Biomedical subjects

M C Nahata

Publications and source records attributed to M C Nahata.

At least 19 recordsLinked to original sources

PubMed2004

Pharmacokinetics of gabapentin in paediatric patients with uncontrolled seizures.

PURPOSE: The pharmacokinetics of gabapentin in paediatric patients with uncontrolled seizures was studied. METHODS: Thirteen paediatric patients (mean age: 9.4 years) with uncontrolled partial seizures were included. Patients received gabapentin orally until doses were individualized to 9.6-39.8 mg/kg/day. Blood samples were obtained just prior to the dose and over 8 h after gabapentin was administered in the fasting state. The plasma concentration of gabapentin was measured by a high-performance liquid chromatography assay. Pharmacokinetic parameters for gabapentin were determined by non-compartment methods using multivariate regression analysis. RESULTS: Data from nine patients were suitable for pharmacokinetic analysis. The C(max) from 0.9 to 5.8 microg/mL (mean: 2.6 +/- 1.7 microg/mL) and T(max) from 0.5 to 2.0 h (mean: 1.6 +/- 1.0 h). The apparent clearance (Cl/F) ranged from 0.12 to 1.12 L/h/kg (mean: 0.50 +/- 0.29 L/h/kg), and the elimination half-life from 3.2 to 12.2 h (mean: 5.5 +/- 0.8 h). Five patients experienced moderate (n = 4) to severe (n = 1) aggressive behaviour and another gained weight on gabapentin. CONCLUSIONS: Our data suggests that gabapentin pharmacokinetics can vary substantially among paediatric patients. Gabapentin was well tolerated in patients with uncontrolled partial seizures up to 6 months of therapy.

Adolescent↗

PubMed2001

Efficacy and safety of aerosolized tobramycin in cystic fibrosis.

Aerosolized tobramycin has been extensively used in cystic fibrosis (CF) patients in order to directly deliver the antibiotic to the endobronchial site of infection, and decrease toxicity by limiting systemic absorption. Aerosolized tobramycin doses ranging from 80 mg twice or three times daily to 600 mg three times daily have been used in various clinical trials. At an 80-mg dose, preservation of pulmonary function with little or no improvement over the baseline was reported. Tobramycin, nebulized at 600 mg three times daily, significantly improved clinical and pulmonary functions and reduced the density of Pseudomonas aeruginosa in the sputum. No ototoxicity or nephrotoxicity was reported at either dose. TOBI, a tobramycin solution for inhalation, received Food and Drug Administration approval for maintenance treatment of P. aeruginosa lung infections in CF patients at least 6 years of age. Patients received TOBI nebulize 300 mg of tobramycin every 12 hr daily for 28 days, followed by 28 days off the drug in alternating cycles. In phase III trials, TOBI improved pulmonary function and decreased sputum density of P. aeruginosa compared to placebo. Serum creatinine was minimally, transiently elevated in both groups. More patients in the TOBI group reported voice alterations. All reports of tinnitus were in the TOBI group. An increased risk of emergence of resistant strains of P. aeruginosa was noted at all doses, after prolonged use.

Administration, Inhalation↗

PubMed2001

Gastrostomy tube placement in nonadherent HIV-infected children.

