acetic acid and aluminum acetate otic

Generic Name: acetic acid and aluminum acetate otic (ah SEE tic AH sid and ah LOO mih num AH seh tate OH tic)

Brand names: Domeboro Otic, Star-Otic, Borofair

What is acetic acid and aluminum acetate otic?

Acetic acid has antibacterial and antifungal activity.

Aluminum acetate helps to reduce itching, stinging, and inflammation that may be associated with an infection.

Together, acetic acid and aluminum acetate are used to treat ear infections.

Acetic acid and aluminum acetate otic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about acetic acid and aluminum acetate otic?

Do not use this medication in the eyes or take it by mouth. Acetic acid and aluminum acetate otic is intended for use in the ears only. Do not touch the dropper opening to any surface, including the ears or hands. The dropper opening is sterile. If it becomes contaminated, it could cause another infection in the ear.

Notify your doctor if the condition does not improve or appears to worsen.

What should I discuss with my healthcare provider before using acetic acid and aluminum acetate otic?

Do not use acetic acid and aluminum acetate otic if the ear drum (tympanic membrane) has ruptured (broken). It may be dangerous for medicine to get into the inner ear. A ruptured ear drum usually causes a considerable amount of pain. A decrease in hearing may also occur. See your doctor if you suspect a ruptured ear drum. Your doctor will know if the ear drum is ruptured by looking into the ear with a special device (otoscope). Do not use acetic acid and aluminum acetate otic without first talking to your doctor if you have had a previous allergic reaction to it or to another similar topical medication such as Burrow's solution or Domeboro topical. It is not known whether acetic acid and aluminum acetate will be harmful to an unborn baby. Do not use acetic acid and aluminum acetate otic without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether acetic acid and aluminum acetate otic passes into breast milk. Do not use acetic acid and aluminum acetate otic without first talking to your doctor if you are breast-feeding a baby.

How should I use acetic acid and aluminum acetate otic?

Use acetic acid and aluminum acetate otic exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you. Do not use this medication in the eyes or take it by mouth. Acetic acid and aluminum acetate otic is intended for use in the ears only.

In general, acetic acid and aluminum acetate otic should be used as follows:

• 
  

  If the drops have been stored in the refrigerator, warm the drops slightly by holding them in the hands for 1 or 2 minutes. Administration of cold drops into the ear may cause dizziness.

  
  


• 
  

  Have another person administer the drops whenever possible. Have the affected person lie on their side or tilt the ear up to make administering a drop easier.

  
  


• 
  

  For adults, hold the earlobe up and back. For children, hold the earlobe down and back. This will allow the drops to run into the ear canal. Carefully instill the prescribed number of drops in the first ear.

  
  


• 
  

  Keep the ear tilted for five minutes to allow the medication to penetrate the ear.

  
  


• 
  

  Repeat the process in the other ear if prescribed.

  
  

Use all of the medication that has been prescribed. Symptoms may begin to improve before the condition is completely treated. If you do not use all of the medication prescribed, the condition could return or worsen.

It is important to use acetic acid and aluminum acetate otic regularly to get the most benefit.

Notify your doctor if the condition does not improve or appears to worsen.

Store acetic acid and aluminum acetate otic at room temperature or in the refrigerator, away from moisture, heat, and direct light. Keep the bottle properly capped. Do not allow the medication to freeze.

What happens if I miss a dose?

Use the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and use only the next regularly scheduled dose. Do not use a double dose of acetic acid and aluminum acetate otic unless otherwise directed by your doctor.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected or if the medication has been ingested.

Symptoms of a acetic acid and aluminum acetate otic overdose are not known.

What should I avoid while using this medication?

Ear infections may sometimes cause dizziness or a loss of balance. Use caution when driving, operating machinery, or performing other hazardous activities if you experience dizziness or a loss of balance.

Acetic acid and aluminum acetate otic side effects

Stop using acetic acid and aluminum acetate otic and seek emergency medical attention or notify your doctor if you experience:

• 
  

  an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or

  
  


• 
  

  ear drainage, discharge, or worsening pain.

