Treatment

Empiric Therapy

• Acid suppression, given for 4-8 wk, is the recommended initial therapy
  • Patients should be treated w/ a 4-wk trial of acid suppression before deciding whether or not therapy has been effective
• It is not clear which class of drugs (PPIs, H₂RAs or prokinetic agents) would be the most appropriate for all patients
  • May consider prescribing based on predominant symptom complaints
• In areas where H pylori infection is prevalent, empiric therapy is not recommended in H pylori-positive patients w/ dyspepsia

• PPIs were shown to be more effective than other agents as initial therapeutic strategy at reducing dyspeptic symptoms in trials of patients w/ uninvestigated dyspepsia when patients were not adequately excluded for GERD
• Patients w/ heartburn symptoms may be treated initially w/ PPI then step-down therapy w/ H₂RAs once their symptoms improve
• Low-dose PPI are used as step-down therapy
• Adverse Reactions:
  • Generally well tolerated; most commonly reported: Headache, diarrhea, rash
  • Less common: GI effects (constipation, flatulence, abdominal pain, N/V, dry mouth); Dermatologic effects (pruritus, urticaria); Musculoskeletal effects (arthralgia, myalgia); Hematological effects (eosinophilia, leukopenia, thrombocytopenia); Other effects (dizziness, fatigue, insomnia, cough, upper resp tract infection)
  • Hypersensitivity reactions, elevated liver enzymes, & isolated cases of photosensitivity & hepatotoxicity have been reported
• Special Instructions:
  • Use w/ caution in patients w/ hepatic impairment; dose adjustment recommended
  • Concomitant use w/ Atazanavir or Nelfinavir is not recommended (PPIs reduce exposure to these drugs)
  • Exclude possibility of gastric malignancy prior to treatment
  • Bone fracture: Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated
• Dosage Guidelines:

• 30 mg PO 24 hrly x 4-24 wk

• 20-40 mg PO 24 hrly x 4 wk

• 15-30 mg PO 24 hrly x 2-4 wk

• 10-20 mg PO 24 hrly x 2-4 wk or 40 mg slow IV

• 20-40 mg PO 24 hrly x 2-4 wk or 40 mg IV 24 hrly x 7 days

• 10-20 mg PO 24 hrly x 4 wk

¹Combination w/ Domperidone is also available, please see the latest MIMS for specific formulations.

2. Histamine₂-Receptor Antagonists (H₂RAs)

• Individual patients may respond to H₂RA therapy
• H₂RAs have been shown to be significantly more effective than placebo
• H₂RAs may also be used as step-down therapy
• Adverse Reactions:
  • CNS effects (headache, dizziness, somnolence, insomnia, agitation); GI effects (diarrhea, N/V); Other effects (rashes, myalgia, arthralgia)
  • Altered LFTs, reversible confusion in the elderly & those w/ renal failure have occasionally occurred
  • Rarely reported effects: Hepatotoxicity, hypersensitivity reactions, CV effects (tachycardia, bradycardia, hypotension), hematologic effects (leucopenia, thrombocytopenia, agranulocytosis), acute pancreatitis
  • Cimetidine has weak anti-androgenic effects; impotence & gynecomastia have occurred & are usually reversible
• Special Instructions:
  • Intravenous injections should be given slowly; intravenous infusion is preferred (esp for high doses & in patients w/ CV impairment)
  • Use w/ caution in patients w/ hepatic & renal impairment; dose adjustment recommended
  • Cimetidine may reduce hepatic metabolism of some drugs through inhibition of cytochrome P450 isoenzymes; closely monitor those on oral anticoagulants, Lidocaine, Phenytoin or Theophylline; dose reduction may be necessary
• Dosage Guidelines:

• 200 mg PO 6-12 hrly or
• 200 mg IM 4-6 hrly or
• Intermittent infusion: 200-400 mg IV 4-6 hrly or
• Continuous infusion: 50-100 mg IV 4-6 hrly

• 10 mg PO when necessary or
• 10 mg PO 1 hr before meals x 2 wk up to 20 mg/day or
• 20 mg IV/IM 12 hrly

• 75 mg PO when necessary up to 150 mg/day PO x 2 wk

• 150 mg PO 12 hrly or
• 300 mg PO at bedtime x 6 wk or
• 50 mg slow IV/IM 6-8 hrly

3. Prokinetic Agents

• Individual patients, often those w/ dysmotility-like symptoms, may respond to prokinetics
• Limited data on efficacy of use as empiric therapy is available

• Adverse Reactions:
  • Transient abdominal cramping, loosening of stool, & mild headache; lightheadedness
• Special Instructions:
  • Hepatic or renal insufficiency
• Dosage Guidelines:
  • 5-10 mg PO 6-8 hrly 15 min before meals

