Zithromax 200mg Sus 30ml(yellow Bx)

Manufacturer PFIZER U.S. Active Ingredient Azithromycin Oral Suspension(az ith roe MYE sin) Pronunciation az ith roe MYE sin
It is used to treat or prevent bacterial infections.
đŸˇī¸
Drug Class
Antibiotic
đŸ§Ŧ
Pharmacologic Class
Macrolide Antibiotic
🤰
Pregnancy Category
Category B
✅
FDA Approved
Nov 1991
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Azithromycin is an antibiotic used to treat various bacterial infections, such as ear infections, strep throat, pneumonia, and certain sexually transmitted infections. It works by stopping the growth of bacteria. It's important to take the full course of medication as prescribed, 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 out of 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 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 and ensure the lid is tightly closed.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember.
If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed one.
💡

Lifestyle & Tips

  • Take exactly as prescribed, do not skip doses or stop early.
  • Oral suspension should be taken on an empty stomach (1 hour before or 2 hours after food) for best absorption, though taking with food may reduce stomach upset.
  • Shake the oral suspension well before each use.
  • Use the provided measuring device for accurate dosing.
  • Do not take antacids containing aluminum or magnesium at the same time; separate by at least 1-2 hours.
  • Avoid excessive sun exposure as azithromycin can increase sun sensitivity.
  • Stay hydrated, especially if experiencing diarrhea.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Varies by indication. Common: 500 mg on Day 1, then 250 mg once daily on Days 2-5 (total 1.5 g) for respiratory tract infections. Or single 1 g dose for certain STIs.
Dose Range: 250 - 2000 mg

Condition-Specific Dosing:

Community-acquired pneumonia (CAP): 500 mg single dose on Day 1, then 250 mg once daily on Days 2-5.
Pharyngitis/Tonsillitis (streptococcal): 500 mg single dose on Day 1, then 250 mg once daily on Days 2-5.
Acute bacterial exacerbations of chronic bronchitis (ABECB): 500 mg single dose on Day 1, then 250 mg once daily on Days 2-5 OR 500 mg once daily for 3 days.
Uncomplicated skin and skin structure infections: 500 mg single dose on Day 1, then 250 mg once daily on Days 2-5.
Urethritis and cervicitis (Chlamydia trachomatis): 1 g single oral dose.
Genital ulcer disease (Chancroid): 1 g single oral dose.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established for routine use; specific indications (e.g., neonatal conjunctivitis due to Chlamydia) may use 20 mg/kg/day for 3 days, but generally avoided due to risk of infantile hypertrophic pyloric stenosis (IHPS).
Infant: For otitis media (â‰Ĩ6 months): 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. For pharyngitis/tonsillitis (â‰Ĩ2 years): 12 mg/kg once daily for 5 days (max 500 mg/day).
Child: For otitis media (â‰Ĩ6 months): 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. For pharyngitis/tonsillitis (â‰Ĩ2 years): 12 mg/kg once daily for 5 days (max 500 mg/day). For CAP (â‰Ĩ6 months): 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5.
Adolescent: Dosing generally follows adult recommendations for weight >45 kg. For weight-based dosing, refer to pediatric guidelines.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl >10 mL/min).
Moderate: No adjustment needed (CrCl >10 mL/min).
Severe: No specific dose adjustment recommendations for severe renal impairment (CrCl <10 mL/min) in the package insert, but caution is advised. Limited data available.
Dialysis: Not significantly removed by hemodialysis or peritoneal dialysis. No specific recommendations, use with caution.

Hepatic Impairment:

Mild: No adjustment.
Moderate: No adjustment.
Severe: Use with caution. Azithromycin is primarily eliminated by the liver. Patients with severe hepatic impairment should be monitored for signs of hepatic dysfunction.

Pharmacology

đŸ”Ŧ

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 Cmax by 50% and AUC by 14% for oral suspension. It is generally recommended to take oral suspension on an empty stomach (at least 1 hour before or 2 hours after a meal) for optimal absorption, though some indications may allow with food to reduce GI upset.