  
  

Other less serious side effects may also occur such as irritation in the ear. Contact your doctor if these side effects seem excessive or unusual.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect my acetic acid and aluminum acetate otic?

Do not use other ear drops during treatment with acetic acid and aluminum acetate otic without first talking to your doctor.

Drugs other than those listed here may also interact with acetic acid and aluminum acetate otic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More acetic acid and aluminum acetate otic resources

• Acetic acid and aluminum acetate otic Side Effects (in more detail)
• Acetic acid and aluminum acetate otic Use in Pregnancy & Breastfeeding
• Acetic acid and aluminum acetate otic Support Group
• 0 Reviews for Acetic acid and aluminum acetate - Add your own review/rating

Compare acetic acid and aluminum acetate otic with other medications

• Otitis Externa

Where can I get more information?

• Your pharmacist has more information about acetic acid and aluminum acetate otic written for health professionals that you may read.

See also: acetic acid and aluminum acetate side effects (in more detail)

Fuzeon

Generic Name: Enfuvirtide
Class: HIV Entry and Fusion Inhibitors
VA Class: AM800
Chemical Name: N - Acetyl - l - tyrosyl - l - threonyl - l - seryl - l - leucyl - l - isoleucyl - l - histidyl - l - seryl - l - leucyl - l - isoleucyl - l - alpha - glutamyl - l - alpha - glutamyl - l - seryl - l
Molecular Formula: C₂₀₄H₃₀₁N₅₁O₆₄
CAS Number: 159519-65-0

Introduction

Antiretroviral; HIV fusion inhibitor.¹

Uses for Fuzeon

Treatment of HIV Infection

Treatment of HIV-1 infection in treatment-experienced (previously treated) patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy; used in conjunction with other antiretrovirals.¹

Safety and efficacy have not been systematically evaluated in treatment-naive patients (have not previously received antiretroviral therapy).^{1 12} Experts state the drug is not recommended for initial treatment.^{5 13}

Postexposure Prophylaxis following Occupational Exposure to HIV

Postexposure prophylaxis of HIV infection† in health-care workers and others exposed occupationally via percutaneous injury or mucous membrane or nonintact skin contact with blood, tissues, or other body fluids associated with a risk for transmission of the virus.¹⁶ Used in conjunction with other antiretrovirals.¹⁶

Not recommended for routine postexposure prophylaxis, but can be considered with expert consultation.¹⁶

Fuzeon Dosage and Administration

Administration

Sub-Q Administration

Administer sub-Q into the upper arm, anterior thigh, or abdomen (avoid the navel).^{1 4 13}

Injection sites should be rotated with each injection (i.e., injections should be made at a site different from the preceding injection site).^{1 4}

Injections should not be made into areas where skin shows signs of a previous injection site reaction and should not be made near anatomical areas where large nerve tracts lie close to the skin (e.g., near the elbow, knee, groin, inferior or medial section of the buttocks).^{1 4} Injections also should not be made directly over blood vessels, near the navel, or into skin abnormalities, moles, scars (including surgical scars), bruises, tattoos, or burn sites.^{1 4}

Refrigerated reconstituted solution should be brought to room temperature before injection.¹

May be self-administered if the clinician determines that the patient and/or their caregiver is competent to safely administer the drug.^{1 4}

Reconstitution

Add 1.1 mL of sterile water for injection diluent provided by the manufacturer to vial containing 108 mg; tap vial gently with a fingertip for 10 seconds and then gently roll between the hands (avoid foaming) to ensure that the drug is in contact with the diluent.^{1 4} Let vial stand until all of the powder goes into solution; reconstitution can take up to 45 minutes.¹ Reconstituted solutions of the drug should not be shaken.⁴

