Tuesday, October 25, 2016

Ansaid


Generic Name: flurbiprofen (flure BI proe fen)

Brand Names: Ansaid


What is Ansaid (flurbiprofen)?

Flurbiprofen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Flurbiprofen works by reducing hormones that cause inflammation and pain in the body.


Flurbiprofen is used to treat pain or inflammation caused by arthritis.


Flurbiprofen may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Ansaid (flurbiprofen)?


This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke. Do not use flurbiprofen just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).


Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking flurbiprofen, especially in older adults.


Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

What should I discuss with my healthcare provider before taking Ansaid (flurbiprofen)?


This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use flurbiprofen just before or after heart bypass surgery (coronary artery bypass graft, or CABG).


This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking flurbiprofen, especially in older adults.


Do not use this medication if you are allergic to flurbiprofen, or if you have:

  • severe kidney disease; or




  • a history of allergic reaction to aspirin or other NSAIDs.



If you have any of these other conditions, you may need a flurbiprofen dose adjustment or special tests:



  • a history of heart attack, stroke, or blood clot;




  • heart disease, congestive heart failure, high blood pressure;




  • a history of stomach ulcer or bleeding;



  • liver or kidney disease;


  • asthma;




  • polyps in your nose;




  • a bleeding or blood clotting disorder; or




  • if you smoke.




FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking flurbiprofen during the last 3 months of pregnancy may harm the unborn baby. Do not take flurbiprofen during pregnancy unless your doctor has told you to. Flurbiprofen can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to a child without the advice of a doctor.

How should I take Ansaid (flurbiprofen)?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


The maximum amount of flurbiprofen for adults is 400 milligrams (mg) per day. Know the amount of flurbiprofen in the specific product you are taking.

If you take flurbiprofen for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled appointments.


Store at room temperature, away from moisture, heat, and light.

See also: Ansaid dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, stomach pain, dizziness, drowsiness, black or bloody stools, coughing up blood, urinating less than usual or not at all, shallow breathing, and fainting.

What should I avoid while taking Ansaid (flurbiprofen)?


Ask a doctor or pharmacist before using any other cold, allergy, or pain medicine. Many medicines available over the counter contain medicines similar to flurbiprofen (such as aspirin, ibuprofen, ketoprofen, or naproxen). Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen. Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Ansaid (flurbiprofen) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking flurbiprofen and seek medical attention or call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;




  • black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;




  • urinating less than usual or not at all;




  • pain, burning, or bleeding when you urinate;




  • swelling, rapid weight gain;




  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);




  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or




  • bruising, severe tingling, numbness, pain, muscle weakness.



Less serious side effects may include:



  • upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;




  • dizziness, headache, nervousness;




  • skin itching or rash;




  • dry mouth;




  • increased sweating, runny nose;




  • blurred vision; or




  • ringing in your ears.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Ansaid (flurbiprofen)?


Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with flurbiprofen may cause you to bruise or bleed easily.


Tell your doctor about all other medicines you use, especially:



  • a blood thinner such as warfarin (Coumadin;




  • a diuretic (water pill) such as furosemide (Lasix);




  • cyclosporine (Gengraf, Neoral, Sandimmune);




  • lithium (Eskalith, Lithobid);




  • methotrexate (Rheumatrex, Trexall);




  • steroids (prednisone and others);




  • aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others;




  • an ACE inhibitor such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others; or




  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.



This list is not complete and other drugs may interact with flurbiprofen. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Ansaid resources


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


  • Ansaid Prescribing Information (FDA)

  • Ansaid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ansaid Monograph (AHFS DI)

  • Ansaid Advanced Consumer (Micromedex) - Includes Dosage Information

  • Flurbiprofen Professional Patient Advice (Wolters Kluwer)

  • Flurbiprofen Sodium eent Monograph (AHFS DI)



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Where can I get more information?


  • Your pharmacist can provide more information about flurbiprofen.

See also: Ansaid side effects (in more detail)


Tottizim




Tottizim may be available in the countries listed below.


Ingredient matches for Tottizim



Ceftazidime

Ceftazidime pentahydrate (a derivative of Ceftazidime) is reported as an ingredient of Tottizim in the following countries:


  • Italy

International Drug Name Search

Advil PM



diphenhydramine citrate, ibuprofen

Dosage Form: tablet, coated
Advil PM (diphenhydramine citrate and ibuprofen)

DRUG FACTS



ACTIVE INGREDIENTS (IN EACH CAPLET)


Diphenhydramine citrate 38 mg


Ibuprofen 200 mg (NSAID)*


*nonsteroidal anti-inflammatory drug



PURPOSES


Nighttime sleep-aid


Pain reliever



USES


  • for relief of occasional sleeplessness when associated with minor aches and pains

  • helps you fall asleep and stay asleep


Warnings



Allergy alert:


Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:


  • hives

  • facial swelling

  • asthma (wheezing)

  • shock

  • skin reddening

  • rash

  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.



Stomach bleeding warning:


This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you


  • are age 60 or older

  • have had stomach ulcers or bleeding problems

  • take a blood thinning (anticoagulant) or steroid drug

  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

  • have 3 or more alcoholic drinks every day while using this product

  • take more or for a longer time than directed


Do not use


  • if you have ever had an allergic reaction to any other pain reliever/fever reducer

  • unless you have time for a full night's sleep

  • in children under 12 years of age

  • right before or after heart surgery

  • with any other product containing diphenhydramine, even one used on skin

  • if you have sleeplessness without pain


Ask a doctor before use if


  • stomach bleeding warning applies to you

  • you have problems or serious side effects from taking pain relievers or fever reducers

  • you have a history of stomach problems, such as heartburn

  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma

  • you are taking a diuretic

  • you have a breathing problem such as emphysema or chronic bronchitis

  • you have glaucoma

  • you have trouble urinating due to an enlarged prostate gland


Ask a doctor or pharmacist before use if you are


  • taking sedatives or tranquilizers, or any other sleep-aid

  • under a doctor’s care for any continuing medical illness

  • taking any other antihistamines

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

  • taking any other drug


When using this product


  • drowsiness will occur

  • avoid alcoholic drinks

  • do not drive a motor vehicle or operate machinery

  • take with food or milk if stomach upset occurs

  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed


Stop use and ask a doctor if


  • you experience any of the following signs of stomach bleeding:
    • feel faint

    • vomit blood

    • have bloody or black stools

    • have stomach pain that does not get better


  • pain gets worse or lasts more than 10 days

  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

  • redness or swelling is present in the painful area

  • any new symptoms appear


If pregnant or breast-feeding,


ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.



