Clarithromycin 250mg/5ml Susp 100ml

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 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
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Chest pain or pressure
Fast heartbeat or abnormal heartbeat
Severe dizziness or fainting
Muscle pain or weakness
Shortness of breath
Weakness on one side of the body
Trouble speaking or thinking
Change 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 (note: diarrhea is common with antibiotics, but a severe form called C. diff-associated diarrhea (CDAD) can occur, which may lead to a life-threatening bowel problem)
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which can affect body organs and be life-threatening
+ 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 do not experience significant side effects, but some may occur. 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
Diarrhea
Change in taste
Upset stomach or vomiting
Gas
Headache

Reporting Side Effects

This list is not exhaustive, and you may experience other 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 symptoms 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).
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. This is crucial because this medication can interact with numerous other drugs, increasing the risk of severe, life-threatening, or fatal side effects. Some examples of medications that may interact with this drug include those used to treat high cholesterol, migraines, and mood disorders.
Note that this is not an exhaustive list of all potential interactions. It is vital to discuss all your medications and health conditions with your doctor to ensure safe treatment.

To minimize potential risks, it is crucial to:

Inform your doctor and pharmacist about all your medications and health conditions.
Verify that it is safe to take this medication with your existing medications and health conditions.
* Avoid starting, stopping, or changing 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. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

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

This drug can cause a type of abnormal heartbeat known as a prolonged QT interval, which may 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 patients with heart disease who took clarithromycin had a higher risk of death within a year or more compared to those who did not take the medication. 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. Additionally, 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)
• HMG-CoA reductase inhibitors (lovastatin, simvastatin) due to risk of rhabdomyolysis
• Ergot alkaloids (ergotamine, dihydroergotamine) due to acute ergot toxicity (vasospasm, ischemia)
• Pimozide, Cisapride, Astemizole, Terfenadine (due to risk of QT prolongation and cardiac arrhythmias)
• Ticagrelor
• Ranolazine
• Lurasidone
• Dronedarone

• Warfarin (increased INR, bleeding risk)
• Oral hypoglycemics (e.g., glipizide, glyburide) and Insulin (risk of severe hypoglycemia)
• Digoxin (increased digoxin levels, toxicity)
• Theophylline (increased theophylline levels, toxicity)
• Carbamazepine (increased carbamazepine levels, toxicity)
• Phenytoin (increased phenytoin levels, toxicity)
• Cyclosporine, Tacrolimus, Sirolimus (increased immunosuppressant levels, nephrotoxicity)
• Sildenafil, Tadalafil, Vardenafil (increased PDE5 inhibitor exposure)
• Quinidine, Disopyramide (increased levels, QT prolongation, arrhythmias)
• Atazanavir, Ritonavir, Saquinavir (bidirectional interaction, dose adjustment needed)
• Verapamil (risk of hypotension, bradycardia, lactic acidosis)
• Other QT-prolonging drugs (e.g., amiodarone, sotalol, antipsychotics)

• Omeprazole (increased clarithromycin and omeprazole levels)
• Rifabutin (increased rifabutin levels, decreased clarithromycin levels)
• Fluconazole (increased clarithromycin levels)
• Midazolam (oral) (increased midazolam levels)
• Alprazolam, Triazolam (increased benzodiazepine levels)
• Cilostazol (increased cilostazol levels)
• Methylprednisolone (increased methylprednisolone levels)
• Phenobarbital, Rifampin, Phenytoin (may decrease clarithromycin levels)
• Zidovudine (decreased zidovudine levels, administer clarithromycin 2 hours apart)

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

• Severe or persistent diarrhea (may indicate C. difficile-associated diarrhea)
• Rash, itching, hives (allergic reaction)
• Yellowing of skin or eyes, dark urine, pale stools (signs of liver dysfunction)
• Unusual muscle pain or weakness, dark urine (signs of rhabdomyolysis)
• Dizziness, palpitations, fainting (signs of cardiac arrhythmia)
• Significant changes in taste or smell
• Hearing loss (rare, usually reversible)

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

Clarithromycin is excreted into human breast milk. The American Academy of Pediatrics considers it to be compatible with breastfeeding, but caution is advised. Monitor breastfed infants for gastrointestinal disturbances (e.g., diarrhea, candidiasis) and potential allergic reactions.

Clarithromycin oral suspension is commonly used in pediatric patients for various infections. Dosing is weight-based (7.5 mg/kg every 12 hours). Safety and efficacy have been established for children 6 months and older. Not recommended for infants under 6 months due to insufficient data.

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 adjustment based on creatinine clearance. They may also be more susceptible to QT prolongation and drug interactions.

• Clarithromycin is known for causing a metallic or bitter taste disturbance, which can affect patient adherence.
• It is a potent CYP3A4 inhibitor, leading to numerous significant drug interactions. Thorough medication reconciliation is crucial.
• There is a warning regarding increased long-term mortality in patients with coronary artery disease who received clarithromycin in a post-trial follow-up study. This should be considered when prescribing to this population.
• Risk of C. difficile-associated diarrhea (CDAD) is present with clarithromycin, as with nearly all antibiotics. Patients should be advised to report severe, persistent diarrhea.
• While generally well-tolerated, GI side effects (nausea, vomiting, abdominal pain, diarrhea) are common.

• 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 antibiotics depending on the specific pathogen and infection site.

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 occurred.