Clarithromycin 125mg/5ml Susp 100ml

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 higher 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 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 eyesight

Important: Antibiotic-Associated 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. This condition can 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.

Severe Skin Reactions

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

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 can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Stomach pain or 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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have previously experienced liver problems while taking this medication.
If you have a history of abnormal heart rhythms, including a prolonged QT interval on an electrocardiogram (ECG).
If you have any of the following health conditions: low magnesium levels, low potassium levels, or a slow heartbeat.
* If you are taking any medications, including prescription and over-the-counter (OTC) drugs, natural products, or vitamins, that may interact with this medication. Certain medications, such as those used to treat high cholesterol, migraines, or mood disorders, should not be taken with this drug.

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 inform your doctor and pharmacist about all your medications and health conditions to ensure safe use. Always check with your doctor before starting, stopping, or changing the dose of any medication to guarantee your safety.

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 a history of 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 yielded 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.

Individuals 65 years or older should exercise caution when using 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
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine)
• Pimozide
• Cisapride
• Astemizole
• Terfenadine

• Oral anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, apixaban)
• Antiarrhythmics (e.g., digoxin, quinidine, disopyramide, amiodarone)
• Calcium channel blockers (e.g., verapamil, amlodipine, diltiazem)
• Immunosuppressants (e.g., cyclosporine, tacrolimus, sirolimus)
• Antidiabetics (e.g., sulfonylureas, repaglinide, nateglinide)
• Benzodiazepines (e.g., midazolam, triazolam)
• Theophylline
• Carbamazepine
• Phenytoin
• Sildenafil, Tadalafil, Vardenafil
• Rifabutin
• Rifampin
• Atazanavir, Ritonavir, Saquinavir (other protease inhibitors)
• Ivabradine
• Ranolazine

• Omeprazole
• Zidovudine
• Efavirenz
• Fluconazole
• Itraconazole
• Ketoconazole
• Cimetidine
• Grapefruit juice

• Antacids (aluminum hydroxide, magnesium hydroxide) - may delay absorption but not extent.

• Diarrhea (especially severe or bloody)
• Abdominal pain or cramping
• Nausea
• Vomiting
• Unusual or metallic taste in mouth
• Headache
• Rash or itching
• Signs of liver problems (yellowing eyes/skin, dark urine, unusual fatigue)
• Signs of kidney problems (changes in urination)
• Signs of allergic reaction (swelling of face/throat, difficulty breathing)
• Muscle pain or weakness (especially if on statins)
• Dizziness or lightheadedness
• Palpitations or irregular heartbeat

Category C. Clarithromycin 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 and its active metabolite are excreted into human breast milk. The amount is small, but there is a potential for adverse effects on the breastfed infant, such as changes in gut flora (diarrhea, candidiasis), and theoretical risk of effects on developing teeth (though less likely than with tetracyclines). Use with caution.

Clarithromycin oral suspension is commonly used and well-established for pediatric bacterial infections (e.g., otitis media, pharyngitis, pneumonia). Dosing is weight-based. Safety and efficacy in children under 6 months have not been fully established for all indications.

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 decreased renal function, which may require dose adjustment. Increased risk of drug interactions due to polypharmacy and increased risk of QT prolongation.

• 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. Always perform a thorough medication reconciliation.
• Risk of C. difficile-associated diarrhea (CDAD) is present with nearly all antibacterial agents, including clarithromycin. Consider CDAD in patients who present with diarrhea after antibiotic use.
• Unlike erythromycin, clarithromycin has less gastrointestinal prokinetic activity, leading to better GI tolerability for some patients.
• The 14-hydroxy metabolite of clarithromycin is active and contributes to its antibacterial spectrum, particularly against H. influenzae.
• There have been post-marketing reports of QT prolongation and ventricular arrhythmias, including Torsades de Pointes, with clarithromycin. Use with caution in patients with pre-existing QT prolongation, uncorrected hypokalemia/hypomagnesemia, or on other QT-prolonging drugs.

• Penicillins (e.g., amoxicillin, penicillin V)
• Cephalosporins (e.g., cefdinir, cefuroxime)
• Tetracyclines (e.g., doxycycline, minocycline - generally not for young children)
• Fluoroquinolones (e.g., levofloxacin, moxifloxacin - generally not first-line for pediatric use)
• Lincosamides (e.g., clindamycin)

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, including the amount taken and the time it happened, to ensure you receive the best possible care.