Distribution:

Vd: 31.1 L/kg (extensive tissue distribution)
ProteinBinding: Concentration-dependent (12% at 0.02 mcg/mL, 52% at 1 mcg/mL)
CnssPenetration: Limited (low concentrations in CSF, but clinically relevant for some CNS infections)

Elimination:

HalfLife: 68 hours (terminal elimination half-life)
Clearance: Not readily available as a single value due to extensive tissue distribution and slow elimination.
ExcretionRoute: Primarily biliary excretion (50% unchanged in feces); minor renal excretion (6-11% unchanged in urine).
Unchanged: Approximately 6% (urine), 50% (feces)
âąī¸

Pharmacodynamics

OnsetOfAction: Rapid (within hours of first dose)
PeakEffect: Achieved at Tmax (2-3 hours), but tissue concentrations peak later and persist for days.
DurationOfAction: Due to extensive tissue distribution and slow release, antibacterial effects persist for several days after the last dose (long post-antibiotic effect).

Safety & Warnings

âš ī¸

Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Chest pain or pressure
Fast heartbeat or abnormal heartbeat
Dizziness or fainting
Changes in hearing
Fever
Changes in eyesight
Diarrhea, especially if it is severe, bloody, or watery (note: diarrhea is a common side effect of antibiotics, but rare cases of C. diff-associated diarrhea (CDAD) can be severe and potentially life-threatening)
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
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which can affect body organs and be life-threatening
+ Signs of severe skin 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

Most people do not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

Headache
Diarrhea
Stomach pain
Upset stomach
Vomiting

Reporting Side Effects

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 bloody diarrhea (may occur up to several months after treatment)
  • Severe stomach pain or cramping
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine
  • Unusual tiredness or weakness
  • 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 or eyes) while taking this medication.
Certain health conditions, such as:
+ Abnormal heart rhythms, including a prolonged QTc interval on an electrocardiogram (ECG) or other irregular heartbeats.
+ Slow heartbeat or 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, 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, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine whether it is safe to take this medication in combination with your other treatments and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
âš ī¸

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 may be life-threatening or fatal. If you have any questions or concerns, consult your doctor.

Myasthenia Gravis
If you have myasthenia gravis, discuss your 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
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 911 or your local poison control center (1-800-222-1222 in the US) immediately. Seek emergency medical attention. Treatment is symptomatic and supportive.

Drug Interactions

🔴

Major Interactions

  • QT prolonging drugs (e.g., Class IA and III antiarrhythmics, cisapride, pimozide, terfenadine, astemizole, some antipsychotics, tricyclic antidepressants, fluoroquinolones, antifungals) - increased risk of Torsades de Pointes.
  • Nelfinavir - significantly increases azithromycin concentrations, monitor for adverse effects.
🟡

Moderate Interactions

  • Antacids (containing aluminum or magnesium) - decrease peak serum levels of azithromycin; administer azithromycin at least 1 hour before or 2 hours after antacids.
  • Warfarin - increased anticoagulant effect (monitor INR).
  • Digoxin - increased serum digoxin levels (monitor digoxin levels).
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - theoretical risk of acute ergot toxicity (vasospasm with peripheral ischemia and dysesthesia); avoid concomitant use.
  • Cyclosporine - increased cyclosporine levels (monitor cyclosporine levels).
  • Statins (e.g., atorvastatin, simvastatin) - theoretical risk of rhabdomyolysis due to potential inhibition of CYP3A4, though azithromycin is a weak inhibitor. Monitor for myopathy.
đŸŸĸ

Minor Interactions

  • Zidovudine - increased phosphorylation of zidovudine's active metabolite (clinical significance uncertain).
  • Carbamazepine - no significant interaction, but monitor levels if co-administered.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Baseline ECG (if risk factors for QT prolongation)

Rationale: To assess baseline QT interval in patients with pre-existing cardiac conditions, electrolyte imbalances, or on other QT-prolonging medications.

Timing: Prior to initiation, especially in high-risk patients.

Liver function tests (LFTs)

Rationale: To assess baseline hepatic function, especially in patients with pre-existing liver disease, given azithromycin's hepatic elimination.

