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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.

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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.

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ELMIRON^® (pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.

Important Safety Information
Pentosan polysulfate sodium is a weak anticoagulant which may increase bleeding. Patients undergoing surgery or who have an increased risk of bleeding should be evaluated for the risk of hemorrhage.

In an 8-year retrospective study, adverse events tended to be infrequent, mild, and transient. Diarrhea, nausea, alopecia (reversible upon discontinuation), headache, rash, dyspepsia, abdominal pain, liver function abnormalities, and dizziness occurred at a frequency of 1% to 4%.

In a 32 week study, 6.3% of 128 patients reported rectal hemorrhage. The severity was described as "mild" in most patients.

ELMIRON^® is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.

The mechanism of action of ELMIRON^® in interstitial cystitis is not fully understood.

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ELMIRON^® is a registered trademark of IVAX Research, Inc., under licence to Ortho-McNeil-Janssen Pharmaceuticals, Inc.

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Last modified August 31, 2009