Amox-Clav ES 600mg/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 protects amoxicillin from degradation by beta-lactamase enzymes produced by many resistant bacteria, thereby extending the antibacterial spectrum of amoxicillin.

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

It is essential to inform your doctor about the following:

If your child has an allergy to this medication, any of its components, or other medications, foods, or substances. Please describe the allergic reaction and the symptoms 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 taking probenecid.

This list is not exhaustive, and it is crucial to discuss all medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.

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, it is recommended to consult with their doctor to determine the most suitable testing methods.

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 prescribed duration, as this may increase the risk of a secondary infection.

A change in tooth color to yellow-gray-brown has been reported in some cases, primarily in children. In most instances, the discoloration lessened or resolved with regular brushing or dental cleaning. If you notice any changes in your child's tooth color, consult with their doctor.

For sexually active children:
Be aware that birth control pills and other hormone-based contraceptives may be less effective while taking this medication. It is recommended that your child uses an additional form of birth control, such as condoms, to prevent pregnancy.

For pregnant or breastfeeding children:
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.

• Warfarin (increased INR/bleeding risk)
• Methotrexate (increased methotrexate levels and toxicity)
• Allopurinol (increased incidence of rash)

• Oral Contraceptives (potential for reduced efficacy)
• Probenecid (increased and prolonged amoxicillin blood levels)
• Mycophenolate mofetil (reduced mycophenolic acid exposure)

• Diarrhea (especially severe or persistent, which could indicate C. difficile infection)
• Rash or hives (signs of allergic reaction)
• Itching
• Nausea/Vomiting
• Abdominal pain
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Unusual tiredness or weakness

Category B. Studies in animals have not shown harm to the fetus, but 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 small amounts into breast milk. Generally considered compatible with breastfeeding.

The ES-600 formulation is specifically designed for pediatric use, particularly for acute otitis media, sinusitis, and community-acquired pneumonia. Dosing is weight-based (mg/kg/day) and should be carefully calculated. Not recommended for infants younger than 3 months.

Dosage adjustment may be necessary in elderly patients due to a higher likelihood of decreased renal function. Monitor renal function. Hepatic function should also be monitored, as elderly patients may be more susceptible to hepatic dysfunction.

• The ES-600 formulation (600mg amoxicillin / 42.9mg clavulanate per 5ml) has a 14:1 amoxicillin to clavulanate ratio, which is different from other Augmentin formulations (e.g., 2:1, 4:1, 7:1). This higher amoxicillin ratio is designed to provide higher amoxicillin concentrations for specific pediatric infections like resistant otitis media.
• Always ensure the correct formulation (e.g., ES-600 vs. standard Augmentin) is prescribed and dispensed, as the clavulanate content varies significantly.
• Reconstituted suspension must be refrigerated and discarded after 10 days.
• Counsel patients to complete the full course of therapy to prevent resistance and ensure eradication of infection.
• Advise patients to take with food to minimize gastrointestinal side effects, which are common with amoxicillin/clavulanate.

• Cephalosporins (e.g., cefdinir, cefuroxime, ceftriaxone)
• Macrolides (e.g., azithromycin, clarithromycin) - if susceptible and beta-lactam allergy
• Fluoroquinolones (e.g., levofloxacin, moxifloxacin) - generally not first-line for pediatric infections due to side effect profile
• Clindamycin (for specific anaerobic or Gram-positive infections)

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 amount, and the time it occurred.