Augmentin ES-600mg Susp 125ml

Amoxicillin is a beta-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to bacterial lysis and death. Clavulanate potassium is a beta-lactamase inhibitor that irreversibly binds to and inactivates a wide range of bacterial beta-lactamase enzymes, thereby protecting amoxicillin from hydrolysis and extending its antibacterial spectrum against beta-lactamase-producing strains.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you or your child experience 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
Rarely, some allergic reactions can be fatal.
Signs of drug-induced enterocolitis syndrome, a type of allergic reaction, such as:
+ Vomiting within 1 to 4 hours after taking this medication
+ Diarrhea within 24 hours after taking this medication
+ Pale or gray skin
+ Feeling tired or unwell
+ Signs of low blood pressure, such as severe dizziness or passing out
Vaginal irritation or discharge
Fever or chills
Unexplained bruising or bleeding
Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form called C. diff-associated diarrhea (CDAD) may occur, which can lead to a life-threatening bowel problem. If your child experiences:
+ Stomach pain
+ Cramps
+ Very loose, watery, or bloody stools
Contact your child's doctor right away. Before treating diarrhea, consult with your child's doctor.
Liver problems have been reported with this medication, and in rare cases, have been fatal. If your child exhibits signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Contact the doctor immediately.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, may occur. These reactions can affect body organs and be life-threatening. Seek medical help right away if your child experiences:
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, eyes, genitals, or any areas of skin
+ Fever
+ Chills
+ Body aches
+ Shortness of breath
+ Swollen glands

Other Possible Side Effects

All medications can cause side effects, but many people experience no side effects or only minor ones. If your child experiences any of the following side effects or any other side effects that bother them or do not go away, contact your child's doctor or seek medical attention:

Diarrhea
Upset stomach
Vomiting
* Diaper rash

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your child's doctor for medical advice.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

If your child has a known allergy to this medication, any of its components, or other drugs, foods, or substances. Please describe the allergy and the symptoms your child experienced.
If your child is allergic to penicillin.
If your child has kidney disease.
If your child has previously experienced liver problems or turned yellow while taking this medication.
If your child has mononucleosis (mono).
If your child is currently taking probenecid.

This list is not exhaustive, and it is crucial to discuss all your child's medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. Before starting, stopping, or changing the dose of any medication, ensure you consult with your doctor to confirm it is safe to do so with your child's specific health conditions and medications.

It is essential to inform all of your child's healthcare providers, including doctors, nurses, pharmacists, and dentists, that your child is taking this medication.

If your child is taking this medication long-term, regular blood tests will be necessary to monitor their condition. Consult with your child's doctor to discuss the details.

This medication may interfere with certain laboratory tests, so it is crucial to notify all healthcare providers and laboratory personnel that your child is taking this drug.

For children with diabetes who test their urine glucose levels, consult with your child's doctor to determine the most suitable testing methods, as this medication may affect the results.

If your child has phenylketonuria (PKU), consult with their doctor, as some products contain phenylalanine.

Do not administer this medication to your child for an extended period beyond the recommended duration, as this may increase the risk of a secondary infection.

A common side effect of this medication is a change in tooth color, typically to a yellow-gray-brown shade, which is more frequently reported in children. In most cases, the discoloration lessens or disappears with regular brushing or dental cleaning. If you notice any changes in your child's tooth color, consult with their doctor.

For children who are or may become sexually active, it is essential to note that this medication may reduce the effectiveness of birth control pills and other hormone-based contraceptives. To prevent pregnancy, your child should use an additional form of birth control, such as a condom, while taking this medication.

If your child is pregnant, becomes pregnant, or is breastfeeding, consult with their doctor to discuss the potential benefits and risks to both your child and the baby.

• Methotrexate: Amoxicillin can decrease renal tubular secretion of methotrexate, increasing its plasma concentrations and potential toxicity. Avoid concomitant use or monitor methotrexate levels closely.
• Warfarin and other oral anticoagulants: May prolong prothrombin time (INR). Monitor INR closely and adjust anticoagulant dose as needed.

• Allopurinol: Concomitant use with amoxicillin may increase the incidence of skin rash, particularly in patients with hyperuricemia.
• Oral Contraceptives: May reduce the efficacy of oral contraceptives. Advise patients to use an alternative or additional method of contraception.
• Probenecid: Decreases renal tubular secretion of amoxicillin, resulting in increased and prolonged blood levels of amoxicillin. Not recommended for concomitant use.
• Mycophenolate mofetil: Amoxicillin/clavulanate may reduce mycophenolate mofetil concentrations. Monitor for reduced efficacy of mycophenolate.

• Typhoid vaccine (live, oral): Antibiotics may inactivate the live bacterial vaccine. Administer at least 24 hours apart.

• Diarrhea (especially severe or bloody diarrhea, which could indicate C. difficile-associated diarrhea)
• Skin rash, itching, hives (signs of allergic reaction)
• Difficulty breathing or swallowing, swelling of face/lips/tongue (signs of severe allergic reaction/anaphylaxis)
• Yellowing of skin or eyes (jaundice), dark urine, pale stools, abdominal pain (signs of liver dysfunction)
• Unusual bruising or bleeding (potential effect on coagulation)
• Signs of superinfection (e.g., oral thrush, vaginal yeast infection)

Category B. Studies in animals have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. Generally considered safe for use during pregnancy when clearly needed.

L2 (Safer). Both amoxicillin and clavulanate are excreted in breast milk in small amounts. Generally considered compatible with breastfeeding, but monitor the infant for potential adverse effects.

Augmentin ES-600 is specifically formulated and primarily indicated for pediatric patients (≥ 3 months of age) for specific infections like acute otitis media and sinusitis, where high-dose amoxicillin is required and the clavulanate component is minimized to reduce gastrointestinal side effects. Dosing is weight-based.

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. Dosage adjustment is necessary in elderly patients with impaired renal function.

• Augmentin ES-600 (14:1 ratio) is specifically designed for pediatric patients with acute otitis media and sinusitis where high-dose amoxicillin is needed, and the clavulanate component is minimized to reduce diarrhea.
• Always ensure the correct formulation (e.g., ES-600, 4:1, 7:1) is dispensed and administered, as the amoxicillin:clavulanate ratio varies and affects dosing and side effect profiles.
• Instruct patients to take the medication at the start of a meal to enhance absorption and reduce gastrointestinal intolerance.
• Emphasize the importance of completing the full course of therapy, even if symptoms improve, to prevent the development of antibiotic resistance.
• Reconstituted suspension must be refrigerated and discarded after 10 days.
• Monitor for signs of C. difficile-associated diarrhea, which can occur during or even several weeks after antibiotic therapy.

• Cefdinir (for AOM, sinusitis)
• Cefuroxime (for AOM, sinusitis)
• Ceftriaxone (parenteral, for severe AOM)
• Azithromycin (for penicillin-allergic patients, though resistance is a concern)
• Clindamycin (for penicillin-allergic patients, specific indications)

If your child's symptoms or health issues persist or worsen, it is essential to contact their doctor promptly. To ensure safe and effective treatment, never share your child's medication with others, and do not administer someone else's medication to your child. Some medications may come with additional patient information leaflets; if you have any questions or concerns about this medication, consult with your child's doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.