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Antacids

Class: Antacids and Adsorbents
- Antiulcer Agents
ATC Class: A02A
VA Class: GA209
CAS Number: 53547-27-6
Brands: Alamag, Alamag Plus, Alka-Mints, Alka-Seltzer Gold Effervescent Antacid, Almacone, Almacone II Hi-Potency, ALternaGEL, Alu-Cap, Alu-Tab, Amphojel, Basaljel, Chooz, Citrocarbonate Granules, Di-Gel, Gaviscon, Gaviscon Extra Strength, Genaton, Kudrox, Lowsium, Lowsium Plus, Maalox, Maalox Advanced Regular Strength, Maalox Advanced Maximum Strength, Maalox Antacid/Anti-Gas Maximum Strength, Maalox Max Quick Dissolve Chewables Antacid/Antigas Maximum Strength, Maalox Quick Dissolve Chewables, Maalox Quick Dissolve Chewables Maximum Strength, Maalox TC, Mag-Al, Mag-Al Plus, Mag-Al XS, Mag-Ox, Marblen, Milk of Magnesia, Mygel, Mygel II, Mylanta, Mylanta Children’s Upset Stomach Relief, Mylanta Fast-Acting, Mylanta Fast-Acting Double Strength, Mylanta Fast-Acting Maximum Strength, Mylanta Supreme Fast Acting, Pepcid Complete, Phillips’ Milk of Magnesia, Riopan Plus, Riopan Plus Double Strength, Rolaids Antacid, Rulox, Tempo, Titralac Extra Strength, Titralac Plus, Titralac Regular, Tums Antacid/Calcium Supplement, Tums E-X Antacid/Calcium Supplement, Tums Ultra Antacid/Calcium Supplement, Uro-Mag

Introduction

Inorganic salts that partially neutralize gastric hydrochloric acid.

Uses for Antacids

Peptic Ulcers

Adjunct to other drugs (e.g., anti-infectives, histamine H2-receptor antagonists, proton-pump inhibitors) for the relief of peptic ulcer pain and to promote the healing of peptic ulcers.

Because of the inconvenience of the regimens needed to promote ulcer healing, high recurrence rate, ineffectiveness in eradicating Helicobacter pylori, palatability issues, and adverse effects, antacids rarely are used alone any longer for the treatment of peptic ulcer disease. Instead, antacids currently are used principally as an adjunct to other antiulcer regimens for as-needed (prn) relief of peptic ulcer pain.

Acid Indigestion

Self-medication for the relief of acid indigestion (dyspepsia), heartburn, and sour stomach and/or bloating (commonly referred as gas).

Gastroesophageal Reflux Disease (GERD)

Self-medication for the relief of mild forms of GERD (e.g., symptoms induced by a heartburn-inducing meal).

Antacids generally provide more rapid but less prolonged relief of GERD symptoms compared with histamine H2-receptor antagonists, and combined therapy generally is more effective than either class of drugs alone.

Consult a clinician if symptoms persist or warning signs of more severe GERD develop (e.g., dysphagia, bleeding, weight loss, choking [acid-induced cough, shortness of breath, and/or hoarseness], chest pain).

Other agents (e.g., histamine H2-receptor antagonists, proton-pump inhibitors) preferred by American College of Gastroenterology (ACG) and American Gastroenterological Association (AGA) for management of more severe forms of GERD.

Have been used for self-medication for the relief of breakthrough symptoms in patients receiving proton-pump inhibitors.

Hyperphosphatemia

Aluminum-containing antacids (except aluminum phosphate): Management of hyperphosphatemia or prevention of recurrent phosphatic renal calculi (in conjunction with a low phosphate diet).

Aluminum carbonate generally preferred to aluminum hydroxide for this use.

Calcium Replacement

Calcium carbonate is used for calcium supplementation.

Stress Ulceration and GI Bleeding

Has been used for prevention of stress ulceration and GI bleeding.

Gastric Acid Aspiration

Has been used for prevention of gastric acid aspiration in patients undergoing cesarean section or emergency surgery; generally has been replaced by histamine H2-receptor antagonist or citrate solution.

Antacids Dosage and Administration

Administration

Oral Administration

Administer orally.

Oral suspensions more rapidly and effectively solubilized than powders or tablets; reserve oral tablets for chronic use in patients who refuse oral suspensions because of inconvenience or unpalatable taste. Rapidly disintegrating tablets may be a suitable alternative in some patients.

Chew tablets, including rapidly dissolving tablets, thoroughly before swallowing.

