Amox-Clav XR 1000/62.5mg Tablets

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 potassium is a beta-lactamase inhibitor that protects amoxicillin from degradation by beta-lactamase enzymes produced by resistant bacteria, thereby extending the antibacterial spectrum of amoxicillin.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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 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, 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 accompanied by stomach pain or cramps (see below for more information on diarrhea)
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 any areas of skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands

Diarrhea: Important Information

Diarrhea is a common side effect of antibiotics, but in rare cases, it can be severe and lead to a life-threatening condition called C. diff-associated diarrhea (CDAD). If you experience stomach pain, cramps, or very loose, watery, or bloody stools, contact your doctor right away. Do not treat diarrhea without consulting your doctor first.

Other Side Effects

Like all medications, this drug can cause side effects, although not everyone will experience them. If you have any of the following side effects or any other concerns, contact your doctor:

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

Reporting 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:

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.
If you have kidney disease or any history of kidney problems.
If you have experienced liver problems or jaundice (turned yellow) while taking this medication in the past.
If you have been diagnosed with mononucleosis (mono).
If you are currently taking probenecid.

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 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 lessened or disappeared after brushing or dental cleaning. If you notice any changes in tooth color, consult 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, consider using an additional form of birth control, such as a condom, while taking this drug.

If you are pregnant, planning to become pregnant, or breastfeeding, it is essential to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.

• Patients with a history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate.
• Patients with severe renal impairment (CrCl < 30 mL/min) or on hemodialysis.

• Warfarin (increased INR/bleeding risk)
• Methotrexate (increased methotrexate toxicity due to reduced renal clearance)
• Allopurinol (increased incidence of rash)

• Oral Contraceptives (theoretical reduction in efficacy due to altered gut flora)
• Probenecid (increases and prolongs amoxicillin blood levels by decreasing renal tubular secretion)
• Mycophenolate mofetil (reduced mycophenolic acid concentration)

• Skin rash, itching, hives (signs of allergic reaction)
• Swelling of face, lips, tongue, or throat (angioedema)
• Difficulty breathing (anaphylaxis)
• Severe or persistent diarrhea, abdominal pain, fever (Clostridioides difficile-associated diarrhea)
• Yellowing of skin or eyes (jaundice), dark urine, unusual fatigue (hepatic dysfunction)
• Nausea, vomiting, abdominal pain

Amoxicillin/clavulanate is generally considered safe for use during pregnancy (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, it should only be used if clearly needed.

Amoxicillin and clavulanate are excreted in small amounts into breast milk. Generally considered compatible with breastfeeding (Lactation Risk L1).

The extended-release formulation (1000/62.5 mg tablet) is not recommended for pediatric patients under 16 years of age due to the high clavulanate content relative to amoxicillin and lack of specific pediatric dosing for this formulation. Other formulations (e.g., suspensions, chewable tablets) are available for pediatric use.

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 selection should be cautious, generally starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy. Renal function should be monitored, and dose adjusted if necessary, as amoxicillin is substantially excreted by the kidney.

• Always take Amox-Clav XR at the start of a meal to enhance absorption and minimize gastrointestinal side effects.
• Swallow the tablets whole; do not crush, chew, or break them, as this will disrupt the extended-release mechanism.
• This extended-release formulation is specifically designed for once-daily dosing and is typically used for more severe or resistant infections like community-acquired pneumonia or acute bacterial sinusitis.
• Emphasize the importance of completing the full course of therapy, even if symptoms improve, to prevent the development of antibiotic resistance.
• Counsel patients on the potential for C. difficile-associated diarrhea, which can occur during or even several weeks after antibiotic therapy.
• Not suitable for patients with severe renal impairment (CrCl < 30 mL/min) or on hemodialysis due to the fixed ratio and extended-release properties.

• Respiratory fluoroquinolones (e.g., Levofloxacin, Moxifloxacin) for CAP or sinusitis in specific cases.
• Macrolides (e.g., Azithromycin, Clarithromycin) for atypical pathogens or in penicillin-allergic patients.
• Cephalosporins (e.g., Cefpodoxime, Cefuroxime) for respiratory tract infections.
• Doxycycline for certain respiratory 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's a good idea to check with your pharmacist for more information. 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.