Azithromycin 200mg/5ml Susp 22.5ml
It is used to treat or prevent bacterial infections.
Drug Class
Antibiotic
Pharmacologic Class
Macrolide antibiotic
Pregnancy Category
Not available
FDA Approved
Nov 1991
DEA Schedule
Not Controlled
Overview
What is this medicine?
Azithromycin is an antibiotic that fights bacteria. It works by stopping the growth of bacteria. It's used to treat various bacterial infections like ear infections, strep throat, pneumonia, and some sexually transmitted infections. It's important to take all of the medicine as prescribed, even if you start feeling better, to ensure the infection is fully cleared.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
You can take this medication with or without food.
However, do not take antacids containing magnesium or aluminum at the same time as your medication. If you have any questions, consult with your doctor or pharmacist.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Measuring and Administering Your Medication
Before using the liquid form of this medication, shake the bottle well.
Measure the liquid dose carefully using the measuring device provided with the medication. If one is not included, ask your pharmacist for a suitable measuring device.
Storing and Disposing of Your Medication
Store the liquid suspension at room temperature or in the refrigerator.
Discard any unused portion of the medication after 10 days.
Keep the medication in its original container and make sure the lid is tightly closed.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
You can take this medication with or without food.
However, do not take antacids containing magnesium or aluminum at the same time as your medication. If you have any questions, consult with your doctor or pharmacist.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Measuring and Administering Your Medication
Before using the liquid form of this medication, shake the bottle well.
Measure the liquid dose carefully using the measuring device provided with the medication. If one is not included, ask your pharmacist for a suitable measuring device.
Storing and Disposing of Your Medication
Store the liquid suspension at room temperature or in the refrigerator.
Discard any unused portion of the medication after 10 days.
Keep the medication in its original container and make sure the lid is tightly closed.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take the full course of medication as prescribed, even if symptoms improve, to prevent antibiotic resistance and recurrence of infection.
- Shake the oral suspension well before each use.
- Measure the dose accurately using the provided measuring device (oral syringe or spoon), not a household spoon.
- Can be taken with or without food, but taking with food may help reduce stomach upset.
- Avoid antacids containing aluminum or magnesium within 2 hours of taking azithromycin, as they can reduce its absorption.
- Stay hydrated, especially if experiencing diarrhea.
Available Forms & Alternatives
Available Strengths:
- Azithromycin 500mg Inj, 1 Vial
- Azithromycin 1gm Pak Powder
- Azithromycin 600mg Tablets
- Azithromycin 200mg/5ml Susp 15ml
- Azithromycin 200mg/5ml Susp 30ml
- Azithromycin 200mg/5ml Susp 22.5ml
- Azithromycin 100mg/5ml Susp 15ml
- Azithromycin 500mg Sdv Inj, 1 Vial
- Azithromycin 250mg Tablets 6-Pak
- Azithromycin 600mg Tablets
- Azithromycin 500mg Tablets Tri-Pack
- Azithromycin 250mg Tablets
- Azithromycin 500mg Tablets
- Azithromycin 600mg Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. E.g., Community-Acquired Pneumonia (CAP): 500 mg on Day 1, then 250 mg once daily on Days 2-5. Pharyngitis/Tonsillitis: 500 mg on Day 1, then 250 mg once daily on Days 2-5. Chlamydia trachomatis: 1 g as a single dose.
Dose Range:
250 - 1000 mg
Condition-Specific Dosing:
Community-Acquired Pneumonia:
500 mg Day 1, then 250 mg Days 2-5
Pharyngitis/Tonsillitis (Streptococcus pyogenes):
500 mg Day 1, then 250 mg Days 2-5
Acute Bacterial Exacerbations of Chronic Bronchitis:
500 mg Day 1, then 250 mg Days 2-5 (5-day regimen) OR 500 mg once daily for 3 days (3-day regimen)
Uncomplicated Skin Structure Infections:
500 mg Day 1, then 250 mg Days 2-5
Urethritis and Cervicitis (Chlamydia trachomatis):
1 g as a single dose
Genital Ulcer Disease (Haemophilus ducreyi):
1 g as a single dose
Pediatric Dosing
Neonatal:
Not established for routine use; specific indications only (e.g., pertussis prophylaxis) with careful consideration.
Infant:
Acute Otitis Media (AOM): 10 mg/kg once daily for 3 days OR 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. Pharyngitis/Tonsillitis (Streptococcus pyogenes): 12 mg/kg once daily for 5 days (max 500 mg/day).
