Zithromax

Stomach upset, diarrhea/loose stools, nausea, vomiting, or abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these unlikely but serious side effects occur: hearing changes (such as decreased hearing, deafness), eye problems (such as drooping eyelids, blurred vision), difficulty speaking/swallowing, muscle weakness, signs of liver problems (such as unusual tiredness, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin, dark urine).Get medical help right away if any of these rare but serious side effects occur: fast/irregular heartbeat, severe dizziness, fainting.This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.An allergic reaction to this medication may return even if you stop the drug. If you have an allergic reaction, continue to watch for any of the above symptoms for several days after your last dose.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Contraindications

Documented hypersensitivity

History of cholestatic jaundice or hepatic impairment associated with prior azithromycin use

Coadministration with pimozide

Cautions

Use with caution in abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death; discontinue azithromycin immediately if signs and symptoms of hepatitis occur

Injection-site reactions can occur with IV route

In treatment of gonorrhea or syphilis, perform susceptibility culture tests before initiating azithromycin therapy; may mask or delay symptoms of incubating gonorrhea or syphilis.

Bacterial or fungal superinfection may result from prolonged use

Prolonged QT interval: Cases of torsades de pointes have been reported during postmarketing surveillance; use with caution in patients with known QT prolongation, history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure; also use with caution if coadministering with drugs that prolong QT interval or proarrhythmic conditions (eg, hypokalemia, hypomagnesemia); elderly patients may be more susceptible to drug-associated effects on QT interval

Pneumonia: PO azithromycin is safe and effective only for community-acquired pneumonia (CAP) due to C pneumoniae, H influenzae, M pneumoniae, or S pneumoniae

Cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) reported; despite successful symptomatic treatment of allergic symptoms, when symptomatic therapy was discontinued, allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure; if allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted; physicians should be aware that allergic symptoms may reappear when symptomatic therapy discontinued

Endocarditis prophylaxis: Indicated only for high-risk patients, per current AHA guidelines

Use caution in renal impairment (CrCl <10 mL/min)

Use with caution in patients with myasthenia gravis (exacerbation may occur)

Immediate release and extended release suspensions are not interchangeable

Use extended release suspension only for treatment of infections that are proven or strongly suspected to be caused by susceptible bacteria

Clostridium difficile associated diarrhea (CDAD) reported and may range in severity from mild diarrhea to fatal colitis; treatment with antibacterial agents alters the normal flora of colon leading to overgrowth of Clostridium difficile

Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome, and toxic epidermal reported ; if allergic reaction occurs, drug should be discontinued and appropriate therapy instituted; physicians should be aware that allergic symptoms may reappear after symptomatic therapy has been discontinued

Following use in neonates (treatment up to 42 days of life), infantile hypertrophic pyloric stenosis reported; direct parents and caregivers to contact physician if vomiting or irritability with feeding occurs

Prescribing antibiotics in absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria

ZITHROMAX tablets may be taken with or without food. However, increased tolerability has been observed when tablets are taken with food.

ZITHROMAX for oral suspension in single 1 g packets can be taken with or without food after constitution.

Patients should also be cautioned not to take aluminum- and magnesium-containing antacids and azithromycin simultaneously.

The patient should be directed to discontinue azithromycin immediately and contact a physician if any signs of an allergic reaction occur.

Patients should be counseled that antibacterial drugs, including ZITHROMAX, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When ZITHROMAX is prescribed to treat bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ZITHROMAX or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibacterial which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial. If this occurs, patients should contact their physician as soon as possible.

Your pharmacist can provide more information about azithromycin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Azithromycin is used to treat certain bacterial infections in many different parts of the body. This medicine may mask or delay the symptoms of syphilis. It is not effective against syphilis infections.

Azithromycin belongs to the class of drugs known as macrolide antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

If you or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you take this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Call your child's doctor right away if your child feels irritable or vomits after feeding. These may be symptoms of a condition called infantile hypertrophic pyloric stenosis.

