Amox-Clav ES 600mg/5ml Susp 200ml

Amoxicillin is a beta-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to one or more penicillin-binding proteins (PBPs), thereby inhibiting the final transpeptidation step of peptidoglycan synthesis in the bacterial cell wall. This leads to inhibition of cell wall biosynthesis and eventually to bacterial cell lysis. Clavulanate potassium is a beta-lactamase inhibitor that protects amoxicillin from degradation by beta-lactamase enzymes produced by many resistant bacteria. It binds irreversibly to beta-lactamase enzymes, preventing them from inactivating 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 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

Like all medications, this drug may cause side effects. Many people experience no side effects or only mild ones. If your child experiences any of the following side effects or any other symptoms 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 an allergy to this medication, any of its components, or other medications, foods, or substances. Be sure to discuss the specific allergy and any symptoms your child has 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 disclose all medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or modify 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 medication long-term, regular blood tests will be necessary to monitor their condition. Consult with your child's doctor to discuss the details of this monitoring.

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 undergo urine glucose testing, it is recommended to consult with their doctor to determine the most suitable testing methods, as this medication may affect the accuracy of these tests.

If your child has phenylketonuria (PKU), consult with their doctor, as some formulations of this medication may 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 common side effect of this medication is a change in tooth color, typically to a yellow-gray-brown hue, which has been reported primarily in children. In most cases, this discoloration can be alleviated or reversed 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: It is essential to note that this medication may reduce the effectiveness of birth control pills and other hormone-based contraceptives. To prevent pregnancy, it is recommended that your child uses an additional form of birth control, such as condoms, 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 of this medication to both your child and the baby.

• Allopurinol (increased risk of rash with amoxicillin)
• Methotrexate (decreased renal clearance of methotrexate, leading to increased toxicity)
• Warfarin and other oral anticoagulants (may prolong prothrombin time/INR, increased bleeding risk)

• Oral contraceptives (may reduce efficacy of oral contraceptives, advise backup contraception)
• Probenecid (decreases renal tubular secretion of amoxicillin, increasing amoxicillin levels and prolonging half-life)
• Mycophenolate mofetil (reduced mycophenolic acid concentration, monitor clinical response)

• Tetracyclines (may antagonize the bactericidal effect of penicillin)

• Skin rash, hives, itching
• Difficulty breathing or swallowing
• Swelling of face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• Hoarseness
• Severe diarrhea (watery or bloody)
• Stomach pain or cramps
• Nausea, vomiting
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Pale stools
• Unusual tiredness or weakness
• Fever, sore throat, chills (signs of superinfection)
• Vaginal itching or discharge
• White patches in mouth or on tongue

Amoxicillin/clavulanate is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. It is generally considered safe for use during pregnancy when clearly needed, but should be used with caution and only if the potential benefit justifies the potential risk.

Amoxicillin and clavulanate are excreted in small amounts into breast milk. Generally considered compatible with breastfeeding (Lactation Risk Category L2).

This ES-600 formulation is specifically designed for pediatric use, particularly for the treatment of acute otitis media and sinusitis in children where a high dose of amoxicillin is required and beta-lactamase producing organisms are suspected. Dosing is weight-based (mg/kg/day). Close monitoring for gastrointestinal side effects and rash is important.

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 primarily based on renal function, which is often diminished in the elderly. Monitor renal function closely.

• Amox-Clav ES-600 (14:1 ratio) is specifically formulated for pediatric patients requiring high-dose amoxicillin for infections like acute otitis media and sinusitis, where beta-lactamase producing strains are common.
• Always ensure the correct formulation (e.g., ES-600 vs. 7:1 or 4:1 ratio) is dispensed, as the clavulanate content varies significantly, impacting dosing and potential side effects.
• Instruct patients to take the suspension at the start of a meal to enhance clavulanate absorption and minimize gastrointestinal intolerance.
• Emphasize the importance of shaking the suspension well before each use and using an accurate measuring device.
• Advise patients to complete the entire course of therapy, even if symptoms improve, to prevent antibiotic resistance and recurrence of infection.
• Counsel on potential side effects, especially diarrhea, and the importance of reporting severe or persistent diarrhea (risk of C. difficile infection).

• Cefdinir (for AOM, sinusitis)
• Cefpodoxime (for AOM, sinusitis)
• Ceftriaxone (parenteral, for severe AOM, sinusitis)
• Azithromycin (for penicillin-allergic patients, though resistance is a concern)
• Clindamycin (for certain anaerobic infections or penicillin-allergic patients)

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 include 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.