Amox-Clav 875-125mg Tablets

Amoxicillin is a semisynthetic antibiotic with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. It inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs), thereby inhibiting the final transpeptidation step of peptidoglycan synthesis in the bacterial cell wall, leading to cell lysis. Clavulanate potassium is a beta-lactamase inhibitor. It inactivates a wide range of beta-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins, 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 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, 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 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 life-threatening. 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 of the following side effects or if they persist, contact your doctor:

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

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 treatments. 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.

Do not take this medication for longer than prescribed, as this may increase the risk of a second infection.

A possible side effect of this medication is a change in tooth color, which may appear as yellow, gray, or brown. This has been reported primarily in children, but in most cases, the discoloration has decreased or resolved 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 birth control methods 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.

• Warfarin (increased INR/bleeding risk)
• Methotrexate (increased methotrexate levels/toxicity)
• Allopurinol (increased incidence of rash)

• Oral contraceptives (potential decreased efficacy of oral contraceptives, though clinical significance debated)
• Probenecid (increases amoxicillin levels by decreasing renal tubular secretion)
• Mycophenolate mofetil (decreased mycophenolic acid exposure)

• Tetracyclines (may antagonize bactericidal effect of amoxicillin)

• Diarrhea (especially severe or persistent, suggestive of C. difficile infection)
• Nausea/vomiting
• Skin rash, itching, hives (signs of allergic reaction)
• Yellowing of skin or eyes (jaundice), dark urine, abdominal pain (signs of hepatic dysfunction)
• Unusual bleeding or bruising (if on warfarin)
• Signs of new infection (e.g., fever, sore throat, vaginal discharge)

Generally considered safe for use during pregnancy (Category B). Studies in animals have not shown harm to the fetus, and there is no evidence of harm in human pregnancies. However, use only if clearly needed.

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

The 875/125 mg tablet is generally not suitable for pediatric patients weighing less than 40 kg or those unable to swallow tablets. Pediatric dosing is typically based on the amoxicillin component (mg/kg/day) using oral suspension or chewable tablets. Careful attention to formulation and strength is crucial to avoid clavulanate overdose in younger children.

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.

• Always take with food or milk to minimize gastrointestinal side effects, which are common.
• Ensure patients complete the full course of therapy to prevent resistance and relapse.
• Counsel patients on the importance of reporting severe or persistent diarrhea, as it could indicate C. difficile infection.
• Be vigilant for signs of hepatic dysfunction, especially in patients with pre-existing liver disease or a history of amoxicillin/clavulanate-induced liver injury. This can occur weeks after discontinuation.
• The 875/125 mg tablet has a fixed ratio of amoxicillin to clavulanate. In renal impairment, while amoxicillin dose may need reduction, the clavulanate component can accumulate. For severe renal impairment, alternative formulations (e.g., 250/125 mg or 500/125 mg) or different antibiotics may be more appropriate to allow for proper amoxicillin dosing without excessive clavulanate.
• Patients with a history of penicillin allergy should be carefully assessed; cross-reactivity with amoxicillin is possible.

• Cephalosporins (e.g., cefdinir, cefpodoxime, 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 is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, do not 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.