Disclaimer:
Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.
Microgestin
Overview
What is Microgestin?
MICROGESTIN and MICROGESTIN Fe are progestogen-estrogen combinations.
MICROGESTIN Fe 1/20 and 1.5/30: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose.
Each white tablet contains norethindrone acetate (17 alpha-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17 beta-diol), 20 mcg. Also contains acacia, NF; lactose, NF; magnesium stearate, NF; starch, NF; confectioner’s sugar, NF; talc, USP.
Each green tablet contains norethindrone acetate (17 alpha-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17 beta-diol), 30 mcg. Also contains acacia, NF; lactose, NF; magnesium stearate, NF; starch, NF; confectioner’s sugar, NF; talc, USP; D&C yellow No. 10; FD&C yellow No. 6; FD&C blue No. 1.
The structural formulas are as follows:
Each brown tablet contains ferrous fumarate, USP; mannitol, USP; povidone, USP; microcrystalline cellulose, NF; sodium starch glycolate, NF; magnesium stearate, NF; sucralose, NF; spearmint flavor.
What does Microgestin look like?
What are the available doses of Microgestin?
Sorry No records found.
What should I talk to my health care provider before I take Microgestin?
Sorry No records found
How should I use Microgestin?
MICROGESTIN and MICROGESTIN Fe are indicated for the prevention of pregnancy in women who elect to use oral contraceptives 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
The tablet dispenser has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in either three or four rows of seven tablets each, with the days of the week appearing on the tablet dispenser above the first row of tablets.
Note:
Important:
The possibility of ovulation and conception prior to initiation of use should be considered.
Dosage and Administration for 21-Day Dosage Regimen
A. Sunday-Start Regimen:
B. Day-1 Regimen:
Tablets should be taken regularly with a meal or at bedtime. It should be stressed that efficacy of medication depends on strict adherence to the dosage schedule.
Special Notes on Administration
If the patient forgets to take one or more tablets, the following is suggested:
One
Two
Two
Day-1 Start Regimen:
Three
Sunday-Start Regimen:
Day-1 Start Regimen:
The possibility of ovulation occurring increases with each successive day that scheduled tablets are missed. While there is little likelihood of ovulation occurring if only one tablet is missed, the possibility of spotting or bleeding is increased. This is particularly likely to occur if two or more consecutive tablets are missed.
In the rare case of bleeding which resembles menstruation, the patient should be advised to discontinue medication and then begin taking tablets from a new tablet dispenser on the next Sunday or the first day (Day 1), depending on her regimen. Persistent bleeding which is not controlled by this method indicates the need for reexamination of the patient, at which time nonfunctional causes should be considered.
Dosage and Administration for 28-Day Dosage Regimen
MICROGESTIN Fe provides a continuous administration regimen consisting of 21 light-colored (white or green) tablets of MICROGESTIN and 7 brown non-hormone containing tablets of ferrous fumarate. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen and do not serve any therapeutic purpose. There is no need for the patient to count days between cycles because there are no “off-tablet days.’’
A. Sunday-Start Regimen:
B. Day-1 Start Regimen:
Tablets should be taken regularly with a meal or at bedtime. It should be stressed that efficacy of medication depends on strict adherence to the dosage schedule.
Special Notes on Administration
If the patient forgets to take one or more tablets, the following is suggested:
One
Two
Two
Day-1 Start Regimen:
Three
Sunday-Start Regimen:
Day-1 Start Regimen:
The possibility of ovulation occurring increases with each successive day that scheduled light-colored tablets are missed. While there is little likelihood of ovulation occurring if only one light-colored tablet is missed, the possibility of spotting or bleeding is increased. This is particularly likely to occur if two or more consecutive light-colored tablets are missed.
If the patient forgets to take any of the seven brown tablets in week four, those brown tablets that were missed are discarded and one brown tablet is taken each day until the pack is empty. A back-up birth control method is not required during this time. A new pack of tablets should be started no later than the eighth day after the last light-colored tablet was taken.
In the rare case of bleeding which resembles menstruation, the patient should be advised to discontinue medication and then begin taking tablets from a new tablet dispenser on the next Sunday or the first day (Day-1), depending on her regimen. Persistent bleeding which is not controlled by this method indicates the need for reexamination of the patient, at which time nonfunctional causes should be considered.
Use of Oral Contraceptives in the Event of a Missed Menstrual Period
After several months on treatment, bleeding may be reduced to a point of virtual absence. This reduced flow may occur as a result of medication, in which event it is not indicative of pregnancy.
