Aims: To assess efficacy and safety of omeprazole in laryngitis due to laryngopharyngeal reflux d... more Aims: To assess efficacy and safety of omeprazole in laryngitis due to laryngopharyngeal reflux disease (LPRD). Materials and methods: It was a prospective, randomized, open label study conducted in 90 patients with laryngitis due to LPRD. Group A (n = 45) received omeprazole and advice about life style modification, group B (n = 45) received only advice about life style modification. Reflux symptom index (RSI), reflux finding score (RFS), quality of life (QoL) and voice handicap index (VHI) were evaluated at 0, 4 and 8 weeks. Results: Percentage reduction in RSI and RFS was signi ficantly higher in group A after 8 weeks (37 vs 29%, 18 vs 13% respec tively). Excess throat mucus, clearing of throat and erythema of posterior larynx improved considerably in group A compared to group B. Conclusion: Omeprazole could be a significant addition to life style modification in LPRD patients particularly for signs and symptoms, such as excess throat mucus, clearing of throat and erythema of posterior larynx.
European Journal of Drug Metabolism and Pharmacokinetics, 2015
3,3&a... more 3,3' Diseleno dipropionic acid (DSePA), a synthetic compound has been shown to have radioprotective activity, especially as a lung radioprotector. In this study, the pharmacokinetics and biodistribution of DSePA in MX-1 tumour bearing SCID mice were evaluated. Twenty SCID mice were administered DSePA (50 mg/kg bodyweight) by oral gavage following which four animals each were sacrificed at 15, 30 min, 1, 2 and 4 h. Blood and tissue samples were collected for determination of DSePA concentration by graphite furnace atomic absorption spectrometry (GFAAS) method. The control group (n = 4) was administered sterile water and sacrificed at 4 h. Peak plasma concentration (C max) of 2.7 µg/ml was observed at 15 min which returned to near baseline (baseline = 0.6 µg/ml) at 1 h following drug administration. Biphasic pharmacokinetics characterized by rapid distribution phase and a slower elimination phase were observed. Highest maximal concentration (C max) of the drug was observed in lung (19.2 µg/g at 30 min) followed by intestine (14.64 µg/g at 15 min) and kidney (12.96 µg/g at 15 min). There was negligible uptake in tumor tissue and no uptake in brain. DSePA has a favorable pharmacokinetic profile which makes it a potentially good candidate for further development as a radioprotective agent.
Laryngopharyngeal reflux disease is the most common laryngeal complains encountered by ENT
surge... more Laryngopharyngeal reflux disease is the most common laryngeal complains encountered by ENT surgeon in outpatient department. This disease is commonly confused with gastroesophageal reflux disease, but it has different pathogenesis than gastroesophageal reflux disease. The mucosa of pharynx and larynx is very sensitive to gastric contents especially digestive enzymes. Management of this condition includes pharmacological and non-pharmacological interventions. Proton pump inhibitors are commonly given for this condition. There are no guidelines for the use of these drugs in this condition. However, recent randomized trials have raised the question of its efficacy in reflux laryngitis. In this review, we will discuss the pathophysiology of laryngopharyngeal reflux disease and the role of proton pump inhibitors in laryngopharyngeal reflux disease.