Child:
AOM: 10 mg/kg once daily for 3 days OR 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. Pharyngitis/Tonsillitis (Streptococcus pyogenes): 12 mg/kg once daily for 5 days (max 500 mg/day). Community-Acquired Pneumonia: 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5.
Adolescent:
Dosing typically follows adult recommendations for weight >45 kg. For weight-based dosing, follow child guidelines.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl >10 mL/min)
Moderate:
No adjustment needed (CrCl >10 mL/min)
Severe:
No specific dose adjustment recommended, but use with caution due to limited data (CrCl <10 mL/min). Monitor for increased systemic exposure.
Dialysis:
Not significantly removed by hemodialysis or peritoneal dialysis. No supplemental dose needed.
Hepatic Impairment:
Mild:
No adjustment
Moderate:
No adjustment
Severe:
Use with caution. Azithromycin is primarily eliminated by the liver. Monitor for signs of hepatic dysfunction.
Pharmacology
Mechanism of Action
Azithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, thereby blocking the translocation of peptides. This action is typically bacteriostatic, but can be bactericidal at high concentrations against susceptible organisms.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 37%
Tmax:
2-3 hours
FoodEffect:
Food decreases the rate and extent of absorption of azithromycin capsules. For oral suspension and tablets, food has no significant effect on bioavailability, but may reduce GI upset.
Distribution:
Vd:
Extensive tissue distribution, approximately 31 L/kg
ProteinBinding:
Variable, 7% to 51% (concentration-dependent)
CnssPenetration:
Limited
Elimination:
HalfLife:
Terminal elimination half-life: 2-4 days (due to extensive tissue distribution and slow release)
Clearance:
Not readily quantifiable due to extensive tissue distribution
ExcretionRoute:
Primarily biliary excretion (major route), with a small amount excreted renally (approximately 6% of unchanged drug)
Unchanged:
Approximately 6% (renal)
Pharmacodynamics
OnsetOfAction:
Rapid (within hours)
PeakEffect:
Achieved at Tmax (2-3 hours), but clinical effect may take longer depending on infection type.
DurationOfAction:
Prolonged due to long half-life and extensive tissue distribution, allowing for short-course therapy (e.g., 5-day or 3-day regimens).
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Chest pain or pressure
Fast heartbeat or abnormal heartbeat
Dizziness or fainting
Changes in hearing
Fever
Changes in eyesight
Diarrhea, especially if it is severe, bloody, or watery (note: diarrhea is a common side effect of antibiotics, but in rare cases, it can lead to a serious condition called C. diff-associated diarrhea, which may cause stomach pain, cramps, or bloody stools)
Liver problems, which may be indicated by:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which may affect body organs and can be life-threatening
+ Signs of severe skin reactions may include:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the mouth, throat, nose, eyes, genitals, or skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands
Other Possible Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Headache
Diarrhea
Stomach pain
Upset stomach
* Vomiting
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Chest pain or pressure
Fast heartbeat or abnormal heartbeat
Dizziness or fainting
Changes in hearing
Fever
Changes in eyesight
Diarrhea, especially if it is severe, bloody, or watery (note: diarrhea is a common side effect of antibiotics, but in rare cases, it can lead to a serious condition called C. diff-associated diarrhea, which may cause stomach pain, cramps, or bloody stools)
Liver problems, which may be indicated by:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which may affect body organs and can be life-threatening
+ Signs of severe skin reactions may include:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the mouth, throat, nose, eyes, genitals, or skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands
Other Possible Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Headache
Diarrhea
Stomach pain
Upset stomach
* Vomiting
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent diarrhea (especially if watery or bloody), which may occur up to 2 months after stopping the medication (sign of C. difficile infection).
- Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, unusual tiredness, severe stomach pain, nausea, vomiting.
- Signs of an allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing.
- Signs of a severe skin reaction: fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling.
- Heart rhythm changes: fast, pounding, or irregular heartbeats, dizziness, fainting (especially if you have a history of heart problems or are taking other medications that affect heart rhythm).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you have previously experienced liver problems or jaundice (yellowing of the skin and eyes) while taking this medication.
