Dosage of Lo / Ovral-28 in details
To achieve maximum contraceptive effectiveness, Lo / Ovral-28® must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Lo / Ovral-28® is one white tablet daily for 21 consecutive days, followed by one light-green 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 Lo / Ovral-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 light-green inert tablet daily for 7 consecutive days.
Withdrawal bleeding should usually occur within three days following discontinuation of white tablets. During the first cycle, contraceptive reliance should not be placed on Lo / Ovral-28® until a white tablet has been taken daily for 7 consecutive 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 light-green 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.
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 Lo / Ovral-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 "WHAT TO DO IF YOU MISS PILLS" section in the DETAILED PATIENT LABELING 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 light-green tablets, she is still protected against pregnancy provided 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 tablets are missed, the possibility of ovulation increases with each successive day that scheduled white tablets are missed.
In the nonlactating mother, Lo / Ovral-28® may be initiated postpartum, for contraception. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. 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 other drugs will affect Lo / Ovral-28?
Some drugs can make Lo/Lo / Ovral-28-28 less effective, which may result in pregnancy. Before using Lo/Lo / Ovral-28-28, tell your doctor if you are using any of the following drugs:
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bosentan (Tracleer);
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an antibiotic or tuberculosis medication;
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drugs to treat hepatitis C, HIV, or AIDS;
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phenobarbital (Solfoton) and other barbiturates;
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St. John's wort; or
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seizure medications.
Tell your doctor about all other medicines you use, especially:
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dantrolene (Dantrium);
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tizanidine (Zanaflex); or
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tranexamic acid (Cyklokapron, Lysteda).
This list is not complete and other drugs may interact with Lo/Lo / Ovral-28-28. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Lo / Ovral-28 interactions
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 breakthrough bleeding. Examples include rifampin, rifabutin, barbiturates, primidone, phenylbutazone, phenytoin, dexamethasone, carbamazepine, felbamate, oxcarbazepine, topiramate, griseofulvin, and modafinil
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, possibly due to a decrease of enterohepatic recirculation of estrogens
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
Herbal products containing St. Johns Wort (Hypericum perforatum) may induce hepatic enzymes (cytochrome P 450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding
During concomitant use of Ethinyl estradiol (Lo / Ovral-28) containing products and substances that may lead to decreased plasma steroid hormone concentrations, it is recommended that a nonhormonal backup method of birth control be used in addition to the regular intake of Lo/Lo / Ovral-28. If the use of a substance which leads to decreased Ethinyl estradiol (Lo / Ovral-28) 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 (Lo / Ovral-28) 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 (Lo / Ovral-28) 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
Increase in plasma levels associated with coadministered drugs: Coadministration of atorvastatin and certain oral contraceptives containing Ethinyl estradiol (Lo / Ovral-28) increase AUC values for Ethinyl estradiol (Lo / Ovral-28) by approximately 20%. The mechanism of this interaction is unknown. Ascorbic acid and acetaminophen increase the bioavailability of Ethinyl estradiol (Lo / Ovral-28) since these drugs act as competitive inhibitors for sulfation of Ethinyl estradiol (Lo / Ovral-28) in the gastrointestinal wall, a known pathway of elimination for Ethinyl estradiol (Lo / Ovral-28). 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 (eg, Ethinyl estradiol (Lo / Ovral-28)) 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
Interactions With Laboratory Tests - Certain endocrine and liver-function tests and blood components may be affected by oral contraceptives
a. Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability
b. Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered
c. Other binding proteins may be elevated in serum ie, 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
d. Triglycerides may be increased and levels of various other lipids and lipoproteins may be affected
e. Glucose tolerance may be decreased
f. 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.
References
- DailyMed. "ETHINYL ESTRADIOL; NORETHINDRONE ACETATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DailyMed. "ETHINYL ESTRADIOL; NORGESTREL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- FDA/SPL Indexing Data. "423D2T571U: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Lo / Ovral-28 are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Lo / Ovral-28. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