Background: Pemetrexed-platinum doublet therapy is a standard treatment for stage IIIb/IV nonsqua... more Background: Pemetrexed-platinum doublet therapy is a standard treatment for stage IIIb/IV nonsquamous non small cell lung cancer (NSCLC). While the regimen is associated with several grade $3 toxicities, hyponatremia is not a commonly reported adverse effect. Here we report an unusually high incidence of grade $3 hyponatremia in Indian patients receiving pemetrexed-platinum doublet, and the pharmacological basis for this phenomenon. Methods: Forty-six patients with advanced NSCLC were enrolled for a bioequivalence study of two pemetrexed formulations. All patients received the pemetrexed-platinum doublet for six cycles followed by single-agent pemetrexed maintenance until progression. Pharmacokinetic blood samples were collected at predefined time points during the first cycle and the concentration-time profile of pemetrexed was investigated by noncompartmental analysis. Hyponatremic episodes were investigated with serum electrolytes, serum osmolality, urinary sodium, and urine osmolality. Results: Sixteen of 46 patients (35%) had at least one episode of grade $3 hyponatremia. Twenty-four episodes of grade $3 hyponatremia were observed in 200 cycles of doublet chemotherapy. Plasma exposure to pemetrexed was significantly higher in patients with high-grade hyponatremia than in those with low-grade or no hyponatremia (P=0.063 and P=0.001, respectively). Pemetrexed clearance in high-grade hyponatremia was quite low compared with normal and low-grade hyponatremia (P=0.001 and P=0.055, respectively). Median pemetrexed exposure in this cohort was much higher than that reported in the literature from Western studies. Conclusion: Higher exposure to pemetrexed is associated with grade $3 hyponatremia. The pharmacogenetic basis for higher exposure to pemetrexed in Indian patients needs further investigation. Keywords: non small cell lung carcinoma, platinum compounds, pharmacokinetics, pharmacogenetics
Background: Drugs can be use for prophylaxis, diagnosis or therapy of disease and are associated ... more Background: Drugs can be use for prophylaxis, diagnosis or therapy of disease and are associated with the risk of producing undesirable / harmful effects, which are known as adverse drug reactions (ADRs). Cutaneous adverse drug reactions (CADRs) are among the most frequent ADRs. In daily clinical practice, almost all physicians come across many instances of suspected CADRs in different forms. The safety of medicines is an essential part of patient safety. ADR could be monitored through active monitoring or through voluntary reporting system in a hospital set-up. Methods: A prospective study was undertaken over a six months period in the patients visiting dermatology in a tertiary care teaching hospital. Patients reporting with cutaneous symptoms were evaluated for any suspected drug related cause. Patients with confirmed drug related cutaneous adverse drug reaction (CADR) were included. To record the details of CADRs, the adverse drug reaction (ADR) form of CDSCO was used. Severity of ADR and outcomes were noted. Causality was assessed using causality assessment scale as per World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria and assessment of severity was done using Modified Hartwig and Siegel scale. Results: During the study period, 51 cases of CADRs were studied. Maximum CADRs was seen with antimicrobials (54.90%), followed by nonsteroidal anti-inflammatory drugs (19.61%). Maculopapular rash was the most common cutaneous manifestation of ADRs (72.55%), followed by urticaria/angioedema (17.65%). The severity of ADRs were mild in 27(52.94%) and moderate in 24(47.06%) and all of them recovered completely. No lethal effects were observed. Conclusion: Common occurrence of cutaneous adverse drug reaction was maculopapular rash and the commonest group of drug associated was found to be antimicrobials. The severity of cutaneous adverse drug reaction was mostly mild.
Aims: To assess efficacy and safety of omeprazole in laryngitis due to laryngopharyngeal reflux d... more Aims: To assess efficacy and safety of omeprazole in laryngitis due to laryngopharyngeal reflux disease (LPRD). Materials and methods: It was a prospective, randomized, open label study conducted in 90 patients with laryngitis due to LPRD. Group A (n = 45) received omeprazole and advice about life style modification, group B (n = 45) received only advice about life style modification. Reflux symptom index (RSI), reflux finding score (RFS), quality of life (QoL) and voice handicap index (VHI) were evaluated at 0, 4 and 8 weeks. Results: Percentage reduction in RSI and RFS was signi ficantly higher in group A after 8 weeks (37 vs 29%, 18 vs 13% respec tively). Excess throat mucus, clearing of throat and erythema of posterior larynx improved considerably in group A compared to group B. Conclusion: Omeprazole could be a significant addition to life style modification in LPRD patients particularly for signs and symptoms, such as excess throat mucus, clearing of throat and erythema of posterior larynx.
