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Dosing information in a standard drug reference: are pediatrics still therapeutically neglected?

Permala J, Hassali MA, Awaisu A, Shafie AA

Pediatr Int, 2010 Apr;52(2):290-5.
PMID: 19744224 DOI: 10.1111/j.1442-200X.2009.02958.x

BACKGROUND: In many countries, the most readily accessible drug information resources, such as the Monthly Index of Medical Specialties (MIMS), lack information concerning use in children. We reviewed the product information (PI) of medications in the most widely used drug information reference in Malaysia in an effort to determine the extent and the nature of available information related to pediatric dosing.
METHODS: The products listed in the 2007 Malaysian MIMS Annual were reviewed for PI on pediatric use as per inclusion and exclusion criteria. The dosing information for each PI was extracted according to age groups. Product information that claimed suitability for use in pediatrics was further evaluated for information on pediatric dosage formulations.
RESULTS: A total of 421 PI items from seven categories of therapeutic classes were reviewed. Of these, 69% gave inadequate pediatric dosing information. The proportions, for each age group of PI items that gave adequate pediatric dosing information were: neonates (13.1%), infants (23.3%), and children (32.2%). Therapeutic classes of drugs differed significantly in terms of dosing information adequacy for all pediatric age groups (P < 0.05). Most PI reviewed under all legal categories provided inadequate pediatric dosing information, but suitable pediatric formulations were commonly (70.1-85.5%) available where the dosing information existed. Overall, category B (prescription only) products did not differ significantly from category C (pharmacy only medicine) products in terms of pediatric dosing information adequacy, except for children.
CONCLUSION: This study has managed to contribute substantial additional information regarding the extent of pediatric dosing information and dosage formulations available in the MIMS Annual, stressing that the majority of PI for the products reviewed did not provide adequate dosing information for pediatric patients, subjecting this population to a therapeutically disadvantaged status.

Matched MeSH terms: Drug Dosage Calculations*
Optimal Antibiotic Dosage for Chronic Kidney Disease Patient: A Pharmacological Manual for Oral Clinicians

Chidambaram R

Recent Pat Antiinfect Drug Discov, 2015;10(2):113-23.
PMID: 26220069

Chronic kidney disease, (CKD) a gradual and inevitable deterioration in renal function, is the disease with the most associations in dentistry. Dosage adjustment is one amongst the vital elements to be familiar with during their oral care. CKD patients take extended duration to filter out medications, therefore dosage must always be tailored under the supervision of nephrologist. The relished benefits from antibiotic could transform as anti-microbial resistance on their abuse and nephrotoxic when contraindicated drugs are encouraged. New patented drug belonging to oxazoliodine group has driven the researchers to handle the emerging AMR. The present communication discusses the pharmacological factors influencing in prescribing the antibiotics for CKD patient from the dentist's point of view. The formulas destined for calculating the optimal dosage of antibiotics have been documented to aid oral physicians.

Matched MeSH terms: Drug Dosage Calculations*
Fulltext Knowledge and certainty about medication administration among nursing students in University Malaysia Sabah

Li Tsu Chong, Josephine Magdeline Joseph, Nur Atikah Binti Mohd Taib, Nurfirna Suzleyna Binti Mohd Salleh, Jennefer Henry