OBJECTIVE: To determine the benefits of gastrostomy tube (G-tube) placement in HIV-infected children receiving highly active antiretroviral therapy (HAART). METHODS: Children who had a G-tube placed due to medication adminsitration difficulties were followed to determine changes in medication adherence and changes in laboratory parameters. Medication adherence and laboratory parameters were reviewed for three months prior to G-tube placement and then were followed for six months after G-tube placement. Viral RNA and CD4+ counts were assessed between the two time periods. Medication adherence was followed by review of pharmacy refill records and pill counts. Parents were surveyed about their opinion regarding the G-tube placement and medication administration in their children. RESULTS: Six children had G-tubes placed due to medication administration difficulties. The G-tube was tolerated in all six cases, although one child developed a staphylococcal infection 13 months after G-tube placement. Before G-tube placement, the medication adherence to HAART averaged 47% +/- 20% SD, with a range of 15-90%. After G-tube placement, medication adherence improved to 90-100%. All parents were satisfied with the G-tube and all reported shorter medication administration times and fewer behavioral problems. Five of six patients had at least a 2-log10 decrease in viral load, and CD4+ percentages improved by an average of 6.4%. CONCLUSIONS: G-tubes were well tolerated by HIV-infected children. Although G-tube placement is not needed in most children with HIV, it may provide an option for parents and children where administration of antiretroviral medication poses extreme difficulty and all other avenues have been exhausted.

Anti-HIV Agents↗

PubMed2001

Safety of intravenous bolus administration of gentamicin in pediatric patients.

OBJECTIVE: To determine the safety of gentamicin administered intravenously as a bolus. METHODS: All patients (n = 123, ages: up to 18y, 121; 21y, 1; 31y, 1) who received gentamicin intravenously as a bolus over a four-month period were studied retrospectively. Patient demographics, type of infection, dosing regimen, length of therapy, peak and trough serum concentrations, blood urea nitrogen, serum creatinine, and urine output were reviewed. Patients were stratified into four groups and data analyzed statistically. RESULTS: Mean initial dose (5.32 +/- 2.38 mg/kg/d) was consistent with established guidelines for age and kidney development, with subsequent adjustments based on serum concentrations. Susceptible organisms were eradicated with a mean length of therapy of 6.9 +/- 6.9 days (range 1-35). Patients received a median of nine doses: 42% received doses every eight hours and 33% received doses every 24 hours. No relationship between dosing and abnormal serum creatinine were found (p = 0.69). The estimated cost savings mainly from less nursing time and lower equipment and supply use were $50/patient with bolus administration of gentamicin. CONCLUSIONS: Intravenous bolus administration was safe in pediatric patients and was associated with lower costs.

Adolescent↗

PubMed2001

Publication of clinical drug trials.

Clinical drug trials are the best means for establishing the efficacy and safety of drug therapy. Peer-reviewed publications are the most efficient and reliable means for wide dissemination of the results. The investigators and industry have an obligation to publish the data obtained from these trials so that patients may receive the most effective treatment in the safest possible way.

Authorship↗

PubMed2001

The safety and antiviral effect of protease inhibitors in children.

STUDY OBJECTIVE: To determine the safety and antiviral effect of protease inhibitors (PIs) over 36 months in pediatric patients infected with the human immunodeficiency virus (HIV). DESIGN: Observational study SETTING: Pediatric immunodeficiency clinic. PATIENTS: Twenty-one children. INTERVENTION: Demographics, dosage regimens, genotype data, viral RNA and CD4+ lymphocyte counts, adverse drug events (ADEs), laboratory tests, and compliance were evaluated over 3 years. Data were analyzed by chi2, repeated measures analysis of variance, and paired t tests. MEASUREMENTS AND MAIN RESULTS: Twenty-one pediatric patients (aged 3 mo-15 yrs) received PIs over the study period. Average daily doses were ritonavir 26 mg/kg in 12 patients, nelfinavir 94 mg/kg in 16, indinavir 49 mg/kg in 5, and saquinavir 43 mg/kg in 4. Five patients developed resistance to an existing PI. Overall compliance was 70%. Baseline HIV-1 RNA plasma concentrations were significantly higher than average follow-up concentrations during 3-36 months in patients taking ritonavir (p<0.001) and nelfinavir (p<0.001). Sample size was insufficient for indinavir or saquinavir. Sixty ADEs occurred, diarrhea being most common. Of patients with ADEs, 55% required increased monitoring and 43% treatment. Ritonavir was associated with the most ADEs (28), followed by nelfinavir (16), indinavir (11), and saquinavir (5). Significant increases between baseline and follow-up cholesterol levels were found with ritonavir (p=0.02) and nelfinavir (p=0.001), and for serum creatinine (p=0.02) and triglycerides (p=0.02) with ritonavir. Follow-up triglycerides were significantly higher than baseline for indinavir (p=0.003). CONCLUSION: Nelfinavir and ritonavir were effective in decreasing HIV-1 viral loads and improving CD4+ lymphocyte counts. Ritonavir was associated with more ADEs than other PIs. Changes in cholesterol, serum creatinine, and triglycerides were noted with some PIs.

