Azithromycin 100mg/5ml Susp 15ml
It is used to treat or prevent bacterial infections.
Drug Class
Antibiotic
Pharmacologic Class
Macrolide antibiotic
Pregnancy Category
B
FDA Approved
Nov 1991
DEA Schedule
Not Controlled
Overview
What is this medicine?
Azithromycin is an antibiotic used to treat various bacterial infections, such as respiratory infections, skin infections, and certain sexually transmitted infections. It works by stopping the growth of bacteria.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. 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 your doctor or pharmacist.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well. Before using the liquid form of this medication, shake the bottle well. To ensure accurate dosing, measure the liquid carefully using the measuring device provided with the medication. If a measuring device is not included, ask your pharmacist for one.
Storing and Disposing of Your Medication
Store the liquid suspension at room temperature or in the refrigerator. Discard any unused portion after 10 days. Keep the medication in its original container, making 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. However, if it's 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 get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. 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 your doctor or pharmacist.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well. Before using the liquid form of this medication, shake the bottle well. To ensure accurate dosing, measure the liquid carefully using the measuring device provided with the medication. If a measuring device is not included, ask your pharmacist for one.
Storing and Disposing of Your Medication
Store the liquid suspension at room temperature or in the refrigerator. Discard any unused portion after 10 days. Keep the medication in its original container, making 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. However, if it's 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 you feel better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
- Shake the oral suspension well before each use.
- Measure the liquid medicine carefully with the provided dosing syringe or spoon, not a household spoon.
- Azithromycin oral suspension can be taken with or without food, but taking it with food may help reduce stomach upset.
- Avoid taking 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. Common: 500 mg once on day 1, then 250 mg once daily on days 2-5 (total 1.5 g); or 500 mg single dose.
Dose Range:
250 - 2000 mg
Condition-Specific Dosing:
Community-acquired pneumonia (CAP):
500 mg single dose on day 1, then 250 mg once daily on days 2-5.
Pharyngitis/Tonsillitis (streptococcal):
500 mg single dose on day 1, then 250 mg once daily on days 2-5.
Acute bacterial exacerbations of chronic bronchitis (ABECB):
500 mg single dose on day 1, then 250 mg once daily on days 2-5; or 500 mg once daily for 3 days.
Uncomplicated skin and skin structure infections:
500 mg single dose on day 1, then 250 mg once daily on days 2-5.
Urethritis and cervicitis (Chlamydia trachomatis):
1 g single oral dose.
Genital ulcer disease (Chancroid):
1 g single oral dose.
Pediatric Dosing
Neonatal:
Not established for routine use; use with caution and specific indications only (e.g., pertussis prophylaxis).
Infant:
10 mg/kg once daily for 1-3 days for otitis media/sinusitis; 12 mg/kg once daily for 5 days for pharyngitis/tonsillitis (max 500 mg/day).
Child:
For otitis media/sinusitis: 10 mg/kg (max 500 mg) on day 1, then 5 mg/kg (max 250 mg) on days 2-5; or 10 mg/kg once daily for 3 days; or 30 mg/kg as a single dose. For pharyngitis/tonsillitis: 12 mg/kg once daily for 5 days (max 500 mg/day).
Adolescent:
Dosing similar to adult, based on weight and indication.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary for CrCl >10 mL/min. Caution advised in severe renal impairment (CrCl <10 mL/min) due to limited data.
Dialysis:
Not significantly removed by hemodialysis or peritoneal dialysis. No specific dose adjustment recommended, but caution advised.
Hepatic Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
Use with caution in patients with severe hepatic impairment as azithromycin is primarily eliminated by the liver. Monitor LFTs.
Pharmacology
Mechanism of Action
Azithromycin is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of susceptible microorganisms. This binding interferes with the translocation of peptides, thereby inhibiting RNA-dependent protein synthesis.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 37%
Tmax:
2-3 hours
FoodEffect:
Oral suspension absorption is increased when taken with food. Tablets can be taken with or without food, but food may decrease peak plasma concentrations by 50% for the immediate-release tablet.
