Rita 21/Rita 28

Rita 21/Rita 28

desogestrel + ethinylestradiol

Manufacturer:

Biolab

Distributor:

Biopharm
Full Prescribing Info
Contents
Desogestrel, ethinyl estradiol, placebo tab (Rita 28 only).
Description
RITA 21: 21 active tablets.
Each tablet contains 0.15 mg desogestrel and 0.03 mg ethinyl estradiol.
RITA 28: 21 active tablets.
Each tablet contains 0.15 mg desogestrel and 0.03 mg ethinyl estradiol.
7 placebo tablets that do not contain any active ingredients.
Action
Pharmacology: Pharmacodynamics: RITA produce a contraceptive effect mainly by suppressing the hypothalamic-pituitary system resulting in prevention of ovulation. The estrogen acts mainly by suppressing secretion of follicle-stimulating hormone (FSH), resulting in prevention of follicular development and the rise of plasma estradiol concentration which is thought to be the stimulus for release of luteinizing hormone (LH). The progestin appears to act mainly by inhibiting the preovulatory rise of LH. Long term administration of these combination products results in inhibition of both FSH and LH secretion. It has been suggested that oral contraceptives may also produce a direct effect on ovarian steroidogenesis or the response of the ovary to gonadotropins. In addition, changes in the cervical mucus may prevent sperm penetration.
Pharmacokinetics: Ethinylestradiol is rapidly absorbed with peak concentrations attained within 2 hours. It undergoes considerable first-pass elimination. Ethinylestradiol is 97% to 98% bound to plasma albumin. The mean elimination half-life varies from 6 to 20 hours. It is excreted in bile and urine as conjugates and undergoes some enterohepatic recirculation.
Desogestrel is rapidly and completely absorbed and converted into 3-keto-desogestrel, the biologically active metabolite. Relative bioavailability is about 84%. Maximum concentrations of the metabolite are reached at about 1.4 hours. Desogestrel is bound to albumin and to sex hormone binding globulins. The mean elimination half-life of desogestrel (metabolite) is 38 ± 20 hours.
Indications/Uses
Oral contraception. RITA is used for the prevention of pregnancy.
Dosage/Direction for Use
How to take RITA 21: The RITA 21 pack contains 21 tablets. On the pack, each tablet is marked with the day of the week on which it is to be taken. Follow the direction of the arrows until all 21 tablets have been taken. Oral contraceptives should be taken as near as possible to the same time each day. For day-1 start, the first day of menstrual bleeding should be counted as day 1. One tablet once daily for 21 days; subsequent courses repeated after 7-day interval, withdrawal bleeding occurs during the 7-day interval. Whether bleeding has stopped or not, the patients should start a new course of the 21-day regimen.
How to take RITA 28: The RITA 28 pack contains 28 tablets. On the pack, each tablet is marked with the number of the day which it is to be taken. Follow the direction of the arrows until all tablets have been taken. Oral contraceptives should be taken as near as possible to the same time each day. Tablets containing estrogen/progestin are administered once daily for 21 consecutive days, followed by inert tablets for 7 days. Each subsequent pack is started the day after the last tablet of the current pack. Withdrawal bleeding usually occurs within 2 or 3 days after the last hormonally active tablet has been taken. Whether bleeding has stopped or not, the patients should start a new course of the 28-day regimen.
Missed Active Dose: While there is little likelihood of ovulation occurring if only 1 tablet is missed, the possibility of spotting or bleeding is increased. The possibility of ovulation occurring increases with each successive day that scheduled tablets are missed. This is particularly likely to occur if ≥ 2 consecutive tablets are missed. Any time ≥ 1 active tablets have been missed, the patient should use another method of contraception for the balance of the cycle until tablets have been taken for 7 consecutive days. If a patient forgets to take ≥ 1 tablet, the following is suggested: One active tablet: Have the patient take this as soon as remembered or she should take 2 tablets the next day; alternatively, the patient can take 1 tablet, discard the other missed tablet, continue as scheduled, and use another form of contraception until menses.
Two consecutive active tablets: The patient should take 2 tablets as soon as remembered with the next pill at the usual time or she should take 2 tablets daily for the next 2 days, then resume the regular schedule.
Overdosage
Symptoms: Serious ill effects have not been reported following acute ingestion of large doses of estrogen-containing drug products by young children. Overdosage of estrogen or estrogen-plus-progestrin therapy may cause nausea and vomiting, breast tenderness, abdominal pain, drowsiness/ fatigue, and withdrawal bleeding may occur in women.
Treatment: Treatment of overdose consists of discontinuation of therapy with institution of appropriate symptomatic care.
Contraindications
Thrombophlebitis, thromboembolic disorders (e.g. valvular heart disease with thrombogenic complications or atrial fibrillation), history of deep vein thrombophlebitis or pulmonary embolism.
Cerebral vascular disease, MI, coronary artery disease.
Known or suspected breast carcinoma or estrogen-dependent neoplasia, carcinoma of endometrium.
Hepatic adenomas/carcinomas.
Undiagnosed abnormal genital bleeding.
Known or suspected pregnancy.
Cholestatic jaundice of pregnancy/jaundice with prior pill use.
Hypersensitivity to any component of the product.
Acute liver disease.
Uncontrolled hypertension.
Headaches with focal neurological symptoms.
Diabetes with vascular complications.
Major surgery with prolonged immobility.
Special Precautions