Keep out of the reach of children.


In case of overdose, get medical help or contact a Poison Control Center right away.



DIRECTIONS


  • do not take more than directed

  • adults and children 12 years and over: take 2 caplets at bedtime

  • do not take more than 2 caplets in 24 hours


OTHER INFORMATION


  • read all warnings and directions before use. Keep carton.

  • store at 20-25°C (68-77°F)

  • avoid excessive heat above 40°C (104°F)


INACTIVE INGREDIENTS


calcium stearate, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide



QUESTIONS OR COMMENTS?


Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL



PRODUCT PACKAGING


The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.


Advil PM


Ibuprofen, 200 mg / Diphenhydramine citrate, 38 mg


Pain Reliever (NSAID) / Nighttime Sleep-Aid


40 Coated Caplets*


*Capsule-Shaped Tablets


See new warnings information


READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION.


Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.


Wyeth


For most recent product information, visit www.Advil.com.


Wyeth Consumer Healthcare, Madison, NJ 07940 USA ©2009 Wyeth


Appearance of the blue Advil PM caplet is a trademark of Wyeth Consumer Healthcare


U.S. Patent Pending










Advil PM 
diphenhydramine citrate, ibuprofen  tablet, coated










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0164
Route of AdministrationORALDEA Schedule    











Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
diphenhydramine citrate (diphenhydramine )diphenhydramine citrate38 mg
ibuprofen (ibuprofen)ibuprofen200 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorBLUE (blue)Scoreno score
ShapeCAPSULESize15mm
FlavorImprint CodeAdvil;PM
Contains      


























































































Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0164-331 BOTTLE In 1 CARTONcontains a BOTTLE
150 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0164-33)
20573-0164-044 TABLET In 1 POUCHNone
30573-0164-201 BOTTLE In 1 CARTONcontains a BOTTLE
320 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0164-20)
40573-0164-301 BOTTLE In 1 CARTONcontains a BOTTLE
440 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0164-30)
50573-0164-401 BOTTLE In 1 CARTONcontains a BOTTLE
580 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0164-40)
60573-0164-431 BOTTLE In 1 CARTONcontains a BOTTLE
6120 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0164-43)
70573-0164-451 BOTTLE In 1 CARTONcontains a BOTTLE
7180 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0164-45)
80573-0164-321 BOTTLE In 1 CARTONcontains a BOTTLE
850 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0164-32)
90573-0164-411 BOTTLE In 1 CARTONcontains a BOTTLE
9100 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0164-41)
100573-0164-913000 POUCH In 1 BOXcontains a POUCH
102 TABLET In 1 POUCHThis package is contained within the BOX (0573-0164-91)
110573-0164-052 POUCH In 1 CARTONcontains a BOTTLE
112 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0164-05)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02139412/21/2005


Labeler - Pfizer Consumer Healthcare (828831730)









Establishment
NameAddressID/FEIOperations
Wyeth Pharmaceuticals Company, Consumer Site829390975MANUFACTURE, ANALYSIS
Revised: 06/2010Pfizer Consumer Healthcare




More Advil PM resources


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


  • Advil PM MedFacts Consumer Leaflet (Wolters Kluwer)



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Amoxicillin



Class: Aminopenicillins
Chemical Name: [2S - [2α,5α,6β(S*)]] - 6 - [[Amino(4 - hydroxyphenyl)acetyl]amino] - 3,3 - dimethyl - 7 - oxo - 4 - thia - 1 - azabicyclo[3.2.0]heptane - 2 - carboxylic acid trihydrate
CAS Number: 61336-70-7
Brands: Amoxil, Trimox, Prevpac

Introduction

Antibacterial; β-lactam antibiotic; an aminopenicillin.6 62


Uses for Amoxicillin


Otitis Media


Treatment of acute otitis media (AOM).1 140 176 177 190 192 199 200 209 210 211 244 AAP, AAFP, CDC, and others recommend amoxicillin as drug of first choice for initial treatment of AOM,190 200 202 204 205 210 244 unless patient has severe illness (moderate to severe otalgia or fever ≥39°C)244 or the infection is suspected of being caused by β-lactamase-producing Haemophilus influenzae or Moraxella catarrhalis, in which case the fixed combination of amoxicillin and clavulanate is recommended for initial treatment.190 200 202 204 205 210 244 Those who fail to respond to amoxicillin should be retreated with amoxicillin and clavulanate.244


Has been used for prevention of recurrent AOM.190 206 207 214 217 219 220 222 223 224 225 226 Such prophylaxis not generally recommended103 104 206 217 220 since it is minimally effective and may promote emergence of resistance.103 104 106 190 202 214 217 Use only in selected patients with >3 episodes within 6 months or >4 episodes within 12 months; drugs of choice are amoxicillin or sulfisoxazole.190 193


