Esomeprazole Magnesium

Class: Proton-pump Inhibitors
Note: This monograph also contains information on Esomeprazole Sodium
VA Class: GA900
Chemical Name: 5-Methoxy-2-[(S)[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole magnesium salt trihydrate
Molecular Formula: C₃₄H₃₆MgN₆O₆S₂•3H₂OC₁₇H₁₈N₃O₃S•Na
CAS Number: 217087-09-7
Brands: Nexium

Special Alerts:

[Posted 03/02/2011] ISSUE: FDA notified healthcare professionals and the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements. In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.

BACKGROUND: PPIs work by reducing the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.

RECOMMENDATION: Healthcare professionals should consider obtaining serum magnesium levels prior to initiation of prescription PPI treatment in patients expected to be on these drugs for long periods of time, as well as patients who take PPIs with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia. For patients taking digoxin, a heart medicine, this is especially important because low magnesium can increase the likelihood of serious side effects. Healthcare professionals should consider obtaining magnesium levels periodically in these patients. For additional information, refer to the Data Summary section of the FDA Drug Safety Communication. For more information visit the FDA website at: and .

[Posted 05/25/2010] FDA notified healthcare professionals and patients of revisions to the prescription and over-the-counter [OTC] labels for proton pump inhibitors, which work by reducing the amount of acid in the stomach, to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.

The new safety information is based on FDA's review of several epidemiological studies that found those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. While the greatest increased risk for fractures in these studies involved people who had been taking prescription proton pump inhibitors for at least one year or who had been taking high doses of the prescription medications (not available over-the-counter), as a precaution, the “Drug Facts” label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk. FDA recommends healthcare professionals, when prescribing proton pump inhibitors, should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.

The safety communication includes a data summary with a table and references which support the epidemiological studies reviewed for this communication. For more information visit the FDA website at: and .

Introduction

Acid- or proton-pump inhibitor; gastric antisecretory agent.^{1 3 5 19 34} S-isomer of omeprazole.^{1 5 9 34}

Uses for Esomeprazole Magnesium

Gastroesophageal Reflux (GERD)

Short-term treatment of symptomatic GERD (e.g., heartburn) in patients without erosive esophagitis.¹

Short-term treatment of erosive esophagitis (diagnostically confirmed) in patients with GERD.¹

Maintain healing, symptom resolution, and decrease recurrence of erosive esophagitis.¹

IV as short-term (≤10 days) alternative to oral therapy in patients with a history of erosive esophagitis who are unable to continue taking the drug orally.³⁴

Duodenal Ulcer

Treatment of Helicobacter pylori infection and duodenal ulcer disease (active duodenal ulcer or history of duodenal ulcer in the past 5 years).¹ Used in conjunction with amoxicillin and clarithromycin (triple therapy).¹

NSAIA-associated Ulcers

Reduction in the occurrence of gastric ulcers associated with chronic NSAIA therapy in patients at risk (i.e., ≥60 years of age and/or history of gastric ulcer).^{1 33} Effect on occurrence of duodenal ulcers not established.^{1 33}

Crohn's Disease-associated Ulcers

Some evidence for use of proton-pump inhibitors (e.g., omeprazole) for gastric acid suppressive therapy as an adjunct in the management of upper GI Crohn's disease†, including esophageal, gastroduodenal, and jejunoileal disease.^{22 23 24 25 26 27 28}

Esomeprazole Magnesium Dosage and Administration

Administration

Oral Administration

Administer orally at least 1 hour before a meal.¹

Antacids may be used concomitantly as needed for pain relief.¹

Capsules

Swallow capsules intact; do not chew or crush.¹

Alternatively, open capsule and mix contents with 1 tablespoon applesauce; swallow immediately without chewing.¹ Applesauce should not be hot and should be soft enough to swallow without chewing.¹

NG Tube

Open capsule, empty intact granules into 60-mL syringe, and mix with 50 mL of water.¹ Replace plunger and shake well for 15 seconds.¹ Hold syringe with tip upright and check tip for remaining granules.¹ Administer immediately through NG tube; flush with additional water.¹ Do not administer if pellets have dissolved or disintegrated.¹

IV Administration

For solution compatibility information, see Compatibility under Stability.

Administer by slow direct IV injection or by IV infusion.³⁴

Flush the IV line with 0.9% sodium chloride, lactated Ringer's, or 5% dextrose injection before and after administration.³⁴

Do not administer with any other drugs or diluents because of potential incompatibilities.³⁴

Reconstitution

For direct IV injection, reconstitute vial containing 20 or 40 mg of esomeprazole with 5 mL of 0.9% sodium chloride injection.³⁴

For IV infusion, reconstitute vial containing 20 or 40 mg of esomeprazole with 5 mL of 5% dextrose, 0.9% sodium chloride, or lactated Ringer's injection.³⁴ Dilute reconstituted solution prior to infusion.³⁴

Dilution

For IV infusion, dilute the reconstituted solution to a final volume of 50 mL with a compatible IV solution (see Compatibility under Stability).³⁴

Rate of Administration

Administer reconstituted solution by slow (over ≥3 minutes) direct IV injection.³⁴

Administer diluted solution by IV infusion over 10–30 minutes.³⁴

Dosage

Available as esomeprazole magnesium and esomeprazole sodium; dosage expressed in terms of esomeprazole.^{1 34}

Pediatric Patients

GERD

Oral

Adolescents 12–17 years of age: 20 or 40 mg once daily for up to 8 weeks.¹

Adults

GERD

GERD Without Erosive Esophagitis

Oral

20 mg once daily for 4 weeks; may give an additional 4 weeks of therapy.¹ Chronic proton-pump inhibitor therapy may be appropriate.²¹

