Clarithromycin 500mg Tablets

Clarithromycin exerts its antibacterial action by binding to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting protein synthesis. It is 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Chest pain or pressure
Rapid or abnormal heartbeat
Severe dizziness or fainting
Muscle pain or weakness
Shortness of breath
Weakness on one side of the body
Difficulty speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred vision
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)
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions that may affect body organs
+ Signs of severe skin reactions 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 no side effects or only mild side effects while taking this medication. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:

Stomach pain
Diarrhea
Changes in taste
Upset stomach or vomiting
Gas
Headache

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.

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 taken this medication and experienced liver problems.
If you have a history of abnormal heart rhythms, including a prolonged QT interval on an electrocardiogram (ECG) or other irregular heartbeat conditions.
If you have any of the following health conditions: low magnesium levels, low potassium levels, or a slow heartbeat (bradycardia).

Additionally, tell your doctor about all the medications you are currently taking, including:

Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

This is crucial because this medication can interact with numerous other drugs, increasing the risk of severe, life-threatening, or fatal side effects. Some specific medications that should not be taken with this drug include certain medications used to treat high cholesterol, migraines, and mood disorders. However, this is not an exhaustive list, and it is vital to discuss all your medications and health conditions with your doctor.

To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication with all your other medications and health conditions. Be sure to inform your doctor and pharmacist about all your medications and health problems to minimize potential risks and interactions.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

Adhere to the prescribed treatment duration, as prolonged use may increase the risk of a second infection. If you have diabetes, closely monitor your blood sugar levels, as this medication may impact them.

This drug may cause a prolonged QT interval, a type of abnormal heartbeat, which can increase the risk of other potentially life-threatening heart rhythm disorders. If you have a history of heart disease, consult your doctor, as one study suggested that people with heart disease who took clarithromycin had a higher risk of death a year or more after treatment. However, other studies have yielded different results.

If you have myasthenia gravis, discuss your treatment with your doctor, as this condition may worsen during treatment with this medication. If your symptoms deteriorate, contact your doctor promptly.

Individuals 65 years or older should exercise caution when taking this medication, as they may be more susceptible to side effects. If you are pregnant or become pregnant while taking this drug, immediately contact your doctor, as it may harm the unborn baby.

If you are breastfeeding, consult your doctor to discuss potential risks to your baby and determine the best course of action.

• Colchicine (in patients with renal or hepatic impairment)
• Lomitapide
• Lovastatin
• Simvastatin
• Ergotamine
• Dihydroergotamine
• Midazolam (oral)
• Pimozide
• Ticagrelor
• Ranolazine
• Ivabradine

• Statins (e.g., atorvastatin, rosuvastatin - increased risk of myopathy/rhabdomyolysis)
• Oral anticoagulants (e.g., warfarin - increased INR/bleeding risk)
• Antiarrhythmics (e.g., amiodarone, disopyramide, dofetilide, quinidine - increased QT prolongation/arrhythmia risk)
• Calcium channel blockers (e.g., verapamil, amlodipine, diltiazem - increased hypotensive and bradycardic effects)
• Immunosuppressants (e.g., cyclosporine, tacrolimus, sirolimus - increased levels and toxicity)
• PDE5 inhibitors (e.g., sildenafil, tadalafil - increased levels)
• Theophylline (increased levels and toxicity)
• Carbamazepine (increased levels and toxicity)
• Phenytoin (increased levels and toxicity)
• Digoxin (increased levels and toxicity)
• Quetiapine (increased levels and toxicity)
• Apixaban, Rivaroxaban (increased levels and bleeding risk)
• Fentanyl, Oxycodone (increased levels and respiratory depression)

• Oral hypoglycemics (e.g., glipizide, glyburide - increased risk of hypoglycemia)
• Corticosteroids (e.g., methylprednisolone - increased levels)
• Rifabutin (decreased clarithromycin levels, increased rifabutin levels)
• Zidovudine (decreased zidovudine absorption - administer clarithromycin 2 hours apart)
• Omeprazole (increased clarithromycin and omeprazole levels)
• Fluconazole (increased clarithromycin levels)
• Ritonavir (significantly increases clarithromycin levels, dose adjustment needed)

• Antacids (may delay absorption, but not significantly affect bioavailability)
• Cimetidine (minor increase in clarithromycin levels)

• Persistent or severe diarrhea (may indicate Clostridioides difficile-associated diarrhea)
• Yellowing of skin or eyes (jaundice), dark urine, pale stools, severe abdominal pain (signs of hepatotoxicity)
• Unusual muscle pain, tenderness, or weakness (signs of myopathy/rhabdomyolysis, especially with statins)
• Palpitations, dizziness, fainting, chest pain (signs of QT prolongation/arrhythmia)
• Signs of allergic reaction: rash, itching, swelling (especially of face/tongue/throat), severe dizziness, trouble breathing
• Hearing loss or tinnitus (rare, usually reversible)

Clarithromycin is classified as Pregnancy Category C. Animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Clarithromycin is excreted into breast milk. The American Academy of Pediatrics considers it compatible with breastfeeding, but caution is advised. Monitor the infant for gastrointestinal disturbances (e.g., diarrhea, candidiasis) and potential effects on gut flora.

Clarithromycin is approved for use in pediatric patients for certain infections. However, the 500mg tablet strength may not be suitable for younger children due to dosing requirements; oral suspension is typically preferred for accurate dosing in children. Dosage is weight-based. Caution is advised in children with hepatic or renal impairment.

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients are more likely to have age-related decreases in renal function, which may require dose adjustment. Increased risk of drug interactions due to polypharmacy. Monitor for QT prolongation and C. difficile infection.

• Clarithromycin is a potent CYP3A4 inhibitor, leading to numerous significant drug interactions. Always review patient's medication list for potential interactions.
• Unlike erythromycin, clarithromycin has better acid stability, leading to improved oral bioavailability and less GI upset.
• The 14-hydroxy metabolite of clarithromycin is active and contributes to its antimicrobial spectrum, particularly against H. influenzae.
• Patients should be advised to complete the full course of therapy to prevent resistance, even if symptoms improve.
• Consider C. difficile infection in patients presenting with severe diarrhea during or after clarithromycin therapy.
• Caution with concomitant use of statins (especially lovastatin, simvastatin) due to increased risk of myopathy/rhabdomyolysis; alternative statins or antibiotics should be considered.
• Monitor INR closely if co-administered with warfarin due to increased bleeding risk.

• Azithromycin (another macrolide, different pharmacokinetic profile, fewer CYP interactions)
• Erythromycin (older macrolide, more GI side effects, more CYP interactions)
• Amoxicillin (for respiratory tract infections, H. pylori)
• Doxycycline (for respiratory tract infections, skin infections)
• Levofloxacin (for respiratory tract infections, but with different side effect profile and resistance concerns)
• Moxifloxacin (for respiratory tract infections)
• Cephalexin (for skin and soft tissue infections)
• Penicillin V (for pharyngitis/tonsillitis)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. 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 details about the medication taken, the amount, and the time it happened.