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Altered serum levels of phenytoin (increased and decreased) have been reported in patients receiving concomitant ciprofloxacin cheap amitriptyline 75 mg mastercard. The concomitant administration of ciprofloxacin with the sulfonylurea glyburide has order amitriptyline 25mg line, on rare occasions buy amitriptyline 50 mg visa, resulted in severe hypoglycaemia cheap 50mg amitriptyline with mastercard. Some quinolones, including ciprofloxacin, have been associated with transient elevations in serum creatinine in patients receiving cyclosporin concomitantly. Quinolones, including ciprofloxacin, have been reported to enhance the effects of the oral anticoagulant warfarin or its derivatives. Renal tubular transport of methotrexate may be inhibited by concomitant administration of ciprofloxacin potentially leading to increased plasma levels of methotrexate. Therefore, patients under methotrexate therapy should be carefully monitored when concomitant ciprofloxacin therapy is indicated. Non-steroidal antiinflammatory drugs (but not aspirin) in combination of very high doses of quinolones have been shown to provoke convulsions in preclinical studies. Respiratory: Dyspnea, epistaxis, laryngeal or pulmonary edema, hiccough, haemoptysis, bronchospasm, pulmonary embolism. Central Nervous System: Restlessness, dizziness, lightheadedness, insomnia, nightmares, hallucinations, manic reaction, irritability, tremor, ataxia, convulsive seizures, lethargy, drowsiness, weakness, malaise, anorexia, phobia, depersonalization, depression, paraesthesia, abnormal gait, grand mal convulsion. Digestive System: Painful oral mucosa, oral candidiasis, dysphagia, intestinal perforation, gastrointestinal bleeding, cholestatic jaundice, hepatitis. Renal/Urogenital: Interstitial nephritis, nephritis, renal failure, polyuria, urinary retention, urethral bleeding, vaginitis, acidosis, breast pain. Skin: Allergic reaction, pruritus, urticaria, photosensitivity, flushing, fever, chills, angioedema, edema of the face, neck, lips, conjunctivae or hands, cutaneous candidiasis, hyperpigmentation, erythema nodosum, sweating. In these patients, depression is usually situational and the risks of medications outweigh the benefits. Caution is advisable in using Citalopram in patients with diseases or conditions that produce altered metabolism or haemodynamic responses. All patients with these events have recovered with discontinuation of citalopram and/or medical intervention. Seizures Although anticonvulsant effects of citalopram have been observed in animal studies, citalopram has not been systematically evaluated in patients with a seizure disorder. Citalopram should be introduced with care in patients with a history of seizure disorder. Thus, patients should be cautioned about the use of such drugs concurrently with citalopram. The initial reconstituted solution is stable for 24 hours when stored at room temperature or refrigerated. The final diluted solution should be used within 6 hours when stored at room temperature or with 24 hours if refrigerated. Clarithromycin exerts its antibacterial action by binding to the 50S ribosomal subunit of susceptible microorganisms resulting in inhibition of protein synthesis. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of antibacterial agents. Monitoring of serum theophylline concentrations should be considered for patients receiving high doses of theophylline or with baseline concentrations in the upper therapeutic range. Elevated digoxin serum concentrations in patients receiving clarithromycin and digoxin concomitantly have also been reported in postmarketing surveillance. Some patients have shown clinical signs consistent with digoxin toxicity, including potentially fatal arrhythmias. Serum digoxin concentrations should be carefully monitored while patients are receiving digoxin and clarithromycin simultaneously. There have been postmarketing reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Rare reports of rhabdomyolysis have been reported in patients taking these drugs concomitantly. A similar interaction may occur with clarithromycin; reduction of sildenafil dosage should be considered. It has activity against Gram-positive aerobes and anaerobes as well as the Gram-negative anaerobes. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of antibacterial agents. Because clindamycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate Usage in Meningitis: Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis. Because of possible clinical significance, the two drugs should not be administered concurrently. Immediately before use, mix the clonazepam solution thoroughly with contents of the diluent vial. Maximum plasma concentrations of clonazepam are reached within 1-4 hours after oral administration. This may require the addition of appropriate anticonvulsants or an increase in their dosages. This should be considered before giving the drug to patients who have difficulty handling secretions. The following paradoxical reactions have been observed: Excitability, irritability, aggressive behavior, agitation, nervousness, hostility, anxiety, sleep disturbances, nightmares and vivid dreams. Respiratory: Chest congestion, rhinorrhea, shortness of breath, hypersecretion in upper respiratory passages. Gastrointestinal: Anorexia, coated tongue, constipation, diarrhoea, dry mouth, encopresis, gastritis, increased appetite, nausea, sore gums. Miscellaneous: Dehydration, general deterioration, fever, lymphadenopathy, weight loss or gain. Hepatic: Hepatomegaly, transient elevations of serum transaminases and alkaline phosphatase. It is not recommended in most patients with severe cardiovascular disease or in those who are otherwise haemodynamically unstable. The benefit of its administration in these patients should be carefully balanced against the potential risks resulting from hypotension. Treatment of acute coronary syndromes (especially post angioplasty when stents are deployed) 2. If a patient is to undergo elective surgery and an antiplatelet effect is not desired, clopidogrel bisulfate should be discontinued 5 days prior to surgery. Clopidogrel bisulfate should be used with caution in patients who have lesions with a propensity to bleed (such as ulcers). It may be more appropriate to use Ranitidine as ulcer prophylaxis in patients on clopidogrel. Treatment of Schizophrenia in patients intolerant or unresponsive to at least 2 classic antipsychotics Note: Clozapine should rarely, if ever, be commenced in patients in the Intensive Care Unit. Any patient who is taking clozapine who is admitted to the Intensive Care Unit for any reason should be discussed with Psychiatry.