Adolescent↗

PubMed2001

Periorbital cellulitis secondary to Conidiobolus incongruus.

A previously healthy, 18-month-old girl developed edema and erythema around her left eye 1 week after getting sand in that eye. The patient did not respond to oral or intravenous antibiotics. A mass developed around the eye, and biopsy revealed Conidiobolus incongruus. The patient failed to respond to amphotericin B 1 mg/kg, and susceptibility tests indicated multiantifungal resistance. A combination of antifungal therapy, hyperbaric oxygen, and surgery was required for successful treatment. Three months after treatment the child was disease free. There is no definitive therapy for Conidiobolus incongruus infections, although various drugs have been administered with some success. When susceptibility tests determine multidrug resistance, radical resection with antifungal chemotherapy and hyperbaric oxygen may be necessary as well as lifesaving.

Amphotericin B↗

PubMed2000

Stability of propylthiouracil in extemporaneously prepared oral suspensions at 4 and 25 degrees C.

The stability of propylthiouracil in two extemporaneously prepared suspensions at 4 and 25 degrees C was studied. Commercially available 50-mg propylthiouracil tablets were used to prepare suspensions in 1:1 Ora-Sweet:Ora-Plus and in 1:1 1% methylcellulose:Simple Syrup, NF, to yield a propylthiouracil concentration of 5 mg/mL. Each suspension was stored in 10 amber plastic prescription bottles, 5 of them at 4 degrees C and the other 5 at 25 degrees C. Three samples were taken from each bottle at 0, 7, 14, 28, 42, 56, 70, and 91 days for assay by stability-indicating high-performance liquid chromatography. More than 90% of the initial propylthiouracil concentration was retained in both suspensions for 70 days at 25 degrees C and for 91 days at 4 degrees C. There were no changes in physical appearance, color, or odor, and the pH remained essentially unchanged. Propylthiouracil 5 mg/mL in two extemporaneously prepared oral suspensions was stable for at least 70 days at 25 degrees C and for at least 91 days at 4 degrees C.

Antithyroid Agents↗

PubMed2000

Pharmacotherapy of acute sinusitis in children.

The pharmacotherapeutic options for acute sinusitis in children are reviewed. Acute sinusitis occurs more frequently in children than in adults. The diagnosis is based primarily on clinical signs and symptoms. Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis are the organisms most frequently implicated. A variety of antimicrobials have FDA-approved labeling for use in the treatment of sinusitis. In randomized, controlled clinical trials identified in a MEDLINE search for the period from 1966 to 1999, amoxicillin had efficacy similar to that of amoxicillin-clavulanate, azithromycin, cefuroxime, and clarithromycin in treating acute sinusitis in children. Azithromycin was effective as a three-day course of treatment. Amoxicillin and cefuroxime are better tolerated than most antibiotics; azithromycin and clarithromycin are also well tolerated. Amoxicillin-clavulanate tends to cause more gastrointestinal symptoms than amoxicillin and is more expensive. Azithromycin is more expensive than amoxicillin but less expensive than other broad-spectrum antimicrobials. Amoxicillin remains the drug of first choice for treating acute sinusitis in children. It has been found to be as effective as other broad-spectrum agents, better tolerated, and less expensive.

Acute Disease↗

PubMed2000

Respiratory syncytial virus (RSV) immune globulin and palivizumab for prevention of RSV infection.

