Zithromax 100mg Susp 15ml(green 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.
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Drug Class
Antibiotic
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Pharmacologic Class
Macrolide antibiotic
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Pregnancy Category
Category B
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FDA Approved
Nov 1991
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Azithromycin is an antibiotic medication used to treat various bacterial infections, such as respiratory infections (like bronchitis or pneumonia), skin infections, ear infections, and certain sexually transmitted infections. It works by stopping the growth of bacteria.
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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 that contain 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 instructed by your doctor or healthcare provider, even if you start to feel better.

Measuring and Administering Your Medication

Before using the liquid form of this medication, shake the bottle well.
Measure liquid doses carefully using the measuring device provided with the medication. If a device is not included, ask your pharmacist for a suitable measuring device.

Storing and Disposing of Your Medication

Store the liquid (suspension) form of this medication 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.
However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take the medication exactly as prescribed by your doctor. Do not skip doses or stop taking it early, even if you feel better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
  • Shake the oral suspension well before each use.
  • Use the provided measuring device (oral syringe or spoon) to ensure an accurate dose.
  • Azithromycin oral suspension can be taken with or without food.
  • Do not share this medication with others.
  • Avoid antacids containing aluminum or magnesium within 2 hours before or 4 hours after taking azithromycin.
  • Stay hydrated, especially if experiencing diarrhea.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. E.g., 500mg once daily for 3 days OR 500mg on day 1, then 250mg once daily for 4 days.
Dose Range: 250 - 2000 mg

Condition-Specific Dosing:

Community-Acquired Pneumonia (CAP): 500mg as a single dose on Day 1, then 250mg once daily on Days 2-5.
Pharyngitis/Tonsillitis (Streptococcus pyogenes): 500mg as a single dose on Day 1, then 250mg once daily on Days 2-5.
Acute Bacterial Exacerbation of COPD: 500mg once daily for 3 days OR 500mg as a single dose on Day 1, then 250mg once daily on Days 2-5.
Uncomplicated Skin/Skin Structure Infections: 500mg as a single dose on Day 1, then 250mg once daily on Days 2-5.
Urethritis/Cervicitis (Chlamydia trachomatis): 1000mg as a single oral dose.
Chancroid (Haemophilus ducreyi): 1000mg as a single oral dose.
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Pediatric Dosing

Neonatal: Not established for routine use; use with caution for specific indications (e.g., pertussis exposure prophylaxis) under expert guidance. Dosing typically 10 mg/kg/day for 5 days.
Infant: 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. Max 500mg/day. For Pharyngitis/Tonsillitis: 12 mg/kg once daily for 5 days. Max 500mg/day.
Child: Same as infant dosing, weight-based. For CAP: 10 mg/kg as a single dose on Day 1, then 5 mg/kg on Days 2-5. Max 500mg/day.
Adolescent: Same as adult dosing, or weight-based if still in pediatric weight range. Max 500mg/day for multi-day regimens, 1000mg for single dose.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment necessary (CrCl > 10 mL/min).
Moderate: No dosage adjustment necessary (CrCl > 10 mL/min).
Severe: No specific dosage adjustment recommendations for CrCl < 10 mL/min, but caution is advised due to limited data. Monitor for adverse effects.
Dialysis: Not significantly removed by hemodialysis or peritoneal dialysis. No supplemental dose needed after dialysis.

Hepatic Impairment:

Mild: No dosage adjustment necessary.
Moderate: No dosage adjustment necessary.
Severe: Use with caution; azithromycin is primarily eliminated by the liver. Monitor for signs of hepatic dysfunction. Dosage adjustment not specifically defined, but may be considered.

Pharmacology

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Mechanism of Action

Azithromycin binds to the 50S ribosomal subunit of susceptible microorganisms, thereby inhibiting bacterial protein synthesis. It does not affect nucleic acid synthesis. This action is typically bacteriostatic, but can be bactericidal at high concentrations against certain organisms.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 37% (oral capsule/tablet). Oral suspension bioavailability is similar or slightly higher.
Tmax: 2-3 hours (oral suspension).
FoodEffect: For oral suspension, food (high-fat meal) increases Cmax by 56% and AUC by 46%. For tablets, food decreases Cmax but does not significantly affect AUC. For optimal absorption of the suspension, it can be taken with or without food.

Distribution:

Vd: Extremely large, approximately 31 L/kg, indicating extensive tissue distribution.
ProteinBinding: Variable, 7% to 50%, decreasing with increasing concentrations.
CnssPenetration: Limited penetration into the cerebrospinal fluid (CSF) in non-inflamed meninges. Higher concentrations may be achieved with inflamed meninges.

