OMEPRAZOLE
( Prilosec OTC™ [OTC]; Prilosec®)
DOSING: ADULTS
Active duodenal ulcer: 20 mg/day for 4-8 weeks
Gastric ulcers: 40 mg/day for 4-8 weeks
Symptomatic GERD: 20 mg/day for up to 4 weeks
Erosive esophagitis: 20 mg/day for 4-8 weeks; maintenance of healing: 20 mg/day for up to 12 months total therapy
Peptic ulcer disease: Eradication of Helicobacter pylori: Dose varies with regimen: 20 mg once daily or 40 mg/day as single dose or in 2 divided doses; requires combination therapy with antibiotics
Frequent heartburn (OTC labeling): Oral: 20 mg/day for 14 days; treatment may be repeated after 4 months if needed
DOSING IN RENAL IMPAIRMENT — No adjustment is necessary.
DOSING IN HEPATIC IMPAIRMENT Specific guidelines are not available; bioavailability is increased with chronic liver disease.
ADMINISTRATION
Capsule: Should be swallowed whole; do not chew or crush. Best if taken before breakfast. Delayed release capsule may be opened and contents added to applesauce.
Tablet: Should be swallowed whole; do not crush or chew.
SIGNIFICANT ADVERSE REACTIONS
Abdominal pain
Cough
Dizziness
Headache
Rash
Diarrhea
Nausea / Vomiting
Constipation
Taste perversion
CONTRAINDICATIONS
Hypersensitivity to omeprazole or substituted benzimidazoles (ie, esomeprazole,
DRUG INTERACTIONS
Antifungal agents (imidazole): Proton pump inhibitors may decrease the absorption of itraconazole , ketoconazole,indinavir , atazanavir and the serum concentration of nelfinavir.
Esomeprazole and omeprazole may increase levels of benzodiazepines metabolized by oxidation –such as , diazepam, midazolam, triazolam
Clozapine: Omeprazole may alter the concentrations/effects of clozapine
CYP2C9 substrates: Omeprazole may increase the levels/effects of CYP2C9 substrates. Example substrates include bosentan, dapsone, fluoxetine, glimepiride, glipizide, losartan, montelukast, nateglinide, paclitaxel, phenytoin, warfarin, and zafirlukast.
CYP2C19 inducers: May decrease the levels/effects of omeprazole. Example inducers include aminoglutethimide, carbamazepine, phenytoin, and rifampin.
CYP2C19 substrates: Omeprazole may increase the levels/effects of CYP2C19 substrates. Example substrates include citalopram, diazepam, methsuximide, phenytoin, propranolol, and sertraline.
HMG-CoA reductase inhibitors: Omeprazole may increase the levels/effects of HMG-CoA reductase inhibitors; monitor..
Iron salts (oral): Omeprazole may decrease the absorption of oral iron salts
Methotrexate: Concurrent use with omeprazole may decrease the excretion of methotrexate.
Phenytoin: Elimination of phenytoin may be prolonged; monitor. Phenytoin may decrease omeprazole levels/effects.
Warfarin: Proton pump inhibitors may increase the levels/effects or warfarin; monitor.
PREGNANCY RISK FACTOR — C
LACTATION — Enters breast milk/not recommended
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NIZATIDINE
Axid® AR [OTC]; Axid®
DOSING IN ADULTS
GERD 150 mg twice daily
Duodenal ulcer- Treatment of active ulcer: 300 mg at bedtime or 150 mg twice daily
Maintenance of healed ulcer: 150 mg/day at bedtime
Gastric ulcer -150 mg twice daily or 300 mg at bedtime
Meal-induced heartburn, acid indigestion, and sour stomach (OTC labeling): Oral: 75 mg tablet [OTC] twice daily, 30-60 minutes prior to consuming food or beverages
DOSING IN RENAL IMPAIRMENT
150 mg every other day
DOSAGE FORMS
Capsule (Axid®): 150 mg, 300 mg
Solution, oral (Axid®): 15 mg/mL (120 mL, 480 mL) [bubble gum flavor]
Tablet (Axid® AR): 75 mg
SIGNIFICANT ADVERSE REACTIONS
Headache
Anxiety
Pruritus
Rash
Abdominal pain
Gynecomastia
CONTRAINDICATIONS — Hypersensitivity to nizatidine or any component of the formulation; hypersensitivity to other H2 antagonists (cross-sensitivity has been observed)
DRUG INTERACTIONS
Antifungal agents (imidazole): Nizatidine may decrease the absorption of itraconazole or ketoconazole.
