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LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

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Overview

What is FAYOSIM?

Fayosim (levonorgestrel and ethinyl estradiol tablets USP, and ethinyl estradiol tablets USP) is an extended-cycle oral contraceptive. Fayosim consists of 42 pink tablets containing 0.15 mg levonorgestrel and 0.02 mg ethinyl estradiol, 21 white tablets containing 0.15 mg levonorgestrel and 0.025 mg ethinyl estradiol, and 21 light blue tablets containing 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol, and 7 mustard tablets containing 0.01 mg ethinyl estradiol. Levonorgestrel is a progestin and ethinyl estradiol is an estrogen.

The structural formulas, molecular formulas, molecular weights, and chemical names for the active components are shown below:

Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-(17α)-(-)-.

Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-.

Each pink tablet contains the following inactive ingredients:

Anhydrous lactose, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C Red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide.

Each white

tablet contains the following inactive ingredients:

Anhydrous lactose, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide.

Each light blue

tablet contains the following inactive ingredients:

Anhydrous lactose, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide.

Each mustard tablet contains the following inactive ingredients:

Anhydrous lactose, FD&C yellow #6 aluminum lake, hypromellose, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polacrillin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide.

Ethinyl Estradiol Tablets USP meets USP Dissolution Test 2.



What does FAYOSIM look like?



What are the available doses of FAYOSIM?

Fayosim (levonorgestrel and ethinyl estradiol tablets, and ethinyl estradiol tablets) are available as round, film-coated, biconvex tablets debossed with "LU" on one side, packaged in Extended-Cycle wallet, each containing a 13-week supply of tablets in the following order:

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

Nursing Mothers: Not recommended for nursing mothers; can decrease milk production. ()

How should I use FAYOSIM?

Fayosim is an estrogen/progestin COC indicated for use by women to prevent pregnancy ().

Instruct patients to take Fayosim once a day by mouth at the same time every day for 91 days. To achieve maximum contraceptive effectiveness, Fayosim must be taken exactly as directed and at intervals not exceeding 24 hours. For patient instructions regarding missed pills, see


What interacts with FAYOSIM?

Sorry No Records found


What are the warnings of FAYOSIM?

Sorry No Records found


What are the precautions of FAYOSIM?

Sorry No Records found


What are the side effects of FAYOSIM?

Sorry No records found


What should I look out for while using FAYOSIM?

  A high risk of arterial or venous thrombotic diseases ()

  Undiagnosed abnormal uterine bleeding ()

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

  Liver tumors or liver disease ()

  Pregnancy ()


What might happen if I take too much FAYOSIM?

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 FAYOSIM?

Cyproheptadine Hydrochloride Syrup (Cyproheptadine Hydrochloride Oral Solution USP, 2 mg/5 mL) in a yellow, peppermint-flavored vehicle is supplied in a 473 mL (16 fl oz) container (NDC 0527-1949-47).Store at 20° to 25°C (68° to 77°F) excursion permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.Distributed by: Lannett Company, Inc. Philadelphia, PA 19154Rev. 12/17 10-1138Cyproheptadine Hydrochloride Syrup (Cyproheptadine Hydrochloride Oral Solution USP, 2 mg/5 mL) in a yellow, peppermint-flavored vehicle is supplied in a 473 mL (16 fl oz) container (NDC 0527-1949-47).Store at 20° to 25°C (68° to 77°F) excursion permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.Distributed by: Lannett Company, Inc. Philadelphia, PA 19154Rev. 12/17 10-1138Cyproheptadine Hydrochloride Syrup (Cyproheptadine Hydrochloride Oral Solution USP, 2 mg/5 mL) in a yellow, peppermint-flavored vehicle is supplied in a 473 mL (16 fl oz) container (NDC 0527-1949-47).Store at 20° to 25°C (68° to 77°F) excursion permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.Distributed by: Lannett Company, Inc. Philadelphia, PA 19154Rev. 12/17 10-1138Cyproheptadine Hydrochloride Syrup (Cyproheptadine Hydrochloride Oral Solution USP, 2 mg/5 mL) in a yellow, peppermint-flavored vehicle is supplied in a 473 mL (16 fl oz) container (NDC 0527-1949-47).Store at 20° to 25°C (68° to 77°F) excursion permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.Distributed by: Lannett Company, Inc. Philadelphia, PA 19154Rev. 12/17 10-1138Cyproheptadine Hydrochloride Syrup (Cyproheptadine Hydrochloride Oral Solution USP, 2 mg/5 mL) in a yellow, peppermint-flavored vehicle is supplied in a 473 mL (16 fl oz) container (NDC 0527-1949-47).Store at 20° to 25°C (68° to 77°F) excursion permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.Distributed by: Lannett Company, Inc. Philadelphia, PA 19154Rev. 12/17 10-1138Cyproheptadine Hydrochloride Syrup (Cyproheptadine Hydrochloride Oral Solution USP, 2 mg/5 mL) in a yellow, peppermint-flavored vehicle is supplied in a 473 mL (16 fl oz) container (NDC 0527-1949-47).Store at 20° to 25°C (68° to 77°F) excursion permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.Distributed by: Lannett Company, Inc. Philadelphia, PA 19154Rev. 12/17 10-1138


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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 ()

  Undiagnosed abnormal uterine bleeding ()

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

  Liver tumors or liver disease ()

  Pregnancy ()

MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines. Antihistamines may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents.

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

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

Start Fayosim 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. Data from a large, prospective cohort safety study of various COCs suggest that this increased risk, as compared to that in non-COC users, is greatest during the first 6 months of COC use. Data from this safety study indicate that the greatest risk of VTE is present after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC. The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued.

Use of Fayosim provides women with more hormonal exposure on a yearly basis than conventional monthly oral contraceptives containing the same strength synthetic estrogens and progestins (an additional 9 and 13 weeks of exposure to progestin and estrogen, respectively, per year). In the clinical trial, three cases of deep vein thrombosis were reported.

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