Clinical Pharmacology Test

Question: You are treating a 2 day old 37 week gestational age infant who is currently receiving IV fluids of D10W with 200 mg/100mL of calcium gluconate running at 140ml/kg/day. The infant has just been diagnosed with disseminated gonococcal infection and the physician is aware of two therapies for gonococcal infections. The physician would like you to design a complete treatment plan and support your decision with the evidence for the agent you used and evidence against the agent you didn't use. Please provide a researched, well-developed answer.

Answer: Current treatment with calcium gluconate at a dosage of ; 140ml/kg/day, should continue via sterile IV administration, as this dosage form will not interact negatively with any proposed therapy, within the scope of this report. Additional therapy will include the use of anti-microbial drugs, which must be diluted with sterile-Water for Injection (WFI) prior to administration. IV - administration of 125 mg ceftriaxone (125 mg), should be diluted to a concentration of 40mg and administered once daily concomitantly with the current therapy of gluconate. A recommended daily allowance for calcium gluconate via IV therapy must be limited to 3 to 4 mEq/kg/day. The infant must be monitored for adverse effects related to hyper-/hypokalemia. Dosing should occur at increments of 60 to 100 mg/kg/dose, and repeated every 10 minutes until the maximum has been reached. The to the fact that the infant is only 2 weeks old, it is recommend that intervals between dosing are doubled (x2) continuous infusion is avoided. A therapy, which considers the application of this effective drug, will ensure that any possible pharyngeal infections are targeted and eliminated. Dosing for this drug should consider the age of the infant. In the event that the infant responds with any adverse event, this drug must be discontinued. Support from clinical trials indicates a high-level of safety in pediatric patients. However, an identical therapy, which will ensure elimination of any possible rectal, urogenital infections, in addition to pharyngeal infections, should be considered using Olofaxin 400mg. Dosing should not exceed 400mg daily for this patient and the drug should be administered in continuous regiments, daily without exceeding. Interventions with additional therapies should not occur to generate concomitant drug dosing. This drug has been proven effective against anti-microbial resistant strains of N. gonorrhea.

Treatment Option #2

A separate option, which utilizes traditional application of penicillin, may occur. The infant may undergo penicillin treatment prior to having a more serious regimen, which is presented in option #1. A comparison of penicillin in patients indicates that the blockbuster anti-microbial drugs; specinomycin and cefuroxime are effective however penicillin remains competitive in analysis of variance (ANOVA) studies. At this point obtaining a culture of sputum or tissue from the two-week-old patient should occur, in a non-invasive manner. A tissue culture should be assessed in order to identify the particular strain of bacteria. If the strain reacts positively against penicillin treatment. The drug may be administered intravenously to the patient, once a day. A dosage form, which is intravenous, should be administered. It is not probable for the patient to receive an oral dosage form of any drug due to their inability to swallow at the infant age. Drug product for penicillin should not be administered concomitantly. The drug may be administered approximately four (4) hours prior to the administration of any other drug products, or after. For systemic diseases children less than 12 years of age should not exceed 25mg/kg/day. Dosing should be divided throughout the patient’s daily routine at intervals of 6-8 hours. Consideration may not apply to the drug administered with additional therapies. However, the maximum dose should me 3g per day. The delivery should be via prophylaxis.

Multiple therapies exist for treatment of this two (2) week old patient. Consideration must be given to ensure that no oral dosage form is administered to the patient. The proper route for administration of any anti-microbial agent should be intravenous. The dosage form should also be diluted to meet the specific needs of the patient. Culture of the bacteria should occur prior to the execution of any treatment in order to assess the particular strain of the bacteria, as it is present. In the event that the strain appears to interact positively with the specifications of penicillin in treatment #2, penicillin, the patient should consider this treatment first. The historical safety data indicates that penicillin would be the safest alternative to any current microbial agents. In the event that therapies are ineffective with penicillin, treatment #1 should be considered.


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