Dosing regimen, changes

If chest pain persists, changes character, increases in severity, or is not relieved by following the recommended dosing regimen, seek prompt medical attention. 

The adjustment of dose and dosing regimen for children and the elderly needs a special consideration because of several differences as compared to an adult individual. The differences may be due to many factors which include changes in pharmacokinetic parameters, age, body weight, surface area, and genetic predisposition. The present chapter provides some basic explanation about their differences and the dosage calculations because of these differences. 

The steady-state maximum concentration (Cmaxss) after the administration of amikacin was 38 mcg/mL, and the steady-state minimum serum concentration was 10 mcg/mL. If the dosing regimen has to be changed, how should it be done ... 

Renal impairment Data in pediatric patients with impaired renal function are not available however, because cefepime pharmacokinetics are similar in adult and pediatric patients, changes in dosing regimen similar to those in adults are recommended for pediatric patients. 

None of the tested covariates was identified as having a clinically relevant impact on the PK of cetuximab. Thus, changes in dose or dosing regimen do not appear to be necessary in any of the subpopulations defined by these covariates. However, it should be noted that the majority of the studied patients had adequate hepatic and renal function. Overall, more than 90 % of the patients included in the PK database had normal hepatic function, more than 60% had normal renal function, and a further 32% had only mild impairment (creatinine clearance 50-80 mL/min). Hence, the effect of more severe renal or hepatic impairment on cetuximab PK remains to be elucidated. 

Dosing Regimen. An application for a new dosing regimen, such as a change from twice daily to once daily. 

Optimization and then selection of final formulations, doses, regimens, and efficacy endpoints for larger scale, multicenter studies. Efficacy endpoints should be able to be measured reliably and should quantitatively reflect clinically relevant changes in the disease or condition of interest. 

Figure 16 Changes to pharmacokinetic parameters over 13-week dosing regimen. (A) Maximum plasma concentration (Cmax) of DFP determined after single doses of 10, 30, or 100 mg/kg of DFP compared to the Cmax after 13 weeks of dosing. (B) AUC after a single dose of 10, 30, or 100 mg/kg of DFP compared with the Cmax after 13 weeks of dosing. Abbreviations DFP, [(5,5-dimethyl-3-(2-propoxy)-4-(4-methanesulfonylphenyl)-2(5//)-furanone)J AUC, area under the plasma concentrationtime curve. Source From Ref. 64.

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