Clarithromycin 125mg/5ml Susp 50ml

Clarithromycin is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of susceptible microorganisms. This binding prevents the translocation of peptides, thereby inhibiting RNA-dependent protein synthesis and leading to a bacteriostatic effect. At high concentrations or against highly susceptible organisms, it may be bactericidal.

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 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

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
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, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
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 drugs, natural products, or vitamins, that should not be taken with this medication, such as certain medications used to treat high cholesterol, migraines, or mood disorders.

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. Do not initiate, discontinue, or modify the dosage of any medication without consulting your doctor first.

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 secondary infection. If you have diabetes (high blood sugar), 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 a prolonged QT interval, which can increase the risk of other potentially life-threatening abnormal heart rhythms. If you have a history of heart disease, consult your doctor, as one study found that patients with heart disease who took clarithromycin had a higher risk of death one 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.

Older adults (65 years 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, notify your doctor immediately, as it may harm the unborn baby.

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

• Colchicine (in patients with renal or hepatic impairment)
• HMG-CoA reductase inhibitors (statins) extensively metabolized by CYP3A4 (e.g., lovastatin, simvastatin) due to increased risk of myopathy/rhabdomyolysis
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine) due to acute ergot toxicity (vasospasm, ischemia)
• Lurasidone
• Pimozide
• Ticagrelor
• Ranolazine
• Midazolam (oral)
• Dronedarone
• Astemizole
• Terfenadine
• Cisapride

• Oral anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, apixaban) - increased bleeding risk
• Antiarrhythmics (e.g., amiodarone, disopyramide, dofetilide, quinidine, sotalol) - increased QT prolongation risk
• Other CYP3A4 substrates (e.g., carbamazepine, cyclosporine, tacrolimus, sirolimus, sildenafil, tadalafil, vardenafil, theophylline, phenytoin, digoxin) - increased drug levels
• Colchicine (in patients with normal renal/hepatic function) - increased colchicine toxicity
• Certain benzodiazepines (e.g., alprazolam, triazolam, IV midazolam) - increased sedation
• Verapamil - increased risk of hypotension, bradyarrhythmias, lactic acidosis
• Quetiapine - increased quetiapine exposure
• Fentanyl, Oxycodone - increased opioid effects
• Ibrutinib, Venetoclax - increased drug exposure

• Antidiabetic agents (e.g., nateglinide, repaglinide, insulin, sulfonylureas) - risk of hypoglycemia
• Corticosteroids (systemic) - increased corticosteroid exposure
• Omeprazole - increased clarithromycin and omeprazole levels
• Ritonavir and other strong CYP3A4 inhibitors - increased clarithromycin levels
• Inducers of CYP3A4 (e.g., rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort) - decreased clarithromycin levels
• Zidovudine - decreased zidovudine absorption (administer clarithromycin at least 4 hours apart)

• Not specifically categorized as minor, but general caution with any drug metabolized by or affecting CYP3A4.

• Severe or persistent diarrhea (may indicate C. difficile infection)
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Pale stools
• Unusual tiredness or weakness
• Severe stomach pain
• Nausea, vomiting
• Rash, itching, hives
• Swelling of face, lips, tongue, or throat (allergic reaction)
• Difficulty breathing or swallowing
• Dizziness, lightheadedness, fainting
• Palpitations or irregular heartbeat
• Muscle pain or weakness (especially if on statins)

Clarithromycin is 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 (L3 - Moderately Safe). Monitor breastfed infants for gastrointestinal disturbances (e.g., diarrhea, candidiasis) and potential effects on gut flora.

Clarithromycin oral suspension is commonly used in pediatric patients for various bacterial infections. Dosing is weight-based (7.5 mg/kg every 12 hours). Safety and efficacy in infants younger than 6 months have not been fully established for all indications. Caution is advised in neonates due to immature hepatic and renal systems.

No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustment is necessary for elderly patients with severe renal impairment (CrCl < 30 mL/min). Elderly patients may be more susceptible to QT prolongation and drug interactions due to polypharmacy and age-related physiological changes.

• Clarithromycin has a unique taste disturbance side effect, often described as metallic or bitter, which can affect patient adherence.
• It is a potent CYP3A4 inhibitor, leading to numerous significant drug interactions. Always perform a thorough medication reconciliation.
• Unlike some other macrolides, clarithromycin has an active metabolite (14-hydroxyclarithromycin) which also contributes to its antimicrobial activity.
• For H. pylori eradication, clarithromycin is typically used in combination with a proton pump inhibitor and another antibiotic (e.g., amoxicillin or metronidazole).
• Patients should be advised to report any signs of liver problems (jaundice, dark urine) or severe, persistent diarrhea (C. difficile) immediately.
• While generally well-tolerated, GI side effects (nausea, vomiting, diarrhea, abdominal pain) are common.

• Azithromycin (another macrolide, different pharmacokinetics and interaction profile)
• Erythromycin (older macrolide, more GI side effects, more frequent dosing)
• Amoxicillin (for susceptible bacterial infections)
• Doxycycline (for susceptible bacterial infections, atypical pathogens)
• Levofloxacin/Moxifloxacin (fluoroquinolones, broader spectrum, different side effect profile, resistance concerns)
• Cephalexin (cephalosporin, for skin/soft tissue infections)
• Penicillin V (for strep throat)

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 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.