Protonix

By G. Jared. Lander University.

Intravenous Increase yield of autologous blood Adult: As epoetn alfa or zeta: 600 U/kg over 2 minutes twice weekly for 3 week before surgery; in conjuncton with iron purchase protonix 40 mg fast delivery, folate and B12 supplementaton discount protonix 40 mg line. Contraindicatons Hypersensitivity to mammalian cell products and human albumin, uncontrolled hypertension. Precautons Ischaemic heart diseases, chronic renal failure, hypertension, seizures, liver dysfuncton, pregnancy (Appendix 7c) and lactaton, interactons (Appendix 6c). Adverse Efects Nausea, vomitng, increased risk of hypertension, myalgia, arthralgia, rashes and urtcaria, headache, confusion, generalized seizures, thrombosis specifcally during dialysis, fever, diarrhoea, tssue swelling, fu- like syndrome, paraesthesia, constpaton, nasal or chest congeston, immunogenicity leading to Pure Red Cell Aplasia. Dose Oral Adult- Iron-defciency anaemia: elemental iron 100 to 200 mg daily in divided doses. Preventon of iron defciency anaemia (in those at partcular risk): for woman- elemental iron 60 mg daily. A-Z track technique (displacement of the skin laterally prior to injecton) is recommended to avoid injecton or leakage into subcutaneous tssue. Contraindicatons Haemosiderosis, haemochromatosis; any form of anaemia not caused by iron defciency; evidence of iron overload; patents receiving repeated blood transfusions; parenteral iron therapy. Adverse Efects Nausea, vomitng, metallic taste; constpaton, diarrhoea, dark stools, epigastric pain, gastrointestnal irritaton; long-term or excessive administraton may cause haemosiderosis; allergic reacton; back pain; staining of teeth. Folic Acid* Pregnancy Category-A Indicatons Treatment of folate-defciency megaloblastc anaemia; preventon of neural tube defect in pregnancy. Dose Oral Adult- Treatment of folate-defciency, megaloblastc anaemia: 5 mg daily for 4 months (up to 15 mg daily may be necessary in malabsorpton states). Preventon of frst occurrence of neural tube defect: 400 to 500 µg daily before concepton and during the frst twelve weeks of pregnancy. Preventon of recurrence of neural tube defect: 5 mg daily (reduced to 4 mg daily, if suitable preparaton available) from at least 4 weeks before concepton untl twelfh week of pregnancy. Contraindicatons Should never be given without vitamin B12 in undiagnosed megaloblastc anaemia or other vitamin B12 defciency states because risk of precipitatng subacute combined degeneraton of the spinal cord; folate- dependent malignant disease. Precautons Women receiving antepileptc therapy need counselling before startng folic acid; pernicious anaemia; folate dependent tumor; interactons (Appendix 6c); pregnancy (Appendix 7c). Hydroxocobalamin Pregnancy Category-C Indicatons Megaloblastc anaemia due to vitamin B12 defciency, congenital intrinsic factor disease. Dose Intramuscular injecton Adult and Child- Megaloblastc anaemia without neurological involvement: initally 1 mg 3 tmes a week for 2 weeks, then 1 mg every 3 months. Megaloblastc anaemia with neurological involvement: initally 1 mg on alternate days untl no further improvement occurs, then 1 mg every 2 months. Tobacco amblyopia and Leber optc atrophy: 1 mg daily for 2 weeks, then 1 mg twice weekly untl no further improvement, then 1 mg every 1 to 3 months. Precautons Except in emergencies, should not be given before diagnosis confrmed; monitor serum potassium levels-arrhythmias secondary to hypokalaemia in early therapy; pregnancy (Appendix 7c). Adverse Efects Itching, exanthema, fever, chills, hot fushes, nausea, dizziness; rarely, acneiform and bullous eruptons, anaphylaxis; hypersensitvity; headache; diarrhoea. Iron Dextran* Pregnancy Category-C Schedule H Indicatons Iron defciency anaemia, preventon of iron defciency before, during or afer pregnancy, to make up iron defciency afer pregnancy and during lactaton. While deciding on parenteral therapy, oral therapy should be stopped at least 24 h before. Contraindicatons History of allergic disorders including asthma and eczema; infecton; actve rheumatoid arthrits; liver disease. Precautons Oral iron not to be given until 5 days after last injection; hepatic impairment; renal impairment; pregnancy (Appendix 7c); interactions (Appendix 6d). Anaphylactc reactons can occur with parenteral iron and a test dose is recommended before each dose; the patent should be carefully observed for 60 min afer the frst test dose and for 15 min afer subsequent test doses (subsequent test doses not necessary for intramuscular administraton). Facilites for cardiopulmonary resuscitaton must be at hand; risk of allergic reactons increased in immune or infammatory conditons. Adverse Efects Less commonly nausea, vomitng, abdominal pain, fushing, dyspnoea, anaphylactc reactons (see Anaphylaxis above), numbness, cramps, blurred vision, pruritus and rash; rarely, diarrhoea, chest pain, hypotension, angioedema, arrhythmias, tachycardia; dizziness, restlessness, fatgue; seizures, tremor, impaired consciousness, myalgia, arthralgia and sweatng; injecton-site rea ctons also reported, thrombophlebits; peripheral vascular fushing; taste disturbances; syncope. Precautons Interactons (Appendix 6c); pregnancy (Appendix 7c); long term administraton of high dose may cause severe peripheral neuropathies. Adverse Efects Sensory neuropathy reported with high doses given for extended periods, numbness; neurotoxicity; hyperesthesia; muscle weakness. It is estmated that 70-80% of prescriptons for antmicrobials are probably advised unnec- essarily by the health professionals. Inspite of the fact that most common colds and diarrhoeal episodes are viral in origin, yet, antmicrobials are used indiscriminately. Reasons for over prescribing are ofen lack of confdence, peer pres- sure, patent pressure and pharmaceutcal company pressure.

