> 35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with other underlying risk factors.

Oral contraceptives must be used with caution in women with cardiovascular disease risk factors. 

Stop GENERESS Fe if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.

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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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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