Amox-Clav ES 600mg/5ml 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. Clavulanate is a beta-lactamase inhibitor that irreversibly binds to and inactivates a wide range of beta-lactamase enzymes produced by many Gram-positive and Gram-negative bacteria, thereby protecting amoxicillin from degradation 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 while 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, 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 help:

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 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 interactions with 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 issues they may have. Always verify with your doctor that it is safe to take this medication alongside other medications 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 will be taking this drug for an extended period, 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. 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.

For children with phenylketonuria (PKU), it is essential to discuss this condition with your child's 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 contraceptives 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 your child's treatment.

• History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate.

• Warfarin (increased INR/bleeding risk due to altered gut flora and vitamin K synthesis)
• Methotrexate (increased methotrexate toxicity due to reduced renal clearance)
• Allopurinol (increased incidence of skin rash, particularly in hyperuricemic patients)

• Probenecid (increases and prolongs amoxicillin blood levels by decreasing renal tubular secretion)
• Oral Contraceptives (potential for reduced efficacy, though evidence is controversial and not consistently demonstrated)
• Mycophenolate Mofetil (reduced mycophenolate exposure due to disruption of enterohepatic recirculation)

• Tetracyclines (may antagonize the bactericidal effect of amoxicillin)
• Chloramphenicol, Macrolides, Sulfonamides (may antagonize the bactericidal effect of amoxicillin)

• Skin rash, hives, itching (signs of allergic reaction)
• Swelling of face, lips, tongue, or throat (angioedema)
• Difficulty breathing or swallowing (anaphylaxis)
• Severe or persistent diarrhea, abdominal pain, fever (C. difficile-associated diarrhea)
• Yellowing of skin or eyes (jaundice), dark urine, pale stools (signs of liver problems)
• Unusual bruising or bleeding (if on warfarin)
• Nausea, vomiting, abdominal discomfort

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.

L1 (Safest). Both amoxicillin and clavulanate are excreted in breast milk in small amounts. Generally considered compatible with breastfeeding.

This ES-600 formulation is specifically designed and dosed for pediatric patients, particularly for acute otitis media and sinusitis. Dosage is weight-based (90 mg/kg/day of amoxicillin component). Close monitoring for gastrointestinal side effects and candidiasis is important.

Dosage adjustment may be necessary based on renal function, as elderly patients are more likely to have decreased renal clearance. Monitor for adverse effects, particularly gastrointestinal and hepatic, as elderly patients may be more susceptible.

• Amox-Clav ES-600 is specifically formulated for pediatric patients with acute otitis media or sinusitis where higher amoxicillin dosing is needed, often due to penicillin-resistant S. pneumoniae or beta-lactamase producing organisms.
• Always ensure the correct formulation (e.g., ES-600 vs. other Augmentin strengths) is prescribed and dispensed, as the clavulanate ratio differs significantly.
• Instruct patients to shake the suspension well before each use and to use an accurate measuring device.
• Taking with food helps reduce gastrointestinal side effects, which are common with this medication.
• Emphasize the importance of completing the full course of antibiotics to prevent resistance, even if symptoms improve.
• Counsel parents on potential side effects like diarrhea and rash, and when to seek medical attention.

• Cefdinir (for AOM/ABS)
• Cefuroxime (for AOM/ABS)
• Ceftriaxone (injectable, for severe AOM/ABS)
• Azithromycin (for AOM/ABS, though resistance is a concern for S. pneumoniae)
• Clindamycin (for penicillin-allergic patients with certain infections)
• Levofloxacin (for severe infections in older children/adults, generally reserved due to side effects)

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 medical attention. When reporting the incident, be prepared to provide detailed information, including the substance taken, the quantity, and the time it occurred.