Hydralazine produces mainly arterial vasodilaton 40mg protonix amex, which reduces lef ventricular aferload and increases stroke volume and cardiac output discount protonix 40mg. Dopamine, an inotropic sympathomimetc, may be given for short periods in the treatment of severe heart failure. Dosage is critcal; at low doses it stmulates myocardial contractlity and increases cardiac output, however, higher doses (more than 5 µg/kg per min) cause vasoconstricton, with a wors- ening of heart failure. Adverse Efects Tachycardia and marked increase in systolic blood pressure indicate overdosage; phlebits; rarely, thrombocytopenia. Dopamine* Pregnancy Category-C Schedule H Indicatons Cardiogenic shock in myocardial infarcton or cardiac surgery; acute heart failure. Dose Intravenous infusion Adult- Cardiogenic shock: into large vein, initally 2 to 5 µg/kg/min; gradually increased by 5 to 10 µg/kg/min according to blood pressure, cardiac output and urine output; seriously ill patents up to 20 to 50 µg/kg/ min. By intravenous route initally 1 to 5 µg/ kg/min can be increased gradually to 5 to 10 µg/kg/min. Contraindicatons Hypersensitvity; tachyarrhythmias, ven- tricular fbrillaton, ischaemic heart disease; pheochromocytoma; hyperthyroidism. Precautons Correct hypovolaemia before and maintain blood volume during treatment; correct hypoxia; hypercapnia and metabolic acidosis before or at same tme as startng treatment; low dose in shock due to myocardial infarcton; history of peripheral vascular disease (increased risk of ischaemia of extremites); elderly; interactons (Appendix 6c); history of atherosclerosis; Raynaud’s disease; diabetc endocardits; dispropotonate increase in diastolic pressure; pregnancy (Appendix 7c); lactaton; paediatrics. Adverse Efects Nausea and vomitng; peripheral vasoconstricton; hypotension with dizziness; faintng; fushing; tachycardia; ectopic beats; palpitatons; anginal pain; headache; dyspnoea; hypertension partcularly in overdosage. Slow intravenous injecton Adult- Acute pulmonary oedema: 20 to 50 mg, if necessary increase by 20 mg step-by- step every 2 h; if efectve single dose is more than 50 mg, at a rate not exceeding 4 mg/ min. Slow intravenous infusion Adult- Oliguria (glomerular fltraton rate less than 20 ml/min): at a rate not exceeding 4 mg/min, initally 250 mg over 1 h. If urine output not satsfactory during the h afer frst dose, infuse 500 mg over 2 h then; if no satsfactory response is there in an h afer second dose, infuse 1g over 4 h. Contraindicatons Renal failure with anuria; precomatose states associated with liver cirrhosis; severe sodium and water depleton; hypersensitvity to sulphonamides and furosemide; hypokalaemia; addison’s disease; lactaton. Adverse Efects Hypokalaemia; hypomagnesaemia; hyponat- raemia; hypochloraemic alkalosis (for symp- toms of fuid and electrolyte imbalance; see introductory notes); increased calcium excreton; hypovolaemia; hyperglycaemia (but less ofen than with thiazide diuret- ics); temporary increase in plasma cho- lesterol and triglyceride concentraton; less commonly hyperuricaemia and gout; rarely, rash; photosensitvity; bone marrow depression (withdraw treatment); pancreat- ts (with large parenteral doses); tnnitus and deafness (with rapid administraton of large parenteral doses and in renal impairment; deafness may be permanent if other ototoxic drugs taken); gastrointestnal upset; malaise; blood dyscrasias; vertgo; orthostatc hypo- tension; jaundice; tnnitus; renal calcifcaton in premature infants. Various