Norgestrel + Ethinyl Estradiol

Norgestrel + Ethinyl Estradiol is used for contraception (to prevent pregnancy) and in the treatment of irregular periods. It helps to prevent releases and fertilization of the egg. Norgestrel + Ethinyl Estradiol can be taken with or without food, but take it at the same time to get the most benefit. It should be taken as your doctor's advice. You should have to start taking the pill on the day one of your menstrual cycle and continue taking it for whole month and start with a new pack once the pack get finished. In case you missed your dose and you are late by 12 hours in taking the missed dose, in that case, you must use a condom while intercourse for a period of 2 days. Nausea, headache, and breast pain are some commonly seen side effects of this medicine. If these bother you or appear serious, let your doctor know. There may be ways of reducing or preventing them. You might experience spotting or bleeding between menstrual periods or missed periods. Consult with your doctor if this occurs frequently or persists longer. Inform your doctor if you notice swelling and pain in your limbs, shortness of breath, chest pain or changes in vision, as it may be a sign of blood clot. Before taking this medicine, let your doctor know if you smoke and are over 35, or if you have ever had a heart attack or have cancer of uterus/cervix, or vagina. Your doctor should also know about all other medicines you are taking as many of these may make this medicine less effective or change the way it works. Do not take the medicine if you are pregnant already or breastfeeding. Norgestrel + Ethinyl Estradiol is a combined oral contraceptive pill. It works by preventing the release of egg (ovulation) and affecting sperm movement in the womb to prevent its union with the egg. It also changes the lining of the womb and renders it unsuitable for pregnancy.

• Contraception

Ethinylestradiol (EE): Reduces LHRH release from hypothalamus, reduces gonadotropin release from pituitary; increase synthesis of DNA, RNA, and various proteins in target tissues. Norgestrel: Progestin; inhibits gonadotropin secretion from pituitary; prevents follicular maturation and ovulation, stimulates growth of mammary tissues. Norgestrel is a progestogen derived from nortestosterone while ethinylestradiol is a synthetic oestrogen. When used together, they inhibit ovulation, and affect other changes such as changes in the cervical mucus and the endometrium, which makes conception unfavourable.

Adult Dose: Oral Contraception Adult The dosage of norgestrel and ethinyl estradiol tablets is one white tablet daily for 21 consecutive days, followed by one inert tablet daily for 7 consecutive days, according to the prescribed schedule. It is recommended that this tablets should be taken at the same time each day. If >2 tablets are missed or in newly started patients, non-hormonal birth control method should be used until the active tablet has been taken consecutively for 7 days. Hepatic Impairment Do not administer Renal Dose: Renal Impairment Use caution; monitor blood pressure

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Norgestrel + Ethinyl Estradiol may be taken with or without food, but it is better to take it at a fixed time.

Common: • Nausea • Headache • Breast pain • Irregular uterine bleeding

[UNSAFE] Norgestrel + Ethinyl Estradiol may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur. Your doctor has prescribed Norgestrel + Ethinyl Estradiol to help you prevent pregnancy. It also results in lighter, less painful and more regular menstrual bleeding. Take your pill at the same time every day to help you remember to take it. You may experience menstrual irregularities such as spotting or bleeding between menstrual periods or missed periods. Consult your doctor if this persists. Do not use Norgestrel + Ethinyl Estradiol if you are obese, over 35, smoke, on prolonged bed rest or have a history of blood clots. Stop taking this medicine and inform your doctor immediately if you notice unexplained swelling and pain in your limbs, shortness of breath, chest pain or changes in vision. These could be symptoms of a blood clot in a vein.

Pregnancy, undiagnosed vaginal bleeding, severe arterial disease (or family history of atherogenic lipid profile); liver adenoma; porphyria; after evacuation of hydatidiform mole; history of breast cancer; hepatic impairment; thrombophloebitis or thromboembolic disorders; breast carcinoma except in selected patients being treated for metastatic disease; oestrogen-dependent tumour; smoking ?40 cigarettes daily; >50 yr; diabetes complications present; BMI >39 kg/m2; migraine with typical focal aura, lasting >72 hr despite treatment or migraine treated with ergot derivatives; BP >160 mmHg systolic and 100 mmHg diastolic; transient ischaemic attacks without headaches; SLE; gallstones; history of haemolytic uraemic syndrome, pruritis during pregnancy; cholestatic jaundice; chorea or deterioration of otosclerosis pemphigoid; breast feeding during 1st 6 mth after delivery.

CYP3A4 inducers may decrease levels/effects eg aminoglutethimide, carbamazepine, nafcillin, nevirapine, atazanavir, nelfinavir, phenobarbital, phenytoin, lamotrigine, rifamycins, griseofulvin and ritonavir; ampicillin, tetracycline and other antibiotics may reduce efficacy; oestrogens may antagonise anticoagulant effect of coumarins; may inhibit metabolism of prednisolone and ciclosporin; may reduce clearance of alprazolam, chlordiazepoxide, diazepam; may increase clearance of lorazepam, oxazepam, temazepam.

[CAUTION] Caution is advised when consuming alcohol with Norgestrel + Ethinyl Estradiol. Please consult your doctor.

[UNSAFE] Norgestrel + Ethinyl Estradiol is highly unsafe to use during pregnancy. Seek your doctor's advice as studies on pregnant women and animals have shown significant harmful effects to the developing baby.

[CONSULT YOUR DOCTOR] Information regarding the use of Norgestrel + Ethinyl Estradiol during breastfeeding is not available. Please consult your doctor.

[CONSULT YOUR DOCTOR] There is limited information available on the use of Norgestrel + Ethinyl Estradiol in patients with kidney disease. Please consult your doctor. [UNSAFE] Norgestrel + Ethinyl Estradiol is probably unsafe to use in patients with liver disease and should be avoided. Please consult your doctor.

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