Atazanavir: Histamine H2 antagonists may decrease the absorption of atazanavir.
PREGNANCY RISK FACTOR — B
LACTATION — Enters breast milk/may be compatible.
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Asacol; Canasa; Lialda; Pentasa; Rowasa
DOSING IN ADULTS
Treatment of ulcerative colitis
Capsule: 1 g 4 times/day
Tablet:
Asacol: 800 mg 3 times/day for 6 weeks
Lialda: 2.4-4.8 g once daily for up to 8 weeks
Maintenance of remission of ulcerative colitis
Capsule: 1 g 4 times/day
Tablet (Asacol): 1.6 g/day in divided doses
Distal ulcerative colitis, proctosigmoiditis, or proctitis: Rectal: Retention enema: 60 mL (4 g) at bedtime, retained overnight, approximately 8 hours
Active ulcerative proctitis: Rectal: Rectal suppository (Canasa): Insert one 1000 mg suppository in rectum daily at bedtime
DOSAGE FORMS
Capsule, controlled release:
Pentasa: 250 mg, 500 mg
Suppository, rectal:
Canasa: 1000 mg [contains saturated vegetable fatty acid esters]
Suspension, rectal: 4 g/60 mL (7s, 28s) Rowasa: 4 g/60 mL (7s, 28s) [contains potassium metabisulfite and sodium benzoate]
Tablet, delayed release [enteric coated]:
Asacol: 400 mg
Lialda: 1.2 g
ADMINISTRATION
Oral: Swallow capsules or tablets whole, do not chew or crush. Do not break outer coating of Asacol, Lialda
Lialda and Mezavant should be taken once daily with a meal.
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.
SIGNIFICANT ADVERSE REACTIONS
Headache
Abdominal pain
Chest pain
Rash
Alopecia
Leg swelling
Cough
Agranulocytosis-more in elderly
Jaundice
Pancreatitis
Renal disease including acute/chronic interstitial nephritis, nephrotic syndrome, and renal failure have been reported. An evaluation of renal function is recommended prior to initiation of therapyand periodically during treatment
Symptomatic worsening of colitis/IBD may occur following initiation of therapy
CONTRAINDICATIONS
Hypersensitivity to mesalamine, salicylates, or any component
Canasa suppositories have saturated vegetable fatty acid esters (contraindicated in patients with allergy to these components).
Rowasa enemq contains potassium metabisulfite; may cause severe hypersensitivity reactions (ie, anaphylaxis) in patients with sulfite allergies.
DRUG INTERACTIONS
Digoxin: Mesalamine may decrease absorption, and thus levels/effects, of digoxin.
Thiopurine analogues (azathioprine, mercaptopurine, thioguanine): Mesalamine may increase the levels/effects of thiopurine analogues; risk of myelosuppression may be increased by aminosalicylates (due to inhibition of TPMT).
PREGNANCY RISK FACTOR — B
LACTATION — Enters breast milk/use caution.
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Purinethol
DOSE IN ADULTS
Initial: 50 mg daily; may increase by 25 mg/day every 1-2 weeks as tolerated to target dose of 1-1.5 mg/kg/day
Please take on an empty stomach (1 hour before or 2 hours after meals)
Dosage adjustment with concurrent allopurinol: Reduce mercaptopurine dosage to 1/4 to 1/3 the usual dose.
Dosage adjustment in TPMT-deficiency: reductions are generally required only in homozygous deficiency.
DOSING IN RENAL IMPAIRMENT
Administer every 48 hours
DOSING IN HEPATIC IMPAIRMENT
Decrease Dose
DOSAGE FORMS
Tablet [scored]: 50 mg
SIGNIFICANT ADVERSE REACTIONS
Jaundice
Leukopenia
Drug fever
Rash
Hyperuricemia
Mucositis
Oligospermia
Opportunistic Infections
CONTRAINDICATIONS
Hypersensitivity to mercaptopurine or any component of the formulation; patients whose disease showed prior resistance to mercaptopurine or thioguanine; severe liver disease, severe bone marrow suppression; pregnancy. Patients on concurrent therapy with drugs which may inhibit TPMT (eg, olsalazine) or xanthine oxidase (eg, allopurinol) may be sensitive to myelosuppressive effects.