Treatment of Erosive Esophagitis

Oral

20 or 40 mg once daily for 4–8 weeks;¹ may give an additional 4–8 weeks of therapy.¹

IV

20 or 40 mg once daily for up to 10 days.³⁴ Discontinue IV administration as soon as patient can resume oral esomeprazole therapy.³⁴

Maintenance of Healing of Erosive Esophagitis

Oral

20 mg once daily; not studied >6 months.¹

Duodenal Ulcer

Helicobacter pylori Infection and Duodenal Ulcer

Oral

Triple therapy: 40 mg once daily for 10 days in conjunction with amoxicillin and clarithromycin.¹

NSAIA-associated Ulcers

Prevention of Gastric Ulcers

Oral

20 or 40 mg once daily; not studied >6 months.¹

Special Populations

Hepatic Impairment

Oral or IV dosage should not exceed 20 mg once daily in patients with severe (Child-Pugh class C) hepatic impairment.^{1 34} No dosage adjustment required for mild or moderate (Child-Pugh class A or B, respectively) hepatic impairment.^{1 34}

Cautions for Esomeprazole Magnesium

Contraindications

• 
  

  Known hypersensitivity to esomeprazole, any ingredient in the formulation, or other substituted benzimidazoles (e.g., lansoprazole, omeprazole, pantoprazole, rabeprazole).^{1 34}

  
  

Warnings/Precautions

General Precautions

GI Effects

Response to esomeprazole does not preclude presence of occult gastric neoplasm.^{1 34} Atrophic gastritis reported occasionally with long-term omeprazole use.^{1 34}

Respiratory Effects

Administration of proton-pump inhibitors has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia).^{29 30}

Hip Fracture

Several observational studies suggest that use of proton-pump inhibitors, particularly in high dosages (i.e., multiple daily doses) and/or for prolonged periods of time (i.e., ≥1 year), may be associated with increased risk of osteoporosis-related fractures of the hip, wrist, or spine.^{35 300 301 302 303 304 305 309} Magnitude of risk is unclear;^{35 300 301 302 303 304 305 310} causality not established.³⁰⁵ FDA is continuing to evaluate this safety concern.³⁰⁵

Use the lowest effective dosage and shortest duration of therapy appropriate for the patient's clinical condition.^{35 301 303 305 307 309}

Individuals at risk for osteoporosis-related fractures should receive an adequate intake of calcium and vitamin D; assess and manage these patients' bone health according to current standards of care.^{35 303 305 307 309}

Cardiovascular Effects

Preliminary safety data from 2 long-term clinical trials comparing esomeprazole or omeprazole with antireflux surgery in patients with severe GERD raised concerns about a potential increased risk of cardiac events (e.g., MI, heart failure, sudden death) in patients receiving these drugs.^{36 37 38} After reviewing data from these and other studies, FDA has concluded that long-term use of these drugs is not likely to be associated with an increased risk of such cardiac events.^{36 37 38} FDA recommends that clinicians continue to prescribe and patients continue to use these drugs in the manner described in the manufacturers' labelings.^{36 37 38}

Specific Populations

Pregnancy

Category B.^{1 34}

Lactation

Not known whether esomeprazole is distributed into milk, but omeprazole is distributed into milk.^{1 34} Discontinue nursing or the drug.^{1 34}

Pediatric Use

Safety and efficacy of oral esomeprazole for short-term treatment of GERD in adolescents 12–17 years of age is supported by controlled clinical trials in adults and safety and pharmacokinetic studies in adolescents.¹ Adverse effects and pharmacokinetics similar in adolescents and adults.¹

Safety and efficacy of oral esomeprazole for short-term treatment of GERD in children <12 years of age or for other uses in pediatric patients not established.¹

Safety and efficacy of IV esomeprazole in pediatric patients not established.³⁴

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.^{1 34}

Hepatic Impairment

Use with caution.^{1 20} (See Hepatic Impairment under Dosage and Administration.)

Common Adverse Effects

Headache, dizziness, diarrhea, nausea, flatulence, dyspepsia, abdominal pain, constipation, dry mouth.^{1 19 34}

Interactions for Esomeprazole Magnesium

Extensively metabolized by CYP isoenzymes, principally CYP2C19; also to lesser extent by CYP3A4.^{1 19 34} May inhibit CYP2C19; unlikely to inhibit CYP3A4, 1A2, 2A6, 2C9, 2D6, or 2E1.^{1 34}

Drugs Metabolized by Hepatic Microsomal Enzymes

Potential to inhibit metabolism of drugs metabolized by CYP2C19.^{1 34} Interaction unlikely with drugs metabolized by other CYP isoenzymes.^{1 34}

