Pharmacological Therapy
Treatment Goals:
- Relief of symptoms
- Healing of esophagitis
- Prevention of recurrence & complications
- Current consensus is that for patients w/ uncomplicated reflux symptoms, empiric therapy is the appropriate initial management
1. Empiric Therapy
- Patients presenting w/ typical symptoms of GERD in the absence of long-standing, frequently recurring, progressive alarm symptoms or complicated disease may be started on empiric treatment w/o further investigation
- Acid suppressive therapy is currently the mainstay of treatment for symptom relief in GERD in both acute & long-term treatment
- Proton pump inhibitor is the drug of choice & recommended as initial therapy because of its superior safety
- Patients w/ chest pain or GERD-related NCCP should have a thorough initial cardiac evaluation prior to starting empiric therapy
- Short course therapy is effective in GERD patients treated empirically & duration varies from 2-8 wk
- Should be tried for 2 wk for patients w/ typical GERD symptoms
- Patients who present w/ atypical or extraesophageal manifestations take a longer time to respond to empiric therapy & often require twice-daily dosing for at least 12 wk
1.1. Proton Pump Inhibitors (PPIs)
- Eg Dexlansoprazole, Esomeprazole, Lansoprazole, Omeprazole, Pantoprazole, Rabeprazole
- Most potent type of acid suppressants
- Provide most rapid symptom relief & heal esophagitis in the highest proportion of patients
- Cornerstone of therapy for erosive esophagitis when given at standard dose once daily for 8 wk
- Recommended for both moderate & severe GERD & its complications
- PPIs are substituted benzimidazoles that irreversibly bind the H+ K+ ATPase, the final step in gastric acid secretion
- Should be given 30-60 min prior to meals to give PPIs time to interact w/ an activated pump
- Dexlansoprazole can be taken w/ or w/o food
- On-demand therapy w/ PPI is used where symptom control is the primary objective (eg patients w/ esophageal GERD syndrome w/o esophagitis)
- Continuous therapy w/ PPI is recommended to maintain a healed mucosa, preventing recurrence of symptoms (eg in patients w/ erosive esophagitis)
- Generally well tolerated; side effects reported were minor such as diarrhea, abdominal pain, headache which resolve as treatment is discontinued
- Superiority in the treatment of reflux esophagitis is supported by several reviews & trials
- Initial management for patients w/ suspected extraesophageal reflux syndrome
- Once- or twice-daily therapy for at least 12 wk as empiric therapy
- Patients w/ partial response to once-daily therapy, adjust dose timing &/or consider twice-daily dosing, esp in patient w/ nighttime symptoms, sleep disturbance, or variable schedules
- A specialist referral should be considered if patient fails empiric therapy w/ PPI as non-GERD etiologies must be excluded
- Pregnant patients w/ GERD may be given a short-term PPI in the last two trimesters of pregnancy if clinically indicated
- Other options include H2RAs, eg Ranitidine, & antacids except for preparations containing sodium bicarbonate
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); 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:
- Adult: 30 mg PO 24 hrly x 4 wk
- Adult & Childn ≥12 yr:
- Initial therapy: 40 mg PO 24 hrly x 4-8 wk
- Maintenance therapy: 20 mg PO 24 hrly
- Similar adult doses may be given IV for those unable to tolerate oral medications
-
Childn 1-11 yr w/ ≥20 kg body wt:
- 10-20 mg PO 24 hrly x 8 wk
- Childn 1-11 yr w/ <20 kg body wt:
- Adult & Childn ≥12 yr:
- Initial therapy: 30 mg PO 24 hrly x 4-8 wk or 30 mg IV (over 30 min) 24 hrly x 7 days
- Maintenance therapy: 15 mg PO 24 hrly
- Childn 1-11 yr w/ >30 kg body wt:
- 30 mg PO 24 hrly x up to 12 wk
-
Childn 1-11 yr w/ <30 kg body wt:
- 15 mg PO 24 hrly x up to 12 wk
- Adult:
- Initial therapy: 20 mg PO 24 hrly x 4-12 wk or 40 mg IV (over 20-30 min) 24 hrly
- Refractory cases: 40 mg PO 24 hrly for 8 wk
- Maintenance therapy: 10-20 mg PO 24 hrly
- Childn >1 yr w/ >20 kg body wt:
- 20 mg PO 24 hrly x 2-4 wk
-
Childn >1 yr w/ 10-20 kg body wt:
- 10 mg PO 24 hrly x 2-4 wk
- Adult:
- Initial therapy: 20-40 mg PO 24 hrly for 4-8 wk or 40 mg IV (over 2-15 min) 24 hrly x 7-10 days
- Severe cases: 40 mg PO 24 hrly for 4-8 wk
- Maintenance therapy: 20-40 mg 24 hrly
- Childn >5 yr:
- >40 kg body wt: 40 mg 24 hrly for up to 8 wk
- 15-40 kg body wt: 20 mg 24 hrly for up to 8 wk
f. Rabeprazole (Na rabeprazole, Sodium rabeprazole)
- Initial therapy: 10-20 mg PO 24 hrly x 4-8 wk
- Maintenance therapy: 10-20 mg PO 24 hrly
1Combination w/ sodium bicarbonate is available. Specific prescribing information may be found in the latest MIMS.