What interacts with Microgestin?
Sorry No Records found
What are the warnings of Microgestin?
Sorry No Records found
What are the precautions of Microgestin?
Sorry No Records found
What are the side effects of Microgestin?
Sorry No records found
What should I look out for while using Microgestin?
Oral contraceptives should not be used in women who currently have the following conditions:
The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, 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 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 principally based 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 a disease, namely, a 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 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 (adapted from References 8 and 9 with the author’s permission). For further information, the reader is referred to a text on epidemiological methods.
1. Thromboembolic Disorders and Other Vascular Problems a. Myocardial infarction
Smoking in combination with oral contraceptive use has been shown to contribute substantially to the incidence of myocardial infarctions in women in their mid-thirties or older with smoking accounting for the majority of excess cases (). Mortality rates associated with circulatory disease have been shown to increase substantially in smokers over the age of 35 and non-smokers over the age of 40 (Table II) among women who use oral contraceptives.
Oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age and obesity (). In particular, some progestogens are known to decrease HDL cholesterol and cause glucose intolerance, while estrogens may create a state of hyperinsulinism (). Oral contraceptives have been shown to increase blood pressure among users (see section in ). Similar effects on risk factors have been associated with an increased risk of heart disease. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.
b. Thromboembolism
A two- to four-fold increase in relative risk of postoperative thromboembolic complications has been reported with the use of oral contraceptives (,). The relative risk of venous thrombosis in women who have predisposing conditions is twice that of women without such medical conditions (,). If feasible, oral contraceptives should be discontinued at least four weeks prior to and for two weeks after elective surgery of a type associated with an increase in risk of thromboembolism and during and following prolonged immobilization. Since the immediate postpartum period is also associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than four to six weeks after delivery in women who elect not to breastfeed.
c. Cerebrovascular disease
In a large study, the relative risk of thrombotic strokes has been shown to range from 3 for normotensive users to 14 for users with severe hypertension (). The relative risk of hemorrhagic stroke is reported to be 1.2 for non-smokers who used oral contraceptives, 2.6 for smokers who did not use oral contraceptives, 7.6 for smokers who used oral contraceptives, 1.8 for normotensive users, and 25.7 for users with severe hypertension (). The attributable risk is also greater in older women ().
d. Dose-related risk of vascular disease from oral contraceptives.
Minimizing exposure to estrogen and progestogen is in keeping with good principles of therapeutics. For any particular oral contraceptive, the dosage regimen prescribed should be one which contains the least amount of estrogen and progestogen that is compatible with the needs of the individual patient. New acceptors of oral contraceptive agents should be started on preparations containing the lowest dose of estrogen which produces satisfactory results for the patient.
e. Persistence of risk of vascular disease
2. Estimates of Mortality from Contraceptive Use
Because of these changes in practice and, also, because of some limited new data which suggest that the risk of cardiovascular disease with the use of oral contraceptives may now be less than previously observed (Porter JB, Hunter J, Jick H, et al. Oral contraceptives and nonfatal vascular disease. Obstet Gynecol 1985;66:1-4; and Porter JB, Hershel J, Walker AM. Mortality among oral contraceptive users. Obstet Gynecol 1987;70:29-32), the Fertility and Maternal Health Drugs Advisory Committee was asked to review the topic in 1989. The Committee concluded that although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy non-smoking women (even with the newer low-dose formulations), there are greater potential health risks associated with pregnancy in older women and with the alternative surgical and medical procedures which may be necessary if such women do not have access to effective and acceptable means of contraception.
Therefore, the Committee recommended that the benefits of oral contraceptive use by healthy non-smoking women over 40 may outweigh the possible risks. Of course, older women, as all women who take oral contraceptives, should take the lowest possible dose formulation that is effective.
3. Carcinoma of the Reproductive Organs
Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women (). However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.
In spite of many studies of the relationship between oral contraceptive use and breast and cervical cancers, a cause and effect relationship has not been established.
4. Hepatic Neoplasia
Studies from Britain have shown an increased risk of developing hepatocellular carcinoma () in long-term (greater than 8 years) oral contraceptive users. However, these cancers are extremely rare in the U.S., and the attributable risk (the excess incidence) of liver cancers in oral contraceptive users approaches less than one per million users.
5. Ocular Lesions
6. Oral Contraceptive Use Before and During Early Pregnancy
The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion.
It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period. Oral contraceptive use should be discontinued if pregnancy is confirmed.
