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Levonorgestrel and Ethinyl Estradiol

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Overview

What is Aviane?

21 orange active tablets each containing 0.10 mg of levonorgestrel, USP (-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, USP, (19-Nor-17α -pregna-1,3,5(10)-trien-20-yne-3,17-diol). The inactive ingredients present are: FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, sodium starch glycolate and titanium dioxide.

7 light-green, inert tablets each containing: 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, microcrystalline cellulose and pregelatinized corn starch.

Levonorgestrel, USP

Ethinyl Estradiol, USP



What does Aviane look like?



What are the available doses of Aviane?

Sorry No records found.

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

Sorry No records found

How should I use Aviane?

Aviane (levonorgestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

Oral contraceptives are highly effective. lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

In a clinical trial with Aviane (levonorgestrel and ethinyl estradiol tablets USP), 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.

To achieve maximum contraceptive effectiveness, Aviane (levonorgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Aviane - 28 is one orange tablet daily for 21 consecutive days, followed by one light-green inert tablet daily for 7 consecutive days, according to the prescribed schedule. It is recommended that Aviane - 28 tablets be taken at the same time each day.

The dispenser should be kept in the wallet supplied to avoid possible fading of the pills. If the pills fade, patients should continue to take them as directed.


What interacts with Aviane?


  • Combination oral contraceptives should not be used in women with any of the following conditions:

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    • WARNINGS
    • Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment



What are the warnings of Aviane?

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.


What are the precautions of Aviane?

1. General

Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

2. Physical Examination and Follow-Up

A periodic personal and family medical history and complete physical examination are appropriate for all women, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen, and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent, or recurrent abnormal vaginal bleeding, appropriate diagnostic measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.

3. Lipid Disorders

Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult (see WARNINGS, 1, 1, and ).

A small proportion of women will have adverse lipid changes while taking oral contraceptives. Nonhormonal contraception should be considered in women with uncontrolled dyslipidemias. Persistent hypertriglyceridemia may occur in a small population of combination oral contraceptive users. Elevations of plasma triglycerides may lead to pancreatitis and other complications.

4. Liver Function

If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function.

5. Fluid Retention

Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.

6. Emotional Disorders

Patients becoming significantly depressed while taking oral contraceptives should stop the medication and use an alternate method of contraception in an attempt to determine whether the symptom is drug related. Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.

7. Contact Lenses

Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.

8. Gastrointestinal

Diarrhea and/or vomiting may reduce hormone absorption resulting in decreased serum concentrations.

9. Drug Interactions

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Coadministration of atorvastatin and certain oral contraceptives containing ethinyl estradiol increases AUC values for ethinyl estradiol by approximately 20%. Ascorbic acid and acetaminophen increase the bioavailability of ethinyl estradiol since these drugs act as competitive inhibitors for sulfation of ethinyl estradiol in the gastrointestinal wall, a known pathway of elimination for ethinyl estradiol. CYP 3A4 inhibitors such as indinavir, itraconazole, ketoconazole, fluconazole, and troleandomycin may increase plasma hormone levels. Troleandomycin may also increase the risk of intrahepatic cholestasis during coadministration with combination oral contraceptives.

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Do not co-administer Aviane with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see , ).

10. Interactions with Laboratory Tests

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Certain endocrine- and liver-function tests and blood components may be affected by oral contraceptives:

11. Carcinogenesis

See section.

12. Pregnancy

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Teratogenic Effects

See and sections.

13. Nursing Mothers

Small amounts of oral contraceptive steroids and/or metabolites have been identified in the milk of nursing mothers, and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, combination oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use combination oral contraceptives but to use other forms of contraception until she has completely weaned her child.

14. Pediatric Use

Safety and efficacy of Aviane tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of Aviane before menarche is not indicated.

15. Geriatric Use

Aviane has not been studied in women over 65 years of age and is not indicated in this population.