European Journal of Drug Metabolism and Pharmacokinetics, 2015
3,3&a... more 3,3' Diseleno dipropionic acid (DSePA), a synthetic compound has been shown to have radioprotective activity, especially as a lung radioprotector. In this study, the pharmacokinetics and biodistribution of DSePA in MX-1 tumour bearing SCID mice were evaluated. Twenty SCID mice were administered DSePA (50 mg/kg bodyweight) by oral gavage following which four animals each were sacrificed at 15, 30 min, 1, 2 and 4 h. Blood and tissue samples were collected for determination of DSePA concentration by graphite furnace atomic absorption spectrometry (GFAAS) method. The control group (n = 4) was administered sterile water and sacrificed at 4 h. Peak plasma concentration (C max) of 2.7 µg/ml was observed at 15 min which returned to near baseline (baseline = 0.6 µg/ml) at 1 h following drug administration. Biphasic pharmacokinetics characterized by rapid distribution phase and a slower elimination phase were observed. Highest maximal concentration (C max) of the drug was observed in lung (19.2 µg/g at 30 min) followed by intestine (14.64 µg/g at 15 min) and kidney (12.96 µg/g at 15 min). There was negligible uptake in tumor tissue and no uptake in brain. DSePA has a favorable pharmacokinetic profile which makes it a potentially good candidate for further development as a radioprotective agent.
Laryngopharyngeal reflux disease is the most common laryngeal complains encountered by ENT
surge... more Laryngopharyngeal reflux disease is the most common laryngeal complains encountered by ENT surgeon in outpatient department. This disease is commonly confused with gastroesophageal reflux disease, but it has different pathogenesis than gastroesophageal reflux disease. The mucosa of pharynx and larynx is very sensitive to gastric contents especially digestive enzymes. Management of this condition includes pharmacological and non-pharmacological interventions. Proton pump inhibitors are commonly given for this condition. There are no guidelines for the use of these drugs in this condition. However, recent randomized trials have raised the question of its efficacy in reflux laryngitis. In this review, we will discuss the pathophysiology of laryngopharyngeal reflux disease and the role of proton pump inhibitors in laryngopharyngeal reflux disease.
Background: Pemetrexed-platinum doublet therapy is a standard treatment for stage IIIb/IV nonsqua... more Background: Pemetrexed-platinum doublet therapy is a standard treatment for stage IIIb/IV nonsquamous non small cell lung cancer (NSCLC). While the regimen is associated with several grade $3 toxicities, hyponatremia is not a commonly reported adverse effect. Here we report an unusually high incidence of grade $3 hyponatremia in Indian patients receiving pemetrexed-platinum doublet, and the pharmacological basis for this phenomenon. Methods: Forty-six patients with advanced NSCLC were enrolled for a bioequivalence study of two pemetrexed formulations. All patients received the pemetrexed-platinum doublet for six cycles followed by single-agent pemetrexed maintenance until progression. Pharmacokinetic blood samples were collected at predefined time points during the first cycle and the concentration-time profile of pemetrexed was investigated by noncompartmental analysis. Hyponatremic episodes were investigated with serum electrolytes, serum osmolality, urinary sodium, and urine osmolality. Results: Sixteen of 46 patients (35%) had at least one episode of grade $3 hyponatremia. Twenty-four episodes of grade $3 hyponatremia were observed in 200 cycles of doublet chemotherapy. Plasma exposure to pemetrexed was significantly higher in patients with high-grade hyponatremia than in those with low-grade or no hyponatremia (P=0.063 and P=0.001, respectively). Pemetrexed clearance in high-grade hyponatremia was quite low compared with normal and low-grade hyponatremia (P=0.001 and P=0.055, respectively). Median pemetrexed exposure in this cohort was much higher than that reported in the literature from Western studies. Conclusion: Higher exposure to pemetrexed is associated with grade $3 hyponatremia. The pharmacogenetic basis for higher exposure to pemetrexed in Indian patients needs further investigation. Keywords: non small cell lung carcinoma, platinum compounds, pharmacokinetics, pharmacogenetics
