Zithromax 200mg Sus 22.5ml(white Bx
It is used to treat or prevent bacterial infections.
Drug Class
Antibiotic
Pharmacologic Class
Macrolide antibiotic
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 respiratory infections (like bronchitis, pneumonia), ear infections, skin infections, and some sexually transmitted infections. It works by stopping the growth of bacteria. It's important to take the full course of medication, even if you feel better, to prevent the infection from returning.
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 feeling well.
Before using the liquid form of this medication, shake the bottle well.
Measure liquid doses accurately 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
To maintain the effectiveness and safety 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, follow these guidelines:
Take the missed dose 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 the missed one.
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 feeling well.
Before using the liquid form of this medication, shake the bottle well.
Measure liquid doses accurately 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
To maintain the effectiveness and safety 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, follow these guidelines:
Take the missed dose 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 the missed one.
Lifestyle & Tips
- Take the oral suspension on an empty stomach (at least 1 hour before or 2 hours after a meal) for best absorption, unless directed otherwise by your doctor to reduce stomach upset.
- Shake the oral suspension well before each use.
- Use the provided measuring device (oral syringe or spoon) to ensure accurate dosing.
- Do not share this medication with others.
- Avoid antacids containing aluminum or magnesium within 2 hours of taking azithromycin.
- Stay hydrated, especially if experiencing diarrhea.
Available Forms & Alternatives
Available Strengths:
- Zithromax 200mg Sus 15ml(purple Bx)
- Zithromax 100mg Susp 15ml(green Bx)
- Zithromax 200mg Sus 22.5ml(white Bx
- Zithromax 1gm Powder Packet
- Zithromax 200mg Sus 30ml(yellow Bx)
- Zithromax 600mg Tabs
- Zithromax 250mg Tabs (z-Pak)
- Zithromax 500mg Tab Tri-Pak
- Zithromax 500mg Tablets
- Zithromax 500mg Sdv Inj, 1 Vial
- Zithromax 250mg Tablets
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
500 mg once daily on day 1, then 250 mg once daily on days 2-5 for a total of 5 days (e.g., for community-acquired pneumonia, pharyngitis/tonsillitis). Single 1 gram dose for uncomplicated urethritis/cervicitis.
Dose Range:
250 - 2000 mg
Condition-Specific Dosing:
Community-acquired pneumonia (CAP):
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Pharyngitis/Tonsillitis (Streptococcus pyogenes):
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic bronchitis (ABECB):
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 OR 500 mg once daily for 3 days.
Uncomplicated skin and skin structure infections:
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Uncomplicated urethritis and cervicitis (Chlamydia trachomatis):
1 gram as a single oral dose.
Genital ulcer disease (Haemophilus ducreyi):
1 gram as a single oral dose.
Acute bacterial sinusitis:
500 mg once daily for 3 days OR 2 grams as a single oral dose.
Mycobacterium avium complex (MAC) prophylaxis:
1200 mg once weekly.
Pediatric Dosing
Neonatal:
Not established (use with caution, consult specialist)
Infant:
10 mg/kg once daily for 3 days OR 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5 (max 500 mg/day). Specific dosing for otitis media: 30 mg/kg as a single dose, or 10 mg/kg once daily for 3 days, or 10 mg/kg on Day 1 then 5 mg/kg on Days 2-5.
Child:
10 mg/kg once daily for 3 days OR 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5 (max 500 mg/day). Specific dosing for otitis media: 30 mg/kg as a single dose, or 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: 12 mg/kg once daily for 5 days (max 500 mg/day).
Adolescent:
Dosing generally follows adult recommendations, adjusted for weight if necessary, or 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5 (max 500 mg/day).
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 supplemental dose needed.
Hepatic Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
Use with caution; dosage adjustment may be necessary, but specific guidelines are not well-established. Azithromycin is primarily eliminated by biliary excretion.
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 the growth of bacteria.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 37% (oral suspension)
Tmax:
2-3 hours
FoodEffect:
Food decreases Cmax by 50% and AUC by 14% for the oral suspension. It is generally recommended to take the oral suspension on an empty stomach (at least 1 hour before or 2 hours after a meal) for optimal absorption, though for some indications, it may be taken with food to minimize GI upset.
