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Cohort 11 Group 4 AM Shift Bauyon, Leslie Cagungao, Giselle Dela Pena, Arrianne Dioso, Prime Letigio, Althea Luna, Edward Munar, Sheerna Navarro, Michelle Nocon, Pia Pacis, Jomar Santos, Aldrin CLONIDINE HYDROCHLORIDE Catapres, Catapres-TTS, Dixaril , Duraclon Classification cardiovascular agent; central-acting antihypertensive; analgesic Indication Step 2 drug in stepped-care approach to treatment of hypertension, either alone or with diuretic or other antihypertensive agents. Epidural administration as adjunct therapy for severe pain. Contraindication Pregnancy (category C), lactation. Use of clonidine patch in polyarteritis nodosa, scleroderma, SLE Warnings/precautions Avoid abrupt discontinuation. Tabs may cause rash if have allergic reaction to patch. Continue tabs to within 4 hours of surgery resume and as soon as possible thereafter. Do not remove patch for surgery. Caution with severe coronary insufficiency, conduction disturbances, recent MI, cerebrovascular disease or chronic cardioversion due to potential risk of altered electrical conductivity or MRI due to occurrence of burn Action Centrally acting antiadrenergic derivative. Stimulates alpha 2-adrenergic receptors in CNS to inhibit sympathetic vasomotor centers. Central actions reduce plasma concentrations of norepinephrine. It decreases systolic and diastolic BP and heart rate. Orthostatic effects tend to be mild and occur infrequently. Also inhibits renin release from kidneys. Side effects CV: Hypotension (epidural), postural hypotension (mild), peripheral edema, ECG changes, tachycardia, bradycardia, flushing, rapid increase in BP with abrupt withdrawal. GI: Dry mouth, constipation, abdominal pain, pseudo-obstruction of large bowel, altered taste, nausea, vomiting, hepatitis, hyperbilirubinemia, weight gain (sodium retention). CNS: Drowsiness, sedation, dizziness, headache, fatigue, weakness, sluggishness, dyspnea, vivid dreams, nightmares, insomnia, behavior changes, agitation, hallucination, nervousness, restlessness, anxiety, mental depression. Skin: Rash, pruritus, thinning of hair, exacerbation of psoriasis; with transdermal patch: hyperpigmentation, recurrent herpes simplex, skin irritation, contact dermatitis, mild erythema. Special Senses: Dry eyes. Urogenital: Impotence, loss of libido. Adverse Reactions dry mouth drowsiness dizziness constipation sedation impotence or sexual dysfunction nausea vomiting alopecia weakness orthostatic symptoms nervousness localized skin reactions (patch) Dosage Adults: (patch) apply to hairless, intact area of upper arm or chest weekly. Taper withdrawal of previous antihypertensive. Initial: 0.1mg/24hr patch weekly. Titrate: may increase after 1-2 weeks. Max: 0.6mg/24hr. (tab) initial:0.1mg bid. Titrate: may increase by 0.1mg weekly. Usual: 0.2-0.6mg/day in divided doses. Max: 2.4mg/day. (patch, tab) renal impairment: adjust according to degree impairment. Nursing Responsibilities Assessment & Drug Effects Monitor BR closely. Determine positional changes (supine, sitting, standing). With epidural administration, frequently monitor BP and HR. Hypotension is a common side effect that may require intervention. Monitor BP closely whenever a drug is added to or withdrawn from therapeutic regimen. Monitor I&O during period of dosage adjustment. Report change in I&O ratio or change in voiding pattern. Determine weight daily. Patients not receiving a concomitant diuretic agent may gain weight, particularly during first 3 or 4 d of therapy, because of marked sodium and water retention. Supervise closely patients with history of mental depression, as they may be subject to further depressive episodes. ZOLPIDEM TITRATE Ambien Classification laxatives, osmotics Definition A white powder for reconstitution. MiraLax (polyethylene glycol 3350, NF) is a synthetic This medication is used to treat occasional constipation. It works by holding water in the stool to soften the stool and increases the number of bowel movements. It is known as an osmotic-type laxative. Molecular weight: polyglycol having an average molecular weight of 3350. The actual molecular weight is not less than 90.0 percent and not greater than 110.0 percent of the nominal value. Chemical Formula The chemical formula is HO(C2H4O)n H in which n represents the average number of oxyethylene groups. Below 55° C it is a free flowing white powder freely soluble in water. Indication Short-term treatment of insomnia Dose 1 packet Route P.O. Dosage Duration of therapy should be limited to 7-10 days Adults: Oral: 10 mg immediately before bedtime; maximum dose: 10 mg Elderly: 5 mg immediately before bedtime Hemodialysis: Not dialyzable Dosing adjustment in hepatic impairment: Decrease dose to 5 mg Administration Ingest immediately before bedtime due to rapid onset of action Monitoring Parameters: Daytime alertness; respiratory and cardiac status Reference Range: 80-150 ng/mL Patient Education Use exactly as directed; do not increase dose or frequency or discontinue without consulting prescriber. Drug may cause physical and/or psychological dependence. While using this medication, do not use alcohol or other prescription or OTC medications (especially, pain medications, sedatives, antihistamines, or hypnotics) without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. You may experience drowsiness, dizziness, or blurred vision (use caution when driving or engaging in tasks requiring alertness until response to drug is known); nausea (small, frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help); or diarrhea (buttermilk, boiled milk, yogurt may help). Report CNS changes (confusion, depression, increased sedation, excitation, headache, abnormal thinking, insomnia, or nightmares); muscle pain or weakness; respiratory difficulty; chest pain or palpitations; or ineffectiveness of medication. Breast-feeding precaution: Consult prescriber if breast-feeding. Nursing Implications Patients may require assistance with ambulation; lower doses in the elderly are usually effective; institute safety measures Additional Information Causes less disturbances in sleep stages as compared to benzodiazepines. Time spent in sleep stages 3 and 4 are maintained; decreases sleep latency. Should not be prescribed in quantities exceeding a 1-month supply. Anesthesia and Critical Care Concerns/Other Considerations Causes less disturbances in sleep stages as compared to benzodiazepines; time spent in sleep stages 3 and 4 