Azithromycin 250mg Tablets
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, skin infections, and some 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, take it exactly as directed by your doctor. 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 with your doctor or pharmacist.
It's essential to continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well. This will help ensure that you receive the full benefits of the treatment.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, avoiding the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method, or look into drug take-back programs in your area.
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 the missed one.
To get the most benefit from your medication, take it exactly as directed by your doctor. 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 with your doctor or pharmacist.
It's essential to continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well. This will help ensure that you receive the full benefits of the treatment.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, avoiding the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method, or look into drug take-back programs in your area.
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 the missed one.
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.
- Do not share your medication with others.
- Avoid antacids containing aluminum or magnesium within 1-2 hours of taking azithromycin.
- If you miss a dose, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and continue your regular schedule. Do not double dose.
Available Forms & Alternatives
Available Strengths:
- Azithromycin 500mg Inj, 1 Vial
- Azithromycin 1gm Pak Powder
- Azithromycin 600mg Tablets
- Azithromycin 200mg/5ml Susp 15ml
- Azithromycin 200mg/5ml Susp 30ml
- Azithromycin 200mg/5ml Susp 22.5ml
- Azithromycin 100mg/5ml Susp 15ml
- Azithromycin 500mg Sdv Inj, 1 Vial
- Azithromycin 250mg Tablets 6-Pak
- Azithromycin 600mg Tablets
- Azithromycin 500mg Tablets Tri-Pack
- Azithromycin 250mg Tablets
- Azithromycin 500mg Tablets
- Azithromycin 600mg Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. E.g., 500 mg once on Day 1, then 250 mg once daily on Days 2-5 for respiratory tract infections; 1000 mg single dose for uncomplicated urethritis/cervicitis.
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 (Streptococcus pyogenes):
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/Skin Structure Infections:
500 mg single dose on Day 1, then 250 mg once daily on Days 2-5.
Uncomplicated Urethritis/Cervicitis (Chlamydia trachomatis):
1000 mg single oral dose.
Genital Ulcer Disease (Chancroid):
1000 mg single oral dose.
Acute Otitis Media:
500 mg single dose on Day 1, then 250 mg once daily on Days 2-5 OR 500 mg once daily for 3 days OR 1500 mg as a single dose.
Pediatric Dosing
Neonatal:
Not established for routine use; use with caution and specific guidance for ophthalmia neonatorum or pneumonia due to C. trachomatis.
Infant:
Dosing for specific indications (e.g., otitis media, pharyngitis) based on weight. E.g., 10 mg/kg once daily for 3 days or 12 mg/kg once daily for 5 days.
Child:
10 mg/kg (max 500 mg) on Day 1, then 5 mg/kg (max 250 mg) on Days 2-5 for most infections. For pharyngitis/tonsillitis (strep), 12 mg/kg once daily for 5 days (max 500 mg/day).
Adolescent:
Adult dosing applies for most indications.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary, but caution is advised due to limited data (CrCl < 10 mL/min).
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. Azithromycin is primarily eliminated by the liver.
Pharmacology
Mechanism of Action
Azithromycin is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, thereby preventing the translocation of peptide chains. This leads to a bacteriostatic effect, although it can be bactericidal at high concentrations against susceptible organisms.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 37%
Tmax:
2-3 hours
FoodEffect:
Food decreases Cmax by 50% and AUC by 18% for the 250 mg tablet; however, the 500 mg tablet can be taken with or without food. Oral suspension absorption is increased with food.
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 (low CSF concentrations, but achieves therapeutic levels in brain tissue in some studies)
Elimination:
HalfLife:
68 hours (terminal half-life)
Clearance:
Not available (primarily biliary excretion)
ExcretionRoute:
Primarily biliary excretion of unchanged drug and metabolites; minor renal excretion (approximately 6% of dose)
Unchanged:
Approximately 6% (renal)
Pharmacodynamics
OnsetOfAction:
Rapid (within hours for antibacterial effect)
PeakEffect:
2-3 hours (plasma concentration); tissue concentrations peak later and are sustained.
DurationOfAction:
Due to extensive tissue distribution and slow release, antibacterial effects persist for several days after the last 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 accompanied by stomach pain or cramps (note: diarrhea is a common side effect of antibiotics, but in rare cases, it can lead to a severe condition called C. diff-associated diarrhea, which may be life-threatening)
Signs of liver problems, such as:
+ 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 do not experience severe side effects, and some may only have minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
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 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 accompanied by stomach pain or cramps (note: diarrhea is a common side effect of antibiotics, but in rare cases, it can lead to a severe condition called C. diff-associated diarrhea, which may be life-threatening)
Signs of liver problems, such as:
+ 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 do not experience severe side effects, and some may only have minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
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 watery diarrhea (may occur up to 2 months after stopping the medication)
- Abdominal cramps or pain
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Unusual tiredness or weakness
- Nausea or vomiting that is severe or persistent
- Fast, pounding, or irregular heartbeat
- Dizziness or fainting
- Severe skin rash, blistering, or peeling
- Swelling of the face, lips, tongue, or throat
- Difficulty breathing or swallowing
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you have previously experienced liver problems or jaundice (yellowing of the skin and eyes) while taking this medication.
Certain heart conditions, such as:
+ Abnormal heart rhythms, including a prolonged QTc interval on an electrocardiogram (ECG) or other irregular heartbeats.