Has been used for management of otitis media with effusion (OME).193 206 208 219 221 227 Anti-infectives not usually recommended;111 115 206 208 219 221 245 they provide only limited benefit in enhancing resolution of effusion and may promote resistance.115 207 208 219 AAP, AAFP, and others recommend watchful waiting for 3 months from date of effusion onset or diagnosis in those 2 months to 12 years of age who are not at risk for speech, language, or learning problems; some suggest a short course of anti-infectives may be considered for possible short-term benefits when parent and/or caregiver expresses a strong aversion to impending surgery.245 If anti-infectives are used, amoxicillin or the fixed combination of amoxicillin and clavulanate recommended.219 221 227


Pharyngitis and Tonsillitis


Treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A β-hemolytic streptococci).1 6 35 39 108 109 110 190 240 242


AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice;190 240 241 242 oral cephalosporins and oral macrolides are considered alternatives.190 240 241 242 Amoxicillin sometimes used instead of penicillin V, especially for young children.35 39 108 109 110 190 242


A second episode can be retreated with the same or other treatment of choice;190 242 other regimens (amoxicillin and clavulanate, clindamycin, penicillin G benzathine with or without rifampin) recommended for symptomatic patients with multiple, recurrent episodes.190 240 242


Consider that multiple, recurrent episodes of symptomatic pharyngitis within several months to years may indicate a streptococcal carrier experiencing repeated episodes of nonstreptococcal (e.g., viral) pharyngitis;240 242 treatment not usually recommended for streptococcal pharyngeal carriers.190 240 242


Respiratory Tract Infections


Treatment of lower respiratory tract infections caused by susceptible Streptococcus (α- or β-hemolytic strains only), S. pneumoniae, Staphylococcus, or H. influenzae.1 6 57 62 73 81


Skin and Skin Structure Infections


Treatment of skin and skin structure infections caused by susceptible Streptococcus (α- or β-hemolytic strains only), Staphylococcus, or Escherichia coli.1


Urinary Tract Infections (UTIs)


Treatment of UTIs caused by susceptible Enterococcus faecalis, Escherichia coli, or Proteus mirabilis.1 3 4 6 75 76 78 81 A drug of choice for treatment of uncomplicated UTIs caused by E. faecalis;81 consider high incidence of amoxicillin-resistant E. coli and other Enterobacteriaceae.6


Gonorrhea


Previously used for treatment of acute uncomplicated gonorrhea (anogenital and urethral) caused by susceptible Neisseria gonorrhoeae.1 6 94 184 No longer recommended for gonorrhea by CDC or other experts94 189 190 (high incidence of penicillin-resistant strains).


Typhoid Fever and other Salmonella Infections


Alternative for treatment of typhoid fever (enteric fever) caused by susceptible Salmonella typhi.6 57 64 66 68 81 190 Drugs of choice are fluoroquinolones and third generation cephalosporins (e.g., ceftriaxone, cefotaxime);81 190 consider that multidrug-resistant strains of S. typhi (strains resistant to ampicillin, amoxicillin, chloramphenicol, and/or co-trimoxazole) reported with increasing frequency.102 190


Treatment of chronic carriers of S. typhi; drugs of choice are fluoroquinolones (e.g., ciprofloxacin), ampicillin, or amoxicillin (with probenecid).6 62 63 65 67 81


Alternative for treatment of gastroenteritis caused by nontyphoidal Salmonella.190 Anti-infectives not indicated in otherwise healthy individuals with uncomplicated (noninvasive) gastroenteritis, but recommended if gastroenteritis is severe and in those at increased risk of invasive disease (e.g., <6 months or >50 years of age; hemoglobinopathies, severe atherosclerosis, valvular heart disease, prostheses, uremia, chronic GI disease, severe colitis; immunocompromised because of malignancy, immunosuppressive therapy, HIV infection).81 120 121 190 Drugs of choice are fluoroquinolones, third generation cephalosporins (cefotaxime, ceftriaxone), ampicillin, amoxicillin, co-trimoxazole, or chloramphenicol, depending on in vitro susceptibility.81 120 121 190


Helicobacter pylori Infection and Duodenal Ulcer Disease


Treatment of Helicobacter pylori infection and duodenal ulcer disease (active or 1-year history of duodenal ulcer);1 168 172 173 174 eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.1 107 116 119 122 168 172 173


Used in a multidrug regimen that includes amoxicillin, clarithromycin, and either lansoprazole or omeprazole (triple therapy).1 81 107 168 169 172 173 174 175 Used with lansoprazole (dual therapy) in those allergic to or intolerant of clarithromycin or when clarithromycin resistance is suspected.1 168 169


Lyme Disease


Treatment of early localized or early disseminated Lyme disease associated with erythema migrans, in the absence of neurologic involvement or third-degree AV heart block.81 95 190 179 181 182 183 184 185 186 188 190 191 238


IDSA, AAP, and others consider amoxicillin a drug of choice for treatment of early localized or early disseminated Lyme disease when oral therapy is appropriate.81 95 179 181 182 185 186 190 232 238 May be used in those with mild Lyme carditis,95 179 181 182 185 186 232 238 Lyme arthritis (without associated neurologic disease),95 181 185 186 190 232 238 or isolated facial nerve palsy (without other neurologic involvement).95 190 238


Amoxicillin is the preferred oral agent for treatment in pregnant women and children <8 years of age who should not receive doxycycline.88 95 179 190 232 238


Chlamydial Infections


Treatment of uncomplicated urethritis and cervicitis caused by Chlamydia trachomatis in pregnant women.81 157 94 189 190 CDC and others recommend amoxicillin or a macrolide (azithromycin, erythromycin) as drugs of choice for treatment of urogenital chlamydial infections in these women.94 189 190


Prevention of Bacterial Endocarditis


Prevention of bacterial endocarditis in patients undergoing certain dental, oral, respiratory tract, or esophageal procedures who have cardiac conditions that put them at high or moderate risk.69 72 96 97 99 100 101 AHA recommends amoxicillin as drug of choice for such prophylaxis.96


