Clarithromycin 250mg/5ml Susp 50ml

Clarithromycin exerts its antibacterial action by binding to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting protein synthesis. It is generally considered 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, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.

Important: Antibiotic-Associated Diarrhea

Diarrhea is a common side effect of antibiotics. However, a severe form called Clostridioides difficile (C. diff)-associated diarrhea (CDAD) may occur, which 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 reactions, which can be life-threatening. If you notice any of the following symptoms, seek medical help right away:
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 Possible 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.
If you have previously experienced liver problems while taking this medication.
A history of abnormal heart rhythms, including a prolonged QT interval on an electrocardiogram (ECG) or other irregular heartbeats.
Certain health conditions, such as:
+ Low magnesium levels (hypomagnesemia)
+ Low potassium levels (hypokalemia)
+ Slow heartbeat (bradycardia)
* Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as some may interact with this medication. Specifically, inform your doctor about medications used to treat:
+ High cholesterol
+ Migraines
+ Mood disorders
+ Other conditions

Please note that this is not an exhaustive list of all potential interactions. This medication can interact with numerous other drugs, which may increase the risk of severe, life-threatening, or fatal side effects. Therefore, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify the dosage of any medication without 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 lead to a second infection. If you have diabetes (high blood sugar), closely monitor your blood sugar levels while taking this medication.

This drug may cause a type of abnormal heartbeat known as a prolonged QT interval, which can increase the risk of other potentially life-threatening abnormal heartbeats. If you have heart disease, consult your doctor, as one study found that people with heart disease who took clarithromycin had a higher risk of death a year or more later compared to those who did not take the medication. However, other studies have reported different results.

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

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Additionally, if you are pregnant or become pregnant while taking this drug, notify your doctor immediately, as it may harm the unborn baby.

If you are breast-feeding, consult your doctor to discuss any potential risks to your baby.

• Colchicine (in patients with renal or hepatic impairment)
• HMG-CoA reductase inhibitors (lovastatin, simvastatin) due to risk of rhabdomyolysis
• Ergot alkaloids (ergotamine, dihydroergotamine) due to acute ergot toxicity
• Pimozide
• Cisapride
• Astemizole
• Terfenadine
• Ticagrelor
• Ranolazine

• Warfarin (increased INR/bleeding risk)
• Oral hypoglycemics (e.g., nateglinide, repaglinide) and insulin (risk of severe hypoglycemia)
• Calcium channel blockers (e.g., verapamil, amlodipine, diltiazem) (risk of hypotension, bradyarrhythmias, lactic acidosis)
• Digoxin (increased digoxin levels)
• Theophylline (increased theophylline levels)
• Carbamazepine (increased carbamazepine levels)
• Phenytoin (increased phenytoin levels)
• Cyclosporine, Tacrolimus, Sirolimus (increased immunosuppressant levels)
• Sildenafil, Tadalafil, Vardenafil (increased PDE5 inhibitor exposure)
• Quetiapine (increased quetiapine exposure)
• Midazolam (oral) (increased midazolam exposure)
• Other QT-prolonging drugs (e.g., antiarrhythmics, antipsychotics)

• Omeprazole (increased clarithromycin and omeprazole levels)
• Rifabutin (increased rifabutin levels, decreased clarithromycin levels)
• Zidovudine (decreased zidovudine absorption)
• Ritonavir (increased clarithromycin levels, dose adjustment needed)
• Atazanavir, Saquinavir (increased clarithromycin levels)
• Fluconazole (increased clarithromycin levels)
• Efavirenz, Nevirapine, Rifampin, Rifapentine (may decrease clarithromycin levels)
• Oral contraceptives (potential for reduced efficacy, though not consistently shown)

• Antacids (may delay absorption, but not extent)

• Persistent or severe diarrhea (may indicate Clostridioides difficile-associated diarrhea)
• Yellowing of skin or eyes (jaundice), dark urine, unusual fatigue (signs of hepatotoxicity)
• Severe abdominal pain, nausea, vomiting (pancreatitis)
• Muscle pain, tenderness, weakness, dark urine (rhabdomyolysis, especially with statins)
• Palpitations, dizziness, fainting (arrhythmias, QT prolongation)
• Rash, itching, swelling (allergic reaction)

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 and its active metabolite are excreted into human breast milk. The American Academy of Pediatrics considers it compatible with breastfeeding, but caution is advised. Monitor breastfed infants for gastrointestinal disturbances (e.g., diarrhea, vomiting, candidiasis) and potential effects on gut flora.

Safety and efficacy have not been established in children younger than 6 months of age. Dosing for children 6 months and older is weight-based. Close monitoring for adverse effects is important.

Elderly patients may be more susceptible to the adverse effects of clarithromycin, particularly those with renal or hepatic impairment. Dose adjustments are necessary for renal impairment. Increased risk of QT prolongation and drug interactions should be considered.

• Clarithromycin is known for causing a metallic or bitter taste disturbance, which can affect patient adherence.
• It is a potent inhibitor of CYP3A4, leading to numerous significant drug interactions. Always review concomitant medications carefully.
• Risk of QT prolongation and Torsades de Pointes, especially with pre-existing cardiac conditions, electrolyte imbalances, or concomitant QT-prolonging drugs.
• Increased risk of C. difficile-associated diarrhea (CDAD) with clarithromycin, as with nearly all antibiotics. Consider CDAD in patients presenting with diarrhea after antibiotic use.
• For H. pylori eradication, clarithromycin is typically used as part of a triple or quadruple therapy regimen.
• The suspension should be shaken well before each use and measured accurately with a dosing device.

• Other macrolides (e.g., Azithromycin, Erythromycin)
• Penicillins (e.g., Amoxicillin, Amoxicillin/Clavulanate)
• Cephalosporins (e.g., Cefdinir, Cefuroxime)
• Tetracyclines (e.g., Doxycycline)
• Fluoroquinolones (e.g., Levofloxacin, Moxifloxacin) - use with caution due to resistance and side effects
• Other classes of antibiotics depending on the specific infection and susceptibility.

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 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 occurred.