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Gastrointestinal (Other)
Alosetron (Lotronex®)
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Drug Category: Selective 5-HT3 Receptor Antagonist.
Indication: Treatment of women with severe
diarrhea-predominant irritable bowel syndrome (IBS) who have failed to
respond to conventional therapy Dosing (Adults) IBS: Female: Oral: Initial: 0.5 mg twice daily for 4 weeks, with or without food; if tolerated, but response is inadequate, may be increased after 4 weeks to 1 mg twice daily. If response is inadequate after 4 weeks of 1 mg twice-daily dosing, discontinue treatment. Note: Discontinue immediately if constipation or signs/symptoms of ischemic colitis occur. Do not reinitiate in patients who develop ischemic colitis. Renal Dosing: The need for dosage adjustment has not been defined (due to limited information on activity of metabolites). Supplied: Tablet: 0.5 mg, 1 mg |
infliximab (Remicade ®):
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INDICATIONS Ankylosing spondylitis: Improving signs and symptoms of disease Crohn's disease: Induction and maintenance of remission in patients with moderate to severe disease who have an inadequate response to conventional therapy; to reduce the number of draining enterocutaneous and rectovaginal fistulas and to maintain fistula closure Rheumatoid arthritis: Inhibits the progression of structural damage and improves physical function in patients with moderate to severe disease; used with methotrexate Mechanism of Action Infliximab is a chimeric monoclonal antibody that binds to human tumor necrosis factor alpha (TNF-alpha), thereby interfering with endogenous TNF-alpha activity. Biological activities of TNF-alpha include the induction of pro-inflammatory cytokines (interleukins), enhancement of leukocyte migration, activation of neutrophils and eosinophils, and the induction of acute phase reactants and tissue degrading enzymes. Animal models have shown TNF-alpha expression causes polyarthritis, and infliximab can prevent disease as well as allow diseased joints to heal. Monoclonal antibody that binds to tumor necrosis factor. Biological activities of TNFa include the induction of proinflammatory cytokines (interleukins), enhancement of leukocyte migration, activation of neutrophils and eosinophils, and the induction of acute phase reactants and tissue degrading enzymes. Dosing (Adults): Ankylosing spondylitis: 5 mg/kg IV at 0, 2, and 6 weeks, followed by 5 mg/kg every 6 weeks thereafter. Crohn's disease: Induction regimen: 5 mg/kg IV over 2 hours. Repeat dose at 2 and 6 weeks, followed by 5 mg/kg every 8 weeks. Dose may be increased to 10 mg/kg in patients who respond but then lose their response. If no response by week 14, consider discontinuing therapy. Psoriatic arthritis (with or without methotrexate): 5 mg/kg IV at 0, 2, and 6 weeks, then every 8 weeks. Rheumatoid arthritis: (In combination with methotrexate therapy): 3 mg/kg IV at 0, 2, and 6 weeks then every 8 weeks thereafter. Doses have ranged from 3-10 mg/kg intravenous infusion repeated at 4 to 8 week intervals. Dosage adjustment with CHF: Weigh risk versus benefits for individual patient: NYHA Class III or IV: </=5 mg/kg |
Mesalamine (Asacol ® , Pentasa)
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INDICATIONS Oral: Treatment and maintenance of remission of mildly to moderately active ulcerative colitis Rectal: Treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis, or proctitis Mechanism of Action Mesalamine (5-aminosalicylic acid) is the active component of sulfasalazine; the specific mechanism of action of mesalamine is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes; action appears topical rather than systemic Adults (usual course of therapy is 3-8 weeks): Oral: Treatment of ulcerative colitis: Capsule: 1 g 4 times/day Tablet: Initial: 800 mg (2 tablets) 3 times/day for 6 weeks Maintenance of remission of ulcerative colitis: Capsule: 1 g 4 times/day Tablet: 1.6 g/day in divided doses Rectal: Retention enema: 60 mL (4 g) at bedtime, retained overnight, approximately 8 hours Rectal suppository (Canasa™): 500 mg: Insert 1 suppository in rectum twice daily; may increase to 3 times/day if inadequate response is seen after 2 weeks. 