Zithromax 1gm Powder Packet

Azithromycin is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, thereby blocking translocation of peptides. It is generally considered bacteriostatic, but can be bactericidal at high concentrations against susceptible organisms.

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 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 right away. 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 notice any of the following symptoms, contact your doctor immediately:

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, may occur with this medication. These reactions can affect not only the skin but also other organs and can be life-threatening. Seek medical help right away 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 may not experience any side effects or may only have 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, you can contact your doctor or the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.

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, 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 heart conditions, including:
+ Abnormal heart rhythms, such as a prolonged QT interval, as shown on an electrocardiogram (ECG)
+ 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, 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.

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

All prescription and over-the-counter (OTC) 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 change the dose of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.

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 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
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.

• Nelfinavir (increased azithromycin concentrations)
• Warfarin (increased INR/bleeding risk, monitor closely)
• QT-prolonging drugs (e.g., antiarrhythmics like amiodarone, sotalol; antipsychotics; tricyclic antidepressants; fluoroquinolones; certain antifungals) - increased risk of Torsades de Pointes
• Colchicine (increased colchicine exposure)

• Antacids containing aluminum or magnesium (decreased azithromycin absorption, administer azithromycin at least 2 hours before or 4 hours after antacids)
• Digoxin (increased digoxin levels, monitor)
• Ergot alkaloids (theoretical risk of ergotism, avoid concomitant use)
• Cyclosporine (increased cyclosporine levels, monitor)
• Statins (theoretical risk of rhabdomyolysis with certain statins, though less significant than with other macrolides)

• Diarrhea (especially severe or persistent, may indicate C. difficile infection)
• Nausea, vomiting, abdominal pain
• Headache, dizziness
• Rash, itching, hives (signs of allergic reaction)
• Yellowing of skin or eyes, dark urine (signs of liver problems)
• Palpitations, chest pain, fainting (signs of cardiac issues)
• Muscle weakness or pain (rare, but consider rhabdomyolysis with statins)

Generally considered acceptable for use during pregnancy when clearly needed. Azithromycin is a Pregnancy Category B drug, meaning animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Considered compatible with breastfeeding. Azithromycin is excreted in human milk in low concentrations. The amount ingested by the infant is small and unlikely to cause adverse effects.

The 1gm single-dose packet is generally not used for young children. For other indications and formulations, azithromycin is widely used in pediatric populations with weight-based dosing. Safety and efficacy for specific indications must be considered.

No dosage adjustment is necessary based on age alone. However, elderly patients may be more susceptible to QT prolongation and should be monitored for cardiac risk factors and concomitant QT-prolonging medications.

• Azithromycin has a very long tissue half-life, allowing for short courses of therapy (e.g., single dose for chlamydia/gonorrhea, 3-5 days for other infections).
• The 1gm single dose is a common treatment for uncomplicated Chlamydia trachomatis infections and, in combination with ceftriaxone, for uncomplicated gonococcal infections.
• Counsel patients to mix the powder completely and drink immediately. Do not save any portion.
• Warn patients about the potential for C. difficile-associated diarrhea, which can occur even weeks after treatment.
• Be mindful of QT prolongation risk, especially in patients with pre-existing cardiac conditions, electrolyte imbalances, or those on other QT-prolonging drugs.
• Less prone to CYP450 interactions compared to erythromycin or clarithromycin, but still requires caution with certain drugs like warfarin.

• Doxycycline (for Chlamydia, often preferred over azithromycin due to lower resistance rates and better efficacy for rectal chlamydia)
• Ceftriaxone (for Gonorrhea, often used in combination with azithromycin or doxycycline)
• Levofloxacin (for certain respiratory or skin infections, but different class)
• Moxifloxacin (for certain respiratory or skin infections, but different class)
• Erythromycin (older macrolide, more GI side effects and drug interactions)
• Clarithromycin (another macrolide, different spectrum and PK/PD)

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 taken, the amount, and the time it happened.