The efficacy, safety, administration, and advantages and disadvantages of respiratory syncytial virus (RSV) immune globulin and palivizumab for preventing RSV infection are discussed. Prevention of RSV infection has attracted considerable attention because of its dinical and economic impact. Studies have shown respiratory syncytial virus immune globulin intravenous (RSV-IGIV) and palivizumab to be effective in decreasing the number of hospitalizations and hospital days attributable to RSV. The number of intensive-care-unit admissions and the severity of RSV infection in high-risk children decreased with the use of these agents. Both agents have been well tolerated, with few adverse effects; however, their high cost necessitates strict guidelines on use. The patient populations at greatest risk are those with bronchopulmonary dysplasia, those with congenital heart disease, those with a history of apnea or respiratory arrest, immunocompromised patients, those with pulmonary consolidation on chest radiography, and those born prematurely. American Academy of Pediatrics guidelines do not preferentially recommend use of either agent; each has advantages and disadvantages. Prophylactic therapy with RSV-IGIV or palivizumab may reduce the likelihood of RSV infection in high-risk patients.

Antibodies, Monoclonal↗

PubMed2000

Comparative palatability of 22 liquid antacids.

OBJECTIVE: To compare the palatability, acid neutralizing capability, and costs of different antacids. METHODS: Volunteers between the ages of 18 and 60 years were given 22 antacids. All antacids were given during a 4-h period in two groups of 11 antacids each. Subjects sampled each antacid in a manner similar to wine tasting and rated each antacid on its smell, taste, texture and aftertaste using a scale of 1-9; 1 being the worst and 9 the best. RESULTS: A total of 73 adults completed the study. Mylanta Lemon Twist and Mylanta Cherry Crème were the most palatable antacids; however, overall the palatability of all the antacids was poor. Maalox MS Cool Mint and ES Gaviscon were the least palatable. The extra strength antacids had the most acid neutralizing capability, and thus would require smaller doses. Amphogel was the most costly antacid per mEq of acid neutralized. Age and gender did not affect the palatability scores. CONCLUSION: Although the regular strengths of Mylanta Lemon Twist and Mylanta Cherry Crème were the most palatable, the extra strength versions of these products have twice the acid neutralizing capability and thus, half the volume is required for each dose. Therefore, these agents may be the antacids of choice.

Adolescent↗

PubMed2000

Pharmacotherapy of lower limb diabetic ulcers.

OBJECTIVE: To discuss the pathophysiology, microbiology, and pharmacotherapy of lower extremity (LE) diabetic ulcers. DATA SOURCES: A MEDLINE search from 1966 to April 1999 was conducted. The search was limited to humans and English-language journals. Key search words included "diabetic ulcer," "fluoroquinolones," "beta-lactam," "hyperbaric oxygen," "diabetes mellitus," "diabetic foot," and "growth factor." STUDY SELECTION: Randomized and nonrandomized studies were selected for review. Results of randomized, placebo-controlled studies were emphasized more than nonrandomized results. DATA SYNTHESIS: LE ulcers are a common cause of hospitalization, and cause significant morbidity and mortality. Staphylococcus aureus is the most common pathogen in non-limb-threatening infections; Gram-negative bacteria and anaerobes are most prevalent in limb-threatening and life-threatening infections. Oral antibiotic therapy may be used in non-limb-threatening infections, if adequate response is achieved in 24-48 hours; otherwise, intravenous antibiotics should be started. Intravenous antibiotics should be the initial therapy for limb-threatening or life- threatening ulcers. Antimicrobial therapy of at least 10-14 days has been effective in treating LE ulcers in the absence of osteomyelitis. Growth factors offer another treatment alternative, although only becaplermin is currently approved for diabetic ulcers. CONCLUSION: Antibiotic therapy has been effective for the treatment of LE diabetic ulcers. However, further studies are required to identify optimal antibiotics and dosage regimens. Growth factors may have a role but additional research is needed to determine when best to initiate this therapy.

