Product Monograph PrCEFTIN® PrCEFTIN® - GlaxoSmithKline

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POSTMARKETING EXPERIENCE WITH CEFTIN ® PRODUCTS In addition to adverse events reported during clinical trials, the following events have been identified during clinical practice in patients treated with CEFTIN ® Tablets or with CEFTIN ® for Oral Suspension and were reported spontaneously. Data are generally insufficient to allow an estimate of incidence or to establish causation. General: The following hypersensitivity reactions have been reported: anaphylaxis, angioedema, pruritus, rash, serum sickness-like reaction, urticaria. Gastrointestinal: Pseudomembranous colitis (see WARNINGS). Hematologic: thrombocytopenia, and leucopenia (sometimes profound). Hepatic: Jaundice (predominantly cholestatic) and hepatitis have been reported very rarely. Infections and Infestations Candida overgrowth. Neurologic: Seizure. Skin: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. Urologic: Renal dysfunction. Symptoms and Treatment of Overdosage For management of a suspected drug overdose, contact your regional Poison Control Centre. November 30, 2010 Page 10 of 43
Other than general supportive treatment, no specific antidote is known. Excessive serum levels of cefuroxime can be reduced by dialysis. For treatment of hypersensitive reactions, See WARNINGS. Dosage and Administration CEFTIN ® (cefuroxime axetil) may be given orally without regard to meals. Absorption is enhanced when CEFTIN ® is administered with food. In comparative bioavailability studies in healthy adults, CEFTIN ® suspension was not bioequivalent to CEFTIN ® tablets. The area under the curve for the suspension averaged 91% of that for the tablet, while the Cmax for the suspension averaged 71% of the Cmax of the tablets. CEFTIN ® suspension contains aspartame, which is a source of phenylalanine and so should be avoided in patients with phenylketonuria. (See WARNINGS) DOSAGE CEFTIN ® TABLETS Adults and Children 12 Years of Age and Older: The usual recommended dosage is 250 mg twice a day. However, dosage may be modified according to the type of infection present as indicated below: TYPE OF INFECTION DOSAGE pharyngitis, tonsillitis, sinusitis, bronchitis, skin structure infections 250 mg twice daily more severe infections eg. pneumonia 500 mg twice daily uncomplicated gonorrhea 1000 mg single dose November 30, 2010 Page 11 of 43
Page 1 and 2: GlaxoSmithKline Inc. 7333 Mississau
Page 3 and 4: This binding results in inhibition
Page 5 and 6: experienced anaphylactic reaction t
Page 7 and 8: Repeated evaluation of the patient'
Page 9: Adverse Reactions The following adv
Page 13 and 14: Pharyngitis and Tonsillitis Infecti
Page 15 and 16: Composition TABLETS Each CEFTIN ®
Page 17 and 18: 3. INVERT the bottle and rock the b
Page 19 and 20: dependent on copper reduction such
Page 21 and 22: Do not mix CEFTIN ® for Oral Suspe
Page 23 and 24: 12. What is in Your Medicine TABLET
Page 25 and 26: Stability to Beta-Lactamases: Altho
Page 27 and 28: Table 4: Pharmacokinetics of cefuro
Page 29 and 30: As can be seen, cefuroxime axetil h
Page 31 and 32: Table 8: Subacute and Chronic Toxic
Page 33 and 34: Rat: 28-week study Rats in the 0.1
Page 35 and 36: In the high-dose (1.6 g/kg/day) gro
Page 37 and 38: In vitro assays Cefuroxime axetil w
Page 39 and 40: There was no evidence that cefuroxi
Page 41 and 42: 13. Fass RJ, Helsel VL: In vitro ac
Page 43: 40. Slevin NJ, Aitken J, Thornley P

Product Monograph PrCEFTIN® PrCEFTIN® - GlaxoSmithKline

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