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Levonorgestrel and Ethinyl Estradiol

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Overview

What is Amethyst?

Twenty-eight (28) white tablets each containing 90 mcg of levonorgestrel (17α)-(–)13-ethyl-17-hydroxy-18, 19-dinorpregn-4-en-20-yn-3-one, a totally synthetic progestogen, and 20 mcg of ethinyl estradiol, (17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol. The inactive ingredients present are microcrystalline cellulose, lactose monohydrate, magnesium stearate, croscarmellose sodium, and povidone.



What does Amethyst look like?



What are the available doses of Amethyst?

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

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How should I use Amethyst?

Amethyst™ (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 for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depend upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. 

Lactation Amenorrhea Method: LAM is a highly effective, method of contraception. 

Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W,

Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition.

: Publishers; 1998.

To achieve maximum contraceptive effectiveness, Amethyst must be taken exactly as directed and at intervals not exceeding 24 hours. The possibility of ovulation and conception prior to initiation of medication should be considered. Women who do not wish to become pregnant after discontinuation should be advised to immediately use another method of birth control. The dosage of Amethyst is one white tablet daily without any tablet-free interval.

It is recommended that Amethyst be taken at the each day.

Initiation of Therapy

Instructions for beginning Amethyst are provided in Table 4 below.

If spotting or unscheduled bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her health care professional. The possibility of ovulation increases with each successive day that scheduled white tablets are missed. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered. Hormonal contraception must be discontinued if pregnancy is confirmed.

The risk of pregnancy increases with each tablet missed. For additional patient instructions regarding missed tablets, see the section in the below.

Amethyst may be initiated no earlier than day 28 postpartum in the nonlactating mother or after a second-trimester abortion due to the increased risk for thromboembolism (see , , and concerning thromboembolic disease). The patient should be advised to use a nonhormonal back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before the start of combined oral contraceptive use or the patient must wait for her first menstrual period.

In the case of first-trimester abortion, if the patient starts Amethyst immediately, additional contraceptive measures are not needed.


What interacts with Amethyst?

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What are the warnings of Amethyst?

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What are the precautions of Amethyst?

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What are the side effects of Amethyst?

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What should I look out for while using Amethyst?

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

The use of oral contraceptives is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke, and transient ischemic attack), hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as certain inherited or acquired thrombophilias, hypertension, hyperlipidemias, obesity, diabetes, and surgery or trauma with increased risk of thrombosis (see ).

Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.

The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher doses of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower doses of both estrogens and progestogens remains to be determined.

Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population. For further information, the reader is referred to a text on epidemiological methods.


What might happen if I take too much Amethyst?

Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, 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 Amethyst?