Reconstituted solution contains 90 mg/mL.¹

Dosage

Must be given in conjunction with other antiretrovirals.¹

Pediatric Patients

Treatment of HIV Infection

Sub-Q

Children 6–16 years of age: 2 mg/kg (maximum 90 mg) twice daily.^{1 13}

Adolescents >16 years of age: 90 mg twice daily.^{1 13}

Adults

Treatment of HIV Infection

Sub-Q

90 mg twice daily.^{1 5}

Postexposure Prophylaxis following Occupational Exposure to HIV†

Sub-Q

90 mg twice daily.¹⁶

Use with expert consultation.¹⁶

Initiate postexposure prophylaxis as soon as possible (within hours rather than days) and continue for 4 weeks, if tolerated.¹⁶

Prescribing Limits

Pediatric Patients

Treatment of HIV Infection

Sub-Q

Children 6–16 years of age: Maximum 90 mg twice daily.¹

Special Populations

Hepatic Impairment

Dosage recommendations not available.⁵

Renal Impairment

Treatment of HIV Infection

Dosage adjustments not needed.^{1 5}

Cautions for Fuzeon

Contraindications

• 
  

  Known hypersensitivity to enfuvirtide or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

Local Reactions

Sub-Q administration associated with injection site reactions (e.g., mild to moderate pain/discomfort, induration, erythema, presence of nodules or cysts, pruritus, ecchymosis) in almost all patients.^{1 2 3}

Injection site reactions persist for >7 days in some patients; injection site reactions at ≥6 sites reported in 23% of patients in phase 3 clinical studies.¹

Infectious Complications

Increased incidence of bacterial pneumonia; has not been directly attributed to the drug.¹ Risk factors included low initial CD4⁺ T-cell counts, high initial viral load, IV drug abuse, smoking, and history of lung disease.¹

Monitor patients (especially those with underlying conditions that may predispose them to pneumonia) carefully for signs and symptoms of pneumonia.¹

Sensitivity Reactions

Hypersensitivity reactions (e.g., rash, fever, nausea and vomiting, chills, rigors, hypotension, elevated serum liver transaminase concentrations) reported; these hypersensitivity reactions have recurred on rechallenge.^{1 2}

Other adverse events that may be immune mediated include primary immune complex reactions, respiratory distress, glomerulonephritis, and Guillain-Barré syndrome.^{1 2}

If hypersensitivity reaction occurs, discontinue and seek immediate medical evaluation.¹

Do not reinitiate enfuvirtide in patients who have experienced a hypersensitivity reaction.¹

General Precautions

Laboratory Test Interferences

Although enfuvirtide has not been studied in non-HIV-infected individuals, the possibility exists that administration of the drug could lead to the production of anti-enfuvirtide antibodies that could cross react with HIV glycoprotein 41(gp41), resulting in a false-positive HIV test using an enzyme-linked immunosorbent assay (ELISA); a confirmatory test (i.e., Western blot) would be expected to be negative.¹

Immune Reconstitution Syndrome

During initial treatment, patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium complex [MAC], M. tuberculosis, cytomegalovirus [CMV], Pneumocystis jiroveci [formerly P. carinii]); this may necessitate further evaluation and treatment.¹

Administration Using Biojector 2000

Neuralgia and/or paresthesia, sometimes lasting up to 6 months, reported following injection into anatomical sites where large nerve tracts lie close to the skin.¹ Bruising and hematomas also reported.¹

Patients receiving anticoagulants and those with hemophilia or other coagulation disorders may be at higher risk for post-injection bleeding.¹

Specific Populations

Pregnancy

Category B.¹

Antiretroviral Pregnancy Registry at 800-258-4263.¹

Some experts state that safety and pharmacokinetic data insufficient to recommend enfuvirtide in pregnant women.¹⁸

Lactation

Enfuvirtide or its metabolites distributed into milk in animals; not known whether distributed into human milk.¹

Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.¹

Pediatric Use

Safety and efficacy not established in children <6 years of age.^{1 13}

Limited efficacy data available in pediatric patients 6–16 years of age.^{1 6 13}

Adverse effects in pediatric patients similar to those in adults; however, infections at the injection site (cellulitis, abscess) reported more frequently in adolescents than adults.¹

