Pharmaceutical Insert Evaluation, Article Review Example

Zithromax is a drug used to treat bacterial infections.  The active ingredient, azithromycin, is derived from erythromycin.  Zithromax can be administered in tablets or oral suspension.  Tablets contain azithromycin dehydrate equivalent to either 250 mg or 500 mg.  Oral suspensions contain azithromycin dehydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg of azithromycin. Azithromycin is contraindicated with certain types of pneumonia, cystic fibrosis, nosocomially acquired infections, bacteremia, immunodeficiency, functional asplenia, hypersensitivity to azithromycin or other macrolides, cholestatic jaundice, and hepatic dysfunction.  Side effects are usually gastrointestinal, but may also effect the cardiovascular system, genitourinary tract, have neurological impacts, or severe allergic and dermatologic reactions.  When tested on adult males, Zithromax’s effective dose is 500 mg.  The bioavailability of one 250 mg tablet is 38%.  Fasting adult males were administered two 250 mg tablets were the first day, followed by one 250 mg tablet the second through fifth days.  Zithromax reached its maximum healing potential at 41µg/mL after 2.5 hours on the first day.  On day five, Zithromax reached its maximum healing potential at 0.4µg/mL after 3.2 hours.  Azithromycin is distributed throughout the body at a “steady-state volume” of 31.1 L/kg.   In adults with mild to moderate renal impairment and severe renal impairment, the administration of a single 1,000 mg tablet increases the maximum healing potential by 5.1% and 61%, respectively.  Geriatric males have the same effective dose of Zithromax as young adults; geriatric women have a higher effective dose by 30-50 %.  The effective dose for the oral suspension of azithromycin is 10 mg/kg in patients ages one to five, and five to fifteen.  The maximum healing potential for pediatric patients ages one through five was 0.216 µg/mL after 1.9 hours, and 0.383 µg/mL after 2.4 hours for patients ages five through fifteen.

Pulmicort Respules is a medication used to treat mild to moderate asthma in children ages twelve months to eight years.  It contains the corticosteroid budesonide, and is administered in a sterile suspension using a jet nebulizer, or “inhaler.”  Pulmicort Respules is available in two dosages, 0.25 mg and 0.5 mg/2 mL.  The amount of medication delivered to the lungs depends on the patient, the jet nebulizer, and the compressor performance.  If the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system is used, the average dose delivered is 17% at a mean flow rate of 5.5 L/min, and the mean nebulization time was less than five minutes.  For asthmatic children of the ages four to six years, the terminal half-life of budesonide after nebulization is 2.3 hours, and the systemic clearance is 0.5 L/min; this is 50% greater than in adults.  The effective dose of budesonide in children ages four to six years is 1 mg by nebulization, and the effective dose in adults is a single 2 mg dose by nebulization.  The total absolute bioavailability following the administration of the Pulmicort Respules medicine with a jet nebulizer was approximately 6% of the labeled dose.  The peak plasma concentration of budesonide occurred 10-30 minutes after start of nebulization.  The volume of distribution at steady-state of budesonide was 3 L/kg, approximately the same as in healthy adults.  Patient with reduced liver function or hepato-pathology should not take Pulmicort Respules, as the elimination of corticosteroids is impaired.  Pulmicort Respules usually begins to improve asthma symptoms within two to eight days of initiation of treatment, although maximum benefit from the medication may not be achieved for at least four to six weeks.