172 resultados para Unlicensed medicines
Resumo:
Plants have been used in the cure of diseases from the origins of the humanity. At present, in Brazil, the use is common because of the difficulty of access of part of the population to medical assistance. It is commonly believed that the medicinal plants of traditional use were already tested and ratified by the long-lasting use by the human species, being considered effective medicines, presenting no collateral effects, not needful, therefore, of evaluation. The miraculous self-medication with medicinal plants goes to the point of substituting therapies in serious diseases such as those of hypoglycemic or anti-diabetic effect. For the test of medicinal plants, it is necessary to consider the material quality to be tested, the plant component used, extraction method, dosage, and the experimental species used. Several plants have already had hypoglycemic effects proven experimentally. The objective of this paper was to accomplish a revision of Brazilian medicinal plants, used popularly, as hypoglycemics that had effects proven in animals and in humans.
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The use of natural active principals is widespread among a great proportion of the rural population, or by people who do not have easy access to medical assistance. These active principles are used as food or medicines, and even for purposes of contraception. It becomes necessary to establish a relationship between the folklore habits and current information on the nature of anti-fertility substances, and knowledge of their mechanisms. Anti-fertility agents may exert their actions in a number of areas, (hypothalamus, anterior pituitary, oviduct, uterus, and vagina), inhibiting synthesis and/or liberation of hormones (follicle-stimulating, luteinizing, and steroid hormones), ovulation, ovum transportation, and implantation process. Therefore, a review of literature was carried out, including of several plants used by women as abortifacient and anti-fertility agents to compare their effects with those obtained among laboratory animals.
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Alzheimer's disease (AD) is a progressive neurodegenerative pathology with severe economic and social impact. There is currently no cure, although cholinesterase inhibitors provide effective temporary relief of symptoms in some patients. Nowadays drug research and development are based on the cholinergic hypothesis that supports the cognition improvement by regulation of the synthesis and release of acetylcholine in the brain. There are only four commercial medicines approved for treatment of AD and natural products have played an important role in the research for new acetylcholinesterase inhibitors.
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BACKGROUND: Retrospective analysis of human toxicity files involving topical medicines for treatment of upper airways diseases (eardrops, topical nasal medicines, lozenges, drops and sprays for oropharyngeal affections). METHODS: Thirty-four brands of eardrops, 48 of topical nasal medicines and 22 of tablets, lozenges and sprays for oropharyngeal affections were selected, from a total of 104 products available in Brazil. We analyzed the registries in the electronic database from the Poison Control Centre of São Paulo (CCI-Jabaquara), Brazil, for the period from January 1996 through December 2000. The cases related to selected pharmaceuticals were collected. RESULTS: 10,823 cases of human toxicity caused by medicines were voluntarily reported to CCI-Jabaquara. Topical medicines for treatment of upper airways diseases accounted for 291 cases (2.68%), from which 240 (82.5%) represented poisoning; 12 (4.1%) involved ear drops, 268 (92%), topical nasal medicines and 11 (3.9%), topical medicines for oropharyngeal affections. Among topical nasal medicines, vasoconstrictors predominated (233 cases), and among medicines for oropharyngeal affections, it was tetracaine (four cases). Considering age distribution, toxicity predominated significantly in children aged from 1 to 4 years (p=0.0003). The main causes of toxicity were: accidental intake of medicines (43%) and error in drug administration (14.8%). Hypereflexia and vomiting were the most frequent symptoms related to toxicity. CONCLUSIONS: There was significant incidence of systemic toxicity due to eardrops, topical nasal and oropharyngeal medicines in children 1 to 4 years-old, whose main cause was accidental intake of these medicines.