16. Information for the Patient

See Patient Labeling printed below.


What are the side effects of Aviane?

An increased risk of the following serious adverse reactions (see section for additional information) has been associated with the use of oral contraceptives:

Thromboembolic and thrombotic disorders and other vascular problems (including thrombophlebitis and venous thrombosis with or without pulmonary embolism, mesenteric thrombosis, arterial thromboembolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs and breasts, hepatic neoplasia (including hepatic adenomas or benign liver tumors), ocular lesions (including retinal vascular thrombosis), gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache including migraine.

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related (alphabetically listed):

The following adverse reactions have been reported in users of oral contraceptives:


What should I look out for while using Aviane?

Combination oral contraceptives should not be used in women with any of the following conditions:


What might happen if I take too much Aviane?

Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, and drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.


How should I store and handle Aviane?

Store at 20º-25º C (68º-77º F); excursions permitted to 15 to 30º C (59 to 86º F) [see USP Controlled Room Temperature].Aviane (levonorgestrel and ethinyl estradiol tablets USP), 0.10 mg/0.02 mg is available as 28 tablets packaged in cartons (NDC: 63187-889-28) of six blister card dispensers. Each blister card dispenser contains 21 orange active tablets and 7 light-green inert tablets. Each orange tablet is round, film coated and debossed with on one side and on the other side. Each light-green tablet is round and debossed with on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.REFERENCES AVAILABLE UPON REQUEST.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Relabeled by:Proficient Rx LPThousand Oaks, CA 91320Rev. B 4/2017Aviane (levonorgestrel and ethinyl estradiol tablets USP), 0.10 mg/0.02 mg is available as 28 tablets packaged in cartons (NDC: 63187-889-28) of six blister card dispensers. Each blister card dispenser contains 21 orange active tablets and 7 light-green inert tablets. Each orange tablet is round, film coated and debossed with on one side and on the other side. Each light-green tablet is round and debossed with on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.REFERENCES AVAILABLE UPON REQUEST.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Relabeled by:Proficient Rx LPThousand Oaks, CA 91320Rev. B 4/2017Aviane (levonorgestrel and ethinyl estradiol tablets USP), 0.10 mg/0.02 mg is available as 28 tablets packaged in cartons (NDC: 63187-889-28) of six blister card dispensers. Each blister card dispenser contains 21 orange active tablets and 7 light-green inert tablets. Each orange tablet is round, film coated and debossed with on one side and on the other side. Each light-green tablet is round and debossed with on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.REFERENCES AVAILABLE UPON REQUEST.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Relabeled by:Proficient Rx LPThousand Oaks, CA 91320Rev. B 4/2017Aviane (levonorgestrel and ethinyl estradiol tablets USP), 0.10 mg/0.02 mg is available as 28 tablets packaged in cartons (NDC: 63187-889-28) of six blister card dispensers. Each blister card dispenser contains 21 orange active tablets and 7 light-green inert tablets. Each orange tablet is round, film coated and debossed with on one side and on the other side. Each light-green tablet is round and debossed with on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.REFERENCES AVAILABLE UPON REQUEST.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Relabeled by:Proficient Rx LPThousand Oaks, CA 91320Rev. B 4/2017Aviane (levonorgestrel and ethinyl estradiol tablets USP), 0.10 mg/0.02 mg is available as 28 tablets packaged in cartons (NDC: 63187-889-28) of six blister card dispensers. Each blister card dispenser contains 21 orange active tablets and 7 light-green inert tablets. Each orange tablet is round, film coated and debossed with on one side and on the other side. Each light-green tablet is round and debossed with on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.REFERENCES AVAILABLE UPON REQUEST.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Relabeled by:Proficient Rx LPThousand Oaks, CA 91320Rev. B 4/2017Aviane (levonorgestrel and ethinyl estradiol tablets USP), 0.10 mg/0.02 mg is available as 28 tablets packaged in cartons (NDC: 63187-889-28) of six blister card dispensers. Each blister card dispenser contains 21 orange active tablets and 7 light-green inert tablets. Each orange tablet is round, film coated and debossed with on one side and on the other side. Each light-green tablet is round and debossed with on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.REFERENCES AVAILABLE UPON REQUEST.