Malaysian Journal of Medicine and Health Sciences, 2020;16(105):46-0.
MyJurnal

Introduction: Medication error always happens among the nurses either the trained out staffs nor in nursing students. These errors may harm any patient that is involved and it may lead tolegislation issue. Therefore, this study aims to identify nursing students knowledge and assurance in medication administration. Methods: This study using a cross-sectional survey design using a convenience sampling method. Ethical approval was obtained from The Fac- ulty of Medicine and Health Sciences Ethical Committee. Adapted questionnaire divided into three sections with 14 multi-choice questions for each section (pharmacology, drug management and drug calculation) score (0-14) and Self perceived certainty on their correct answer were scored (1-high certainty, 2-moderate and 3-low certainty). Questionnaires were distributed through the online google form to Diploma of Nursing students of year two and three of Faculty Medicine and Health Science of University Malaysia Sabah. Result reported in mean (+SD). Results: Total of71 students volunteered responded to the survey. 42.3% of respondents (n=30) are the Year Two students and 57.7% (n=41) are the Year Three students.In knowledge about pharmacology mean score was 9.33 (2.37) and their certainty mean score was 1.9 (0.55), Drug management mean score was 8.42 (2.55) and their certainty mean score was 1.90 (0.45), While for their drug calculation mean score was 8.04 (3.03) and certainty mean score was
2.13 (0.51). Conclusion: Knowledge in drug management and drug calculation both were below the appropriate score (less than 9) respectively. These indicate that more practices and training on the medication administration should be done to the students in order familiar with the context of medication administration. Their certainty level found moderate indicate that their confidence level on medication administration should be reinforced. Nursing educators need to facilitate the students in their learning process and training periods to gain their confidence before their graduation.

Matched MeSH terms: Drug Dosage Calculations
Correlation of tumour response with starting tumour size and dose of tamoxifen in an N-methyl-N-nitrosourea (NMU)-induced rat mammary cancer model

Yankuzo HM, Emilia ST, Shaari R, Yaacob NS

Asian Pac J Cancer Prev, 2014;15(16):6721-6.
PMID: 25169515

BACKGROUND: The aim of this preliminary study was to address variations of responses observed with different starting tumor sizes of 10 and 15 mm, and the effects of different doses of tamoxifen (TAM) on experimental rat mammary tumors.
MATERIALS AND METHODS: Thirty-five inbred female Sprague Dawley rats aged 43 days were administered with three weekly doses of N-methyl-N-nitrosourea (NMU) intraperitoneally (ip) at 50 mg/kg body weight. Animals were randomized (beginning from 10 mm tumor size) into four TAM-treated (50, 100, 200 and 500 μg/day) groups of six animals each, and another group (n=6) treated with TAM 100 μg/day at starting tumour size of 15 mm. The animals were treated by oral gavage daily for 8 weeks before sacrifice.
RESULTS: Serum urea and creatinine, and overall physical tumor burden were significantly modulated in animals treated with variable doses of TAM compared to the untreated controls (n=5). Final body weight and tumor number were significantly different in the 10 mm-treated animals compared to those treated at 15 mm. There were no significant differences in histopathological features among all the groups.
CONCLUSIONS: Our findings suggest the importance of standardizing tumour size and drug doses before initiation of treatment, particularly in the direct comparison of basic end-tumour physical parameters.

Matched MeSH terms: Drug Dosage Calculations*
Methods for Predicting Warfarin Dose Requirements

Saffian SM, Wright DF, Roberts RL, Duffull SB

Ther Drug Monit, 2015 Aug;37(4):531-8.
PMID: 25549208 DOI: 10.1097/FTD.0000000000000177

The aim of this study was to compare the predictive performance of different warfarin dosing methods.

Matched MeSH terms: Drug Dosage Calculations*
Development of improved dosing regimens for mycophenolate mofetil based on population pharmacokinetic analyses in adults with lupus nephritis

Abd Rahman AN, Tett SE, Abdul Gafor HA, McWhinney BC, Staatz CE

Eur J Drug Metab Pharmacokinet, 2017 Dec;42(6):993-1004.
PMID: 28536776 DOI: 10.1007/s13318-017-0420-3