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Boric Acid Alcohol insoluble substances Absence of metallic borates and insoluble impurities 2 amitriptyline 25 mg sale. Chloramine Alcohol-insoluble matter : Sodium chloride impurity : Shake 1 g for 30 mts cheap 75 mg amitriptyline free shipping. The residue washed with 5 m1 of ethanol (96% v/v) and dried at 100 to 105°C and weighed buy amitriptyline 10 mg with visa. Filter amitriptyline 10mg line, wash the residue on the filter with hot alcohol (90% v/v) until the washings cease to be coloured violet. In the same vein, tests for clarity of solution offer another means of limiting insoluble parent drug sub- stances in their correspondingly more highly water-soluble derivatives. Limits of Soluble Matter In order to detect the presence of some very specific impurities normally present in the official substances the limits of soluble impurities have been laid down in different pharmacopoeias. Water-soluble medium) filter through paper, previously washed with a mixture of 10 barium salts are highly ml dil. Magnesium : Prepare the sample solution by adding 10 ml Magnesium : of a 1% w/v soln. Limits of Moisture, Volatile Matter and Residual Solvents A good number of pharmaceutical substances usually absorb moisture on storage thereby causing deterioration. Such an anomaly can be safely restricted and limited by imposing an essential requirement for the loss in weight (Loss on Drying) when the pharmaceutical chemical is subjected to drying under specified conditions. The quantum of heat that may be applied to the substance varies widely as per the following norms : (a) Nature of the substance (b) Decomposition characterisics of the substance. Various official compendia recommended different temperatures and duration of drying either at atmos- pheric or reduced pressure (vacuum). Pharmaceutical Substance Drying Conditions Drying Time Prescribed Limit (°C) (Hrs. Pharmaceutical Substance Drying Conditions Drying Time Prescribed Limit (°C) (Hrs) (%) Inorganic Salt Hydrates : l. The chromatographic procedure may be carried out by employing : (a) A stainless-steel column (1 m × 2 mm) packed with porous polymer beads e. From the chromatograms obtained and taking into account any water detectable in solution (1), calculate the percentage w/w of water taking 0. Limits of Non-Volatile Matter Pharmaceutical chemicals belonging to the domain of inorganic as well as organic substances containing readily volatile matter for which the various official compendia prescribe limits of non-volatile matter. It is pertinent to mention here that the Pharmacopoeia usually makes a clear distinction between substances that are readily volatile and substances that are volatile upon strong ignition, for instance : (a) Readily Volatile : e. Limits of Residue on Ignition In fact, the limits of residue on ignition are basically applicable to the following two categories of pharmaceutical substances, namely : (a) Those which are completely volatile when ignited e. Limits of Loss on Ignition Official compendia include the limits of ‘loss on ignition’ which is generally applied to relatively stable pharmaceutical substances that are likely to contain thermolabile impurities. Limits on Ash Value The ash values usually represent the inorganic residue present in official herbal drugs and pharmaceuti- cal substances. These values are categorized into four heads, namely : (a) Ash Value (Total Ash), (b) Acid-Insoluble Ash, (c) Sulphated Ash, and (d) Water-Soluble Ash. These values would be explained with the help of some typical examples stated below : 1. Ash Value (Total Ash) Ash value normally designates the presence