classes of drugs used as lipid lowering drugs are- H mg-CoA reductase inhibitors They are the most efcacious and tolerable drugs like simv- astatn, pravastatn, atorvastatn etc. They are primarily indi- cated in secondary preventon of myocardial infarcton and stroke in patents who have symptomatc atherosclerotc disease following acute myocardial infarcton or stroke and in primary preventon of arterial disease in patents who are at high risk because of elevated serum cholesterol concentra- ton. Common adverse efects include mild gastrointestnal disturbances, rhabdomyolysis etc. Fibric acid derivatves This class of drugs including fenofbrate, gemfbrozil etc are indicated in patents with mixed dyslipidemia (i. Bile acid sequestrants Drugs like cholestyramine, colestpol though are not clinically popular because of interference with absorpton of many drugs like digoxin, warfarin etc and poor patent acceptability, but can be indicated in heterozygous familiar hypercholeste- rolemia. Adverse efects include fushing, palpitatons and gastrointestnal tract disturbances. Contraindicatons Hypersensitvity; actve liver diseases or unexplained persistent elevaton of serum transaminase; pregnancy (Appendix 7c), lactaton. Precautons Patents who consume substantal quanttes of alcohol and have a history of liver diseases, Children below 10 years, premenarcheal females; interactons (Appendix 6a, 6c). Adverse Efects Myopathy is the serious adverse efect; headache; infrequent elevaton of creatnine phosphokinase; rhabdomyolysis; insomnia; dizziness; abdominal pain, constpaton, diarrhoea, dyspepsia, fatulence and nausea. Ezetmibe Pregnancy Category-C Indicatons Hypercholesterolemia, hyperlipidaemias, homozygous familial sitosterolaemia. Contraindicatons Hypersensitvity, children below 10 years, pregnancy (Appendix 7c), interactons (Appendix 6c, 6d), lactaton, moderate to severe liver disease or unexplained serum transaminase elevaton, acute pancreatts. Precautons Renal or mild hepatc impairment, immediately discontnue ezetmibe and any H mg-CoA reductase inhibitor or fbrates if myopathy is diagnosed. Storage Store protected from light and moisture at a temperature not exceeding 30⁰C Fenofbrate Pregnancy Category-C Schedule H Indicatons Hypercholesterolemia, hypertriglyceridemia. Dose Hyperlipidemia: Adult- Inital dose 67 mg 2-4 tmes a day (micronized) or 200 mg/day in divided doses (non-micronized). Contraindicatons Hypersensitvity, severe renal and hepatc impairment, preexistng gall bladder disease, primary biliary cirrhosis, pregnancy (Appendix 7c), lactaton. Nicotnic acid Pregnancy Category-C Schedule H Indicatons High risk hyperlipidaemia, nicotnic acid defciency, peripheral vascular disease. Hyperlipidaemia: Adult- 1-2 g, two to three tmes daily, maximum dose- 6 g per day; (As extended release tablets max. Peripheral vascular disease: Adult- 100- 150 mg, three to fve tmes daily; (Extended release preparaton-) 300-400 mg 12 hourly. Contraindicatons Hypersensitvity, liver disease, severe hypotension, diabetes, arterial bleeding. Precautons Gout, hepatc dysfuncton, children, pregnancy (Appendix 7c), lactaton, myasthenia gravis, interactons (Appendix 6a and 6c). Adverse Efects Headache, diarrhoea, vomitng, faintng, peptc ulcer, hyperuricaemia, gout, toxic amblyopia, fushing, hyperpigmentaton, dry skin, muscle pain, jaundice, pruritus, atrial fbrillaton. Flushing can be blocked by administering 300 mg of aspirin half an hour before taking niacin, or by taking one tablet of ibuprofen per day.

