Azithromycin 200mg/5ml Susp 15ml
It is used to treat or prevent bacterial infections.
Drug Class
Macrolide antibiotic
Pharmacologic Class
Macrolide; Protein synthesis inhibitor
Pregnancy Category
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 ear infections, strep throat, pneumonia, and some sexually transmitted infections. It works by stopping the growth of bacteria.
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 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 liquid doses 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 with the lid 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 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 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 liquid doses 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 with the lid 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 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 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 using the provided measuring spoon or cup, not a household spoon.
- Store the reconstituted suspension at room temperature or in the refrigerator as directed by the pharmacist, and discard any unused portion after the specified time (usually 10 days).
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. For respiratory tract infections, skin/skin structure infections: 500 mg as a single dose on Day 1, then 250 mg once daily on Days 2-5. For Chlamydia trachomatis: 1 g as a single dose. For Neisseria gonorrhoeae: 2 g as a single dose (often with ceftriaxone).
Dose Range:
250 - 2000 mg
Condition-Specific Dosing:
Community-acquired pneumonia:
500 mg single dose on Day 1, then 250 mg once daily on Days 2-5.
Pharyngitis/Tonsillitis (Streptococcus pyogenes):
500 mg single dose on Day 1, then 250 mg once daily on Days 2-5.
Acute bacterial exacerbations of chronic bronchitis:
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 as a single dose.
Genital ulcer disease (Haemophilus ducreyi):
1 g as a single dose.
Uncomplicated gonorrhoea:
2 g as a single dose (often in combination with ceftriaxone).
Pediatric Dosing
Neonatal:
Not established for routine use; use with caution and specific guidance for ophthalmia neonatorum or pneumonia due to C. trachomatis.
Infant:
For acute otitis media (âĨ6 months): 30 mg/kg as a single dose OR 10 mg/kg once daily for 3 days OR 10 mg/kg as a single dose on Day 1, then 5 mg/kg once daily on Days 2-5. For pharyngitis/tonsillitis (âĨ2 years): 12 mg/kg once daily for 5 days (max 500 mg/day).
Child:
For acute otitis media (âĨ6 months): 30 mg/kg as a single dose OR 10 mg/kg once daily for 3 days OR 10 mg/kg as a single dose on Day 1, then 5 mg/kg once daily on Days 2-5. For pharyngitis/tonsillitis (âĨ2 years): 12 mg/kg once daily for 5 days (max 500 mg/day). For community-acquired pneumonia (âĨ6 months): 10 mg/kg as a single dose on Day 1, then 5 mg/kg once daily on Days 2-5.
Adolescent:
Dosing generally follows adult recommendations for weight-appropriate adolescents (e.g., 1 g single dose for Chlamydia trachomatis).
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary (CrCl < 10 mL/min), but caution is advised due to limited data.
Dialysis:
Not significantly removed by hemodialysis or peritoneal dialysis. No specific dose adjustment needed.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
Use with caution; monitor for signs of worsening liver function.
Severe:
Avoid use if possible; if necessary, use with extreme caution and close monitoring of liver function tests.
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% (oral suspension)
Tmax:
2-3 hours
FoodEffect:
Food decreases the Cmax by 50% and the AUC by 18% for the oral suspension. However, the oral suspension can be taken with or without food to minimize gastrointestinal upset.
Distribution:
Vd:
Extremely large (approximately 31 L/kg), indicating extensive tissue distribution.
ProteinBinding:
Concentration-dependent, ranging from 7% (at 1 mcg/mL) to 50% (at 0.02 mcg/mL).
CnssPenetration:
Limited penetration into the cerebrospinal fluid (CSF) in non-inflamed meninges.
Elimination:
HalfLife:
Terminal elimination half-life is 2-4 days (due to extensive tissue distribution and slow release from tissues).
Clearance:
Not readily quantifiable due to extensive tissue distribution.
ExcretionRoute:
Primarily excreted unchanged in the bile (approximately 50% of an oral dose). A small amount is excreted renally (approximately 6-11% unchanged).
Unchanged:
Approximately 50% (biliary), 6-11% (renal)
Pharmacodynamics
OnsetOfAction:
Rapid, typically within hours of first dose.
