Azithromycin 250mg Tablets 6-Pak
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 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. It's important to take all of the medication as prescribed, even if you start feeling better.
How to Use This Medicine
Taking Your Medication
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.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you are unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are any drug take-back programs in your area.
Missing 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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
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.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you are unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are any drug take-back programs in your area.
Missing 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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Complete the entire course of medication, even if symptoms improve, to prevent recurrence and development of antibiotic resistance.
- Do not take antacids containing aluminum or magnesium at the same time as azithromycin; separate by at least 2 hours.
- Avoid excessive sun exposure as azithromycin can increase sensitivity to sunlight.
- Report any signs of severe diarrhea, especially if bloody or watery, as it could indicate a serious infection (C. difficile).
- Avoid alcohol if experiencing stomach upset, though no direct interaction is known.
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:
For respiratory tract infections, 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. (Total 1.5 g)
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 2-5, or 500 mg once daily for 3 days.
Pharyngitis/Tonsillitis (Streptococcus pyogenes):
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2-5.
Acute bacterial exacerbations of chronic bronchitis (ABECB):
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2-5, 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 2-5.
Urethritis and cervicitis (Chlamydia trachomatis):
1 g as a single oral dose.
Genital ulcer disease (Haemophilus ducreyi):
1 g as a single oral dose.
Pediatric Dosing
Neonatal:
Not established for routine use; specific indications may exist under specialist guidance.
Infant:
Not established for routine use; specific indications may exist under specialist guidance.
Child:
10 mg/kg as a single dose on Day 1 (max 500 mg), followed by 5 mg/kg once daily on Days 2-5 (max 250 mg/day) for otitis media, pharyngitis/tonsillitis. For CAP: 10 mg/kg on Day 1 (max 500 mg), then 5 mg/kg on Days 2-5 (max 250 mg/day).
Adolescent:
Same as adult dosing for most indications.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary (CrCl < 10 mL/min). However, caution is advised due to limited data.
Dialysis:
Not significantly removed by hemodialysis or peritoneal dialysis. No supplemental dose needed.
Hepatic Impairment:
Mild:
No specific dosage adjustment recommended.
Moderate:
Use with caution. Monitor for signs of worsening liver function.
Severe:
Avoid use due to potential for hepatotoxicity and lack of data.
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:
Food decreases Cmax by 50% and AUC by 18% for oral suspension; for tablets, food does not significantly affect bioavailability, but it is recommended to take 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 0.05 mcg/mL)
CnssPenetration:
Limited
Elimination:
HalfLife:
68 hours (terminal elimination half-life)
Clearance:
Not available (primarily biliary excretion)
ExcretionRoute:
Biliary (major), Renal (minor)
Unchanged:
Approximately 6% (renal)
Pharmacodynamics
OnsetOfAction:
Rapid (within hours)
PeakEffect:
Not directly applicable for antibiotics (related to bacterial eradication over time)
DurationOfAction:
Prolonged due to long tissue half-life, allowing for once-daily dosing and shorter treatment courses.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 help right away:
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 accompanied by stomach pain or cramps (note: diarrhea is common with antibiotics, but rare cases of C. diff-associated diarrhea (CDAD) can occur, which may lead to life-threatening bowel problems)
Liver problems, 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 include:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the mouth, throat, nose, eyes, genitals, or any areas of skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands
Other Possible Side Effects
Most people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following symptoms or if they bother you or do not go away, 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 medical help right away:
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 accompanied by stomach pain or cramps (note: diarrhea is common with antibiotics, but rare cases of C. diff-associated diarrhea (CDAD) can occur, which may lead to life-threatening bowel problems)
Liver problems, 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 include:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the mouth, throat, nose, eyes, genitals, or any areas of skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands
Other Possible Side Effects
Most people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following symptoms or if they bother you or do not go away, 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 with fever or blood)
- Signs of allergic reaction (hives, rash, swelling of face/lips/tongue, difficulty breathing)
- Yellowing of skin or eyes (jaundice), dark urine, unusual tiredness, or abdominal pain (signs of liver problems)
- Fast, pounding, or irregular heartbeat, dizziness, or fainting (signs of heart rhythm problems)
- Severe skin rash with peeling or blistering (Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Muscle pain or weakness (rare, but could indicate rhabdomyolysis)
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 and its symptoms.
If you have previously experienced liver problems or jaundice (yellowing of the skin or eyes) 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 it is crucial to consult with 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 vital to inform your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking.
Any natural products, vitamins, or supplements you are using.
* Your complete medical history, including any health problems you have or have had in the past.
Before starting, stopping, or changing the dosage 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 and its symptoms.
If you have previously experienced liver problems or jaundice (yellowing of the skin or eyes) 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 it is crucial to consult with 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 vital to inform your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking.
Any natural products, vitamins, or supplements you are using.
* Your complete medical history, including any health problems you have or have had in the past.
Before starting, stopping, or changing the dosage of any medication, including this one, you must consult with your doctor to ensure your safety.