Prevention of bacterial endocarditis in patients undergoing certain GU and GI (except esophageal) procedures who have cardiac conditions that put them at moderate-risk.96


An alternative for follow-up to an initial parenteral regimen for prevention of bacterial endocarditis in patients undergoing certain GU and GI (except esophageal procedures who have cardiac conditions that put them at high-risk.96


Consult most recent AHA recommendations for specific information on which cardiac conditions are associated with high or moderate risk of endocarditis and which procedures require prophylaxis.96


Prevention of S. pneumoniae Infections in Asplenic Individuals


Prevention of S. pneumoniae infections in children with anatomic or functional asplenia (e.g., congenital, resulting from sickle cell disease or surgery)190 or children with malignant neoplasms or thalassemia.190


Oral penicillin V usually drug of choice;74 190 some experts recommend amoxicillin.190


Children at increased risk for pneumococcal infections should receive pneumococcal 7-valent conjugate vaccine and pneumococcal 23-valent polysaccharide vaccine.190 243 Long-term anti-infective prophylaxis recommended for children with functional or anatomic asplenia regardless of vaccination status.74 190 243


Anthrax


An alternative for postexposure prophylaxis of anthrax following exposure to aerosolized Bacillus anthracis spores (inhalational anthrax).190 228 229 231 233 235 236 239 Ciprofloxacin or doxycycline are initial drugs of choice for postexposure prophylaxis following a suspected or confirmed bioterrorism-related anthrax exposure.190 231 235 If penicillin susceptibility is confirmed, consideration can be given to changing prophylaxis to a penicillin in infants and children and in pregnant or lactating women; amoxicillin usually recommended.190 231 233 236 239


An alternative for treatment of inhalational anthrax when a parenteral regimen is not available (e.g., when there are supply or logistic problems in a mass-casualty setting).231


An alternative for treatment of cutaneous anthrax.231 If cutaneous anthrax occurs in the context of biologic warfare or bioterrorism, initial drugs of choice are ciprofloxacin or doxycycline.231 If penicillin susceptibility is confirmed, consideration can be given to changing to a penicillin in infants and children or in pregnant or lactating women; amoxicillin usually is recommended.231 239


Amoxicillin Dosage and Administration


Administration


Oral Administration


Administer orally without regard to meals.1 4 10 22 29 38 40


Following reconstitution, the required amount of oral suspension should be placed directly on the child’s tongue for swallowing.1 Alternatively, the required amount of suspension can be added to infant formula, milk, fruit juice, water, ginger ale, or cold drinks and these fluids taken immediately and completely consumed.1


For most infections, continue therapy for at least 48–72 hours after patient becomes asymptomatic or evidence that the infection is eradicated is obtained.1 The drug should be given for at least 10 days for treatment of infections caused by S. pyogenes (group A β-hemolytic streptococci).1


Reconstitution

Reconstitute oral suspension at the time of dispensing.1 Tap bottle to thoroughly loosen powder and then add the amount of water specified on the bottle in 2 portions; agitate vigorously after each addition.1


Agitate suspension well prior to administration of each dose.1


Dosage


Available as the trihydrate;1 dosage expressed in terms of anhydrous amoxicillin.1


Pediatric Patients


Neonates and infants ≤12 weeks (3 months) of age can receive amoxicillin in a dosage up to 30 mg/kg daily given in divided doses every 12 hours.1


Pediatric dosage specified below is for those >3 months of age weighing <40 kg.1


Children weighing ≥40 kg should receive usual adult dosage.1


Otitis Media

Treatment of Acute Otitis Media (AOM)

Oral

80–90 mg/kg daily given in 2 or 3 divided doses recommended by AAP, AAFP, CDC, and others.190 200 201 205 215 244


Usual duration is 10 days;190 200 201 205 215 optimal duration is uncertain.244 AAP and AAFP recommend 10 days in those <6 years of age and in those with severe disease and state 5–7 days may be appropriate in those ≥6 years of age with mild to moderate AOM.244


Prevention of Recurrent AOM

Oral

20 mg/kg daily given in 1 or 2 divided doses has been used.214 220


Pharyngitis and Tonsillitis

Oral

45 mg/kg daily in 2 divided doses or 40 mg/kg daily in 3 divided doses for 10 days.1 39 108 109


50 mg/kg once daily35 or 750 mg once daily for 10 days.110


Follow-up throat cultures after treatment of pharyngitis and tonsillitis not indicated in asymptomatic patients,190 240 242 but recommended 2–7 days after treatment in those who remain symptomatic, develop recurring symptoms, or have a history of rheumatic fever and are at unusually high risk for recurrence.240 242


Ear, Nose, and Throat Infections

Oral

25 mg/kg daily in divided doses every 12 hours or 20 mg/kg daily in divided doses every 8 hours for mild to moderate infections per manufacturer.1


45 mg/kg daily in divided doses every 12 hours or 40 mg/kg in divided doses every 8 hours for severe infections per manufacturer.1


Respiratory Tract Infections

Oral

45 mg/kg daily in divided doses every 12 hours or 40 mg/kg daily in divided doses every 8 hours for mild, moderate, or severe lower respiratory tract infections.1


Skin and Skin Structure Infections

Oral

25 mg/kg daily in divided doses every 12 hours or 20 mg/kg daily in divided doses every 8 hours for mild to moderate infections.1


45 mg/kg daily in divided doses every 12 hours or 40 mg/kg daily in divided doses every 8 hours for severe infections or those caused by less susceptible bacteria.1


Urinary Tract Infections (UTIs)

Oral

25 mg/kg daily in divided doses every 12 hours or 20 mg/kg daily in divided doses every 8 hours for mild to moderate infections.1