of inorganic salts e. The official ash values are of prime importance in examination of the purity of powdered drugs as enumerated below : (i) To detect and check adulteration with exhausted drugs e. The most common procedure recommended for crude drugs is described below : Procedure : Incinerate 2 to 3 g of the ground drug in a tared platinum or silica dish at a temperature not exceeding 450°C until free from carbon. Acid-Insoluble Ash The method described above for ‘total ash’ present in crude drugs containing calcium oxalate has certain serious anomalies, namely : • Offers variable results upon ashing based on the conditions of ignition. Hence, the treatment of the ‘total ash’ with acid virtually leaves silica exclusively and thus comparatively forms a better test to detect and limit excess of soil in the drug than does the ash. Repeat until the difference between two successive weighings is not more than l mg. Calculate the percentage of acid-insoluble ash with reference to the air-dried drug. Sulphated Ash The estimation of ‘sulphated ash’ is broadly employed in the case of : (a) Unorganized drugs e. The general method for the determination of ‘sulphated ash’ is enumerated below : Procedure : Heat a silica or platimum crucible to redness for 30 minutes, allow to cool in a desiccator and weigh. Place a suitable quantity of the substance being examined, accurately weighed in the crucible, add 2 ml of 1 M sulphuric acid and heat, first on a waterbath and then cautiously over a flame to about 600°C. Continue heating until all black particles have disappeared and then allow to cool. Add a few drops of 1 M sulphuric acid, heat to ignition as before and allow to cool. Add a few drops of a 16% solution of ammonium carbonate, evaporate to dryness and cautiously ignite. Following are the examples to depict the ‘sulphated ash’ present in various official pharmaceutical chemicals : S. Water-Soluble Ash Water-soluble ash is specifically useful in detecting such samples which have been extracted with water. Now, calculate the percentage of water-soluble ash with reference to the air-dried drug. A typical example of an official drug is that of ‘Ginger’, the water-soluble ash of which is found to be not more than 6. These impurities very often creep into the final product through a number of means stated below, namely : (a) Through atmospheric pollution. In short, all prescribed tests for impurities in the Pharmacopoeia usually fix certain limits of tolerance. For lead, arsenic and iron general quantitative or limit tests are precisely laid down which, with necessary variations and modification are rigidly applicable to pharmaceutical substances. Limit Tests for Lead Theory : The offcial test is based on the conversion of traces of lead salts present in the pharmaceutical substances to lead sulphide, which is obtained in colloidal form by the addition of sodium sulphide in an alkaline medium achieved by a fairly high concentration of ammonium acetate. The reaction may be expressed as follows : PbCl2 + Na2S → PbS B + 2NaCl The brown colour, caused due to colloidal lead sulphide in the test solution is compared with that produced from a known amount of lead. Equipment : Nessler Cylinders (or Nessler Glasses) : According to the British Standard Specifica- tion No : 612, 966—a pair of cylinders made of the same glass and having the same diameter with a graduation mark at the same height from the base in both cylinders (Figure 1). The final comparison is made by viewing down through the solution against a light background. Note : The solution must be prepared and stored in polyethylene or glass containers free from soluble lead salts.