Smoking: Cigarette smoking increases the risk of serious cardiovascular side effect from RITA. This risk increases with age and with heavy smoking (≥ 15 cigarettes per day) and is quite marked in women > 35 years of age. Women who use RITA should not smoke.
Thromboembolism: Be alert to the earliest symptoms of thromboembolic and thrombotic disorders. Should any of these occur or be suspected, discontinue the drug immediately.
MI: MI risk associated with RITA use is increased. The risk is primarily in smokers or women with other underlying risk factors for coronary artery disease such as hypertension, hypercholesterolemia, morbid obesity and diabetes. The risk is very low in women < 30 years of age.
Cerebrovascular diseases: RITA increase the risk of cerebrovascular event (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest in hypertensive women > 35 years of age who also smoke.
Age: The risk of cerebrovascular and circulatory disease in RITA users is substantially increased in women ≥ 35 years of age with other risk factor (e.g. smoking, uncontrolled hypertension, hypercholesterolemia [LDL 190], obesity, diabetes).
Carcinoma: Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian, and cervical cancer in women using combined oral contraceptives. While there are conflicting reports, the overall evidence in the literature suggests that use of oral contraceptives is not associated with an increase in the risk of developing breast cancer, regardless of age and parity of first use. Close clinical surveillance of all women taking oral contraceptives is essential; they should be reexamined at least once a year. In all cases of undiagnosed persistent or recurrent abnormal vaginal bleeding, rule out malignancy. Monitor women with a strong family history of breast cancer or who have breast nodules, fibrocystic disease of the breast, cervical dysplasia, or abnormal mammograms.
Effects on glucose: Decreased glucose tolerance has been observed in a significant percentage of patients receiving oral contraceptives. Fasting blood glucose concentrations are not altered in most patients; however, increased plasma insulin and blood pyruvate concentrations may occur. Pre-diabetic and diabetic patients should be carefully monitored during estrogen-progestin contraceptive therapy.
Elevated blood pressure: Increased in blood pressure may occur in women receiving estrogen-progestin contraceptive therapy. Blood pressure elevations are usually minor, but clinically important hypertension may occur in some women.
Monitoring: It is good medical practice for all women to have annual history and physical examinations. Physical examination may be deferred until after initiation of oral contraceptives if requested by the patient and judged appropriated by the health care provider.
Use In Pregnancy & Lactation
Pregnancy: Category x. Pregnant women should not use this drug. Rule out pregnancy before initiating or continuing OCs and always consider it if withdrawal bleeding does not occur.
Lactation: Combination OCs given in the postpartum period may interfere with lactation, decreasing the quantity and quality of breast milk.
Adverse Reactions
Serious adverse reactions: Arterial thromboembolism, cerebral hemorrhage; cerebral thrombosis, coronary thrombosis, focal nodular hyperplasia, gallbladder disease, hepatic adenomas or benign liver tumors, hypertension, MI, pulmonary embolism, thrombophlebitis and venous thrombosis with or without embolism.
Other side effects: CNS: Dizziness, headache, mental depression, migraine.
Dermatologic: Melasma, rash.
Endocrine: Breast pain, tenderness, enlargement, secretion.
GI: Abdominal cramps, nausea and vomiting.
GU: Amenorrhea during and after treatment, change in cervical erosion and secretion, vaginal candidiasis.
Ophthalmic: Contact lens intolerance.
Miscellaneous: Weight change.
Drug Interactions
Drugs affecting hepatic microsomal enzyme: Clinically important drug interactions may occur when RITA is administered with other drugs metabolized by the hepatic microsomal cytochrome P-450 (CYP) enzyme system. Metabolism of estrogens is mediated by the CYP3A4 isoenzyme, and the possibility exists that drugs that induce this isoenzyme may reduce ethinyl estradiol concentrations. Rifampin reportedly decreases contraceptive efficacy and increases breakthrough bleeding during concomitant use with oral contraceptives. These effects have been attributed to enhanced metabolism of both the estrogenic and progestinic components of oral contraceptives, presumably by induction of hepatic microsomal enzymes. It has been suggested that similar effects may occur during concomitant therapy with other known inducers of hepatic microsomal enzymes, including barbiturates, bosentan, carbamazepine, dexamethasone, griseofulvin, phenytoin, felbamate, oxcarbazepine, rifabutin, modafinil, topiramate and primidone. Herbal supplements containing St. John's wort may decrease contraceptive efficacy of estrogen-progestin contraceptives. Because of the risk of contraceptive failure during concomitant use of estrogen-progestin contraceptives with known inducers of hepatic microsomal enzymes, it has been suggested that alternate methods of contraceptive preparations with increased dosage be considered.
Anti-retroviral agents: Concomitant use of oral contraceptives and some HIV-protease inhibitors or non-nucleoside reverse transcriptase inhibitors may reduce the efficacy of the oral contraceptive.
Storage
Do not store above 30°C. Protect from light and moisture.
MIMS Class
ATC Classification
G03AA09 - desogestrel and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Presentation/Packing
Rita 21 tab (round, biconvex, white tablet, engraved "R" on one side and plain on the other) 1 x 21's. Rita 28 tab [round, biconvex, white tablet, engraved "R" on one side and plain on the other (placebo tablets: round, flat, white tablet)] 1 x 28's.
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