Elimination:

HalfLife: Terminal elimination half-life is 2-4 days (due to extensive tissue distribution and slow release from tissues).
Clearance: Not readily quantifiable due to extensive tissue distribution.
ExcretionRoute: Primarily biliary excretion of unchanged drug and metabolites. A small amount is excreted renally (approximately 6% of the dose).
Unchanged: Approximately 6% of the administered dose is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Rapid, within hours of administration.
PeakEffect: Peak plasma concentrations reached in 2-3 hours, but tissue concentrations peak later and are significantly higher than plasma levels.
DurationOfAction: Due to its long half-life and extensive tissue distribution, antibacterial effects persist for several days after the last dose, allowing for short treatment courses.
Note: Pharmacodynamics are best described by the ratio of the area under the concentration-time curve to the minimum inhibitory concentration (AUC/MIC) and peak concentration to MIC (Cmax/MIC).

Safety & Warnings

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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 accompanied by stomach pain or cramps (a rare but potentially life-threatening condition called C. diff-associated diarrhea, or CDAD, may occur)
Liver problems, which may be 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 also affect internal organs
+ Signs of these reactions may include:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the mouth, throat, nose, eyes, genitals, or skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands

Other Possible Side Effects

Most people experience either no side effects or only mild side effects while taking this medication. However, if you notice any of the following symptoms or if they persist or bother you, contact your doctor or seek medical attention:

Headache
Diarrhea
Stomach pain
Upset stomach
* Vomiting

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe, watery diarrhea or bloody stools (may occur up to 2 months after stopping the medication)
  • New or worsening rash, blistering, or peeling skin
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine or pale stools
  • Severe stomach pain or nausea/vomiting
  • Unusual tiredness or weakness
  • Fast, pounding, or irregular heartbeat
  • Severe dizziness or fainting spells
  • Swelling of the face, lips, tongue, or throat (signs of allergic reaction)
  • Difficulty breathing or swallowing
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have previously experienced liver problems or jaundice (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 (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, such as those that prolong the QT interval. There are many medications that can have this effect, so be sure to ask your doctor or pharmacist if you are unsure.

To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins
Any health problems you have

This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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
In newborns taking this medication, a severe stomach problem can occur. If your child vomits or becomes irritable during feeding, contact your doctor immediately.
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Overdose Information

Overdose Symptoms:

  • Severe nausea
  • Vomiting
  • Diarrhea
  • Reversible hearing loss

What to Do:

In case of suspected overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is symptomatic and supportive. Gastric lavage and general supportive measures are indicated.

Drug Interactions

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Contraindicated Interactions

  • Pimozide (risk of QT prolongation and ventricular arrhythmias)
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Major Interactions

  • QT-prolonging drugs (e.g., amiodarone, sotalol, quinidine, disopyramide, dofetilide, cisapride, terfenadine, astemizole, some antipsychotics like thioridazine, some fluoroquinolones like moxifloxacin, tricyclic antidepressants)
  • Warfarin (increased anticoagulant effect, monitor INR)
  • Nelfinavir (increased azithromycin serum concentrations)
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine - risk of acute ergot toxicity)
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Moderate Interactions

  • Antacids containing aluminum or magnesium (decreased azithromycin peak serum concentrations, administer azithromycin at least 2 hours before or 4 hours after antacids)
  • Digoxin (increased digoxin serum concentrations)
  • Cyclosporine (increased cyclosporine serum concentrations)
  • Colchicine (increased colchicine exposure)
  • Statins (e.g., simvastatin, lovastatin - theoretical increased risk of myopathy/rhabdomyolysis, though less significant than with other macrolides)
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Minor Interactions

  • Zidovudine (increased zidovudine phosphorylation to its active metabolite in peripheral blood mononuclear cells, clinical significance uncertain)

Monitoring

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Baseline Monitoring

Liver Function Tests (LFTs)

Rationale: To assess baseline hepatic function, especially in patients with pre-existing liver disease, as azithromycin is primarily eliminated by the liver.

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

Electrocardiogram (ECG)

Rationale: To assess baseline QT interval, especially in patients with known QT prolongation, risk factors for QT prolongation (e.g., uncorrected hypokalemia or hypomagnesemia, bradycardia, heart failure), or those receiving other QT-prolonging medications.

Timing: Prior to initiation in at-risk patients.