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The chemical, biological, pharmacological and toxicological study of plants used in medical treatments by different societies around the world has been intensifying over the years, primarily in the search for new herbal, homeopathic or even allopathic medicines. Motivated by this interest, we are investigating some Brazilian plant species, among them a tree, Brosimum gaudichaudii Trecul (Moraceae), found in Brazil's savannah-like prairies and scrub-forest (cerrado) and mesophytic forest. Several extracts have been made and separated into fractions and some compounds have been isolated - principally coumarins - and their respective structures analyzed by spectrophotometric and other methods. By collaborating with researchers in other fields, we have been able to carry out various bioassays and even basic clinical tests, namely: determination of anti-helminthic, anti-microbial, photosensitizing, anticancer and mutagenic activities, toxicological and pathogenic studies, with the aim of discovering a genuinely Brazilian herbal or homeopathic medicine.
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This study was carried out in order to identify the interactions that occur most often between prescribed drugs as they are taken by elderly patients attending municipal public health centers in the city of Jaú, São Paulo State, Brazil. It is known that older people frequently have to live with chronic health problems, which oblige them to use the health service a great deal and to consume large quantities of medicines. When concomitant diseases are present, and polytherapy is being applied, the likelihood of adverse reactions and interactions between drugs increases. The population under study consisted of 148 persons aged 65 or more who frequented the pharmacy at the Núcleo de Gestão Assistencial (Municipal Health Centre, NGA25) in Jaú, between August and December 2004. Data were collected from medical prescriptions, the independent variables being the age and sex of the patient. For each patient, the pharmacological classes of drugs taken and drug-drug interactions were recorded. It was found that the mean numbers of drugs consumed were 3.8 among women and 3.9 among men. In terms of age, the highest number of drugs (4.2) was used in the group aged 75 to 84 years. The most frequently prescribed classes, in decreasing order, were: antihypertensives, 25.0%, heart drugs, 15.5%, diuretics, and anti-diabetic drugs, 10.7%. It was concluded that the classes most involved in drug-drug interactions were heart drugs, diuretics and antihypertensives. The most problematic active constituents were digoxin, amiodarone, frusemide, captopril, propranolol and nifedipine.
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Aim: To evaluate the presence of preservatives, dyes, sweeteners and flavouring substances in 73 pharmaceutical preparations of 35 medicines for oral administration, according to drug labeling information about the excipients. Methods: 35 medications were selected, both over-the-counter and prescription durgs, marketed in Brazil. The sample included: analgesic/antipyretic, antimicrobial, mucoregulatory, cough and cold, decongestant, antihistamine, bronchodilator, corticosteroid, antiinflammatory and vitamin medications. We collected data on 73 preparations of these drugs, according to drug labeling information regarding preservatives, dyes, sweeteners and flavourings. Results: Methylparaben and propylparaben were the most common preservatives found (43% and 35.6% respectively). The most common sweeteners were: sucrose (sugar) (53.4%), sodium saccharin (38.3%) and sorbitol (36.9%). Twenty-one medicines (28,7%) contained two sweeteners. Colourless medicines predominated (43.8%), followed by those with sunset yellow dye (FD&C yellow no. 6) (15%). Five products (6.8%) contained more than one colour agent. Tartrazine (FD&C yellow no. 5) was present in seven preparations (9.5%). Fruit was the most common flavouring found (83%). Labelings of drugs which contained sugar frequently omitted its exact concentration (77%). Of the four labelings of medicines which contained aspartame, two did not warn patients regarding phenylketonuria. Conclusions: Omission and inacuracy of drug labeling information on pharmaceutical excipients may expose susceptible individuals to adverse reactions caused by preservatives and dyes. Complications of inadvertent intake of sugar-containing medicines by diabetics, or aspartame intake by patients with phenylketonuria may also occur.
