{"title":"A Therapeutic Dose of Isoniazid Induced Seizure Episode","authors":"R. A. Kumar, Aishwarya Aishwarya T.V, E. Paul","doi":"10.5530/PTB.2018.4.4","DOIUrl":"https://doi.org/10.5530/PTB.2018.4.4","url":null,"abstract":"Seizures are a common complication of drug intoxication, and up to 9% of cases are caused by a drug or poison. Most drug-induced seizures are selflimited. It occurs generally as a result of inadequate inhibitory influences (e.g., gamma amino butyric acid, GABA) or excessive excitatory stimulation (e.g. glutamate) although many other neurotransmitters play a role. To minimize the risk of adverse events, the dose must be adjusted for the patient’s age and medical history. Adverse events associated with INH are dose-related, with approximately 1-2% occurring during conventional low-dose therapy. Seizures refractory to standard anticonvulsant therapy were controlled with the administration of pyridoxine. Benzodiazepines are the first-line treatment for drug-induced seizures, with addition of pyridoxine if isoniazid or other hydrazine toxicity is suspected. This is a case report of 29-year-old female patient admitted to the hospital for the complaints of severe breathlessness. She was diagnosed for pulmonary tuberculosis for which CAT 1 ATT regimen was initiated on her sixth day of admission. One hour later after the administration of first dose of ATT drug an episode of seizure was developed which lasted for 5 min. The drug was then stopped, and she was given vitamin B6 tablet of 40 mg. Re-challenging of each ATT drugs were carried out one by one. Patient did not develop any further episode of seizure even after continuing the drugs. She restarted antitubercular regimen and continued along with pyridoxine. This reports a case of seizure induced on a therapeutic dose of isoniazid.","PeriodicalId":416050,"journal":{"name":"Pharmacology, Toxicology and Biomedical Reports","volume":"4 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2018-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130653716","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Informed Consent Template by Strategic Initiative for Developing Capacity in Ethical Review. A Good Alternate?","authors":"K. V. Chary","doi":"10.5530/PTB.2018.4.1","DOIUrl":"https://doi.org/10.5530/PTB.2018.4.1","url":null,"abstract":"Correspondence: Dr. Krishnan Vengadaragava Chary Department of Pharmacology, Saveetha Medical College, Chennai 602105, Tamil Nadu, INDIA. Phone no: 9894930069 Email: doctorkrishforu@gmail.com DOI: 10.5530/PTB.2018.4.1 Obtaining informed consent from (ICF) the participants of a clinical trial, bioavailability and bioequivalence studies, and investigator initiated research consists of two documents; participants’ information sheet and informed consent form. Informed consent is also a mandate for epidemiological and observational studies. It ensure participants autonomy to enroll them in trials and also legally valid for their post trial access and compensation. As a dictum, it should be in English and vernacular language signed by study subjects or their legally accepted representative (LAR).1 There are valid differences in opinion about amount of information that should be in given consent form. Participant information sheet in too much number of pages is often perceived tedious by the subjects and it is more complex when it comes to countries like India where there is diversity in language; Whereas it is an important for a sponsor and investigator to disclose all the elements, for an example, all the possible and rare adverse effects in the information to protect them from legal liability. Patient’s ability to understand and thereby willing to participate in a study is challenged by amount of information and its simplicity. Too lengthy and complexity in understanding them is seen even in western scenario. In a study conducted by Hames B et al. in 2016 among Netherlands, Denmark and Norway population concluded that readability is not within acceptable range of the study subject’s educational profile. This sort of assessment scale [Gunning’s fog index] is neither developed nor adopted in our scenario.2-3 Utilizing the commonly made information sheet with back translation in vernacular language cannot be relied as simple and understandable by the all the participants and patients often tend to overlook essential elements in the information sheet. Study data comprehensiveness is one of the major tasks to be tackled to achieve patient’s participants in our trial on their own. In order to develop comprehensive information sheet and consent form, Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), an independent global network, supported by World health organization (WHO) for raising standards of ethics developed a model format containing all relevant materials of an informed consent. Highlights of SIDCER form is given in Table 1. S No SICDER ICF Template features","PeriodicalId":416050,"journal":{"name":"Pharmacology, Toxicology and Biomedical Reports","volume":"123 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2018-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122479111","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
G. Pauly, R. Kashyap, Raghavendra Kini, P. Rao, G. Bhandarkar, Devika Shetty
{"title":"Appalling Adverse Effects of Amlodipine in a Chronic Kidney Disease Patient: A Case of Drug-Induced Gingival Overgrowth","authors":"G. Pauly, R. Kashyap, Raghavendra Kini, P. Rao, G. Bhandarkar, Devika Shetty","doi":"10.5530/ptb.2018.4.3","DOIUrl":"https://doi.org/10.5530/ptb.2018.4.3","url":null,"abstract":"Calcium channel blockers have been widely used in clinical practice because of their antihypertensive capacity. Prevention of renal damage is a very important aim of antihypertensive therapy. This is particularly so taking into account the high prevalence of chronic kidney disease (CKD) in the general population. Medications taken for medical conditions often manifest local to systemic side-effects including the oral cavity. Gingival overgrowth is one such unwanted adverse effect. It is a well-documented side effect associated with three major classes of drugs: anticonvulsants, calcium channel blockers (CCB), and immune-suppressants. Despite a greater understanding of pathogenesis of drug induced gingival overgrowth (DIGO), its treatment still remains a challenge for the dental practitioner and treatment is still largely limited to maintenance of improved level of oral hygiene and surgical removal of overgrown tissue. There is a need for the dental surgeons to discuss this issue with their medical colleagues and to practice statutory care while prescribing the drugs associated with gingival overgrowth.","PeriodicalId":416050,"journal":{"name":"Pharmacology, Toxicology and Biomedical Reports","volume":"2 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2018-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129669509","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Y. Alomi, M. El-bahnasawi, M. Kamran, Tasneen Shaweesh, Soha Alhaj, R. A. Radwan
{"title":"The Clinical Outcomes of Pharmacist Interventions at Critical Care Services of Private Hospital in Riyadh City, Saudi Arabia","authors":"Y. Alomi, M. El-bahnasawi, M. Kamran, Tasneen Shaweesh, Soha Alhaj, R. A. Radwan","doi":"10.5530/ptb.2019.5.4","DOIUrl":"https://doi.org/10.5530/ptb.2019.5.4","url":null,"abstract":"Yousef Ahmed Alomi*, The Former General Manager of General Administration of Pharmaceutical Care Former Head, National Clinical Pharmacy and Pharmacy Practice Former Head, Pharmacy R and D Administration Ministry of Health, Riyadh, SAUDI ARABIA. Manal El-Bahnasawi, Head, Pharmacy Services Sulaiman Al-Habib Medical Group, Riyadh, SAUDI ARABIA. Mohammed Kamran , Clinical Pharmacy Staff, Pharmacy Services Sulaiman Al-Habib Medical Group, Riyadh, SAUDI ARABIA. Tasneen Shaweesh, Clinical Pharmacy Staff, Pharmacy Services Sulaiman AlHabib Medical Group, Riyadh, SAUDI ARABIA. Soha Alhaj, Clinical Pharmacy Staff, Pharmacy Services Sulaiman Al-Habib Medical Group, Riyadh, SAUDI ARABIA. Reem Ahmed Radwan, Staff Pharmacist, Pharmacy Services Armed Forces Center for Health Rehabitition Taif, SAUDI ARABIA.","PeriodicalId":416050,"journal":{"name":"Pharmacology, Toxicology and Biomedical Reports","volume":"28 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133203931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}