1000 mg: Insert 1 suppository in rectum daily at bedtime Note: Suppositories should be retained for at least 1-3 hours to achieve maximum benefit. Note: Some patients may require rectal and oral therapy concurrently. Elderly: See adult dosing; use with caution Administration Oral: Swallow capsules or tablets whole, do not chew or crush. Rectal enema: Shake bottle well. Retain enemas for 8 hours or as long as practical. Suppository: Remove foil wrapper; avoid excessive handling. Should be retained for at least 1-3 hours to achieve maximum benefit. Supplied Capsule, controlled release (Pentasa®): 250 mg Suppository, rectal (Canasa™): 500 mg, 1000 mg [contains saturated vegetable fatty acid esters] Suspension, rectal: 4 g/60 mL (7s) [contains potassium metabisulfite and sodium benzoate] Rowasa®: 4 g/60 mL (7s, 28s) [contains potassium metabisulfite and sodium benzoate] Tablet, delayed release [enteric coated] (Asacol®): 400 mg |
misoprostol (Cytotec ® )
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INDICATIONS Prevention of NSAID-induced gastric ulcers; medical termination of pregnancy of </= 49 days (in conjunction with mifepristone) Mechanism of Action Misoprostol is a synthetic prostaglandin E1 analog that replaces the protective prostaglandins consumed with prostaglandin-inhibiting therapies (eg, NSAIDs); has been shown to induce uterine contractions Dosage - Oral: Adults: Prevention of NSAID-induced gastric ulcers: 200 mcg 4 times/day with food; if not tolerated, may decrease dose to 100 mcg 4 times/day with food or 200 mcg twice daily with food; last dose of the day should be taken at bedtime Medical termination of pregnancy: Refer to Mifepristone monograph. Intravaginal: Adults: Labor induction or cervical ripening (unlabeled use): 25 mcg ( 1 /4 of 100 mcg tablet); may repeat at intervals no more frequent than every 3-6 hours. Do not use in patients with previous cesarean delivery or prior major uterine surgery. Administration Incidence of diarrhea may be lessened by having patient take dose right after meals. Therapy is usually begun on the second or third day of the next normal menstrual period. Supplied Tablet: 100 mcg, 200 mcg |
Neomycin:
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INDICATIONS Orally to prepare GI tract for surgery; topically to treat minor skin infections; treatment of diarrhea caused by E. coli ; adjunct in the treatment of hepatic encephalopathy; bladder irrigation Mechanism of Action Interferes with bacterial protein synthesis by binding to 30S ribosomal subunits Dosage Children: Oral: Preoperative intestinal antisepsis: 90 mg/kg/day divided every 4 hours for 2 days; or 25 mg/kg at 1 PM, 2 PM, and 11 PM on the day preceding surgery as an adjunct to mechanical cleansing of the intestine and in combination with erythromycin base Hepatic encephalopathy: 50-100 mg/kg/day in divided doses every 6-8 hours or 2.5-7 g/m 2 /day divided every 4-6 hours for 5-6 days not to exceed 12 g/day Children and Adults: Topical: Topical solutions containing 0.1% to 1% neomycin have been used for irrigation =================== Adults: Oral: Preoperative intestinal antisepsis: 1 g each hour for 4 doses then 1 g every 4 hours for 5 doses; or 1 g at 1 PM, 2 PM, and 11 PM on day preceding surgery as an adjunct to mechanical cleansing of the bowel and oral erythromycin; or 6 g/day divided every 4 hours for 2-3 days Hepatic encephalopathy: 500-2000 mg every 6-8 hours or 4-12 g/day divided every 4-6 hours for 5-6 days Chronic hepatic insufficiency: 4 g/day for an indefinite period =================== Supplied Powder, micronized, as sulfate [for prescription compounding] (Neo-Rx): (10 g, 100 g) Solution, oral, as sulfate (Neo-Fradin™): 125 mg/5 mL (60 mL, 480 mL) [contains benzoic acid; cherry flavor] Tablet, as sulfate: 500 mg |
octreotide (Sandostatin ®)
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INDICATIONS Control of symptoms in patients with metastatic carcinoid and vasoactive intestinal peptide-secreting tumors (VIPomas); pancreatic tumors, gastrinoma, secretory diarrhea, acromegaly Mechanism of Action Mimics natural somatostatin by inhibiting serotonin release, and the secretion of gastrin, VIP, insulin, glucagon, secretin, motilin, and pancreatic polypeptide. Decreases growth hormone and IGF-1 in acromegaly. Adults: SubQ: Initial: 50 mcg 1-2 times/day and titrate dose based on patient tolerance and response Carcinoid: 100-600 mcg/day in 2-4 divided doses VIPomas: 200-300 mcg/day in 2-4 divided doses Diarrhea: Initial: I.V.: 50-100 mcg every 8 hours; increase by 100 mcg/dose at 48-hour intervals; maximum dose: 500 mcg every 8 hours Esophageal varices bleeding: I.V. bolus: 25-50 mcg