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Zmax


Zmax

Generic Name: azithromycin (Oral route)

ay-zith-roe-MYE-sin

Commonly used brand name(s):

In the U.S.

  • Zithromax
  • Zithromax Tri-Pak
  • Zithromax Z-Pak
  • Zmax

Available Dosage Forms:

  • Powder for Suspension
  • Tablet
  • Capsule
  • Powder for Suspension, Extended Release

Therapeutic Class: Antibiotic

Chemical Class: Macrolide

Uses For Zmax

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.

Before Using Zmax

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of azithromycin in children and infants 6 months of age and older. Safety and efficacy have not been established in infants below 6 months of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of azithromycin in the elderly.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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

  • Dihydroergotamine
  • Ergoloid Mesylates
  • Ergonovine
  • Ergotamine
  • Methylergonovine
  • Methysergide
  • Pimozide

Using this medicine 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.

  • Acecainide
  • Amiodarone
  • Azimilide
  • Bretylium
  • Disopyramide
  • Dofetilide
  • Ibutilide
  • Propafenone
  • Sematilide
  • Sotalol
  • Tedisamil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Atorvastatin
  • Digoxin
  • Fentanyl
  • Lovastatin
  • Nelfinavir
  • Rifabutin
  • Simvastatin
  • Theophylline
  • Warfarin

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

  • Heart rhythm problems (e.g., prolonged QT interval), history of or
  • Myasthenia gravis—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—Effects may be increased because of slower removal of the medicine from the body.

Proper Use of azithromycin

This section provides information on the proper use of a number of products that contain azithromycin. It may not be specific to Zmax. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take azithromycin tablets with or without food.

Measure the extended-release oral liquid with a marked measuring spoon, syringe, or cup. You or your child must take this medicine within 12 hours after it has been mixed with water. It is best to take the extended-release oral liquid on an empty stomach or at least 1 hour before or 2 hours after a meal. If your child does not use all of the medicine in the bottle, throw it away after you give the dose.

Keep using this medicine for the full treatment time, even if you or your child feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

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

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

  • For oral dosage form (extended-release suspension):
    • For treatment of infections:
      • Adults—2 grams (g) once a day as a single dose.
      • Children weighing 75 pounds (34 kg) or more— 2 g once a day as a single dose.
      • Children and infants 6 months of age and older weighing less than 75 pounds (34 kg)—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 60 milligrams (mg) per kilogram (kg) of body weight once a day as a single dose.
      • Infants below 6 months of age—Use and dose must be determined by your doctor.
  • For oral dosage forms (suspension or tablets):
    • For treatment of infections:
      • Adults—500 to 2000 milligrams (mg) once a day as a single dose. Depending on the type of infection, this may be followed with doses of 250 to 500 mg once a day for several days.
      • Children and infants 6 months of age and older—Dose is based on body weight and must be determined by your doctor. However, the recommended dose is 10 to 30 milligrams (mg) per kilogram (kg) once a day as a single dose. Depending on the type of infection, this may be followed with doses of 5 to 12 mg/kg once a day for several days.
      • Infants below 6 months of age—Use and dose must be determined by your doctor.

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.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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

Do not refrigerate or freeze the extended-release oral liquid. Throw away any unused liquid after your dose.

You may store the oral liquid at room temperature or in the refrigerator. Do not freeze the bottle. Do not keep the oral liquid for more than 10 days. Throw away any unused liquid after all doses are completed.

Precautions While Using Zmax

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; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you take this medicine.

Azithromycin may cause diarrhea, and in some cases it can be severe. 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 have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

If you or your child vomits within one hour of taking the extended-release oral liquid, call your doctor right away to see if more medicine is needed.

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.

Zmax Side Effects

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

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

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
  • difficulty with breathing
  • 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
  • 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
  • rash
  • red irritated eyes
  • red skin lesions, often with a purple center
  • redness or swelling in the ear
  • runny nose
  • shivering
  • shortness of breath
  • 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 in swallowing
  • trouble sleeping
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal pain
  • voice changes
  • vomiting of blood
  • wheezing
  • yellow eyes or skin
Incidence not known
  • Abdominal or stomach cramps
  • abdominal 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 from a lying or sitting position suddenly
  • 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 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, 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
  • shortness of breath
  • sleepiness or unusual drowsiness
  • sleeplessness
  • sore mouth or tongue
  • stomach upset
  • thick, white vaginal discharge with no odor or with a mild odor
  • unable to sleep
  • white patches in the mouth, tongue, or throat
Incidence not known
  • Difficulty in moving
  • fear or nervousness
  • increased sensitivity of skin to sunlight
  • muscle pain or stiffness
  • pain in 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.

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  • Zmax Suspension MedFacts Consumer Leaflet (Wolters Kluwer)
  • Zmax Prescribing Information (FDA)
  • Zmax Detailed Consumer Information (PDR)
  • Azithromycin Professional Patient Advice (Wolters Kluwer)
  • Azithromycin Detailed Consumer Information (PDR)
  • Azithromycin MedFacts Consumer Leaflet (Wolters Kluwer)
  • Zithromax Prescribing Information (FDA)
  • Zithromax Consumer Overview