Augmentin 400mg/5ml Susp 50ml

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 protects amoxicillin from degradation by beta-lactamase enzymes produced by resistant bacteria, thereby extending amoxicillin's 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 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, 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 right away. Before treating diarrhea, consult with your doctor.
Liver problems have been reported with this medication, and in rare cases, have been fatal. Seek medical attention immediately 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, may occur. These reactions 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 any areas of skin
+ Fever
+ Chills
+ Body aches
+ Shortness of breath
+ Swollen glands

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:

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

This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, 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 dosage or administration of 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 medications. Never start, stop, or change the dose 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, particularly in children, is a change in tooth color to a yellow-gray-brown hue. In most cases, this discoloration can be reduced or eliminated with regular brushing or dental cleaning. If you notice any changes 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.

• Allopurinol (increased risk of rash)
• Warfarin and other oral anticoagulants (increased INR/bleeding risk)
• Methotrexate (decreased renal clearance of methotrexate, leading to increased toxicity)
• Mycophenolate mofetil (reduced mycophenolic acid concentration)

• Probenecid (decreased renal tubular secretion of amoxicillin, leading to increased and prolonged amoxicillin levels)
• Oral contraceptives (potential for reduced efficacy, though evidence is limited and controversial)
• Typhoid vaccine (live, oral) (antibiotics may inactivate the vaccine)
• Tetracyclines (may interfere with bactericidal effect of penicillins)

• Aminoglycosides (in vitro inactivation, but not clinically significant in vivo for systemic use)

• Rash (maculopapular, urticarial)
• Pruritus
• Dyspnea, wheezing, angioedema (signs of anaphylaxis)
• Severe or persistent diarrhea (especially bloody or watery)
• Yellowing of skin or eyes (jaundice)
• Dark urine, pale stools
• Unusual fatigue or weakness
• Abdominal pain

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 (Compatible). Both amoxicillin and clavulanate are excreted in breast milk in small amounts. Generally considered safe for nursing infants. Monitor infant for diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.

Dosing is weight-based and depends on the severity and type of infection. The 400mg/5ml formulation (7:1 ratio) is commonly used for pediatric patients. Ensure accurate measurement using an oral syringe or measuring spoon. Not recommended for neonates without specific guidelines.

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 is necessary based on renal function, which is often decreased in the elderly. Monitor for adverse effects, especially GI upset and liver function.

• Always confirm the specific Augmentin formulation (e.g., 400mg/5ml, 600mg/5ml, 875mg/125mg) as the amoxicillin to clavulanate ratio can vary, impacting dosing, especially in pediatrics.
• Taking Augmentin with food, particularly at the start of a meal, significantly reduces the incidence of gastrointestinal side effects (e.g., diarrhea, nausea).
• Diarrhea is a common side effect; advise patients to report severe or persistent diarrhea, as it could indicate Clostridioides difficile-associated diarrhea (CDAD).
• Liver dysfunction, including cholestatic jaundice, can occur, even after discontinuation of therapy. Monitor LFTs in patients with pre-existing hepatic impairment or during prolonged therapy.
• Ensure patients understand the importance of completing the full course of antibiotics to prevent antibiotic resistance and relapse.
• The suspension must be refrigerated after reconstitution and discarded after 10 days.

• 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
• Doxycycline (for certain respiratory or skin infections)

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.