DRUG INTERACTIONS
Allopurinol: Can cause increased levels of mercaptopurine by inhibition of xanthine oxidase; decrease dose of mercaptopurine by 75% when both drugs are used concomitantly; may potentiate effect of bone marrow suppression (reduce mercaptopurine to 25% of dose).
Aminosalicylates (olsalazine, mesalamine, sulfasalazine): May inhibit TPMT, increasing toxicity/myelosuppression of mercaptopurine.
Azathioprine: Metabolized to mercaptopurine, concomitant use may result in profound myelosuppression and should be avoided
Hepatotoxic drugs: Any agent which could potentially alter the metabolic function of the liver could produce higher drug levels and greater toxicities from either mercaptopurine or 6-TG.
Warfarin: mercaptopurine inhibits the anticoagulation effect of warfarin
PREGNANCY RISK FACTOR — D
LACTATION — Enters breast milk/contraindicated.
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Hyoscyamine (Anaspaz, Levbid, Levsin/SL, Levsinex, Levsin, NuLev)
Dicyclomine ( Bentyl)
Polyethylene glycol 3350 ( GlycoLax, MiraLax)
Lubiprostone ( Amitiza)
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Sulfasalazine ( Azulfidine)
Mesalamine( Asacol,Lialda,Pentasa,Canasa,Rowasa)
Azathioprine( Azasan,Imuran)
Mercaptopurine ( Purinethol)
Steroids (Prednisone)
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Amitiza
DOSING IN ADULTS
Idiopathic constipation-24 mcg twice daily ( to be taken with food)
Irritable bowel Syndrome ( in women > 18 years )-8 mcg thrice a day
DOSAGE FORMS
24 mcg, 8 mcg
SIGNIFICANT ADVERSE REACTIONS
Headache
Nausea
Diarrhea
Edema
CONTRAINDICATIONS — Hypersensitivity to lubiprostone or any component of the formulation; known mechanical bowel obstruction
PREGNANCY RISK FACTOR — C
Women of childbearing potential should have a negative pregnancy test prior to starting therapy and should be capable of complying with effective contraception.
LACTATION — Excretion in breast milk unknown/not recommended.
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LANSOPRAZOLE
( Prevacid® SoluTab™; Prevacid®)
DOSING IN ADULTS
Symptomatic GERD: Short-term treatment: 15 mg once daily for up to 8 weeks
Erosive esophagitis: Short-term treatment: 30 mg once daily for up to 8 weeks; continued treatment for an additional 8 weeks may be considered for recurrence or for patients who do not heal after the first 8 weeks of therapy; maintenance therapy: 15 mg once daily
Duodenal ulcer: Short-term treatment: 15 mg once daily for 4 weeks; maintenance therapy: 15 mg once daily
Peptic ulcer disease: Eradication of Helicobacter pylori: 30 mg once daily or 60 mg/day in 2 divided doses; requires combination therapy with antibiotics
Gastric ulcer: Short-term treatment: 30 mg once daily for up to 8 weeks
NSAID-associated gastric ulcer (healing): 30 mg once daily for 8 weeks; controlled studies did not extend past 8 weeks
NSAID-associated gastric ulcer (to reduce risk): 15 mg once daily for up to 12 weeks; controlled studies did not extend past 12 weeks
DOSING IN RENAL IMPAIRMENT
No adjustment is necessary.
DOSING IN HEPATIC IMPAIRMENT
May require a dose reduction.
DOSAGE FORMS
Capsule, delayed release:
Prevacid®: 15 mg, 30 mg
Granules, for oral suspension, delayed release:
Prevacid®: 15 mg/packet (30s) [strawberry flavor], 30 mg/packet (30s) [strawberry flavor] [DSC]
Tablet, orally disintegrating:
Prevacid® SoluTab™: 15 mg [contains phenylalanine 2.5 mg; strawberry flavor]; 30 mg [contains phenylalanine 5.1 mg; strawberry flavor]
ADMINISTRATION
Best if taken before breakfast. The intact granules should not be chewed or crushed. Capsules may be opened and the intact granules sprinkled on 1 tablespoon of applesauce, cottage cheese, yogurt, or strained pears. The granules should then be swallowed immediately. Capsules may be opened and emptied into ~60 mL orange juice, apple juice, or tomato juice; mix and swallow immediately. Rinse the glass with additional juice and swallow to assure complete delivery of the dose.
