Amox-Clav 400mg/5ml Susp 100ml

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 many 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 immediately or seek 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, such as 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 have been reported with this medication, and in rare cases, have been fatal. If you notice:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
contact your doctor right away.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, may occur. These reactions can affect body organs and be life-threatening. Seek 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

All medications can cause side effects, but many people experience no side effects or only minor ones. If you are concerned about any side effects or if they persist, contact your doctor or seek medical attention. Common side effects include:

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, 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 or any other medications that may interact with this drug.

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 is a change in tooth color to a yellow-gray-brown hue, 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.

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.

• Warfarin (increased INR, bleeding risk)
• Methotrexate (increased methotrexate levels and toxicity)

• Allopurinol (increased incidence of rash)
• Probenecid (increased and prolonged amoxicillin blood levels)
• Oral Contraceptives (theoretical reduction in efficacy, consider backup method)
• Mycophenolate Mofetil (reduced mycophenolic acid concentration)

• Skin rash, itching, hives (signs of allergic reaction)
• Severe or persistent diarrhea (may indicate C. difficile infection)
• Nausea, vomiting, abdominal pain
• Yellowing of skin or eyes (jaundice), dark urine, pale stools (signs of liver injury)
• 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, and 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.

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

This 400mg/5ml suspension formulation is commonly used in pediatric patients. Dosing is weight-based and varies by infection type and severity. Close attention to accurate dosing and monitoring for side effects (e.g., diarrhea, rash) is crucial.

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 age-related decline in renal function is common.

• Always shake the oral suspension well before each dose to ensure uniform distribution of the medication.
• Refrigerate the reconstituted suspension and discard after 10 days to maintain potency and stability.
• Taking the medication with food can significantly reduce gastrointestinal side effects like nausea and diarrhea.
• This medication is ineffective against viral infections (e.g., common cold, flu); avoid inappropriate use to prevent antibiotic resistance.
• Patients should be advised to report any signs of severe diarrhea, especially if bloody or watery, as it could indicate Clostridioides difficile-associated diarrhea (CDAD), which can occur even weeks after therapy.
• Monitor for signs of cholestatic jaundice, which can occur during or shortly after treatment, and may be delayed for several weeks after cessation of therapy. It is more common in elderly males and with prolonged treatment.

• Cephalosporins (e.g., Cefdinir, Cefuroxime, Ceftriaxone)
• Macrolides (e.g., Azithromycin, Clarithromycin) for specific infections or penicillin allergy
• Fluoroquinolones (e.g., Levofloxacin, Moxifloxacin) for specific infections, generally reserved due to side effect profile
• Tetracyclines (e.g., Doxycycline) for specific 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 this 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.