Clarithromycin 250mg Tablets

Clarithromycin exerts its antibacterial action by binding to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting protein synthesis. This action is typically bacteriostatic, but can be bactericidal at high concentrations against highly 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 immediate medical attention:

Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Chest pain or pressure, rapid heartbeat, or irregular heartbeat.
Severe dizziness or fainting.
Muscle pain or weakness.
Shortness of breath.
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.

Important: Antibiotic-Associated Diarrhea

Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form called Clostridioides difficile (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.

Severe Skin Reactions

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions. These reactions can affect body organs and be life-threatening. Seek medical help immediately if you notice:

Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in your mouth, throat, nose, eyes, genitals, or 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. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Stomach pain or diarrhea
Change in taste
Upset stomach or vomiting
Gas
Headache

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 heartbeats.
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

Certain medications, such as those used to treat high cholesterol, migraines, or mood disorders, should not be taken with this medication. There are many other medications that may interact with this drug, which can increase the risk of severe, life-threatening, or fatal side effects.

To ensure your safety, it is crucial to inform your doctor and pharmacist about all your medications and health conditions. This will help determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Until you understand how this drug affects you, avoid driving and other activities that require alertness.

Do not exceed the prescribed duration of treatment, as this may increase the risk of a second infection. If you have diabetes, it is crucial to closely monitor your blood sugar levels while taking this medication.

This drug may cause a type of abnormal heartbeat known as prolonged QT interval, 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 aged 65 and 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)
• Ergotamine, Dihydroergotamine
• HMG-CoA Reductase Inhibitors (statins) extensively metabolized by CYP3A4 (e.g., lovastatin, simvastatin) due to increased risk of myopathy/rhabdomyolysis
• Lurasidone
• Pimozide
• Ticagrelor
• Ranolazine
• Midazolam (oral)
• Domperidone

• Colchicine (in patients with normal renal/hepatic function, dose reduction required)
• Other HMG-CoA Reductase Inhibitors (e.g., atorvastatin, rosuvastatin - use lowest dose, monitor for myopathy)
• Oral Anticoagulants (e.g., warfarin - increased INR/bleeding risk)
• Antiarrhythmics (e.g., disopyramide, quinidine, dofetilide, amiodarone - increased QT prolongation risk)
• Calcium Channel Blockers (e.g., verapamil, amlodipine, diltiazem - increased hypotensive and bradycardic effects)
• Immunosuppressants (e.g., cyclosporine, tacrolimus, sirolimus - increased levels)
• Antidiabetic agents (e.g., nateglinide, repaglinide - increased hypoglycemia risk)
• Sildenafil, Tadalafil, Vardenafil (increased exposure)
• Theophylline (increased levels)
• Carbamazepine (increased levels)
• Phenytoin (increased levels)
• Digoxin (increased levels)
• Rifabutin (increased rifabutin levels, decreased clarithromycin levels)
• HIV Protease Inhibitors (e.g., atazanavir, ritonavir - complex interactions, often increased clarithromycin levels)
• QT-prolonging drugs (e.g., antipsychotics, tricyclic antidepressants, other macrolides)

• Benzodiazepines (e.g., alprazolam, triazolam - increased sedation)
• Corticosteroids (e.g., methylprednisolone - increased exposure)
• Omeprazole (increased clarithromycin and omeprazole levels)
• Zidovudine (decreased zidovudine absorption, administer doses at least 4 hours apart)

• Antacids (may slightly delay absorption, but not clinically significant)

• Severe or persistent diarrhea (may indicate Clostridioides difficile-associated diarrhea)
• Rash, itching, hives, 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 liver problems)
• Chest pain, palpitations, dizziness, fainting (signs of QT prolongation or arrhythmia)
• Muscle pain, tenderness, weakness (signs of myopathy/rhabdomyolysis, especially with statins)

Clarithromycin is classified as Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, and 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 various infections. Dosing is weight-based (7.5 mg/kg every 12 hours). Safety and efficacy in children under 6 months of age have not been established for all indications. Oral suspension is available for easier administration.

No specific dose adjustment is required based on age alone. However, elderly patients are more likely to have age-related decreases in renal function, which may necessitate dose adjustments. They may also be more susceptible to QT prolongation and drug interactions due to polypharmacy. Monitor renal function and concomitant medications carefully.

• Clarithromycin is a potent CYP3A4 inhibitor; careful review of concomitant medications is crucial to avoid serious drug interactions (e.g., statins, colchicine, QT-prolonging drugs).
• It is one of the few macrolides with significant activity against H. influenzae, partly due to its active metabolite (14-hydroxyclarithromycin).
• Taste disturbance (dysgeusia) is a common side effect, often described as a metallic or bitter taste.
• While generally well-tolerated, it can cause gastrointestinal upset; taking with food may help.
• There have been post-marketing reports of liver dysfunction, including elevated liver enzymes, hepatocellular and/or cholestatic hepatitis, with or without jaundice. Discontinue if signs/symptoms of hepatitis occur.
• A long-term observational study suggested an increased risk of cardiovascular events (MI, stroke) in patients with coronary artery disease who received clarithromycin compared to other antibiotics. This finding requires further investigation and is not definitively established as a causal link.

• Azithromycin (another macrolide, different pharmacokinetic profile, fewer drug interactions)
• Erythromycin (older macrolide, more GI side effects, more drug interactions)
• Amoxicillin (penicillin-class antibiotic)
• Doxycycline (tetracycline-class antibiotic)
• Levofloxacin (fluoroquinolone-class antibiotic)
• Cefuroxime (cephalosporin-class antibiotic)

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 a separate 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.