Distribution:
Vd:
31.1 L/kg (extensive tissue distribution)
ProteinBinding:
Concentration-dependent (12% at 1 mcg/mL, 52% at 0.05 mcg/mL)
CnssPenetration:
Limited (low concentrations in CSF in non-inflamed meninges)
Elimination:
HalfLife:
68 hours (terminal elimination half-life)
Clearance:
Not available (primarily eliminated unchanged)
ExcretionRoute:
Mainly biliary excretion (50% unchanged in feces); minor renal excretion (6-12% unchanged in urine)
Unchanged:
Approximately 50% in feces, 6-12% in urine
Pharmacodynamics
OnsetOfAction:
Rapid (within hours)
PeakEffect:
Not applicable for antibacterial effect, but peak plasma concentrations reached in 2-3 hours.
DurationOfAction:
Prolonged due to extensive tissue distribution and long half-life, allowing for once-daily dosing and shorter treatment courses.
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 also affect internal organs
+ Symptoms 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 not have any side effects at all. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Headache
Diarrhea
Stomach pain
Upset stomach
* Vomiting
Reporting 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 also affect internal organs
+ Symptoms 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 not have any side effects at all. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Headache
Diarrhea
Stomach pain
Upset stomach
* Vomiting
Reporting 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 bloody or watery)
- New or worsening abdominal pain
- Yellowing of the skin or eyes (jaundice)
- Dark urine or pale stools
- Unusual tiredness or weakness
- Severe skin rash, blistering, or peeling
- Swelling of the face, lips, tongue, or throat
- Difficulty breathing or swallowing
- Fast, pounding, or irregular heartbeat
- Dizziness or fainting
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:
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 (turned yellow) while taking this medication.
Certain health conditions, such as:
+ Abnormal heart rhythms, including a prolonged QTc interval on an electrocardiogram (ECG) or other irregular heartbeats
+ 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, particularly 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, vitamins, or supplements you are using
* Your complete medical history, including all health problems
Before starting, stopping, or changing the dosage of any medication, you must consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
It is essential to inform your doctor about the following:
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 (turned yellow) while taking this medication.
Certain health conditions, such as:
+ Abnormal heart rhythms, including a prolonged QTc interval on an electrocardiogram (ECG) or other irregular heartbeats
+ 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, particularly 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, vitamins, or supplements you are using
* Your complete medical history, including all health problems
Before starting, stopping, or changing the dosage of any medication, you must consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
Precautions & Cautions
Important Warnings and Cautions 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 using this medication for an extended period may increase the risk of a second infection.
Severe Heart Rhythm Changes
This medication can cause severe heart rhythm changes, including a prolonged QT interval, which may be life-threatening or fatal. If you have any questions or concerns, consult your doctor.
Myasthenia Gravis
If you have myasthenia gravis, discuss your condition with your doctor. 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.
Special Considerations 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 Breast-Feeding
If you are pregnant, plan to become pregnant, or are breast-feeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
Newborns
In newborns taking this medication, a severe stomach problem can occur. 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 using this medication for an extended period may increase the risk of a second infection.
Severe Heart Rhythm Changes
This medication can cause severe heart rhythm changes, including a prolonged QT interval, which may be life-threatening or fatal. If you have any questions or concerns, consult your doctor.
Myasthenia Gravis
If you have myasthenia gravis, discuss your condition with your doctor. 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.
Special Considerations 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 Breast-Feeding
If you are pregnant, plan to become pregnant, or are breast-feeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
Newborns
In newborns taking this medication, a severe stomach problem can occur. 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. Gastric lavage and general supportive measures may be indicated.