Geriatric Use

Insufficient experience in those ≥65 years of age to determine whether they respond differently than younger adults.¹

Common Adverse Effects

Injection site reactions; GI effects (diarrhea, nausea); fatigue.¹

Interactions for Fuzeon

Does not inhibit CYP-450 isoenzymes.¹

Does not affect metabolism of CYP3A4, CYP2D6, CYP1A2, CYP2C19, or CYP2E1 substrates.¹

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interactions unlikely.¹

Specific Drugs and Laboratory Tests

Drug	Interaction	Comments
Anticoagulants	Higher risk for postinjection bleeding when enfuvirtide administered using a Biojector needle-free device1
Efavirenz	In vitro evidence of additive or synergistic antiretroviral effects1
Lamivudine	In vitro evidence of additive or synergistic antiretroviral effects1
Indinavir	In vitro evidence of additive or synergistic antiretroviral effects1
Nelfinavir	In vitro evidence of additive or synergistic antiretroviral effects1
Rifampin	Pharmacokinetic interaction unlikely1
Ritonavir	Possible increase in plasma concentrations and AUC of enfuvirtide1	Not considered clinically important1
Saquinavir	Possible increase in AUC of enfuvirtide with ritonavir-boosted saquinavir1	Not considered clinically important1
Test, Enzyme-linked immunosorbent assay (ELISA) for HIV	Possible false-positive in non-HIV-infected individuals given enfuvirtide1	Confirmatory test (i.e., Western blot) expected to be negative1
Tipranavir	In vitro evidence of synergistic antiretroviral effects17
Zidovudine	In vitro evidence of additive or synergistic antiretroviral effects1

Fuzeon Pharmacokinetics

Absorption

Bioavailability

Almost completely absorbed following sub-Q administration; absolute bioavailability is 84.3%.¹

Systemic absorption is comparable following injection into the abdomen, thigh, or arm.¹

Systemic absorption in adults is comparable following sub-Q injection using the Biojector 2000 needle-free device or a 27-gauge ½-inch needle and syringe.¹⁹

Special Populations

Plasma concentrations in children 6–16 years of age receiving enfuvirtide 2 mg/kg twice daily (maximum 90 mg twice daily) similar to those reported in adults receiving the recommended dosage.¹

Distribution

Plasma Protein Binding

92%; bound mainly to albumin and, to a lesser extent, α-1 acid glycoprotein.¹

Elimination

Metabolism/Elimination

Expected to undergo catabolism to its constituent amino acids, with subsequent recycling of the amino acids in the body pool.¹

Hemodialysis does not have a clinically important effect on enfuvirtide clearance.¹

Half-life

3.8 hours.¹

Special Populations

Pharmacokinetics not evaluated in hepatic impairment.¹

Clearance not affected in patients with renal impairment with Cl_cr >35 mL/minute.¹ Clearance reduced by 38% in patients with severe renal impairment (Cl_cr 11–35 mL/minute) and 14–28% in patients with end-stage renal disease undergoing dialysis.¹

Stability

Storage

Parenteral

Powder for Injection

25°C (may be exposed to 15–30°C).¹

Store reconstituted solution under refrigeration at 2–8°C; discard 24 hours after reconstitution.¹

Actions and SpectrumActions

• 
  

  Pharmacologically and structurally different from other currently available antiretrovirals.¹

  
  


• 
  

  Active against HIV-1; inactive against HIV-2.¹

  
  


• 
  

  Interferes with entry of HIV-1 into target cells by inhibiting fusion of the viral and cellular membranes.¹

  
  


• 
  

  HIV-1 with reduced susceptibility to enfuvirtide have been selected in vitro and have emerged during therapy with the drug.¹

  
  


• 
  

  Cross-resistance between enfuvirtide and nucleoside reverse transcriptase inhibitors (NRTIs), nonnucleoside reverse transcriptase inhibitors (NNRTIs), or HIV protease inhibitors (PIs) is highly unlikely since the drugs have different mechanisms of action.¹²