Dosage

Available as various inorganic salts (e.g., aluminum carbonate, aluminum hydroxide, calcium carbonate, magnesium hydroxide, magnesium oxide, sodium bicarbonate); dosage is expressed in terms of mEq of acid neutralizing capacity.

Dose and frequency of administration depend on the acid secretory rate of the stomach, gastric emptying time, and the disorder being treated.

Adults

Peptic Ulcers

For peptic ulcer disease, dosages of antacids are empirical and various antacid dosages have been used.

Adjunctive Therapy
Oral

For supplemental ulcer pain relief, 40–80 mEq acid neutralizing capacity on an as-needed (prn) basis.

Treatment
Oral

Other therapies currently are preferred for treatment of active peptic ulcers. (See Peptic Ulcers under Uses.)

If antacids are used for the treatment of peptic ulcers, usual high-dose regimens for ulcer healing employ 80–160 mEq acid neutralizing capacity, given 1 and 3 hours after meals and at bedtime.

Additional doses of antacids may be administered to relieve ulcer pain that occurs between regularly scheduled doses.

In patients with duodenal ulcers, antacids usually are given for 4–6 weeks. If symptoms of duodenal ulcer recur, antacids can be administered 1 and 3 hours after meals and at bedtime for 1 week and, if pain is relieved, less frequently for an additional 1–2 weeks.

In patients with gastric ulcers, antacids are administered until healing is complete.

Gastroesophageal Reflux Disease (GERD)

For GERD, dosages of antacids are empirical and various antacid dosages have been used.

Oral

For relief of heartburn, one recommended regimen employs 40–80 mEq acid neutralizing capacity on an as-needed (prn) basis intially. If necessary, dosage can be titrated to a regularly scheduled basis such as 40–80 mEq acid neutralizing capacity given after meals and at bedtime.

Hyperphosphatemia
Oral

In conjunction with dietary phosphate restriction in the management of hyperphosphatemia, 30–40 mL of aluminum hydroxide or aluminum carbonate suspension is administered 3 or 4 times daily.

Calcium Replacement
Oral

For calcium replacement dosage with calcium carbonate, see Dosage in Calcium Salts 40:12.

Stress Ulceration and GI Bleeding
Oral

In the management of stress ulceration and GI bleeding, antacids are usually administered every hour, and the antacid dosage should be titrated to maintain the nasogastric aspirate above pH 3.5.

For severe symptoms, antacid suspensions may be diluted with water or milk and given by continuous intragastric infusion.

Gastric Acid Aspiration
Oral

To reduce the risk of anesthesia-induced gastric acid aspiration, an antacid suspension has been given 30 minutes before anesthesia.

Prescribing Limits

Adults

GERD
Oral

Do not exceed 500–600 mEq acid neutralizing capacity daily or regularly scheduled (versus as-needed; prn) therapy for longer than 2 weeks continuously.

Sodium Bicarbonate

Maximum daily dosage of sodium or bicarbonate is 200 mEq in patients <60 years of age and 100 mEq in patients >60 years of age. Contraindicated for prolonged therapy because it may cause metabolic alkalosis or sodium overload.

Cautions for Antacids

Contraindications

  • Sodium bicarbonate is contraindicated and use of other sodium-containing antacids should be restricted in patients on low-sodium diets and in those with CHF, renal failure, edema, or cirrhosis.

Warnings/Precautions

Warnings

Phenylketonuria

Some antacids may contain aspartame (e.g., NutraSweet), which is metabolized in the GI tract to phenylalanine following oral administration.

Sensitivity Reactions

Tartrazine Sensitivity

Some antacid formulations contain the dye tartrazine (FD&C yellow No. 5), which may cause allergic-type reactions (bronchial asthma in susceptible individuals) in certain susceptible individuals (e.g., patients who are sensitive to aspirin).

General Precautions

Aluminum Antacids

Risk of hypophosphatemia with prolonged administration or large doses, particularly in patients with inadequate dietary intake of phosphorus.

Monitor serum phosphate concentrations at monthly or bimonthly intervals in patients on maintenance hemodialysis who are receiving chronic aluminum antacid therapy.

Calcium Carbonate

May cause gastric hypersecretion and acid rebound.

May cause the milk-alkali syndrome (characterized by hypercalcemia, metabolic alkalosis and, rarely, renal insufficiency).

Monitor serum calcium concentrations weekly and whenever manifestations of hypercalcemia occur in patients receiving large doses of calcium carbonate.

