MEDROXYPROGESTERONE
is preferred today. 10 mg Modus ® (Glaxo - SmithKline)twice a day started at least 6 days before expected menses. Withdrawal bleeding occurs within 2 to 3 days of stopping the MEDROXYPROGESTERONE acetate You have the details here.
Postponement of Menses with OVRAL - G ®
Norgestrel I.P. 500 µg
Ethinyl estradiol I.P. 50 µg.
For postponement of menses, one tablet should be taken daily starting with the 20th day i.e. eight days prior to expected date of menstruation. With this dosage, the menstrual period can be postponed to the 40th day i.e. about two weeks beyond the expected date. [1]
Withdrawal bleeding should usually occur within 3 days after the last tablet is taken.
The following is taken from the prescribing information of the makers of OVRAL - G ® for health care professionals.www.wyethindia.com
CONTRAINDICATIONS
Deep vein thrombosis (current or history)
Thromboembolism (current or history)
Cerebrovascular or coronary artery disease
Thrombogenic valvulopathies
Thrombogenic rhythm disorders
Diabetes with vascular involvement
Uncontrolled hypertension
Known or suspected carcinoma of the breast or other known or suspected estrogen dependent neoplasia
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 Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg. ("OVRAL G")
WARNINGS
Cigarette smoking
Cigarette smoking increases the risk of serious cardiovascular side effects from the use of Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg. The risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg. should be strongly advised not to smoke..
Venous and arterial thrombosis and thromboembolism
Use of Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg. is associated with an increased risk of venous and arterial thrombotic and thromboembolic events. Some epidemiological studies suggest that estrogen-progesterone combination with 50 µg or more of ethinylestradiol may be associated with a higher risk of such events than estrogen-progesterone combination with a lower dose of ethinylestradiol.
For any particular estrogen/progestin combination, the dosage regimen prescribed should be one which contains the least amount of estrogen and progestin that is compatible with a low failure rate and the needs of the individual patient. Minimizing exposure to estrogens & progestins is in keeping good principles of therapeutics.
Venous thrombosis and thromboembolism
Use of Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg increases the risk of venous thrombotic and thromboembolic events.
Reported events include deep venous thrombosis and pulmonary embolism. For information on retinal vascular thrombosis.
The use of Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg carries an increased risk of venous thrombotic and thromboembolic events compared with no use. The excess risk is highest during the first year a woman ever uses a combined oral contraceptive. This increased risk is less than the risk of venous thrombotic and thromboembolic events associated with pregnancy which is estimated as 60 cases per 100,000 woman-years. Venous thromboembolism is fatal in 1-2% of cases.
The risk of venous thrombotic and thromboembolic events is further increased in women with conditions predisposing for venous thrombosis and thromboembolism. Caution must be exercised when prescribing Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg for such women.
Examples of predisposing conditions for venous thrombosis and thromboembolism are:
· certain inherited or acquired thrombophilias (the presence of an inherited thrombophilia may be indicated by a family history of venous thrombotic/thromboembolic events)
· obesity
· surgery or trauma with increased risk of thrombosis
· recent delivery or second-trimester abortion
· prolonged immobilization
· increasing age
If feasible, Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg (Ovral-G) should be discontinued:
· for four weeks prior to and for two weeks after elective surgery with increased risk of thrombosis, and
· during prolonged immobilization.
· Since the immediate post-partum period is associated with an increased risk of thromboembolism,
· Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg should be started no earlier than day 28 after delivery or second-trimester abortion.
Arterial thrombosis and thromboembolism
The use of Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg increases the risk of arterial thrombotic and thromboembolic events.
Reported events include myocardial infarction and cerebrovascular events (ischemic and hemorrhagic stroke).
The risk of arterial thrombotic and thromboembolic events is further increased in women with underlying risk factors.
Caution must be exercised when prescribing Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg for women with risk factors for arterial thrombotic and thromboembolic events.
