Azithromycin 500mg Sdv Inj, 1 Vial

Azithromycin binds to the 50S ribosomal subunit of susceptible microorganisms, thereby inhibiting bacterial protein synthesis. It is generally considered bacteriostatic, but can be bactericidal at high concentrations against certain 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 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:

Liver problems have been reported with this medication, and in rare cases, they have been fatal. 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, may occur with this medication. These reactions can be life-threatening and may affect other organs in the body. If you experience any of the following symptoms, seek medical help immediately:
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 may cause side effects. Many people experience no side effects or only minor ones. If you experience any of the following side effects or any other side effects that bother you or do not go away, contact your doctor:
Headache
Diarrhea
Stomach pain
Upset stomach
Vomiting
Pain at the injection site

Reporting Side Effects:

If you have questions about side effects or want to report a side effect, 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.

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. 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 with your doctor or pharmacist if you are unsure.

This list is not exhaustive, and it is vital to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe for you to take this medication with your existing health conditions and medications. Never start, stop, or change the dosage of any medication without first consulting your doctor.

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 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 signs of myasthenia gravis, such as new or worsening muscle weakness, difficulty chewing or swallowing, breathing problems, droopy eyelids, or changes in vision (e.g., blurred vision or double vision), can occur in people with or without a history of the condition. If you experience any of these symptoms, contact your doctor immediately.

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 right away.

• Pimozide (risk of severe QT prolongation and arrhythmias)

• Amiodarone (increased risk of QT prolongation, Torsades de Pointes)
• Dofetilide (increased risk of QT prolongation, Torsades de Pointes)
• Sotalol (increased risk of QT prolongation, Torsades de Pointes)
• Quinidine (increased risk of QT prolongation, Torsades de Pointes)
• Disopyramide (increased risk of QT prolongation, Torsades de Pointes)
• Procainamide (increased risk of QT prolongation, Torsades de Pointes)
• Cisapride (increased risk of QT prolongation, Torsades de Pointes)
• Ergot alkaloids (e.g., Ergotamine, Dihydroergotamine - risk of acute ergot toxicity)
• Warfarin (increased anticoagulant effect, elevated INR)
• Digoxin (increased serum digoxin levels)
• Colchicine (increased colchicine exposure, toxicity)
• Statins (e.g., Simvastatin, Lovastatin - increased risk of myopathy/rhabdomyolysis)

• Antacids (oral only, not relevant for IV)
• Nelfinavir (increased azithromycin concentrations)
• Cyclosporine (potential for increased cyclosporine levels)
• Phenytoin (potential for increased phenytoin levels)
• Theophylline (potential for increased theophylline levels)
• Fluoroquinolones (e.g., Moxifloxacin, Levofloxacin - additive QT prolongation risk)
• Antipsychotics (e.g., Ziprasidone, Quetiapine - additive QT prolongation risk)
• Tricyclic antidepressants (e.g., Amitriptyline - additive QT prolongation risk)

• Not available

• Severe or persistent diarrhea (may indicate Clostridioides difficile-associated diarrhea)
• Rash, hives, itching, swelling of face/lips/tongue/throat (signs of allergic reaction)
• Yellowing of skin or eyes (jaundice), dark urine, pale stools, severe stomach pain, nausea, vomiting (signs of hepatotoxicity)
• Palpitations, dizziness, fainting, irregular heartbeat (signs of QT prolongation/arrhythmia)
• Muscle pain, weakness, dark urine (signs of rhabdomyolysis, especially with statins)
• Hearing changes (rare, usually reversible)

Azithromycin is classified as 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. It should be used during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus.

Azithromycin is excreted in human milk. The amount of azithromycin ingested by a breastfed infant is low. The American Academy of Pediatrics considers azithromycin compatible with breastfeeding. Monitor breastfed infants for potential adverse effects such as diarrhea, vomiting, or rash.

Azithromycin IV is approved for use in pediatric patients for certain indications (e.g., CAP). Dosing is weight-based. Safety and effectiveness in infants younger than 6 months for CAP have not been established. Close monitoring for adverse effects is crucial.

No specific dosage adjustment is required for elderly patients. However, elderly patients may be more susceptible to QT prolongation due to a higher prevalence of underlying cardiac conditions or concomitant medications. Monitor ECG and electrolytes closely in this population.

• Azithromycin IV must be reconstituted and then diluted prior to intravenous infusion. It should be infused over no less than 60 minutes.
• Do not administer azithromycin IV as a bolus or intramuscularly.
• Azithromycin is not effective against viral infections; avoid inappropriate use to prevent antibiotic resistance.
• Patients should be switched from IV to oral azithromycin as soon as clinically appropriate.
• Be aware of the risk of Clostridioides difficile-associated diarrhea (CDAD), which can occur during or even months after azithromycin therapy.
• Monitor for signs of hepatotoxicity and cardiac arrhythmias (especially QT prolongation).

• Other macrolides (e.g., Clarithromycin, Erythromycin - though IV forms may have different side effect profiles or indications)
• Beta-lactam antibiotics (e.g., Ceftriaxone, Ampicillin/Sulbactam for CAP or PID)
• Fluoroquinolones (e.g., Levofloxacin, Moxifloxacin for CAP or PID)
• Tetracyclines (e.g., Doxycycline for PID)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion to ensure prompt and effective treatment.