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In a cohort study cheap amitriptyline 25mg otc, data on all pooled analysis that is pertinent to a particular cancer sites and all causes of death should have Monograph (see Part A buy 50mg amitriptyline free shipping, Section 4) buy 50 mg amitriptyline free shipping. Additionally generic amitriptyline 50mg free shipping, been given, to reveal the possibility of reporting as a means of gaining insight from the results of bias. In a case–control study, the efects of inves- multiple individual studies, ad hoc calculations tigated factors other than the exposure of interest that combine data from diferent studies may should have been reported. Te results estimates of relative risk, absolute rates of can- of such original calculations, which would be cer, confdence intervals and signifcance tests, specifed in the text by presentation in square and to adjust for confounding should have been brackets, might involve updates of previously clearly stated by the authors. Tese methods have conducted analyses that incorporate the results been reviewed for case–control studies (Breslow of more recent studies or de-novo analyses. Combined analyses of data from (d) Temporal efects multiple studies are a means of resolving this ambiguity, and well conducted analyses can be Detailed analyses of both relative and abso- considered. Tere are two types of combined lute risks in relation to temporal variables, such analysis. Te frst involves combining summary as age at frst exposure, time since frst exposure, statistics such as relative risks from individual duration of exposure, cumulative exposure, peak studies (meta-analysis) and the second involves a exposure (when appropriate) and time since pooled analysis of the raw data from the individ- cessation of exposure, are reviewed and sum- ual studies (pooled analysis) (Greenland, 1998). Analyses of temporal Te advantages of combined analyses are relationships may be useful in making causal increased precision due to increased sample size inferences. In addition, such analyses may sug- and the opportunity to explore potential con- gest whether a carcinogen acts early or late in the founders, interactions and modifying efects process of carcinogenesis, although, at best, they 16 Preamble allow only indirect inferences about mechanisms (f) Criteria for causality of carcinogenesis. Afer the quality of individual epidemiologi- cal studies of cancer has been summarized and (e) Use of biomarkers in epidemiological assessed, a judgement is made concerning the studies strength of evidence that the agent in question Biomarkers indicate molecular, cellular or is carcinogenic to humans. In making its judge- other biological changes and are increasingly ment, the Working Group considers several crite- used in epidemiological studies for various pur- ria for causality (Hill, 1965). Tis is a rapidly evolving feld that encom- of the same design or that use diferent epidemi- passes developments in genomics, epigenomics ological approaches or under diferent circum- and other emerging technologies. If there are inconsistent and interindividual diferences in susceptibility results among investigations, possible reasons to the agent(s) being evaluated may contribute are sought (such as diferences in exposure), and to the identifcation of carcinogenic hazards to results of studies that are judged to be of high humans. If the polymorphism has been demon- quality are given more weight than those of stud- strated experimentally to modify the functional ies that are judged to be methodologically less activity of the gene product in a manner that is sound. Te demonstration of a decline in risk afer ity may provide evidence that reinforces biologi- cessation of or reduction in exposure in indi- cal plausibility. It should be noted, however, that viduals or in whole populations also supports a when data on genetic susceptibility originate causal interpretation of the fndings. On the one hand, an agent results and inconsistencies across studies, and may be specifc in causing tumours at one site or such data therefore require careful evaluation. On the other, carci- If the known phenotype of a genetic polymor- nogenicity may be evident through the causation phism can explain the carcinogenic mechanism of multiple tumour types. Temporality, precision of the agent being evaluated, data on this pheno- of estimates of efect, biological plausibility and type may be useful in making causal inferences. Such a judgement requires tal animals was established or highly suspected frst that the studies meet, to a sufcient degree, before epidemiological studies confrmed their the standards of design and analysis described carcinogenicity in humans (Vainio et al. Specifcally, the possibility that bias, con- Although this association cannot establish that founding or misclassifcation of exposure or out- all agents that cause cancer in experimental ani- come could explain the observed results should mals also cause cancer in humans, it is biologically be considered and excluded with reasonable cer- plausible that agents for which there is sufcient tainty. In addition, all studies that are judged to evidence of carcinogenicity in experimental ani- be methodologically sound should (a) be con- mals (see Part B, Section 6b) also present a car- sistent with an estimate of efect of unity for any cinogenic hazard to humans. Accordingly, in observed level of exposure, (b) when considered the absence of additional scientifc information, together, provide a pooled estimate of relative these agents are considered to pose a carcinogenic risk that is at or near to unity, and (c) have a nar- hazard to humans. Examples of additional scien- row confdence interval, due to sufcient popula- tifc information are data that demonstrate that tion size. Moreover, no individual study nor the a given agent causes cancer in animals through pooled results of all the studies