• Adverse Reactions:
  • Endocrine effects (increase in plasma-prolactin concentrations, may lead to galactorrhea or gynecomastia, reduced libido); Rashes; CNS effects (extrapyramidal reactions & drowsiness are less common than Metoclopramide)
• Special Instructions:
  • Avoid in patients in whom stimulation of muscular contractions may adversely affect GI conditions (eg GI hemorrhage, obstruction, perforation); avoid in patients w/ prolactinoma
• Dosage Guidelines:
  • 10-20 mg PO 6-8 hrly 15-30 min before meals & at bedtime

• Adverse Reactions:
  • CNS effects (dizziness, headache, tremor); Endocrine effects (increase in prolactin level, gynecomastia); GI effects (diarrhea, constipation, abdominal pain, nausea); Hepatic effect (jaundice); Hematologic effects (leukopenia, thrombocytopenia); Other effects (rash, redness, itching, anaphylactoid reaction)
• Special Instructions:
  • Use w/ caution in the elderly & in patients w/ renal or hepatic impairment
  • Acetylcholine action is enhanced & may produce cholinergic side effects
  • Contraindicated in pregnancy & in patients w/ known hypersensiti­vity to Itopride & in whom increase in GI motility could be harmful
• Dosage Guidelines:
  • 50 mg PO 8 hrly before meals

• Adverse Reactions:
  • CNS effects (restlessness, drowsiness, headache, extrapyramidal reactions & dystonic reactions have been reported eg tardive dyskinesia & parkinsonian symptoms); Endocrine effects (increased prolactin resulting in galactorrhea or gynecomastia); GI effect (diarrhea)
• Special Instructions:
  • Avoid in patients in whom stimulation of muscular contractions may adversely affect GI conditions (eg GI hemorrhage, obstruction, perforation)
  • Should be avoided in patients w/ pheochromocytoma, epilepsy, Parkinson’s disease, history of depression & in patients taking drugs that can also cause extrapyramidal symptoms
  • Use w/ caution in patients w/ renal or hepatic impairment
• Dosage Guidelines:
  • 5-15 mg PO 6-8 hrly before meals or
  • 10 mg IM/slow IV 8 hrly
  • Max dose: 30 mg/day

• Adverse Reactions:
  • GI effects (diarrhea, dry mouth, increased LFTs, hepatic dysfunction, abdominal pain, N/V); CNS effects (headache, dizziness); Hematologic effects (eosinophilia, leucopenia); Other effects (malaise, palpitations)
• Special Instructions:
  • Use w/ caution in elderly, pregnant or lactating patients
  • Not to be taken >2 wk
  • Should be avoided in patients w/ GI hemorrhage, mechanical obstruction or perforation
• Dosage Guidelines:
  • 5 mg PO 8 hrly

• Adverse Reactions:
  • Diarrhea, constipation
• Special Instructions:
  • Impaired renal function, low phosphate diet
• Dosage Guidelines:
  • 1-2 tab PO after meals & at bedtime

³Combinations w/ antacids are also available, please see the latest MIMS for specific formulations.

• Self-treatment w/ antacid w/ or w/o alginates may be continued for immediate symptom relief but additional therapy is appropriate to manage persistent or more severe symptoms
• Antacids & alginates effectively reduce acid but evidence of healing effect has not been demonstrated

• May cause constipation, hypophosphatemia & rarely osteomalacia
• Al accumulation may occur in renal impairment
• Administer other medications 2-3 hr apart to avoid drug interaction
• Drug interactions may be caused by increased gastric pH or by drug adsorption in the gut
• Large doses can cause intestinal obstruction
• Dosage Guidelines:
  • 178 mg/tab
    • 1-2 tab PO after meals & at bedtime
  • 200 mg/tab
    • 2-4 tab PO after meals & at bedtime
  • 233 mg/tab
    • 2-4 tab PO 6-8 hrly
  • 325 mg/tab
    • 1-2 tab PO 6-8 hrly
  • 360 mg/tab
    • 1-4 tab PO up to 4x/day
  • 600 mg/tab
    • 1-2 tab PO 6 hrly
  • 200 mg/5 mL susp
    • 5-10 mL PO after meals & at bedtime
  • 225 mg/5 mL susp
    • 5-10 mL PO 6 hrly
  • 320 mg/5 mL susp
    • 5-30 mL PO as required between meals & at bedtime
  • 400 mg/5 mL susp
    • 5 mL PO 8 hrly

• May cause constipation
• Administer other medications 2-3 hr apart to avoid drug interactions
• Drug interactions may be caused by increased gastric pH or by drug adsorption in the gut
• Dosage Guidelines:
  • 80 mg/tab
    • 2-4 tab PO after meals & at bedtime
  • 200 mg/tab
    • 2-4 tab PO 8 hrly
  • 500 mg/tab
    • 1-4 tab PO as required
    • Max dose: 16 tab/day
  • 680 mg/tab
    • 2 tab PO as required
    • Max dose: 16 tab/day
  • 160 mg/10 mL liqd
    • 10-20 mL PO after meals & at bedtime
  • 200 mg/5 mL susp
    • 5-10 mL PO after meals & at bedtime

