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Levonorgestrel and Ethinyl Estradiol
Overview
What is Levora?
21 white Levora® 0.15/30-28 tablets, each containing 0.15 mg of levonorgestrel, ((-)-13 betaethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.03 mg of ethinyl estradiol, (19-nor-17a-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and 7 peach inert tablets.
The white Levora® 0.15/30 tablets contain the following inactive ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone.
The inactive peach tablets in the 28-day regimen of Levora® 0.15/30 contain the following inactive ingredients: FD&C Yellow No. 6 Lake, Lactose Anhydrous, Lactose Monohydrate, Magnesium Stearate and Microcrystalline Cellulose.
What does Levora look like?
What are the available doses of Levora?
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What should I talk to my health care provider before I take Levora?
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How should I use Levora?
Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Oral contraceptives are highly effective. Table I 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 and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
NA - not available
Depending on method (calendar, ovulation, symptothermal, post-ovulation) Adapted from Hatcher RA et al, . NY, NY: Ardent Media, Inc., 1998.
To achieve maximum contraceptive effectiveness, Levora® 0.15/30-28 (levonorgestrel and ethinyl estradiol tablets, 0.15mg/0.03mg) must be taken exactly as directed and at intervals not exceeding 24 hours.
The dosage of Levora® 0.15/30-28 is one white tablet daily for 21 consecutive days, followed by one peach inert tablet daily for 7 consecutive days, according to prescribed schedule.
It is recommended that tablets be taken at the same time each day, preferably after the evening meal or at bedtime.
During the first cycle of medication, the patient is instructed to begin taking Levora® 0.15/30-28 on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. One white tablet should be taken daily for 21 consecutive days, followed by one peach inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle, contraceptive reliance should not be placed on Levora® 0.15/30-28 until a white tablet has been taken daily for 7 consecutive days and a nonhormonal back-up method of birth control should be used during those 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.
The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week (Sunday) on which she began her first course, following the same schedule: 21 days on white tablets—7 days on peach inert tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself by using another method of birth control until she has taken a white tablet daily for 7 consecutive days.
When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts Levora® 0.15/30-28. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of Levora® 0.15/30-28 on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin Levora® 0.15/30-28 the next day. If switching from an implant or injection, the patient should start Levora® 0.15/30-28 on the day of implant removal or, if using an injection, the day the next injection would be due. In switching from a progestin-only pill, injection or implant, the patient should be advised to use a nonhormonal back-up method of birth control for the first 7 days of tablet-taking.
If spotting or breakthrough 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 physician. Although the occurrence of pregnancy is highly unlikely if Levora® 0.15/30-28 is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. 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 at the time of the first missed period and appropriate diagnostic measures taken before the medication is resumed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.
For additional patient instructions regarding missed pills, see the “” section in the below.
Any time the patient misses two or more white tablets, she should also use another method of contraception until she has taken a white tablet daily for seven consecutive days. If the patient misses one or more peach tablets, she is still protected against pregnancy she begins taking white tablets again on the proper day.
If breakthrough bleeding occurs following missed white tablets, it will usually be transient and of no consequence. While there is little likelihood of ovulation occurring if only one or two white tablets are missed, the possibility of ovulation increases with each successive day that scheduled white tablets are missed.
Levora® 0.15/30-28 may be initiated no earlier than day 28 postpartum in the non-lactating 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 Levora® 0.15/30-28 immediately, additional contraceptive measures are not needed. It is to be noted that early resumption of ovulation may occur if Parlodel(bromocriptine mesylate) has been used for the prevention of lactation.
What interacts with Levora?
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What are the warnings of Levora?
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What are the precautions of Levora?
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What are the side effects of Levora?
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What should I look out for while using Levora?
Combination oral contraceptives should not be used in women with any of the following conditions: Thrombophlebitis or thromboembolic disorders. A past history of deep-vein thrombophlebitis or thromboembolic disorders. Cerebral-vascular or coronary artery disease. Thrombogenic valvulopathies. Thrombogenic rhythm disorders. Diabetes with vascular involvement. Uncontrolled hypertension. Known or suspected carcinoma of the breast. Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior pill use. Hepatic adenomas or carcinomas, or active liver disease, as long as liver function has not returned to normal. Known or suspected pregnancy. Hypersensitivity to any of the components of Levora® 0.15/30-28 (levonorgestrel and ethinyl estradiol tablets).
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, and stroke), 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, and diabetes.
Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.
The information contained in this package insert is based principally on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations 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 non-users. 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 non-users. 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 Levora?
Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.
How should I store and handle Levora?