Specific Drugs

Drug	Interaction	Comments
Amoxicillin	Pharmacokinetic interaction unlikely1 34
Atazanavir	Possible altered oral absorption of atazanavir, resulting in decreased plasma atazanavir concentrations; possible loss of virologic response1 31	Manufacturer of esomeprazole states that concomitant administration with atazanavir is not recommended1 Antiretroviral treatment-naive patients: If a proton-pump inhibitor is used concomitantly with atazanavir, administer ritonavir-boosted atazanavir (atazanavir 300 mg and ritonavir 100 mg once daily with food); administer the proton-pump inhibitor approximately 12 hours before ritonavir-boosted atazanavir31 32 For treatment-naive patients, dosage of proton-pump inhibitor should not exceed omeprazole 20 mg daily (or equivalent)31 32 Antiretroviral treatment-experienced patients: Concomitant use of proton-pump inhibitors with atazanavir not recommended31 32
Clarithromycin	Increased plasma concentrations of esomeprazole and 14-hydroxyclarithromycin 1	Not considered clinically important1 34 316
Clopidogrel	Certain CYP2C19 inhibitors (e.g., omeprazole) reduce exposure to clopidogrel's active metabolite and decrease platelet inhibitory effects; potentially may reduce clopidogrel's clinical efficacy.44 224 225 228 232 233 236 311 Extent to which other proton-pump inhibitors (which may differ in CYP2C19-inhibitory potency) may interfere with clopidogrel's effects is unknown40 41 42 46 224 232	Assess risks and benefits of concomitant proton-pump inhibitor and clopidogrel use in individual patients312 313 314 315 316 American College of Cardiology Foundation/American College of Gastroenterology/American Heart Association (ACCF/ACG/AHA) states that GI bleeding risk reduction with concomitant proton-pump inhibitor in patients with risk factors for GI bleeding (e.g., advanced age; concomitant use of warfarin, corticosteroids, or nonsteroidal anti-inflammatory drugs (NSAIAs); H. pylori infection) may outweigh potential reduction in cardiovascular efficacy of antiplatelet treatment associated with a drug–drug interaction.311 In patients without such risk factors, ACCF/ACG/AHA states that risk/benefit balance may favor use of antiplatelet therapy without a proton-pump inhibitor.311
Diazepam	Decreased diazepam metabolism and increased plasma concentrations1 34	Not considered clinically important1 34
Gastric pH-dependent drugs (e.g., digoxin, iron salts, ketoconazole)	Esomeprazole may decrease drug absorption1 34
NSAIAs (naproxen, rofecoxib)	Pharmacokinetic interaction unlikely1 34
Oral contraceptives	No change in esomeprazole pharmacokinetics1 34
Phenytoin	Pharmacokinetic interaction unlikely1 34
Quinidine	Pharmacokinetic interaction unlikely1 34
Sucralfate	Possible delayed proton-pump inhibitor absorption and decreased bioavailability c	Administer proton-pump inhibitor at least 30 minutes before sucralfatec
Warfarin	Potential for decreased warfarin metabolism and changes in prothrombin measures1 34	Monitor PT and INR1 34

Esomeprazole Magnesium Pharmacokinetics

Absorption

Bioavailability

Bioavailability is 64% after a single 40-mg oral dose.¹ Bioavailability is 90% after repeated oral doses of 40 mg once daily.¹

Food

AUC decreased by 43–53% when a 40-mg oral dose was administered with food.¹

Special Populations

Following oral dosage of 40 mg once daily in patients with severe (Child-Pugh class C) hepatic impairment, steady-state AUCs were 2–3 times greater than those in patients with normal hepatic function.^{1 34}

Distribution

Extent

Not known whether esomeprazole is distributed into milk, but omeprazole is distributed into milk.^{1 34} Not known whether esomeprazole crosses the placenta.^{1 34}

Prolonged binding to gastric parietal proton pump enzyme.^{1 6}

Plasma Protein Binding

97%.^{1 34}

Elimination

Metabolism

Metabolized to inactive metabolites in the liver by CYP isoenzymes, principally by CYP2C19, and to lesser extent by CYP3A4.^{1 34}

Elimination Route

Excreted principally in urine (80% as inactive metabolites, <1% as active drug); remainder in feces as inactive metabolites.^{1 34}

Half-life

Adults, oral administration: 1–1.5 hours.¹ Slower elimination than R-omeprazole or racemic omeprazole (0.5–1 hour).^{1 5 6}

Adults, IV administration: 1.1–1.4 hours; prolonged with increasing dose.³⁴

Adolescents 12–17 years of age, oral administration: 0.8–1.2 hours.¹

Special Populations

In patients with poor CYP2C19 metabolizer phenotype, steady-state AUCs were 2 times greater than those in patients with extensive (or rapid) metabolizer phenotype.^{1 34}

Stability

Storage

Oral

Capsules

25°C (may be exposed to 15–30°C) in tightly-closed containers.¹

Parenteral

Powder for IV Injection or Infusion

Powder: 25°C (may be exposed to 15–30°C).³⁴ Protect from light.³⁴

Reconstituted solution: Room temperature (up to 30°C) for up to 12 hours.³⁴

Admixture: Room temperature (up to 30°C) for up to 6 hours (in 50 mL of 5% dextrose injection) or 12 hours (in 50 mL of lactated Ringer's or 0.9% sodium chloride injection).³⁴

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Oral

Capsules

Use extemporaneous mixture of capsule contents (enteric-coated pellets) and applesauce immediately; do not store for future use.¹ Applesauce should not be hot.¹

Parenteral

Solution Compatibility³⁴

Compatible
Dextrose 5% in water
Ringer's injection, lactated
Sodium chloride 0.9%

Actions

• 
  

  Inhibits basal and stimulated gastric acid secretion.^{1 2 7 8 9}

  
  


• 
  

  Concentrates in acid conditions of parietal cell secretory canaliculi; forms active sulfenamide metabolite that irreversibly binds to and inactivates hydrogen-potassium ATPase (proton- or acid pump), blocking final step in secretion of hydrochloric acid.^{1 2 4 7 8 9 10 34} Acid secretion is inhibited until additional hydrogen-potassium ATPase is synthesized, resulting in prolonged duration of action.^{2 4 7 8 9 10}

  
  


• 
  

  More esomeprazole reaches and blocks proton pump than does R-omeprazole; therefore, provides greater intragastric pH control than racemic omeprazole.^{1 5}

  
  


• 
  

  Suppresses H. pylori in patients with duodenal ulcer and/or reflux esophagitis who are infected with the organism.² Combined therapy with esomeprazole and appropriate anti-infectives (i.e., amoxicillin, clarithromycin) can effectively eradicate H. pylori gastric infection.^{1 2}

  
  

Advice to Patients

• 
  

  Importance of swallowing capsule intact, without crushing or chewing.¹

  
  


• 
  

  Importance of taking 1 hour before a meal.¹

  
  


• 
  

  If mixed with applesauce for administration, importance of mixing capsule contents with applesauce soft enough to swallow without chewing.¹ Importance of not using hot applesauce.¹ Importance of immediately swallowing mixture without crushing or chewing;¹ do not store for later use.¹

  
  


• 
  

  Importance of advising patients that use of multiple daily doses of the drug for an extended period of time may increase the risk of fractures of the hip, wrist, or spine.^{305 309}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹ Antacids may be used concomitantly as needed for pain relief.¹

  
  


• 
  

  Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed.^{1 34}

  
  


• 
  

  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.