are maintained. Zolpidem decreases sleep latency; should not be prescribed in quantities exceeding a 1-month supply. References http://health.yahoo.com/sleep-medications/zolpidem/healthwise--d00910a1.html http://www.rxlist.com/ambien-drug.htm POLYETHYLENE GLYCOL (PEG) Miralax Classification laxatives, osmotics Definition A white powder for reconstitution. MiraLax (polyethylene glycol 3350, NF) is a synthetic This medication is used to treat occasional constipation. It works by holding water in the stool to soften the stool and increases the number of bowel movements. It is known as an osmotic-type laxative. Molecular weight: polyglycol having an average molecular weight of 3350. The actual molecular weight is not less than 90.0 percent and not greater than 110.0 percent of the nominal value. Chemical Formula The chemical formula is HO(C2H4O)n H in which n represents the average number of oxyethylene groups. Below 55° C it is a free flowing white powder freely soluble in water. Indication constipation Dose 1 packet Route P.O. Pharmakodynamics Onset: unknown Peak: 2-4 days Duration: unknown Normal dosage range: 17g. (one heaping teaspoon) in 8oz. of water may be used for up to two weeks Mechanism of Action Acts as an osmotic agent, drawing water into the lumen of the GI tract. Indicated for evacuation of the GI tract without water or electrolyte imbalance. Precaution Ask patient if with any allergic reaction to the medication Side effects Bloating, cramps, gas, nausea High doses may cause diarrhea and excessive frequency Contraindications Gi obstructions, gastric retention, toxic colitis, megacolon Use cautiously in abdominal pain of uncertain cause, particularly if accompanied by fever Nursing consideration Inform patient that 2-4 days may be required to produce a bowel movement. Should not be used for more than 2 weeks. Take on prescribed time. Skip the one missed and return to regular schedule. Do not take two doses at once. Prolonged, frequent or excessive use may result in electrolyte imbalance and laxative dependence . Advice patient to notify health care professional if unusual cramps, bloating or diarrhea occurs. Reference http://www.scribd.com/doc/6686280/MiraLax CINACALCET Sensipar Classification Calcimimetic agent Indications Sensipar® is indicated for the treatment of secondary hyperparathyroidism in patients with Chronic Kidney Disease on dialysis. Sensipar® is indicated for the treatment of hypercalcemia in patients with parathyroid carcinoma. Contraindications Sensipar® is contraindicated component(s) of this product. in patients with hypersensitivity to any Pharmacokinetics Absorption and Distribution After oral administration of cinacalcet, maximum plasma concentration (Cmax) is achieved in approximately 2 to 6 hours. A food-effect study in healthy volunteers indicated that the Cmax and area under the curve (AUC(0-inf)) were increased 82% and 68%, respectively, when cinacalcet was administered with a high-fat meal compared to fasting. Cmax and AUC(0-inf) of cinacalcet were increased 65% and 50%, respectively, when cinacalcet was administered with a low-fat meal compared to fasting. After absorption, cinacalcet concentrations decline in a biphasic fashion with a terminal half-life of 30 to 40 hours. Steady-state drug levels are achieved within 7 days. The mean accumulation ratio is approximately 2 with once-daily oral administration. The median accumulation ratio is approximately 2 to 5 with twice-daily oral administration. The AUC and Cmax of cinacalcet increase proportionally over the dose range of 30 to 180 mg once daily. The pharmacokinetic profile of cinacalcet does not change over time with once- daily dosing of 30 to 180 mg. The volume of distribution is high (approximately 1000 L), indicating extensive distribution. Cinacalcet is approximately 93 to 97% bound to plasma protein(s). The ratio of blood cinacalcet concentration to plasma cinacalcet concentration is 0.80 at a blood cinacalcet concentration of 10 ng/mL. Metabolism and Excretion Cinacalcet is metabolized by multiple enzymes, primarily CYP3A4, CYP2D6 and CYP1A2. After administration of a 75 mg radiolabeled dose to healthy volunteers, cinacalcet was rapidly and extensively metabolized via: 1) oxidative N-dealkylation to hydrocinnamic acid and hydroxy-hydrocinnamic acid, which are further metabolized via β-oxidation and glycine conjugation; the oxidative Ndealkylation process also generates metabolites that contain the naphthalene ring; and 2) oxidation of the naphthalene ring on the parent drug to form dihydrodiols, which are further conjugated with glucuronic acid. The plasma concentrations of the major circulating metabolites including the cinnamic acid derivatives and glucuronidated dihydrodiols markedly exceed parent drug concentrations. The hydrocinnamic acid metabolite was shown to be inactive at concentrations up to 10 μM in a cell-based assay measuring calcium-receptor activation. The glucuronide conjugates formed after cinacalcet oxidation were shown to have a potency approximately 0.003 times that of cinacalcet in a cell-based assay measuring a calcimimetic response. Renal excretion of metabolites was the primary route of elimination of radioactivity. Approximately 80% of the dose was recovered in the urine and 15% in the feces. Pharmacodynamics Reduction in intact PTH (iPTH) levels correlated with cinacalcet concentrations in CKD patients. The nadir in iPTH level occurs approximately 2 to 6 hours post dose, corresponding with the Cmax of cinacalcet. After steady state is reached, serum calcium concentrations remain constant over the dosing interval in CKD patients. How Supplied Sensipar® 30 mg tablets are formulated as light-green, film-coated, oval-shaped tablets printed with “AMGEN” on one side and “30”on the opposite side, packaged in bottles of 30 tablets. (NDC 55513-073-30) Sensipar® 60 mg tablets are formulated as light-green, film-coated, oval-shaped tablets printed with “AMGEN” on one side and “60”on the opposite side, packaged in bottles of 30 tablets. (NDC 55513-074-30) Sensipar® 90 mg tablets are formulated as light-green, film-coated, oval-shaped tablets printed with “AMGEN” on one side and “90”on the opposite side, packaged in bottles of 30 tablets. (NDC 55513-075-30) Dosage and Administration Sensipar® tablets should be taken whole and should not be divided. Sensipar® should be taken with food or shortly after a meal. Dosage must be individualized All iPTH measurements during the Sensipar® trials