Drug Interactions
Major Interactions
- Amiodarone
- Disopyramide
- Dofetilide
- Ibutilide
- Procainamide
- Quinidine
- Sotalol
- Pimozide
- Thioridazine
- Cisapride
- Ergotamine
- Dihydroergotamine
Moderate Interactions
- Warfarin
- Cyclosporine
- Digoxin
- Nelfinavir
- Antacids (containing aluminum or magnesium)
- Fluoroquinolones (e.g., Moxifloxacin, Levofloxacin)
- Hydroxychloroquine
- Chloroquine
- Statins (e.g., Simvastatin, Atorvastatin - theoretical risk of rhabdomyolysis, but less significant than other macrolides)
Minor Interactions
- Zidovudine (decreased Cmax and AUC of zidovudine metabolite)
Monitoring
Baseline Monitoring
Patient history for pre-existing QT prolongation or risk factors
Rationale: To identify patients at increased risk for Torsades de Pointes (TdP)
Timing: Prior to initiation
Electrolyte levels (Potassium, Magnesium)
Rationale: Hypokalemia or hypomagnesemia can increase the risk of QT prolongation
Timing: Prior to initiation, especially in at-risk patients
Liver function tests (LFTs)
Rationale: Azithromycin is primarily eliminated by the liver; rare cases of hepatic dysfunction have been reported
Timing: Prior to initiation in patients with pre-existing hepatic impairment
Routine Monitoring
Signs/symptoms of hepatotoxicity (e.g., jaundice, dark urine, abdominal pain)
Frequency: Daily during therapy
Target: N/A
Action Threshold: Discontinue azithromycin and evaluate if symptoms occur
Signs/symptoms of C. difficile-associated diarrhea (CDAD)
Frequency: Daily during and up to 2 months post-therapy
Target: N/A
Action Threshold: Evaluate for CDAD if severe diarrhea occurs
ECG (QTc interval)
Frequency: As clinically indicated, especially in patients with risk factors for QT prolongation
Target: <450 ms (men), <470 ms (women)
Action Threshold: Consider discontinuation or alternative if QTc significantly prolongs or exceeds 500 ms
INR (for patients on warfarin)
Frequency: More frequently during and after azithromycin therapy
Target: 2.0-3.0 (or patient-specific target)
Action Threshold: Adjust warfarin dose as needed to maintain target INR
Symptom Monitoring
- Diarrhea (especially severe or persistent)
- Abdominal pain
- Nausea
- Vomiting
- Rash
- Itching
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Light-colored stools
- Unusual tiredness
- Signs of allergic reaction (swelling of face/throat, difficulty breathing)
- Palpitations or irregular heartbeat
- Dizziness or fainting
Special Patient Groups
Pregnancy
Generally considered safe for use during pregnancy when clearly needed. Animal studies have not shown harm to the fetus. Human data are reassuring, but well-controlled studies are limited.
Trimester-Specific Risks:
First Trimester:
Low risk; no increased risk of major birth defects observed.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
Considered moderately safe. Azithromycin is excreted into breast milk in low concentrations. Monitor breastfed infant for gastrointestinal disturbances (e.g., diarrhea, vomiting, candidiasis) and rash.
Infant Risk:
Low risk of adverse effects; potential for altered gut flora or allergic sensitization.
Pediatric Use
Dosing is weight-based and varies by indication. Safety and efficacy established for various pediatric infections. Caution in neonates due to limited data and potential for infantile hypertrophic pyloric stenosis (IHPS) with macrolides, though less commonly associated with azithromycin than erythromycin.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may be more susceptible to drug-associated QT interval prolongation and should be monitored for this risk.
Clinical Information
Clinical Pearls
- Azithromycin has a very long half-life, allowing for shorter treatment courses (e.g., 3-day or 5-day regimens) compared to other antibiotics.
- It concentrates well in tissues, particularly phagocytes, leading to sustained drug levels at the site of infection.
- While generally well-tolerated, GI upset (nausea, diarrhea) is common. Taking the suspension with food may help.
- Counsel patients on the importance of completing the full course of therapy to prevent resistance.
- Be mindful of the QT prolongation risk, especially in patients with pre-existing cardiac conditions, electrolyte imbalances, or those on other QT-prolonging medications.
- Azithromycin is a common choice for atypical pneumonia (e.g., Mycoplasma, Chlamydia) and certain STIs.
Alternative Therapies
- Clarithromycin (another macrolide)
- Erythromycin (another macrolide)
- Doxycycline (tetracycline, for atypical pneumonia, STIs)
- Amoxicillin/Clavulanate (beta-lactam, for respiratory/skin infections)
- Levofloxacin (fluoroquinolone, for respiratory/skin infections)
- Cefdinir (cephalosporin, for respiratory/skin infections)
Cost & Coverage
Average Cost:
Varies, typically $10-$30 per 15ml (100mg/5ml) suspension
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. 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 details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.