Azithromycin 1gm Pak Powder

Manufacturer GREENSTONE Active Ingredient Azithromycin Single-Dose Packet(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 certain bacterial infections. This 1-gram packet is a single, high dose often used for sexually transmitted infections like Chlamydia. It works by stopping the growth of bacteria.
📋

How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take the medication with or without food, as directed. 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.

To prepare the medication, empty the powder packet into 1/4 cup (60 mL) of water. Mix well and drink the entire contents. Then, rinse the cup with more water and drink the rinse water to ensure you receive the full dose.

Continue taking this medication as prescribed by your doctor or healthcare provider, even if you start feeling well.

Storing and Disposing of Your Medication

Store the medication at room temperature in a dry place, avoiding storage in a bathroom.

Missing a Dose

Since this medication is typically taken as a single dose, if you miss your dose, take it as soon as you remember.
💡

Lifestyle & Tips

  • Take the entire dose as prescribed, even if you feel better.
  • Mix the powder completely in water (usually 2-4 ounces) and drink immediately. Do not save for later.
  • Take on an empty stomach (at least 1 hour before or 2 hours after a meal) for best absorption.
  • Avoid antacids containing aluminum or magnesium within 2 hours of taking azithromycin.
  • Do not share this medication with others.
  • Practice safe sex to prevent reinfection or transmission of STIs.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: 1 gram (1000 mg) orally as a single dose
Dose Range: 1000 - 1000 mg

Condition-Specific Dosing:

uncomplicated urethritis and cervicitis due to Chlamydia trachomatis: 1 gram orally as a single dose
uncomplicated genital ulcer disease due to Haemophilus ducreyi (chancroid): 1 gram orally as a single dose
uncomplicated gonococcal infections (as part of combination therapy): 1 gram orally as a single dose (often with ceftriaxone)
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established for 1gm pak; general azithromycin dosing is weight-based for other indications.
Infant: Not established for 1gm pak; general azithromycin dosing is weight-based for other indications.
Child: Not established for 1gm pak; general azithromycin dosing is weight-based for other indications (e.g., 10-12 mg/kg/day for 1-5 days).
Adolescent: For indications where 1gm single dose is appropriate (e.g., Chlamydia), dosing may be similar to adults, but generally weight-based dosing is preferred for other infections.
âš•ī¸

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.
Dialysis: Not significantly removed by hemodialysis or peritoneal dialysis; no supplemental dose needed.

Hepatic Impairment:

Mild: No dosage adjustment necessary.
Moderate: Use with caution; monitor for signs of worsening liver function.
Severe: Contraindicated in patients with severe hepatic impairment due to potential for hepatotoxicity.

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 the rate and extent of absorption of the oral suspension and tablets. The 1gm single-dose packet should be taken on an empty stomach (at least 1 hour before or 2 hours after a meal).

Distribution:

Vd: Approximately 31.1 L/kg (very large, indicating extensive tissue distribution)
ProteinBinding: Concentration-dependent, ranging from 7% at 1 mcg/mL to 51% at 0.02 mcg/mL
CnssPenetration: Limited (low concentrations in CSF)

Elimination:

HalfLife: Terminal elimination half-life is 68 hours (due to extensive tissue uptake and slow release)
Clearance: Not available (primarily eliminated unchanged)
ExcretionRoute: Primarily biliary excretion (approximately 50% unchanged in feces); minor renal excretion (approximately 6% unchanged in urine)
Unchanged: Approximately 50% in feces, 6% in urine
âąī¸

Pharmacodynamics

OnsetOfAction: Rapid (within hours)
PeakEffect: Not directly applicable for single dose, but peak plasma concentrations reached in 2-3 hours.
DurationOfAction: Due to extensive tissue distribution and slow release, therapeutic concentrations persist in tissues for several days after the last dose, allowing for short-course or single-dose regimens.
Confidence: High

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 (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 Clostridioides difficile-associated diarrhea (CDAD) may occur. CDAD can happen during or several months after taking antibiotics and may lead to a life-threatening bowel problem. 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 and Severe Skin Reactions

Liver problems, which can be fatal, have been reported with this medication. If you notice any signs of liver problems, such as:
Dark urine
Tiredness
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
contact your doctor right away.

Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, may also occur. These reactions can affect body organs and 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

Most people do not experience significant side effects or only have minor 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 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 watery diarrhea (especially if bloody or persistent, even weeks after treatment)
  • Severe stomach pain or cramps
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine
  • Unusual tiredness or weakness
  • Nausea or vomiting that is severe or doesn't go away
  • Fast, pounding, or irregular heartbeat
  • Dizziness or fainting
  • Signs of an allergic reaction (rash, hives, swelling of face/lips/tongue/throat, difficulty breathing or swallowing)
  • Severe skin reactions (e.g., blistering, peeling skin)
📋

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, as seen on an electrocardiogram (ECG)
+ 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 it is crucial to ask your doctor or pharmacist if you are unsure.

This list is not exhaustive, and it is vital to inform your doctor and pharmacist about all the medications you are taking, including:

Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins

Additionally, share any health problems you have, as this information will help your doctor determine whether it is safe for you to take this medication. Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
âš ī¸

Precautions & Cautions

Important Warnings and Precautions 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 treatment duration, as prolonged use may increase the risk of a second infection.