Prescribed Limit : The colour of the resulting solution is greater than that obtained by repeating the operation with no substance enclosed in the successive portions of filter paper burnt in the method for oxygen flask combustion buy cheap protonix 20 mg on line, but adding 3 cheap 20mg protonix with mastercard. Tetrachloroethylene (Free Chlorine) Perform the limit test as stated under chloroform. Selenium Sulphide Theory : Selenium is very toxic and its contamination is usually controlled by an absorptiometric method after destruction of the organic compound with fuming nitric acid. The latter converts selenium (Se) as selenous acid (H2SeO3), which on subsequent treatment with 3,3′-diaminobenzidine under controlled experimental pa- rameters, results into the formation of a highly coloured compound known as 3,4-diaminophenylpiazselenol. The latter is consequently extracted with toluene after making the aqueous solution alkaline, and the colour compared with a standard prepared likewise from a known amount of selenium. Prescribed Limit : The measured absorbance at 420 nm is not greater than that of a solution prepared by treating 5 ml of selenium standard solution (1 ppm Se) in the same manner (5 ppm, calculated as Se). What is the importance of ‘Purity’ in pharmaceutical chemicals for manufacturing drugs? Give a comprehensive account on the following aspects : (a) Biological response Vs chemical purity. Elaborate with specific examples the various sampling procedures and errors commonly encountered in a quality control laboratory. Why do the chemical purity and bioavailability of a ‘drug’ equally important to determine the efficiency of a ‘dosage form’? What are the various ‘physical parameters’ that ultimately establish the purity of a drug substance? Discuss the ‘miscellaneous characteristic features’ included in ‘official compendia’ to establish the purity, authenticity and identification of drugs. Give a detailed account on the ‘Limit Tests’ Vs ‘Quantitative Determinations’ by providing suitable examples. Describe the theory, apparatus and procedure involved in the ‘limit tests’ for metallic impurities e. Elaborate the various ‘limit tests’ recommended for the ‘Non-metallic Impurities’ in official compendia e. How will you determine the limit test for ‘Iron’ in Calcium Lactate and Zinc Oxide? Volumetric analysis essentially comprises of the most precise and accurate measurement of interacting solutions or reagents. It makes use of a number of graduated apparatus, such as : graduated (volumetric) flasks, burettes, pipettes and measuring cylinder of different capacities (volumes). However, it is pertinent to mention here that quite a few techniques related to measurement of pharmaceutical substances and reagents involved is more or less common to both gravimetric and volumetric analysis. Besides, in gravimetric analysis, some more additional techniques play a vital role, namely : precipitation, filtration, washing of the precipitate and ignition of the precipitate. Biomedical analytical chemistry happens to be one of the latest disciplines which essentially embraces the principles and techniques of both analytical chemistry and biochemistry. This particular aspect of analytical chemistry has gained significant cognizance in the recent past by virtue of certain important techniques being included very much within its scope of analysis, namely : colorimetric assays, enzymic assays, radioimmunoassays and automated methods of clinical analysis. It is, however, important to mention here that certain other routine procedures also carried out in a clinical laboratory fall beyond the scope of biomedical analytical chemistry, narnely : microbiological assays, heamatological assays, serum analysis, urine analysis and assays of other body fluids. Titrant is the solution of known strength (or concentration) employed in the assay e. Titration is the process of adding and then actually measuring the volume of titrant consumed in the assay. Indicator is a chemical substance sensitive enough to display an apparent change in colour very close to the point in the ongoing titration process at which equivalent quantities of analyte and titrant have almost virtually reacted with each other. Equivalence Point (or Stoichiometric Point) is the point at which there appears an abrupt change in certain characteristic of the prevailing reaction mixture—a change that is either ascertained electrometrically or is visibly spotted by the use of indicators. In usual practice, the volumetric titrations may be accomplished either by direct titration method e. In other words, 1 g of H, acting as a reducing agent, loses electrons equivalent to 96,500 C. Thus, most calculations in volumetric determinations (titrimetry) are enormously facilitated by using titer values, which may be seen in the following chapters related to various categories of volumetric titrations. For instance, in the offcial procedure for the assay of tartaric acid, it is stated that ‘Each millilitre of 1 N sodium hydroxide is equivalent to 75. However, the weights are measured upto the fourth place of decimal by using a manually operated good analytical balance or a single-pan electrical balance that need to be calibrated periodically with the help of a standard weight box. In the broader sense, volumetric apparatus may be divided into two categories, namely : (a) To deliver a definite volume of liquid, and (b) To contain a definite volume of liquid. A burette is a graduated glass tube of uniform bore throughout the entire length, used for the accurate delivery and measurement of variable volumes of liquids. They are usually closed at the bottom either by a Teflon or glass stopcock to monitor and control the outflow of liquid. The tolerances on capacity for burettes, as speci- fied in the relevant Indian Standards Institution, specifications are given in Table 2.

