Lydia Clair

Lydia Clair Special Precautions

cyproterone + ethinylestradiol

Manufacturer:

DKT

Distributor:

MCE
Full Prescribing Info
Special Precautions
Physical Examination and Follow up: Before estrogen/progestogen combinations are used, a thorough history and physical examination should be made including a blood pressure determination. Breasts, liver, extremities, abdomen and pelvic organs should be examined. A Papanicolaou smear should be taken if the patient has been sexually active and a urinalysis should be done.
The first follow up examination should be done 3 months after the initial prescription, thereafter; examinations should be conducted at regular intervals during long-term treatment and more frequently for those patients at greater risk for adverse effects. At each annual visit, examination should include those procedures outlined previously that were done at the initial visit.
Hepatic Function: Patients who have had jaundice should be given estrogen/progestogen combinations with great care and under dose observation.
If there is a clear-cut history of cholestatic jaundice, especially if it occurred during pregnancy, other methods of treatment should be prescribed. The development of severe generalized pruritus or icterus requires that the medication be withdrawn until the problem is resolved. If the jaundice should prove to be cholestatic in type, therapy should not be resumed. In patients taking estrogen/progestogen combinations, changes in the composition of the bile may occur and an increased incidence of gallstones has been reported. Hepatic nodules (adenoma and focal nodular hyperplasia have been reported, particularly in long-term users of estrogen/progestogen combinations. Although these lesions are uncommon, they have caused fatal intra-abdominal hemorrhage and should be considered in women presenting with an abdominal mass, acute abdominal pain, or evidence of intra-abdominal bleeding.
Hypertension: Patients with essential hypertension whose blood pressure is well controlled may be given the drug but only under the close supervision. If a significant elevation of blood pressure in previously normotensive or hypertensive subjects occurs at any time during the administration of the drug, cessation of medication is necessary.
Migraine and Headache: The onset or exacerbation of migraine or the development of headache of a new pattern which is recurrent persistent, or severe, requires discontinuation of medication and evaluation of the cause.
Diabetes: Diabetic patients, or those with a family history of diabetes, should be observed closely to detect any alterations in carbohydrate metabolism. Patients predisposed to diabetes who can be kept under close supervision may be given estrogen/progestogen combinations under strict medical supervision. Young diabetic patients whose disease is of recent origin, well-controlled, and not associated with hypertension or other signs of vascular disease such as ocular fundal changes, should be closely observed.
Metabolic and Endocrine Diseases: In metabolic or endocrine diseases and when metabolism of calcium and phosphorus is abnormal, careful clinical evaluation should precede medication and a regular follow-up is recommended.
Ocular Disease: Progressive astigmatic error, possibly leading to keratoconus, has been noted in some myopic women receiving drugs of the estrogen/progestogen class. In women who developed myopia at or near puberty, and in whom myopia stabilized in adult life, estrogen/progestogen combinations after some 6 months of use have increased the refractive error 2- to 3-fold. Women with a family history of myopic astigmatism or keratoconus who are using such therapy may experience rapid advancement of the ocular disorder. Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist and temporary or permanent cessation of wear considered.
Connective Tissue Disease: The use of estrogen/progestogen combinations in some women has been associated with positive lupus erythematous cell tests and with clinical lupus erythematous. In some instances exacerbation of rheumatoid arthritis and synovitis has been observed.
Breasts: Although estrogen/progestogen-combination use has not been shown to increase the risk of developing breast cancer, particular attention should be paid to women who have an immediate family history of this disease and are therefore more prone to its development. Careful monitoring is mandatory because, if a breast cancer should develop, estrogen-containing drugs may cause a rapid progression if the malignancy is hormone-dependent.
Special judgment should be used in prescribing such medications for women with fibrocystic disease of the breast.
Women receiving such medications should be instructed in self-examination of their breasts. Their physicians should be notified whenever any masses are detected.
Vaginal Bleeding: Persistent irregular vaginal bleeding requires special diagnostic judgment to exclude the possibility of pregnancy or neoplasm.
Fibroids: Patients with fibroids (leiomyomata) should be carefully observed. Sudden enlargement, pain or tenderness requires discontinuance of medication.
Age: In general, women in the later reproductive years gradually assume an increasing risk of circulatory and metabolic complications which becomes more prominent at 35 years of age, In view of this, closer observation, shorter duration of estrogen/progestogen combination use and avoidance of cigarette smoking is advisable. Alternatively, adoption of other means of therapy should be considered for this age group. Estrogen/progestogen combinations may mask the onset of climacteric.
Emotional Disorders: Patients with a history of emotional disturbances, especially the depressive type, are more prone to have a recurrence of depression while taking estrogen/progestogen combinations, In cases of a serious recurrence, a trial of an alternate method of therapy should be made which may help to clarify the possible relationship.
Laboratory Tests: Results of laboratory tests should be interpreted in light of the fact that the patient is taking estrogen/progestogen therapy. The laboratory tests listed as follows are modified.
Liver function tests: Aspartate serum transaminase (AST): variously reported elevations. Alkaline phosphatase and gamma glutamine transaminase (GGT): slightly elevated.
Coagulation tests: Minimal elevation of test values reported for such parameters as Factors VII, VIII, IX and X.
Thyroid function tests: Protein binding of thyroxine is increased as indicated by increased total serum thyroxine concentrations and decreased T3 resin uptake.
Lipoproteins: Small changes of unproven clinical significance may occur in lipoprotein cholesterol fractions.
Gonadotropins: LH and FSH levels are suppressed by the use of estrogen/progestogen therapy. Wait 2 weeks after discontinuing the use of estrogen/progestogen therapy before measurements are made.
Tissue Specimens: Pathologists should be advised of estrogen/progestogen therapy when specimens obtained from surgical procedures are submitted for examination.
Return to Fertility: After discontinuing therapy, the patient should delay pregnancy until at least 1 normal menstrual cycle has occurred. The patient should be instructed to use a non-hormonal method of contraception during this time period.
Amenorrhea: Women having a history of oligomenorrhea, secondary amenorrhea, or irregular cycles may remain anovulatory or become amenorrheic following estrogen/progestogen combination therapy. Amenorrhea, especially if associated with breast secretion that continues for 6 months or more after withdrawal warrants a careful assessment of hypothalamic-pituitary function.
Thromboembolic Complications-Post-surgery: Retrospective studies have reported an increased risk of post-surgery thromboembolic complications In estrogen/progestogen-combination users. If feasible, such drugs should be discontinued at least 1 month prior to elective major surgery. Medication should not be resumed until at least 2 weeks after hospital discharge following surgery.
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