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.Amethyst™ (levonorgestrel and ethinyl estradiol tablets, USP 90 mcg levonorgestrel and 20 mcg ethinyl estradiol) is available in a 28 tablet dispenser, arranged in 4 rows of 7 active tablets as follows: 28 round, white, flat face, beveled edge, uncoated tablets debossed with " on one side and " on the other side ( 52544-295-28).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References available upon request. Brands listed are the trademarks of their respective owners. Manufactured by:Warner Chilcott Company, LLCFajardo, Puerto Rico 00738 Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2017Amethyst™ (levonorgestrel and ethinyl estradiol tablets, USP 90 mcg levonorgestrel and 20 mcg ethinyl estradiol) is available in a 28 tablet dispenser, arranged in 4 rows of 7 active tablets as follows: 28 round, white, flat face, beveled edge, uncoated tablets debossed with " on one side and " on the other side ( 52544-295-28).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References available upon request. Brands listed are the trademarks of their respective owners. Manufactured by:Warner Chilcott Company, LLCFajardo, Puerto Rico 00738 Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2017Amethyst™ (levonorgestrel and ethinyl estradiol tablets, USP 90 mcg levonorgestrel and 20 mcg ethinyl estradiol) is available in a 28 tablet dispenser, arranged in 4 rows of 7 active tablets as follows: 28 round, white, flat face, beveled edge, uncoated tablets debossed with " on one side and " on the other side ( 52544-295-28).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References available upon request. Brands listed are the trademarks of their respective owners. Manufactured by:Warner Chilcott Company, LLCFajardo, Puerto Rico 00738 Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2017Amethyst™ (levonorgestrel and ethinyl estradiol tablets, USP 90 mcg levonorgestrel and 20 mcg ethinyl estradiol) is available in a 28 tablet dispenser, arranged in 4 rows of 7 active tablets as follows: 28 round, white, flat face, beveled edge, uncoated tablets debossed with " on one side and " on the other side ( 52544-295-28).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References available upon request. Brands listed are the trademarks of their respective owners. Manufactured by:Warner Chilcott Company, LLCFajardo, Puerto Rico 00738 Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2017Amethyst™ (levonorgestrel and ethinyl estradiol tablets, USP 90 mcg levonorgestrel and 20 mcg ethinyl estradiol) is available in a 28 tablet dispenser, arranged in 4 rows of 7 active tablets as follows: 28 round, white, flat face, beveled edge, uncoated tablets debossed with " on one side and " on the other side ( 52544-295-28).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References available upon request. Brands listed are the trademarks of their respective owners. Manufactured by:Warner Chilcott Company, LLCFajardo, Puerto Rico 00738 Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2017Amethyst™ (levonorgestrel and ethinyl estradiol tablets, USP 90 mcg levonorgestrel and 20 mcg ethinyl estradiol) is available in a 28 tablet dispenser, arranged in 4 rows of 7 active tablets as follows: 28 round, white, flat face, beveled edge, uncoated tablets debossed with " on one side and " on the other side ( 52544-295-28).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References available upon request. Brands listed are the trademarks of their respective owners. Manufactured by:Warner Chilcott Company, LLCFajardo, Puerto Rico 00738 Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2017Amethyst™ (levonorgestrel and ethinyl estradiol tablets, USP 90 mcg levonorgestrel and 20 mcg ethinyl estradiol) is available in a 28 tablet dispenser, arranged in 4 rows of 7 active tablets as follows: 28 round, white, flat face, beveled edge, uncoated tablets debossed with " on one side and " on the other side ( 52544-295-28).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References available upon request. Brands listed are the trademarks of their respective owners. Manufactured by:Warner Chilcott Company, LLCFajardo, Puerto Rico 00738 Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2017Amethyst™ (levonorgestrel and ethinyl estradiol tablets, USP 90 mcg levonorgestrel and 20 mcg ethinyl estradiol) is available in a 28 tablet dispenser, arranged in 4 rows of 7 active tablets as follows: 28 round, white, flat face, beveled edge, uncoated tablets debossed with " on one side and " on the other side ( 52544-295-28).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References available upon request. Brands listed are the trademarks of their respective owners. Manufactured by:Warner Chilcott Company, LLCFajardo, Puerto Rico 00738 Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 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:

The use of oral contraceptives is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke, and transient ischemic attack), hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as certain inherited or acquired thrombophilias, hypertension, hyperlipidemias, obesity, diabetes, and surgery or trauma with increased risk of thrombosis (see ).

Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.

The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher doses of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower doses of both estrogens and progestogens remains to be determined.

Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population. For further information, the reader is referred to a text on epidemiological methods.

Changes in Contraceptive Effectiveness Associated with Coadministration of Other Products:

Contraceptive effectiveness may be reduced when hormonal contraceptives are coadministered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids. This could result in unintended pregnancy or unscheduled bleeding. Examples include rifampin, rifabutin, barbiturates, primidone, phenylbutazone, phenytoin, dexamethasone, carbamazepine, felbamate, oxcarbazepine, topiramate, griseofulvin, and modafinil. In such cases a nonhormonal back-up method of birth control should be considered.