Certain heart conditions, such as:
+ Abnormal heart rhythms, including a prolonged QT interval on an electrocardiogram (ECG)
+ Slow heartbeat
+ Low potassium or magnesium levels
+ Heart failure (a weakened heart)
+ A history of torsades de pointes, a specific type of abnormal heartbeat
If you are taking any medications that can cause abnormal heart rhythms, including those that prolong the QT interval. There are many medications that can have this effect, so it is crucial to consult with your doctor or pharmacist if you are unsure.
To ensure your safety, it is vital to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your medical history, including any health problems you have or have had
Do not start, stop, or change the dosage of any medication without first consulting your doctor. This will help prevent potential interactions and ensure that it is safe for you to take this medication with your other medications and health conditions.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you have previously experienced liver problems or jaundice (yellowing of the skin and eyes) while taking this medication.
Certain heart conditions, such as:
+ Abnormal heart rhythms, including a prolonged QT interval on an electrocardiogram (ECG)
+ Slow heartbeat
+ Low potassium or magnesium levels
+ Heart failure (a weakened heart)
+ A history of torsades de pointes, a specific type of abnormal heartbeat
If you are taking any medications that can cause abnormal heart rhythms, including those that prolong the QT interval. There are many medications that can have this effect, so it is crucial to consult with your doctor or pharmacist if you are unsure.
To ensure your safety, it is vital to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your medical history, including any health problems you have or have had
Do not start, stop, or change the dosage of any medication without first consulting your doctor. This will help prevent potential interactions and ensure that it is safe for you to take this medication with your other medications and health conditions.
Precautions & Cautions
Important Information for Patients Taking This Medication
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to the prescribed duration of treatment, as prolonged use may increase the risk of a second infection.
Warning: Severe Heart Rhythm Changes
This medication can cause severe heart rhythm changes, including prolonged QT interval, which can be life-threatening or fatal. If you have any questions or concerns, discuss them with your doctor.
Special Considerations for Myasthenia Gravis
If you have myasthenia gravis, consult your doctor before taking this medication. Monitor your symptoms closely, and contact your doctor if they worsen. Additionally, be aware that myasthenia gravis symptoms can occur in people without a prior diagnosis. Seek immediate medical attention if you experience new or worsening muscle weakness, difficulty chewing or swallowing, breathing problems, droopy eyelids, or changes in vision, such as blurred vision or double vision.
Precautions for Older Adults
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
Special Warning for Newborns
Newborns taking this medication are at risk of developing a severe stomach problem. If your child vomits or becomes irritable during feeding, contact your doctor immediately.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to the prescribed duration of treatment, as prolonged use may increase the risk of a second infection.
Warning: Severe Heart Rhythm Changes
This medication can cause severe heart rhythm changes, including prolonged QT interval, which can be life-threatening or fatal. If you have any questions or concerns, discuss them with your doctor.
Special Considerations for Myasthenia Gravis
If you have myasthenia gravis, consult your doctor before taking this medication. Monitor your symptoms closely, and contact your doctor if they worsen. Additionally, be aware that myasthenia gravis symptoms can occur in people without a prior diagnosis. Seek immediate medical attention if you experience new or worsening muscle weakness, difficulty chewing or swallowing, breathing problems, droopy eyelids, or changes in vision, such as blurred vision or double vision.
Precautions for Older Adults
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
Special Warning for Newborns
Newborns taking this medication are at risk of developing a severe stomach problem. If your child vomits or becomes irritable during feeding, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Severe nausea
- Vomiting
- Diarrhea
- Reversible hearing loss
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is symptomatic and supportive.
Drug Interactions
Major Interactions
- Amiodarone
- Disopyramide
- Dofetilide
- Dronedarone
- Ibutilide
- Pimozide
- Procainamide
- Quinidine
- Sotalol
- Colchicine (in patients with renal/hepatic impairment)
- Nelfinavir
Moderate Interactions
- Antacids (containing aluminum or magnesium)
- Warfarin
- Digoxin
- Cyclosporine
- Ergot alkaloids (e.g., ergotamine, dihydroergotamine)
- Statins (e.g., simvastatin, lovastatin)
- Phenytoin
- Theophylline
- Terfenadine
- Astemizole
- Cisapride
- Fluoroquinolones (e.g., moxifloxacin, levofloxacin)
- Other QT-prolonging drugs
Minor Interactions
- Zidovudine
Monitoring
Baseline Monitoring
Liver function tests (LFTs)
Rationale: To assess baseline hepatic function, especially in patients with pre-existing liver disease, as azithromycin is primarily eliminated by the liver.