45 mg/kg daily in divided doses every 12 hours or 40 mg/kg daily in divided doses every 8 hours for severe infections or those caused by less susceptible bacteria.1


Gonorrhea

Oral

Prepubertal children ≥2 years of age: 50 mg/kg as a single dose given with a single dose of probenecid (25 mg/kg).1


No longer recommended for gonorrhea by the CDC or other experts.94 189


Lyme Disease

Oral

25–50 mg/kg daily (up to 2 g daily) in 2–3 divided doses for 14–21 days for treatment of early localized or early disseminated Lyme disease.95 179 181 182 185 190 238


50 mg/kg daily in 3 divided doses for 14–28 days for mild Lyme carditis95 179 181 182 185 186 or for 28 days for Lyme arthritis (without associated neurologic disease).95 190 181 185 186 232 238


Prevention of Bacterial Endocarditis

Patients Undergoing Certain Dental, Oral, Respiratory Tract, or Esophageal Procedures

Oral

50 mg/kg given 1 hour prior to the procedure.96


Patients Undergoing Certain GU or GI (except Esophageal) Procedures

Oral

50 mg/kg as a single dose given 1 hour prior to the procedure for moderate-risk patients.96


For high-risk patients, give an initial IM or IV dose of ampicillin with IM or IV gentamicin within 30 minutes of starting the procedure followed by 25 mg/kg of amoxicillin 6 hours later.96


Prevention of S. pneumoniae Infections in Asplenic Individuals

Oral

20 mg/kg daily in children with anatomic or functional asplenia.190


In infants with sickle cell anemia, initiate prophylaxis as soon as diagnosis is established (preferably by 2 months of age);190 74 continue until approximately 5 years of age.190 74 243 Appropriate duration in children with asplenia from other causes unknown;190 some experts recommend that asplenic children at high risk receive prophylaxis throughout childhood and into adulthood.190


Anthrax

Postexposure Prophylaxis

Oral

80 mg/kg daily (maximum 1.5 g daily) given in divided doses every 8 hours for 60 days for postexposure prophylaxis following exposure to B. anthracis spores (inhalational anthrax).190 231 233 239


500 mg every 8 hours for 60 days in those weighing ≥20 kg.231


Use only if penicillin susceptibility is confirmed.190 228


Inhalational Anthrax

Oral

80 mg/kg daily (maximum 1.5 g daily) given in divided doses every 8 hours for 60 days for treatment of inhalational anthrax in a mass-casualty setting.231


500 mg every 8 hours for 60 days for those weighing ≥20 kg.231


Cutaneous Anthrax

Oral

80 mg/kg daily (maximum 1.5 g daily) given in divided doses every 8 hours for treatment of uncomplicated cutaneous anthrax.234 231


Treat for 60 days if cutaneous anthrax occurred as the result of exposure to aerosolized anthrax spores;231 234 7–10 days may be adequate if it occurred as the result of natural or endemic exposure to anthrax.231 234


Adults


Pharyngitis and Tonsillitis

Oral

500 mg 3 times daily39 or 750 mg once daily for 10 days.35 110


Follow-up throat cultures after treatment of pharyngitis and tonsillitis not indicated in asymptomatic patients,190 240 242 but recommended 2–7 days after treatment in those who remain symptomatic, develop recurring symptoms, or have a history of rheumatic fever and are at unusually high risk for recurrence.240 242


Ear, Nose, and Throat Infections

Oral

500 mg every 12 hours or 250 mg every 8 hours for mild to moderate infections per manufacturer.1


875 mg every 12 hours or 500 mg every 8 hours for severe infections or those caused by less susceptible bacteria per manufacturer.1


Respiratory Tract Infections

Oral

875 mg every 12 hours or 500 mg every 8 hours for mild, moderate, or severe lower respiratory tract infections.1


Skin and Skin Structure Infections

Oral

500 mg every 12 hours or 250 mg every 8 hours for mild to moderate infections.1


875 mg every 12 hours or 500 mg every 8 hours for severe infections or those caused by less susceptible bacteria.1


Urinary Tract Infections (UTIs)

Oral

500 mg every 12 hours or 250 mg every 8 hours for mild to moderate infections.1


875 mg every 12 hours or 500 mg every 8 hours for severe infections or those caused by less susceptible bacteria.1


Gonorrhea

Oral

3 g as a single dose.1


No longer recommended for gonorrhea by the CDC or other experts.94 189


Typhoid Fever

Oral

100 mg/kg daily or 1–1.5 g every 6 hours for 14 days.6


Helicobacter pylori Infection and Duodenal Ulcer Disease

Oral

1 g 2 times daily for 10 or 14 days given in conjunction with clarithromycin and either lansoprazole or omeprazole (triple therapy).1 168 172 173 174


1 g 3 times daily for 14 days given in conjunction with lansoprazole (dual therapy).1 168


Lyme Disease

Oral

500 mg 3 times daily for 14–21 days for treatment of early localized or early disseminated Lyme disease.95 238


500 mg 3 times daily for 14–28 days for mild Lyme carditis95 179 181 182 185 186 or for 28 days for Lyme arthritis (without associated neurologic disease).95 190 181 185 186 232 238


Chlamydial Infections

Oral

500 mg 3 times daily for 7 days for treatment of chlamydial infections in pregnant women.94 189 190


Repeat testing (preferably by culture) recommended 3 weeks after completion of treatment.94


Prevention of Bacterial Endocarditis

Patients Undergoing Certain Dental, Oral, Respiratory Tract, or Esophageal Procedures

Oral

2 g given 1 hour prior to the procedure.96


Patients Undergoing Certain GU or GI (except Esophageal) Procedures

Oral

2 g given 1 hour prior to the procedure in moderate-risk patients.96


For high-risk patients, give an initial IM or IV dose of ampicillin with IM or IV gentamicin within 30 minutes of starting the procedure followed by 1 g of amoxicillin 6 hours later.96