2Combination w/ Domperidone is available. Specific prescribing information may be found in the latest MIMS.
1.2. Histamine2-Receptor Antagonists (H2RAs)
- Eg Cimetidine, Famotidine, Nizatidine, Ranitidine, Roxatidine
- Recommended in divided doses for symptomatic relief of milder forms of GERD
- Have a role in inhibiting nocturnal acid secretion in mild erosive esophagitis or NERD
- When given either after an evening meal or at bedtime, H2RAs often provide effective nighttime relief
- When given as a supplement to PPI therapy, only a small dose of H2RAs at bedtime is recommended & given at a well-separated time from PPI evening dose
- Decrease gastric acid production, particularly in the postprandial state, w/o affecting esophagogastric barrier dysfunction
- Associated w/ a low incidence of adverse effects (4%)
- May be given intermittently to patients intolerant of PPIs
- Numerous, randomized, controlled trials have shown that standard dose of H2RAs is more effective than placebo in the treatment of reflux symptoms & healing of esophagitis
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:
- 800 mg PO 24 hrly or 400-600 mg PO 12 hrly or 300-400 mg PO 6 hrly
- Duration of treatment: 4-12 wk, depending on severity (All doses should be taken w/ food)
- Initial therapy: 20-40 mg PO 12 hrly x 6-12 wk
- Maintenance therapy: 20 mg PO 12 hrly (May be taken w/ or w/o food)
- 150-300 mg PO 12 hrly for up to 12 wk (May be taken w/ or w/o food)
- 150 mg PO 12 hrly or 300 mg PO at bedtime for up to 8 wk or 50 mg IM or slow IV for 1-2 min 6-8 hrly or intermittent IV infusion at 25 mg/hr for 2 hr repeated 6-8 hrly
- Severe cases: 150 mg PO 6 hrly x 12 wk
- 75 mg PO 12 hrly or 150 mg PO at bedtime x 6-8 wk
2. Maintenance Therapy
- Goal is to have a symptom-free patient w/o esophagitis
- Use the lowest dose & least potent medication that can obtain a complete & sustained symptomatic response
- The need for maintenance therapy is determined by the impact of the residual symptoms on the patient’s quality of life
- Type of maintenance therapy based on duration of treatment:
- Continuous maintenance therapy refers to daily administration of treatment for mths or even yrs to prevent relapse of GERD symptoms
- Given mainly for those w/ moderate to severe erosive reflux disease
- Discontinuous therapy is either intermittent or on-demand
- Intermittent therapy is patient-initiated short courses of therapy w/ a fixed duration taken even after symptoms have resolved
- On-demand therapy is when patient starts treatment when symptoms occur & continues until these are gone
- Both intermittent & on-demand therapy are recommended for long-term maintenance of acid suppression & in patients w/ mild symptoms & w/ NERD
Options for Chronic Acid Suppression:
- Step-up therapy involves starting treatment w/ the less potent agents & moving up for treatment response
- If patient does not respond to an H2RA w/in 2 wk, switch to PPI
- If patient does not respond to the standard once-daily treatment for 8 wk, double the dose of the same PPI (30 min prior to breakfast & 30 min prior to dinner) or switch to a different PPI
- If patient still does not respond to above regimens, patient’s symptoms are likely not secondary to reflux & warrant diagnostic testing
- Step-down therapy makes use initially of a potent acid suppressant, then decreasing dose or switching to less-potent agents
- Begins w/ the patient taking PPI for 8 wk, followed by an H2RA if GERD symptoms were adequately controlled w/ a PPI
- This is followed by stepping down further to on-demand use of antacids if patient was asymptomatic while taking an H2RA
- Majority of patients who experienced symptom relief after being placed on more than a single daily dose of PPI can be successfully stepped down to single-dose therapy w/o recurrence of reflux symptoms
- Maintenance treatment for GERD is recommended at the lowest effective dose
- Step-down therapy should be attempted
- Chronic PPI therapy for adequate symptom control
- Even w/ adequate symptom control & PPI tolerability, the likelihood of long-term spontaneous remission of the disease is low