Examples of risk factors for arterial thrombotic and thromboembolic events are:
· smoking
· certain inherited and acquired thrombophilias
· hypertension
· hyperlipidemias
· obesity
· increasing age
Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg users with migraine (particularly migraine with aura) may be at increased risk of stroke.
Ocular Lesions
With use of Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg, there have been reports of retinal vascular thrombosis, which may lead to partial or complete loss of vision. If there are signs or symptoms such as visual changes, onset of proptosis or diplopia, papilledema, or retinal vascular lesions, Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg should be discontinued and the cause immediately evaluated.
Carcinoma of the reproductive organs
Some studies suggest that Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg use may be associated with an increase in the risk of cervical intraepithelial neoplasia or invasive cervical cancer 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 cases of undiagnosed abnormal genital bleeding, adequate diagnostic measures are indicated.
A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are using Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg compared to never users.
The increased risk gradually disappears during the course of the 10 years after cessation of Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg use. These studies do not provide evidence for causation. The observed pattern of increased risk of breast cancer diagnosis may be due to earlier detection of breast cancer in Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg users (due to more regular clinical monitoring), the biological effects of Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg, or a combination of both. Because breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg users is small in relation to the lifetime risk of breast cancer. Breast cancers diagnosed in ever-users tend to be less advanced clinically than the cancers diagnosed in never-users.
Hepatic neoplasia/ Liver disease
In very rare cases hepatic adenomas, and in extremely rare cases, hepatocellular carcinoma may be associated with Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg ("Ovral-G") use. The risk appears to increase with duration of Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg use. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.
Women with a history of Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg -related cholestasis or women with cholestasis during pregnancy are more likely to have this condition with Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg use. If these patients receive Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg they should be carefully monitored and, if the condition recurs, Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg should be discontinued.
Blood Pressure
Increases in blood pressure have been reported in women taking Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg. In women with hypertension, a history of hypertension or hypertension related diseases (including certain renal diseases), another drug may be preferable. If Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg are used in such cases, close monitoring is recommended and, if a significant increase in blood pressure occurs,Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg should be discontinued.
Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg use is contraindicated in women with uncontrolled hypertension.
Headache
The onset or exacerbation of migraine or development of headache of a new pattern, which is recurrent, persistent, or severe, requires discontinuation of the drug and evaluation of the cause.
PRECAUTIONS
Medical examinations
A complete personal and family medical history and physical examination, including blood pressure, should be taken prior to the initiation of Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg use.
Such medical examinations should be repeated periodically during the use of Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg.
Carbohydrate and lipid effects
Glucose intolerance has been reported in Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg users. Women with impaired glucose tolerance or diabetes mellitus who use Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg should be carefully monitored.
Persistent hypertriglyceridemia may occur in a small proportion of Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg users.
In patients with elevated triglycerides, estrogen-containing preparations may be associated with rare but large elevations of plasma triglycerides which may lead to pancreatitis.
Women who are being treated for hyperlipidemias should be followed closely if they elect to use Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg.
Depression
Women with a history of depression who use Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg should be carefully observed and the drug discontinued if depression recurs to a serious degree. Patients becoming significantly depressed while taking Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg should stop the medication and use an alternate drug in an attempt to determine whether the symptom is drug-related.
Other
Patients should be counseled that this product does not protect against HIV infection (AIDS) or other sexually transmitted diseases.
Diarrhea and/or vomiting may reduce hormone absorption resulting in decreased serum concentrations.
PREGNANCY
Extensive epidemiological studies have revealed no increased risk of birth defects in children born to women who used Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg prior to pregnancy.
Studies do not suggest a teratogenic effect; particularly insofar as cardiac anomalies and limb-reduction defects are concerned, when taken inadvertently during early pregnancy.
Important Disclaimer:
The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.
See POSTPONEMENT OF MENSES WITH THE MEDICINE OF CHOICE
MEDROXYPROGESTERONE
Source for
Ethinyl estradiol I.P.50 µg and Norgestrel I.P. 500 µg, OVRAL - G ®
Courtesy:
www.wyethindia.com[1]
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