+ Slow heartbeat.
+ Low levels of potassium or magnesium in your blood.
+ 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 your doctor or pharmacist if you are unsure.
This list is not exhaustive, and it is vital to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication in combination with your other treatments and health status. Never start, stop, or adjust 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 and eyes) while taking this medication.
Certain heart conditions, such as:
+ Abnormal heart rhythms, including a prolonged QTc interval on an electrocardiogram (ECG) or other irregular heartbeats.
+ Slow heartbeat.
+ Low levels of potassium or magnesium in your blood.
+ 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 your doctor or pharmacist if you are unsure.
This list is not exhaustive, and it is vital to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication in combination with your other treatments and health status. Never start, stop, or adjust 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, 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
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, this medication can cause 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, 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
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, this medication can cause 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 911 or Poison Control (1-800-222-1222) immediately. Treatment is symptomatic and supportive. Gastric lavage and general supportive measures are indicated.
Drug Interactions
Major Interactions
- Nelfinavir (increased azithromycin levels)
- Warfarin (increased INR/bleeding risk)
- QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, cisapride, pimozide, terfenadine, astemizole, some antipsychotics, some antidepressants, fluoroquinolones, antifungals) - increased risk of Torsades de Pointes.
- Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - theoretical risk of ergotism (though less than with erythromycin/clarithromycin).
Moderate Interactions
- Antacids (aluminum/magnesium-containing) - decreased azithromycin peak serum levels (administer azithromycin at least 1 hour before or 2 hours after antacid).
- Digoxin (increased digoxin levels)
- Colchicine (increased colchicine exposure)
- Cyclosporine (increased cyclosporine levels)
- Statins (e.g., simvastatin, lovastatin) - theoretical increased risk of myopathy/rhabdomyolysis (less significant than with other macrolides).
Minor Interactions
- Zidovudine (increased zidovudine phosphorylation)
Monitoring
Baseline Monitoring
Patient history (cardiac, hepatic, renal, electrolyte imbalances)
Rationale: To identify risk factors for adverse effects (e.g., QT prolongation, liver injury).
Timing: Prior to initiation of therapy.
Baseline ECG
Rationale: Consider for patients with known QT prolongation, uncorrected hypokalemia/hypomagnesemia, clinically significant bradycardia, or receiving other QT-prolonging drugs.
Timing: Prior to initiation, if risk factors present.
Routine Monitoring
Signs/symptoms of C. difficile-associated diarrhea (CDAD)
Frequency: Daily during and after therapy
Target: Absence of severe diarrhea, abdominal pain, fever.
Action Threshold: If severe, persistent diarrhea occurs, discontinue azithromycin and initiate appropriate therapy.
Signs/symptoms of hepatotoxicity (e.g., fatigue, anorexia, dark urine, jaundice, tender right upper quadrant)
Frequency: As clinically indicated
Target: Absence of symptoms.
Action Threshold: Discontinue azithromycin if signs/symptoms of hepatitis occur.
ECG monitoring (QTc interval)
Frequency: As clinically indicated, especially in high-risk patients
Target: QTc < 450 ms (men), < 470 ms (women)
Action Threshold: Discontinue azithromycin if significant QT prolongation or arrhythmias occur.
INR (for patients on warfarin)
Frequency: More frequently during and after azithromycin therapy
Target: Therapeutic range for indication
Action Threshold: Adjust warfarin dose as needed to maintain INR within target range.
Symptom Monitoring
- Severe or persistent diarrhea
- Abdominal pain
- Nausea
- Vomiting
- Headache
- Dizziness
- Fatigue
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Light-colored stools
- Unusual bleeding or bruising
- Palpitations or irregular heartbeat
- Chest pain
- Shortness of breath
- Rash
- Swelling of face, lips, tongue, or throat (signs of allergic reaction)
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.
Trimester-Specific Risks:
First Trimester:
No evidence of increased risk of congenital anomalies.
Second Trimester:
No evidence of increased risk of congenital anomalies.
Third Trimester:
No evidence of increased risk of congenital anomalies.
Lactation
Considered compatible with breastfeeding. Azithromycin is excreted in human milk in small amounts. Monitor breastfed infant for gastrointestinal disturbances (e.g., diarrhea, vomiting, candidiasis) and rash.
Infant Risk:
Low risk of adverse effects to the breastfed infant.
Pediatric Use
Dosing is weight-based for most pediatric indications. Safety and effectiveness have been established for children 6 months and older for certain infections. Not recommended for infants younger than 6 months for acute otitis media or pharyngitis/tonsillitis.
Geriatric Use
No dosage adjustment is necessary based on age alone. However, elderly patients may be more susceptible to drug-associated QT interval prolongation and should be monitored for cardiac events and pre-existing conditions.
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 achieves high concentrations in tissues and phagocytes, which contributes to its prolonged post-antibiotic effect.
- While generally well-tolerated, GI upset (nausea, diarrhea, abdominal pain) is common.
- Counsel patients on the importance of completing the full course to prevent resistance, even if symptoms improve quickly.
- 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; educate patients on symptoms and to seek medical attention if severe diarrhea occurs.
Alternative Therapies
- Amoxicillin
- Doxycycline
- Levofloxacin
- Moxifloxacin
- Clarithromycin
- Erythromycin
- Cefdinir
- Cefuroxime
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets
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 for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about 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 medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.