Product Details

Contraindications of Primolut Depot

Primolut Depot should not be used in the presence of any of the conditions listed below, which are derived also from information on other progestogen-only products. Should any of the conditions appear during the use of Primolut Depot, the use of the preparation must be discontinued immediately. Active venous thromboembolic disorders Arterial and cardiovascular disease present or in history (e.g. myocardial infarction, cerebrovascular accident, ischemic heart disease) Diabetes mellitus with vascular involvement Presence or history of severe hepatic disease as long as liver function values have not returned to normal Presence or history of liver tumors (benign or malignant) Known or suspected sex hormone-dependent malignancies Hypersensitivity to hydroxyprogesterone caproate or to any of the excipients Special warnings and special precautions for use If any of the conditions/risk factors mentioned below is present or deteriorates, an individual risk-benefit analysis should be done before Primolut Depot is started or continued. Circulatory disorders It has been concluded from epidemiological surveys that the use of oral estrogen/progestogen containing ovulation inhibitors is attended by an increased incidence of thromboembolic diseases. Therefore, one should keep the possibility of an increased thromboembolic risk in mind, particularly where there is a history of thromboembolic diseases. Generally recognized risk factors for venous thromboembolism (VTE) include a positive personal or family history (VTE in a sibling or a parent at a relatively early age), age, obesity, prolonged immobilization, major surgery or major trauma. The increased risk of thromboembolism in the puerperium must be considered. Treatment should be stopped at once if there are symptoms of an arterial or venous thrombotic event or suspicion thereof. Tumors In rare cases, benign liver tumors, and even more rarely, malignant liver tumors have been reported in users of hormonal substances such as the one contained in Primolut Depot. In isolated cases, these tumors have led to life-threatening intra-abdominal hemorrhages. A hepatic tumor should be considered in the differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal hemorrhage occur in women taking Primolut Depot. Other conditions Strict medical supervision is necessary if the patient suffers from diabetes. 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 when taking Primolut Depot . Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree. Medical examination A complete medical history should be taken and a physical and gynecological examination should be performed prior to the initiation or reinstitution of the use of Primolut Depot, guided by the contraindications (Section 4.3) and warnings (Section 4.4), and these should be repeated during the use of Primolut Depot. The frequency and nature of these assessments should be adapted to the individual woman but should generally include special reference to blood pressure, breasts, abdomen and pelvic organs, and should also include cervical cytology. Pregnancy must be excluded in the appropriate indications. Interaction with other medicaments and other forms of interaction Drug interactions which result in an increased clearance of sex hormones can lead to decreased therapeutic efficacy. This has been established with many hepatic enzyme-inducing drugs (including phenytoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, St. Johns wort, and rifabutin); griseofulvin, is also suspected. Sex steroids may interfere with the metabolism of other drugs. Accordingly, plasma and tissue concentrations may be affected (e.g. cyclosporin). Note: The prescribing information of concomitant medications should be consulted to identify potential interactions. • Laboratory tests The use of progestogens may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of (carrier) proteins, e.g. corticosteroid binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. Changes generally remain within the normal laboratory range. Pregnancy and lactation Pregnancy Pregnancy should be ruled out unless Primolut Depot is being used for the treatment of habitual and threatened abortion. Epidemiological studies have revealed neither an increased risk of birth defects in children born to women who used sex steroids prior to pregnancy, nor a teratogenic effect when sex steroids were used inadvertently during early pregnancy. A possible association between the administration of female sex hormones in early pregnancy and the occurrence of malformations has been the subject of discussions in recent years. According to the present state of scientific knowledge, the assumption that there may be a causal association can be regarded as unfounded. However, it must be clearly understood, that no drug – including sex hormones – can be claimed with absolute certainty to be free from teratogenic effects. This remaining uncertainty is the reason why, in certain indications, the exclusion of pregnancy is called for before the start of sex hormone therapy. Lactation Cyclical function is usually absent during lactation – particularly during short-lasting lactation. Since this is a physiological situation, there is no need to use Primolut Depot. It is not known whether hydroxyprogesterone and its metabolites are excreted in human milk.