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levonorgestrel and ethinyl estradiol
Overview
What is Orsythia?
21 pink active tablets each containing 0.1 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol. The inactive ingredients present are FD&C red #40 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch and vitamin E.
7 light-green inert tablets, each containing FD&C blue #2, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol and pregelatinized starch.
What does Orsythia look like?
What are the available doses of Orsythia?
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What should I talk to my health care provider before I take Orsythia?
Sorry No records found
How should I use Orsythia?
ORSYTHIA (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 levonorgestrel implants, depends 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, temporary 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. New York NY: Irvington Publishers; 1998.
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In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 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 back-up contraception and/or missing 3 or more consecutive pills.
To achieve maximum contraceptive effectiveness, ORSYTHIA (levonorgestrel and ethinyl estradiol tablets USP) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of ORSYTHIA (levonorgestrel and ethinyl estradiol tablets USP) is one pink 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 ORSYTHIA (levonorgestrel and ethinyl estradiol tablets USP) 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 Orsythia?
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What are the warnings of Orsythia?
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What are the precautions of Orsythia?
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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.
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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.
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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 , , 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.
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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.
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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.
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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.
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7. Contact Lenses
Contact-lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
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8. Gastrointestinal
Diarrhea and/or vomiting may reduce hormone absorption resulting in decreased serum concentrations.
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9. Drug Interactions
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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 breakthrough bleeding. Examples include rifampin, rifabutin, barbiturates, primidone, phenylbutazone, phenytoin, dexamethasone, carbamazepine, felbamate, oxcarbazepine, topiramate, griseofulvin, and modafinil. In such cases a back-up nonhormonal method of birth control should be considered.
Several cases of contraceptive failure and breakthrough 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.
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. Healthcare providers should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.
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Do not co-administer Orsythia with HCV drug combinations containing ombitasvir/ paritaprevir/ ritonavir, with or without dasabuvir, due to potential for ALT elevations (see
).
Herbal products containing St. John's Wort (Hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding.
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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. CYP3A4 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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Combination hormonal contraceptives containing some synthetic estrogens (e.g., ethinyl estradiol) may inhibit the metabolism of other compounds. Increased plasma concentrations of cyclosporin, prednisolone and other corticosteroids, and theophylline have been reported with concomitant administration of oral contraceptives. Decreased plasma concentrations of acetaminophen 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.
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- Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.
- Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T by column or by radioimmunoassay. Free T resin uptake is decreased, reflecting the elevated TBG; free T concentration is unaltered.
- Other binding proteins may be elevated in serum i.e., corticosteroid binding globulin (CBG), sex hormone-binding globulins (SHBG) leading to increased levels of total circulating corticosteroids and sex steroids respectively. Free or biologically active hormone concentrations are unchanged.
- Triglycerides may be increased and levels of various other lipids and lipoproteins may be affected.
- Glucose tolerance may be decreased.
- Serum folate levels may be depressed by oral-contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.
10. Interactions With Laboratory Tests
Certain endocrine- and liver-function tests and blood components may be affected by oral contraceptives:
11. Carcinogenesis
See .
12. Pregnancy
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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.
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14. Pediatric Use
Safety and efficacy of levonorgestrel and ethinyl estradiol 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 levonorgestrel and ethinyl estradiol before menarche is not indicated.
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15. Geriatric Use
Levonorgestrel and ethinyl estradiol have not been studied in women over 65 years of age and are not indicated in this population.
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16. Information for the Patient
See Patient Labeling Printed Below.
What are the side effects of Orsythia?
Sorry No records found
What should I look out for while using Orsythia?
Combination oral contraceptives should not be used in women with any of the following conditions:
Thrombophlebitis or thromboembolic disorders
A history of deep-vein thrombophlebitis or thromboembolic disorders
Cerebrovascular or coronary artery disease (current or past history)
Valvular heart disease with thrombogenic complications
Thrombogenic rhythm disorders
Hereditary or acquired thrombophilias
Major surgery with prolonged immobilization
Diabetes with vascular involvement
Headaches with focal neurological symptoms
Uncontrolled hypertension
Known or suspected carcinoma of the breast or personal history of breast cancer
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
Known or suspected pregnancy
Hypersensitivity to any of the components of levonorgestrel and ethinyl estradiol
Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see
).
What might happen if I take too much Orsythia?
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 Orsythia?