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This study was carried out in the city of Araraquara (SP, Brazil), where 1829 people selected randomly from 42 districts were interviewed with regard to their use of medicines, in particular whether and how they read the insert information sheet and the most frequently read items and problems encountered in the text. Surveys were performed in two stages, the first when package inserts were regulated in Brazil by Portaria SVS 110/1997 (Ministry of Health directive) and the second after the new regulation (RDC 140/2003) came into force. Out of 1829 people interviewed, 1597 reported using some medicine. The markedly similar results in both stages of the research pointed to the difficulties encounteved in reading the package inserts, due to the small letters, the obscure language and the massive amount of information. This paper shows that package inserts of medicines need to be simpler, so the patients have an idea of the importance of the medicine and are able to realize soon any problem that might appear due to the use of the medicine and what action they should take. Furthermore, it will be helpful to the evaluation of the package inserts of medicines, elaborated in conformity with RDC 140, if they work effectively as a source of information and guidance for the patient are not simply given a new layout, while maintaining items that impede their understanding and use.
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Migration of components from plastic packaging into foodstuffs or into medicines is a very important issue, concerning public health. Using experimental techniques, like gas chromatography-mass spectrometry, these essays measure total migration and specific migration of components from plastic packaging. This work presents an explanation and applications of a numerical technique tool for this measurement, allowing the comprehension of the diffusion process and the estimate of component migration in difficult or impractical measurements. As an application example, the non-uniform influence of initial concentration profile on the migration is presented, demonstrating the necessity of this profile determination for high quality considerations on involved metrology.
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Many studies had described the morbi-mortality related to medicines. As for the strategies to reduce the possible risks for medicine therapy is very important to readvise the pharmaceutical activity, once the pharmacist has potential for constitute an essential part for the solution of problems related to the utilization of medicines. The purpose of this work was to demonstrate that the therapeutic subdosage and the microbiological contamination may be directly involved with the inappropriate manipulation of medicines stored in residences. Liquid dosage forms containing dipyrone market in Brazil and stored at homes in Araraquara (SP) were analyzed regarding quantitative and microbiological analysis. Only in 57% from 128 samples analyzed the drug quantity was in accordance. Moreover, 26.2% from 128 samples analyzed presented S. aureus, E. coli and Salmonella sp. These results demonstrated clear reduction in their quality, as well as the presence of molds and/or bacteria in some medicines that still agreed with the expirations dates, showing the importance of the pharmacist in advising the correct use and store of medicines.
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Reactive oxygen species (ROS) and free radical species have been implicated in initiating, accompanying or causing many diseases in living organisms; there is thus, a continual need for antioxidants molecules to inactivate ROS/free radicals. Many studies of plants crude extracts have demonstrated free-radical scavenging and antioxidant action. Maytenus species have long been used, in several countries, as traditional medicines against gastric ulcers, dyspepsia and others gastric problems and for their anti-inflammatory properties. In this study, Maytenus aquifolium (Celastraceae) root bark ethanol extract was assessed for its ability to scavenge free radicals and reactive oxygen species. The results were expressed as percentage inhibition of the active species. The extract was efficient against studied reactive species: DPPH radical (obtained inhibition = 35.5 ± 1.3 %), ABTS.+ (IC50 = 0.0036 ± 0.0003 mg/mL), HOCl (IC50 = 0.002 ± 0.0001 mg/mL), O2 .- (obtained inhibition = 36.0 ± 2.1 %), and NO. (obtained inhibition = 18.3 ± 0.4 %). Uniterms Oxidant species Free radicals Maytenus aquifolium Oxidative damage.
