| The adverse event profile of buprenorphine was also characterized in the dose-controlled study of buprenor-phine solution, over a range of doses in four months of treatment. Table 4 shows adverse events reported by at least 5% of subjects in any dose group in the dose-controlled study. Table 4. Adverse Events (³ 5%) by Body System and Treatment Group in a 16 �?week Study | Body System / Adverse Event (COSTART Technology ) | Buprenorphine Dose* | | Very Low* (N=18.4) | Low* (N=18.0) | Moderate* (N=18.6) | High* (N=18.1) | Total (N=73.1 | | N(%) | N(%) | N(%) | N(%) | N(%) | | Body as a whole | | Abscess | 9(5%) | 2(1%) | 3 (2%) | 2 (1%) | 16 (2%) | | Astheria | 26 (14%) | 28 (16%) | 26(14%) | 24(13%) | 104(14%) | | Chills | 11(6%) | 12(7%) | 9(5%) | 10(6%) | 42(6%) | | Fever | 7 (4%) | 2(1%) | 2(1%) | 10(6%) | 21(3%) | | Flu Syndrome | 4(2%) | 13(7%) | 19(10%) | 8(4%) | 44(6%) | | Headache | 51(28%) | 62(34%) | 54(29%) | 53(29%) | 220(30%) | | Infection | 32(17%) | 39(22%) | 38(20%) | 40(22%) | 149(20%) | | Injury Accidental | 5(3%) | 10(6%) | 5(3%) | 5(3%) | 25(3%) | | Pain | 47(26%) | 37(21%) | 49(26%) | 44(24%) | 177(24%) | | Pain Back | 18(10%) | 29(16%) | 28(15%) | 27(15%) | 102(14%) | | Withdrawal Syndrome | 45(24%) | 40(22%) | 41(22%) | 36(20%) | 162(22%) | | Digestive System | | Constipation | 10 (5%) | 23(13%) | 23(12%) | 26(14%) | 82(11%) | | Diarhea | 19(10%) | 8(4%) | 9(5%) | 4(2%) | 40(5%) | | Dyspepsia | 6(3%) | 10(6%) | 4(2%) | 4(2%) | 24(3%) | | Nausea | 12(7%) | 22(12%) | 23(12%) | 18(10%) | 75(10%) | | Vomiting | 8(4%) | 6(3%) | 10(5%) | 14(8%) | | | Nervous System | | Anxiety | 22(12%) | 24(13%) | 20(11%) | 25(14%) | 91(12%) | | Depression | 24(13%) | 16(9%) | 25(13%) | 18(10%) | 83(11%) | | Dizziness | 4(2%) | 9(5%) | 7(4%) | 11(6%) | 31(4%) | | Insomnia | 42(23%) | 50(28%) | 43(23%) | 51(28%) | 186(25%) | | Nervousress | 12(7%) | 11(6%) | 10(5%) | 13(7%) | 46(6%) | | Somnolence | 5(3%) | 13(7%) | 9(5%) | 11(6%) | 38(5%) | | Repiratory System | | Cough Increase | 5 (3%) | 11 (6%) | 6 (3%) | 4 (2%) | 26(4%) | | Pharyngitis | 6 (3%) | 7 (4%) | 6 (3%) | 9 (5%) | 28 (4%) | | Rhinitis | 27 (15%) | 16 (9%) | 15 (8%) | 21 (12%) | 79 (11%) | | Skin and Appendages | | Sweat | 23 (13%) | 21(12%) | 20 (11%) | 23 (13%) | 87(12%) | | Special Senses | | Runny Eyes | 13 (7%) | 9 (5%) | 6 (3%) | 6 (3%) | 34 (5%) | *Sublingual solution. Doses in this table cannot necessarily be delivered in tablet form, but for comparison purposes: "Very low" dose (1mg solution) would be less than a tablet dose of 2 mg
"Low" dose (4mg solution) approximates a 6 mg tablet dose
"Moderate" dose (8mg solution) approximates a 12 mg tablet dose
"High" dose (16mg solution) approximates a 24 mg tablet dose
DRUG ABUSE AND DEPENDENCE SUBOXONE and SUBUTEX are controlled as Schedule III narcotics under the Controlled Substances Act. Buprenorphine is a partial agonist at the mu-opioid receptor and chronic administration produces dependence of the opioid type, characterized by moderate withdrawal upon abrupt discontinuation or rapid taper. The withdrawal syndrome is milder than seen with full agonists, and may be delayed in onset (SEE WARNINGS ). Neonatal withdrawal has been reported in the infants of women treated with SUBUTEX during pregnancy (See PRECAUTIONS). SUBOXONE contains naloxone and if misused parenterally, is highly likely to produce marked and intense withdrawal symptoms in subjects dependent on other opioid agonists. DRUG INTERACTIONS Buprenorphine is metabolized to norbuprenorphine by cytochrome CYP 3A4. Because CYP 3A4 inhibitors may increase plasma concentrations of buprenorphine, patients already on CYP 3A4 inhibitors such as azole antifungals (e.g. ketoconazole), macrolide antibiotics (e.g. erythromycin), and HIV protease inhibitors (e.g. ritonavir, indi-navir and saquinavir) should have their dose of SUBUTEX or SUBOXONE adjusted. Based on anecdotal reports, there may be an interaction between buprenorphine and benzodiazepines. There have been a number of reports in the post-marketing experience of coma and death associated with the concomitant intravenous misuse of buprenorphine and benzodiazepines by addicts. In many of these cases, buprenorphine was misused by self-injection of crushed SUBUTEX tablets. SUBUTEX and SUBOXONE should be prescribed with caution to patients on benzodiazepines or other drugs that act on the central nervous system, regardless of whether these drugs are taken on the advice of a physician or are taken as drugs of abuse. Patients should be warned of the potential danger of the intravenous self-administration of benzodiazepines while under treatment with SUBOXONE or SUBUTEX. | 
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