should show any a species-specifc mechanism that does not oper- consistent tendency that the relative risk of can- ate in humans or data that demonstrate that the cer increases with increasing level of exposure. Experience with extent of impurities or contaminants present in human cancer indicates that the period from frst the agent being evaluated are given when avail- exposure to the development of clinical cancer is able. Animal species, strain (including genetic sometimes longer than 20 years; latent periods background where applicable), sex, numbers per substantially shorter than 30 years cannot pro- group, age at start of treatment, route of expo- vide evidence for lack of carcinogenicity. Tose studies in experimental animals that are judged to be irrel- evant to the evaluation or judged to be inadequate 18 Preamble (e. Guidelines An assessment of carcinogenicity involves for conducting long-term carcinogenicity exper- several considerations of qualitative impor- iments have been published (e. Another larly in inhalation experiments; (iii) whether the consideration is that chemical and toxicological doses, duration of treatment and route of expo- interactions of components in a mixture may sure were appropriate; (iv) whether the survival alter dose–response relationships. Te relevance of treated animals was similar to that of con- to human exposure of the test mixture adminis- trols; (v) whether there were adequate numbers tered in the animal experiment is also assessed. When benign tumours (a) occur together Te relevance of results obtained with an with and originate from the same cell type as agent that is analogous (e. Such results may provide stage in the progression to malignancy, they are biological and mechanistic information that is usually combined in the assessment of tumour relevant to the understanding of the process of incidence (Huf et al. Te occurrence of carcinogenesis in humans and may strengthen lesions presumed to be preneoplastic may in cer- the biological plausibility that the agent being tain instances aid in assessing the biological plau- evaluated is carcinogenic to humans (see Part B, sibility of any neoplastic response observed. When detailed informa- ground and age of the animal, and on the dose, tion on survival is not available, comparisons route, timing and duration of the exposure. Te lethal- Te form of the dose–response relation- ity of the tumour also requires consideration: for ship can vary widely, depending on the par- rapidly fatal tumours, the time of death provides ticular agent under study and the target organ. Since many chemicals require metabolic fcult to determine, methods such as the Poly-K activation before being converted to their reac- test that do not require such information can tive intermediates, both metabolic and toxicoki- also be used. When results are available on the netic aspects are important in determining the number and size of tumours seen in experimen- dose–response pattern. Te dose–response relationship Formal statistical methods have been devel- can also be afected by diferences in survival oped to incorporate historical control data into among the treatment groups. Tese methods assign an appropriate weight to (c) Statistical analyses historical and concurrent controls on the basis Factors considered include the adequacy of of the extent of between-study and within-study the information given for each treatment group: variability: less weight is given to historical con- (i) number of animals studied and number exam- trols when they show a high degree of variability, ined histologically, (ii) number of animals with a and greater weight when they show little varia- given tumour type and (iii) length of survival. It is generally not appropriate to discount Te statistical methods used should be clearly a tumour response that is signifcantly increased stated and should be the generally accepted tech- compared with concurrent controls by arguing niques refned for this purpose (Peto et al. For example, a mutation in a between-study variability and are, thus, of little gene that codes for an enzyme that metabolizes relevance to the current experiment. In analys- the agent under study could be discussed in the ing results for uncommon tumours, however, the subsections on toxicokinetics, mechanisms and analysis may be improved by considering histori- individual susceptibility if it also exists as an cal control data, particularly when between-study inherited polymorphism. Historical controls should be selected to resemble the concurrent controls as (a) Toxicokinetic data closely as possible with respect to species, gen- Toxicokinetics refers to the absorption, dis- der and strain, as well as other factors such as tribution, metabolism and elimination of agents basal diet and general laboratory environment, in humans, experimental animals and, where which may afect tumour-response rates in con- relevant, cellular systems. Studies experiments than for epidemiological studies that indicate the metabolic fate of the agent in due to diferences in animal strains, they can be humans and in experimental animals are sum- useful aids in interpreting animal data when the marized briefy, and comparisons of data from experimental protocols are sufciently similar. Mechanistic and other relevant between exposure and the dose that reaches the data target site may be important for the extrapola- tion of hazards between species and in clarifying Mechanistic and other relevant data may pro- the role of in-vitro fndings. Te nature of the mechanistic and other relevant data To provide focus, the Working Group depends on the biological activity of the agent attempts to identify the possible mechanisms by being considered. Relevant topics may include toxi- given to gaps in the data and to data that suggests cokinetics, mechanisms of carcinogenesis, sus- that more than one mechanism may be operat- ceptible individuals, populations and life-stages, ing.