PeakEffect:
Bactericidal effects are concentration-dependent, but clinical effects are observed within 24-48 hours.
DurationOfAction:
Prolonged due to long tissue half-life, allowing for once-daily dosing and shorter treatment courses (e.g., 3-5 days).
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's severe, bloody, or watery) - although diarrhea is common with antibiotics, a rare but serious condition called C. diff-associated diarrhea (CDAD) may occur, which can lead to life-threatening bowel problems
Stomach pain, cramps, or very loose stools (if you experience these symptoms, contact your doctor before treating diarrhea)
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes (jaundice)
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions that may affect body organs
+ Signs of these 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
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you notice any of the following:
Headache
Diarrhea
Stomach pain
Upset stomach
Vomiting
If you experience any of these side effects or any other symptoms that concern you or don't go away, contact your doctor for advice.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. If you have questions about side effects, contact your doctor for guidance.
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's severe, bloody, or watery) - although diarrhea is common with antibiotics, a rare but serious condition called C. diff-associated diarrhea (CDAD) may occur, which can lead to life-threatening bowel problems
Stomach pain, cramps, or very loose stools (if you experience these symptoms, contact your doctor before treating diarrhea)
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes (jaundice)
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions that may affect body organs
+ Signs of these 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
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you notice any of the following:
Headache
Diarrhea
Stomach pain
Upset stomach
Vomiting
If you experience any of these side effects or any other symptoms that concern you or don't go away, contact your doctor for advice.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. If you have questions about side effects, contact your doctor for guidance.
Seek Immediate Medical Attention If You Experience:
- Severe or watery diarrhea that does not stop, especially if it contains blood or mucus (may be a sign of C. difficile infection).
- Signs of an allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing.
- Signs of liver problems: yellowing of the skin or eyes (jaundice), dark urine, pale stools, unusual tiredness, nausea, vomiting, stomach pain.
- Signs of heart problems: fast, pounding, or irregular heartbeat, dizziness, fainting.
- Severe skin reactions: blistering, peeling, or red skin rash.
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, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have previously experienced liver problems or jaundice (turning yellow) while taking this medication.
Certain health conditions, including:
+ Abnormal heart rhythms, such as a prolonged QT interval on an electrocardiogram (ECG) or other irregular heartbeats.
+ Slow heartbeat.
+ Low levels of potassium or magnesium in your blood.
+ Heart failure, also known as a weak 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, such as those that prolong the QT interval. There are many medications that can have this effect, so be sure to ask your doctor or pharmacist if you are unsure.
This is not an exhaustive list of all potential interactions between this medication and other substances or health conditions. Therefore, it is crucial to inform your doctor and pharmacist about:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any health problems you have or have had in the past.
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have previously experienced liver problems or jaundice (turning yellow) while taking this medication.
Certain health conditions, including:
+ Abnormal heart rhythms, such as a prolonged QT interval on an electrocardiogram (ECG) or other irregular heartbeats.
+ Slow heartbeat.
+ Low levels of potassium or magnesium in your blood.
+ Heart failure, also known as a weak 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, such as those that prolong the QT interval. There are many medications that can have this effect, so be sure to ask your doctor or pharmacist if you are unsure.
This is not an exhaustive list of all potential interactions between this medication and other substances or health conditions. Therefore, it is crucial to inform your doctor and pharmacist about:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any health problems you have or have had in the past.
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety.
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 prolonged use may increase the risk of a second infection.
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.
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.
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 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.
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 prolonged use may increase the risk of a second infection.
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.
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.
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 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.
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
- Hearing loss (reversible)
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 are indicated.
Drug Interactions
Major Interactions
- QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, cisapride, pimozide, terfenadine, astemizole, some antipsychotics, tricyclic antidepressants)
- Nelfinavir (increases azithromycin serum concentrations)
Moderate Interactions
- Antacids (aluminum and magnesium-containing: decrease azithromycin peak serum levels but not AUC)
- Warfarin (potential for increased INR)
- Digoxin (potential for increased digoxin levels)
- Cyclosporine (potential for increased cyclosporine levels)
- Ergot derivatives (e.g., ergotamine, dihydroergotamine: theoretical risk of acute ergotism)
- Statins (e.g., simvastatin, lovastatin: theoretical risk of rhabdomyolysis, though less common than with other macrolides)
Minor Interactions
- Zidovudine (azithromycin increases zidovudine phosphorylation in peripheral blood mononuclear cells)
Monitoring
Baseline Monitoring
Electrocardiogram (ECG)
Rationale: To assess baseline QT interval, especially in patients with known QT prolongation, risk factors for QT prolongation (e.g., uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, concomitant use of other QT-prolonging drugs), or significant cardiac disease.