  
  

Advice to Patients

• 
  

  Critical nature of compliance with HIV therapy.¹ Importance of using enfuvirtide in conjunction with other antiretrovirals—not for monotherapy.¹

  
  


• 
  

  Antiretroviral therapy is not a cure for HIV infection, and opportunistic infections still may occur.¹ HIV transmission via sexual contact or sharing needles is not prevented by antiretrovirals.¹

  
  


• 
  

  Importance of clinicians providing appropriate instruction on use of enfuvirtide to patients and/or their caregivers who are allowed to administer the drug in the home setting.¹

  
  


• 
  

  Importance of administering enfuvirtide into the preferred sites (i.e., upper arm, abdomen, anterior thigh).¹ Injections should not be made near anatomical areas where large nerve tracts lie close to the skin (e.g., near the elbow, knee, groin, inferior or medial section of the buttocks), directly over a blood vessel, near the navel, or into skin abnormalities, moles, scars (including surgical scars), bruises, tattoos, or burn sites.¹

  
  


• 
  

  Importance of reading the patient package insert from the manufacturer.¹

  
  


• 
  

  Importance of monitoring for signs and symptoms of injection site reactions and contacting clinician if such reactions are severe or there are signs of infection such as oozing, increased heat, swelling, redness, or pain.^{1 4}

  
  


• 
  

  Importance of monitoring for signs and symptoms of pneumonia (cough with fever, rapid breathing, shortness of breath) and contacting clinician if these occur.^{1 4}

  
  


• 
  

  Importance of discontinuing enfuvirtide and informing clinician if manifestations of a hypersensitivity reaction (combinations of rash, fever, nausea and vomiting, chills, rigors, and/or hypotension) occur.¹

  
  


• 
  

  Advise that dizziness may occur; necessity of exercising caution when driving or operating machinery.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

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

Enfuvirtide

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection	108 mg (to provide 90 mg)	Fuzeon (with sterile water for injection diluent)	Roche

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 October 01, 2009. 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.

References

1. Roche. Fuzeon (enfuvirtide) prescribing information. Nutley, NJ; 2008 Dec.

2. Lalezaru JP, Henry K, O’Hearn M et al. Enfuvirtide, an HIV-1 fusion inhibitor, for drug-resistant HIV infection in North and South America. N Engl J Med. 2003; 348:2175-85. [IDIS 498400] [PubMed 12637625]

3. Lalezari JP, Eron JJ, Carlson M et al. A phase II clinical study of the long-term safety and antiviral activity of enfuvirtide-based antiretroviral therapy. AIDS. 2003; 17:691-8. [PubMed 12646792]

4. Roche. Injection instructions: Fuzeon (enfuvirtide). From the Fuzeon web site. (Assessed 2005 Sep 8.)

5. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents (November 3, 2008). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.

6. Church JA, Cunningham C, Hughes M et al. Safety and antiretroviral activity of chronic subcutaneous administration of T-20 in human immunodeficiency virus 1-infected children. Pediatr Infect Dis J. 2002; 21:653-9. [IDIS 487366] [PubMed 12237598]

7. Lazzarin A, Clotet B, Cooper D et al for the TORO2 study group. Efficacy of enfuvirtide in patients infected with drug-resistant HIV-1 in Europe and Australia. N Engl J Med. 2003; 348:2186-95. [IDIS 498401] [PubMed 12773645]

8. Chronimed Statscript Pharmacy. Chronimed to be exclusive U.S. distributor of Fuzeon; contract signed with Roche. From the Chronimed web site. (Assessed 2003 May 12.)