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Levora® 0.15/30-28 Tablets (levonorgestrel and ethinyl estradiol, 0.15mg/0.03mg) are available in packages of 6 compact dispensers, each containing 28 Tablets:Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature]. References available upon request. Manufactured by: Corona, CA 92880 USADistributed by: Parsippany, NJ 07054 USARevised: January 2014Levora® 0.15/30-28 Tablets (levonorgestrel and ethinyl estradiol, 0.15mg/0.03mg) are available in packages of 6 compact dispensers, each containing 28 Tablets:Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature]. References available upon request. Manufactured by: Corona, CA 92880 USADistributed by: Parsippany, NJ 07054 USARevised: January 2014Levora® 0.15/30-28 Tablets (levonorgestrel and ethinyl estradiol, 0.15mg/0.03mg) are available in packages of 6 compact dispensers, each containing 28 Tablets:Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature]. References available upon request. Manufactured by: Corona, CA 92880 USADistributed by: Parsippany, NJ 07054 USARevised: January 2014Levora® 0.15/30-28 Tablets (levonorgestrel and ethinyl estradiol, 0.15mg/0.03mg) are available in packages of 6 compact dispensers, each containing 28 Tablets:Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature]. References available upon request. Manufactured by: Corona, CA 92880 USADistributed by: Parsippany, NJ 07054 USARevised: January 2014Levora® 0.15/30-28 Tablets (levonorgestrel and ethinyl estradiol, 0.15mg/0.03mg) are available in packages of 6 compact dispensers, each containing 28 Tablets:Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature]. References available upon request. Manufactured by: Corona, CA 92880 USADistributed by: Parsippany, NJ 07054 USARevised: January 2014
Clinical Information
Chemical Structure
No Image foundClinical 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: Thrombophlebitis or thromboembolic disorders. A past history of deep-vein thrombophlebitis or thromboembolic disorders. Cerebral-vascular or coronary artery disease. Thrombogenic valvulopathies. Thrombogenic rhythm disorders. Diabetes with vascular involvement. Uncontrolled hypertension. Known or suspected carcinoma of the breast. Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior pill use. Hepatic adenomas or carcinomas, or active liver disease, as long as liver function has not returned to normal. Known or suspected pregnancy. Hypersensitivity to any of the components of Levora® 0.15/30-28 (levonorgestrel and ethinyl estradiol tablets).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, and stroke), 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, and diabetes.
Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.
The information contained in this package insert is based principally on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations 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 non-users. 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 non-users. 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.
Interactions between ethinyl estradiol and other substances may lead to decreased or increased serum ethinyl estradiol concentrations. Decreased ethinyl estradiol plasma concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the combination oral contraceptive.
Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when co-administered, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Reduced ethinyl estradiol concentrations have been associated with concomitant use of substances that induce hepatic microsomal enzymes, such as rifampin, rifabutin, barbiturates, phenylbutazone, phenytoin sodium, griseofulvin, topiramate, some protease inhibitors, modafinil, and possibly St. John’s wort.
Substances that may decrease plasma ethinyl estradiol concentrations by other mechanisms include any substance that reduces gut transit time and certain antibiotics (e.g. ampicillin and other penicillins, tetracyclines) by a decrease of enterohepatic circulation of estrogens.
During concomitant use of ethinyl estradiol containing products and substances that may lead to decreased plasma steroid hormone concentrations, it is recommended that a nonhormonal back-up method of birth control be used in addition to the regular intake of Levora® 0.15/30-28 (levonorgestrel and ethinyl estradiol tablets). If the use of a substance which leads to decreased ethinyl estradiol plasma concentrations is required for a prolonged period of time, combination oral contraceptives should not be considered the primary contraceptive.
After discontinuation of substances that may lead to decreased ethinyl estradiol plasma concentrations, use of a nonhormonal back-up method of birth control is recommended for 7 days. Longer use of a back-up method is advisable after discontinuation of substances that have led to induction of hepatic microsomal enzymes, resulting in decreased ethinyl estradiol concentrations. It may take several weeks until enzyme induction has completely subsided, depending on dosage, duration of use, and rate of elimination of the inducing substance.
Some substances may increase plasma ethinyl estradiol concentrations. These include:
Ethinyl estradiol may interfere with the mechanism of other drugs by inhibiting hepatic microsomal enzymes or by inducing hepatic drug conjugation, particularly glucuronidation. Accordingly, tissue concentrations may be either increased (e.g. cyclosporine, theophylline, corticosteroids) or decreased.
The prescribing information of concomitant medications should be consulted to identify potential interactions.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
An increased risk of the following serious adverse reactions (see section for additional information) has been associated with the use of oral contraceptives:
Thromboembolic disorders and other vascular problems (including thrombophlebitis, arterial thromboembolism, pulmonary embolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs, 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.
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
Nausea Vomiting Gastrointestinal symptoms (such as abdominal pain, cramps and bloating) Breakthrough bleeding Spotting Change in menstrual flow Amenorrhea Temporary infertility after discontinuation of treatment Edema/fluid retention Melasma/chloasma which may persist Breast changes: tenderness, pain, enlargement, secretion Change in weight or appetite (increase or decrease) Change in cervical erosion and secretion Diminution in lactation when given immediately postpartum Cholestatic jaundice Rash (allergic) Mood changes, including depression Vaginitis, including candidiasis Change in corneal curvature (steepening) Intolerance to contact lenses Mesenteric thrombosis Decrease in serum folate levels Exacerbation of systemic lupus erythematosus Exacerbation of porphyria Exacerbation of chorea Aggravation of varicose veins Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms.
The following adverse reactions have been reported in users of oral contraceptives, and the association has been neither confirmed nor refuted:
Congenital anomalies Premenstrual syndrome Cataracts Optic neuritis, which may lead to partial or complete loss of vision Cystitis-like syndrome Nervousness Dizziness Hirsutism Loss of scalp hair Erythema multiforme Erythema nodosum Hemorrhagic eruption Impaired renal function Hemolytic uremic syndrome Budd-Chiari syndrome Acne Changes in libido Colitis Sickle-cell disease Cerebral-vascular disease with mitral valve prolapse Lupus-like syndromes Pancreatitis Dysmenorrhea
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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