Esomeprazole Magnesium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules, delayed-release (containing enteric-coated pellets)	20 mg (of esomeprazole)	Nexium	AstraZeneca
		40 mg (of esomeprazole)	Nexium	AstraZeneca

Esomeprazole Sodium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IV use	20 mg (of esomeprazole)	Nexium I.V.	AstraZeneca
		40 mg (of esomeprazole)	Nexium I.V.	AstraZeneca

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

NexIUM 20MG Delayed-release Capsules (ASTRAZENECA LP): 30/$200.99 or 90/$547.96

NexIUM 40MG Delayed-release Capsules (ASTRAZENECA LP): 30/$182.99 or 90/$524.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 24, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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

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224. Sanofi-Aventis/Bristol-Myers Squibb. Plavix, (clopidogrel bisulfate) tablets prescribing information. New York, NY; 2010 Mar.

225. Food and Drug Administration. Early communication about an ongoing safety review of clopidogrel bisulfate (marketed as Plavix). Rockville, MD; 2009 Jan 26. From FDA website.

226. Siller-Matula JM, Spiel AO, Lang IM et al. Effects of pantoprazole and esomeprazole on platelet inhibition by clopidogrel. Am Heart J. 2009; 157:148.e1-5.

227. Gilard M, Arnaud B, Le Gal G et al. Influence of omeprazole on the antiplatelet action of clopidogrel associated to aspirin. J Thromb Haemost. 2006; 4:2508-9. [PubMed 16898956]

228. Anon. PPI interactions with clopidogrel. Med Lett Drugs Ther. 2009; 51:2-3.

229. Aubert RE, Epstein RS, Teagarden JR et al. Proton pump inhibitors effect on clopidogrel effectiveness: The clopidogrel Medco outcomes study. Circulation. 2008; 118:S_815, Abstract 3998.

230. Lau WC, Gurbel PA. The drug-drug interaction between proton pump inhibitors and clopidogrel. CMAJ. 2009; 180:699-700. [PubMed 19332744]

232. Food and Drug Administration. Information for heathcare professionals: Update to the labeling of clopidogrel bisulfate (marketed as Plavix) to alert heathcare professionals about a drug interaction with omeprazole (marketed as Prilosec and Prilosec OTC). Rockville, MD; 2009 Nov 17. From FDA website.

233. Food and Drug Administration. Follow-up to the January 26, 2009 Early Communication about an ongoing safety review of clopidogrel bisulfate (marketed as Plavix) and omeprazole (marketed as Prilosec and Prilosec OTC). Rockville, MD; 2009 Nov 17. From FDA website.

235. Ho PM, Maddox TM, Wang L et al. Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome. JAMA. 2009; 301:937-44.

236. Norgard NB, Mathews KD, Wall GC. Drug-drug interaction between clopidogrel and the proton pump inhibitors. Ann Pharmacother. 2009; 43:1266-74. [PubMed 19470853]

237. Last EJ, Sheehan AH. Review of recent evidence: potential interaction between clopidogrel and proton pump inhibitors. Am J Health Syst Pharm. 2009; 66:2117-22. [PubMed 19923312]

238. Stanek EJ, Aubert RE, Flockhart DA et al. A national study of the effect of individual proton pump inhibitors on cardiovascular outcomes in patients treated with clopidogrel following coronary stenting: the Clopidogrel Medco Outcomes Study. Available from website. Accessed 2009 Dec 15.

240. Stockl KM, Le L, Zakharyan A et al. Risk of rehospitalization for patients using clopidogrel with a proton pump inhibitor. Arch Intern Med. 2010; 170:704-10. [PubMed 20421557]

243. Juurlink DN. Proton pump inhibitors and clopidogrel: putting the interaction in perspective. Circulation. 2009; 120:2310-2. [PubMed 19933929]

248. Khalique SC, Cheng-Lai A. Drug interaction between clopidogrel and proton pump inhibitors. Cardiol Rev. 2009 Jul-Aug; 17:198-200. [PubMed 19525682]

250. Rude MK, Chey WD. Proton-pump inhibitors, clopidogrel, and cardiovascular adverse events: fact, fiction, or something in between?. Gastroenterology. 2009; 137:1168-71. [PubMed 19635603]

300. Vestergaard P, Rejnmark L, Mosekilde L. Proton pump inhibitors, histamine H2 receptor antagonists, and other antacid medications and the risk of fracture. Calcif Tissue Int. 2006; 79:76-83. [PubMed 16927047]

301. Corley DA, Kubo A, Zhao W et al. Proton pump inhibitors and histamine-2 receptor antagonists are associated with hip fractures among at-risk patients. Gastroenterology. 2010; 139:93-101. [PubMed 17190895]

302. Yu EW, Blackwell T, Ensrud KE et al. Acid-suppressive medications and risk of bone loss and fracture in older adults. Calcif Tissue Int. 2008; 83:251-9. [PubMed 19931262]

303. Gray SL, LaCroix AZ, Larson J et al. Proton pump inhibitor use, hip fracture, and change in bone mineral density in postmenopausal women: results from the Women's Health Initiative. Arch Intern Med. 2010; 170:765-71. [PubMed 20458083]

304. Targownik LE, Lix LM, Metge CJ et al. Use of proton pump inhibitors and risk of osteoporosis-related fractures. CMAJ. 2008; 179:319-26. [PubMed 18695179]

305. Food and Drug Administration. Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors. May 25, 2010. From FDA web site.