9. Fuzeon progressive distribution program. From the Fuzeon web site. (Assessed 2003 May 12.)

10. Wei X, Decker JM, Liu H et al. Emergence of resistant human immunodeficiency virus type 1 in patients receiving fusion inhibitor (T-20) monotherapy. Antimicrob Agents Chemother. 2002; 46:1896-1905. [IDIS 481643] [PubMed 12019106]

11. Zhang X, Nieforth K, Lang JM et al. Pharmacokinetics of plasma enfuvirtide after subcutaneous administration to patients with human immunodeficiency virus: inverse Gaussian density absorption and 2-compartment disposition. Clin Pharmacol Ther. 2002; 72:10-9. [IDIS 484779] [PubMed 12152000]

12. Roche. Nutley, NJ: Personal communication.

13. Working Group on Antiretroviral Therapy and Medical Management of HIV-infected Children of the National Resource Center at the François-Xavier Bagnoud Center, Health Resources and Services Administration (HRSA), and National Institutes of Health (NIH). Guidelines for the use of antiretroviral agents in pediatric HIV infection (February 23, 2009). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.

14. Hammer SM, Saag MS, Schechter M et al. Treatment of adult HIV infection: 2006 recommendations of the International AIDS Society–USA panel. JAMA. 2006; 296:827-43. [PubMed 16905788]

15. Gazzard B, for the BHIVA Guidelines Writing Committee. British HIV association (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy (2005). HIV Med. 2005; 6(Suppl 2):1-61.

16. Center for Disease Control and Prevention. Updated U.S. public health service guidelines for the management of occupational exposures to HIV and recommendations for postexposure prophylaxis. MMWR Recomm Rep. 2005; 54(No. RR-9):1-17.

17. Boehringer Ingelheim. Aptivus (tipranavir) capsules prescribing information. Ridgefield, CT; 2006 Jun 27.

18. Perinatal HIV Guidelines Working Group. US Public Health Service task force recommendations for use of antiretroviral drugs in pregnant HIV-infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States (April 29, 2009). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.

19. True AL, Chiu YY, Demasi RA et al. Pharmacokinetic bioequivalence of enfuvirtide using a needle-free device versus standard needle administration. Pharmacotherapy. 2006; 26: 1679-86. [PubMed 17125431]

More Fuzeon resources

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

• Fuzeon Prescribing Information (FDA)


• Fuzeon Consumer Overview


• Fuzeon Advanced Consumer (Micromedex) - Includes Dosage Information


• Fuzeon MedFacts Consumer Leaflet (Wolters Kluwer)


• Enfuvirtide Professional Patient Advice (Wolters Kluwer)

Compare Fuzeon with other medications

• HIV Infection

antacid

Class Name: antacid (Oral route)

Commonly used brand name(s)

In the U.S.

• Alternagel


• Alu-Cap


• Brioschi


• Dewee's Carminative


• Dulcolax Milk of Magnesia


• Kaopectate


• Mag-Gel 600


• Mag-Ox 400


• Pepto Bismol


• Phillips Milk of Magnesia


• Riopan


• Rolaids


• Tums

In Canada

• Alumag


• Amphojel


• Amphojel 500


• Antacid


• Antacid Plus


• Antacid Stomaax


• Antacid Stomaax Plus Simethicone Antiflatulent


• Baros


• Bismuth Extra Strength


• Bismuth Original Formula


• Diovol


• Diovol Ex

Available Dosage Forms:

• Liquid


• Tablet


• Powder for Suspension


• Capsule


• Tablet, Chewable


• Suspension


• Solution


• Powder


• Tablet, Extended Release


• Wafer


• Tablet, Effervescent


• Granule


• Powder, Effervescent

Uses For This Medicine

Antacids are taken by mouth to relieve heartburn, sour stomach, or acid indigestion. They work by neutralizing excess stomach acid. Some antacid combinations also contain simethicone, which may relieve the symptoms of excess gas. Antacids alone or in combination with simethicone may also be used to treat the symptoms of stomach or duodenal ulcers.

With larger doses than those used for the antacid effect, magnesium hydroxide (magnesia) and magnesium oxide antacids produce a laxative effect. The information that follows applies only to their use as an antacid.