When the bleeder for external wells shall emit product consistency is specified in the steam continuously during the entire scheduled process 40 mg protonix with amex, the consistency of processing period discount protonix 20 mg fast delivery. I (4–1–10 Edition) shall be the reference instrument for additional bleeders shall be located not indicating the processing temperature. Each Bleeders may be installed at positions retort shall have an accurate tempera- other than those specified above, as ture-recording device. Graduations on long as there is evidence in the form of the temperature-recording devices heat distribution data that they ac- shall not exceed 2 °F within a range of complish adequate removal of air and 10 °F of the processing temperature. Each chart shall have a working scale In retorts having top steam inlet and of not more than 55 °F per inch within bottom venting, a bleeder shall be in- a range of 20 °F of the processing tem- stalled in the bottom of the retort to perature. All bleeders shall be adjusted to agree as nearly as pos- be arranged in a way that enables the sible with, but to be in no event higher operator to observe that they are func- than, the known accurate mercury-in- tioning properly. A means of preventing unauthor- The air in each retort shall be removed ized changes in adjustment shall be before processing is started. A lock, or a notice from man- tribution data or documentary proof agement posted at or near the record- from the manufacturer or from a com- ing device that provides a warning that petent processing authority, dem- only authorized persons are permitted onstrating that adequate venting is to make adjustments, is a satisfactory achieved, shall be kept on file. At the means for preventing unauthorized time steam is turned on, the drain changes. The recorder may be com- should be opened for a time sufficient bined with the steam controller and to remove steam condensate from the may be a recording-controlling instru- retort and provision should be made for ment. The temperature-recorder bulb containing drainage of condensate dur- shall be installed either within the re- ing the retort operation. Each temperature-recorder bulb speed of the retort shall be specified in well shall have a 1⁄16-inch or larger the schedules process. The speed shall bleeder opening emitting steam con- be adjusted, as necessary, to ensure tinuously during the processing period. The rotational speed should have adequate filter systems to as well as the process time shall be re- ensure a supply of clean, dry air. Each retort should Alternatively, a recording tachometer be equipped with a pressure gage, may be used to provide a continuous which should be graduated in divisions record of the speed. A lock, or a be equipped with an automatic steam notice from management posted at or controller to maintain the retort tem- near the speed-adjustment device that perature. This may be a recording-con- provides a warning that only author- trolling instrument when combined ized persons are permitted to make ad- with a recording thermometer. A justments, is a satisfactory means of steam controller activated by the preventing unauthorized changes. Critical factors able if it is mechanically maintained specified in the schedules process shall so that it operates satisfactorily. Bleeders, except those for essing record at intervals of sufficient thermometer wells, shall be one-eighth frequency to ensure that the factors inch or larger and shall be wide open are within the limits specified in the during the entire process, including the scheduled process. Graduations on seam (vent hole) cans may be measured the temperature-recording devices by net weight determinations. When shall not exceed 2 °F within a range of the product consistency is specified in 10 °F of the processing temperature. The temperature chart shall and recorded at intervals of sufficient be adjusted to agree as nearly as pos- frequency to ensure that the consist- sible with, but to be in no event higher ency is as specified in the scheduled than, the known accurate mercury-in- process. Minimum closing machine glass thermometer during the process vacuum in vacuum-packed products, time. A means of preventing unauthor- maximum fill-in or drained weight, ized changes in adjustment shall be minimum net weight, and percent sol- provided. A lock, or a notice from man- ids shall be as specified in the sched- agement posted at or near the record- uled process for all products for which ing device that provides a warning that deviations from such specifications only authorized persons are permitted may affect the scheduled process. All to make adjustment, is a satisfactory measurements and recordings of crit- means for preventing unauthorized ical factors should be made at intervals changes. The temperature-recorder bulb agitating retorts—(1) Indicating mercury- shall be installed either within the re- in-glass thermometer. Each retort shall tort shell or in a well attached to the be equipped with at least one mercury- shell. Air-operated temperature con- in-glass thermometer whose divisions trollers should have adequate filter are easily readable to 1 °F and whose systems to ensure a supply of clean dry temperature range does not exceed 17 air. Each retort should against a known accurate standard be equipped with a pressure gage which thermometer upon installation and at should be graduated in divisions of 2 least once a year thereafter, or more pounds or less. Records of thermometer ac- be equipped with an automatic steam curacy checks which specify date, controller to maintain the retort tem- standard use, method used, and person perature. This may be a recording-con- performing the test should be main- trolling instrument when combined tained. The rotational that includes the date on which it was speed of the retort shall be specified in last tested for accuracy. The speed shall eter that has a divided mercury column be adjusted, as necessary, to ensure or that cannot be adjusted to the that the speed is as specified in the standard shall be repaired or replaced scheduled process. Ther- as well as the process time shall be re- mometers shall be installed where they corded for each retort load processed.