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 a prolonged QT interval, which may be life-threatening or fatal. If you have any questions or concerns, discuss them with your doctor.
Special Considerations
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.
Age-Related Precautions
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.
Warning: 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, discuss them with your doctor.
Special Considerations
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.
Age-Related Precautions
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
- Reversible hearing loss
What to Do:
Call 1-800-222-1222 (Poison Control). Treatment is symptomatic and supportive. Gastric lavage and general supportive measures are indicated.
Drug Interactions
Major Interactions
- Amiodarone
- Disopyramide
- Dofetilide
- Dronedarone
- Ibutilide
- Pimozide
- Procainamide
- Quinidine
- Sotalol
- Warfarin (increased INR/bleeding risk)
- Nelfinavir (increased azithromycin levels)
- Colchicine (increased colchicine levels)
Moderate Interactions
- Antacids (aluminum/magnesium-containing) - reduce absorption of azithromycin
- Cyclosporine (increased cyclosporine levels)
- Digoxin (increased digoxin levels)
- Ergot alkaloids (ergotism risk)
- Statins (potential for rhabdomyolysis, though less common than with other macrolides)
- QT-prolonging drugs (e.g., antipsychotics, tricyclic antidepressants, fluoroquinolones)
Monitoring
Baseline Monitoring
Culture and Susceptibility
Rationale: To identify the causative pathogen and confirm its susceptibility to azithromycin, guiding appropriate antibiotic selection.
Timing: Prior to initiation of therapy, if clinically indicated.
Electrolytes (Potassium, Magnesium)
Rationale: To identify baseline abnormalities that may predispose to QT prolongation.
Timing: Prior to initiation in patients at risk for arrhythmias.
ECG
Rationale: To assess baseline QTc interval in patients with known or suspected QT prolongation, bradycardia, or those on other QT-prolonging drugs.
Timing: Prior to initiation in high-risk patients.
Routine Monitoring
INR (International Normalized Ratio)
Frequency: Frequently, especially at initiation and discontinuation of azithromycin
Target: Therapeutic range for warfarin
Action Threshold: Significant deviation from target range; adjust warfarin dose as needed.
Liver Function Tests (LFTs)
Frequency: As clinically indicated, especially in patients with pre-existing hepatic impairment or prolonged therapy.
Target: Within normal limits
Action Threshold: Significant elevation; consider discontinuation if signs of hepatotoxicity develop.
ECG (QTc interval)
Frequency: As clinically indicated, especially in patients with risk factors for QT prolongation or on concomitant QT-prolonging drugs.
Target: < 450 ms (men), < 470 ms (women)
Action Threshold: QTc > 500 ms or increase of > 60 ms from baseline; consider discontinuation or alternative therapy.
Symptom Monitoring
- Diarrhea (especially severe or persistent, may indicate C. difficile infection)
- Abdominal pain
- Nausea/Vomiting
- Signs of allergic reaction (rash, itching, swelling, difficulty breathing)
- Signs of liver injury (unusual fatigue, dark urine, yellowing of skin/eyes, right upper quadrant pain)
- Signs of cardiac arrhythmia (palpitations, dizziness, fainting)
- Muscle pain or weakness (rare, but possible rhabdomyolysis)
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 fetal abnormalities. However, use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Low risk; no evidence of increased risk of major birth defects.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
Considered compatible with breastfeeding (L2). Azithromycin is excreted in human milk in low concentrations. Monitor breastfed infants for gastrointestinal disturbances (e.g., diarrhea, vomiting, candidiasis) and theoretical risk of effects on gut flora.
Infant Risk:
Low risk
Pediatric Use
Dosage adjustments are necessary based on weight and age. Safety and effectiveness have been established for pediatric patients 6 months of age and older for certain infections. Not recommended for infants younger than 6 months due to limited data.
Geriatric Use
No dosage adjustment is necessary based solely on age. However, elderly patients may be more susceptible to QT prolongation and should be monitored carefully, especially if they have pre-existing cardiac conditions or are on other QT-prolonging medications.
Clinical Information
Clinical Pearls
- Azithromycin has a very long tissue 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 in phagocytes, which contributes to its efficacy against intracellular pathogens.
- Less prone to CYP450 interactions compared to erythromycin or clarithromycin, making it a safer choice for patients on multiple medications.
- Despite its generally good safety profile, be vigilant for QT prolongation, especially in patients with pre-existing cardiac conditions, electrolyte imbalances, or concomitant use of other QT-prolonging drugs.
- Always consider C. difficile-associated diarrhea (CDAD) in patients presenting with diarrhea after antibiotic use, even after a short course of azithromycin.
- The 6-pak of 250mg tablets is commonly used for the 5-day course (500mg Day 1, then 250mg Days 2-5, total 1.5g or 6 tablets).
Alternative Therapies
- Amoxicillin
- Doxycycline
- Levofloxacin
- Moxifloxacin
- Clarithromycin
- Erythromycin
- Cefdinir
- Cefuroxime
Cost & Coverage
Average Cost:
$10 - $50 per 6 x 250mg tablets (generic)
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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.