Anthrax

Postexposure Prophylaxis

Oral

500 mg every 8 hours for 60 days for postexposure prophylaxis following exposure to B. anthracis spores; use only if penicillin susceptibility confirmed.231 233 236


Inhalational Anthrax

Oral

500 mg every 8 hours for 60 days for treatment of inhalational anthrax.231


Cutaneous Anthrax

Oral

500 mg every 8 hours for treatment of inhalational anthrax.231


Treat for 60 days if cutaneous anthrax occurred as the result of exposure to aerosolized anthrax spores;231 234 7–10 days may be adequate if it occurred as the result of natural or endemic exposure to anthrax.231 234


Prescribing Limits


Pediatric Patients


Neonates and Infants ≤12 weeks (3 Months) of Age

Oral

Maximum 30 mg/kg daily in divided doses every 12 hours.1


Prevention of Bacterial Endocarditis

Oral

Dosage should not exceed adult dosage for prevention of bacterial endocarditis.96


Special Populations


Renal Impairment


Dosage adjustment necessary in severe renal impairment.1 6 41 82 83


Do not use 875-mg tablets in those with severe renal impairment and GFR <30 mL/minute.1


Dosage recommendations not available for pediatric patients with renal impairment.1











Dosage for Adults with Renal Impairment

GFR (mL/min)



Daily Dosage



10–30



250 or 500 mg every 12 hours depending on infection severity1



<10



250 or 500 mg every 24 hours depending on infection severity1



Hemodialysis Patients



250 or 500 mg every 24 hours depending on infection severity; with an additional dose both during and at the end of dialysis1


Cautions for Amoxicillin


Contraindications



  • Known hypersensitivity to any penicillin.1



Warnings/Precautions


Warnings


Superinfection/Clostridium difficile-associated Colitis

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.1 21 Discontinue and institute appropriate therapy if superinfection occurs.1


Treatment with anti-infectives may permit overgrowth of clostridia.1 Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.1 194 195 196 197 198


Some mild cases of C. difficile-associated diarrhea and colitis may respond to discontinuance alone.1 194 195 196 197 198 Manage moderate to severe cases with fluid, electrolyte, and protein supplementation; appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) recommended if colitis is severe.1 194 195 196 197 198


Sensitivity Reactions


Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, reported with penicillins.1 6 51 53 55


Prior to initiation of therapy, make careful inquiry regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other drugs.1 Partial cross-allergenicity occurs among penicillins and other β-lactam antibiotics including cephalosporins and cephamycins.1 6


If a severe hypersensitivity reaction occurs, discontinue immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).1


General Precautions


Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of amoxicillin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.1


When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1


Hepatic Effects

Moderate increases in serum AST and/or ALT reported.1


Hepatic dysfunction, including cholestatic jaundice, hepatic cholestasis, and acute cytolytic hepatitis reported.1


Assess hepatic function periodically during prolonged therapy.1


Renal Effects

Assess renal function periodically during prolonged therapy.1


Hematologic Effects

Adverse hematologic effects (e.g., anemia, hemolytic anemia, leukopenia, agranulocytosis, thrombocytopenia, thrombocytopenic purpura) reported with penicillins.1 Usually reversible when drug discontinued; may be a hypersensitivity reaction.1


Assess hematologic function periodically during prolonged therapy.1


Mononucleosis

Possible increased risk of rash in patients with mononucleosis; use in these patients not recommended.4 29 54 60


Phenylketonuria

200- and 400-mg chewable tablets contain aspartame (NutraSweet), which is metabolized in the GI tract to provide 1.82 or 3.64 mg of phenylalanine, respectively.1 3


Oral suspensions do not contain aspartame and can be used in individuals with phenylketonuria (i.e., homozygous genetic deficiency of phenylalanine hydroxylase) and other individuals who must restrict their intake of phenylalanine.1


Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.


Specific Populations


Pregnancy

Category B.


Recommended as an alternative for various indications in pregnant women (e.g., treatment of chlamydial infections,94 189 190 treatment of Lyme disease,88 95 181 182 190 191 postexposure prophylaxis or treatment of anthrax).231


Lactation

Distributed into milk; use with caution.1 4 6 26 49


Use in a breast-feeding woman may result in sensitization of infants.1


Recommended as an alternative for postexposure prophylaxis or treatment of anthrax in women who are breast-feeding.239


Pediatric Use

Renal clearance of amoxicillin may be delayed in neonates and young infants because of incompletely developed renal function.20 27 32 62 128


Neonates and infants ≤12 weeks (3 months) of age should receive no more than 30 mg/kg daily given in divided doses every 12 hours.1


Tooth discoloration (brown, yellow, gray) reported rarely, most frequently in pediatric patients.1 Brushing or dental cleaning reduces or eliminates discoloration in most cases.1


Geriatric Use

Renal clearance may be decreased.


Hepatic Impairment

Assess hepatic function periodically during prolonged therapy.1


Renal Impairment

Assess renal function periodically during prolonged therapy.1


Dosage adjustments necessary in severe renal impairment.1 41 82 83


Common Adverse Effects


Adverse GI effects (e.g., nausea, vomiting, diarrhea), hypersensitivity reactions (e.g., rash).1 4 52 142


Interactions for Amoxicillin


Specific Drugs and Laboratory Tests

















Drug



Interaction



Comments



Allopurinol



Possible increased incidence of rash;59 61 84 reported with ampicillin but no data regarding amoxicillin59 61 84



Unclear whether potentiation of rash is caused by allopurinol or hyperuricemia present in these patients59 61 84



Chloramphenicol



In vitro evidence of antagonism1



Clinical importance unclear1



Clavulanic acid



In vitro and in vivo synergistic bactericidal effect13 14 15 16 84 85 86 87 127



Used to therapeutic advantage in infections caused by β-lactamase-producing bacteria;84 commercially available in fixed combination with clavulanate potassium84



Macrolides



In vitro evidence of antagonism1



Clinic

AeroBid



Generic Name: flunisolide inhalation (flew NISS oh lide)

Brand Names: AeroBid, AeroBid-M


What is AeroBid (flunisolide inhalation)?

