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Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol

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Overview

What is Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol?

Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is an extended-cycle oral contraceptive. Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets consists of 42 light pink tablets containing 0.15 mg levonorgestrel and 0.02 mg ethinyl estradiol, 21 pink tablets containing 0.15 mg levonorgestrel and 0.025 mg ethinyl estradiol, and 21 purple tablets containing 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol, and 7 yellow 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

CHO MW: 312.4

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

Ethinyl Estradiol

CHO MW: 296.4

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

Each light pink tablet contains the following inactive ingredients:

anhydrous lactose, D&C Red no. 27/phloxine aluminum lake, FD&C Blue no. 2/Indigo Carmine aluminum lake, FD&C Yellow no. 6/Sunset Yellow FCF aluminum lake, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol/macrogol, titanium dioxide, and triacetin.

Each pink tablet contains the following inactive ingredients:

anhydrous lactose, D&C Red no. 27/phloxine aluminum lake, FD&C Blue no. 2/Indigo Carmine aluminum lake, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol/macrogol, titanium dioxide and triacetin.

Each purple tablet contains the following inactive ingredients:

anhydrous lactose, D&C Red no. 27/phloxine aluminum lake, FD&C Blue no. 1/Brilliant blue FCF aluminum lake, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol/macrogol, titanium dioxide and triacetin.

Each yellow tablet contains the following inactive ingredients:

anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C Yellow no. 6/Sunset Yellow FCF aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol/macrogol, polysorbate 80 and titanium dioxide.



What does Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol look like?



What are the available doses of Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol?

Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets consists of 91 tablets in the following order ():

What should I talk to my health care provider before I take Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol?

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

How should I use Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol?

Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is indicated for use by females of reproductive age to prevent pregnancy.

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


What interacts with Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol?

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What are the warnings of Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol?

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What are the precautions of Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol?

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What are the side effects of Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol?

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What should I look out for while using Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol?

Do not prescribe levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets to women who are known to have the following conditions:

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (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 Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol?

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 Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol?

