Augmentin Es Suspension (50 Ml)

AUGMENTIN ES SUSPENSION (50 ML) by GLAXO SMITHKLINE PHARMACEUTICALS LIMITED

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• Brand Name: AUGMENTIN ES SUSPENSION
• Common Names: Amoxicillin and Clavulanate Potassium Oral Suspension

Composition: AUGMENTIN ES SUSPENSION contains two active ingredients: Amoxicillin trihydrate and Potassium clavulanate (or clavulanic acid). When reconstituted, each 5 mL of the suspension contains 600 mg of amoxicillin and 42.9 mg of clavulanic acid.

Uses: AUGMENTIN ES SUSPENSION is an antibiotic prescribed for bacterial infections, primarily in pediatric patients. It is specifically indicated for acute otitis media (AOM), including persistent or recurrent AOM, caused by susceptible bacteria such as Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. It also treats other bacterial infections like those of the lungs (e.g., pneumonia), ear, nasal sinus, urinary tract, skin, and soft tissues. It is not effective against viral infections.

Dosage and Administration: For pediatric patients aged 3 months and older, weighing less than 40 kg, the recommended dose is 90 mg/kg/day (based on amoxicillin) given in two divided doses every 12 hours, for 10 days. The suspension should be taken at the start of a meal to minimize gastrointestinal discomfort and enhance absorption. Before administration, the powder must be reconstituted with water as directed, and the bottle should be shaken well before each use.

Side Effects: Common side effects may include diarrhea, nausea, vomiting, skin rash, and fungal infections such as mucocutaneous candidiasis or vaginal yeast infection. More serious, though rare, side effects can include severe allergic reactions (e.g., anaphylaxis, Stevens-Johnson syndrome), liver problems (jaundice), and Clostridium difficile-associated diarrhea.

Precautions: AUGMENTIN ES is contraindicated in patients with a history of hypersensitivity to penicillins or other beta-lactam antibiotics, or those with a history of liver dysfunction associated with amoxicillin/clavulanate. Caution is advised for patients with renal impairment, and dose adjustments may be necessary or the medicine may be not recommended depending on the degree of impairment. It contains aspartame, which is a source of phenylalanine, so it should be used with caution in patients with phenylketonuria. Concomitant use with probenecid is not recommended, and allopurinol may increase the likelihood of allergic skin reactions.

Storage: The dry powder for oral suspension should be stored in a cool, dry place below 25°C or 30°C, protected from moisture. Once reconstituted, the suspension must be stored in a refrigerator (2°C to 8°C) and used within 10 days; it should not be frozen. Discard any unused portion after 10 days.

Frequently Asked Questions about AUGMENTIN ES SUSPENSION (50 ML)

AUGMENTIN ES SUSPENSION (50 ML) is an antibiotic medication widely used to treat bacterial infections, particularly in children. It combines two active ingredients: amoxicillin and clavulanic acid. This FAQ aims to provide concise and accurate information about this medicine.

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1. What is AUGMENTIN ES SUSPENSION used for?

AUGMENTIN ES SUSPENSION is primarily used to treat a variety of bacterial infections, especially in pediatric patients (3 months to 12 years old). These include recurrent or persistent acute otitis media (middle ear infection), as well as infections of the lungs (e.g., pneumonia), ear, nasal sinus, throat, urinary tract, skin, soft tissue, and bones. It is important to note that it is ineffective against viral infections like the common cold.

2. How does AUGMENTIN ES SUSPENSION work?

This medicine works through the combined action of its two components: amoxicillin and clavulanic acid. Amoxicillin is a penicillin-type antibiotic that works by stopping the growth of bacteria by preventing the formation of their protective cell walls, which are essential for their survival. Clavulanic acid is a beta-lactamase inhibitor. Some bacteria produce enzymes called beta-lactamases that can break down amoxicillin, making it ineffective. Clavulanic acid blocks these enzymes, thereby protecting amoxicillin and enhancing its ability to kill a wider range of bacteria.