Flunisolide is a steroid. It prevents the release of substances in the body that cause inflammation.


Flunisolide inhalation is used to prevent asthma attacks. It will not treat an asthma attack that has already begun.


Flunisolide may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about AeroBid (flunisolide inhalation)?


Do not use flunisolide inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, faster-acting inhalation medication to treat an asthma attack.

Contact your doctor if your asthma symptoms do not improve after using flunisolide inhalation for 4 weeks.


Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. Your dosage needs may also change if you have surgery, are ill, are under stress, or have recently had an asthma attack. If you were switched from an oral (taken by mouth) steroid to flunisolide inhalation, you may need to go back to taking the oral medicine if you are under stress or have an asthma attack or other medical emergency. Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency.

What should I discuss with my healthcare provider before using AeroBid (flunisolide inhalation)?


Before using this medication, tell your doctor if you have been sick or had an infection of any kind (especially tuberculosis). You may not be able to use flunisolide inhalation until you are well.


FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether flunisolide passes into breast milk or if it could harm a nursing baby. Do not use flunisolide inhalation without telling your doctor if you are breast-feeding a baby.

Flunisolide can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.


Do not give this medicine to a child younger than 5 years old.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk of osteoporosis.


How should I use AeroBid (flunisolide inhalation)?


Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Flunisolide comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.


Do not use flunisolide inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, faster-acting inhalation medication to treat an asthma attack.

To reduce the chance of developing a yeast infection in your mouth, rinse with water after using flunisolide inhalation. Do not swallow.


Asthma is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor.


It is important to use flunisolide inhalation regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.


Contact your doctor if your asthma symptoms do not improve after using flunisolide inhalation for 4 weeks.


Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. Your dosage needs may also change if you have surgery, are ill, are under stress, or have recently had an asthma attack. If you were switched from an oral (taken by mouth) steroid to flunisolide inhalation, you may need to go back to taking the oral medicine if you are under stress or have an asthma attack or other medical emergency. Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency. Store flunisolide inhalation at room temperature away from moisture and heat. Keep the medicine canister away from high heat, such as open flame or in a car on a hot day. The canister may explode if it gets too hot.

What happens if I miss a dose?


Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of flunisolide inhalation is not expected to produce life-threatening symptoms.


What should I avoid while using AeroBid (flunisolide inhalation)?


Steroid medication can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. Avoid being near people who are sick or have infections. Contact your doctor if you have been exposed to someone with measles or chicken pox.


AeroBid (flunisolide inhalation) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

  • weakness, tired feeling, nausea, loss of appetite, weight loss;




  • fast or pounding heartbeats, pain or fluttering in your chest;




  • wheezing or breathing problems after using this medication;




  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;




  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);




  • worsening asthma symptoms.



Less serious side effects may include:



  • nausea, diarrhea, upset stomach;




  • headache, dizziness;




  • dryness in your mouth, nose, or throat;




  • white patches or sores inside your mouth or on your lips;




  • stuffy nose, sinus pain, sore throat, cough; or




  • hoarseness or deepened voice.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect AeroBid (flunisolide inhalation)?


There may be other drugs that can interact with flunisolide inhalation. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More AeroBid resources


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


  • AeroBid Monograph (AHFS DI)

  • Flunisolide Prescribing Information (FDA)

  • Flunisolide Professional Patient Advice (Wolters Kluwer)

  • Aerobid Aerosol Inhaler MedFacts Consumer Leaflet (Wolters Kluwer)

  • Aerobid Prescribing Information (FDA)



Compare AeroBid with other medications


  • Asthma


Where can I get more information?


  • Your pharmacist can provide more information about flunisolide inhalation.

See also: AeroBid side effects (in more detail)


Abacavir/Lamivudine


Pronunciation: a-BAK-a-vir/la-MIV-ue-deen
Generic Name: Abacavir/Lamivudine
Brand Name: Epzicom

Severe and sometimes fatal allergic reactions (achiness, cough, diarrhea, difficulty breathing, fever, nausea, rash, sore throat, stomach pain, tiredness, vomiting) have been associated with the use of abacavir. Stop taking Abacavir/Lamivudine if any of these symptoms occur and talk with your health care provider. Do not restart Abacavir/Lamivudine if symptoms of a severe allergic reaction occur. Severe allergic reactions, including very low blood pressure or death, have occurred in patients who restart Abacavir/Lamivudine, even if they have no history or unrecognized symptoms of an allergic reaction. Do not stop and restart Abacavir/Lamivudine unless directed to do so by your doctor.


Patients who have a certain gene type called HLA-B*5701 have an increased risk of having an allergic reaction to abacavir. A lab test may be performed before you start Abacavir/Lamivudine to see if you have this gene type. Discuss any questions or concerns with your doctor.


High levels of lactic acid in the blood (lactic acidosis) and severe liver problems that can cause death have also been associated with the use of Abacavir/Lamivudine. Tell your doctor immediately if you have dark urine, fast or irregular heartbeat, pale stools, rapid or difficult breathing, stomach pain, unusual dizziness or lightheadedness, unusual muscle pain or tenderness, unusual tiredness or weakness, or yellowing of the eyes and skin. Contact your doctor right away if you start to feel unusually cold, especially in your arms and legs, or if you have a general feeling of being unwell. Severe worsening of hepatitis B has been reported in patients who are infected with both HIV and hepatitis B and have discontinued lamivudine. Liver function should be monitored closely for at least several months after discontinuing lamivudine. The long-term effects of Abacavir/Lamivudine are not known at this time.





