Generic Name: Ethinylestradiol 30mcg + Gestodene 75mcg, Manufacturer: Incepta Pharmaceuticals Ltd.
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Indications of Gestop 28
Gestop 28 is a drug cocktail used to treat irregular periods and as a method of contraception (to prevent conception). This medication aids in stopping the release of the egg and its fertilization. Additionally, it might aid in lowering the risk of ovarian cancer. Gestop 28 can be taken with or without food, however, the best results come from taking it simultaneously. It should be regarded as medical advice.
Pharmacology
This is a composite oral contraceptive pill that contains the synthetic progestin Gestodene and the synthetic estrogen ethinyl estradiol. The contraceptive effect of this tablet is based on the interaction of many factors, the most important of which is the inhibition of ovulation and changes in cervical secretions. When the tablet is taken according to directions, it will prevent the eggs from maturing to the point where they can be fertilized, and the cervical mucus remains viscous, thus forming a sperm barrier, making the endometrium unable to accept implantation. In addition to preventing pregnancy, the estrogen/progestin combination has several positive properties. In addition to the negative properties, it can also be used to determine contraceptive methods. Cycles are more regular, menstruation is usually less painful, and bleeding is lighter.
Gestodene has anti-mineral corticoid activity and can counteract the sodium retention associated with estrogens. In combination with ethinyl estradiol, Gestodene shows a favorable lipid profile with an increase in HDL high-density lipoproteins. Gestodene exerts antiandrogenic activity and does not counteract the increase in ethinyl estradiol-related sex hormone binding globulin (SHBG), which can be used to bind and inactivate endogenous androgens. Gestodene does not have androgen, estrogen, glucocorticoid, or anti-glucocorticoid activity. This, combined with the anti-mineralocorticoid and anti-androgenic properties, gives Gestodene biochemical and pharmacological characteristics very similar to the natural hormone progesterone.
Dosage & Administration
When and how to take the tablets: This tablet pack contains 21 tablets. On the pack, each tablet is marked with the day of the week on which it is to be taken. Take your tablet at about the same time each day, with some water if necessary. Follow the direction of the arrows until all 21 tablets have been taken. During the next 7 days don't take any tablets. A period should begin during these 7 days (the withdrawal bleed), unusually it will start on days 2-3 after the last tablet. Start taking your next pack on the 8th day even if your period continues. This means that you will always start new packs on the same day of the week and also that you have your withdrawal bleeding on about the same days each month.
Starting your first pack of this tablet: When no hormonal contraceptive has been used in the past month. Start taking this tablet on the first day of your cycle, i.e. the first day of menstrual bleeding. Take a tablet marked with that day of the week. For example, if your period starts on a Sunday, take a tablet marked Sunday. Then follow the days in order. You may also start on days 2-5 of your cycle, but in that case, make sure you also use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking in the first cycle.
When changing from another combined Pill: You can start taking this tablet the day after you have the last tablet from your present Pill pack (this means no tablet-free break). If your present Pill pack also contains inactive tablets you can start this tablet on the day after taking the first active tablet (if you are not sure which this is, ask your doctor or pharmacist). You can also start later, but never later than the day following the tablet-free break of your present Pill (or the day after the last inactive tablet of your present Pill).
When changing from progestogen-only Pill (Mini Pill): You can stop taking the mini pill any day and start taking this tablet the next day, at the same time. But make sure you also use an additional-contraceptive method (a barrier method) for the first 7 days of tablet-taking when having intercourse.
When changing from an Injectable or Implant: Start using this tablet when your next injection is due or on the day that your implant is removed. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet-taking when having intercourse.
After having a baby: If you have just had a baby, your doctor may tell you to wait until after your first normal period before you start taking this tablet. Sometimes it is possible to start sooner. Your doctor will advise you. If you are breastfeeding and want to take this tablet you should discuss this first with your doctor.
After a miscarriage or an abortion: Your doctor will advise you.
If too many this tablet tablets are taken (overdose): There have been no reports of serious harmful effects from taking too many this tablet tablets at one time. If you have taken several tablets at a time, you may have nausea, vomiting, or vaginal bleeding. If you discover that a child has taken this tablet ask your doctor for advice.
When you want to stop taking this tablet: You can stop taking this tablet at any time you want. If you do not want to become pregnant, ask your doctor about other methods of birth control. If you stop taking this tablet because you want to get pregnant, it is generally recommended that you wait until you have had a natural period before trying to conceive.
Interactions of Gestop 28
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 the efficacy of the oral contraceptive. Examples 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 Rosen 28 & other drugs that may lead to decreased ethinylestradiol serum concentrations, it is recommended that a non-hormonal backup method of contraception be used in addition to the regular intake of Rosen 28.
Contraindications
Side Effects of Gestop 28
Different types of tablets suit different types of women. 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
Use During Pregnancy :
The administration of Rosen 28 is contraindicated during pregnancy. Pregnancy must be excluded before starting Rosen 28. If pregnancy occurs during the use of Rosen 28, the preparation must be withdrawn immediately.
Oral contraceptives have not been shown to have any deleterious effects on the fetus 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 :
Estrogen-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 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 estrogen-containing oral contraceptives should be deferred until the infant has been completely weaned.
Precautions
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 drospirenone-containing COCs causes the prevalence of VTE & ATE may be up to 9.8 for 10,000 women/ year.
Storage Conditions
Store in a cool and dry place. Keep away from light & out of reach of children.
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