E-Z-Hd

Generic Name: barium sulfate (Oral route, Rectal route)

BAR-ee-um SUL-fate

Commonly used brand name(s)

In the U.S.

• Bar-Test


• E-Z-Disk


• Readi-Cat


• Volumen

In Canada

• Acb


• Baro-Cat


• Barosperse Enema


• Colobar-100


• Epi-C


• Epi-Stat


• Esobar


• Esopho-Cat Esophageal Cream


• E-Z-Cat


• E-Z-Hd


• E-Z-Jug


• E-Z-Paque

Available Dosage Forms:

• Kit


• Suspension


• Powder for Suspension


• Enema


• Paste


• Tablet


• Liquid

Therapeutic Class: Diagnostic Agent, Radiological Contrast Media

Uses For E-Z-Hd

Barium sulfate is a radiopaque agent. Radiopaque agents are used to help diagnose certain medical problems. Since radiopaque agents are opaque to (block) x-rays, the areas of the body in which they are localized will appear white on the x-ray film. This creates the needed distinction, or contrast, between one organ and other tissues. The contrast will help the doctor see any special conditions that may exist in that organ or part of the body.

Barium sulfate is taken by mouth or given rectally by enema. If taken by mouth, it makes the esophagus, the stomach, and/or the small intestine opaque to the x-rays so that they can be "photographed". If it is given by enema, the colon and/or the small intestine can be seen and photographed by x-rays.

The dose of barium sulfate will be different for different patients and depends on the type of test. The strength of the suspension and tablet is determined by how much barium they contain. Different tests will require a different strength and amount of suspension (some may require the tablet form), depending on the age of the patient, the contrast needed, and the x-ray equipment used.

Barium sulfate is to be used only by or under the direct supervision of a doctor.

Before Using E-Z-Hd

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of barium sulfate in children with use in other age groups, this agent is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

This contrast agent has been used in older people and has not been shown to cause different side effects or problems in them than it does in younger adults.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma, hay fever, or other allergies (history of)—If you have a history of these conditions, the risk of having a reaction, such as an allergic reaction to the additives in the barium sulfate preparation, is greater

• Cystic fibrosis—The risk of blockage in the small bowel is greater

• Dehydration—Barium sulfate may cause severe constipation

• Intestinal blockage or perforation—Barium sulfate may make this condition worse

Proper Use of barium sulfate

This section provides information on the proper use of a number of products that contain barium sulfate. It may not be specific to E-Z-Hd. Please read with care.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions While Using E-Z-Hd

Make sure to drink plenty of liquids after the test. Otherwise, barium sulfate may cause severe constipation.

E-Z-Hd Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Bloating


• constipation (severe, continuing)


• cramping (severe)


• nausea or vomiting


• stomach or lower abdominal pain


• tightness in chest or troubled breathing


• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Constipation or diarrhea


• cramping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: E-Z-Hd side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More E-Z-Hd resources

• E-Z-Hd Side Effects (in more detail)
• E-Z-Hd Use in Pregnancy & Breastfeeding
• E-Z-Hd Support Group
• 0 Reviews for E-Z-Hd - Add your own review/rating

• Baro-Cat Prescribing Information (FDA)


• Barosperse Prescribing Information (FDA)


• Barotrast oral and rectal Concise Consumer Information (Cerner Multum)


• E-Z-Cat Dry Prescribing Information (FDA)


• E-Z-HD oral and rectal Concise Consumer Information (Cerner Multum)


• Entrobar Prescribing Information (FDA)


• Intropaste Prescribing Information (FDA)


• Liquid E-Z Paque Prescribing Information (FDA)


• Polibar ACB Prescribing Information (FDA)

Compare E-Z-Hd with other medications

• Computed Tomography

Freezone Liquid

Pronunciation: sal-ih-SILL-ik AS-id
Generic Name: Salicylic Acid
Brand Name: Examples include Freezone and Occlusal-HP

Freezone Liquid is used for:

Removing corns, calluses, and warts. It may also be used for other conditions as determined by your doctor.

Freezone Liquid is a topical salicylate. It works by causing the skin to swell, soften, and then slough or peel in areas where it is applied.

Do NOT use Freezone Liquid if:

• you are allergic to any ingredient in Freezone Liquid


• you have diabetes or poor blood circulation

Contact your doctor or health care provider right away if any of these apply to you.

Before using Freezone Liquid:

Some medical conditions may interact with Freezone Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)


• if you have liver or kidney problems, a skin infection, or skin irritation

Some MEDICINES MAY INTERACT with Freezone Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants, (eg, heparin, warfarin), aspirin, methotrexate, or sulfonylureas (eg, glipizide) because the risk of side effects may be increased by Freezone Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Freezone Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Freezone Liquid:

Use Freezone Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• First soak the affected area in warm water for about 5 minutes. Dry thoroughly. Apply 1 drop at a time to sufficiently cover each affected area. Let dry.


• Cover the area with a small adhesive bandage or dressing (if practical) unless your doctor has instructed you not to. Unless your hands are being treated, be sure to wash your hands after each application.


• If you miss a dose of Freezone Liquid, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Freezone Liquid.