Azithromycin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you or your child have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you or your child have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

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

More common

• Diarrhea
• loose stools

Less common

• Blistering, crusting, irritation, itching, or reddening of the skin
• cracked, dry, or scaly skin
• fever
• swelling

Rare

• Abdominal or stomach pain
• blistering, peeling, or loosening of the skin
• bloody or cloudy urine
• bloody, black, or tarry stools
• body aches or pain
• burning while urinating
• chest pain
• chills
• congestion
• cough increased
• cough producing mucus
• dark urine
• difficult or labored breathing
• difficult or painful urination
• dizziness
• drowsiness
• dryness or soreness of the throat
• earache
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• general feeling of discomfort or illness
• general feeling of tiredness or weakness
• headache
• indigestion
• irregular or slow heart rate
• itching or rash
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• loss of appetite
• muscle aches and pains
• nausea or vomiting
• noisy breathing
• passing of gas
• red skin lesions, often with a purple center
• red, irritated eyes
• redness or swelling in the ear
• runny nose
• shivering
• sneezing
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain, continuing
• stomach pain, fullness, or discomfort
• stuffy nose
• sweating
• swelling of the face, ankles, hands, feet, or lower legs
• tender, swollen glands in the neck
• tightness in the chest
• trouble with sleeping
• trouble with swallowing
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• upper right abdominal or stomach pain
• voice changes
• vomiting of blood
• yellow eyes or skin

Incidence not known

• Abdominal or stomach cramps or tenderness
• bleeding gums
• bloating
• blood in the urine or stools
• blurred vision
• change in hearing
• clay-colored stools
• coma
• confusion
• constipation
• continuing ringing or buzzing or other unexplained noise in the ears
• decreased urine output
• depression
• diarrhea, watery and severe, which may also be bloody
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• greatly decreased frequency of urination or amount of urine
• hives
• hostility
• increased thirst
• irritability
• lethargy
• loss of hearing
• lower back or side pain
• muscle twitching
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• seizures
• stupor
• unusual weight loss

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:

Rare

• Acid or sour stomach
• aggressive or angry
• bad, unusual, or unpleasant (after) taste
• belching
• burning feeling in the chest or stomach
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• changes in the color of the tongue
• crying
• depersonalization
• dry mouth
• dysphoria
• euphoria
• excess air or gas in the stomach or intestines
• feeling of constant movement of self or surroundings
• full feeling
• heartburn
• hyperventilation
• increase in body movements
• itching of the vagina or genital area
• lack or loss of strength
• mental depression
• nervousness
• pain during sexual intercourse
• paranoia
• quick to react or overreact emotionally
• rapidly changing moods
• rash with flat lesions or small raised lesions on the skin
• redness of the skin
• restlessness
• sensation of spinning
• shaking
• sleepiness or unusual drowsiness
• stomach upset
• thick, white vaginal discharge with no odor or with a mild odor
• white patches in the mouth, tongue, or throat

Incidence not known

• Difficulty with moving
• increased sensitivity of the skin to sunlight
• muscle pain or stiffness
• pain in the joints
• redness or other discoloration of the skin
• severe sunburn
• trouble sitting still

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.

Hypersensitivity

Zithromax is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide drug.

Hepatic Dysfunction

Zithromax is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, most of the reported adverse reactions were mild to moderate in severity and were reversible upon discontinuation of the drug. Approximately 0.7% of the patients from the multiple-dose clinical trials discontinued Zithromax (azithromycin) therapy because of treatment-related adverse reactions. Serious adverse reactions included angioedema and cholestatic jaundice. Most of the adverse reactions leading to discontinuation were related to the gastrointestinal tract, e.g., nausea, vomiting, diarrhea, or abdominal pain. [see Clinical Studies (14.2)]

Multiple-dose regimen

Overall, the most common adverse reactions in adult patients receiving a multiple-dose regimen of Zithromax were related to the gastrointestinal system with diarrhea/loose stools (5%), nausea (3%), and abdominal pain (3%) being the most frequently reported.

No other adverse reactions occurred in patients on the multiple-dose regimen of Zithromax with a frequency greater than 1%. Adverse reactions that occurred with a frequency of 1% or less included the following:

Cardiovascular: Palpitations and chest pain.

Gastrointestinal: Dyspepsia, flatulence, vomiting, melena, and cholestatic jaundice.

Genitourinary: Monilia, vaginitis, and nephritis.

Nervous System: Dizziness, headache, vertigo, and somnolence.

General: Fatigue.

Allergic: Rash, photosensitivity, and angioedema.