3. What is the usual dosage for AUGMENTIN ES SUSPENSION?

For pediatric patients aged 3 months and older, the recommended dose of AUGMENTIN ES SUSPENSION is 90 mg/kg/day (based on the amoxicillin component) divided into two doses, administered every 12 hours for 10 days. The dosage should be carefully measured using a special measuring device, not a household spoon. It is crucial to follow your doctor's specific instructions for dosing based on the child's age, weight, and the severity of the infection. There is no experience with this specific formulation in adults or children weighing over 40 kg.

4. What are the possible side effects of AUGMENTIN ES SUSPENSION?

Common side effects include diarrhea, nausea, vomiting, skin rash, and fungal infections (like oral thrush or vaginal yeast infection). These are usually mild to moderate and temporary. More serious, but rare, side effects can include severe stomach pain, watery or bloody diarrhea, signs of liver problems (such as persistent nausea/vomiting, dark urine, yellowing eyes/skin), easy bruising or bleeding, and severe allergic reactions (e.g., hives, difficulty breathing, swelling of the face/tongue/throat). If any serious side effects occur, medical attention should be sought immediately.

5. Is AUGMENTIN ES SUSPENSION safe during pregnancy or breastfeeding?

During pregnancy, AUGMENTIN ES SUSPENSION should be used only when clearly needed and as advised by a doctor. Animal studies have not shown harmful effects, and limited human data do not indicate an increased risk of congenital malformations. However, caution is advised, especially as one study suggested a potential increased risk of necrotizing enterocolitis in newborns when used for preterm premature rupture of membranes.

Amoxicillin and clavulanic acid are excreted in human milk. While generally considered safe during breastfeeding, caution should be exercised as it can cause symptoms in breastfed babies such as diarrhea, discomfort, or rash. Consult your doctor before breastfeeding while on this medication.

6. Can AUGMENTIN ES SUSPENSION be taken with other medications?

Yes, AUGMENTIN ES SUSPENSION can interact with other medications. It's important to inform your doctor about all medications, supplements, and herbal products you are currently taking. Notable interactions include:

• Probenecid: Can increase and prolong blood levels of amoxicillin.
• Allopurinol: May increase the incidence of rashes.
• Oral Contraceptives: Amoxicillin/clavulanate may reduce the efficacy of oral contraceptives.
• Methotrexate: AUGMENTIN ES SUSPENSION can increase methotrexate levels, raising the risk of side effects.
• Warfarin (and other oral anticoagulants): May increase the blood-thinning effects and risk of bleeding. Close monitoring and possible dosage adjustments may be necessary.
• Live bacterial vaccines (e.g., typhoid vaccine): May not work as effectively.

7. What precautions should be taken while using AUGMENTIN ES SUSPENSION?

Do not use AUGMENTIN ES SUSPENSION if you have a history of hypersensitivity or allergic reactions to penicillins, cephalosporins, or other beta-lactam antibiotics. Patients with a history of liver disease or severe kidney impairment should use this medication with caution, and hepatic function may need to be monitored. The suspension contains aspartame and should be used with caution in patients with phenylketonuria. It is crucial to complete the full course of therapy as prescribed, even if symptoms improve, to prevent antibiotic resistance and ensure the infection is fully treated.

8. What happens if a dose of AUGMENTIN ES SUSPENSION is missed?

If a dose is missed, take it as soon as you remember. However, if it is almost time for the next scheduled dose, skip the missed dose and take the next dose at the regular time. Do not double the dose to make up for a missed one, as this can increase the risk of side effects. It is important to maintain consistent medication levels to effectively treat the infection and prevent resistance.

9. How should AUGMENTIN ES SUSPENSION be stored?

The dry powder for oral suspension should be stored at room temperature, generally below 25°C (77°F), in its original container, protected from moisture. Once reconstituted with water, the suspension must be stored in a refrigerator (2°C to 8°C) and used within 10 days. Do not freeze the reconstituted suspension. Any unused medicine after this period should be discarded. Shake the bottle well before each use of the reconstituted suspension.