7. Gallbladder Disease
8. Carbohydrate And Lipid Metabolic Effects
A small proportion of women will have persistent hypertriglyceridemia while on the pill. As discussed earlier (see and ), changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users.
9. Elevated Blood Pressure
Women with a history of hypertension or hypertension-related diseases or renal disease () should be encouraged to use another method of contraception. If women elect to use oral contraceptives, they should be monitored closely, and if significant elevation of blood pressure occurs, oral contraceptives should be discontinued. For most women, elevated blood pressure will return to normal after stopping oral contraceptives (), and there is no difference in the occurrence of hypertension among ever and never users.()
10. Headache
11. Bleeding Irregularities
Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was preexistent.
What might happen if I take too much Microgestin?
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 Microgestin?
MICROGESTIN 1/20 is available in dispensers each containing 21 white tablets. Each tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Available in packages of 6 dispensers.NDCMICROGESTIN Fe 1/20 is available in dispensers each containing 21 white tablets and 7 brown tablets. Each white tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers.NDCMICROGESTIN 1.5/30 is available in dispensers each containing 21 green tablets. Each tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Available in packages of 6 dispensers.NDCMICROGESTIN Fe 1.5/30 is available in dispensers each containing 21 green tablets and 7 brown tablets. Each green tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers.NDCStore below 30˚ C (86˚ F). MICROGESTIN 1/20 is available in dispensers each containing 21 white tablets. Each tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Available in packages of 6 dispensers.NDCMICROGESTIN Fe 1/20 is available in dispensers each containing 21 white tablets and 7 brown tablets. Each white tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers.NDCMICROGESTIN 1.5/30 is available in dispensers each containing 21 green tablets. Each tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Available in packages of 6 dispensers.NDCMICROGESTIN Fe 1.5/30 is available in dispensers each containing 21 green tablets and 7 brown tablets. Each green tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers.NDCStore below 30˚ C (86˚ F). MICROGESTIN 1/20 is available in dispensers each containing 21 white tablets. Each tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Available in packages of 6 dispensers.NDCMICROGESTIN Fe 1/20 is available in dispensers each containing 21 white tablets and 7 brown tablets. Each white tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers.NDCMICROGESTIN 1.5/30 is available in dispensers each containing 21 green tablets. Each tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Available in packages of 6 dispensers.NDCMICROGESTIN Fe 1.5/30 is available in dispensers each containing 21 green tablets and 7 brown tablets. Each green tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers.NDCStore below 30˚ C (86˚ F). MICROGESTIN 1/20 is available in dispensers each containing 21 white tablets. Each tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Available in packages of 6 dispensers.NDCMICROGESTIN Fe 1/20 is available in dispensers each containing 21 white tablets and 7 brown tablets. Each white tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers.NDCMICROGESTIN 1.5/30 is available in dispensers each containing 21 green tablets. Each tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Available in packages of 6 dispensers.NDCMICROGESTIN Fe 1.5/30 is available in dispensers each containing 21 green tablets and 7 brown tablets. Each green tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers.NDCStore below 30˚ C (86˚ F). MICROGESTIN 1/20 is available in dispensers each containing 21 white tablets. Each tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Available in packages of 6 dispensers.NDCMICROGESTIN Fe 1/20 is available in dispensers each containing 21 white tablets and 7 brown tablets. Each white tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers.NDCMICROGESTIN 1.5/30 is available in dispensers each containing 21 green tablets. Each tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Available in packages of 6 dispensers.NDCMICROGESTIN Fe 1.5/30 is available in dispensers each containing 21 green tablets and 7 brown tablets. Each green tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers.NDCStore below 30˚ C (86˚ F). MICROGESTIN 1/20 is available in dispensers each containing 21 white tablets. Each tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Available in packages of 6 dispensers.NDCMICROGESTIN Fe 1/20 is available in dispensers each containing 21 white tablets and 7 brown tablets. Each white tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers.NDCMICROGESTIN 1.5/30 is available in dispensers each containing 21 green tablets. Each tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Available in packages of 6 dispensers.NDCMICROGESTIN Fe 1.5/30 is available in dispensers each containing 21 green tablets and 7 brown tablets. Each green tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers.NDCStore below 30˚ C (86˚ F). MICROGESTIN 1/20 is available in dispensers each containing 21 white tablets. Each tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Available in packages of 6 dispensers.NDCMICROGESTIN Fe 1/20 is available in dispensers each containing 21 white tablets and 7 brown tablets. Each white tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers.NDCMICROGESTIN 1.5/30 is available in dispensers each containing 21 green tablets. Each tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Available in packages of 6 dispensers.NDCMICROGESTIN Fe 1.5/30 is available in dispensers each containing 21 green tablets and 7 brown tablets. Each green tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers.NDCStore below 30˚ C (86˚ F). MICROGESTIN 1/20 is available in dispensers each containing 21 white tablets. Each tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Available in packages of 6 dispensers.NDCMICROGESTIN Fe 1/20 is available in dispensers each containing 21 white tablets and 7 brown tablets. Each white tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers.NDCMICROGESTIN 1.5/30 is available in dispensers each containing 21 green tablets. Each tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Available in packages of 6 dispensers.NDCMICROGESTIN Fe 1.5/30 is available in dispensers each containing 21 green tablets and 7 brown tablets. Each green tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers.NDCStore below 30˚ C (86˚ F). MICROGESTIN 1/20 is available in dispensers each containing 21 white tablets. Each tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Available in packages of 6 dispensers.NDCMICROGESTIN Fe 1/20 is available in dispensers each containing 21 white tablets and 7 brown tablets. Each white tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers.NDCMICROGESTIN 1.5/30 is available in dispensers each containing 21 green tablets. Each tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Available in packages of 6 dispensers.NDCMICROGESTIN Fe 1.5/30 is available in dispensers each containing 21 green tablets and 7 brown tablets. Each green tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers.NDCStore below 30˚ C (86˚ F).
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).
Pharmacokinetics
Absorption
Distribution
Metabolism
Excretion
Special PopulationRace
:
Renal Insufficiency
Hepatic Insufficiency
Drug-Drug Interactions
Non-Clinical Toxicology
Oral contraceptives should not be used in women who currently have the following conditions:The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, 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 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 principally based 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 a disease, namely, a 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 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 (adapted from References 8 and 9 with the author’s permission). For further information, the reader is referred to a text on epidemiological methods.
1. Thromboembolic Disorders and Other Vascular Problems a. Myocardial infarction
Smoking in combination with oral contraceptive use has been shown to contribute substantially to the incidence of myocardial infarctions in women in their mid-thirties or older with smoking accounting for the majority of excess cases (). Mortality rates associated with circulatory disease have been shown to increase substantially in smokers over the age of 35 and non-smokers over the age of 40 (Table II) among women who use oral contraceptives.
Oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age and obesity (). In particular, some progestogens are known to decrease HDL cholesterol and cause glucose intolerance, while estrogens may create a state of hyperinsulinism (). Oral contraceptives have been shown to increase blood pressure among users (see section in ). Similar effects on risk factors have been associated with an increased risk of heart disease. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.
b. Thromboembolism
A two- to four-fold increase in relative risk of postoperative thromboembolic complications has been reported with the use of oral contraceptives (,). The relative risk of venous thrombosis in women who have predisposing conditions is twice that of women without such medical conditions (,). If feasible, oral contraceptives should be discontinued at least four weeks prior to and for two weeks after elective surgery of a type associated with an increase in risk of thromboembolism and during and following prolonged immobilization. Since the immediate postpartum period is also associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than four to six weeks after delivery in women who elect not to breastfeed.
c. Cerebrovascular disease
In a large study, the relative risk of thrombotic strokes has been shown to range from 3 for normotensive users to 14 for users with severe hypertension (). The relative risk of hemorrhagic stroke is reported to be 1.2 for non-smokers who used oral contraceptives, 2.6 for smokers who did not use oral contraceptives, 7.6 for smokers who used oral contraceptives, 1.8 for normotensive users, and 25.7 for users with severe hypertension (). The attributable risk is also greater in older women ().
d. Dose-related risk of vascular disease from oral contraceptives.
Minimizing exposure to estrogen and progestogen is in keeping with good principles of therapeutics. For any particular oral contraceptive, the dosage regimen prescribed should be one which contains the least amount of estrogen and progestogen that is compatible with the needs of the individual patient. New acceptors of oral contraceptive agents should be started on preparations containing the lowest dose of estrogen which produces satisfactory results for the patient.
e. Persistence of risk of vascular disease
2. Estimates of Mortality from Contraceptive Use
Because of these changes in practice and, also, because of some limited new data which suggest that the risk of cardiovascular disease with the use of oral contraceptives may now be less than previously observed (Porter JB, Hunter J, Jick H, et al. Oral contraceptives and nonfatal vascular disease. Obstet Gynecol 1985;66:1-4; and Porter JB, Hershel J, Walker AM. Mortality among oral contraceptive users. Obstet Gynecol 1987;70:29-32), the Fertility and Maternal Health Drugs Advisory Committee was asked to review the topic in 1989. The Committee concluded that although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy non-smoking women (even with the newer low-dose formulations), there are greater potential health risks associated with pregnancy in older women and with the alternative surgical and medical procedures which may be necessary if such women do not have access to effective and acceptable means of contraception.
