Co Amoxiclav (Amocled) 125mg/31.25/5ml Powder for Oral Suspension 60ml

Product Description:

Co-Amoxiclav (Amocled) 125mg/31.25mg/5ml Powder for Oral Suspension is a combination antibiotic used for the treatment of a variety of bacterial infections. It contains Amoxicillin (125mg) and Clavulanic acid (31.25mg) in a 5ml dose of suspension. Amoxicillin is a penicillin-type antibiotic that works by inhibiting the growth of bacteria, while Clavulanic acid helps prevent bacterial resistance by inhibiting beta-lactamase, an enzyme produced by certain bacteria that would otherwise inactivate amoxicillin. This combination allows Co-Amoxiclav to treat a broader spectrum of bacterial infections compared to amoxicillin alone.

The oral suspension form is designed for easier administration in children and adults who may have difficulty swallowing tablets or capsules.

Indications:

Co-Amoxiclav (Amocled) is indicated for the treatment of infections caused by susceptible bacteria, including:

1. Respiratory tract infections:

   • Pneumonia and bronchitis (including chronic obstructive pulmonary disease exacerbations).

   • Sinusitis and pharyngitis.

   • Otitis media (middle ear infections).

2. Urinary tract infections (UTIs):

   • Cystitis (bladder infections).

   • Pyelonephritis (kidney infections).

3. Skin and soft tissue infections:

   • Abscesses, cellulitis, and wound infections.

4. Dental infections:

   • Abscesses or infections after dental procedures.

5. Bone and joint infections:

   • For conditions like osteomyelitis.

6. Intra-abdominal infections:

   • Including infections like peritonitis or intra-abdominal abscesses.

7. Gastrointestinal infections:

   • Infections caused by susceptible organisms.

Dosage and Administration:

Dosage:

• The typical dosage is based on the severity of the infection and the patient's age and weight. Co-Amoxiclav (Amocled) should be administered orally after shaking the suspension well to ensure an even distribution of the medication.

1. Adults and Children over 12 years:

   • Mild to moderate infections: 5ml (125mg/31.25mg) every 8 hours.

   • Severe infections: 10ml (250mg/62.5mg) every 8 hours.

2. Children (under 12 years):

   • The dosage depends on the child's weight and the type of infection. For children aged 2-12 years, the typical dose is:

     • 20-40mg/kg body weight per day divided into 2-3 doses, depending on the severity of the infection.

   • For infants and toddlers (under 2 years), dosing should be adjusted carefully according to the weight and physician's recommendation.

Preparation of Suspension:

• Add the appropriate amount of water to the powder to make the suspension, as per the manufacturer's instructions.

• Shake the bottle thoroughly before each dose to ensure uniform suspension.

Side Effects:

Common side effects associated with Co-Amoxiclav (Amocled) may include:

1. Gastrointestinal issues:

   • Diarrhea

   • Nausea

   • Vomiting

   • Abdominal discomfort or pain

2. Skin reactions:

   • Rashes or hives

   • Itching or mild skin irritation

3. Liver-related effects:

   • Elevated liver enzymes (which are typically reversible once the medication is stopped).

4. Headache or dizziness.

Serious Side Effects (Less common but require immediate medical attention):

1. Severe allergic reactions:

   • Anaphylaxis (a severe allergic reaction with difficulty breathing, swelling of the face and throat, or rash).

2. Severe skin reactions:

   • Stevens-Johnson Syndrome (a rare, severe form of a skin reaction).

   • Toxic epidermal necrolysis (a life-threatening skin condition).

3. Hepatic injury:

   • Severe liver issues, including hepatitis or jaundice.

4. Blood disorders:

   • Thrombocytopenia (low platelet count).

   • Leukopenia (low white blood cell count).

   • Hemolytic anemia (destruction of red blood cells).

5. Renal impairment:

   • Symptoms may include dark urine, swelling, or changes in urine output.

Contraindications:

Co-Amoxiclav (Amocled) should not be used in the following conditions:

1. Allergy to penicillin or cephalosporins:

   • If a patient is allergic to penicillin, cephalosporins, or clavulanic acid, Co-Amoxiclav should not be used due to the risk of severe allergic reactions (e.g., anaphylaxis).

2. History of severe liver damage:

   • Liver dysfunction or jaundice associated with previous use of amoxicillin or amoxicillin/clavulanate combination drugs is a contraindication.

3. Mononucleosis (Infectious mononucleosis):

   • Patients with mononucleosis are at an increased risk of developing rashes when treated with amoxicillin, so this medication should not be used in these patients.

4. Severe renal impairment:

   • Caution should be used in patients with severe kidney dysfunction (creatinine clearance less than 30mL/min). The dose may need adjustment.

5. **Patients with a history of cholestatic jaundice or liver dysfunction related to prior amoxicillin/clavulanic acid therapy should avoid this medication.

Precautions:

1. Renal Impairment:

   • In patients with kidney problems, dose adjustment is necessary, and renal function should be monitored during therapy.

2. Clostridium difficile-associated diarrhea:

   • Co-Amoxiclav can cause gastrointestinal disturbances, including diarrhea, which may be associated with C. difficile infection. If severe diarrhea occurs, the drug should be discontinued, and appropriate medical attention should be sought.

3. Prolonged use:

   • Prolonged use can lead to overgrowth of non-susceptible organisms, including yeasts like Candida. If superinfection occurs, the drug should be discontinued, and appropriate treatment should be initiated.

4. Pregnancy and Breastfeeding:

   • Pregnancy: Co-Amoxiclav can be used during pregnancy if the benefits outweigh the risks, but it is important to consult a healthcare provider first.

   • Breastfeeding: The drug is excreted in breast milk, but it is generally considered safe for use during breastfeeding in appropriate doses. However, monitoring of the infant for potential side effects (e.g., diarrhea or rash) is recommended.

5. Antibiotic Resistance:

   • Like all antibiotics, Co-Amoxiclav should be used as prescribed, and not overused, to help prevent the development of antibiotic-resistant bacteria.

Drug Interactions:

• Oral contraceptives: Co-Amoxiclav may reduce the effectiveness of oral contraceptives. Additional contraceptive measures are recommended.

• Methotrexate: Concomitant use with methotrexate may increase the toxicity of methotrexate.

• Warfarin: Co-Amoxiclav may increase the effects of warfarin (blood thinners), increasing the risk of bleeding.

• Probenecid: Co-administration with probenecid can increase blood levels of amoxicillin.

Summary:

Co-Amoxiclav (Amocled) 125mg/31.25mg/5ml Powder for Oral Suspension is an effective antibiotic used for treating a range of bacterial infections, including respiratory, urinary, skin, and soft tissue infections. It is especially useful in patients who may have difficulty swallowing tablets. It is well tolerated but may cause side effects such as nausea, diarrhea, and allergic reactions. Care should be taken in patients with liver or kidney problems. It is contraindicated in patients with a history of severe allergies to penicillins, mononucleosis, or liver disease. Always consult with a healthcare provider before starting treatment with Co-Amoxiclav to ensure appropriate use.