were obtained using the Nichols IRMA. In patients with end-stage renal disease, testosterone levels are often below the normal range. In a placebo-controlled trial in patients with CKD on dialysis, there were reductions in total and free testosterone in male patients following six months of treatment with Sensipar®. Levels of total testosterone decreased by a median of 15.8% in the Sensipar® -treated patients and by 0.6% in the placebo-treated patients. Levels of free testosterone decreased by a median of 31.3% in the Sensipar® -treated patients and by 16.3% in the placebo-treated patients. The clinical significance of these reductions in serum testosterone is unknown. Side Effects Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease on Dialysi9 In 3 double-blind placebo-controlled clinical trials, 1126 CKD patients on dialysis received study drug (656 Sensipar®, 470 placebo) for up to 6 months. The most frequently reported adverse events (incidence of at least 5% in the Sensipar® group and greater than placebo) are provided in Table 2. The most frequently reported events in the Sensipar® group were nausea, vomiting, and diarrhea. Table 2. Adverse Event Incidence ( ≥ 5%) in Patients on Dialysis Placebo Sensipar® Event*: (n = 470) (n = 656) (%) (%) Nausea 19 31 Vomiting 15 27 Diarrhea 20 21 Myalgia 14 15 Dizziness 8 10 Hypertension 5 7 Asthenia 4 7 Anorexia 4 6 Pain Chest, Non-Cardiac 4 6 Access Infection 4 5 * Included are events that were reported at a greater incidence in the Sensipar ® group than in the placebo group. The incidence of serious adverse events (29% vs. 31%) was similar in the Sensipar® and placebo groups, respectively. Nursing Considerations It is recommended that Sensipar® be taken with food or shortly after a meal. Tablets should be taken whole and should not be divided. SIMVASTATIN Zocor Classification Cholesterol-lowering agent; Antilipemic Indication Simvastatin is used for reducing total cholesterol, LDL cholesterol, and triglycerides, and for increasing HDL cholesterol. In patients with coronary heart disease, diabetes, peripheral vessel disease, or history of stroke or other cerebrovascular disease, simvastatin is prescribed for reducing the risk of mortality by reducing death from coronary heart disease, reducing nonfatal myocardial infarction (heart attack) and stroke, and reducing the need for coronary and noncoronary revascularization procedures Contraindications • • • Hypersensitivity to simvastatin or to any of the excipients Active liver disease or unexplained persistent elevations of serum transaminases Pregnancy and lactation (see section 4.6) Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone) (see section 4.5). Pharmacokinetics Simvastatin is an inactive lactone which is readily hydrolyzed in vivo to the corresponding beta hydroxyacid, a potent inhibitor of HMG CoA reductase. Hydrolysis takes place mainly in the liver; the rate of hydrolysis in human plasma is very slow. Absorption In man simvastatin is well absorbed and undergoes extensive hepatic first-pass extraction. The extraction in the liver is dependent on the hepatic blood flow. The liver is the primary site of action of the active form. The availability of the beta hydroxyacid to the systemic circulation following an oral dose of simvastatin was found to be less than 5 % of the dose. Maximum plasma concentration of active inhibitors is reached approximately 1 2 hours after administration of simvastatin. Concomitant food intake does not affect the absorption. The pharmacokinetics of single and multiple doses of simvastatin showed that no accumulation of medicinal product occurred after multiple dosing. Distribution The protein binding of simvastatin and its active metabolite is > 95 %. Elimination Simvastatin is a substrate of CYP3A4 (see sections 4.3 and 4.5). The major metabolites of simvastatin present in human plasma are the beta hydroxyacid and four additional active metabolites. Following an oral dose of radioactive simvastatin to man, 13 % of the radioactivity was excreted in the urine and 60 % in the faeces within 96 hours. The amount recovered in the faeces represents absorbed medicinal product equivalents excreted in bile as well as unabsorbed medicinal product. Following an intravenous injection of the beta hydroxyacid metabolite, its half-life averaged 1.9 hours. An average of only 0.3 % of the IV dose was excreted in urine as inhibitors. Pharmacodynamics Pharmacotherapeutic group: HMG CoA reductase inhibitor ATC-Code: C10A A01 After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed in the liver to the corresponding active beta hydroxyacid form which has a potent activity in inhibiting HMG CoA reductase (3 hydroxy – 3 methylglutaryl CoA reductase). This enzyme catalyses the conversion of HMG CoA to mevalonate, an early and ratelimiting step in the biosynthesis of cholesterol. 'Zocor' has been shown to reduce both normal and elevated LDL C concentrations. LDL is formed from very-low-density protein (VLDL) and is catabolised predominantly by the high affinity LDL receptor. The mechanism of the LDL lowering effect of 'Zocor' may involve both reduction of VLDL-cholesterol (VLDL C) concentration and induction of the LDL receptor, leading to reduced production and increased catabolism of LDL C. Apolipoprotein B also falls substantially during treatment with 'Zocor'. In addition, 'Zocor' moderately increases HDL C and reduces plasma TG. As a result of these changes the ratios of total- to HDL C and LDL- to HDL C are reduced. How Supplied Tablets: 5, 10, 20, 40, and 80 mg. Oral disintegrating tablets: 10, 20, 40, and 80 mg. Dosage The dose range for is 5-80 mg/day given preferably in the evening. The usual staring dose is 20-40 mg once daily. Dose adjustments are made at weekly intervals. Administration Take this medication by mouth usually once daily in the evening, with or without food. Certain medical conditions (e.g., familial hypercholesterolemia) may require more frequent dosage instructions as directed by your doctor. Dosage is based on your medical condition, response to therapy, and use of certain interacting medicines. Many of the drugs listed in the Drug Interactions section may increase the chances of muscle injury when used with simvastatin. Consult your doctor or pharmacist for more details. Limit the amount of grapefruit or grapefruit juice you may eat or drink (less than 1 quart a day) while being treated with this medication, unless specifically directed otherwise. Grapefruit juice may increase the amount of certain medications in your bloodstream. Consult your doctor or pharmacist for more details. If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take simvastatin at least 1 hour before or at least 2 hours after these medications. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. It may take up to 4 weeks before the full benefit of this drug takes effect. It is important to continue taking this medication even if you feel well. Most people with high cholesterol or triglycerides do not feel sick. Side Effects The most common side effects of simvastatin are headache, nausea, vomiting, diarrhea, abdominal pain, muscle pain, and abnormal liver tests. Hypersensitivity reactions have also been reported. The most serious potential side effects are liver damage and muscle inflammation or breakdown. Simvastatin is a statin. Therefore it shares side effects, such as liver and muscle damage associated with all statins. Serious liver damage caused by statins is rare. More often, statins cause abnormalities of liver tests, and, therefore, periodic measurement of liver tests in the blood is recommended for all statins. Abnormal tests usually return to normal even if a statin is continued, but if the abnormal test value is greater than three times the upper limit of normal, the statin usually is stopped. Liver tests should be measured before simvastatin is started and periodically thereafter or if there is a medical concern about liver damage. Liver tests should be performed before the 80 mg dose of simvastatin is initiated, three months after initiation and then periodically thereafter. Inflammation of the muscles caused by statins can lead to a serious breakdown of muscle cells called rhabdomyolysis. Rhabdomyolysis causes the release of muscle protein (myoglobin) into the blood. Myoglobin can cause kidney failure and even death. When used alone, statins cause rhabdomyolysis in less than one percent of patients. To prevent the development of rhabdomyolysis, patients taking simvastatin should contact their healthcare provider immediately if they develop unexplained muscle pain, weakness, or muscle tenderness. Nursing Considerations Monitor the client’s blood lipid levels (cholesterol, triglycerides, low-density lipoprotein [LDL], and high-density lipoprotein [HDL] every 6 to 8 wk for the first 6 months after lovastatin therapy and then every 3 to 6 months. For lipid level profile, the client should fast for 12 to 14 hours. Desired cholesterol value is <200 mg/dL; triglyceride value is <150 mg/dL (can vary); LDL is <130 mg/dL; and HDL is >60mg/dL. Cholesterol levels of >240 mg/dL, LDL levels of >160 mg/dL, and HDL levels of <35mg/dL can lead to severe cardiovascular or cerebral vascular accident. Monitor laboratory tests for liver function, such as ALT, ALP, and GGTP. Antilipemic drugs may cause liver disorder. Observe for signs and symptoms of GI upset. Taking the drug with sufficient water or with meals may alleviate some of the GI discomfort. GENTAMICIN SULFATE Classifications antiinfective; aminoglycoside antibiotic Dosage and Route Moderate to Severe Infection Adult: IV/IM 1.5–2 mg/kg loading dose followed by 3–5 mg/kg/d in 2–3 divided doses Intrathecal 4–8 mg preservative free q.d. Topical 1–2 drops of solution in eye q4h up to 2 drops q1h or small amount of ointment b.i.d. or t.i.d. Child: IV/IM 6–7.5 mg/kg/d in 3–4 divided doses Intrathecal >3 mo, 1–2 mg preservative free q.d. Neonate: IV/IM 2.5 mg/kg q12–24h Acute Pelvic Inflammatory Disease Adult: IV/IM 2 mg/kg followed by 1.5 mg/kg q8h Prophylaxis of Bacterial Endocarditis Adult: IV/IM 1.5 mg/kg 30 min before procedure, may repeat in 8 h Child: IV/IM < 27 kg, 2 mg/kg 30 min before procedure, may repeat in 8 h Broad-spectrum aminoglycoside purpurea. Action is usually bacteriocidal. antibiotic derived from Micromonospora Indication Parenteral use restricted to treatment of serious infections of GI, respiratory, and urinary tracts, CNS, bone, skin, and soft tissue (including burns) when other less toxic antimicrobial agents are ineffective or are contraindicated. Has been used in combination with other antibiotics. Also used topically for primary and secondary skin infections and for superficial infections of external eye and its adnexa. Contraindication History of hypersensitivity to or toxic reaction with any aminoglycoside antibiotic. Safe use during pregnancy (category C) or lactation is not established Side effects Special Senses: Ototoxicity (vestibular disturbances, impaired hearing), optic neuritis. CNS: neuromuscular blockade: skeletal muscle weakness, apnea, respiratory paralysis (high doses); arachnoiditis (intrathecal use). CV: hypotension or hypertension. GI: Nausea, vomiting, transient increase in AST, ALT, and serum LDH and bilirubin; hepatomegaly, splenomegaly. Hematologic: Increased or decreased reticulocyte counts; granulocytopenia, thrombocytopenia (fever, bleeding tendency), thrombocytopenic purpura, anemia. Body as a Whole: Hypersensitivity (rash, pruritus, urticaria, exfoliative dermatitis, eosinophilia, burning sensation of skin, drug fever, joint pains, laryngeal edema, anaphylaxis). Urogenital: Nephrotoxicity: proteinuria, tubular necrosis, cells or casts in urine, hematuria, rising BUN, nonprotein nitrogen, serum creatinine; decreased creatinine clearance. Other: Local irritation and pain following IM use; thrombophlebitis, abscess, superinfections, syndrome of hypocalcemia (tetany, weakness, hypokalemia, hypomagnesemia). Nursing Considerations Assessment & Drug Effects Lab tests: Perform C&S and renal function prior to first dose and periodically during therapy; therapy may begin pending test results. Determine creatinine clearance and serum drug concentrations at frequent intervals, particularly for patients with impaired renal function, infants (renal immaturity), older adults, patients receiving high doses or therapy beyond 10 d, patients with fever or extensive burns, edema, obesity. Repeat C&S if improvement does not occur in 3–5 d; reevaluate therapy. Note: Dosages are generally adjusted to maintain peak serum gentamicin concentrations of 4– 10 g/mL, and trough concentrations of 1–2 g/mL. Peak concentrations above 12 g/mL and trough concentrations above 2 g/mL are associated with toxicity. Draw blood specimens for peak serum gentamicin concentration 30 min–1h after IM administration, and 30 min after completion of a 30–60 min IV infusion. Draw blood specimens for trough