Aged↗

PubMed2000

Clinical use of fluoroquinolones in children.

OBJECTIVE: To review the pharmacokinetics, efficacy, and safety of fluoroquinolones in children. DATA SOURCES: A MEDLINE search (January 1966-March 1998) was conducted for relevant literature. STUDY SELECTION AND DATA EXTRACTION: Data from compassionate use and published studies were reviewed for the assessment of pharmacokinetics, efficacy, and safety of fluoroquinolones in children. DATA SYNTHESIS: Fluoroquinolones have a broad spectrum coverage of gram-positive and gram-negative bacteria, including Pseudomonas aeruginosa and intracellular organisms. Fluoroquinolones are well absorbed from the gastrointestinal tract, have excellent tissue penetration, low protein binding, and long elimination half-lives. These antibiotics are effective in treating various infections and are well tolerated in adults. However, the use of fluoroquinolones in children has been restricted due to potential cartilage damage that occurred in research with immature animals. Fluoroquinolones have been used in children on a compassionate basis. Ciprofloxacin is the most frequently used fluoroquinolone in children, most often in the treatment of pulmonary infection in cystic fibrosis as well as salmonellosis and shigellosis. Other uses include chronic suppurative otitis media, meningitis, septicemia, and urinary tract infection. Safety data of fluoroquinolones in children appear to be similar to those in adults. Fluoroquinolones are associated with tendinitis and reversible arthralgia in adults and children. However, direct association between fluoroquinolones and arthropathy remains uncertain. CONCLUSIONS: Fluoroquinolones have been found to be effective in treating certain infections in children. Additional research is needed to define the optimal dosage regimens in pediatric patients. Although fluoroquinolones appear to be well tolerated, further investigations are needed to determine the risk of arthropathy in children. However, their use in children should not be withheld when the benefits outweigh the risks.

Animals↗

PubMed2000

Aerosolized furosemide in the treatment of acute respiratory distress and possible bronchopulmonary dysplasia in preterm neonates.

OBJECTIVE: To review the efficacy and safety of inhaled furosemide in the treatment of acute respiratory distress and possible bronchopulmonary dysplasia (BPD) in preterm neonates receiving ventilator and oxygen support. DATA SOURCES: A MEDLINE search was performed from January 1966 to December 1998 using the key words inhaled or aerosolized furosemide, BPD, preterm, neonate, and infant newborn. STUDY SELECTION AND DATA EXTRACTION: All clinical trials involving the use of inhaled furosemide in ventilator- and oxygen-dependent preterm neonates with acute respiratory distress and possible BPD were evaluated. DATA SYNTHESIS: Inhaled furosemide 1 and 2 mg/kg has improved pulmonary function in preterm neonates without significant adverse effects. However, only a single dose of inhaled furosemide was used in these trials, and pulmonary functions were monitored for only two or four hours after administration. CONCLUSIONS: Inhaled furosemide may be effective, but studies are needed to determine the optimal dosage regimen and long-term risks and benefits of its use in these patients.

Administration, Inhalation↗

PubMed2000

Treatment of listeriosis.

OBJECTIVE: To review the most currently accepted treatment options for the treatment of listeriosis. DATA SOURCES: Clinical literature was accessed through MEDLINE (1966-October 1999). Key search terms included Listeria monocytogenes, food-borne illness, penicillins, fluoroquinolones, cephalosporins, and vancomycin. DATA SYNTHESIS: Listeriosis is mainly a food-borne illness caused by L. monocytogenes; people most prone to the disease are pregnant women, newborns, elderly, and those with HIV or other diseases compromising immunity. Listeria infections are associated with a high mortality rate, and thus effective antibiotic treatment is essential. Although a variety of antibiotics have activity against the organism, ampicillin alone or in combination with gentamicin remains the treatment of choice. Some patients may require alternative therapies due to allergies or certain disease states. Second-line agents for these cases include trimethoprim/sulfamethoxazole, erythromycin, vancomycin, and the fluoroquinolones. Cephalosporins are not active against Listeria. CONCLUSIONS: Ampicillin is currently the drug of choice for treating L. monocytogenes infections. Many antibiotics have been shown to be effective and are used as second-line agents. However, further study is required for some of the most recently introduced antibiotics, such as the fluoroquinolones, to determine their place in the treatment of Listeria infections.