BACKGROUND AND OBJECTIVE: Mycophenolic acid (MPA) provides effective treatment for lupus nephritis patients. Owing to its large pharmacokinetic variability, it is questionable whether standard fixed dose therapy can achieve optimal MPA exposure. The aim of this study was to develop a population pharmacokinetic model of MPA and its metabolite, 7-O-MPA-β-glucuronide (MPAG), to identify important covariate influences and better predict patient dosing requirements.
METHODS: MPA and MPAG concentration-time profiles were collected from 25 patients receiving mycophenolate mofetil (MMF) with or without cyclosporine (CsA) co-therapy. Samples were collected pre-dose and at 1, 2, 4, 6 and 8 h post-dose on one or two occasions.
RESULTS: A total of 225 and 226 concentration-time measurements of MPA and MPAG, respectively, were used to develop the model, utilizing NONMEM® software. A two-compartment model with first-order absorption and elimination for MPA and a one-compartment model with first-order elimination and enterohepatic circulation (EHC) for MPAG best described the data. Apparent clearance of MPAG (CL/F MPAG) significantly decreased with reducing renal function and extent of EHC was reduced with concomitant CsA use. Simulations using the final model showed that a 70-kg subject with a creatinine clearance of 90 mL/min receiving concomitant CsA would require 1.25 g of MMF twice daily while a similar subject who did not receive concomitant CsA would require 0.75 g twice daily to achieve a MPA area under the concentration-time curve from 0 to 12 h (AUC0-12) of 45 mg·h/L.
CONCLUSION: A 'tiered' dosing approach considering patient renal function and CsA co-therapy, rather than a 'one dose fits all' approach, would help individualize MMF therapy in adult lupus nephritis patients to ensure more patients have optimal MPA exposure.
Study site: Nephrology and Systemic Lupus Erythematosus (SLE) Clinics, Pusat Perubatan Universiti Kebangsaan Malaysia (PPUKM), Kuala Lumpur, Malaysia

Matched MeSH terms: Drug Dosage Calculations*
Challenges in pediatric drug use: A pharmacist point of view

Balan S, Hassali MA, Mak VSL

Res Social Adm Pharm, 2017 May-Jun;13(3):653-655.
PMID: 27493130 DOI: 10.1016/j.sapharm.2016.06.014

The pediatric population is an enormously diverse segment of population varying both in size and age. The diversity caused pharmacists face various challenges primarily related to procuring, provision as well as use of drugs in this group of patients. Pediatric dose calculation is particularly a concern for pharmacists. Another challenge faced by pharmacists is unavailability of suitable formulations for pediatric use. This has also led many pharmacists to prepare extemporaneous liquid preparations, even though stability data on such preparations are scarce. Some extemporaneous preparations contain excipients which are potentially harmful in children. Besides that, inadequate labeling and drug information for pediatric drug use had not only challenged pharmacists in recommending and optimizing drug use in children, but also inadvertently caused many drugs used outside the approved terms of the product license (off-label use). Pharmacists are striving to stay connected to overcome the common and comparable challenges faced in their day to day duties and strive to maximize the safe and effective use of medicines for children.

Matched MeSH terms: Drug Dosage Calculations
Fulltext Preparation and characterization of a gastric floating dosage form of capecitabine

Taghizadeh Davoudi E, Ibrahim Noordin M, Kadivar A, Kamalidehghan B, Farjam AS, Akbari Javar H

Biomed Res Int, 2013;2013:495319.
PMID: 24288681 DOI: 10.1155/2013/495319

Gastrointestinal disturbances, such as nausea and vomiting, are considered amongst the main adverse effects associated with oral anticancer drugs due to their fast release in the gastrointestinal tract (GIT). Sustained release formulations with proper release profiles can overcome some side effects of conventional formulations. The current study was designed to prepare sustained release tablets of Capecitabine, which is approved by the Food and Drug Administration (FDA) for the treatment of advanced breast cancer, using hydroxypropyl methylcellulose (HPMC), carbomer934P, sodium alginate, and sodium bicarbonate. Tablets were prepared using the wet granulation method and characterized such that floating lag time, total floating time, hardness, friability, drug content, weight uniformity, and in vitro drug release were investigated. The sustained release tablets showed good hardness and passed the friability test. The tablets' floating lag time was determined to be 30-200 seconds, and it floated more than 24 hours and released the drug for 24 hours. Then, the stability test was done and compared with the initial samples. In conclusion, by adjusting the right ratios of the excipients including release-retarding gel-forming polymers like HPMC K4M, Na alginate, carbomer934P, and sodium bicarbonate, sustained release Capecitabine floating tablet was formulated.

Matched MeSH terms: Drug Dosage Calculations