Timing: Prior to initiation, if risk factors are present.
Liver Function Tests (LFTs)
Rationale: To assess baseline hepatic function, particularly in patients with pre-existing hepatic impairment, as azithromycin is primarily eliminated via the liver.
Timing: Prior to initiation, if hepatic impairment is suspected or known.
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: If severe diarrhea or colitis develops, discontinue azithromycin and initiate appropriate treatment.
Signs and symptoms of allergic reactions (e.g., rash, pruritus, angioedema)
Frequency: Daily during therapy.
Target: Absence of allergic symptoms.
Action Threshold: Discontinue immediately if signs of hypersensitivity or severe skin reactions occur.
Resolution of infection symptoms
Frequency: Daily during therapy and at follow-up.
Target: Improvement or resolution of fever, pain, inflammation.
Action Threshold: If no improvement or worsening, re-evaluate diagnosis and treatment.
Symptom Monitoring
- Diarrhea (especially severe or persistent)
- Abdominal pain
- Nausea
- Vomiting
- Rash
- Itching
- Swelling of face/lips/tongue/throat (angioedema)
- Difficulty breathing
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Unusual tiredness
- Light-colored stools
- Palpitations or irregular heartbeat
- Dizziness or fainting
Special Patient Groups
Pregnancy
Azithromycin is generally considered safe for use during pregnancy (Pregnancy Category B). Studies in animals have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed.
Trimester-Specific Risks:
First Trimester:
No increased risk of major birth defects observed in human studies.
Second Trimester:
Generally considered safe; often used for infections during this trimester.
Third Trimester:
Generally considered safe; often used for infections during this trimester.
Lactation
Azithromycin is excreted in human milk in small amounts. It is generally considered compatible with breastfeeding (Lactation Risk L2). Monitor breastfed infants for potential gastrointestinal disturbances (e.g., diarrhea, vomiting, candidiasis) or allergic reactions.
Infant Risk:
Low risk of adverse effects for the breastfed infant. Potential for minor gastrointestinal upset or alteration of gut flora.
Pediatric Use
Widely used in pediatric populations for various bacterial infections. Dosing is weight-based. Caution is advised in infants younger than 6 months due to limited data. Risk of infantile hypertrophic pyloric stenosis (IHPS) has been reported in neonates and young infants treated with macrolides, including azithromycin.
Geriatric Use
No specific dosage adjustment is necessary based solely on age. However, elderly patients may be more susceptible to the QT-prolonging effects of azithromycin and should be monitored for cardiac arrhythmias. Consider baseline cardiac risk factors.
Clinical Information
Clinical Pearls
- Azithromycin has a very long tissue half-life, allowing for shorter treatment durations (e.g., 3-5 days) compared to other antibiotics.
- It is highly concentrated in tissues, particularly phagocytes, which contributes to its effectiveness against intracellular pathogens.
- While generally well-tolerated, GI upset (nausea, diarrhea, abdominal pain) is common. Taking the suspension with food may help reduce these symptoms, though it can slightly reduce absorption.
- Counsel patients on the importance of completing the entire course of therapy to prevent resistance and recurrence.
- Be aware of the potential for QT prolongation, especially in patients with pre-existing cardiac conditions, electrolyte imbalances, or those taking other QT-prolonging drugs.
- Azithromycin is a common cause of C. difficile-associated diarrhea (CDAD), even after therapy is discontinued.
Alternative Therapies
- Amoxicillin
- Clarithromycin
- Erythromycin
- Doxycycline
- Levofloxacin
- Ceftriaxone
Cost & Coverage
Average Cost:
Typically $10-$50 per 15ml bottle (200mg/5ml)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 for more information. If you have any questions or concerns about your medication, don't hesitate to discuss them with 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.