INDICATION

ORTHO TRI-CYCLEN® LO Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

IMPORTANT SAFETY INFORMATION

Boxed WARNING

Cigarette smoking increases the risk of serious cardiovascular side effects from hormonal contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use hormonal contraception, including ORTHO TRI-CYCLEN® LO Tablets are strongly advised not to smoke.

Contraindications

Thrombophlebitis or thromboembolic disorders, history of deep vein thrombophlebitis or thromboembolic disorders, cerebral vascular or coronary artery disease (current or past), valvular heart disease with complications, severe hypertension, diabetes with vascular involvement, headaches with focal neurological symptoms, major surgery with prolonged immobilization, known or suspected carcinoma of the breast or history of breast cancer, carcinoma of the endometrium or other estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, cholestatic jaundice of pregnancy or jaundice with prior pill use, hepatic adenomas or carcinomas, known or suspected pregnancy (Category X), or hypersensitivity to ORTHO TRI-CYCLEN® LO Tablets

ORTHO TRI-CYCLEN® LO is not indicated for use in emergency contraception, adolescents who have not reached menarche, or in women over 65 years of age.

Warnings and Precautions

Thromboembolic disorders and other vascular problems

The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia and gallbladder disease; the risk of serious morbidity and mortality is very small in healthy women without underlying risk factors. The risk increases significantly in the presence of underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes.

Carcinoma of the reproductive organs and breasts: Slight increased risk of breast cancer and increased risk of cervical intraepithelial neoplasia.

Hepatic neoplasia: Rare incidence of benign hepatic adenomas; rupture may cause death through intra-abdominal hemorrhage.

Ocular lesions: Reports of retinal thrombosis associated with oral contraceptive use. Discontinue and institute appropriate diagnostic and therapeutic measures immediately in the event of unexplained partial or complete loss of vision.

Carbohydrate effects: Decreases glucose tolerance, directly related to estrogen dose; monitor prediabetic and diabetic women.

Headache: Discontinue in the event of onset or exacerbation of migraine or development of a new pattern in headaches which is recurrent, persistent or severe.

Bleeding irregularities

• Evaluate non-hormonal causes and rule out malignancy or pregnancy in the event of breakthrough bleeding or spotting and abnormal vaginal bleeding Rule out pregnancy in the event of amenorrhea
• Ectopic pregnancy: Ectopic pregnancy may occur.

Lipid disorders: Some progesterones may elevate LDL levels.

Liver function: Discontinue if jaundice occurs.

Fluid retention: May cause fluid retention; prescribe with caution and monitor in patients with conditions that might be aggravated by fluid retention.

Emotional disorders: Monitor if used in women with history of depression; discontinue if depression recurs.

Contact lenses: Visual changes or changes in lens tolerance should be assessed by an ophthalmologist.

Nursing mothers: advise not to use oral contraceptives.

Drug Interactions

• Changes in contraceptive effectiveness may result in pregnancy or breakthrough bleeding when coadministered with antibiotics, anticonvulsants, other drugs that increase the metabolism of contraceptive steroids, bosentan and herbal products containing St. John's Wort. Significant increases and decreases in plasma levels of estrogen and progestin have been reported with coadministered anti-HIV protease inhibitors; refer to package insert of individual anti-HIV protease inhibitors for further information
• Increase in plasma ethinyl estradiol levels when coadministered with atorvastin, ascorbic acid, acetaminophen. CYP 3A4 inhibitors may increase plasma hormone levels
• Increase in plasma levels of coadministered cyclosporine, prednisolone and theophylline
• Decreased plasma concentrations of coadministered acetaminophen and Iamotrigine (may reduce seizure control, dosage adjust Iamotrigine if necessary)
• Increased clearance of co administered temezepam, salicyclic acid, morphine and clofibric acid

Adverse Reactions

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:

Nausea, vomiting, gastrointestinal symptoms (such as abdominal cramps and bloating), breakthrough bleeding, spotting, change in menstrual flow, amenorrhea, temporary infertility after discontinuation of treatment, edema, melasma which may persist, breast changes including tenderness, enlargement, and secretion, change in weight (increase or decrease), change in cervical erosion and secretion, diminution in lactation when given immediately postpartum, cholestatic jaundice, migraine, allergic reaction, including rash, urticaria, and angioedema, mental depression, reduced tolerance to carbohydrates, vaginal candidiasis, change in corneal curvature (steepening), intolerance to contact lenses, mesenteric thrombosis, retinal thrombosis

The Pill does not protect against HIV or sexually transmitted diseases.

Please click here for full Prescribing Information, including Boxed Warning.

ELMIRON® is a weak anticoagulant (blood thinner) which may increase bleeding. Among the most common adverse reactions are alopecia, diarrhea, and nausea. Please see full Important Safety Information below.

IMPORTANT SAFETY INFORMATION

• Contraindications: ELMIRON® is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients
• Anticoagulant Activity: ELMIRON® is a weak anticoagulant (blood thinner) which may increase bleeding. Patients undergoing invasive surgery or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to anticoagulant therapy or high doses of anti-inflammatory drugs) should be evaluated for the risk of hemorrhage
• Alopecia: In clinical trials of ELMIRON®, alopecia began within the first 4 weeks of treatment. Ninety-seven percent (97%) of the cases of alopecia reported were alopecia areata, limited to a single area on the scalp
• Use in Pregnancy: ELMIRON® is a Pregnancy Category B drug
• Most Common Adverse Reactions (frequency 1% to 4%): Alopecia (4%), diarrhea (4%), nausea (4%), headache (3%), rash (3%), dyspepsia (2%), abdominal pain (2%), liver function abnormalities (1%), dizziness (1%)