Background: Drugs can be use for prophylaxis, diagnosis or therapy of disease and are associated ... more Background: Drugs can be use for prophylaxis, diagnosis or therapy of disease and are associated with the risk of producing undesirable / harmful effects, which are known as adverse drug reactions (ADRs). Cutaneous adverse drug reactions (CADRs) are among the most frequent ADRs. In daily clinical practice, almost all physicians come across many instances of suspected CADRs in different forms. The safety of medicines is an essential part of patient safety. ADR could be monitored through active monitoring or through voluntary reporting system in a hospital set-up. Methods: A prospective study was undertaken over a six months period in the patients visiting dermatology in a tertiary care teaching hospital. Patients reporting with cutaneous symptoms were evaluated for any suspected drug related cause. Patients with confirmed drug related cutaneous adverse drug reaction (CADR) were included. To record the details of CADRs, the adverse drug reaction (ADR) form of CDSCO was used. Severity of ADR and outcomes were noted. Causality was assessed using causality assessment scale as per World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria and assessment of severity was done using Modified Hartwig and Siegel scale. Results: During the study period, 51 cases of CADRs were studied. Maximum CADRs was seen with antimicrobials (54.90%), followed by nonsteroidal anti-inflammatory drugs (19.61%). Maculopapular rash was the most common cutaneous manifestation of ADRs (72.55%), followed by urticaria/angioedema (17.65%). The severity of ADRs were mild in 27(52.94%) and moderate in 24(47.06%) and all of them recovered completely. No lethal effects were observed. Conclusion: Common occurrence of cutaneous adverse drug reaction was maculopapular rash and the commonest group of drug associated was found to be antimicrobials. The severity of cutaneous adverse drug reaction was mostly mild.
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surgeon in outpatient department. This disease is commonly confused with gastroesophageal reflux
disease, but it has different pathogenesis than gastroesophageal reflux disease. The mucosa of pharynx
and larynx is very sensitive to gastric contents especially digestive enzymes. Management of this
condition includes pharmacological and non-pharmacological interventions. Proton pump inhibitors are
commonly given for this condition. There are no guidelines for the use of these drugs in this condition.
However, recent randomized trials have raised the question of its efficacy in reflux laryngitis. In this
review, we will discuss the pathophysiology of laryngopharyngeal reflux disease and the role of proton
pump inhibitors in laryngopharyngeal reflux disease.
Methods: Forty-six patients with advanced NSCLC were enrolled for a bioequivalence study of two pemetrexed formulations. All patients received the pemetrexed-platinum doublet for six cycles followed by single-agent pemetrexed maintenance until progression. Pharmacokinetic blood samples were collected at predefined time points during the first cycle and the concentration-time profile of pemetrexed was investigated by noncompartmental analysis. Hyponatremic episodes were investigated with serum electrolytes, serum osmolality, urinary sodium, and urine osmolality.
Results: Sixteen of 46 patients (35%) had at least one episode of grade $3 hyponatremia. Twenty-four episodes of grade $3 hyponatremia were observed in 200 cycles of doublet chemotherapy. Plasma exposure to pemetrexed was significantly higher in patients with high-grade hyponatremia than in those with low-grade or no hyponatremia (P=0.063 and P=0.001, respectively). Pemetrexed clearance in high-grade hyponatremia was quite low compared with normal and low-grade hyponatremia (P=0.001 and P=0.055, respectively). Median pemetrexed exposure in this cohort was much higher than that reported in the literature from Western studies.
Conclusion: Higher exposure to pemetrexed is associated with grade $3 hyponatremia. The pharmacogenetic basis for higher exposure to pemetrexed in Indian patients needs further investigation.
Keywords: non small cell lung carcinoma, platinum compounds, pharmacokinetics, pharmacogenetics
Methods: A prospective study was undertaken over a six months period in the patients visiting dermatology in a tertiary care teaching hospital. Patients reporting with cutaneous symptoms were evaluated for any suspected drug related cause. Patients with confirmed drug related cutaneous adverse drug reaction (CADR) were included. To record the details of CADRs, the adverse drug reaction (ADR) form of CDSCO was used. Severity of ADR and outcomes were noted. Causality was assessed using causality assessment scale as per World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria and assessment of severity was done using Modified Hartwig and Siegel scale.