- Though PPIs are generally safe w/ long-term use, careful consideration is required in patients at risk for complications, eg iron deficiency, vit B12 deficiency, increased susceptibility to enteric infections, fractures & pneumonia
- For patients w/ suspected extraesophageal GERD syndrome w/ a concomitant esophageal GERD syndrome, maintenance therapy w/ once- or twice-daily PPIs
3. Adjunctive Pharmacotherapy
3.1. Antacids3 & Alginates
- Effective in symptom relief; antacid-alginate combination is recommended for episodic & postprandial reflux symptoms
- Usually taken after each meal & at bedtime
- Alginate reacts w/ gastric acid creating a viscous gel or raft above the gastric contents that acts as a mechanical barrier to reduce reflux into the esophagus
- Mode of action is physical & does not depend on systemic absorption
- Use w/ caution in patients w/ renal insufficiency
- 216 mg/tab
- Adult & childn 6-12 yr: 1-2 tab PO 6-8 hrly (Doses should be taken on an empty stomach
b. Aluminum hydroxide [Al(OH)3]
- Constipation; phosphate depletion may occur w/ prolonged use or in large doses
- Contraindicated in hypophosphatemia
- Use w/ caution in chronic renal failure; may cause phosphate depletion
- To reduce constipating effects, aluminum hydroxide is often given w/ magnesium-containing antacid (eg magnesium hydroxide, magnesium oxide)
- 600 mg/tab
- 1-2 tab PO 6 hrly (May be taken w/ or w/o food)
c. Calcium carbonate (CaCO3)
- GI effects (constipation, flatulence); Metabolic effects (hypercalcemia, metabolic alkalosis)
- Contraindicated in hypercalcemia, presence of or history of renal calculi, hypophosphatemia, patients w/ suspected digoxin toxicity
- Use w/ caution in renal impairment, hypercalcemia-associated diseases, hypoparathyroid disease
- 500 mg/tab
- 2-4 tab PO as symptoms occur
- Max: 15 tabs (May be taken w/ or w/o food)
- Occasionally diarrhea, soft stools, dry mouth
- May interfere w/ absorption of tetracyclines
- Use w/ caution in renal or cardiac disorder, diarrhea, hypermagnesemia
- 500 mg/tab; 100 mg/mL susp
- Adult: 1000 mg PO
- 6-8 hrly (Should be taken on an empty stomach)
e. Magnesium hydroxide [Mg(OH)2]
- GI effects (diarrhea, abdominal cramps); hypermagnesemia in patients w/ renal impairment
- Contraindicated in intestinal obstruction, fecal impaction, renal failure
- Use w/ caution in colostomy, ileostomy, electrolyte imbalance
- Monitor for toxicity in patients w/ impaired renal function
- Usually given in combination w/ an aluminum-containing antacid to decrease diarrhea
- 400 mg/5 mL susp
- 15 mL PO at bedtime (May be taken w/ or w/o food)
- GI effects (cramping, diarrhea, vomiting, upset stomach, paralytic ileus); Other effects (rashes, hives, itching, hypermagnesemia)
- Contraindicated in renal failure
- Use w/ caution in renal impairment, bowel obstruction
- Usually given in combination w/ an aluminum-containing antacid to decrease diarrhea
- 84.5 mg/cap
- 400 mg/day PO (Should be taken on an empty stomach)
g. Sodium bicarbonate (NaHCO3)
- GI effects (cramps, belching, flatulence)
- Excessive use of bicarbonate may lead to hypokalemia & metabolic alkalosis, esp in patients w/ impaired renal function
- Contraindicated in renal failure
- Use w/ caution in renal impairment, bowel obstruction
- Usually given in combination w/ an aluminum-containing antacid to decrease diarrhea
- Adult: 3-6 tab PO 6 hrly (Should be taken w/ food)
- Adult: 2-4 tab PO 8 hrly (Should be taken w/ food)
3.1.1. Intestinal Adsorbent
a. Bismuth salicylate (Bismuth subsalicylate)
- Darkening of stool & tongue, hypersensitivity reactions
- Use w/ caution in patients w/ renal impairment
- Avoid in patients w/ salicylate or aspirin sensitivity, history of severe Gi bleeding & coagulopathy
- 262 mg/15 mL susp; 262 mg/tab; 524 mg tab
- 524 mg PO every 1/2-1 hr
- Max dose: 8 doses/day
3Various combinations of antacids are available. Al & Mg are usually combined to decrease constipation/diarrhea. Please see the latest MIMS for available formulations.