Anti-Bacterial Agents↗

PubMed2000

Syncope associated with concurrent amitriptyline and fluconazole therapy.

OBJECTIVE: To report on a 12-year-old white male with prostatic rhabdomyosarcoma who experienced episodes of syncope attributed to concurrent amitriptyline and fluconazole therapy, confirmed by readministration. CASE REPORT: The patient began experiencing syncopal episodes periodically over a seven-month period. These repeated episodes occurred when fluconazole was administered for periodic mucositis secondary to chemotherapy. The patient had received fluconazole in the past with no difficulty and had been receiving a stable dose of amitriptyline for neuropathic pain. On discontinuation of amitriptyline, no further episodes were noted. DISCUSSION: Concurrent administration of fluconazole with amitriptyline likely resulted in the decreased metabolism of amitriptytine. Three case reports presented in the literature of adults receiving concurrent amitriptyline and fluconazole have shown an increase in serum amitriptyline concentrations with concurrent administration of fluconazole; however, none of these patients were rechallenged. Literature available on amitriptyline overdose confirms that syncope and the adverse events noted in the case studies may result from elevated amitriptyline plasma concentrations. CONCLUSIONS: The consistent presentation of syncope in our patient during readministration of amitriptytine and fluconazole strongly suggests a drug-drug interaction.

Amitriptyline↗

PubMed2000

Duration of penicillin prophylaxis in sickle cell anemia: issues and controversies.

Functional asplenia occurs in 94% of patients with homozygous sickle cell anemia by 5 years of age and may result in fatal septicemia due to encapsulated microorganisms such as Streptococcus pneumoniae. Penicillin prophylaxis in these patients significantly reduces the risk of septicemia; however, continuation of prophylaxis beyond 5 years of age is controversial, since the risk of developing septicemia is reduced after this age and prolonged prophylaxis may lead to emergence of penicillin resistance. Although reports of penicillin-resistant pneumococci in patients receiving penicillin prophylaxis are conflicting, the prevalence of these organisms in the general population in North America increased from 5% in 1989 to more than 35% in 1997. Discontinuation of prophylaxis after age 5 years may be recommended because of lack of benefit, difficulty maintaining compliance, reduced risk of developing pneumococcal bacteremia after that age, and increase in prevalence of penicillin-resistant pneumococci worldwide.

Anemia, Sickle Cell↗

PubMed2000

Acute hepatitis and bleeding possibly induced by zidovudine and ritonavir in an infant with HIV infection.

Acute hepatitis led to abnormal coagulopathy, bleeding, and death in a nonhemophiliac infant infected with the human immunodeficiency virus, possibly due to zidovudine or ritonavir or both. Acute hepatitis during ritonavir treatment and episodes of spontaneous bleeding have been reported in patients with hemophilia. Zidovudine is associated with elevated liver enzymes, elevated bilirubin, and hepatomegaly leading to abnormal coagulopathy, bleeding, and death in adults. A temporal relationship between the start of combination antiretroviral therapy and onset of hepatosplenomegaly and rise in liver enzymes suggests that zidovudine or ritonavir, or both, are the likely cause of this adverse event. Ritonavir is believed to cause direct hepatotoxicity, probably by inducing acute mitochondrial toxicity, and may hasten reverse transcriptase inhibitor-induced liver toxicity. Liver function of patients receiving a combination of nucleoside reverse transcriptase inhibitor and protease inhibitors should be closely monitored.

Acute Disease↗