Chronic therapy with 1200 mg weekly regimen

The nature of adverse reactions seen with the 1200 mg weekly dosing regimen for the prevention of Mycobacterium avium infection in severely immunocompromised HIV-infected patients were similar to those seen with short-term dosing regimens. [see Clinical Studies (14)]

Chronic therapy with 600 mg daily regimen combined with ethambutol

The nature of adverse reactions seen with the 600 mg daily dosing regimen for the treatment of Mycobacterium avium complex infection in severely immunocompromised HIV-infected patients were similar to those seen with short term dosing regimens. Five percent of patients experienced reversible hearing impairment in the pivotal clinical trial for the treatment of disseminated MAC in patients with AIDS. Hearing impairment has been reported with macrolide antibiotics, especially at higher doses. Other treatment-related adverse reactions occurring in >5% of subjects and seen at any time during a median of 87.5 days of therapy include: abdominal pain (14%), nausea (14%), vomiting (13%), diarrhea (12%), flatulence (5%), headache (5%), and abnormal vision (5%). Discontinuations from treatment due to laboratory abnormalities or adverse reactions considered related to study drug occurred in 8 of 88 (9.1%) of subjects.

Single 1 gram dose regimen

Overall, the most common adverse reactions in patients receiving a single-dose regimen of 1 gram of Zithromax were related to the gastrointestinal system and were more frequently reported than in patients receiving the multiple-dose regimen.

Adverse reactions that occurred in patients on the single 1 gram dosing regimen of Zithromax with a frequency of 1% or greater included diarrhea/loose stools (7%), nausea (5%), abdominal pain (5%), vomiting (2%), dyspepsia (1%), and vaginitis (1%).

Post-marketing Experience

The following adverse reactions have been identified during post approval use of azithromycin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reactions reported with azithromycin during the postmarketing period in adult and/or pediatric patients for which a causal relationship may not be established include:

Allergic: Arthralgia, edema, urticaria, and angioedema.

Cardiovascular: Arrhythmias, including ventricular tachycardia, and hypotension. There have been reports of QT prolongation and torsades de pointes.

Gastrointestinal: Anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhea pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis, and tongue discoloration.

General: Asthenia, paresthesia, fatigue, malaise, and anaphylaxis

Genitourinary: Interstitial nephritis, acute renal failure, and vaginitis.

Hematopoietic: Thrombocytopenia.

Liver/Biliary: Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure. [see Warnings and Precautions (5.2)]

Nervous System: Convulsions, dizziness/vertigo, headache, somnolence, hyperactivity, nervousness, agitation, and syncope.

Psychiatric: Aggressive reaction and anxiety.

Skin/Appendages: Pruritus, and serious skin reactions including erythema multiforme, AGEP, Stevens-Johnson Syndrome, toxic epidermal necrolysis, and DRESS.

Special Senses: Hearing disturbances including hearing loss, deafness, and/or tinnitus, and reports of taste/smell perversion and/or loss.

Laboratory Abnormalities

Significant abnormalities (irrespective of drug relationship) occurring during the clinical trials were reported as follows:

• With an incidence of 1–2%, elevated serum creatine phosphokinase, potassium, ALT (SGPT), GGT, and AST (SGOT).
• With an incidence of less than 1%, leukopenia, neutropenia, decreased platelet count, elevated serum alkaline phosphatase, bilirubin, BUN, creatinine, blood glucose, LDH, and phosphate.

When follow-up was provided, changes in laboratory tests appeared to be reversible.

In multiple-dose clinical trials involving more than 3000 patients, 3 patients discontinued therapy because of treatment-related liver enzyme abnormalities and 1 because of a renal function abnormality.

In a phase 1 drug interaction study performed in normal volunteers, 1 of 6 subjects given the combination of azithromycin and rifabutin, 1 of 7 given rifabutin alone, and 0 of 6 given azithromycin alone developed a clinically significant neutropenia (<500 cells/mm3).

Laboratory abnormalities seen in clinical trials for the prevention of disseminated Mycobacterium avium disease in severely immunocompromised HIV-infected patients. [see Clinical Studies (14)]

Chronic therapy (median duration: 87.5 days, range: 1–229 days) that resulted in laboratory abnormalities in >5% of subjects with normal baseline values in the pivotal trial for treatment of disseminated MAC in severely immunocompromised HIV-infected patients treated with azithromycin 600 mg daily in combination with ethambutol include: a reduction in absolute neutrophils to <50% of the lower limit of normal (10/52, 19%) and an increase to five times the upper limit of normal in alkaline phosphatase (3/35, 9%). These findings in subjects with normal baseline values are similar when compared to all subjects for analyses of neutrophil reductions (22/75, 29%) and elevated alkaline phosphatase (16/80, 20%). Causality of these laboratory abnormalities due to the use of study drug has not been established.