Augmentin ES 600/5ml Susp 75ml

Amoxicillin is a beta-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to bacterial lysis. 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.

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 with this medication. These reactions can affect body organs and be fatal. 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 all possible side effects. If you have questions or concerns about side effects, contact your child's doctor for medical advice.

Before Your Child Takes This Medication: Inform Your Doctor If:
- Your child has an allergy to this medication, any of its components, or other drugs, foods, or substances, and describe the allergic reaction they experienced.
- Your child is allergic to penicillin.
- Your child has kidney disease.
- Your child has previously experienced jaundice (turned yellow) or liver-related side effects while taking this medication.
- Your child has mononucleosis (mono).
- Your child is currently taking probenecid.

Important: This list does not include all possible drug interactions or health issues that may affect the use of this medication. It is crucial to inform your doctor and pharmacist about all prescription and over-the-counter medications, natural products, and vitamins your child is taking, as well as any health problems they have. Always verify with your doctor that it is safe to take this medication alongside other drugs and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

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 drug for an extended period, regular blood tests will be necessary to monitor their condition. Be sure to discuss this with your child's doctor.

This medication may interfere with certain laboratory tests, so it is crucial to notify all healthcare providers and lab personnel that your child is taking this drug. If your child has diabetes and you are testing their urine glucose levels, consult with your child's doctor to determine the most suitable tests to use.

If your child has phenylketonuria (PKU), consult with their doctor, as some products may contain phenylalanine. Do not administer this medication to your child for longer than prescribed, as this may increase the risk of a second infection.

A possible side effect of this medication is a change in tooth color to yellow-gray-brown, which has been reported primarily 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.

If your child is sexually active or may become sexually active, it is essential to note that birth control pills and other hormone-based birth control methods may be less effective while taking this medication. To prevent pregnancy, your child should use an additional form of birth control, such as a condom, in conjunction with 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. This will help you make an informed decision about their care.

• Warfarin (increased INR, bleeding risk)
• Methotrexate (increased methotrexate levels, toxicity)
• Allopurinol (increased risk of rash)

• Probenecid (increases amoxicillin levels by decreasing renal tubular secretion)
• Oral Contraceptives (potential for reduced efficacy, though clinical significance debated)
• Mycophenolate Mofetil (reduced MMF exposure, monitor clinical response)

• Diarrhea (especially severe or bloody)
• Abdominal pain
• Nausea
• Vomiting
• Skin rash
• Hives
• Itching
• Difficulty breathing or swallowing
• Swelling of face, throat, or tongue
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Unusual tiredness
• Flu-like symptoms

Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefits outweigh the potential risks.

Amoxicillin and clavulanate are excreted in breast milk. Generally considered compatible with breastfeeding, but monitor the infant for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic sensitization.

Augmentin ES-600 is specifically formulated and dosed for pediatric patients (≥3 months) for certain infections (e.g., acute otitis media) where a higher amoxicillin dose and beta-lactamase inhibition are required. 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. Monitor for adverse effects, especially gastrointestinal and hepatic.

• Augmentin ES-600 has a unique 14:1 amoxicillin to clavulanate ratio, designed to deliver a higher amoxicillin dose while minimizing clavulanate exposure, which can cause GI side effects. This ratio is particularly useful for pediatric acute otitis media (AOM) where high-dose amoxicillin is indicated and beta-lactamase producing strains are suspected.
• Always ensure the correct formulation (ES-600) is dispensed, as other Augmentin suspensions have different ratios (e.g., 4:1 or 7:1) and different dosing instructions.
• Instruct patients to shake the suspension well before each use and to use an accurate measuring device.
• Refrigeration is required for the reconstituted suspension, and it must be discarded after 10 days.
• Counsel patients on the importance of taking the medication with food to reduce gastrointestinal side effects, which are common with amoxicillin/clavulanate.
• Emphasize completing the full course of therapy, even if symptoms improve, to prevent resistance and recurrence of infection.

• Other beta-lactam antibiotics (e.g., cefdinir, cefuroxime, ceftriaxone for AOM/sinusitis)
• Macrolide antibiotics (e.g., azithromycin, clarithromycin, if penicillin allergy or specific pathogen)
• Fluoroquinolones (e.g., levofloxacin, moxifloxacin, typically for adults or specific severe infections)
• Other antibiotic classes depending on the specific infection and pathogen susceptibility.

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 an additional patient information leaflet; 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 call the poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the substance taken, the amount, and the time it occurred.