Magnesium Antacids

Commonly cause a laxative effect, and frequent administration of these antacids alone often cannot be tolerated; repeated doses cause diarrhea which may cause fluid and electrolyte imbalances.

Sodium Bicarbonate

May cause metabolic alkalosis when given in large doses.

Medication Errors

Serious medication errors have been reported to FDA in which consumers used Maalox Total Relief (bismuth subsalicylate) when they intended to use traditional Maalox liquid antacid products containing aluminum hydroxide, magnesium hydroxide, and simethicone (e.g., Maalox Advanced Regular Strength, Maalox Advanced Maximum Strength). Because of the potential for serious adverse effects associated with accidental use of bismuth subsalicylate (which is chemically related to aspirin), the manufacturer of Maalox Total Relief initially agreed to change the trade name of the product to one that did not include “Maalox”; however, the manufacturer instead discontinued the bismuth subsalicylate preparation in the summer of 2010.

Specific Populations

Renal Impairment

Aluminum Antacids: Long-term administration in patients with renal failure or chronic renal failure may result in hyperaluminemia since small amounts of aluminum are absorbed from the GI tract and excretion of aluminum is decreased in patients with renal failure. Aluminum accumulation in the CNS may be the cause of dialysis encephalopathy, while aluminum accumulation in the bones may result in or worsen dialysis osteomalacia.

Calcium Carbonate: Patients with renal impairment or dehydration and electrolyte imbalance are predisposed to developing the milk-alkali syndrome. Hypercalcemia risk in chronic hemodialysis patients.

Magnesium Antacids: In patients with severe renal impairment, hypermagnesemia characterized by hypotension, nausea, vomiting, ECG changes, respiratory or mental depression, and coma. Do not administer in patients with renal failure, and antacids containing more than 50 mEq of magnesium in the recommended daily dosage should be used cautiously and only under the supervision of a clinician who should monitor electrolytes in patients with renal disease.

Sodium Bicarbonate: May cause metabolic alkalosis in patients with renal insufficiency.

Common Adverse Effects

With prolonged administration, constipation (e.g., aluminum salts, calcium carbonate), diarrhea (e.g., magnesium salts), gastric distension/flatulence (e.g., sodium bicarbonate), and gastric hypersecretion/acid rebound (e.g., calcium carbonate).

Interactions for Antacids

All antacids potentially may increase or decrease the rate and/or extent of absorption of concomitantly administered oral drugs by changing GI transit time or by binding or chelating the drug. In vitro studies indicate that magnesium hydroxide or trisilicate has the greatest potential for drug binding and aluminum hydroxide and calcium carbonate are intermediate.

Specific Drugs and Food

Drug

Interaction

Comments

Aspirin

Pharmacokinetic (increased absorption of buffered or enteric-coated aspirin or decreased blood salicylate concentrations) interactions

Chlordiazepoxide

Possible decreased chlordiazepoxide absorption with aluminum hydroxide and magnesium preparations

Diazepam

Possible increased diazepam absorption with aluminum hydroxide

Digoxin

Possible decreased digoxin absorption

Space doses of the drugs as far apart as possible

Indomethacin

Possible decreased indomethacin absorption

Space doses of the drugs as far apart as possible

Iron salts

Possible decreased absorption of iron salts

Space doses of the drugs as far apart as possible

Isoniazid

Possible decreased isoniazid absorption with aluminum hydroxide

Administer isoniazid at least 1 hour before aluminum-containing antacids

Milk or other calcium-containing foods

Possible milk-alkali syndrome with chronic administration of bicarbonate and milk or calcium

Naproxen

Possible increased naproxen absorption with sodium bicarbonate

Possible decreased naproxen absorption with magnesium oxide or aluminum hydroxide

Pseudoephedrine

Possible increased pseudoephedrine absorption with aluminum hydroxide

Tetracyclines

Possible decreased tetracycline absorption

Allow 1–2 hours to elapse between doses of antacids and tetracyclines

Actions

  • Mechanism of action in the treatment of peptic ulcers is based on ability of antacids to react with hydrochloric acid and thus increase gastric pH.

  • With usual doses, antacids generally do not increase and maintain gastric pH above 4–5.

  • Antacids, in decreasing order of their ability to neutralize a given amount of acid, are calcium carbonate, sodium bicarbonate, magnesium salts, and aluminum salts.