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The integrity of packaging of dosage form is one of the impor- tant tasks of inspecton for pharmacist as these protect the drug in a tailored fashion best amitriptyline 50 mg. Afer each inspecton purchase 75mg amitriptyline otc, products showing any signs of instability should be subjected to sample analysis to ensure quality generic amitriptyline 10 mg otc. Aerosols Aerosols should be stored in a clean separate area away from heat and sunlight because the container contents are under pressure cheap amitriptyline 75 mg otc, flled containers must be checked for weight loss over the expiraton datng period, for contents under pres- sure. The label should display “Do not expose to heat or store at a temperature above 40⁰C, keep out of reach of children”. Creams Creams can be destroyed under extreme temperature fuctua- tons hence they should be stored at temperature above 10oC and not exceeding 30⁰C. If the creams are opened and diluted they should not be kept for more than 14 days to avoid micro- bial contaminaton. Ophthalmic Solutons and Drops They should be stored according to the conditons specifed on the label. Afer opening they should not be used for more than one month at home and not more than 15 days in hospitals. Suppositories Suppositories should be protected from heat and preferably stored in the refrigerator. Polyethylene glycol supposito- ries and suppositories enclosed in solid shell are less prone to distorton at temperature slightly above body tempera- ture. Glycerinated gelatn suppositories should be protected from heat, moisture and dry air by packaging in well sealed containers and storing in a cold place. Vaccines Liquid vaccines are to be stored between 2⁰ - 8⁰C and should not be frozen. All lyophilized vaccines should be stored between 2⁰- 8⁰C and for long term storage can be kept at or below -20⁰C or otherwise as specifed in the individual mono- graphs. Communicatng the Prescripton to the Patent It is important that the drugs reach the patent in good and potent conditons and the patent should know and under- stand fully how to keep them tll they are consumed. It is equally important that the patent should know the way each medicine is used. Communicatng how and where to store the drugs to the Patent: The following table may be used to guide and provide infor- maton on the way to store the drugs when they are dispensed to the patents. This is based on the recommended storage conditons as given on the labels of the drug products and Indian Pharmacopoeial notes in the General Chapters. On the label Meaning Tell the Patent/ Representatve of the Patent Do not store To be stored in Keep in the General over 8⁰C refrigerator Compartment of the (from +2⁰C to +8⁰C refrigerator and do not keep in the place where you make Ice. Do not store To be stored at room Keep in any part of the over 30 ⁰C temperature house, except in Bath room/ (from +2⁰C to +30⁰C) Kitchen. Do not To be kept in Keep in the General freeze refrigerator (from Compartment of the +2⁰C to +8⁰C but refrigerator and do not keep not in the freezer in the place where you make chamber) Ice. Keep to be provided by in any part of the house, the manufacturer in except in Bath room/Kitchen. Keep in a the manufacturer cupboard/drawer or in a box in a light-resistant with lid closed, in any part container. Transit period care and Use of Cool Packs: It is equally important to ensure that patents who carry drugs requiring special storage conditons like ant-cancer drugs, several types of insulins, vaccines, sera, toxoids, would need to carry them in cold conditons tll they reach the place where they will keep for some tme before usage or to another hospital/nursing home tll it is administered. In such cases during transit they need to be packed in “Thermo cool boxes with lid”, (#) with the drug product packs kept surrounded by adequate number of “Cool Packs”. Such packs help in keeping the drug products in the box retain tempera- tures below 8⁰C for as much as 8 to 10 hours, which is gener- ally adequate for transit protecton. In case such cool packs are not available, it is recommended to use normal “Hot cases” (#) that people use to carry food, but stufng the inside of the hot case boxes with sufcient ice cubes surrounding the drug packs kept inside, and the hot case suitably closed and sealed with sealing tapes. Cool packs can also be made by packing sufcient ice cubes into suitable sized self sealing polybags. It is carried out for specifc drugs at various tme intervals in order to maintain a relatvely constant concentra- ton of the partcular drug in the bloodstream and to optmize drug therapy. Apart from this, it also plays a signifcant role for drugs having large inter-individual variatons; rela- tvely toxic drugs used in concomitant disease conditons, for escalaton of dose, drugs showing wide variaton in their metabolism, major organ failure, poisoning cases, failure of therapeutc response, to enhance patent compliance, etc. It is very important in such situatons in which the drugs are to be taken on chronic or life long basis (chronic disease conditons such as bipolar disorder, organ transplant rejecton, neurolog- ical disorders etc. The tming and frequency of blood collec- ton afer the medicaton and correct interpretaton of results of analysis and their correlaton with clinical features ensures the best therapeutc outcome. Indicatons for drug monitoring: • Drugs whose efcacy is difcult to establish clinically, like Phenytoin. Example: Patents with renal failure have decreased clearance of digoxin and therefore are at a higher risk of toxicity. Example: Patents with chronic obstructve pulmonary disease treated with theophylline. Drugs whose pharmacological efects can easily be used to dose ttraton, like oral hypoglycemic agents, ant-hypertensive drugs. Usually “trough” concentratons are measured by taking the sample just before the subsequent dose. Drugs whose half-lives are much shorter than the dosing interval, the peak and trough levels may be indicated to evaluate the dosage of drugs. The folowing table summarizes the therapeutc concentraton range of various drugs Table: Important drugs requiring therapeutc monitoring S.

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