Carton containing two epinephrine injection, USP auto-injectors 0.3 mg: NDC 0115-1694-49. Carton containing one epinephrine injection, USP auto-injector 0.3 mg: NDC 0115-1694-30. Carton containing two epinephrine injection, USP auto-injectors 0.15 mg: NDC 0115-1695-49. Carton containing one epinephrine injection, USP auto-injector 0.15 mg: NDC 0115-1695-30. Rx onlyCarton containing two epinephrine injection, USP auto-injectors 0.3 mg: NDC 0115-1694-49. Carton containing one epinephrine injection, USP auto-injector 0.3 mg: NDC 0115-1694-30. Carton containing two epinephrine injection, USP auto-injectors 0.15 mg: NDC 0115-1695-49. Carton containing one epinephrine injection, USP auto-injector 0.15 mg: NDC 0115-1695-30. Rx onlyORSYTHIA (levonorgestrel (0.1 mg) and ethinyl estradiol (0.02 mg) tablets USP) is packaged in cartons of 3 and 6 blister pack tablet dispensers. Each blister pack tablet dispenser contains 28 tablets as follows: 21 active tablets, pink, round, film-coated tablet debossed with "93" on one side and "684" on the other side.7 inert tablets, light-green, round, film-coated tablet debossed with "93" on one side and "743" on the other side.Blister pack tablet dispenser NDC 0603-7634-01Boxes of 3 blister pack tablet dispensers NDC 0603-7634-49Boxes of 6 blister pack tablet dispensers NDC 0603-7634-17ORSYTHIA (levonorgestrel (0.1 mg) and ethinyl estradiol (0.02 mg) tablets USP) is packaged in cartons of 3 and 6 blister pack tablet dispensers. Each blister pack tablet dispenser contains 28 tablets as follows: 21 active tablets, pink, round, film-coated tablet debossed with "93" on one side and "684" on the other side.7 inert tablets, light-green, round, film-coated tablet debossed with "93" on one side and "743" on the other side.Blister pack tablet dispenser NDC 0603-7634-01Boxes of 3 blister pack tablet dispensers NDC 0603-7634-49Boxes of 6 blister pack tablet dispensers NDC 0603-7634-17ORSYTHIA (levonorgestrel (0.1 mg) and ethinyl estradiol (0.02 mg) tablets USP) is packaged in cartons of 3 and 6 blister pack tablet dispensers. Each blister pack tablet dispenser contains 28 tablets as follows: 21 active tablets, pink, round, film-coated tablet debossed with "93" on one side and "684" on the other side.7 inert tablets, light-green, round, film-coated tablet debossed with "93" on one side and "743" on the other side.Blister pack tablet dispenser NDC 0603-7634-01Boxes of 3 blister pack tablet dispensers NDC 0603-7634-49Boxes of 6 blister pack tablet dispensers NDC 0603-7634-17ORSYTHIA (levonorgestrel (0.1 mg) and ethinyl estradiol (0.02 mg) tablets USP) is packaged in cartons of 3 and 6 blister pack tablet dispensers. Each blister pack tablet dispenser contains 28 tablets as follows: 21 active tablets, pink, round, film-coated tablet debossed with "93" on one side and "684" on the other side.7 inert tablets, light-green, round, film-coated tablet debossed with "93" on one side and "743" on the other side.Blister pack tablet dispenser NDC 0603-7634-01Boxes of 3 blister pack tablet dispensers NDC 0603-7634-49Boxes of 6 blister pack tablet dispensers NDC 0603-7634-17
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 history of deep-vein thrombophlebitis or thromboembolic disorders
Cerebrovascular or coronary artery disease (current or past history)
Valvular heart disease with thrombogenic complications
Thrombogenic rhythm disorders
Hereditary or acquired thrombophilias
Major surgery with prolonged immobilization
Diabetes with vascular involvement
Headaches with focal neurological symptoms
Uncontrolled hypertension
Known or suspected carcinoma of the breast or personal history of breast cancer
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
Known or suspected pregnancy
Hypersensitivity to any of the components of levonorgestrel and ethinyl estradiol
Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see ).
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 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):
AcneAmenorrheaAnaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptomsBreast changes: tenderness, pain, enlargement, secretionBudd-Chiari syndromeCervical erosion and secretion, change inCholestatic jaundiceChorea, exacerbation ofColitisContact lenses, intolerance toCorneal curvature (steepening), change inDizzinessEdema/fluid retentionErythema multiformeErythema nodosumGastrointestinal symptoms (such as abdominal pain, cramps, and bloating)HirsutismInfertility after discontinuation of treatment, temporaryLactation, diminution in, when given immediately postpartumLibido, change inMelasma/chloasma which may persistMenstrual flow, change inMood changes, including depressionNauseaNervousnessPancreatitisPorphyria, exacerbation ofRash (allergic)Scalp hair, loss ofSerum folate levels, decrease inSpottingSystemic lupus erythematosus, exacerbation ofUnscheduled bleedingVaginitis, including candidiasisVaricose veins, aggravation ofVomiting Weight or appetite (increase or decrease), change in
The following adverse reactions have been reported in users of oral contraceptives:
CataractsCystitis-like syndromeDysmenorrheaHemolytic uremic syndromeHemorrhagic eruptionOptic neuritis, which may lead to partial or complete loss of visionPremenstrual syndrome Renal function, impaired
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. 315.72Tips
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