Zithromax 200mg Sus 15ml(purple 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
Macrolide Antibiotic
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Pharmacologic Class
Macrolide Antibacterial
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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 medicine used to treat various bacterial infections, such as ear infections, strep throat, pneumonia, and some skin infections. It works by stopping the growth of bacteria.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. However, do not take antacids containing magnesium or aluminum at the same time as this medication. If you have any questions, consult your doctor or pharmacist.

Continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling better. Before using the liquid form, shake the bottle well. To ensure accurate dosing, measure the liquid carefully using the measuring device that comes with the medication. If no device is provided, ask your pharmacist for a suitable measuring tool.

Storing and Disposing of Your Medication

Store the liquid suspension at room temperature or in the refrigerator. Discard any unused portion after 10 days. Keep the medication in its original container, making sure the lid is tightly closed.

Missing 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.
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Lifestyle & Tips

  • Take the medicine exactly as prescribed, even if you feel better, to ensure the infection is fully treated and to prevent antibiotic resistance.
  • Do not take antacids containing aluminum or magnesium within 2 hours of taking azithromycin oral suspension.
  • Shake the oral suspension well before each use.
  • Use the provided measuring device (oral syringe or spoon) for accurate dosing.
  • Store at room temperature, away from moisture and heat.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by infection. E.g., Community-acquired pneumonia: 500 mg on Day 1, then 250 mg once daily on Days 2-5. Pharyngitis/Tonsillitis: 500 mg once daily for 3 days.
Dose Range: 250 - 2000 mg

Condition-Specific Dosing:

Chlamydia trachomatis: 1000 mg as a single dose
Gonorrhea: 2000 mg as a single dose (often with ceftriaxone)
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Pediatric Dosing

Neonatal: Not recommended due to risk of Infantile Hypertrophic Pyloric Stenosis (IHPS)
Infant: 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. (Max 500mg/day)
Child: Pharyngitis/Tonsillitis (â‰Ĩ2 years): 12 mg/kg once daily for 5 days. (Max 500mg/day)
Adolescent: Same as adult dosing for specific indications, adjusted for weight if necessary.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment needed
Moderate: No dosage adjustment needed
Severe: Caution advised; monitor for adverse effects. No specific dose adjustment recommended.
Dialysis: Not significantly removed by dialysis. No specific dose adjustment needed.

Hepatic Impairment:

Mild: No dosage adjustment needed
Moderate: No dosage adjustment needed
Severe: Caution advised; monitor for adverse effects. Use with caution due to primary hepatic elimination.

Pharmacology

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Mechanism of Action

Azithromycin binds to the 50S ribosomal subunit of susceptible microorganisms, thereby inhibiting bacterial protein synthesis. It is bacteriostatic.
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Pharmacokinetics

Absorption:

Bioavailability: 37%
Tmax: 2-3 hours
FoodEffect: Absorption of oral suspension is not significantly affected by food, but for tablets, food can decrease Cmax.

Distribution:

Vd: 31.1 L/kg (extensive tissue distribution)
ProteinBinding: 7-51% (concentration-dependent)
CnssPenetration: Limited

Elimination:

HalfLife: 68 hours (terminal)
Clearance: Not available (primarily biliary excretion)
ExcretionRoute: Biliary (major), Renal (minor)
Unchanged: Approximately 6% in urine
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Pharmacodynamics

OnsetOfAction: Rapid (within hours)
PeakEffect: Not directly applicable (antibacterial effect builds over time)
DurationOfAction: Prolonged due to long half-life and tissue concentration (allows for shorter courses of therapy)
Confidence: Medium

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 watery (see below for more information on diarrhea)
Stomach pain, cramps, or very loose stools

Important Information About Diarrhea

Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form of diarrhea called C. diff-associated diarrhea (CDAD) may occur. This condition can lead to life-threatening bowel problems. If you experience stomach pain, cramps, or very loose, watery, or bloody stools, contact your doctor immediately. Before treating diarrhea, consult with your doctor.

Liver Problems

Liver problems have been reported with this medication, and in rare cases, they can be life-threatening. If you experience any of the following symptoms, contact your doctor right away:
Dark urine
Tiredness
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes

Severe Skin Reactions

Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, can occur with this medication. These reactions can affect the skin and other organs, and in some cases, they can be life-threatening. Seek medical help immediately if you experience:
Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in your mouth, throat, nose, eyes, genitals, or any areas of skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands

Other Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
Diarrhea
Stomach pain
Upset stomach
* Vomiting

Reporting Side Effects

If you have questions about side effects or want to report any 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 treatment)
  • New or worsening rash, hives, or itching
  • Swelling of the face, lips, tongue, or throat; difficulty breathing or swallowing (signs of severe allergic reaction)
  • Yellowing of the skin or eyes (jaundice), dark urine, unusual tiredness (signs of liver problems)
  • Fast, pounding, or irregular heartbeat; dizziness or fainting (signs of heart rhythm problems)
  • Severe stomach pain with or without vomiting
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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 conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you have previously experienced liver problems or jaundice (yellowing of the skin or eyes) while taking this medication.
Certain heart conditions, such as:
+ Long QTc interval on an electrocardiogram (ECG) or other abnormal heart rhythms
+ Slow heartbeat
+ Low potassium or magnesium levels
+ Heart failure (a weakened heart)
+ A history of torsades de pointes, a specific type of abnormal heartbeat
If you are taking any medications that can cause abnormal heart rhythms, particularly 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.