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Tuberculosis (TB) is a very serious problem worldwide and the increasing number of multiple drugs resistant TB cases makes the search for new anti-TB drugs an urgent need. Indigenous knowledge about the use of native plants to treat illnesses has contributed to the discovery of new medicines. In this study, the antimycobacterial activity of seven medicinal drinks was assessed: Ananas sativus (hydroalcoholic fruit extract), Aristolochia triangularis (aqueous and hydroalcoholic leaf, root and stem extracts), Bromelia antiacantha (hydroalcoholic fruit extract), Stryphnodendron adstringens (hydroalcoholic bark extract), Tabebuia ovellanedae (hydroalcoholic bark extract), Vernonia polyanthes (hydroalcoholic root extract), all used by the Vanuíre indigenous community in the treatment of respiratory diseases. The activity was evaluated by using a time-to-kill assay, in which Mycobacterium tuberculosis H37Rv was cultured on Löwenstein-Jensen medium, after thirty minutes, one, three, six, twelve and twenty-four hours contact of the bacteria with each drink. Within half to one hour contact, the hydroalcoholic drinks of A. triangularis, S. adstringens, T. ovellanedae and V. polyanthes reduced the bacterial growth by 2 orders of magnitude in CFU/mL, and all bacterial growth was absent after three hours contact. In contrast, no mycobactericidal effect was detected in the aqueous extract of A. triangularis or in the hydroalcoholic beverages of A. sativus and B. antiacantha, even after twenty-four hours contact.
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In spite of the stated Brazilian policy on medicines that their quality, effectiveness and safety should be ensured at reasonable cost, hospitals in the ANVISA Surveillance Network have been receiving notifications of technical complaints, adverse reactions and suspected therapeutic ineffectiveness (STI) of medicines. The purpose of this study was to identify the medicines notified for suspicion of therapeutic ineffectiveness, at a university hospital participating in the national Surveillance Network, and to investigate the existence of polymorphs of any of the drugs involved, by examining the literature. There were 31 notifications of STI in a period of 18 months, concerning 11 different drugs, all of which were 'similar' drugs (neither original nor licensed by originator); five of these could contain polymorphs, according to the literature. However, this does not mean that the other drugs could not contain some unknown polymorphs, more studies being needed on polymorphism, especially in the cases of reported therapeutic ineffectiveness. Therefore, tests of polymorphism should be made part of the routine quality control of the raw materials during the development of medicines and in the studies of pharmaceutical equivalence to 'reference' medicines (innovative brands). The stability test should also involve a study of polymorphism, in order to confirm the solid state stability of the drug. All these measures will assure the effectiveness of medicines, since the reproducibility in the quality of pharmaceutical products could be monitored, as well as the equivalence of each production batch with the batch selected to determine the bioequivalence with the reference brand.
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Introduction: It was observed a considerable growth of elderly people. They are who use more medicines. The physiological changes associated with the age advancing can make pharmacokinetic and pharmacodynamic alterations. The cognitive decline, physical limitations and associate chronic pathology affect the medications appropriately use ability. Aims: Based in a literature review, appoint the main pharmacological groups prescribed to the elderly and the drug-drug interaction risks. Conclusion: The most of elderly use continually at least 3 medicines, the most prescribed are to cardiovascular and psychic diseases treatment.
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A survey to determine the availability of 20 essential medicines for the diseases with highest prevalence in primary health care was conducted in the city of Araraquara. The presence and the price of these medicines in private sector pharmacies and drugstores of the city were recorded. Two forms, recommended by the WHO, were used in the survey, one for availability and the other for prices. The drugs most commonly available in pharmacies and drugstores were: propranolol (90.5%), captopril (96%) and ranitidine (96%), while the least available were ferrous sulfate (27%), beclomethasone (33.8%) and ibuprofen (41.9%). The drugs that showed the greatest variation among the prices charged were: propranolol (97.1%), hydrochlorothiazide (96.4%) and glibenclamide (95.0%), while the least variable were salbutamol (30.8%) and trimethoprim-sulfamethoxazole (30.2%). Generic drugs, which were half (10) of those assessed, had the lowest prices. The indicators of access, referring to the ability of patients to acquire drugs for the treatment of major diseases at the primary health care level, showed that no establishment stocked all 20 essential drugs and that wide variations existed in their prices, undermining their availability to drug users, whose only sources are pharmacies and drugstores. These data demonstrate the importance of the popular pharmacy to improve the access to medicines, by lowering the cost and increasing the availability of the items selected for the National List of Essential Drugs (RENAME).