Distribution:
Vd:
31.1 L/kg (extensive tissue distribution)
ProteinBinding:
Concentration-dependent (12% at 1 mcg/mL, 52% at 0.02 mcg/mL)
CnssPenetration:
Limited (poor penetration into CSF in non-inflamed meninges)
Elimination:
HalfLife:
68 hours (terminal elimination half-life)
Clearance:
Not available (complex elimination due to extensive tissue distribution)
ExcretionRoute:
Primarily biliary excretion (approximately 50% unchanged drug), with a small amount (about 6%) excreted renally.
Unchanged:
Approximately 50% in bile, 6% in urine
Pharmacodynamics
OnsetOfAction:
Rapid (within hours of first dose)
PeakEffect:
Achieved at Tmax (2-3 hours), but tissue concentrations peak later and are sustained.
DurationOfAction:
Prolonged due to long half-life and extensive tissue distribution, allowing for once-daily dosing and shorter treatment courses (e.g., 5 days or single dose).
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 medical attention immediately:
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) - 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, watery, or bloody 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
+ 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
Like all medications, this drug may cause side effects in some people. While many individuals may not experience any side effects or only minor ones, it is essential to contact your doctor or seek medical help if you notice any of the following:
Headache
Diarrhea
Stomach pain
Upset stomach
Vomiting
These are not all the possible side effects that may occur. 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 medical attention immediately:
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) - 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, watery, or bloody 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
+ 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
Like all medications, this drug may cause side effects in some people. While many individuals may not experience any side effects or only minor ones, it is essential to contact your doctor or seek medical help if you notice any of the following:
Headache
Diarrhea
Stomach pain
Upset stomach
Vomiting
These are not all the possible side effects that may occur. 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, watery diarrhea that does not stop, especially if it occurs weeks after finishing the medication (could be C. difficile infection).
- Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, unusual tiredness, severe stomach pain, light-colored stools.
- Signs of an allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing.
- Irregular heartbeat, palpitations, dizziness, or fainting (could be a sign of a serious heart rhythm problem).
- Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) characterized by fever, sore throat, body aches, skin rash, blistering, and peeling.
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 or eyes) while taking this medication.
Certain heart conditions, such as:
+ Abnormal heartbeat patterns, 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 heartbeat patterns, including those that prolong the QT interval. There are many medications that can have this effect, so it is crucial to consult your doctor or pharmacist if you are unsure.
This list is not exhaustive, and it is vital to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or change the dosage of any medication without first consulting 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 or eyes) while taking this medication.
Certain heart conditions, such as:
+ Abnormal heartbeat patterns, 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 heartbeat patterns, including those that prolong the QT interval. There are many medications that can have this effect, so it is crucial to consult your doctor or pharmacist if you are unsure.
This list is not exhaustive, and it is vital to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
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, consult your doctor.
Myasthenia Gravis
If you have myasthenia gravis, discuss your treatment 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
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
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.
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, consult your doctor.
Myasthenia Gravis
If you have myasthenia gravis, discuss your treatment 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
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
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:
Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. Treatment is symptomatic and supportive.
Drug Interactions
Major Interactions
- Amiodarone
- Disopyramide
- Dofetilide
- Ibutilide
- Procainamide
- Quinidine
- Sotalol
- Pimozide
- Thioridazine
- Cisapride
- Colchicine (in patients with renal/hepatic impairment)
- Nelfinavir (increased azithromycin levels)
Moderate Interactions
- Antacids (aluminum/magnesium-containing)
- Warfarin
- Digoxin
- Cyclosporine
- Ergot alkaloids (e.g., ergotamine, dihydroergotamine)
- Statins (e.g., simvastatin, lovastatin - rhabdomyolysis risk)
- Fluoroquinolones (e.g., moxifloxacin, levofloxacin - additive QT prolongation)
- Other QT-prolonging drugs (e.g., tricyclic antidepressants, antipsychotics)
Minor Interactions
- Zidovudine (decreased Cmax and AUC of zidovudine metabolite)
Monitoring
Baseline Monitoring
Patient history (cardiac, hepatic, renal disease)
Rationale: To identify risk factors for adverse effects (e.g., QT prolongation, hepatotoxicity).
Timing: Prior to initiation of therapy.
Electrolytes (Potassium, Magnesium)
Rationale: To identify pre-existing electrolyte imbalances that increase risk of QT prolongation.