Results: During the study period, 51 cases of CADRs were studied. Maximum CADRs was seen with antimicrobials (54.90%), followed by nonsteroidal anti-inflammatory drugs (19.61%). Maculopapular rash was the most common cutaneous manifestation of ADRs (72.55%), followed by urticaria/angioedema (17.65%). The severity of ADRs were mild in 27(52.94%) and moderate in 24(47.06%) and all of them recovered completely. No lethal effects were observed.
Conclusion: Common occurrence of cutaneous adverse drug reaction was maculopapular rash and the commonest group of drug associated was found to be antimicrobials. The severity of cutaneous adverse drug reaction was mostly mild.
surgeon in outpatient department. This disease is commonly confused with gastroesophageal reflux
disease, but it has different pathogenesis than gastroesophageal reflux disease. The mucosa of pharynx
and larynx is very sensitive to gastric contents especially digestive enzymes. Management of this
condition includes pharmacological and non-pharmacological interventions. Proton pump inhibitors are
commonly given for this condition. There are no guidelines for the use of these drugs in this condition.
However, recent randomized trials have raised the question of its efficacy in reflux laryngitis. In this
review, we will discuss the pathophysiology of laryngopharyngeal reflux disease and the role of proton
pump inhibitors in laryngopharyngeal reflux disease.
Methods: Forty-six patients with advanced NSCLC were enrolled for a bioequivalence study of two pemetrexed formulations. All patients received the pemetrexed-platinum doublet for six cycles followed by single-agent pemetrexed maintenance until progression. Pharmacokinetic blood samples were collected at predefined time points during the first cycle and the concentration-time profile of pemetrexed was investigated by noncompartmental analysis. Hyponatremic episodes were investigated with serum electrolytes, serum osmolality, urinary sodium, and urine osmolality.
Results: Sixteen of 46 patients (35%) had at least one episode of grade $3 hyponatremia. Twenty-four episodes of grade $3 hyponatremia were observed in 200 cycles of doublet chemotherapy. Plasma exposure to pemetrexed was significantly higher in patients with high-grade hyponatremia than in those with low-grade or no hyponatremia (P=0.063 and P=0.001, respectively). Pemetrexed clearance in high-grade hyponatremia was quite low compared with normal and low-grade hyponatremia (P=0.001 and P=0.055, respectively). Median pemetrexed exposure in this cohort was much higher than that reported in the literature from Western studies.
Conclusion: Higher exposure to pemetrexed is associated with grade $3 hyponatremia. The pharmacogenetic basis for higher exposure to pemetrexed in Indian patients needs further investigation.
Keywords: non small cell lung carcinoma, platinum compounds, pharmacokinetics, pharmacogenetics
Methods: A prospective study was undertaken over a six months period in the patients visiting dermatology in a tertiary care teaching hospital. Patients reporting with cutaneous symptoms were evaluated for any suspected drug related cause. Patients with confirmed drug related cutaneous adverse drug reaction (CADR) were included. To record the details of CADRs, the adverse drug reaction (ADR) form of CDSCO was used. Severity of ADR and outcomes were noted. Causality was assessed using causality assessment scale as per World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria and assessment of severity was done using Modified Hartwig and Siegel scale.
Results: During the study period, 51 cases of CADRs were studied. Maximum CADRs was seen with antimicrobials (54.90%), followed by nonsteroidal anti-inflammatory drugs (19.61%). Maculopapular rash was the most common cutaneous manifestation of ADRs (72.55%), followed by urticaria/angioedema (17.65%). The severity of ADRs were mild in 27(52.94%) and moderate in 24(47.06%) and all of them recovered completely. No lethal effects were observed.
Conclusion: Common occurrence of cutaneous adverse drug reaction was maculopapular rash and the commonest group of drug associated was found to be antimicrobials. The severity of cutaneous adverse drug reaction was mostly mild.