  • Aluminum-containing antacids (except aluminum phosphate) combine with dietary phosphate in the intestine forming insoluble, nonabsorbable aluminum phosphate which is excreted in the feces. If phosphate intake is limited and renal function is normal, aluminum antacids (except aluminum phosphate) decrease phosphate absorption and hypophosphatemia and hypophosphaturia occur.

  • Magnesium-containing antacids have a laxative action.

Advice to Patients

  • Advise patients to consult a clinician if ulcer pain worsens or is not relieved after the first week of therapy.

  • Importance of consulting a clinician if GERD symptoms persist or warning signs of more severe GERD develop (e.g., dysphagia, bleeding, weight loss, choking [acid-induced cough, shortness of breath, and/or hoarseness], chest pain).

  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Aluminum Carbonate, Basic

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

equivalent to dried aluminum hydroxide gel 608 mg or aluminum hydroxide 500 mg

Basaljel

Wyeth

Tablets

equivalent to dried aluminum hydroxide gel 608 mg or aluminum hydroxide 500 mg

Basaljel (scored)

Wyeth

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Aluminum Hydroxide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

475 mg

Alu-Cap

3M

Suspension

320 mg/5 mL*

Aluminum Hydroxide Suspension

Amphojel

Wyeth

600 mg/5 mL

ALternaGEL

J&J-Merck

Tablets

300 mg

Amphojel

Wyeth

Tablets, film-coated

600 mg

Alu-Tab

3M

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Calcium Carbonate, Precipitated (Precipitated Chalk)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder*

Oral

Pieces, chewing gum

500 mg

Chooz

Insight

Suspension

400 mg/5 mL

Mylanta Children’s Upset Stomach Relief

J&J-Merck

1.25 g/5 mL*

Calcium Carbonate Suspension

Tablets

1.25 g*

Calcium Carbonate Tablets (scored)

Tablets, chewable

400 mg

Mylanta Children’s Upset Stomach Relief

J&J-Merck

420 mg

Titralac Regular

3M

500 mg

Tums Antacid/Calcium Supplement

GlaxoSmithKline

650 mg*

Calcium Carbonate Chewable Tablets

750 mg

Titralac Extra Strength

3M

Tums E-X Antacid/Calcium Supplement

GlaxoSmithKline

850 mg

Alka-Mints

Bayer

1 g

Tums Ultra Antacid/Calcium Supplement

GlaxoSmithKline

Tablets, chewable, rapidly disintegrating

600 mg

Maalox Quick Dissolve Chewables

Novartis

1 g

Maalox Quick Dissolve Chewables Maximum Strength

Novartis

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Dihydroxyaluminum Sodium Carbonate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder*

Magaldrate (Aluminum Magnesium Hydroxide)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Suspension

540 mg/5 mL

Lowsium

Rugby

Magaldrate Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Suspension

540 mg/5 mL with Simethicone 40 mg/5 mL

Lowsium Plus

Rugby

Riopan Plus

Wyeth

1080 mg/5 mL with Simethicone 40 mg/5mL

Riopan Plus Double Strength

Wyeth

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Magnesium Carbonate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder*

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Magnesium Hydroxide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder*

Oral

Suspension

400 mg/5 mL*

Milk of Magnesia

Phillips’ Milk of Magnesia

Bayer

800 mg/5 mL

Phillips’ Milk of Magnesia Concentrate

Bayer

1.2 g/5 mL*

Milk of Magnesia Concentrate

Roxane

Tablets

300 mg*

Phillips’ Milk of Magnesia

Bayer

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Magnesium Oxide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder*

Oral

Capsules

140 mg

Uro-Mag

Blaine

Tablets

400 mg*

Magnesium Oxide Tablets

Mag-Ox 400

Blaine

420 mg*

Magnesium Oxide Tablets

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Magnesium Trisilicate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder*

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Sodium Bicarbonate (Baking Soda)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder*

Oral

For solution

0.78 g/3.9 g

Citrocarbonate Granules

Lee

Tablets

325 mg*

Sodium Bicarbonate Tablets

650 mg*

Sodium Bicarbonate Tablets

Aluminum Hydroxide and Magnesium Carbonate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Suspension

Aluminum Hydroxide 31.7 mg/5 mL and Magnesium Carbonate 119.3 mg/5 mL

Gaviscon Liquid

GlaxoSmithKline

Genaton Liquid

Teva

Aluminum Hydroxide 254 mg/5 mL and Magnesium Carbonate 237.5 mg/5 mL

Gaviscon Extra Strength

GlaxoSmithKline

Tablets, chewable

Aluminum Hydroxide 160 mg and Magnesium Carbonate 105 mg

Gaviscon Extra Strength

GlaxoSmithKline

Aluminum Hydroxide and Magnesium Hydroxide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Suspension