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense and keep product in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense and keep product in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet. Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP are supplied as5 mg/6.25 mgSalmon pink coloured, biconvex, round, film coated tablets debossed with UL on one side and | | on other side.Bottles of 20:   NDC 68788-6880-2Bottles of 30:   NDC 68788-6880-3Bottles of 60:   NDC 68788-6880-6Bottles of 90:   NDC 68788-6880-9Bottles of 100:   NDC 68788-6880-1Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature].Dispense in a tight container.Please address medical inquiries to Unichem's toll free # 1-866-562-4616.Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP are supplied as5 mg/6.25 mgSalmon pink coloured, biconvex, round, film coated tablets debossed with UL on one side and | | on other side.Bottles of 20:   NDC 68788-6880-2Bottles of 30:   NDC 68788-6880-3Bottles of 60:   NDC 68788-6880-6Bottles of 90:   NDC 68788-6880-9Bottles of 100:   NDC 68788-6880-1Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature].Dispense in a tight container.Please address medical inquiries to Unichem's toll free # 1-866-562-4616.Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP are supplied as5 mg/6.25 mgSalmon pink coloured, biconvex, round, film coated tablets debossed with UL on one side and | | on other side.Bottles of 20:   NDC 68788-6880-2Bottles of 30:   NDC 68788-6880-3Bottles of 60:   NDC 68788-6880-6Bottles of 90:   NDC 68788-6880-9Bottles of 100:   NDC 68788-6880-1Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature].Dispense in a tight container.Please address medical inquiries to Unichem's toll free # 1-866-562-4616.Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP are supplied as5 mg/6.25 mgSalmon pink coloured, biconvex, round, film coated tablets debossed with UL on one side and | | on other side.Bottles of 20:   NDC 68788-6880-2Bottles of 30:   NDC 68788-6880-3Bottles of 60:   NDC 68788-6880-6Bottles of 90:   NDC 68788-6880-9Bottles of 100:   NDC 68788-6880-1Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature].Dispense in a tight container.Please address medical inquiries to Unichem's toll free # 1-866-562-4616.Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP are supplied as5 mg/6.25 mgSalmon pink coloured, biconvex, round, film coated tablets debossed with UL on one side and | | on other side.Bottles of 20:   NDC 68788-6880-2Bottles of 30:   NDC 68788-6880-3Bottles of 60:   NDC 68788-6880-6Bottles of 90:   NDC 68788-6880-9Bottles of 100:   NDC 68788-6880-1Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature].Dispense in a tight container.Please address medical inquiries to Unichem's toll free # 1-866-562-4616.Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP are supplied as5 mg/6.25 mgSalmon pink coloured, biconvex, round, film coated tablets debossed with UL on one side and | | on other side.Bottles of 20:   NDC 68788-6880-2Bottles of 30:   NDC 68788-6880-3Bottles of 60:   NDC 68788-6880-6Bottles of 90:   NDC 68788-6880-9Bottles of 100:   NDC 68788-6880-1Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature].Dispense in a tight container.Please address medical inquiries to Unichem's toll free # 1-866-562-4616.Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP are supplied as5 mg/6.25 mgSalmon pink coloured, biconvex, round, film coated tablets debossed with UL on one side and | | on other side.Bottles of 20:   NDC 68788-6880-2Bottles of 30:   NDC 68788-6880-3Bottles of 60:   NDC 68788-6880-6Bottles of 90:   NDC 68788-6880-9Bottles of 100:   NDC 68788-6880-1Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature].Dispense in a tight container.Please address medical inquiries to Unichem's toll free # 1-866-562-4616.Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP are supplied as5 mg/6.25 mgSalmon pink coloured, biconvex, round, film coated tablets debossed with UL on one side and | | on other side.Bottles of 20:   NDC 68788-6880-2Bottles of 30:   NDC 68788-6880-3Bottles of 60:   NDC 68788-6880-6Bottles of 90:   NDC 68788-6880-9Bottles of 100:   NDC 68788-6880-1Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature].Dispense in a tight container.Please address medical inquiries to Unichem's toll free # 1-866-562-4616.Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP are supplied as5 mg/6.25 mgSalmon pink coloured, biconvex, round, film coated tablets debossed with UL on one side and | | on other side.Bottles of 20:   NDC 68788-6880-2Bottles of 30:   NDC 68788-6880-3Bottles of 60:   NDC 68788-6880-6Bottles of 90:   NDC 68788-6880-9Bottles of 100:   NDC 68788-6880-1Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature].Dispense in a tight container.Please address medical inquiries to Unichem's toll free # 1-866-562-4616.Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP are supplied as5 mg/6.25 mgSalmon pink coloured, biconvex, round, film coated tablets debossed with UL on one side and | | on other side.Bottles of 20:   NDC 68788-6880-2Bottles of 30:   NDC 68788-6880-3Bottles of 60:   NDC 68788-6880-6Bottles of 90:   NDC 68788-6880-9Bottles of 100:   NDC 68788-6880-1Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature].Dispense in a tight container.Please address medical inquiries to Unichem's toll free # 1-866-562-4616.Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP are supplied as5 mg/6.25 mgSalmon pink coloured, biconvex, round, film coated tablets debossed with UL on one side and | | on other side.Bottles of 20:   NDC 68788-6880-2Bottles of 30:   NDC 68788-6880-3Bottles of 60:   NDC 68788-6880-6Bottles of 90:   NDC 68788-6880-9Bottles of 100:   NDC 68788-6880-1Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature].Dispense in a tight container.Please address medical inquiries to Unichem's toll free # 1-866-562-4616.


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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 levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets to women who are known to have the following conditions:

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (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.

BISOPROLOL FUMARATE should not be combined with other beta-blocking agents. Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored, because the added beta-adrenergic blocking action of BISOPROLOL FUMARATE may produce excessive reduction of sympathetic activity. In patients receiving concurrent therapy with clonidine, if therapy is to be discontinued, it is suggested that BISOPROLOL FUMARATE be discontinued for several days before the withdrawal of clonidine.

BISOPROLOL FUMARATE should be used with care when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide, are used concurrently.

Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

Concurrent use of rifampin increases the metabolic clearance of BISOPROLOL FUMARATE, resulting in a shortened elimination half-life of BISOPROLOL FUMARATE. However, initial dose modification is generally not necessary. Pharmacokinetic studies document no clinically relevant interactions with other agents given concomitantly, including thiazide diuretics and cimetidine. There was no effect of BISOPROLOL FUMARATE on prothrombin time in patients on stable doses of warfarin.

Risk of Anaphylactic Reaction: While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.

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

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

Start levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets 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 levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets 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.

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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