Delayed release oral suspension granules should be mixed with 2 tablespoonfuls (30 mL) of water; no other liquid should be used. Stir well and drink immediately
ADVERSE REACTIONS SIGNIFICANT
Headache
Diarrhea
Abdominal pain
Nausea
CONTRAINDICATIONS — Hypersensitivity to lansoprazole, substituted benzimidazoles (ie, esomeprazole, omeprazole, pantoprazole, rabeprazole), or any component of the formulation
DRUG INTERACTIONS
Antiretrovirals: Proton pump inhibitors may decrease the absorption of atazanavir and Indinavir. Concurrent use is not recommended.
Antifungal agents (imidazoles): Proton pump inhibitors may decrease the absorption of itraconazole and ketoconazole.
CYP2C19 inducers: May decrease the levels/effects of lansoprazole. Example inducers include aminoglutethimide, carbamazepine, fosphenytoin, phenytoin, and rifampin.
CYP2C19 substrates: Lansoprazole may increase the levels/effects of CYP2C19 substrates. Example substrates include citalopram, diazepam, methsuximide, phenytoin, propranolol, and sertraline.
CYP3A4 inducers: CYP3A4 inducers may decrease the levels/effects of lansoprazole. Example inducers include aminoglutethimide, carbamazepine, nafcillin, nevirapine, phenobarbital, phenytoin, and rifamycins.
HMG-CoA reductase inhibitors: Proton pump inhibitors may increase the serum concentration of HMG-CoA reductase inhibitors.
Iron salts (oral): Lansoprazole may decrease the absorption of oral iron salts.
Methotrexate: Proton pump inhibitors may decrease the excretion of methotrexate.
PREGNANCY RISK FACTOR B
LACTATION — Excretion in breast milk unknown/not recommended.
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Anaspaz, Levbid, Levsin/SL, Levsinex, Levsin, NuLev
DOSING IN ADULTS
Oral or S.L.: 0.125-0.25 mg every 4 hours or as needed (before meals or food); maximum: 1.5 mg/24 hours
Oral, timed release: 0.375-0.75 mg every 12 hours; maximum: 1.5 mg/24 hours
DOSAGE FORMS
Capsule, timed release, as sulfate (Levsinex): 0.375 mg
Elixir, as sulfate: 0.125 mg/5 mL (480 mL)
Levsin: 0.125 mg/5 mL (480 mL) [contains alcohol 20%; orange flavor]
Tablet, as sulfate (Anaspaz, Levsin): 0.125 mg
Tablet, extended release, as sulfate (Levbid) 0.375 mg
Tablet, orally disintegrating, as sulfate (NuLev): 0.125 mg [contains phenylalanine 1.7 mg/tablet, mint flavor]
Tablet, sublingual, as sulfate: 0.125 mg
SIGNIFICANT ADVERSE REACTIONS
Dry mouth
Palpitation
Dizziness
Lactation suppression
Bloating
Constipation
Urinary retention
Blurred vision
Decreased Sweating
CONTRAINDICATIONS — Hypersensitivity to belladonna alkaloids or any component of the formulation; glaucoma; obstructive uropathy; myasthenia gravis; obstructive GI tract disease, paralytic ileus, unstable cardiovascular status in acute hemorrhage, myocardial ischemia
DRUG INTERACTIONS
Antacids: Antacids may decrease absorption of hyoscyamine; administer hyoscyamine before meals and give antacids after meals.
Antihistamines: Additive adverse effects may occur with some antihistamines due to cholinergic blockade.
Antimuscarinics: Additive adverse effects may occur due to cholinergic blockade.
Haloperidol: Additive adverse effects may occur due to cholinergic blockade.
Phenothiazines: Additive adverse effects may occur due to cholinergic blockade.
Tricyclic antidepressants: Additive adverse effects may occur due to cholinergic blockade.
PREGNANCY RISK FACTOR — C
LACTATION — Enters breast milk/not recommended
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Cimetidine (Tagamet)
Ranitidine (Zantac)
Famotidine (Pepcid)
Nizatidine (Axid)
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