Important safety information:

• Freezone Liquid is for external use only. Avoid getting Freezone Liquid in your eyes, nose, or mouth, or on the genitals. If contact with your eyes occurs, flush with water for 15 minutes. Do not inhale the vapors of Freezone Liquid.


• Do not use Freezone Liquid longer or more often than recommended by your doctor or on the package label.


• Check with your doctor before use if you have a condition that covers a large area of the body.


• Be sure to apply Freezone Liquid only to the affected area and not to normal healthy skin.


• Do not use Freezone Liquid on skin that is irritated, infected, or reddened.


• Do not use Freezone Liquid on open skin wounds, moles, birthmarks, genital warts, warts on the face, or warts growing hair.


• Do not use any other medicines or drying products on your skin unless your doctor instructs you otherwise.


• Freezone Liquid may interfere with certain lab test results. Make sure your doctor and lab personnel know you are using Freezone Liquid.


• Freezone Liquid is extremely flammable. Do not store or use Freezone Liquid near a fire or other open flame.


• Freezone Liquid may be harmful if swallowed. If you may have taken Freezone Liquid by mouth, contact your local poison control center or emergency room immediately.


• Freezone Liquid contains a salicylate, which has been linked to Reye syndrome. Do not use Freezone Liquid on children or teenagers during or after chickenpox, flu, or other viral infections without checking with your doctor or pharmacist.


• Caution is advised when using Freezone Liquid in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Freezone Liquid during pregnancy. It is unknown if Freezone Liquid is excreted in breast milk. If you are or will be breast-feeding while you are using Freezone Liquid, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Freezone Liquid:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dry, peeling, red, or scaling skin.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Freezone side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; diarrhea; dizziness; loss of appetite; loss of hearing; mental disturbances; nausea; rapid or difficult breathing; ringing in the ears; seizures; sluggishness; vomiting; yellowing of the skin or eyes.

Proper storage of Freezone Liquid:

Store Freezone Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Freezone Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Freezone Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Freezone Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Freezone Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Freezone resources

• Freezone Side Effects (in more detail)
• Freezone Use in Pregnancy & Breastfeeding
• Freezone Drug Interactions
• Freezone Support Group
• 0 Reviews for Freezone - Add your own review/rating

Compare Freezone with other medications

• Acne
• Dermatological Disorders

Exall Liquid

carbetapentane citrate and guaifenesin

Dosage Form: liquid
Exall Liquid

Exall Liquid

Rx Only

Antitussive / Expectorant


DESCRIPTION: ExallTM Liquid is alcohol-free, dye-free, sugar-free, colorless liquid for oral administration having a cherry odor and flavor.


Each teaspoonful (5 mL) for oral administration contains:

Carbetapentane Citrate........................ 10 mg

Guaifenesin.......................................100 mg


Inactive ingredients: Cherry Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.


Carbetapentane Citrate (1-Phenylcyclopentanecarboxylic acid 2-(2-diethylaminoethoxy) ethyl ester citrate) is a white crystalline powder.

It is freely soluble in water and chloroform. Its structure is as follows:

Guaifenesin (1,2-Propanediol, 3-(2-methoxyphenoxy)-, (±)-) is a white to slightly gray, crystalline powder, having a bitter taste.

It may have a slight characteristic odor. It is soluble in water, alcohol, chloroform, glycerin, and propylene glycol. Its structure is as follows:

CLINICAL PHARMACOLOGY:

Antitussive and expectorant actions.

Carbetapentane Citrate is a centrally acting non-narcotic antitussive. Carbetapentane citrate has atropine-like and local anesthetic actions,

as well as temporarily controls and suppresses the cough reflex by selective depression of the medullary cough center. It has no significant

analgesic or sedative properties, does not depress respiration or predispose to addiction with usual doses.

Guaifenesin has an expectorant action, which increases the output of respiratory tract fluid by reducing adhesiveness and surface tension.

By increasing respiratory tract fluid, guaifenesin reduces the viscosity of secretions, and facilitates expectoration of retained secretions.

Guaifenesin is readily absorbed from the gastrointestinal tract and is rapidly metabolized and renally excreted. Guaifenesin has a plasma

half-life of one hour. The major urinary metabolite is beta-(2-methoxyphenoxy) lactic acid. Sinus and bronchial drainage is improved and dry,

non-productive coughs become more productive and less frequent. Guaifenesin helps loosen phlegm (mucus) and thin bronchial secretions

to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive.

INDICATIONS AND USAGE:

For temporary relief of productive and non-productive cough accompanying respiratory tract congestion associated with the common

cold, influenza, sinusitis, and bronchitis.

CONTRAINDICATIONS:

ExallTM Liquid is contraindicated in infants and newborns, and in patients with a known hypersensitivity to any of the ingredients

and in patients receiving monoamine oxidase inhibitor (MAOI) therapy, including 14 days after stopping.

WARNINGS:

General: Before prescribing any medication to suppress or modify cough, it is important that the underlying cause of the cough is identified.

Information for Patients:

Patients should be instructed to take ExallTM Liquid only as prescribed. Do not exceed the recommended dose. If nervousness,

dizziness, or sleeplessness occur, discontinue use and consult a physician.

Drug/Laboratory Test Interactions:

Carbetapentane citrate should not be used in patients receiving MAO inhibitors, including 14 days after stopping the MAOI drug.

The use of carbetapentane citrate may result in additive CNS depressant effects when coadministered with alcohol, antihistamines,

psychotropics or other drugs that produce CNS depression.

Guaifenesin may produce an increase in urinary 5-hydroxyindoleacetic acid and may therefore interfere with the interpretation of

this test for the diagnosis of carcinoid syndrome. It may also falsely elevate the VMA test for catechols. Administration of this

drug should be discontinued 48 hours prior to the collection of urine specimens for such tests.