levels just before the next IM or IV dose. Use nonheparinized tubes to collect blood. CLOPIDOGREL (AS BISULFATE) Plavix Classification Antiplatelet agent Action Inhibits platelet aggregation by blocking ADP receptors on platelets, prevents clumping of platelets. Indication Reduction of atherosclerotic events in: recent MI or stroke, peripheral arterial disease; non-ST-segment elevation acute coronary syndrome (unstable angina/non-Qwave MI) or ST-segment elevation acute MI; see literature. Contraindication Active pathologic bleeding (eg, peptic ulcer, intracranial hemorrhage). Risk of bleeding (eg, surgery, ulcers, trauma, concomitant NSAIDs). Severe hepatic or renal disease. Consider discontinuing 5 days before elective surgery. Pregnancy (Cat.B). Nursing mothers: not recommended. Side effects Bleeding, GI upset/ulcers, bruising, rash, pruritus, dizziness, headache; rare: thrombotic thrombocytopenic purpura, neutropenia, agranulocytosis. Interaction Caution with drugs that increase risk of bleeding (eg, NSAIDs, warfarin), and with drugs metabolized by CYP2C9 (eg, phenytoin, tolbutamide, tamoxifen, warfarin, torsemide, fluvastatin, many NSAIDs). Pharmacodynamics Onset: 3-7 days Peak: within 24 hours Duration:5 days Normal dosage range: 75mg once daily Availability 75mg, 300mg; tabs Nursing Consideration Assess for symptoms of MI, stroke during treatment. Monitors liver function studies: AST, ALT, bilirubin, creatinine if patient is on long term therapy. Monitor blood studies: CBC, Hgb, Hct, protime, cholesterol if the patient is on long term therapy; thrombocytopenia and neutropenia may occur. CAPSAICIN Capsagel, Salonpas-Hot, Zostrix Classification Antipruritic, Topical analgesic Dosage Pain: Topical (0.025-0.075% cream) three to five times daily. Apply thin film of cream. No residue should remain. Less frequent use (<3 times daily) may decrease clinical efficacy and increase local discomfort. Avoid contact with eyes and broken or irritated skin. For Post Herpetic Neuralgia, apply to skin only after zoster lesions have healed. Transient burning may occur on application but generally disappears in several days. Psoriasis: Topical (0.01-0.025% cream) four to six times daily. Mode of Action Capsaicin is a naturally occurring substance derived from plants of the Solanaceae family (red peppers) with the chemical name trans-8-methyl-N-vanillyl-6noneamide. The precise mechanism of action is not fully understood but capsaicin renders skin and joints insensitive to pain by initial release then depletion of substance P (the principal chemical mediator) in peripheral sensory neurons and in joint tissues. Initial exposure to capsaicin induces an intense excitation after which the neurons become temporarily inactive. Capsaicin decreases substance P induced activation of inflammatory mediators involved with the pathogenesis of rheumatoid arthritis. Capsaicin may provide effective relief of burning, shooting neuropathic pain and pain associated with inflammatory joint diseases. Capsaicin does not appear to act directly on central cells in the brain and spinal cord Indication For temporary relief of pain from rheumatoid arthritis, osteoarthritis, post mastectomy pain and relief of neuralgias e.g. diabetic neuropathy, post herpetic neuralgia, phantom limb pain; treatment of psoriasis vulgaris, hemodialysis associated pruritus Contraindication broken skin skin irritation previous allergic reactions to capsaicin, hot peppers, other drugs, dyes, foods, preservatives breastfeeding pregnancy or current attempts to become pregnant not to be used by children under 2 years of age Pharmacokinetics Onset: 14-28 days (up to 4 weeks) Peak effect: variable Duration of Action: 3-6 hours Pharmacodynamics Elimination: hepatic Side effects/adverse effects Warmth, stinging, or burning on the application site may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly. Coughing, sneezing, watery eyes, or throat irritation may occur if you breathe in the dried residue from the medication. Use caution to avoid inhaling the residue. If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: blistering/swelling at the application site. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Nursing considerations Instruct patient the following: 1. For the cream, gel, and lotion forms, apply a thin layer of medication to the affected area and rub in gently and thoroughly. You may want to use a cotton ball/swab or latex glove to apply the medication to avoid touching the medication with your hands. 2. Do not apply the medication in the eyes, mouth, nostrils, or genitals. If you do get the medication in those areas, flush with plenty of water. Also, do not apply this medication to skin that is injured or irritated (e.g., cut, scraped, sunburned). 3. Do not apply this medication immediately before or after activities such as bathing, swimming, sun bathing, or heavy exercise. Do not bandage or wrap the affected 4. 5. 6. 7. 8. area or use a heating pad on that area. Doing so may increase the risk of side effects. After applying the medication, wash your hands unless you are using this medication to treat the hands. If treating the hands, wait at least 30 minutes after applying the medication to wash your hands. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. Capsaicin may cause transient burning on initial application. Local reactions diminish with continued therapy but can be persistent and severe in some patients. Avoid mixing capsaicin cream with other topical medications This medication may sometimes take up to 2 months to work. Tell your doctor if your condition persists for more than 7 days, if it worsens, or if it keeps returning. If you think you may have a serious medical problem, seek immediate medical attention. B COMPLEX-VITAMIN C-FOLIC ACID Nephro-vite Classification Multivitamins Dosage Take this medication by mouth, usually once daily or as directed by the physician. Mode of Action Vitamins are important building blocks of the body and help keep you in good health. B vitamins include thiamine, riboflavin, niacin/niacinamide, vitamin B6, vitamin B12, folic acid, and pantothenic acid. Indication For the distinctive nutritional needs of renal patients. To treat or prevent vitamin deficiency due to poor diet, certain illnesses, or during pregnancy. Contraindication Hypersensitivity to the drug Side effects/adverse effects Constipation, diarrhea, or upset stomach may occur. These effects are usually temporary and may disappear as your body adjusts to this medication. If any of these effects persist or worsen, contact your doctor or pharmacist promptly. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching, swelling, severe dizziness, trouble breathing. Nursing considerations Instruct patient the following: 1. If you are taking chewable tablets, chew the tablet thoroughly before swallowing. 2. If you are taking a timed-release capsule or tablet, swallow it whole. Do not crush, chew, or break the capsule/tablet. Doing so can destroy the long action of the drug and may increase side effects. 3. If you are taking a liquid product, use a medication-measuring device to carefully measure the dose. Do not use a household spoon. Some liquid products need to be shaken before each dose. Some products that contain vitamin B12 need to be placed under the tongue and held there before swallowing. Follow label directions carefully to get the most benefit. 4. Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time each day. 5. Avoid taking more than one multivitamin product at the same time unless your doctor tells you to. Taking similar vitamin products together can result in a vitamin overdose or serious side effects. 6. Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement. 7. Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin. 8. Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended. 9. Take your multivitamin with a full glass of water. 10. Liquid multivitamins may sometimes be mixed with water, fruit juice, or infant formula (but not milk or other dairy products). Follow the directions on the medicine label. 11. Store this medication at room temperature away from moisture and heat. Keep the liquid medicine from freezing. 12. Store multivitamins in their original container. Storing multivitamins in a glass container can ruin the medication. 13. Do not take multivitamins without telling your doctor if you are pregnant or plan to become pregnant. Some vitamins and minerals can harm an unborn baby if taken in large doses. You may need to use a prenatal vitamin specially formulated for pregnant women. 14. Multivitamins can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. LEVOCARNITINE Is a naturally occurring substance that functions in the transport of long-chain fatty acids for energy production by the body. Classification Amino acid derivative Indication Levocarnitine is indicated for the prevention and treatment of carnitine deficiency in patients with end stage renal disease (ESRD) who are undergoing hemodialysis Carnitine deficiency maybe due to: o Congenital defect in synthesis or utilization o Presence of uremia o Reduced renal synthesis o Removal during dialysis (similar to shape and size of creatinine, thus can be easily dialyzed out during dialysis treatment) o Lack of red meat and dairy products in patient’s diet L-carnitine administration in dialysis patients is associated with: o An increase in hematocrit / hemoglobin o A decrease in EPO dose while maintaining the hematocrit at the same level o Relationship between carnitine, EPO and hematocrit: erytrhrocyte membranes are unstable, resulting in shortened lifespan and hemolysis; by establishing the erythrocyte membrane, carnitine decreases hemolysis and improves anemia Other benefits of L-carnitine: o Decreased muscle cramps and weakness o Decreased intradialytic hypotension o Increased cardiac output o Increased exercise capacity Contraindication None known Adverse Reaction Transient nausea and vomiting have been observed. Less frequent are body odor, nausea and gastritis. Seizures have been reported to occur in patients. Storage Store vials at room temperature (25 degrees C). Discard unused portion of an open vial (formulation does not contain preservative) Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. DO NOT USE IF DISCOLORED OR IF PARTICULATE MATTER IS VISIBLE. Dosage and Administration Recommended starting dose: 10-20 mg/kg dry body weight as a slow 2-3 minute bolus injection into the venous return line after each dialysis session. OR 1 g daily as a divided oral dose Nursing Considerations Treatment should be continued for at least 3-6 months as the response to Lcarnitine takes weeks to develop LEVOCARNITINE – CRITERIA FOR ADMINISTRATION Intravenous Levocarnitine will be covered only for those ESRD patients who have been on dialysis for a minimum of three months, have a low serum Lcarnitine level and one of the following criteria: o Erythropoietin-resistant anemia o Chronic hypotension Effective immediately, physicians are required to provide medical documentation for new orders for the administration of Levocarnitine. The following documents must be reviewed, completed and signed by the physician, prior to administration: o FMCNA Criteria for Administration of Levocarnitine (FMCNA CS-I-173 Form) - establishes the criteria for administration of Levocarnitine in FMCNA facilities o Levocarnitine Administration Checklist (FMCNA CS-I-170 Form) - this checklist must be completed in conjunction with an initial order for Levocarnitine. The physician must select one of the following criteria, as identified in the FMCNA Criteria for Administration of Levocarnitine, prior to administration: Erythropoietin-resistant anemia Chronic unresponsive intradialytic hypotension Levocarnitine Follow-Up (FMCNA CS-I-171 Form) - the physician must complete this documentation every six (6) months after initiation of Levocarnitine therapy. Nursing staff may assist the physician in recording the medical information on the checklist and six (6) month follow-up, and must sign the document in the appropriate area. The original signed documents must be placed in the patient’s medical record to ensure timely retrieval if required by a fiscal intermediary to provide evidence that the patient has been appropriately evaluated and treated by the physician. o References FMC Procedure Manual, Fresenius Medical Care, North America 2007 Ahmad S, Manual of Clinical Dialysis 1999, 13:127-128 Labonia WD, L-carnitine effects on hemodialyzed patients treated with erythropoietin. Am J Kidney Dis 1995, 26:75 Megri K, Trombert JC, Zannier A. Role of L-carnitine deficiency in persistent anemia of maintenance hemodialysis (MHD) patients treated by erythropoietin (EPO)[Abstract] Societe Francaise De Nephrologie Toulouse 1997; 153 Nilsson-Ehle P, Cederblad G, Fagher B et al. Plasma lipoproteins, liver function and glucose metabolism in hemodialysis patients: lack of effect of L-carnitine supplementation Scand J. Clin Lab Invest 1985, 45:179-184 Trovato G, Ginardi V, Di Marco V et al. Long term L-carnitine on chronic anemia DEXTROSE - DEXTROSE HYDROUS INJECTION, SOLUTION Hospira 50% Dextrose Injection, USP Concentrated dextrose in water Concentrated source of carbohydrate calories for intravenous infusion. NOTE: These solutions are hypertonic. Description 50% Dextrose Injection, USP (concentrated dextrose in water) is a sterile, nonpyrogenic, hypertonic solution of Dextrose, USP in water for injection for intravenous administration after appropriate admixture or dilution. The solutions contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution. . Dextrose Injection, USP is a parenteral fluid and nutrient replenisher. Clinical Pharmacology When administered intravenously, solutions containing carbohydrate in the form of dextrose restore blood glucose levels and provide calories. Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein sparing action. Dextrose injection undergoes oxidation to carbon dioxide and water. Indications and Uses 50% Dextrose Injection, USP (concentrated dextrose in water) in partial-fill containers is indicated for admixture with amino acids or dilution with other compatible I.V. fluids to provide variable final dextrose concentrations for intravenous infusion in patients whose condition requires parenteral nutrition. Contraindications A concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present nor in the presence of delirium tremens if the patient is already dehydrated. Dextrose injection without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur. Warnings Hypertonic dextrose solutions should be given and possible hyperosmolar syndrome may result Symptoms of hyperosmolar syndrome, such as consciousness, especially in patients with chronic carbohydrate intolerance. slowly. Significant hyperglycemia from too rapid administration. mental confusion and loss of uremia and those with known The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. For Peripheral Vein Administration Hypertonic dextrose solutions (above 5% concentration) should be given slowly, preferably through a small bore needle into a large vein, to minimize venous irritation. For Central Venous Administration Concentrated dextrose should be administered via central vein after appropriate admixture or dilution when required. Precautions Electrolyte deficits, particularly in serum potassium and phosphate, may occur during prolonged use of concentrated dextrose solutions. Blood electrolyte monitoring is essential, and fluid and electrolyte imbalances should be corrected. Essential vitamins and minerals also should be provided as needed. To minimize hyperglycemia and consequent glycosuria, it is desirable to monitor blood and urine glucose and if necessary, add insulin. When concentrated dextrose infusion is abruptly withdrawn, it is advisable to follow with the administration of 5% or 10% dextrose to avoid rebound hypoglycemia. Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus. Care should be exercised to insure that the needle (or catheter) is well within the lumen of the vein and that extravasation does not occur. Concentrated dextrose solutions should not be administered subcutaneously or intramuscularly. Do not administer unless solution is clear and container is undamaged. Discard unused portion. . Adverse Reactions Hyperosmolar syndrome, resulting from excessively rapid administration of concentrated dextrose may cause hypovolemia, dehydration, mental confusion and/or loss of consciousness. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary. Overdosage In the event of overhydration or solute overload during therapy, reevaluate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS. Dosage and Administration Concentrated Dextrose in Water is administered by slow intravenous infusion (a) After admixture with amino acid solutions or (b) After dilution with other compatible I.V. fluids. Dosage should be adjusted to meet the requirements of each individual patient. Reference http://www.drugs.com/pdr/potassium-chloride.html HYDROCORTISONE SODIUM SUCCINATE Solu-Cortef Classification Anti-inflammatory Adrenocortical Steroid Dosage Form for Injection Actions Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent antiinflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune response to diverse stimuli. Hydrocortisone sodium succinate has the same metabolic and anti-inflammatory actions as hydrocortisone. When given parenterally and in equimolar quantities, the two compounds are equivalent in biologic activity. Following the intravenous injection of hydrocortisone sodium succinate, demonstrable effects are evident within one hour and persist for a variable period. Excretion of the administered dose is nearly complete within 12 hours. Thus, if constantly high blood levels are required, injections should be made every 4 to 6 hours. This preparation is also rapidly absorbed when administered intramuscularly and is excreted in a pattern similar to that observed after intravenous injection. Contraindications The use of Solu-Cortef Sterile Powder is contraindicated in premature infants because the 100 mg, 250 mg, 500 mg and 1000 mg ACT-O-VIAL System contain benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants. Solu-Cortef Sterile Powder is also contraindicated in systemic fungal infections and patients with known hypersensitivity to the product and its constituents. Mode of Administration This preparation may be administered by intravenous injection, by intravenous infusion, or by intramuscular injection, the preferred method for initial emergency use being intravenous injection. Following the initial emergency period, consideration should be given to employing a longer acting injectable preparation or an oral preparation. Therapy is initiated by administering Solu-Cortef Sterile Powder intravenously over a period of 30 seconds (eg, 100 mg) to 10 minutes (eg, 500 mg or more). In general, high dose corticosteroid therapy should be continued only until the patient's condition has stabilized—usually not beyond 48 to 72 hours. Route of Administration INTRAMUSCULAR, INTRAVENOUS Side Effects Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in body fat; changes in menstrual periods; changes in skin color; chest pain; easy bruising or bleeding; mental or mood changes (eg, depression); muscle pain, weakness, or wasting; swelling of feet or legs; seizures; severe nausea or vomiting; sudden