Overdose of Norethisterone in details
Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may be manifested by nausea, vomiting, breast enlargement and vaginal bleeding. There is no specific antidote and treatment should be symptomatic. Gastric lavage may be employed if the overdose is large and the patient is seen sufficiently early (within four hours).
Norethisterone warnings
You should not use medroxyprogesterone if you are pregnant, or if you have liver disease, a hormone-related cancer such as breast or uterine cancer, a history of stroke or blood clot, or abnormal vaginal bleeding that has not been checked by a doctor. Medroxyprogesterone will not prevent heart disease, breast cancer, or dementia, and may actually increase the risk of developing these conditions in post-menopausal women.
Medroxyprogesterone may also increase the risk of uterine or ovarian cancer in some women. Long-term treatment with estrogens and progestins (such as medroxyprogesterone) may also increase your risk of heart attack, blood clot, or stroke.
Talk to your doctor about your specific risks and benefits of taking this medication, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.
FDA pregnancy category X. Medroxyprogesterone can cause birth defects. Do not use if this medication you are pregnant. Tell your doctor right away if you become pregnant during treatment. You should not use this medication if you are allergic to medroxyprogesterone, or if you have:
abnormal vaginal bleeding that has not been diagnosed;
a hormone-related cancer such as breast or uterine cancer;
liver disease; or
a history of stroke or blood clot.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely take medroxyprogesterone:
heart disease, congestive heart failure, recent stroke or heart attack
high blood pressure;
high cholesterol or triglycerides;
low levels of calcium in your blood;
severe pelvic pain;
recent miscarriage or abortion;
epilepsy;
asthma;
migraine headaches;
a thyroid disorder;
kidney disease,
diabetes; or
lupus.
Medroxyprogesterone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Medroxyprogesterone will not prevent heart disease, breast cancer, or dementia, and may actually increase the risk of developing these conditions in post-menopausal women. Medroxyprogesterone may also increase the risk of uterine or ovarian cancer in some women. Long-term treatment with estrogens and progestins (such as medroxyprogesterone) may also increase your risk of heart attack, blood clot, or stroke.
Talk to your doctor about your specific risks and benefits of taking this medication, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.
Avoid smoking while you are taking medroxyprogesterone. Smoking greatly increases your risk of blood clots.
Norethisterone precautions
Assessment of women prior to starting oral contraceptives (and at regular intervals thereafter) should include a personal and family medical history of each woman. Physical examination should be guided by this and by the contraindications for Norethisterone. The frequency and nature of these assessments should be based upon relevant guidelines and should be adapted to the individual woman, but should include measurement of blood pressure and, if judged appropriate by the clinician, breast, abdominal and pelvic examination including cervical cytology.
Malignant hepatic tumours have been reported on rare occasions in long-term users of contraceptives. Benign hepatic tumours have also been associated with oral contraceptive usage. A hepatic tumour should be considered in the differential diagnosis when upper abdominal pain, enlarged liver or signs of intra-abdominal haemorrhage occur.
A statistical association between the use of oral contraceptives and the occurrence of thrombosis, embolism or haemorrhage has been reported. Patients receiving oral contraceptives should be kept under regular surveillance, in view of the possibility of development of conditions such as thromboembolism.
The risk of coronary artery disease in women taking oral contraceptives is increased by the presence of other predisposing factors such as cigarette smoking, hypercholesterolaemia, obesity, diabetes, history of pre-eclamptic toxaemia and increasing age. After the age of thirty-five years, the patient and physician should carefully re-assess the risk/benefit ratio of using oral contraceptives as opposed to alternative methods of contraception.
Norethisterone should be discontinued at least 4 weeks before elective surgery or during periods of prolonged immobilisation. It would be reasonable to resume Norethisterone 2 weeks after surgery provided the woman is ambulant. However, every woman should be considered individually with regard to the nature of the operation, the extent of immobilisation, the presence of additional risk factors and the chance of unwanted conception.
Norethisterone should be discontinued if there is a gradual or sudden, partial or complete loss of vision or any evidence of ocular changes, onset or aggravation of migraine or development of headache of a new kind which is recurrent, persistent or severe, suspicion of thrombosis or infarction, significant rise in blood pressure or if jaundice occurs.
Caution should be exercised where there is the possibility of an interaction between a preexisting disorder and a known or suspected adverse effect. The use of Norethisterone in women suffering from epilepsy, or with a history of migraine or cardiac or renal dysfunction may result in exacerbation of these disorders because of fluid retention. Caution should also be observed in women who wear contact lenses, women with impaired carbohydrate tolerance, depression, gallstones, a past history of liver disease, varicose veins, hypertension, asthma or any disease that is prone to worsen during pregnancy (eg, multiple sclerosis, porphyria, tetany and otosclerosis).
An increased risk of congenital abnormalities, including heart defects and limb defects, has been reported following the use of sex hormones, including oral contraceptives, in pregnancy. If the patient does not adhere to the prescribed schedule, the possibility of pregnancy should be considered at the time of the 1st missed period and further use of oral contraceptives should be withheld until pregnancy has been ruled out. It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen. If pregnancy is confirmed the patient should be advised of the potential risks to the foetus and the advisability of continuing the pregnancy should be discussed in the light of these risks. It is advisable to discontinue Norethisterone 3 months before a planned pregnancy.
Progestogen-only oral contraceptives may offer less protection against ectopic pregnancy, than against intrauterine pregnancy.
A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk of having breast cancer diagnosed in women who are currently using oral contraceptives (OC). The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in OC users, the biological effects of OCs or a combination of both. The additional breast cancers diagnosed in current users of OCs or in women who have used OCs in the last ten years are more likely to be localised to the breast than those in women who never used OCs.
Breast cancer is rare among women under 40 years whether or not they take OCs. Whilst the background risk increases with age, the excess number of breast cancer diagnoses in current and recent progesterone-only pill (POP) users is small in relation to the overall risk of breast cancer, possibly of similar magnitude to that associated with combined OCs. However, for POPs, the evidence is based on much smaller populations of users and so is less conclusive than that for combined OCs.
The most important risk factor for breast cancer in POP users is the age women discontinue the POP; the older the age at stopping, the more breast cancers are diagnosed. Duration of use is less important and the excess risk gradually disappears during the course of the 10 years after stopping POP use, such that by 10 years there appears to be no excess.
The evidence suggests that compared with never-users, among 10,000 women who use POPs for up to 5 years but stop by age 20, there would be much less than 1 extra case of breast cancer diagnosed up to 10 years afterwards. For those stopping by age 30 after 5 years use of the POP, there would be an estimated 2-3 extra cases (additional to the 44 cases of breast cancer per 10,000 women in this age group never exposed to oral contraceptives). For those stopping by age 40 after 5 years use, there would be an estimated 10 extra cases diagnosed up to 10 years afterwards (additional to the 160 cases of breast cancer per 10,000 never-exposed women in this age group).
It is important to inform patients that users of all contraceptive pills appear to have a small increase in the risk of being diagnosed with breast cancer, compared with non-users of oral contraceptives, but this has to be weighed against the known benefits.
Effects on Ability to Drive and Use Machines: None known.
References
- DailyMed. "NORETHINDRONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "norethindrone". http://www.drugbank.ca/drugs/DB00717 (accessed September 17, 2018).
- MeSH. "Contraceptives, Oral, Synthetic". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