Timing: Prior to initiation, especially in high-risk patients.
ECG
Rationale: To assess baseline QTc interval in patients with known QT prolongation, bradycardia, heart failure, or those on other QT-prolonging drugs.
Timing: Prior to initiation in high-risk patients.
Routine Monitoring
Signs and symptoms of hepatotoxicity (e.g., jaundice, dark urine, fatigue)
Frequency: Daily during therapy and for several weeks post-therapy.
Target: Absence of symptoms
Action Threshold: Discontinue azithromycin and evaluate liver function if symptoms occur.
Signs and symptoms of C. difficile-associated diarrhea (CDAD)
Frequency: Daily during therapy and for up to 2 months post-therapy.
Target: Absence of severe, persistent diarrhea
Action Threshold: Evaluate for CDAD if severe diarrhea occurs.
ECG (QTc interval)
Frequency: Not routinely recommended for short courses in healthy individuals. Consider for high-risk patients during therapy.
Target: < 450 ms (men), < 470 ms (women)
Action Threshold: Discontinue if QTc prolongation > 500 ms or increase > 60 ms from baseline.
INR (if on warfarin)
Frequency: More frequently during and after azithromycin therapy.
Target: Therapeutic range for warfarin
Action Threshold: Adjust warfarin dose as needed.
Symptom Monitoring
- Severe or persistent diarrhea
- Abdominal pain
- Nausea
- Vomiting
- Jaundice
- Dark urine
- Unusual fatigue
- Light-colored stools
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Palpitations
- Dizziness
- Fainting spells
Special Patient Groups
Pregnancy
Azithromycin is generally considered safe for use during pregnancy (Category B). Studies in animals have not shown harm to the fetus, and human data suggest a low risk. It should be used only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk; no evidence of increased congenital malformations.
Second Trimester:
Low risk; commonly used for infections during this trimester.
Third Trimester:
Low risk; commonly used for infections, including preterm labor-related infections.
Lactation
Azithromycin is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding (L3 - Moderately Safe). Monitor the infant for potential gastrointestinal upset (diarrhea, vomiting), candidiasis (thrush, diaper rash), or allergic reactions.
Infant Risk:
Low; potential for mild GI upset or alteration of gut flora in infant. Serious adverse effects are rare.
Pediatric Use
Dosage is weight-based. Oral suspension is commonly used. Safety and efficacy in infants younger than 6 months for acute otitis media and community-acquired pneumonia have not been established. Safety and efficacy in pediatric patients under 2 years of age for pharyngitis/tonsillitis have not been established. Close monitoring for adverse effects is important.
Geriatric Use
No dosage adjustment is generally needed based on age alone. However, elderly patients may be more susceptible to QT prolongation due to age-related changes in cardiac function, pre-existing cardiac conditions, or concomitant medications. Monitor for cardiac adverse events and consider baseline ECG in high-risk elderly patients.
Clinical Information
Clinical Pearls
- Azithromycin has a very long half-life, allowing for shorter treatment courses (e.g., 3-5 days) compared to other antibiotics.
- It concentrates well in tissues, leading to sustained drug levels at the site of infection.
- While generally well-tolerated, GI upset (nausea, diarrhea, abdominal pain) is common.
- Counsel patients on the importance of completing the full course of therapy, even if symptoms improve, to prevent resistance and relapse.
- Be aware of the potential for QT prolongation, especially in patients with pre-existing cardiac conditions, electrolyte imbalances, or those on other QT-prolonging drugs.
- Azithromycin is a common cause of C. difficile-associated diarrhea (CDAD); counsel patients to report severe, persistent diarrhea.
- Unlike erythromycin and clarithromycin, azithromycin is a weak CYP3A4 inhibitor, leading to fewer significant drug interactions via this pathway, but P-gp interactions are still relevant (e.g., digoxin, colchicine).
Alternative Therapies
- Amoxicillin
- Doxycycline
- Levofloxacin
- Moxifloxacin
- Clarithromycin
- Erythromycin
- Cefdinir
- Cefpodoxime
- Penicillin V (for Strep pharyngitis)
Cost & Coverage
Average Cost:
Varies widely by pharmacy and formulation (e.g., $20-$100+ for a course of suspension) per 22.5ml bottle (200mg/5ml)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. 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 details. If you have any questions or concerns about this 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 seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.