severe dizziness or headache; symptoms of infection (eg, fever, chills, sore throat); tendon or bone pain; thinning of the skin; unusual skin sensation; unusual weight gain; vision changes or other eye problems; vomit that looks like coffee grounds. Nursing Measures Give daily before 9 AM to mimic normal peak diurnal corticosteroid levels and minimize HPA suppression. Space multiple doses evenly throughout the day. Do not give IM injections if patient has thrombocytopenic purpura. Rotate sites of IM repository injections to avoid local atrophy. Use minimal doses for minimal duration to minimize adverse effects. Taper doses when discontinuing high-dose or long-term therapy. Arrange for increased dosage when patient is subject to unusual stress. Use alternate-day maintenance therapy with short-acting corticosteroids whenever possible. Do not give live virus vaccines with immunosuppressive doses of hydrocortisone. Provide antacids between meals to help avoid peptic ulcer. References Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases. Philadelphia: WBSaunders Company 1992:1050–1. 2. Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954–63. MAGNESIUM SULFATE Classification Anti-convulsant, Anti-Arrhythmics Dosage Arrythmia: IV 1-6 grams over several minutes then continuous IV infusion 3-20 mg/min for 5-48 hours Action Decreased acetylcholine released Indications Magnesium replacement Arrhythmia Contraindications Heart block and myocardial damage. Toxemia of pregnancy. Nursing Management Monitor I&O. Make sure urine output is 100 ml or more in 4 hours before each dose. Take appropriate seizure preacautions. Keep IV Ca Gluconate at bedside. Reference http://www.scribd.com/doc/-Emergency-Drugs SEVELAMER CARBONATE Renvela Classification phosphate binder Indication control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis It helps prevent hypocalcemia (low levels of calcium in the body) caused by elevated phosphorus. It binds with phosphate in the digestive tract, which decreases the amount of phosphate absorbed into the body. Contraindication Hypersensitivity Hypophosphatemia Patients with bowel obstruction patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation, or major GI tract surgery Pharmacokinetics/Pharmacodynamics Mechanism of Action Renvela contains sevelamer carbonate, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium. It contains multiple amines separated by one carbon from the polymer backbone. These amines exist in a protonated form in the intestine and interact with phosphate molecules through ionic and hydrogen bonding. By binding phosphate in the dietary tract and decreasing absorption, sevelamer carbonate lowers the phosphate concentration in the serum. Pharmacodynamics In addition to effects on serum phosphate levels, sevelamer hydrochloride has been shown to bind bile acids in vitro and in vivo in experimental animal models. Bile acid binding by ion exchange resins is a well-established method of lowering blood cholesterol. Because sevelamer binds bile acids, it may interfere with normal fat absorption and thus may reduce absorption of fat soluble vitamins such as A, D and K. In clinical trials of sevelamer hydrochloride, both the mean total and LDL cholesterol declined by 15-31%. This effect is observed after 2 weeks. Triglycerides, HDL cholesterol and albumin did not change. Pharmacokinetics A mass balance study using 14C-sevelamer hydrochloride, in 16 healthy male and female volunteers showed that sevelamer hydrochloride is not systemically absorbed. No absorption studies have been performed in patients with renal disease. Dosage and Administration Starting dose is one or two 800 mg tablets three times per day with meals. Adjust by one tablet per meal in two week intervals as needed to obtain serum phosphorus target (3.5 to 5.5 mg/dL). Availability: Tablets: 800 mg (3) Nursing Administration Avoid taking any other medicines within 1 hour before or 3 hours after you take this medication. Renvela can bind to other medications and make them less effective. Serum bicarbonate and chloride levels should be monitored Vitamins D, E, K (coagulation parameters), and folic acid levels should be monitored The most frequently occurring adverse reactions in a short-term study with sevelamer carbonate tablets were nausea and vomiting Patients should be informed to take Renvela with meals and to adhere to their prescribed diets Do not crush, chew, or break the sevelamer tablet. Swallow the pill whole. Sevelamer tablets expand when they are wet, and breaking or crushing the pill may make it harder to swallow. Before taking sevelamer, tell your doctor if you are taking ciprofloxacin (Cipro), a heart rhythm medication, or a seizure medication. POTASSIUM ACETATE Classification Electrolyte Indication Prophylaxis and treatment of moderate to severe potassium loss when PO therapy is not feasible Potassium acetate is used as an additive for preparing specific IV formulas when client needs cannot be met by usual nutrient or electrolyte preparation. Contraindication severe renal insufficiency or adrenal insufficiency and in diseases where high potassium levels may be encountered Pharmacokinetics From 80-90% of potassium intake is excreted by the kidney and is partially reabsorbed from the glomerular filtrate. Dosage 40 mEq (2 mEq/mL) Each 20 mL vial contains 3.93 g of potassium acetate which provides 40 mEq each of potassium (K+) and acetate (CH3COO−). Mode of Administration Potassium Acetate Injection, USP, 40 mEq is administered intravenously only after dilution in a larger volume of fluid. The dose and rate of administration are dependent upon the individual needs of the patient. ECG and serum potassium should be monitored as a guide to dosage. Nursing Administration To avoid potassium intoxication, infuse potassium-containing solutions slowly. Potassium replacement therapy should be monitored whenever possible by continuous or serial electrocardiography (ECG). Serum potassium levels are not necessarily dependable indicators of tissue potassium levels. Do not administer unless solution is clear and seal is intact. Discard unused portion. High plasma concentrations of potassium may cause death by cardiac depression, arrhythmias or arrest. Use with caution in the presence of cardiac disease, particularly in digitalized patients or in the presence of renal disease. Solutions containing acetate ion should be used with caution as excess administration may result in metabolic alkalosis.