Carcinogenesis, Mutagenesis, and Impairment of Fertility:

No adequate and well-controlled studies have been conducted to determine whether the components of ExallTM  Liquid

have a potential for carcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy:

Pregnancy Category C: Animal reproduction studies have not been conducted with this product. It is also not known whether it can

cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should not be administered

to pregnant women.

Nursing Mothers:

Due to the possible passage of the ingredients into breast milk, this product should not be given to nursing mothers.

Pediatric use:

Safety and effectiveness in pediatric patients below the age of six have not been established. Product not intended for administration

for children 6 years of age and under.

ADVERSE REACTIONS:

Adverse effects associated with carbetapentane citrate are rare, but nausea and/or other gastrointestinal disturbances sometimes occur.

Guaifenesin is well tolerated and has a wide margin of safety. Adverse effects associated with guaifenesin usually result from doses larger

than those required for expectoration.

OVERDOSAGE:

Signs and Symptoms: Overdosage with carbetapentane citrate may produce central excitement and mental confusion. Guaifenesin is

unlikely to produce toxic effects since its toxicity is low. When laboratory animals were administered guaifenesin in doses up to 5 g/kg

by stomach tube, no toxicity resulted.

Treatment: The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by the

administration of ipecac liquid is a preferred method, however, vomiting should not be induced in patients with impaired consciousness.

Precautions against aspiration must be taken, especially in infants and children. Following emesis, any drug remaining in the stomach

may be absorbed by activated charcoal administered as a slurry with water.

DOSAGE AND ADMINISTRATION:

Adults and children 12 years of age and older:

1-2 teaspoonfuls (5-10 mL) every 4-6 hours, not to exceed 12 teaspoonfuls in a 24 hour period.

Children 6 to 12 years of age:

1 teaspoonful (5 ml) every 4-6 hours, not to exceed 6 teaspoonfuls in a 24 hour period.

Children under 6 years of age:

Consult a physician.

HOW SUPPLIED:

ExallTM Liquid is a colorless, cherry flavored liquid and supplied in bottles of 16 fl oz (473 mL), NDC 63717-554-16, or samples

of 1/2 fl oz (15 mL), NDC 63717-554-99.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE,

CONTACT A POISON CONTROL CENTER AND SEEK PROFESSIONAL ASSISTANCE IMMEDIATELY.

Store at 20o to 25oC (68o to 77oF). [See USP Controlled Room Temperature]

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container with a child-resistant closure.

Rx Only

Manufactured for:

Hawthorn Pharmaceuticals, Inc.

Madison, MS 39110

HI255   08/09

PRODUCT PACKAGING:

The packaging below represents the labeling currently used.

NDC 63717-554-16

ExallTM Liquid

Antitussive / Expectorant

Each teaspoonful (5 mL) for oral administration contains:

Carbetapentane Citrate..... 10 mg

Guaifenesin.................... 100 mg

Rx Only

Dye Free/Sugar Free/Alcohol Free

Hawthorn Pharmaceuticals, Inc.

16 fl oz (473 mL)

Side Panel:

USUAL DOSAGE: See Package Insert for Complete Dosage Recommendations.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON

CONTROL CENTER IMMEDIATELY.

Store at 20o to 25oC (68o to 77oF). [See USP Controlled Room Temperature]

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

This bottle is not to be dispensed to the consumer. Dispense in a tight, light-resistant container with a child-resistant closure.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 (Toll Free).

Manufactured for: Hawthorn Pharmaceuticals, Inc., Madison, MS 39110

HL209   08/09

Exall Liquid  carbetapentane citrate, guaifenesin   liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63717-554 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carbetapentane Citrate (Carbetapentane) Carbetapentane Citrate 10 mg  in 5 mL Guaifenesin (Guaifenesin) Guaifenesin 100 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor CHERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63717-554-16 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved other		08/24/2009

Labeler - Hawthorn Pharmaceuticals, Inc. (118049704)

Revised: 08/2009Hawthorn Pharmaceuticals, Inc.

More Exall Liquid resources

• Exall Liquid Side Effects (in more detail)
• Exall Liquid Dosage
• Exall Liquid Use in Pregnancy & Breastfeeding
• Exall Liquid Drug Interactions
• Exall Liquid Support Group
• 0 Reviews for Exall - Add your own review/rating

Compare Exall Liquid with other medications

• Cough

Naphazoline/Zinc Drops

Pronunciation: na-FAZ-oh-leen
Generic Name: Naphazoline/Zinc
Brand Name: VasoClear-A

Naphazoline/Zinc Drops are used for:

Temporarily relieving redness, burning, and discomfort caused by minor eye irritation. It may also be used for other conditions as determined by your doctor.

Naphazoline/Zinc Drops are an eye decongestant and astringent. It works by constricting the blood vessels in the eye and coating the eye, which relieves redness and dryness.

Do NOT use Naphazoline/Zinc Drops if:

• you are allergic to any ingredient in Naphazoline/Zinc Drops


• you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Naphazoline/Zinc Drops:

Some medical conditions may interact with Naphazoline/Zinc Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have glaucoma, high blood pressure, diabetes, heart problems, or thyroid problems, or you are taking medicine for high blood pressure

Some MEDICINES MAY INTERACT with Naphazoline/Zinc Drops. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Tricyclic antidepressants (eg, amitriptyline) because they may decrease Naphazoline/Zinc Drops's effectiveness


• Cocaine, furazolidone, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Naphazoline/Zinc Drops's side effects, such as headache, fever, and high blood pressure


• Bromocriptine or cocaine because the risk of their side effects may be increased by Naphazoline/Zinc Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if Naphazoline/Zinc Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Naphazoline/Zinc Drops:

Use Naphazoline/Zinc Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Naphazoline/Zinc Drops are for use in the eye only. Avoid contact with other mucous membranes.


