Amox-Clav 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 cell lysis and death. Clavulanate is a beta-lactamase inhibitor that irreversibly binds to and inactivates a wide range of bacterial beta-lactamase enzymes, preventing the degradation of amoxicillin and extending its antibacterial spectrum against beta-lactamase-producing strains.

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, 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 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 fatal and may also affect other body 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 Possible Side Effects

Not all side effects are severe, and many people may not experience any side effects or only minor ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

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

Reporting Side Effects

This is not an exhaustive list of 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:

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 other medications. Never start, stop, or change 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 long-term, 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 experience a change 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, 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 taking this medication to both you and your baby.

• Allopurinol (increased risk of rash with amoxicillin)
• Warfarin (increased INR/bleeding risk)
• Methotrexate (decreased renal clearance of methotrexate, increased toxicity)
• Oral Contraceptives (potential decreased efficacy of oral contraceptives)

• Probenecid (decreased renal tubular secretion of amoxicillin, increased and prolonged amoxicillin levels)
• Mycophenolate Mofetil (reduced mycophenolic acid concentration)
• Typhoid Vaccine (live, oral) (antibiotics may inactivate the vaccine)

• Rash
• Itching
• Hives
• Difficulty breathing or swallowing
• Swelling of face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• Severe diarrhea (watery or bloody)
• Abdominal pain
• Nausea
• Vomiting
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Pale stools
• Unusual tiredness or weakness

Generally considered safe for use during 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. Use only if clearly needed.

Amoxicillin and clavulanate are excreted in breast milk in small amounts. Generally considered compatible with breastfeeding (L2 - Safer).

This specific formulation (400mg/5ml) is primarily designed for pediatric use, especially for higher-dose amoxicillin regimens (e.g., 90 mg/kg/day) for resistant otitis media. Dosing is weight-based and age-dependent. Not recommended for neonates (<12 weeks) due to immature renal function and potential for adverse effects.

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 may be necessary based on renal function, which commonly declines with age. Monitor for adverse effects, especially gastrointestinal and hepatic.

• This 400mg/5ml (7:1 ratio) formulation is specifically designed for pediatric patients, particularly for infections like acute otitis media where higher amoxicillin doses are recommended to overcome resistance.
• Always ensure the correct formulation (e.g., 7:1 vs. 4:1 ratio) is dispensed, as clavulanate content differs and impacts dosing and side effects.
• Advise patients to take with food to minimize GI upset, which is a common side effect.
• Emphasize the importance of completing the full course of therapy to prevent resistance, even if symptoms improve.
• Refrigeration is required for the reconstituted suspension, and it must be discarded after 10 days.
• Be vigilant for signs of C. difficile-associated diarrhea, which can occur during or even weeks after therapy.

• Cephalosporins (e.g., Cefdinir, Cefpodoxime, Cefuroxime)
• Macrolides (e.g., Azithromycin, Clarithromycin) - Note: Resistance is common for some pathogens.
• Fluoroquinolones (e.g., Levofloxacin, Moxifloxacin) - Generally not first-line for pediatric infections due to side effect profile.
• Doxycycline (for older children/adolescents for specific indications)

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 your 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 details about the medication taken, the amount, and the time it happened.