Amox-Clav 200/28.5mg Chew Tabs

Amoxicillin is a beta-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to bacterial lysis. 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 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
Signs of a rare allergic reaction called drug-induced enterocolitis syndrome, 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, especially if it is severe, bloody, or watery (a condition called C. diff-associated diarrhea, or CDAD, may occur, which can lead to a life-threatening bowel problem)
Signs of liver problems, such as:
+ 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)
+ Other serious reactions, which can affect body organs and be life-threatening
+ Signs of these reactions may include:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the mouth, throat, nose, eyes, genitals, or 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 experience no side effects or only mild ones. If you notice any of the following side effects, or if they bother you or do not go away, contact your doctor:

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

Reporting Side Effects

This list is not exhaustive, and you may experience other 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 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 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 is a change in tooth color to yellow-gray-brown, which has been reported primarily in children. In most cases, the discoloration lessens or disappears with regular brushing or dental cleaning. If you notice any changes 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 will need to discuss the potential benefits and risks of this medication to both you and your baby.

• Patients with a history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate.

• Warfarin (increased INR, bleeding risk)
• Methotrexate (increased methotrexate levels, toxicity)
• Mycophenolate mofetil (reduced mycophenolic acid concentration)

• Allopurinol (increased risk of rash)
• Oral contraceptives (theoretical reduction in efficacy, advise backup method)
• Probenecid (increases amoxicillin plasma concentrations and prolongs half-life)
• Typhoid vaccine (live, oral) (may reduce therapeutic effect of vaccine)

• Signs of allergic reaction (rash, itching, hives, swelling, difficulty breathing)
• Severe or persistent diarrhea (may indicate C. difficile infection)
• Signs of superinfection (new or worsening fever, oral thrush, vaginal yeast infection)
• Signs of liver injury (yellowing of skin/eyes, dark urine, unusual fatigue, abdominal pain)
• Signs of kidney injury (decreased urine output, swelling)

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.

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

This 200/28.5mg chewable tablet formulation is primarily indicated for pediatric patients. Dosing must be carefully calculated based on the child's weight and the severity/type of infection, using the amoxicillin component. Ensure appropriate strength and formulation (e.g., chewable vs. suspension) for the child's age and ability to take medication.

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 in elderly patients with renal impairment, as amoxicillin and clavulanate are primarily eliminated by the kidneys. Monitor renal function.

• Always advise patients to take amoxicillin/clavulanate at the start of a meal to enhance absorption and minimize GI side effects, particularly diarrhea.
• Emphasize the importance of completing the full course of therapy, even if symptoms improve, to prevent resistance and recurrence.
• Counsel patients on the potential for C. difficile-associated diarrhea, and to seek medical attention if severe, watery, or bloody diarrhea occurs.
• Be aware of the potential for drug-induced liver injury, which can occur during or several weeks after therapy. Monitor liver function in patients on prolonged therapy or with pre-existing liver conditions.
• This 200/28.5mg chewable tablet is a lower strength, typically used for pediatric patients with specific dosing regimens (e.g., 45 mg/kg/day divided q12h). Ensure correct strength and formulation are prescribed for the patient's age and weight.

• Other beta-lactam antibiotics (e.g., cephalexin, cefdinir, cefuroxime)
• Macrolide antibiotics (e.g., azithromycin, clarithromycin) for penicillin-allergic patients or specific pathogens
• Fluoroquinolones (e.g., levofloxacin, moxifloxacin) for specific indications and older patients
• Tetracyclines (e.g., doxycycline) for specific indications

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. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.