This page contains brief details about the drug , it's indication, dosage & administaration, mechanism of action, related brands with strength, warnings and common side effects.
Background and Date of Approval
Gestodene and ethinyl estradiol are commonly used in combination oral contraceptives. The FDA initially approved Gestodene, Ethinyl Estradiol on August 13, 2008.
Mechanism of Action of undefined
The Gestodene and Ethinyl Estradiol work through multiple mechanisms to prevent pregnancy and regulate menstrual cycles. Ethinyl Estradiol, a synthetic form of estrogen, stabilises the endometrial lining and helps control the menstrual cycle. It also inhibits the release of gonadotropins (LH and FSH) from the pituitary gland, preventing ovulation.
Gestodene, a synthetic progestin, thickens the cervical mucus, making it difficult for sperm to enter the uterus. It also alters the uterine lining, making it less receptive to implantation. Together, these actions prevent fertilisation and implantation, providing effective contraception.
Additionally, they help regulate menstrual bleeding, reduce menstrual cramps, and manage conditions like PCOS and endometriosis by suppressing ovarian function.
Uses of undefined
Gestodene and Ethinyl Estradiol are used primarily for pregnancy prevention as an oral contraceptive. They also help regulate menstrual cycles, manage acne (especially hormonal acne), and treat conditions like polycystic ovary syndrome (PCOS). Additionally, they are used to alleviate symptoms of endometriosis and to reduce heavy or painful periods (dysmenorrhea).
undefined Drug administaration and Dosage available
Gestodene and Ethinyl Estradiol are commonly taken orally in the form of a tablet, with one tablet usually taken once a day at the same time for 21 consecutive days. After completing the 21-day course, a 7-day break is observed, during which menstruation-like bleeding typically occurs. A new pack should be started after the 7-day break.
The tablets can be taken with or without food, but it is important to take them at the same time each day to maintain consistency. If a dose is missed, it should be taken as soon as remembered, within 12 hours of the regular dose.
If more than 12 hours have passed, refer to the product instructions or consult a healthcare provider for advice. Always follow the guidance of your healthcare provider regarding dosage and missed doses.
Warnings, Precautions and Side Effects of undefined
Warnings
- Blood clots: There is an increased risk of venous thromboembolism (VTE), deep vein thrombosis (DVT), pulmonary embolism (PE), and stroke. This risk is higher in women who smoke, are over 35 years old, or have other risk factors for cardiovascular disease.
- Cancer risk: Long-term use may be associated with an increased risk of breast cancer and cervical cancer. Regular screening and monitoring are recommended.
- Liver conditions: This combination should be used with caution in women with a history of liver disease or hepatic tumours, as it may affect liver function.
- Pregnancy: This medication is not for use during pregnancy. It should be discontinued if pregnancy occurs. It is also not recommended during breastfeeding.
- Hormonal imbalances: Women with conditions like endometriosis, uterine fibroids, or polycystic ovary syndrome (PCOS) should use it cautiously and under medical supervision.
Precautions
Use with caution in women with a history of high blood pressure, diabetes, high cholesterol, or obesity, as these conditions increase cardiovascular risk. Regular blood pressure monitoring is advised. Inform your healthcare provider about any other medications, especially antibiotics or anti-seizure drugs, as they may interact.
Women who smoke or are over 35 should be closely monitored for thromboembolic risks. Seek immediate medical attention for serious side effects, such as severe headaches, vision changes, or leg pain.
Side Effects
Common side effects include:
- Nausea or vomiting
- Headaches or migraine
- Breast tenderness or enlargement
- Mood changes or depression
- Weight gain or fluid retention
- Spotting or breakthrough bleeding (especially during the first few months of use)
- Decreased libido or sexual dysfunction
Rare but serious side effects include:
- Blood clots (deep vein thrombosis, pulmonary embolism, stroke, or heart attack)
- Severe allergic reactions (rash, itching, swelling)
- Liver problems (jaundice, abnormal liver function tests)
- High blood pressure
- Vision problems (e.g., blurry vision or visual disturbances)
Word Of Advice
Always follow your healthcare provider’s instructions for proper use. Avoid smoking and inform your doctor of any pre-existing conditions, especially cardiovascular or liver issues. Regular check-ups and monitoring are essential, particularly if you experience any unusual symptoms. Do not skip doses, and seek prompt medical advice if you suspect any serious side effects.
Frequently Asked Question
References
- https://labeling.pfizer.com/ShowLabeling.aspx?id=14834
- Täuber U, Kuhnz W, Hümpel M. Pharmacokinetics of gestodene and ethinyl estradiol after oral administration of a monophasic contraceptive. https://pubmed.ncbi.nlm.nih.gov/2220966/
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020713s010lbl.pdf
- https://www.sciencedirect.com/science/article/abs/pii/000293789091358J
Disclaimer
The drug information on this page is not a substitute for medical advice, it is meant for educational purposes only. For further details consult your doctor about your medical condition to know if you are eligible to receive this treatment.