3.2. Propulsives/Prokinetic Agents
- Eg Domperidone, Metoclopramide, Itopride, Mosapride
- Effective in patients w/ mild symptoms
- Domperidone has the advantage of having less pyramidal effects
- Oral Metoclopramide may be given to patients unresponsive to conventional therapy
- Long-term use is not recommended because of risk of neurological & other adverse effects
- Treatment duration should be kept as short as possible, ie up to 5 days (not to exceed 12 wk)
- CNS effects (drowsiness, dizziness, headache, extrapyramidal symptoms or EPS); Endocrine effects (amenorrhea, galactorrhea); GI effect (diarrhea)
- Contraindicated in Parkinson’s disease, GI perforation, pheochromocytoma
- Use w/ caution in renal impairment
- May impair ability to drive or operate machineries
- Adult: 75-300 mg/day PO in divided doses
- Childn: 5 mg/kg/day
- CNS effects (drowsiness, dizziness, headache, EPS, depression); Endocrine effect (galactorrhea); CV effects (hypotension, hypertension); GI effect (diarrhea)
- Contraindicated in GI hemorrhage, obstruction & perforation, in pheochromocytoma
- Use w/ caution in renal impairment, children, Parkinson’s disease, history of depression
- May impair ability to drive or operate machineries
- Adult: 20-60 mg/day PO in divided doses
- On large doses: Drowsiness, dizziness, breast tension
- Contraindicated in GI hemorrhage, obstruction & perforation, in tardive dyskinesia
- Use w/ caution in children
- May impair ability to drive or operate machineries
- Adult: 0.5 mg PO 8 hrly (30 min before meals)
- CNS effects (dizziness, depression); CV effect (chest pain); GI effects (nausea, abdominal cramps, borborygmi, diarrhea); Other effects (fatigue, lower back pain, rash, pruritus, angioedema, bronchospasm)
- Contraindicated in GI hemorrhage, obstruction & perforation
- Use w/ caution in arrhythmias, ventricular tachycardia, ventricular fibrillation, history of heart disease, CHF, renal impairment, hypocalcemia, hypomagnesemia, respiratory disorders
- Adult:
- Initial therapy: 5 mg PO 6-8 hrly
- Max dose: 40 mg/day
-
Childn:
- Initial therapy: 0.2-0.8 mg/kg PO 6-8 hrly
- Max dose: 20 mg/day
- Doses to be taken 15 min before meals
- GI effect (abdominal cramps); Endocrine effects (elevated prolactin levels, galactorrhea, gynecomastia); Dermatologic effects (rash, urticaria)
- Contraindicated in GI perforation, hemorrhage & obstruction, in prolactinoma
- Use w/ caution in renal & hepatic impairment, infants <1 yr
- Adult:10-20 mg PO 6-8 hrly
- Childn: 0.25-0.5 mg/kg body wt PO 6-8 hrly
- Doses to be taken 15-30 min before meals & at bedtime
- CNS effects (dizziness, headache, tremor); Endocrine effects (gynecomastia, increased prolactin levels); GI effects (diarrhea, constipation, abdominal pain, nausea, jaundice); Dermatologic effects (rash, redness, itching); Hematologic effects (leukopenia, thrombocytopenia)
- Contraindicated in GI perforation, hemorrhage & obstruction
- Safety in children <16 yr has not been established
- Itopride enhances the action of acetylcholine & may produce cholinergic side effects; data on long-term use are not available
- Adult: 50 mg PO 8 hrly before meals
- 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)
- 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
- Adult: 5-10 mg PO 8 hrly
- Max dose: 30 mg/day
- Childn >6 yr: Max of 0.5 mg/kg/day in 2 divided doses
- Childn <6 yr: Max of 0.1 mg/kg in a single dose
- Doses should be taken at least 15 min before meals
- CNS effects (dizziness, headache, lightheadedness); GI effects (diarrhea, abdominal pain, dry mouth, jaundice, increased triglycerides, elevated liver enzymes, taste abnormality, N/V); CV effect (palpitations); Hematologic effects (leukopenia, eosinophilia)
- Contraindicated in GI perforation, hemorrhage & obstruction
- Should not be taken >2 wk
- May impair ability to drive or operate machineries
- Adult: 5 mg PO 8 hrly
- May take before or after meals
4Combination w/ Pantoprazole is available. Specific prescribing information may be found in the latest MIMS.