• May cause diarrhea which is dose-dependent
• Hypermagnesemia may occur in patients w/ impaired renal function
• Administer other medications 2-3 hr apart to avoid drug interactions
• Drug interactions may be caused by increased gastric pH or by drug adsorption in the gut
• Dosage Guidelines:
  • 233 mg/tab
    • 1-2 tab PO 1 hr after meals & at bedtime
  • 311 mg/tab
    • 2-4 tab PO 1 hr after meals
  • 200 mg/5 mL susp
    • 5-10 mL PO 6 hrly
  • 240 mg/15 mL susp
    • 5-10 mL PO 6-8 hrly
  • 300 mg/15 mL susp
    • 15 mL PO 6 hrly
  • 400 mg/5 mL susp
    • 5-15 mL PO up to 4x/day

• May cause diarrhea which is dose-dependent
• Hypermagnesemia may occur in patients w/ impaired renal function
• Administer other medications 2-3 hr apart to avoid drug interactions
• Drug interactions may be caused by increased gastric pH or by drug adsorption in the gut
• Dosage Guidelines:
  • 250 mg/tab
    • 1/2-1 tab PO 6-8 hrly
  • 40 mg/tab
    • 1-2 tab PO 6-8 hrly

• Drug interactions may be caused by increased gastric pH or increased urinary pH which may affect drug elimination
• Dosage Guidelines:
  
  • 133.5 mg/tab
    • 2-4 tab PO after meals & at bedtime
  • 60 mg/tab
    • 2 tab PO 8 hrly
  • 325 mg/tab
    • 2-6 tab PO 6-8 hrly
  • 650 mg/tab
    • 2-4 tab PO 8 hrly
  • 267 mg/10 mL liqd
    • 10-20 mL PO after meals & at bedtime

Intestinal Adsorbent

4.6. Bismuth salicylate (Bismuth subsalicylate) 

• Adverse Reactions:
  • Darkening of stool & tongue, hypersensitivity reactions
• Special Instructions:
  • Use w/ caution in patients w/ renal impairment
  • Avoid in patients w/ salicylate or aspirin sensitivity, history of severe GI bleeding & coagulopathy
• Dosage Guidelines:
  • 524 mg PO every 1/2-1 hr
  • Max dose: 8 doses/day
  • 1048 mg PO 12 hrly
  • May repeat every 1 hr to
  • Max dose: 4 doses/day

• Adverse Reactions:
  • GI effects (dry mouth, constipation); Neurologic effects (drowsiness, amnesia); hypotension, urinary retention
• Special Instructions:
  • Use w/ caution in patients w/ epilepsy; CV, hepatic, or renal disease; respiratory depression; osteomalacia
  • Contraindicated in glaucoma & prostatic hypertrophy
• Dosage Guidelines:
  • 1-2 tab PO up to 4x/day

• Adverse Reactions:
  • Gastric upset, myalgias, reversible rhabdomyolysis
• Special Instructions:
  • Use w/ caution in patients >60 yr or on multiple drug therapy
  • Contraindicated in patients w/ current or history of chronic liver disease, history of hyperthermia, mitochondrial myopathy, renal insufficiency
• Dosage Guidelines:
  • 1 cap PO 8 hrly

• Special Instructions:
  • Use w/ caution in patients on oral anticoagulants or other drugs metabolized by the liver
  • Contraindicated in 1st trimester of pregnancy
• Dosage Guidelines:
  • 1-2 cap PO 8 hrly

• Adverse Reactions:
  • Pulpy stools
• Special Instructions:
  • Avoid in patients w/ acute cholecystitis, obstructive hepatobiliary disease, inflammatory bile duct disease, parenchymal liver disease, starvation diet; pregnant & fertile women who do not use contraception
• Dosage Guidelines:
  • 250 mg PO 24 hrly before bedtime

• Adverse Reactions:
  • GI effects (N/V, abdominal discomfort); hypersensitivity reaction; hyperuricemia or hyperuricosuria has occurred w/ high doses
• Special Instructions:
  • Maintain hydration when receiving high-strength preparation
• Dosage Guidelines:
  • 1-2 tab PO w/ meals

• Adverse Reactions:
  • Diarrhea, black coloration of stool, hypernatremia, hypokalemia
• Special Instructions:
  • Vomiting
  • Should be avoided in intestinal obstruction
• Dosage Guidelines:
  • 3 tab PO 6-8 hrly after meals

All dosage recommendations are for non-pregnant & non-breastfeeding women, non-elderly adults w/ normal renal & hepatic function unless otherwise stated.

Not all products are available or approved for above use in all countries. 

Products listed above may not be mentioned in the disease management chart but have been placed here based on indications listed in regional manufacturers’ product information.

Click the link below for specific prescribing information of products available in respective countries.

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