Timing: Prior to initiation in patients with known or suspected hepatic impairment.
Electrocardiogram (ECG)
Rationale: To assess baseline QTc interval in patients with known QT prolongation, risk factors for QT prolongation (e.g., uncorrected hypokalemia/hypomagnesemia, bradycardia, heart failure), or those on other QT-prolonging medications.
Timing: Prior to initiation in high-risk patients.
Routine Monitoring
Signs and symptoms of C. difficile-associated diarrhea (CDAD)
Frequency: Throughout therapy and for up to 2 months post-therapy
Target: Absence of severe diarrhea, abdominal pain, fever
Action Threshold: Onset of persistent diarrhea, especially if severe or bloody; discontinue azithromycin and initiate appropriate therapy.
Signs and symptoms of superinfection (e.g., fungal infections)
Frequency: Throughout therapy
Target: Absence of new infections
Action Threshold: Development of new or worsening signs/symptoms of infection; discontinue azithromycin and initiate appropriate therapy.
INR (International Normalized Ratio)
Frequency: More frequently (e.g., daily to every few days) if co-administered with warfarin
Target: Therapeutic range for warfarin
Action Threshold: Significant increase in INR; adjust warfarin dose as needed.
QTc interval (ECG)
Frequency: As clinically indicated, especially in high-risk patients or those developing symptoms (e.g., palpitations, syncope)
Target: <450 ms (men), <470 ms (women)
Action Threshold: Significant QTc prolongation (>500 ms or >60 ms increase from baseline); discontinue azithromycin and manage electrolyte imbalances.
Symptom Monitoring
- Diarrhea (especially severe or bloody)
- Abdominal pain
- Nausea
- Vomiting
- Headache
- Dizziness
- Palpitations
- Syncope
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Unusual fatigue
- Rash
- Itching
- Swelling of face, lips, tongue, or throat (angioedema)
- Difficulty breathing
- Severe skin reactions (e.g., blistering, peeling)
Special Patient Groups
Pregnancy
Generally considered safe for use during pregnancy when clearly needed. Studies in pregnant women have not shown an increased risk of major birth defects or miscarriage. However, it should only be used if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Low risk, no consistent evidence of teratogenicity.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
Considered compatible with breastfeeding (L2). Azithromycin is excreted in human milk in small amounts. The amount ingested by the infant is generally low and not expected to cause adverse effects. Monitor breastfed infants for diarrhea, vomiting, or rash.
Infant Risk:
Low risk
Pediatric Use
Widely used in pediatric populations for various bacterial infections. Dosing is weight-based and specific to age and indication. Oral suspension is commonly used for ease of administration. Safety and efficacy established for children 6 months and older for most indications. Use in infants <6 months requires careful consideration.
Geriatric Use
No specific dose adjustment is required based on age alone. However, elderly patients may be more susceptible to the QT-prolonging effects of azithromycin due to a higher prevalence of underlying cardiac conditions or concomitant medications. Monitor for cardiac adverse events.
Clinical Information
Clinical Pearls
- Azithromycin's long half-life allows for short-course therapy (e.g., 3-day or 5-day regimens) or single-dose therapy for certain infections, improving patient adherence.
- It concentrates well in tissues, leading to higher tissue concentrations than plasma concentrations, which contributes to its efficacy.
- While generally well-tolerated, GI upset (nausea, diarrhea, abdominal pain) is common. Taking with food may help.
- Counsel patients on the risk of C. difficile-associated diarrhea, which can occur even weeks after completing therapy.
- Be mindful of the risk of QT prolongation, especially in patients with pre-existing cardiac conditions, electrolyte imbalances, or those on other QT-prolonging drugs.
- Azithromycin is a common choice for atypical pneumonia (e.g., Mycoplasma, Chlamydophila) and certain sexually transmitted infections.
Alternative Therapies
- Other macrolides (e.g., clarithromycin, erythromycin)
- Tetracyclines (e.g., doxycycline)
- Beta-lactam antibiotics (e.g., amoxicillin, penicillin, cephalexin) for susceptible infections
- Fluoroquinolones (e.g., levofloxacin, moxifloxacin) for certain respiratory or skin infections
- Clindamycin
Cost & Coverage
Average Cost:
Varies widely, typically low for generic per 22.5ml suspension (200mg/5ml)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.