Abacavir/Lamivudine is used for:

Treating HIV infection. Abacavir/Lamivudine is used in combination with other medicines.


Abacavir/Lamivudine is a nucleoside analog reverse transcriptase inhibitor (NRTI) combination. It works by blocking HIV from reproducing.


Do NOT use Abacavir/Lamivudine if:


  • you are allergic to any ingredient in Abacavir/Lamivudine

  • you have liver problems, an enlarged liver, abnormal liver function tests, severe kidney problems, or the blood disorder lactic acidosis

  • you are taking another medicine that contains abacavir or lamivudine

  • you are taking zalcitabine

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



Before using Abacavir/Lamivudine:


Some medical conditions may interact with Abacavir/Lamivudine. 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 a history of kidney problems, heart problems (eg, a heart attack), high blood pressure, high cholesterol, diabetes, pancreatitis, smoking, alcohol dependence, hepatitis B infection, nerve disorders, or obesity problems

  • if you have a history of high levels of lactic acid in the blood or are at risk of liver problems

  • if you are taking any other medicine for HIV infection

  • if you have been tested and know whether you have a gene type called HLA-B*5701

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


  • Interferon alpha or trimethoprim/sulfamethoxazole (TMP-SMZ) because they may increase the risk of Abacavir/Lamivudine's side effects

  • Ribavirin or zalcitabine because the effectiveness of both medicines may be decreased

  • Methadone because its effectiveness may be decreased by Abacavir/Lamivudine

  • Other medicines that contain abacavir or lamivudine because the risk of side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Abacavir/Lamivudine 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 Abacavir/Lamivudine:


Use Abacavir/Lamivudine as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Abacavir/Lamivudine comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Abacavir/Lamivudine refilled.

  • Take Abacavir/Lamivudine by mouth with or without food.

  • Taking Abacavir/Lamivudine at the same time each day will help you remember to take it.

  • Continue to take Abacavir/Lamivudine even if you feel well. Do not miss any doses. Failure to do so may decrease the effectiveness of Abacavir/Lamivudine and increase the risk that your HIV will no longer be sensitive to Abacavir/Lamivudine or to other similar medicines.

  • If you miss a dose of Abacavir/Lamivudine, take 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 take 2 doses at once.

Ask your health care provider any questions you may have about how to use Abacavir/Lamivudine.



Important safety information:


  • Abacavir/Lamivudine may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Abacavir/Lamivudine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Drinking alcohol while taking Abacavir/Lamivudine may cause an increased risk of side effects. Talk to your doctor before drinking alcohol while you are taking Abacavir/Lamivudine.

  • Abacavir/Lamivudine is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.

  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Abacavir/Lamivudine, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.

  • If you stop taking Abacavir/Lamivudine even for a few days (eg, if you run out of your medicine and do not get it refilled right away), contact your doctor before you start taking it again. You may experience a serious allergic reaction if you stop taking Abacavir/Lamivudine and then start again.

  • Abacavir/Lamivudine does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.

  • Abacavir/Lamivudine contains abacavir and lamivudine. Before you start any new medicine, check the label to see if it has abacavir or lamivudine in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Carry an ID card at all times that says you take Abacavir/Lamivudine.

  • Abacavir/Lamivudine may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Abacavir/Lamivudine.

  • Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Abacavir/Lamivudine. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.

  • Diabetes patients - Abacavir/Lamivudine may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

  • Patients who have a certain gene type called HLA-B*5701 have an increased risk of a severe or even fatal allergic reaction to Abacavir/Lamivudine. A lab test may be performed before you start Abacavir/Lamivudine to see if you have this gene type. Discuss any questions or concerns with your doctor.

  • Lab tests, including complete blood cell counts and liver function, may be performed while you use Abacavir/Lamivudine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Abacavir/Lamivudine should not be used in CHILDREN younger than 18 years; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Abacavir/Lamivudine while you are pregnant. Abacavir/Lamivudine is found in breast milk. Do not breast-feed while taking Abacavir/Lamivudine. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Abacavir/Lamivudine to the baby.


Possible side effects of Abacavir/Lamivudine:


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:



Dizziness; headache; trouble sleeping.



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

Severe allergic reactions (fever; rash; tiredness; achiness; nausea; diarrhea; vomiting; stomach pain; sore throat; hives; itching; difficulty breathing; cough; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or discomfort, numbness of an arm or leg, shortness of breath, or sudden vision changes; decreased urination; exhaustion; fainting; flu-like illness; mental or mood problems (eg, depression); mouth ulcers; muscle pain, cramping, or weakness; numbness, tingling, or pain in the hands and feet; red, swollen, blistered, or peeling skin; seizures; severe dizziness; swelling; symptoms of lactic acidosis (eg, fast or irregular heartbeat; feeling cold, especially in your arms and legs; rapid or difficult breathing; stomach pain with nausea and vomiting; unusual dizziness or lightheadedness; unusual tiredness or weakness); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the eyes or skin).



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: Abacavir/Lamivudine 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.


Proper storage of Abacavir/Lamivudine:

Store Abacavir/Lamivudine 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 in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Abacavir/Lamivudine out of the reach of children and away from pets.


General information:


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

  • Abacavir/Lamivudine 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 Abacavir/Lamivudine. 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 Abacavir/Lamivudine resources


  • Abacavir/Lamivudine Side Effects (in more detail)
  • Abacavir/Lamivudine Use in Pregnancy & Breastfeeding
  • Abacavir/Lamivudine Drug Interactions
  • Abacavir/Lamivudine Support Group
  • 1 Review for Abacavir/Lamivudine - Add your own review/rating


Compare Abacavir/Lamivudine with other medications


  • HIV Infection
  • Nonoccupational Exposure