4. Other drugs used in the treatment of GERD5
a. Alginic acid/Al(OH)3/Mg carbonate
- GI effects (diarrhea or constipation, abdominal distention, hiccups)
- Use w/ caution in patients w/ Na-restricted diet
- 1-2 tab PO 12 hrly [per tab: Alginic acid 200 mg/Al(OH)3 30 mg/Mg carbonate 40 mg]
- Max dose: 3 g of Al(OH)3, 2 g of Mg carbonate in a 24-hr period for <2 wk
b. Al(OH)3-Mg carbonate/Attapulgite (activated)
- Related to Aluminium: Phosphorus depletion during prolonged use or at high dosages
- Use w/ caution in patients bedridden or w/ megacolon (risk of scatoma)
- Take into account the dose of aluminium in case of renal insufficiency & chronic dialysis (risk of encephalopathy)
- Avoid in patients w/ severe renal insufficiency and digestive tract stenosis
- 1 sachet daily into a half glass of water after meals [per sachet: Al(OH)3-Mg carbonate 0.5 g/Attapulgite (activated) 2.5 g]
c. Na alginate/K bicarbonate
- Skin rashes have been reported
- Use w/ caution in patients on Na-restricted diet, in patients <12 yr
- Adult, elderly & childn >12 yr: 500-1000 mg (Na alginate) PO
- Doses taken w/ food (after meals & at bedtime)
d. Na alginate/Na bicarbonate/Ca carbonate
- GI effect (abdominal distension)
- Use w/ caution in patients w/ Na- and Ca-restricted diet, in heart failure & renal dysfunction
- May be used during pregnancy & lactation
- Adult & childn >12 yr: 500-1000 mg (Na alginate) PO
- Childn 6-12 yr: 250-500 mg (Na alginate) PO
- Doses taken w/ food (after meals & at bedtime)
e. Sucralfate
- GI effects (constipation; less frequently GI disturbances & dry mouth); Other effects (dizziness, skin rashes)
- Contraindicated in patients on dialysis
- Use w/ caution in patients w/ renal impairment
- Concomitant use w/ antacids should not be <30 min before or after Sucralfate
- Adult: 1 g PO 6 hrly or 2 g PO 12 hrly
- Should be taken on an empty stomach (1 hr before or 2 hr after meals)
5Various combinations are available. Please see the latest MIMS for available formulations.
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Antireflux Surgery
Indications for Antireflux Surgery
- Failed medical management
- Medication side effects, inadequate symptom control, refractory GERD (persistence of GERD symptoms in compliant patients despite standard treatment or twice-daily dosing of PPI for at least 8 wk)
- Severe GERD complications (eg peptic stricture, Barrett’s esophagus)
- Large hiatal hernia
- Extraesophageal conditions (eg cough, asthma, chest pain, aspiration)
- Young patients requiring long-term management
- Patient preference
- Despite success w/ medications, patient may opt for surgery due to cost of medications, life-long need to take acid-suppressive agents
- However, patient should be advised against surgery if symptoms are well controlled on medical therapy
Antireflux Surgery
- Has evolved from open type to a laparoscopic procedure & in recent years, to transoral incisionless fundoplication
- Surgical success is highest in patients presenting w/ typical GERD symptoms & demonstrating good response to treatment w/ PPI
- Esophageal manometry & ambulatory reflux studies should be done before surgery to rule out other disorders, eg achalasia, non-reflux-induced esophageal spasm, scleroderma
Fundoplication
- Involves either a partial or a complete (360 degrees) wrap of the LES w/ a section of the stomach, thus, increasing LES pressure
- Advantages include less pain, fewer incisional hernias, shorter hospital stay, quicker return to work, less defective wraps at follow-up endoscopy
- Complications include inability to belch & vomit, persistent dysphagia, postprandial pain, epigastric fullness, bloating, temporary swallowing discomfort, intense flatus
- Trans-oral or endoluminal fundoplication is a new modified version of an open or laparoscopic fundoplication & involves accessing the stomach through the mouth, eliminating the need for incisions
- Is currently not recommended as an alternative to medical or traditional surgery as data are lacking to support its role
- Recent publications have, however, noted long-term follow-up of patients who had antireflux surgery (up to 13 yr post-op) showed a high rate of symptom relapse which required continuing intake of antireflux medications
- Expertise or experience of the surgeon performing the procedure is highly predictive of clinical success
Endoluminal Treatments
- Recent procedures, eg titanium beads implantation & full-thickness plication, intend to reduce acid reflux episodes or transient lower esophageal sphincter relaxations & increase LES basal pressure
- Currently performed in clinical trials as durable long-term benefits have not been shown
All dosage recommendations are for non-pregnant & non-breastfeeding women, non-elderly adults w/ normal renal & hepatic function unless otherwise stated.
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