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Routine Monitoring

INR (International Normalized Ratio)

Frequency: Regularly, especially during and after azithromycin therapy

Target: Therapeutic range for warfarin

Action Threshold: If INR is outside target range, adjust warfarin dose and monitor more frequently.

Signs and Symptoms of Hepatotoxicity

Frequency: Daily during therapy and for several weeks post-therapy

Target: N/A

Action Threshold: If signs (e.g., jaundice, dark urine, severe fatigue, abdominal pain) occur, discontinue azithromycin and perform LFTs.

Signs and Symptoms of QT Prolongation/Arrhythmias

Frequency: Daily during therapy

Target: N/A

Action Threshold: If symptoms (e.g., palpitations, dizziness, syncope) occur, perform ECG and consider discontinuation.

Signs and Symptoms of Clostridioides difficile-associated diarrhea (CDAD)

Frequency: Daily during therapy and for up to 2 months post-therapy

Target: N/A

Action Threshold: If severe, persistent diarrhea and abdominal pain occur, test for C. difficile and initiate appropriate treatment.

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Symptom Monitoring

  • Diarrhea (especially severe or bloody)
  • Abdominal pain or cramping
  • Nausea
  • Vomiting
  • Rash or severe skin reactions (e.g., Stevens-Johnson syndrome, DRESS syndrome)
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Pale stools
  • Unusual fatigue or weakness
  • Irregular heartbeat or palpitations
  • Dizziness or lightheadedness
  • Fainting (syncope)
  • Hearing changes (rare, usually reversible)

Special Patient Groups

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Pregnancy

Azithromycin is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. It is generally considered safe for use during pregnancy when clearly indicated and the benefits outweigh the potential risks.

Trimester-Specific Risks:

First Trimester: No increased risk of congenital malformations observed in human studies.
Second Trimester: Generally considered safe; often used for specific infections (e.g., chlamydia).
Third Trimester: Generally considered safe; often used for specific infections (e.g., chlamydia, preterm labor prophylaxis in some cases).
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Lactation

Azithromycin is excreted in human milk in small amounts. The American Academy of Pediatrics considers azithromycin to be compatible with breastfeeding. Monitor breastfed infants for potential gastrointestinal disturbances (e.g., diarrhea, vomiting, candidiasis) or rash.

Infant Risk: Low risk. Potential for mild gastrointestinal upset in the infant. Long-term effects are unknown.
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Pediatric Use

Widely used in pediatric populations for various bacterial infections. Dosing is weight-based. Safety and efficacy established for children 6 months and older for specific indications. Use in neonates and infants younger than 6 months is generally limited to specific, severe infections due to limited data and potential for infantile hypertrophic pyloric stenosis (IHPS) with macrolides (though less reported with azithromycin than erythromycin).

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Geriatric Use

No specific dosage adjustment is required based solely on age. However, elderly patients may be at increased risk for QT prolongation and Torsades de Pointes, especially if they have pre-existing cardiac conditions or are on other QT-prolonging medications. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Azithromycin's long half-life allows for shorter treatment courses (e.g., 3-day or 5-day regimens) and once-daily dosing, which can improve patient adherence.
  • It achieves high concentrations in tissues and phagocytes, leading to sustained antibacterial activity even after plasma levels decline.
  • While generally well-tolerated, it carries a risk of QT prolongation, particularly in patients with pre-existing cardiac conditions, electrolyte imbalances, or concurrent use of other QT-prolonging drugs. An ECG should be considered in at-risk patients.
  • Like all antibiotics, azithromycin can cause Clostridioides difficile-associated diarrhea (CDAD), ranging from mild diarrhea to fatal colitis. This can occur during or up to 2 months after therapy.
  • Azithromycin is not effective against viral infections (e.g., common cold, flu). Prescribing for viral infections contributes to antibiotic resistance.
  • The oral suspension should be shaken well before each use and measured accurately with a dosing syringe or spoon, not a household spoon.
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Alternative Therapies

  • Other macrolides (e.g., clarithromycin, erythromycin)
  • Beta-lactam antibiotics (e.g., amoxicillin, amoxicillin/clavulanate, penicillin, cephalexin)
  • Tetracyclines (e.g., doxycycline, minocycline)
  • Fluoroquinolones (e.g., levofloxacin, moxifloxacin - generally reserved for specific indications due to broader spectrum and potential for serious side effects)
  • Lincosamides (e.g., clindamycin)
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Cost & Coverage

Average Cost: Not available Varies by concentration and volume
Generic Available: Yes
Insurance Coverage: Typically Tier 1 or Tier 2 for generic; Tier 3 or higher for brand.
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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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.