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ORTHO TRI-CYCLEN^® LO (norgestimate/ethinyl estradiol) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as their method of contraception.

IMPORTANT SAFETY INFORMATION
Serious as well as minor side effects have been reported with the use of oral contraceptives. Serious risks include blood clots, stroke and heart attacks. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35. Women who use oral contraceptives are strongly advised not to smoke. The Pill does not protect against HIV or sexually transmitted diseases.

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

ORTHO EVRA^® (norelgestromin/ethinyl estradiol transdermal system) is indicated for the prevention of pregnancy in women who elect to use a transdermal patch as a method of contraception.

The pharmacokinetic profile for ORTHO EVRA^® transdermal patch is different from that of an oral contraceptive. Healthcare professionals should balance the higher estrogen exposure and possible increased risk of venous thromboembolism with ORTHO EVRA^® against the chance of pregnancy if a contraceptive pill is not taken daily.

Application site reaction has been reported.

IMPORTANT SAFETY INFORMATION
Serious as well as minor side effects have been reported with the use of hormonal contraceptives. Serious risks include blood clots, stroke and heart attacks. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35. Women who use the contraceptive patch are strongly advised not to smoke.

The pharmacokinetic (PK) profile for the ORTHO EVRA^® patch is different from the PK profile for oral contraceptives in that it has higher steady state concentrations (60% higher) and lower peak concentrations (25% lower) of ethinyl estradiol (EE) compared with an oral contraceptive containing 35 mcg EE. It is not known whether there are changes in the risk of serious adverse events based on the differences in PK profiles of EE in women using ORTHO EVRA compared with women using oral contraceptives containing 35 mcg EE. Increased estrogen exposure may increase the risk of adverse events, including venous thromboembolism. (See CLINICAL PHARMACOLOGY, Transdermal versus Oral Contraceptives, BOLDED WARNING in the Package Insert).

The results of epidemiologic studies evaluating the risk of venous thromboembolism (VTE) among women using ORTHO EVRA^® compared to those using oral contraceptives containing 30-35 mcg EE and either levonorgestrel or norgestimate reported odds ratios ranging from 0.9 (no increase in risk) to 2.5 (approximate doubling of risk).

The Patch 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%)

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This information is intended for the use of our customers, patients, and healthcare professionals in the United States and Puerto Rico only. Ortho Women's Health & Urology™ recognizes that the Internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The prescribing information included here may not be appropriate for use outside the United States and Puerto Rico.

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Last modified Aug 31 2009 at 12:29:51 EDT