followed by continuous I.V. infusion of 25-50 mcg/hour Acromegaly: Initial: SubQ: 50 mcg 3 times/day; titrate to achieve growth hormone levels <5 ng/mL or IGF-I (somatomedin C) levels <1.9 U/mL in males and <2.2 U/mL in females; usual effective dose 100 mcg 3 times/day; range 300-1500 mcg/day Note: Should be withdrawn yearly for a 4-week interval in patients who have received irradiation. Resume if levels increase and signs/symptoms recur. =================== Acromegaly, carcinoid tumors, and VIPomas (depot injection): Patients must be stabilized on subcutaneous octreotide for at least 2 weeks before switching to the long-acting depot: Upon switch: 20 mg I.M. intragluteally every 4 weeks for 2-3 months, then the dose may be modified based upon response =================== Dosage adjustment for acromegaly: After 3 months of depot injections the dosage may be continued or modified as follows: GH </= 2.5 ng/mL, IGF-1 is normal, symptoms controlled: Maintain octreotide LAR® at 20 mg I.M. every 4 weeks GH >2.5 ng/mL, IGF-1 is elevated, and/or symptoms uncontrolled: Increase octreotide LAR® to 30 mg I.M. every 4 weeks GH </= 1 ng/mL, IGF-1 is normal, symptoms controlled: Reduce octreotide LAR® to 10 mg I.M. every 4 weeks Dosages >40 mg are not recommended =================== Dosage adjustment for carcinoid tumors and VIPomas: After 2 months of depot injections the dosage may be continued or modified as follows: Increase to 30 mg I.M. every 4 weeks if symptoms are inadequately controlled. Decrease to 10 mg I.M. every 4 weeks, for a trial period, if initially responsive to 20 mg dose. Dosage >30 mg is not recommended. =================== Supplied Injection, microspheres for suspension, as acetate [depot formulation] (Sandostatin LAR®): 10 mg, 20 mg, 30 mg [with diluent and syringe] Injection, solution, as acetate (Sandostatin®): 0.05 mg/mL (1 mL); 0.1 mg/mL (1 mL); 0.2 mg/mL (5 mL); 0.5 mg/mL (1 mL); 1 mg/mL (5 mL) |
olsalazine (Dipentum ® )
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INDICATIONS Maintenance of remission of ulcerative colitis in patients intolerant to sulfasalazine Dosing (Adults): Ulcerative colitis: 500mg orally bid. Administration Take with food in evenly divided doses. Supplied Capsule, as sodium: 250 mg |
Orlistat (Xenical ®)
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INDICATIONS Management of obesity, including weight loss and weight management when used in conjunction with a reduced-calorie diet; reduce the risk of weight regain after prior weight loss; indicated for obese patients with an initial body mass index (BMI) >/= 30 kg/m2 or >/= 27 kg/m2 in the presence of other risk factors Mechanism of Action A reversible inhibitor of gastric and pancreatic lipases thus inhibiting absorption of dietary fats by 30% (at doses of 120 mg 3 times/day). Dosing (Adults): Weight loss: Oral: Children >/= 12 years and Adults: 120 mg 3 times/day with each main meal containing fat (during or up to 1 hour after the meal); omit dose if meal is occasionally missed or contains no fat. Supplied Capsule: 120 mg |
sucralfate (Carafate ® )
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INDICATIONS Short-term management of duodenal ulcers; maintenance of duodenal ulcers Mechanism of Action Forms a complex by binding with positively charged proteins in exudates, forming a viscous paste-like, adhesive substance. This selectively forms a protective coating that protects the lining against peptic acid, pepsin, and bile salts. Dosing Oral: Adults: Stress ulcer prophylaxis: 1 g 4 times/day Stress ulcer treatment: 1 g every 4 hours Duodenal ulcer: Treatment: 1 g 4 times/day on an empty stomach and at bedtime for 4-8 weeks, or alternatively 2 g twice daily; treatment is recommended for 4-8 weeks in adults, the elderly may require 12 weeks Maintenance: Prophylaxis: 1 g twice daily Stomatitis (unlabeled use): 1 g/10 mL suspension, swish and spit or swish and swallow 4 times/day Dosage comment in renal impairment: Aluminum salt is minimally absorbed (<5%), however, may accumulate in renal failure Administration Tablet may be broken or dissolved in water before ingestion. Administer with water on an empty stomach. Supplied Suspension, oral: 1 g/10 mL (10 mL) Carafate®: 1 g/10 mL (420 mL) Tablet (Carafate®): 1 g |
Sulfasalazine (Azulfadine ®)