Aluminum Hydroxide 200 mg/5 mL and Magnesium Hydroxide 200 mg/5 mL

Mag-Al

Pharmaceutical Associates

Aluminum Hydroxide 225 mg/5 mL and Magnesium Hydroxide 200 mg/5 mL

Alamag

Teva, URL

Maalox

Novartis

Rulox

Rugby

Aluminum Hydroxide 600 mg/5 mL and Magnesium Hydroxide 300 mg/5 mL

Maalox TC

Novartis

Tablets, chewable

Aluminum Hydroxide 200 mg and Magnesium Hydroxide 200 mg

Rulox #1

Rugby

Aluminum Hydroxide and Magnesium Hydroxide Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Suspension

Aluminum Hydroxide 200 mg/5 mL, Magnesium Hydroxide 200 mg/5 mL, and Simethicone 20 mg/5 mL

Almacone

Rugby

Di-Gel

Schering-Plough

Maalox Advanced Regular Strength

Novartis

Mag-Al Plus

Pharmaceutical Associates

Mygel

Sandoz

Mylanta Fast-Acting

J&J-Merck

Aluminum Hydroxide 225 mg/5 mL, Magnesium Hydroxide 200 mg/5 mL, and Simethicone 25 mg/5 mL

Alamag Plus

Teva

Aluminum Hydroxide 400 mg/5 mL, Magnesium Hydroxide 400 mg/5 mL, and Simethicone 40 mg/5 mL

Almacone II Hi-Potency

Rugby

Antacid Double Strength

Teva

Maalox Advanced Maximum Strength

Novartis

Mag-Al XS

Pharmaceutical Associates

Mygel II

Sandoz

Mylanta Fast-Acting Double Strength

J&J-Merck

Aluminum Hydroxide 500 mg/5 mL, Magnesium Hydroxide 450 mg/5 mL, and Simethicone 40 mg/5 mL

Kudrox

Schwarz

Maalox Antacid/Anti-Gas Maximum Strength

Novartis

Tablets, chewable

Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg

Almacone

Rugby

Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 25 mg

Tempo

Blairex

Aluminum Hydroxide and Magnesium Trisilicate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, chewable

Aluminum Hydroxide 80 mg and Magnesium Trisilicate 20 mg

Gaviscon

GlaxoSmithKline

Genaton

Teva

Calcium Carbonate and Magnesium Carbonate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Suspension

Calcium Carbonate 520 mg/5 mL and Magnesium Carbonate 400 mg/5 mL

Marblen

Fleming

Calcium Carbonate and Magnesium Hydroxide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Suspension

Calcium Carbonate 400 mg/5 mL and Magnesium Hydroxide 135 mg/5 mL

Mylanta Supreme Fast Acting

J&J-Merck

Tablets

Calcium Carbonate 550 mg and Magnesium Hydroxide 125 mg

Mylanta Gelcaps

J&J-Merck

Tablets, chewable

Calcium Carbonate 350 mg and Magnesium Hydroxide 150 mg

Mylanta Fast-Acting

J&J-Merck

Calcium Carbonate 500 mg and Magnesium Hydroxide 110 mg

Rolaids Antacid

Pfizer

Calcium Carbonate 700 mg and Magnesium Hydroxide 300 mg

Mylanta Fast-Acting Maximum Strength

J&J-Merck

Calcium Carbonate and Magnesium Hydroxide Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

Calcium Carbonate 280 mg, Magnesium Hydroxide 128 mg, and Simethicone 20 mg

Di-Gel

Schering-Plough

Tablets, chewable

Calicum Carbonate 800 mg, Magnesium Hydroxide 165 mg, and Famotidine 10 mg

Pepcid Complete

J&J-Merck

Other Calcium Carbonate Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

420 mg with Simethicone 21 mg

Titralac Plus

3M

Tablets, chewable, rapidly disintegrating

1 g with Simethicone 60 mg

Maalox Max Quick Dissolve Chewables Antacid/Antigas Maximum Strength

Novartis

Potassium Bicarbonate and Sodium Bicarbonate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, for solution

Potassium Bicarbonate 312 mg and Sodium Bicarbonate 958 mg

Alka-Seltzer Gold Effervescent Antacid

Bayer

AHFS DI Essentials™. © Copyright 2021, Selected Revisions February 1, 2011. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

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