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Novelon Tablet Ethinylestradiol + Drospirenone [For oral contraception] 0.03 mg+3 mg
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Ethinylestradiol & Drospirenone is indicated in oral contraception, prevention of pregnancy.
Oral Contraceptive preparations
Ethinylestradiol is a synthetic version of oestrogen and Drospirenone is a synthetic form of progesterone. The hormonal components of this tablet inhibit ovulation by suppressing gonadotropin release. Secondary mechanisms, which may contribute to the effectiveness of this tablet as a contraceptive, include changes in the cervical mucus (which increase the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation).
Drospirenone has antimineralocorticoid activity, counteracting oestrogen related sodium retention. In combination with ethinylestradiol, drospirenone displays a favourable lipid profile with an increase in high-density lipoproteinHDL. Drospirenone exerts antiandrogenic activity and does not counteract the ethinylestradiol-related sex hormone binding globulin (SHBG) increase which is useful for binding and inactivating the endogenous androgens.
Dosage & Administration
How to Take Ethinylestradiol & Drospirenone: To achieve maximum contraceptive effectiveness, Ethinylestradiol & Drospirenone must be taken in the order directed on the package and at intervals not exceeding 24 hours. Women should be instructed to take the tablets at about the same time every day, preferably after the evening meal or at bedtime. One tablet is to be taken daily for 28 consecutive days. Each subsequent pack is started on the day after the current pack is completed.
- If you have decided to take Ethinylestradiol & Drospirenone for contraception, wait for your next menstruation begins.
- From the first day of your menstruation, start taking the first light yellow tablet from the left corner of the top row (with arrow mark) of your Ethinylestradiol & Drospirenone tablet pack.
- Continue taking one light yellow tablet each day along the arrow mark.
- After taking 21 light yellow tablets for 21 days, then continue taking one white placebo tablet every day from the last row in the pack for next 7 days.
- It is most likely that your menstruation will start while taking the white tablets. Do not discontinue taking the white tablets. Taking of the white tablets for 7 days will help you keep your tablet taking routine. If your menstruation does not start during this time, check with your doctor to make sure you are not pregnant.
- After completing the seven white tablets, start taking light yellow tablets from another Ethinylestradiol & Drospirenone pack and continue taking the tablet as long as you don’t want to be pregnant.
Management of Missed Tablets: If you forgot to take a tablet one day, take the missed tablet as soon as you remember. This may mean taking two tablets the very next day. Additionally you should use some other method of contraception while you are taking the tablets & until your next menstruation. If you forget to take the tablets for two continuous days, then it is likely that you will no longer be protected against pregnancy. You should therefore discontinue taking the tablet and adopt some other temporary methods (condom/foam tablet) till your next menstruation. Discard the unfinished pack of tablets and start taking tablets from the very first white tablet of the top row from a fresh pack from the first day of next menstruation.
How to Delay a Period: To delay a period you should continue with another new pack of Ethinylestradiol & Drospirenone just after finishing the light yellow active tablet of the present pack (that is no need to take white placebo tablet of present pack). The extension can be carried on for as long as wished until the end of the second pack. When you wish your period to begin, just stop tablet taking. While using the second pack woman may have some breakthrough bleeding or spotting. Start with your next pack after the usual 7 day white inactive tablet interval.
Advice in Case of Vomiting: If vomiting occurs within 4 hours after white active tablet taking, absorption may not be complete. In such an event, the advice concerning Management of Missed Tablets is applicable. The woman must take the extra active tablet(s) needed from a back up pack after vomiting.
Interactions between ethinylestradiol and other drugs may lead to decreased or increased ethinylestradiol concentrations, respectively. Decreased ethinylestradiol serum concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the oral contraceptive. Example of substances that may decrease serum ethinylestradiol concentrations include rifampicin, phenytoin, primidone, rifabutin, dexamethasone, griseofulvin, topiramate, some protease inhibitors, modafinil, ritonavir and barbiturates. Certain antibiotics including ampicillin, other penicillins and tetracyclines may reduce the efficacy of oral contraceptives. During concomitant use of this tablet & other drugs that may lead to decreased ethinylestradiol serum concentrations, it is recommended that a non-hormonal back-up method of contraception to be used in addition to the regular intake of this tablet.
- If you are pregnant
- If you are over 45 years of age
- If you are a heavy smoker (more than 20 cigarette/day)
- If you have got heart disease, clotting of blood in the vein
- If you suffer from liver disease or jaundice
- If you are suffer from high blood pressure, migraine, feel something hard in your breast, diabetes with vascular involvement, experience excessive bleeding for which no reason has yet been ascertained
- Hypersensitivity to any of the components of Drospirenone + Ethinylestradiol
Different types of tablet suit different types of woman. At the initial stage some women may experience side-effects like dizziness, headache, nausea or inter-menstrual bleeding. If taken regularly, such types of side-effects normally go away after 2-3 months. If she continues to have the side effects beyond 2-3 months, she could consult with a doctor. After starting one brand of oral contraceptive tablets, if you feel any inconvenience such as migraine, changes in eyesight or speech, unusual pain or swelling in your legs, sharp chest pains or shortness of breath, yellow skin or a rise in blood pressure take advice from your doctor or contact the nearest family planning center.
Pregnancy & Lactation
Use During Pregnancy: The administration of this tablet is contraindicated during pregnancy. Pregnancy must be excluded before starting this tablet. If pregnancy occurs during use of this tablet, the preparation must be withdrawn immediately. Oral contraceptives have not been shown to have any deleterious effects on the foetus or to increase the incidence of miscarriage in women who discontinue their use prior to conception. However, in women who discontinue oral contraceptives with the intent of becoming pregnant, a non-hormonal method of contraception is recommended for three months before attempting to conceive.
Use during Lactation: Oestrogen-containing oral contraceptives given in the postpartum period may interfere with lactation. There may be a decrease in the quantity and a change in the composition of the breast milk. Furthermore, small amounts of contraceptive steroids and/or metabolites have been identified in the milk of mothers receiving them. A few adverse effects have been reported, including jaundice and breast enlargement. The use of oestrogen-containing oral contraceptives should be deferred until the infant has been completely weaned.
Precautions & Warnings
Epidemiological studies have suggested an association between the use of COCs and an increased risk of arterial, venous thrombotic and thromboembolic diseases such as myocardial infarction, deep venous thrombosis, pulmonary embolism and of cerebrovascular accidents. These events occur rarely. Venous thromboembolism (VTE) manifesting as deep venous thrombosis and/or pulmonary embolism may occur during the use of all COCs. In a clinical study it has been found that after the use of drospirenon containing COCs cause the prevalence of VTE & ATE may be upto 9.8 for 10,000 women/ year.
Use in Special Populations
Paediatric Use: Ethinylestradiol & Drospirenone is only indicated after menarche. There is no data suggesting the need for a dosage adjustment.
Use in the Elderly: Ethinylestradiol & Drospirenone is not indicated after menopause.
Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, 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.
Store in a cool and dry place. Keep away from light & out of reach of children.
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