Amox-Clav 400mg/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 and death. 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 notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or 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 fainting
Vaginal irritation or discharge
Fever or chills
Unexplained bruising or bleeding
Diarrhea is a common side effect of antibiotics, but rarely, a severe form called C. diff-associated diarrhea (CDAD) may occur. If you experience:
+ Stomach pain or cramps
+ Very loose, watery, or bloody stools
+ Call your doctor right away, and do not treat diarrhea without consulting your doctor first.
Liver problems, which can be fatal, may occur. Seek medical help immediately if you experience:
+ 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, may occur. These can be life-threatening and may affect other organs. Seek medical help right away if you experience:
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, eyes, genitals, or skin
+ Fever
+ Chills
+ Body aches
+ Shortness of breath
+ Swollen glands

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you are concerned about any side effects or if they persist, contact your doctor. Common side effects include:

For all patients taking this medication:
+ Diarrhea
+ Upset stomach
+ Vomiting
* For children:
+ Diaper rash

Reporting Side Effects

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 impact your ability to take this medication.
Existing kidney disease, as this may affect how your body processes the medication.
Previous experiences with liver problems or jaundice (turning yellow) while taking this medication.
If you have been diagnosed with mononucleosis (mono).
Current use of 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 with your existing health conditions and other drugs. 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 a yellow-gray-brown hue, which has been reported primarily in children. In most cases, this discoloration can be reduced or eliminated with regular brushing or dental cleaning. If you experience a change in tooth color, consult with your doctor.

Women taking birth control pills or other hormone-based contraceptives should be aware that this medication may reduce their effectiveness. To prevent pregnancy, consider using 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 will need to discuss the potential benefits and risks of taking this medication to both you and your baby.

• Methotrexate (increased methotrexate levels and toxicity due to reduced renal clearance)
• Warfarin (increased INR/bleeding risk, especially with high doses or prolonged use)
• Mycophenolate mofetil (reduced mycophenolate levels due to disruption of enterohepatic recirculation)

• Allopurinol (increased incidence of rash with amoxicillin)
• Oral Contraceptives (potential reduction in efficacy, though evidence is debated)
• Probenecid (increases and prolongs amoxicillin blood levels by decreasing renal tubular secretion)
• Typhoid vaccine (live, oral) (antibiotics may inactivate the vaccine)

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

Amoxicillin/clavulanate is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, but 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 to the fetus.

Amoxicillin and clavulanate are excreted in small amounts into breast milk. Generally considered compatible with breastfeeding. Monitor breastfed infants for potential adverse effects.

Dosing is weight-based and varies by infection severity. The 400mg/5ml suspension is commonly used in pediatric patients. Close monitoring for gastrointestinal side effects and rash is important. Not recommended for neonates (<3 months) due to immature renal function and limited data.

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 often necessary due to age-related decline in renal function. Monitor renal function closely.

• Always complete the full course of therapy to prevent the development of antibiotic resistance.
• Taking the medication with food helps reduce gastrointestinal side effects like nausea and diarrhea.
• The 400mg/5ml suspension is a high-dose formulation often used for more resistant infections or in areas with high rates of penicillin-resistant S. pneumoniae.
• Patients should be advised to report any signs of severe diarrhea (especially if bloody) or allergic reactions immediately.
• Reconstituted suspension must be refrigerated and discarded after 10 days.
• Amoxicillin/clavulanate is not effective against viral infections.

• Cephalosporins (e.g., Cefdinir, Cefuroxime, Ceftriaxone)
• Macrolides (e.g., Azithromycin, Clarithromycin) - for atypical pathogens or penicillin allergy
• Fluoroquinolones (e.g., Levofloxacin, Moxifloxacin) - for specific indications and resistance patterns
• Tetracyclines (e.g., Doxycycline) - for specific indications

If your symptoms or health issues persist or worsen, it's 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 be sure 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.