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Diclac 75 mg pro rel tabs diclofenac (vials) 200 mg ibuprofen, diclofenac Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis A prospective study in 507 rats determined that diclofenac and indomethacin were mutagenic in a dose-response fashion dose-dependent manner (Liu and Shimojo, 2006). Based on in vitro studies using Ames and in vivo studies using Sprague-Dawley rats, diclofenac has been shown to cause chromosome aberrations, chromosomal translocations and breakage (Konstantinova et al., 1993). In a cell culture system, diclofenac, indomethacin and aspirin were reported to cause chromosomal breaks and rearrangement (Kotkin, 1994). No studies were reported to indicate that diclofenac or indomethacin are genotoxic. Mutagenesis Lack of studies could not be determined for indomethacin; it is suspected but currently unclassified that this is the case. Diclofenac, indomethacin and aspirin have been reported to cause chromosomal breaks and translocations (Kotkin, 1994; Kotkin Kotkin, Koob, 1994). Based on in vitro studies using Ames and in vivo studies using Sprague-Dawley rats, diclofenac and indomethacin best drugstore eye cream for dry skin have been reported to cause chromosomal breaks and translocation (Kotkin, 1994; Kotkin Kotkin, Koob, 1994). In a cell culture system, diclofenac, indomethacin and aspirin were reported to cause chromosomal breaks and translocation (Kotkin, 1994; Kotkin Kotkin, Koob, 1994). No studies were reported to indicate that diclofenac or indomethacin are genotoxic. Impairment of Fertility In a study mice, diclofenac was reported to have no effect on fertility (Kotkin, 1994; Kotkin and Kotkin, 1994) Pregnancy Category C Risk Summary Teratogenic Effects The Diclac 200 Capsules 100mg $334 - $1.67 Per pill use of products has not been evaluated for teratogenic effects. Labor and Delivery Diclofenac is indicated for the treatment of osteoarthritis knee. There is no information that these products are associated with teratogenicity or increased incidence of teratoma formation during labor. Neonatal Effects Studies have not been conducted to assess the effect of use products on the health of neonates. Animal studies have shown an increase in placental weight and an increase in placental weight at birth (Kojima et al., 2008). Nursing Mothers Safety and efficacy in breast-feeding neonates have not been established. Pediatric Use Safety and efficacy in pediatric patients with arthritis have not been established. Geriatric Use Safety and efficacy in geriatric patients with osteoarthritis have not been established. ADVERSE REACTIONS Common adverse reactions include: gastrointestinal discomfort (numerous), abdominal pain constipation, nausea/vomiting, asthenia, headache, abdominal discomfort, vomiting and diarrhea. Psychiatric Events In clinical trials, anxiety and depression are commonly reported; however, anxiety and depression are reported infrequently in clinical trials (Nurses' Health Study, 2002), and clinical trials of the preventive use products have not indicated a relationship between the use of these substances and increased incidence of anxiety, depression or both (Gottlieb et al., 2007). The most common adverse reactions associated with the use of these products are headache, nausea, vomiting, indigestion and diarrhea (Nurses' Health Study, 2002; Kotkin and Kotkin, 1994). Other Adverse Reactions Common adverse reactions associated with the use of products are asthenia (numerous), urinary tract infection diarrhea muscle or joint pain and swelling (numerous) (Gottlieb, 2007). TIMING The time course of adverse events following the use of therapeutic doses each the products is summarized in Table 2, which the therapeutic exposure (TEC) is defined as the shortest period of time for which the risk-benefit ratio was evaluated. Table 2: Summary of TECs the Prescribed Products in Treatment of Arthritis Adverse Event Dose of Product

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