Timing: Prior to initiation in patients with suspected or known hepatic impairment.

📊

Routine Monitoring

Signs and symptoms of C. difficile-associated diarrhea (CDAD)

Frequency: Throughout therapy and for up to several months post-therapy.

Target: Absence of severe diarrhea, abdominal pain, fever.

Action Threshold: If severe, persistent diarrhea occurs, discontinue azithromycin and initiate appropriate treatment.

Signs and symptoms of hepatotoxicity (e.g., jaundice, dark urine, fatigue, abdominal pain)

Frequency: Periodically during prolonged therapy or in patients with hepatic impairment.

Target: Normal liver function.

Action Threshold: Discontinue azithromycin if signs/symptoms of liver injury 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: If QTc prolongation occurs, consider discontinuing azithromycin or managing risk factors.

INR (for patients on warfarin)

Frequency: More frequently during and after azithromycin therapy.

Target: Therapeutic INR range for the patient's indication.

Action Threshold: Adjust warfarin dose as needed to maintain target INR.

đŸ‘ī¸

Symptom Monitoring

  • Diarrhea (especially severe or bloody)
  • Abdominal pain
  • Nausea/Vomiting
  • Rash or itching (signs of allergic reaction)
  • Swelling of face, lips, tongue, or throat (angioedema)
  • Difficulty breathing or swallowing
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Unusual fatigue or weakness
  • Palpitations or irregular heartbeat
  • Dizziness or fainting

Special Patient Groups

🤰

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. Generally considered safe for use during pregnancy when clearly needed, especially for specific infections like Chlamydia.

Trimester-Specific Risks:

First Trimester: Low risk, often used for Chlamydia treatment.
Second Trimester: Low risk.
Third Trimester: Low risk.
🤱

Lactation

L3 (Moderately safe). Azithromycin is excreted in human milk in low concentrations. While generally considered compatible with breastfeeding, monitor breastfed infants for potential gastrointestinal disturbances (e.g., diarrhea, vomiting, candidiasis) and theoretical risk of effects on infant gut flora.

Infant Risk: Low to moderate. Potential for mild GI upset in infant. Risk of altering infant gut flora is theoretical but generally not a major concern with short courses.
đŸ‘ļ

Pediatric Use

Dosing is weight-based and varies by indication. Caution advised in infants younger than 6 months due to potential association with infantile hypertrophic pyloric stenosis (IHPS), particularly with erythromycin, but also reported with azithromycin. Benefits must outweigh risks.

👴

Geriatric Use

No overall differences in safety or effectiveness observed between elderly and younger patients. However, elderly patients may be more susceptible to QT prolongation and Torsades de Pointes, especially if they have pre-existing cardiac conditions or are on other QT-prolonging medications. Monitor carefully.

Clinical Information

💎

Clinical Pearls

  • Azithromycin has a very long half-life, allowing for once-daily dosing and shorter treatment durations (e.g., 3-day or 5-day courses, or single dose).
  • Known for its excellent tissue penetration and accumulation in phagocytes, leading to high concentrations at infection sites.
  • Commonly causes GI upset (nausea, diarrhea, abdominal pain); taking with food may help, but may reduce absorption of the oral suspension.
  • Important to counsel patients on the risk of C. difficile-associated diarrhea, which can occur even weeks after completing therapy.
  • While generally well-tolerated, be mindful of the rare but serious risks of QT prolongation, Torsades de Pointes, and hepatotoxicity, especially in susceptible patients.
  • Not effective against viral infections.
🔄

Alternative Therapies

  • Other macrolides (e.g., erythromycin, clarithromycin)
  • Beta-lactam antibiotics (e.g., amoxicillin, amoxicillin/clavulanate, cephalexin)
  • Tetracyclines (e.g., doxycycline)
  • Fluoroquinolones (e.g., levofloxacin, moxifloxacin)
  • Clindamycin
💰

Cost & Coverage

Average Cost: Varies widely by pharmacy and formulation (e.g., $20-$100+ for a typical course of oral suspension) per 30ml (200mg/5ml) bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for 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 this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened.