Dosage regimens

The nurse gives the patient and family an explanation of the prescribed drug and dosage regimen, as well as situations that should be avoided. The nurse develops a teaching plan to include one or more of the following items of information ... 

Educating the Patient and Family The nurse reviews the dosage regimen and possible adverse drug reactions with the patient. The following points are included in the patient teaching plan ... 

The patient demonstrates knowledge of treatment and dosage regimen, adverse drug reactions, risks of treatment, and importance of complying with the primary health care provider s recommendations. 

The patient verbalizes an understanding of Hie dosage regimen and Hie importance of conHnued follow-up care. 

Name and description of the investigational product(s). A summary of findings from non-clinical sfudies and from clinioal trials that is relevant to the trial. Summary of the known and potential risks and benefits, if any, to human subjects. Description of and justification for the route of administration, dosage, dosage regimen, and treatment period(s). A statement that the trial will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s). Description of the population to be studied. References to literature and data that are relevant to the trial, and that provide background for the trial... 

Type of Study Study Location of Objective(s) Identifier Study Report of the Study Study Design and Type of Control Test Product(s) Dosage Regimen Route of Administration Number of Subjects Healthy Subjects or Diagnosis of Patients Duration of Treatment Study Status Type of Report... 

Efficacy Supplement = submissions for such changes as a new indication or dosage regimen for an approved product, a comparative efficacy claim naming another product, or a significant alteration in the patient population e.g., prescription to Over-The-Counter switch ... 

New dosage regimen for the original product approved 8 years after approval of the original product. 

The new dosage regimen may not be approved until 11 years after the original product was approved (i.e. 8 + 3). 

In an attempt to simulate in rats the dosage regimen commonly employed by abusers of amphetamines, METH was administered (10 or 15 mg/kg every 6 hours four to six doses), after which the animals were killed (Koda and Gibb 1971 Koda and Gibb 1973). TH activity and catecholamine con-eentrations were measured in various brain regions and in the adrenal. Neostriatal TH aetivity was depressed in a dose-dependent manner and reaehed its nadir at 36 hours. Dopamine (DA) and norepinephrine concentrations were initially elevated, but then deereased in parallel with TH aetivity. Adrenal TH aetivity was elevated, presumably because of stress assoeiated with the toxie doses of METH. 

What would have been an appropriate gentamicin dosage regimen that would have avoided elevated plasma concentrations ... 

TABLE 53-7. Dosage Regimens and Cost of Prescription Agents for Osteoporosis... 

TABLE 56-1. Dosage Regimens for Acute Gout and Antihyperuricemic Treatment... 

Clinicians should be aware that dosage regimens with the same drug maybe different depending on the infectious process. For example, ciprofloxacin, a fluoroquinolone, has various dosage regimens based on site of infection. The dosing for uncomplicated UTIs is 250 mg twice daily for 3 days. For complicated UTIs, the dose is 500 mg twice daily for 7 to... 

L. Z. Benet, Input factors as determinants of drug activity route, dose, dosage regimen, and the drug delivery system, in Principles and Techniques of Human Research and Therapeutics, Vol. 3, (F. G. McMahon, Ed.), Futura, New York, 1974, pp. 9-23. 

Within the medical community it has been acknowledged that elderly patients often respond to drug therapy differently from their younger counterparts. Aside from alteration of various pharmacokinetic and pharmacodynamic processes, elderly patients tend to suffer from a number of chronic conditions and, thus, have more complex dosage regimens. Additionally, a variety of physical limitations prevalent among the elderly may hinder their ability to self-administer medication. 

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