Loading…
PORTIA is a brand name for Levonorgestrel, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Ophthalmologic. The risk of arterial thrombotic and thromboembolic event is further increased in women with underlying risk factors. Examples of risk factors for arterial thrombotic and thromboembolic events are smoking hypertension, hyperlipidemias, obesity and increasing age.
Caution must be exercised when prescribing COCs for women with risk factors for arterial thrombotic and thromboembolic events. Hepatic/Biliary/Pancreatic Hepatic Function PORTIA is contraindicated in patients with active liver disease or abnormal liver function testing (see CONTRAINDICATIONS and DRUG INTERACTIONS: Drug-Laboratory Test Interactions).
Acute or chronic disturbances of liver function necessitate the discontinuation of COC use until markers of liver function return to normal. Hepatocellular injury has been reported with COC use. Early identification of drug-related hepatocellular injury can decrease the severity of hepatotoxicity when the drug is discontinued.
If hepatocellular injury is diagnosed, patients should stop their COC, use a non- hormonal form of contraception and consult their doctor. Hepatitis C During clinical trials with patients treated for HCV infections with the combination of ombitasvir, paritaprevir, ritonavir and dasabuvir with or without ribavirin, it was found that transaminase (ALT) elevations higher than 5 times the upper limit of normal (ULN) were significantly more frequent in women using ethinyl estradiol-containing medications such as COCs.
Therefore PORTIA 21 and PORTIA 28 are contraindicated in hepatitis C patients during treatment with these drugs (see CONTRAINDICATIONS and DRUG INTERACTIONS). Gallbladder Disease For women with symptomatic gall bladder disease, consideration should be given to whether the benefits of COCs outweigh the risks.
COC use these patients may worsen existing disease. Jaundice Patients who have had jaundice, should be given oral contraceptives only with great care and under close observation. Oral contraceptive-related cholestasis has been described in women with a history of pregnancy-related cholestasis.
Women with a history of cholestasis may have the condition recur with subsequent hormonal contraceptive use, and in this instance, PORTIA should be discontinued. The development of severe generalized pruritus or icterus requires that the medication be withdrawn until the problem is resolved.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Levonorgestrel in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Page 10 of 52 If a patient develops jaundice that proves to be cholestatic in type, the use of oral contraceptives should not be resumed. In patients taking hormonal contraceptives, changes in the composition of the bile may occur and an increased incidence of gallstones has been reported.
Hepatic Nodules Hepatic nodules (adenoma and focal nodular hyperplasia) have been reported, particularly in long-term users of oral contraceptives. Although these lesions are extremely rare, 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.
Pancreatic Function Please see WARNINGS AND PRECAUTIONS:
Endocrine and Metabolism: Lipid and Other Metabolic Effects. Immune Angioedema Exogenous estrogens may induce or exacerbate symptoms of angioedema, in particular in women with hereditary angioedema. Neurologic Migraine and Headache The onset or exacerbation of migraine or the development of headache of a new pattern that is recurrent, persistent or severe, requires discontinuation of COCs and evaluation of the cause.
(see CONTRAINDICATIONS) Women with migraine headaches who take oral contraceptives may be at increased risk of stroke. (see CONTRAINDICATIONS) Ophthalmologic Patients who are pregnant or are taking oral contraceptives may experience corneal edema that may cause visual disturbances and changes in tolerance to contact lenses, especially of the rigid type.
Soft contact lenses usually do not cause disturbances. If visual changes or alterations in tolerance to contact lenses occur, temporary or permanent cessation of wear may be advised. With use of oral contraceptives there have been reports of retinal vascular thrombosis which may lead to partial or complete loss of vision.
If there are signs or symptoms such as visual changes, onset of proptosis or diplopia, papilledema, or retinal vascular lesions, the oral contraceptives should be discontinued and the cause immediately evaluated. Peri-Operative Considerations Thromboembolic Complications – Post-surgery There is an increased risk of thromboembolic complications in oral contraceptive users after major Page 11 of 52 surgery.
If feasible, oral contraceptives should be discontinued and an alternative method substituted at least one month prior to major elective surgery and during periods of prolonged immobilization. Oral contraceptive use should not be resumed for at least two weeks after major elective surgery, and only after the first menstrual period has occurred following hospital discharge.
Psychiatric Patients with a history of emotional disturbances, especially the depressive type, may be more prone to have a recurrence of depression while taking oral contraceptives. Women with a history of depression who use oral contraceptives should be carefully observed and the drug discontinued if depression recurs to a serious degree.
Patients becoming significantly depressed while taking oral contraceptives should stop the medication and use an alternate method of contraception in an attempt to determine whether the symptom is drug-related. Women with premenstrual syndrome (PMS) may have a varied response to oral contraceptives, ranging from symptomatic improvement to worsening of the condition.
Renal Fluid Retention Hormonal contraceptives may cause some degree of fluid retention. Sexual Function/Reproduction Return to Fertility After discontinuing oral contraceptives therapy, the patient should delay pregnancy until at least one normal spontaneous menstrual cycle has occurred in order to date […]