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

All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your medical history, including any health problems you have

Do not start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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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 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 for Older Adults
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will discuss the potential benefits and risks of this medication 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, contact a poison control center immediately. Call 1-800-222-1222. Treatment is supportive and symptomatic.

Drug Interactions

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Contraindicated Interactions

  • Pimozide (risk of QT prolongation)
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Major Interactions

  • QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, cisapride, terfenadine, astemizole, some antipsychotics, tricyclic antidepressants)
  • Warfarin (increased INR and bleeding risk)
  • Nelfinavir (increased azithromycin serum concentrations)
  • Antacids containing aluminum or magnesium (decreased azithromycin absorption)
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Moderate Interactions

  • Digoxin (increased digoxin levels)
  • Cyclosporine (increased cyclosporine levels)
  • Ergot alkaloids (potential for ergotism)
  • Statins (e.g., simvastatin, lovastatin - theoretical increased risk of rhabdomyolysis, though less than other macrolides)
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Minor Interactions

  • Not many clinically significant minor interactions reported for azithromycin compared to other macrolides.

Monitoring

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Baseline Monitoring

Electrocardiogram (ECG)

Rationale: To assess baseline QT interval, especially in patients with known QT prolongation, bradycardia, or those receiving other QT-prolonging medications.

Timing: Prior to initiation in high-risk patients

Liver Function Tests (LFTs)

Rationale: To assess baseline hepatic function, particularly in patients with pre-existing hepatic impairment.

Timing: Prior to initiation in patients with hepatic impairment

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Routine Monitoring

Clinical response to therapy

Frequency: Daily during treatment

Target: Resolution of infection symptoms

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure or resistance.

Adverse effects (e.g., GI upset, rash)

Frequency: Daily during treatment

Target: Absence or mild, tolerable symptoms

Action Threshold: Severe or persistent adverse effects may require discontinuation.

INR (if on warfarin)

Frequency: Closely monitor during and after azithromycin therapy

Target: Therapeutic range for warfarin

Action Threshold: INR outside target range requires dose adjustment of warfarin.

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Symptom Monitoring

  • Severe or persistent diarrhea (may indicate Clostridioides difficile-associated diarrhea)
  • Rash, hives, swelling (signs of allergic reaction)
  • Yellowing of skin or eyes, dark urine, unusual fatigue (signs of hepatotoxicity)
  • Palpitations, dizziness, fainting (signs of QT prolongation or arrhythmia)
  • Hearing changes (rare, usually reversible)

Special Patient Groups

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Pregnancy

Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefit outweighs the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Generally considered low risk, but use only when clinically indicated.
Second Trimester: Generally considered low risk.
Third Trimester: Generally considered low risk.
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Lactation

Excreted in breast milk in small amounts. Generally considered compatible with breastfeeding, but monitor breastfed infant for potential adverse effects.

Infant Risk: L3 (Moderately Safe). Potential for infant gastrointestinal upset (diarrhea, vomiting), rash, or alteration of gut flora. Risk of IHPS in young infants is theoretical but not well-established via breast milk.
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Pediatric Use

Widely used in pediatric populations. However, caution is advised in neonates and young infants (under 6 weeks) due to the reported association with Infantile Hypertrophic Pyloric Stenosis (IHPS). Close monitoring for vomiting and feeding intolerance is crucial.

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Geriatric Use

No specific dosage adjustment is required based on age alone. However, elderly patients may be more susceptible to QT prolongation and Clostridioides difficile-associated diarrhea. Monitor for these adverse effects.

Clinical Information

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Clinical Pearls

  • Azithromycin has a very long tissue half-life, allowing for shorter treatment courses (e.g., 3-5 days) compared to other antibiotics.
  • It achieves high concentrations in tissues and phagocytes, which contributes to its efficacy against intracellular pathogens.
  • Less prone to drug interactions via CYP450 inhibition compared to erythromycin or clarithromycin.
  • Risk of Clostridioides difficile-associated diarrhea (CDAD) is a concern with all antibiotics, including azithromycin.
  • Counsel patients to complete the entire course of therapy, even if symptoms improve, to prevent resistance and ensure eradication of the infection.
  • The 'purple Bx' likely refers to a specific packaging or kit for a short course, e.g., a 3-day pediatric course.
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Alternative Therapies

  • Other macrolides (e.g., clarithromycin, erythromycin)
  • Beta-lactam antibiotics (e.g., amoxicillin, penicillin, cephalexin) for susceptible infections
  • Tetracyclines (e.g., doxycycline) for certain atypical infections or STIs
  • Fluoroquinolones (e.g., levofloxacin, moxifloxacin) for specific indications, often as second-line due to resistance concerns.
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 for a course of generic oral suspension per 15ml bottle (200mg/5ml concentration)
Generic Available: Yes
Insurance Coverage: Tier 1 (generic) or Tier 3 (brand) on most formularies
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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 details. 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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.