Amox-Clav 250mg/5ml Susp 75ml

Amoxicillin is a beta-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell 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 while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

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, including 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 you experience:
+ Stomach pain
+ Cramps
+ Very loose, watery, or bloody stools
+ Contact your doctor immediately. Before treating diarrhea, consult with your doctor.
Liver problems, which can be fatal, have been associated with this medication. Seek medical help right away if you notice:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, can occur. These reactions can affect body organs and be fatal. Get medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in your 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 can cause side effects. Many people may not experience any side effects or only minor ones. If you are concerned about any side effects or if they persist, contact your doctor or seek medical help.

Common side effects for all patients taking this medication include:

Diarrhea
Upset stomach
Vomiting

In children, a common side effect is:

* Diaper rash

This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

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

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you are allergic to penicillin, as this may affect your ability to take this medication.
Existing kidney disease, as this may impact the medication's effectiveness or increase the risk of side effects.
Previous experiences with liver problems or jaundice (turning yellow) while taking this medication.
If you have been diagnosed with mononucleosis (mono), as this may require special consideration.
If you are currently taking probenecid, as this may interact with the medication.

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

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition.

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

Individuals with phenylketonuria (PKU) should discuss this condition with their doctor, as some products may contain phenylalanine.

Do not take this medication for longer than prescribed, as this may increase the risk of a second infection. A common side effect of this drug is a change in tooth color to yellow-gray-brown, which is more frequently reported in children. In most cases, the discoloration lessens or disappears with regular brushing or dental cleaning. If you experience a change in tooth color, consult with your doctor.

When taking this medication, birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy. To minimize the risk of unplanned pregnancy, use an additional form of birth control, such as a condom, while taking this drug.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.

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

• Allopurinol (increased incidence of rash)
• Oral Contraceptives (potential for reduced efficacy, though clinical significance debated)
• Probenecid (decreased renal tubular secretion of amoxicillin, leading to increased and prolonged amoxicillin blood levels)
• Mycophenolate mofetil (reduced mycophenolic acid exposure)

• Diarrhea (especially severe or bloody)
• Nausea/Vomiting
• Rash/Hives
• Itching
• Signs of allergic reaction (swelling of face/throat, difficulty breathing)
• Signs of liver injury (yellowing of skin/eyes, dark urine, unusual fatigue, abdominal pain)
• Signs of superinfection (new or worsening symptoms, oral/vaginal candidiasis)

Generally considered safe for use during pregnancy (Category B). Studies in animals have not shown harm to the fetus, and human data do not suggest an increased risk of birth defects. However, use only if clearly needed.

Considered compatible with breastfeeding (L2). Both amoxicillin and clavulanate are excreted in small amounts into breast milk. Monitor infant for diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.

Dosing is weight-based and varies significantly by age and severity of infection. Careful calculation is essential. Neonates and infants <3 months require specific dosing due to immature renal function. Oral suspension is commonly used for pediatric patients.

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. Dose adjustment may be necessary based on renal function, which commonly declines with age. Monitor for hepatic dysfunction.

• Always administer with food or at the start of a meal to enhance absorption and minimize GI side effects (e.g., diarrhea, nausea).
• The clavulanate component is responsible for most of the GI side effects, particularly diarrhea.
• Ensure patients complete the full prescribed course of therapy, even if symptoms improve, to prevent resistance.
• Amoxicillin/clavulanate is a common cause of drug-induced liver injury, which can be severe and cholestatic, often with a delayed onset (weeks after discontinuation). Monitor LFTs in prolonged therapy or at-risk patients.
• Not effective against MRSA or atypical pathogens.
• The 250mg/5ml suspension typically refers to the amoxicillin component, with clavulanate being a fixed ratio (e.g., 250mg amoxicillin / 62.5mg clavulanate per 5ml). Always verify the exact formulation.
• Different formulations (e.g., 250/125, 500/125, 875/125) have different amoxicillin to clavulanate ratios. The 250mg/5ml suspension is often 250mg amoxicillin with 62.5mg clavulanate per 5ml (4:1 ratio).
• The ES-600 formulation (600mg amoxicillin / 42.9mg clavulanate per 5ml) is specifically designed for pediatric otitis media and has a lower clavulanate ratio to reduce diarrhea.

• Cephalosporins (e.g., Cefdinir, Cefuroxime, Cefpodoxime for respiratory/skin infections)
• Macrolides (e.g., Azithromycin, Clarithromycin for respiratory infections, if beta-lactam allergy)
• Fluoroquinolones (e.g., Levofloxacin, Moxifloxacin for severe respiratory/urinary infections, with caution)
• Doxycycline (for certain respiratory, skin, or atypical infections)
• Clindamycin (for skin and soft tissue infections, anaerobic infections)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.