Some antacids, like aluminum carbonate and aluminum hydroxide, may be prescribed with a low-phosphate diet to treat hyperphosphatemia (too much phosphate in the blood). Aluminum carbonate and aluminum hydroxide may also be used with a low-phosphate diet to prevent the formation of some kinds of kidney stones. Aluminum hydroxide may also be used for other conditions as determined by your doctor.

These medicines are available without a prescription. However, your doctor may have special instructions on the proper use and dose of these medicines for your medical problem.

Importance of Diet

Make certain your health care professional knows if you are on a low-sodium diet. Some antacids contain large amounts of sodium.

Before Using This Medicine

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Antacids should not be given to young children (under 6 years of age) unless ordered by their doctor. Since children cannot usually describe their symptoms very well, a doctor should first check the child. The child may have a condition that needs other treatment. If so, antacids will not help and may even cause unwanted effects or make the condition worse. In addition, aluminum- or magnesium-containing medicines should not be given to premature or very young children because they may cause serious side effects, especially when given to children who have kidney disease or who are dehydrated.

Geriatric

Aluminum-containing antacids should not be used by elderly persons with bone problems or with Alzheimer's disease. The aluminum may cause their condition to get worse.

Pregnancy

Studies on effects in pregnancy have not been done in either humans or animals. However, there have been reports of antacids causing side effects in babies whose mothers took antacids for a long time, especially in high doses during pregnancy. Also, sodium-containing medicines should be avoided if you tend to retain (keep) body water.

Breast Feeding

Some aluminum-, calcium-, or magnesium-containing antacids may pass into breast milk. However, these medicines have not been reported to cause problems in nursing babies.

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. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Amantadine


• Atropine


• Belladonna


• Belladonna Alkaloids


• Benztropine


• Biperiden


• Clidinium


• Darifenacin


• Dicyclomine


• Eplerenone


• Glycopyrrolate


• Hyoscyamine


• Methscopolamine


• Oxybutynin


• Procyclidine


• Scopolamine


• Solifenacin


• Tolterodine


• Trihexyphenidyl

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alacepril


• Amiloride


• Atazanavir


• Benazepril


• Canrenoate


• Captopril


• Cilazapril


• Dasatinib


• Delapril


• Delavirdine


• Enalaprilat


• Enalapril Maleate


• Fosinopril


• Imidapril


• Indomethacin


• Licorice


• Lisinopril


• Methotrexate


• Moexipril


• Mycophenolate Mofetil


• Mycophenolic Acid


• Pentopril


• Perindopril


• Quinapril


• Quinine


• Ramipril


• Rilpivirine


• Spirapril


• Spironolactone


• Temocapril


• Tizanidine


• Tolazoline


• Trandolapril


• Triamterene


• Zofenopril

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Alzheimer's disease (for aluminum-containing antacids only) or


• Appendicitis (or signs of) or


• Bone fractures or


• Colitis or


• Constipation (severe and continuing) or


• Hemorrhoids or


• Intestinal blockage or


• Intestinal or rectal bleeding—Antacids may make these conditions worse

• Colostomy or


• Ileostomy or


• Inflamed bowel—Use of antacids may cause the body to retain (keep) water and electrolytes such as sodium and/or potassium

• Edema (swelling of feet or lower legs) or


• Heart disease or


• Liver disease or


• Toxemia of pregnancy—Use of sodium-containing antacids may cause the body to retain (keep) water

• Kidney disease—Antacids may cause higher blood levels of aluminum, calcium, or magnesium, which may increase the risk of serious side effects

• Sarcoidosis—Use of calcium-containing antacids may cause kidney problems or too much calcium in the blood

• Underactive parathyroid glands—Use with calcium-containing antacids may cause too much calcium in the blood

Proper Use of This Medicine

For patients taking the chewable tablet form of this medicine:

• Chew the tablets well before swallowing. This is to allow the medicine to work faster and be more effective.

For patients taking this medicine for a stomach or duodenal ulcer:

• Take it exactly as directed and for the full time of treatment as ordered by your doctor, to obtain maximum relief of your symptoms.


