Progynova Special Precautions

If any of the conditions/risk factors mentioned as follows is present or deteriorates, an individual risk-benefit analysis should be done before HRT is started or continued.
Venous Thromboembolism: Epidemiological studies have suggested that HRT may be associated with an increased relative risk of developing venous thromboembolism (VTE) ie, deep venous thrombosis or pulmonary embolism. Risk/benefit should therefore be carefully weighed in consultation with the patient when prescribing HRT to women with a risk factor for VTE.
Generally recognized risk factors for VTE include a personal history, a family history (the occurrence of VTE in a direct relative at a relatively early age may indicate genetic disposition) and severe obesity. The risk of VTE also increases with age. There is no consensus about the possible role of varicose veins in VTE.
The risk of VTE may be temporarily increased with prolonged immobilization, major elective or post-traumatic surgery, or major trauma. Depending on the nature of the event and the duration of the immobilization, consideration should be given to a temporary discontinuation of HRT.
Treatment should be stopped at once if there are symptoms of a thrombotic event or suspicion thereof.
Endometrial Cancer: Prolonged exposure to unopposed estrogens increases the risk of development of endometrial hyperplasia or carcinoma. Studies have suggested that the addition of progestogens to the regimen reduces the risk of endometrial hyperplasia and cancer.
Breast Cancer: A meta-analysis from 51 epidemiological studies reported that there is a modest increase in the risk of having breast cancer diagnosed in women who have used HRT for >5 years. The findings may be due to an earlier diagnosis, the biological effects of HRT, or a combination of both. The relative risk increases with duration of treatment (by 2.3%/year of use). This is comparable to the increased risk of breast cancer observed in women with every year of delay of natural menopause (2.8%/year of delay). The increased risk gradually disappears during the course of the first 5 years after cessation of HRT. Breast cancers found in women using HRT are more likely to be localized to the breast than those found in non-users.
Liver Tumor: In rare cases, benign and even more rarely, malignant liver tumors have been observed after the use of hormonal substances eg, the one contained in Progynova. In isolated cases, these tumors led to life-threatening intra-abdominal hemorrhage. A hepatic tumor should be considered in the differential diagnosis, if upper abdominal pain, enlarged liver or signs of intra-abdominal hemorrhage occur.
Gallbladder Disease: Estrogens are known to increase the lithogenicity of the bile. Some women are predisposed to gallbladder disease during estrogen therapy.
Other Conditions: Treatment should be stopped at once if migrainous or frequent and unusually severe headaches occur for the first time, or if there are other symptoms that are possible premonitory signs of cerebrovascular occlusion.
A general association between HRT use and development of clinical hypertension has not been established. Small increases in blood pressure have been reported in women taking HRT, clinically relevant increases are rare. However, if in individual cases, a sustained clinically significant hypertension develops during the use of HRT, then withdrawing the HRT may be considered.
Nonsevere disturbances of liver function, including hyperbilirubinemias eg, Dubin-Johnson syndrome or Rotor syndrome, need close supervision and liver function should be checked periodically. In case of deterioration of markers of liver function, use of HRT should be stopped.
Recurrence of cholestatic jaundice or cholestatic pruritus which occurred first during pregnancy or previous use of sex steroids necessitates the immediate discontinuation of HRT.
Women with moderately elevated levels of triglycerides need special surveillance. HRT in these women may be associated with a further increase of triglyceride levels bearing the risk of acute pancreatitis.
Although HRT may have an effect on peripheral insulin resistance and glucose tolerance, there is generally no need to alter the therapeutic regimen in diabetics using HRT. However, diabetic women should be carefully monitored while taking HRT.
Certain patients may develop undesirable manifestations of estrogenic stimulation under HRT eg, abnormal uterine bleeding. Frequent or persistent abnormal uterine bleeding during treatment is an indication for endometrial assessment.
Uterine myomas may increase in size under the influence of estrogens. If this is observed, treatment should be discontinued.
Should endometriosis be reactivated under treatment, discontinuation of therapy is recommended.
Should there be a suspicion of a prolactinoma, this should be ruled out before starting treatment.
Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking HRT.
The following conditions have been reported to occur or deteriorate with HRT use. Although the evidence of an association with HRT use is inconclusive, women with these conditions and treated with HRT should be carefully monitored: Epilepsy, benign breast disease, asthma, migraine, porphyria, otosclerosis and systemic lupus erythematosus.
Medical Examination/Consultation: A complete medical history should be taken and a physical examination should be conducted prior to the initiation or reinstitution of HRT, guided by the contraindications and warnings and should be repeated periodically. The frequency and nature of these examinations should be based on established practice guidelines and be adapted to the individual woman, but should generally include pelvic organs, including routine cervical cytology, abdomen, breasts and blood pressure.
Effects on the Ability to Drive or Operate Machinery: No adverse effects.
Use in pregnancy & lactation: HRT is not indicated for use during pregnancy or lactation.
Extensive epidemiological studies have revealed neither an increased risk of birth defects in children born to women who used sex hormones prior to pregnancy, nor a teratogenic effect when sex hormones were taken inadvertently during early pregnancy.
Small amounts of sex hormones may be excreted in human milk.