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INDICATIONS Management of ulcerative colitis; enteric coated tablets are also used for rheumatoid arthritis (including juvenile rheumatoid arthritis) in patients who inadequately respond to analgesics and NSAIDs Mechanism of Action Acts locally in the colon to decrease the inflammatory response and systemically interferes with secretion by inhibiting prostaglandin synthesis Adults: Ulcerative colitis: Initial: 1 g 3-4 times/day, 2 g/day maintenance in divided doses; may initiate therapy with 0.5-1 g/day Rheumatoid arthritis: Enteric coated tablet: Initial: 0.5-1 g/day; increase weekly to maintenance dose of 2 g/day in 2 divided doses; maximum: 3 g/day (if response to 2 g/day is inadequate after 12 weeks of treatment) Dosing interval in renal impairment: Clcr 10-30 mL/minute: Administer twice daily Clcr<10 mL/minute: Administer once daily Dosing adjustment in hepatic impairment: Avoid use Administration GI intolerance is common during the first few days of therapy (administer with meals). Supplied Tablet (Azulfidine®): 500 mg Tablet, delayed release, enteric coated (Azulfidine® EN-tabs®): 500 mg |
Ursodiol (Actigall ®)
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Gallstone dissolution: Oral: 8-10 mg/kg/day in
2-3 divided doses; use beyond 24 months is not established; obtain
ultrasound images at 6-month intervals for the first year of therapy;
30% of patients have stone recurrence after dissolution. Gallstone prevention: Oral: 300 mg twice daily. Primary biliary cirrhosis: Oral: 13-15 mg/kg/day in 2-4 divided doses (with food). Supplied: [Supplied: 300 capsule] |
vasopressin (Pitressin ®)
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INDICATIONS Treatment of diabetes insipidus; prevention and treatment of postoperative abdominal distention; differential diagnosis of diabetes insipidus Adjunct in the treatment of GI hemorrhage and esophageal varices; pulseless ventricular tachycardia (VT)/ventricular fibrillation (VF); vasodilatory shock (septic shock); out-of-hospital asystole Mechanism of Action Increases cyclic adenosine monophosphate (cAMP) which increases water permeability at the renal tubule resulting in decreased urine volume and increased osmolality; causes peristalsis by directly stimulating the smooth muscle in the GI tract DOSING Diabetes insipidus (highly variable dosage; titrated based on serum and urine sodium and osmolality in addition to fluid balance and urine output): I.M., SubQ: Children: 2.5-10 units 2-4 times/day as needed Adults: 5-10 units 2-4 times/day as needed (dosage range 5-60 units/day) Continuous I.V. infusion: Children and Adults: 0.5 milliunit/kg/hour (0.0005 unit/kg/hour); double dosage as needed every 30 minutes to a maximum of 0.01 unit/kg/hour. Intranasal: Administer on cotton pledget, as nasal spray, or by dropper. ====================== Abdominal distention: Adults: I.M.: 5 units stat, 10 units every 3-4 hours ====================== GI hemorrhage (unlabeled use): I.V. infusion: Dilute in NS or D5W to 0.1-1 unit/mL Children: Initial: 0.002-0.005 units/kg/minute; titrate dose as needed; maximum: 0.01 unit/kg/minute; continue at same dosage (if bleeding stops) for 12 hours, then taper off over 24-48 hours AdAdults: Initial: 0.2-0.4 unit/minute, then titrate dose as needed, if bleeding stops; continue at same dose for 12 hours, taper off over 24-48 hours ====================== Out-of-hospital asystole (unlabeled use): Adults: I.V.: 40 units; if spontaneous circulation is not restored in 3 minutes, then repeat dose Pulseless VT/VF (ACLS protocol): I.V.: 40 units (as a single dose only); if no I.V. access, administer 40 units diluted with NS (to a total volume of 10 mL) endotracheally Vasodilatory shock/septic shock (unlabeled use): Adults: I.V.: Vasopressin has been used in doses of 0.01-0.1 units/minute for the treatment of septic shock. Doses >0.05 units/minute may have more cardiovascular side effects. Most case reports have used 0.04 units/minute continuous infusion as a fixed dose. ====================== Administration I.V.: Use extreme caution to avoid travasation because of risk of necrosis and gangrene. In treatment of varices, infusions are often supplemented with nitroglycerin infusions to minimize cardiac effects. GIGI hemorrhage: Administration requires the use of an infusion pump and should be administered in a peripheral line. Vasodilatory shock: Administration through a central catheter is recommended. ====================== Supplied Injection, solution: 20 units/mL (0.5 mL, 1 mL, 10 mL) Pitressin®: 20 units/mL (1 mL) |
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