• Take it 1 and 3 hours after meals and at bedtime for best results, unless otherwise directed by your doctor.

For patients taking aluminum carbonate or aluminum hydroxide to prevent kidney stones:

• Drink plenty of fluids for best results, unless otherwise directed by your doctor.

For patients taking aluminum carbonate or aluminum hydroxide for hyperphosphatemia (too much phosphate in the blood):

• Your doctor may want you to follow a low-phosphate diet. If you have any questions about this, check with your doctor.

Dosing

The dose medicines in this class 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 these medicines. 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.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine

If this medicine has been ordered by your doctor and you will be taking it in large doses, or for a long time, your doctor should check your progress at regular visits. This is to make sure the medicine does not cause unwanted effects.

Some tests may be affected by this medicine. Tell the doctor in charge that you are taking this medicine before you have any tests to determine how much acid your stomach produces.

Do not take this medicine:

• if you have any signs of appendicitis or inflamed bowel (such as stomach or lower abdominal pain, cramping, bloating, soreness, nausea, or vomiting). Instead, check with your doctor as soon as possible.


• within 1 to 2 hours or more of taking other medicine by mouth. To do so may keep the other medicine from working properly.

For patients on a sodium-restricted diet:

• Some antacids (especially those containing sodium bicarbonate) contain a large amount of sodium. If you have any questions about this, check with your health care professional.

For patients taking this medicine for increased stomach acid:

• Do not take it for more than 2 weeks unless otherwise directed by your doctor. Antacids should be used only for occasional relief.


• If your stomach problem is not helped by the antacid or if it keeps coming back, check with your doctor.


• Using magnesium- or sodium bicarbonate-containing antacids too often, or in high doses, may produce a laxative effect. This happens fairly often and depends on the individual's sensitivity to the medicine.

For patients taking aluminum-containing antacids (including magaldrate):

• Before you have any test in which a radiopharmaceutical will be used, tell the doctor in charge that you are taking this medicine. The results of the test may be affected by aluminum-containing antacids.

For patients taking calcium- or sodium bicarbonate-containing antacids

• Do not take the antacid with large amounts of milk or milk products. To do so may increase the chance of side effects.

Side Effects of This Medicine

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.

Along with its needed effects, a medicine may cause some unwanted effects. Although the following side effects occur very rarely when this medicine is taken as recommended, they may be more likely to occur if: too much medicine is taken; it is taken in large doses; it is taken for a long time; or it is taken by patients with kidney disease.

Check with your doctor as soon as possible if any of the following side effects occur:

For aluminum-containing antacids (including magaldrate)

• Bone pain


• constipation (severe and continuing)


• feeling of discomfort (continuing)


• loss of appetite (continuing)


• mood or mental changes


• muscle weakness


• swelling of wrists or ankles


• weight loss (unusual)

For calcium-containing antacids

• Constipation (severe and continuing)


• difficult or painful urination


• frequent urge to urinate


• headache (continuing)


• loss of appetite (continuing)


• mood or mental changes


• muscle pain or twitching


• nausea or vomiting


• nervousness or restlessness


• slow breathing


• unpleasant taste


• unusual tiredness or weakness

For magnesium-containing antacids (including magaldrate)

• Difficult or painful urination (with magnesium trisilicate)


• dizziness or lightheadedness


• feeling of discomfort (continuing)


• irregular heartbeat


• loss of appetite (continuing)


• mood or mental changes


• muscle weakness


• unusual tiredness or weakness


• weight loss (unusual)

For sodium bicarbonate-containing antacids

• Frequent urge to urinate


• headache (continuing)


• loss of appetite (continuing)


• muscle pain or twitching


• nausea or vomiting


• nervousness or restlessness


• slow breathing


• swelling of feet or lower legs


• unpleasant taste


• unusual tiredness or weakness

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

• Chalky taste

Less common

• Constipation (mild)


• diarrhea or laxative effect


• increased thirst


• speckling or whitish discoloration of stools


• stomach cramps

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.

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