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Relabeled by:Proficient Rx LPThousand Oaks, CA 91320Rev. B 4/2017Aviane (levonorgestrel and ethinyl estradiol tablets USP), 0.10 mg/0.02 mg is available as 28 tablets packaged in cartons (NDC: 63187-889-28) of six blister card dispensers. Each blister card dispenser contains 21 orange active tablets and 7 light-green inert tablets. Each orange tablet is round, film coated and debossed with on one side and on the other side. Each light-green tablet is round and debossed with on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.REFERENCES AVAILABLE UPON REQUEST.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Relabeled by:Proficient Rx LPThousand Oaks, CA 91320Rev. B 4/2017Aviane (levonorgestrel and ethinyl estradiol tablets USP), 0.10 mg/0.02 mg is available as 28 tablets packaged in cartons (NDC: 63187-889-28) of six blister card dispensers. Each blister card dispenser contains 21 orange active tablets and 7 light-green inert tablets. Each orange tablet is round, film coated and debossed with on one side and on the other side. Each light-green tablet is round and debossed with on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.REFERENCES AVAILABLE UPON REQUEST.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Relabeled by:Proficient Rx LPThousand Oaks, CA 91320Rev. B 4/2017Aviane (levonorgestrel and ethinyl estradiol tablets USP), 0.10 mg/0.02 mg is available as 28 tablets packaged in cartons (NDC: 63187-889-28) of six blister card dispensers. Each blister card dispenser contains 21 orange active tablets and 7 light-green inert tablets. Each orange tablet is round, film coated and debossed with on one side and on the other side. Each light-green tablet is round and debossed with on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.REFERENCES AVAILABLE UPON REQUEST.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Relabeled by:Proficient Rx LPThousand Oaks, CA 91320Rev. B 4/2017Aviane (levonorgestrel and ethinyl estradiol tablets USP), 0.10 mg/0.02 mg is available as 28 tablets packaged in cartons (NDC: 63187-889-28) of six blister card dispensers. Each blister card dispenser contains 21 orange active tablets and 7 light-green inert tablets. Each orange tablet is round, film coated and debossed with on one side and on the other side. Each light-green tablet is round and debossed with on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.REFERENCES AVAILABLE UPON REQUEST.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Relabeled by:Proficient Rx LPThousand Oaks, CA 91320Rev. B 4/2017Aviane (levonorgestrel and ethinyl estradiol tablets USP), 0.10 mg/0.02 mg is available as 28 tablets packaged in cartons (NDC: 63187-889-28) of six blister card dispensers. Each blister card dispenser contains 21 orange active tablets and 7 light-green inert tablets. Each orange tablet is round, film coated and debossed with on one side and on the other side. Each light-green tablet is round and debossed with on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.REFERENCES AVAILABLE UPON REQUEST.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Relabeled by:Proficient Rx LPThousand Oaks, CA 91320Rev. B 4/2017


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).

Non-Clinical Toxicology
Combination oral contraceptives should not be used in women with any of the following conditions:

Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

An increased risk of the following serious adverse reactions (see section for additional information) has been associated with the use of oral contraceptives:

Thromboembolic and thrombotic disorders and other vascular problems (including thrombophlebitis and venous thrombosis with or without pulmonary embolism, mesenteric thrombosis, arterial thromboembolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs and breasts, hepatic neoplasia (including hepatic adenomas or benign liver tumors), ocular lesions (including retinal vascular thrombosis), gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache including migraine.

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related (alphabetically listed):

The following adverse reactions have been reported in users of oral contraceptives:

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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

Tips

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Interactions

Interactions

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