Therefore, the Committee recommended that the benefits of oral contraceptive use by healthy non-smoking women over 40 may outweigh the possible risks. Of course, older women, as all women who take oral contraceptives, should take the lowest possible dose formulation that is effective.
3. Carcinoma of the Reproductive Organs
Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women (). However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.
In spite of many studies of the relationship between oral contraceptive use and breast and cervical cancers, a cause and effect relationship has not been established.
4. Hepatic Neoplasia
Studies from Britain have shown an increased risk of developing hepatocellular carcinoma () in long-term (greater than 8 years) oral contraceptive users. However, these cancers are extremely rare in the U.S., and the attributable risk (the excess incidence) of liver cancers in oral contraceptive users approaches less than one per million users.
5. Ocular Lesions
6. Oral Contraceptive Use Before and During Early Pregnancy
The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion.
It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period. Oral contraceptive use should be discontinued if pregnancy is confirmed.
7. Gallbladder Disease
8. Carbohydrate And Lipid Metabolic Effects
A small proportion of women will have persistent hypertriglyceridemia while on the pill. As discussed earlier (see and ), changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users.
9. Elevated Blood Pressure
Women with a history of hypertension or hypertension-related diseases or renal disease () should be encouraged to use another method of contraception. If women elect to use oral contraceptives, they should be monitored closely, and if significant elevation of blood pressure occurs, oral contraceptives should be discontinued. For most women, elevated blood pressure will return to normal after stopping oral contraceptives (), and there is no difference in the occurrence of hypertension among ever and never users.()
10. Headache
11. Bleeding Irregularities
Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was preexistent.
Lorazepam Injection, like other injectable benzodiazepines, produces additive depression of the central nervous system when administered with other CNS depressants such as ethyl alcohol, phenothiazines, barbiturates, MAO inhibitors, and other antidepressants.
When scopolamine is used concomitantly with injectable lorazepam, an increased incidence of sedation, hallucinations and irrational behavior has been observed.
There have been rare reports of significant respiratory depression, stupor and/or hypotension with the concomitant use of loxapine and lorazepam.
Marked sedation, excessive salivation, ataxia, and, rarely, death have been reported with the concomitant use of clozapine and lorazepam.
Apnea, coma, bradycardia, arrhythmia, heart arrest, and death have been reported with the concomitant use of haloperidol and lorazepam.
The risk of using lorazepam in combination with scopolamine, loxapine, clozapine, haloperidol, or other CNS-depressant drugs has not been systematically evaluated. Therefore, caution is advised if the concomitant administration of lorazepam and these drugs is required.
Concurrent administration of any of the following drugs with lorazepam had no effect on the pharmacokinetics of lorazepam: metoprolol, cimetidine, ranitidine, disulfiram, propranolol, metronidazole, and propoxyphene. No change in lorazepam dosage is necessary when concomitantly given with any of these drugs.
1. Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
2. Physical Examination and Follow-Up
3. Lipid Disorders
4. Liver Function
5. Fluid Retention
6. Emotional Disorders
7. Contact Lenses
Rifampin:
Anticonvulsants:
Troglitazone:
Antibiotics:
Atorvastatin:
Other:
Effects of Oral Contraceptives on Other Drugs
Oral contraceptive combinations containing ethinyl estradiol may inhibit the metabolism of other compounds. Increased plasma concentrations of cyclosporine, prednisolone, and theophylline have been reported with concomitant administration of oral contraceptives. In addition, oral contraceptives may induce the conjugation of other compounds. Decreased plasma concentrations of acetaminophen and increased clearance of temazepam, salicylic acid, morphine, and clofibric acid have been noted when these drugs were administered with oral contraceptives.
9. Interactions With Laboratory Tests
10. Carcinogenesis
11. Pregnancy
12. Nursing Mothers
13. Pediatric Use
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see section):
There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed:
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:
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.
Review
Read user comments about the side effects, benefits, and effectiveness of losartan oral.
Overall User Ratings
514Total User Reviews
User Reviews
Learn about
User Reviews
Professional
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
Tips
Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).