Severe Heart Rhythm Changes
This medication can cause severe heart rhythm changes, including a 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 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
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
Newborns taking this medication are at risk of developing 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:

In case of overdose, contact a poison control center immediately. Call 1-800-222-1222. Treatment is symptomatic and supportive. Gastric lavage and general supportive measures are indicated.

Drug Interactions

🔴

Major Interactions

  • Nelfinavir (increased azithromycin concentrations)
  • QT-prolonging drugs (e.g., antiarrhythmics like amiodarone, quinidine; antipsychotics like pimozide; tricyclic antidepressants; fluoroquinolones; some antihistamines)
  • Warfarin (potential for increased INR/bleeding)
🟡

Moderate Interactions

  • Antacids containing aluminum or magnesium (decreased azithromycin absorption)
  • Digoxin (potential for increased digoxin levels)
  • Cyclosporine (potential for increased cyclosporine levels)
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine - theoretical risk of ergotism, though less likely than with other macrolides)
  • Statins (potential for rhabdomyolysis, though less common than with other macrolides)
đŸŸĸ

Minor Interactions

  • Zidovudine (increased zidovudine phosphorylation)

Monitoring

đŸ”Ŧ

Baseline Monitoring

Liver function tests (ALT, AST, bilirubin)

Rationale: To assess baseline hepatic function, especially in patients with pre-existing liver disease, due to risk of hepatotoxicity.

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

Electrocardiogram (ECG)

Rationale: To assess baseline QT interval in patients with known QT prolongation, uncorrected hypokalemia/hypomagnesemia, clinically significant bradycardia, or receiving other QT-prolonging drugs.

Timing: Prior to initiation in at-risk patients.

📊

Routine Monitoring

Signs and symptoms of infection resolution

Frequency: Daily during treatment and post-treatment

Target: Resolution of fever, pain, discharge, etc.

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

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

Frequency: Daily during and for several weeks after treatment

Target: Absence of severe diarrhea, abdominal pain, fever

Action Threshold: Onset of persistent diarrhea, especially if severe or bloody, requires immediate evaluation and discontinuation of azithromycin.

Signs and symptoms of hepatotoxicity

Frequency: Monitor clinically during and after treatment

Target: Absence of jaundice, dark urine, fatigue, abdominal pain

Action Threshold: Any signs of liver injury warrant discontinuation and evaluation.

INR (if on warfarin)

Frequency: More frequently during and after azithromycin co-administration

Target: Therapeutic range for warfarin indication

Action Threshold: Significant increase in INR warrants warfarin dose adjustment.

đŸ‘ī¸

Symptom Monitoring

  • Diarrhea (especially severe or bloody)
  • Abdominal pain
  • Nausea
  • Vomiting
  • Rash
  • Itching
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Unusual fatigue
  • Signs of allergic reaction (swelling of face/throat, difficulty breathing)
  • Palpitations or irregular heartbeat (signs of QT prolongation)

Special Patient Groups

🤰

Pregnancy

Azithromycin is generally considered safe and is a preferred agent for treating Chlamydia trachomatis infection in pregnant women. It is classified as Pregnancy Category B.

Trimester-Specific Risks:

First Trimester: No evidence of increased risk of congenital anomalies in humans.
Second Trimester: No evidence of increased risk of congenital anomalies in humans.
Third Trimester: No evidence of increased risk of congenital anomalies in humans.
🤱

Lactation

Azithromycin is excreted in human milk in small amounts. It is generally considered compatible with breastfeeding (Lactation Risk Category L3 - Moderately Safe). Monitor breastfed infant for diarrhea, vomiting, or rash.

Infant Risk: Low risk of adverse effects; potential for alteration of infant gut flora, diarrhea, or rash.
đŸ‘ļ

Pediatric Use

The 1gm single-dose packet is generally not recommended for pediatric patients due to the high dose. Pediatric dosing for azithromycin in other formulations is weight-based and indicated for specific infections (e.g., otitis media, pharyngitis).

👴

Geriatric Use

No specific dosage adjustment is required based on age. However, elderly patients may be more susceptible to the QT-prolonging effects of azithromycin and should be monitored for cardiovascular risk factors and concomitant QT-prolonging medications.

Clinical Information

💎

Clinical Pearls

  • Azithromycin has a very long tissue half-life, allowing for short-course or single-dose regimens.
  • The 1gm single-dose packet is particularly useful for improving adherence in the treatment of STIs.
  • Despite its macrolide classification, azithromycin has minimal interaction with the CYP450 system compared to erythromycin or clarithromycin.
  • Always advise patients to take the 1gm packet on an empty stomach for optimal absorption.
  • Counsel patients on the importance of completing the full course of therapy, even for a single dose, and potential for C. difficile infection.
🔄

Alternative Therapies

  • Doxycycline (for Chlamydia trachomatis)
  • Ceftriaxone (for Neisseria gonorrhoeae)
  • Erythromycin (another macrolide, but different dosing and side effect profile)
  • Levofloxacin (for certain respiratory or skin infections, but different class)
💰

Cost & Coverage

Average Cost: Varies, typically $10-$50 per 1gm single dose packet
Generic Available: Yes
Insurance Coverage: Tier 1 or 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 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, to ensure you receive the best possible care.