• To use Naphazoline/Zinc Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.


• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.


• If you miss a dose of Naphazoline/Zinc Drops and you are using it regularly, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Ask your health care provider any questions you may have about how to use Naphazoline/Zinc Drops.

Important safety information:

• Remove contact lenses before using Naphazoline/Zinc Drops.


• Do not use Naphazoline/Zinc Drops if it becomes cloudy or changes color.


• Contact your doctor if you experience changes in your vision, eye pain, irritation, soreness, or continued redness, or if your condition does not improve after 3 days.


• Do not exceed the recommended dose or use Naphazoline/Zinc Drops for longer than prescribed without checking with your doctor. Eye redness may be increased by overuse of Naphazoline/Zinc Drops.


• Use Naphazoline/Zinc Drops with caution in CHILDREN because they may be more sensitive to its effects.


• Different brands of Naphazoline/Zinc Drops may have different dosing instructions for CHILDREN on the package labeling. Follow the dosing instructions provided on the package labeling or by your doctor. If you are unsure of the dose to give a child, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Naphazoline/Zinc Drops, discuss with your doctor the benefits and risks of using Naphazoline/Zinc Drops during pregnancy. It is unknown if Naphazoline/Zinc Drops are excreted in breast milk. If you are or will be breast-feeding while you are using Naphazoline/Zinc Drops, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Naphazoline/Zinc Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; minor stinging or tingling when the medicine is dropped into the eye.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; eye pain; worsening or persistent eye irritation or redness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Naphazoline/Zinc side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Naphazoline/Zinc Drops may be harmful if swallowed, especially in children.

Proper storage of Naphazoline/Zinc Drops:

Store Naphazoline/Zinc Drops at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Naphazoline/Zinc Drops out of the reach of children and away from pets.

General information:

• If you have any questions about Naphazoline/Zinc Drops, please talk with your doctor, pharmacist, or other health care provider.


• Naphazoline/Zinc Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Naphazoline/Zinc Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Naphazoline/Zinc resources

• Naphazoline/Zinc Side Effects (in more detail)
• Naphazoline/Zinc Use in Pregnancy & Breastfeeding
• Naphazoline/Zinc Drug Interactions
• Naphazoline/Zinc Support Group
• 0 Reviews for Naphazoline/Zinc - Add your own review/rating

Compare Naphazoline/Zinc with other medications

• Eye Dryness/Redness
• Eye Redness/Itching

Efudex Cream

Pronunciation: FLURE-oh-UE-ra-sil
Generic Name: Fluorouracil
Brand Name: Efudex

Efudex Cream is used for:

Treating multiple actinic or solar keratoses (skin growths caused by exposure to sunlight). It may also be used for other conditions as determined by your doctor.

Efudex Cream is an antineoplastic. It works by blocking the growth of certain cells. This causes cell death.

Do NOT use Efudex Cream if:

• you are allergic to any ingredient in Efudex Cream


• you are pregnant or may become pregnant


• you have the metabolic disorder dihydropyrimidine dehydrogenase (DPD) enzyme deficiency

Contact your doctor or health care provider right away if any of these apply to you.

Before using Efudex Cream:

Some medical conditions may interact with Efudex Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if the area of skin being treated is damaged or inflamed, or has open sores

Some MEDICINES MAY INTERACT with Efudex Cream. Because little, if any, of Efudex Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Efudex Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Efudex Cream:

Use Efudex Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Use a nonmetallic applicator or wear rubber gloves while applying Efudex Cream.


• Gently wash the area where you will apply Efudex Cream. Rinse well, pat dry with a towel, and wait 10 minutes before applying Efudex Cream.


• Wash your hands immediately after applying Efudex Cream, unless they are part of the treated area.


• Do not bandage or cover the treated area, unless directed to do so by your doctor.


• Efudex Cream is for external use only. Do not get it in your eyes, nose, mouth, or genital area. If you get it in your eyes, rinse with a generous amount of cool water right away and contact your doctor.


• If you miss a dose of Efudex Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Efudex Cream.

Important safety information:

• Complete healing of the lesions may not occur for 1 to 2 months after you stop using Efudex Cream.


• The treated areas may be unattractive during therapy and for several weeks after treatment has stopped.


• Efudex Cream may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Efudex Cream. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Do not use other medicines or products on the treated area without first checking with your doctor.


• Do not use Efudex Cream for future skin problems without first checking with your doctor.


• Lab tests, including biopsies, may be performed while you use Efudex Cream. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Efudex Cream should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Efudex Cream if you are pregnant. It may cause harm to the fetus. If you think you may be pregnant, contact your doctor right away. It is not known if Efudex Cream is found in breast milk. Do not breast-feed while taking Efudex Cream.

Possible side effects of Efudex Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning, crusting, redness, pain, soreness, inflammation, or irritation of the skin.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; change in skin color; chills; fever; scarring or sores on the treated area; severe or persistent burning, crusting, redness, pain, soreness, inflammation, or irritation of the skin; severe stomach pain; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Efudex side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Efudex Cream may be harmful if swallowed.

Proper storage of Efudex Cream:

Store Efudex Cream at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Efudex Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Efudex Cream, please talk with your doctor, pharmacist, or other health care provider.


• Efudex Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Efudex Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Efudex resources

• Efudex Side Effects (in more detail)
• Efudex Use in Pregnancy & Breastfeeding
• Efudex Support Group
• 9 Reviews for Efudex - Add your own review/rating

Compare Efudex with other medications

• Actinic Keratosis
• Basal Cell Carcinoma
• Skin Cancer