Several cases of contraceptive failure and unscheduled bleeding have been reported in the literature with concomitant administration of antibiotics such as ampicillin and other penicillins, and tetracyclines. However, clinical pharmacology studies investigating drug interactions between combined oral contraceptives and these antibiotics have reported inconsistent results. Enterohepatic recirculation of estrogens may also be decreased by substances that reduce gut transit time.

Several of the anti-HIV protease inhibitors have been studied with coadministration of oral combination hormonal contraceptives; significant changes (increase and decrease) in the plasma levels of the estrogen and progestin have been noted in some cases. The safety and efficacy of oral contraceptive products may be affected with coadministration of anti-HIV protease inhibitors. Health care professionals should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.

Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation

Do not coadminister levonorgestrel and ethinyl estradiol tablets with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see ).

Herbal products containing Wort may induce hepatic enzymes (cytochrome P 450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in unscheduled bleeding.

Increase in Plasma Levels Associated with Coadministered Drugs:

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.

Changes in Plasma Levels of Coadministered Drugs:

Combination hormonal contraceptives containing some synthetic estrogens (e.g., ethinyl estradiol) may inhibit the metabolism of other compounds. Increased plasma concentrations of cyclosporine, prednisolone and other corticosteroids, and theophylline have been reported with concomitant administration of oral contraceptives. Decreased plasma concentrations of acetaminophen and lamotrigine, and increased clearance of temazepam, salicylic acid, morphine, and clofibric acid, due to induction of conjugation (particularly glucuronidation), have been noted when these drugs were administered with oral contraceptives.

The prescribing information of concomitant medications should be consulted to identify potential interactions.

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.

Scheduled withdrawal bleeding does not occur with the use of levonorgestrel and ethinyl estradiol, therefore, the absence of withdrawal bleeding cannot be used as a sign of an unexpected pregnancy and as such, unexpected pregnancy may be difficult to recognize. Although pregnancy is unlikely if levonorgestrel and ethinyl estradiol are taken as directed, if for any reason, pregnancy is suspected in a woman using levonorgestrel and ethinyl estradiol, a pregnancy test should be performed.

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, transient ischemic attack)

• Carcinoma of the reproductive organs and breasts

• Hepatic neoplasia/liver disease (including hepatic adenomas or benign liver tumors)

• Ocular lesions (including retinal vascular thrombosis)

• Gallbladder disease

• Carbohydrate and lipid effects

• Elevated blood pressure

• Headache including migraine

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

• Acne

• Amenorrhea

• Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms

• Breast changes: tenderness, pain, enlargement, secretion

• Budd-Chiari syndrome

• Cervical erosion and secretion, change in

• Cholestatic jaundice

• Chorea, exacerbation of

• Colitis

• Contact lenses, intolerance to

• Corneal curvature (steepening), change in

• Dizziness

• Edema/fluid retention

• Erythema multiforme

• Erythema nodosum

• Focal nodular hyperplasia

• Gastrointestinal symptoms (such as abdominal pain, cramps, and bloating)

• Hirsutism

• Infertility after discontinuation of treatment, temporary

• Lactation, diminution in, when given immediately postpartum

• Libido, change in

• Melasma/chloasma which may persist

• Menstrual flow, change in

• Mood changes, including depression

• Nausea

• Nervousness

• Pancreatitis

• Porphyria, exacerbation of

• Rash (allergic)

• Scalp hair, loss of

• Serum folate levels, decrease in

• Spotting

• Systemic lupus erythematosus, exacerbation of

• Unscheduled bleeding

• Vaginitis, including candidiasis

• Varicose veins, aggravation of

• Vomiting

• Weight or appetite (increase or decrease), change in

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

• Cataracts

• Cystitis-like syndrome

• Dysmenorrhea

• Hemolytic uremic syndrome

• Hemorrhagic eruption

• Optic neuritis, which may lead to partial or complete loss of vision

• Premenstrual syndrome

• Renal function, impaired

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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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