Azithromycin Oral Suspension

Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor directs you to do so. A different medication may be necessary in that case.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

• It is used to treat or prevent bacterial infections.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• A fast heartbeat.
• A heartbeat that does not feel normal.
• Change in hearing.
• Hearing loss.
• Chest pain or pressure.
• Ringing in ears.
• Seizures.
• Very bad dizziness or passing out.
• Trouble swallowing or speaking.
• Fever.
• Swollen gland.
• Vaginal itching or discharge.
• It is common to have diarrhea when taking azithromycin oral suspension. Rarely, a very bad form of diarrhea called Clostridium difficile (C diff)–associated diarrhea (CDAD) may occur. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while you are taking this medicine or within a few months after you stop taking it. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with your doctor.
• Very bad and sometimes deadly liver problems have happened with azithromycin oral suspension. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration (2)].

Adult Patients

• Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. • Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. • Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy. • Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. • Uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae. • Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae. • Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.

Pediatric Patients

  [see Use in Specific Populations (8.4) and Clinical Studies (14.2)] • Acute otitis media (> 6 months of age) caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae • Community-acquired pneumonia (> 6 months of age) due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumonia, or Streptococcus pneumoniae in patients appropriate for oral therapy. • Pharyngitis/tonsillitis (> 2 years of age) caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.

Limitations of Use

Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:

• patients with cystic fibrosis, • patients with nosocomial infections, • patients with known or suspected bacteremia, • patients requiring hospitalization, • elderly or debilitated patients, or • patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin for oral suspension and other antibacterial drugs, azithromycin for oral suspension should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Azithromycin for oral suspension USP after constitution contains a flavored pink suspension. Azithromycin for oral suspension USP is supplied to provide 100 mg/5 mL or 200 mg/5 mL suspension in bottles as follows:

Azithromycin contents per bottle	NDC
300 mg	0093-2027-23
600 mg	0093-2026-23
900 mg	0093-2026-94
1200 mg	0093-2026-31

[see Dosage and Administration (2)] for constitution instructions with each bottle type.

Storage: Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

PROTECT FROM FREEZING.

Store constituted suspension between 5° to 25°C (41° to 77°F) and discard when full dosing is completed.

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

Azithromycin for Oral Suspension USP 100 mg per 5 mL, 300 mg Carton Text

NDC 0093-2027-23

AZITHROMYCIN for

Oral Suspension USP

100 mg* per 5 mL

300 mg (15 mL when mixed)

FOR ORAL USE ONLY.

Cherry Flavored

PHARMACIST: Please dispense with

enclosed Patient Information leaflet

Rx only

300 mg (15 mL when mixed)

TEVA

More Common Side Effects

The more common side effects of azithromycin oral suspension can include:

• diarrhea

• nausea

• stomach pain

• vomiting

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious Side Effects

Call your doctor right away if you have serious side effects. Call 9-1-1 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Liver problems. Symptoms can include:

  • tiredness or weakness
  • loss of appetite
  • upper stomach pain
  • dark-colored urine
  • yellowing of your skin or eyes

• QT prolongation (a heart rhythm problem). Symptoms can include:

  • fast or irregular heart rhythm

• Allergic reactions. Symptoms can include:

  • skin reactions, including hives or the severe skin reactions Stevens-Johnson syndrome or toxic epidermal necrolysis. Symptoms can include:
    • red, blistering skin
    • skin sloughing (shedding dead skin cells)
  • trouble breathing
  • swelling of your face, lips, tongue, or throat

• Infantile hypertrophic pyloric stenosis (in newborns). Symptoms can include:

  • vomiting after eating
  • irritability with feeding
  • lack of weight gain

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.