Amoxicillin IP 500mg Clavulanic Acid IP 125mg Tablet

If you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins or any of the other ingredients of  tablets.

If you have ever had a severe allergic (hypersensitive) reaction to any other antibiotic. This can include a skin rash or swelling of the face or neck.

If you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not take it if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking it.

Amoxicillin + Clavulanic Acid and Pregnancy

Category B:Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Amoxicillin + Clavulanic Acid and Lactation

Caution when used during lactation
Ampicillin-class antibiotics are excreted in human milk; therefore, caution should be exercised when Amoxicillin and Clavulanic acid is administered to a nursing woman.

Amoxicillin + Clavulanic Acid and Children

Safety and efficacy of Amoxicillin and Clavulanic acid for Oral Suspension 600 mg/42.9 mg per 5 mL in infants younger than 3 months have not been established. Safety and efficacy of Amoxicillin and Clavulanic acid for Oral Suspension 600 mg/42.9 mg per 5 mL have been demonstrated for treatment of acute otitis media in infants and children 3 months to 12 years

Amoxicillin + Clavulanic Acid and Other Contraindications

Penicillin allergy

( Amoxicillin and Clavulanic Acid) may cause side effects.

Diarrhea

Upset stomach

Vomiting

Mild skin rash

Oral

This is Preferred Dosage:
Adult: Based on amoxicillin dose, 250-500 mg every 8 hours or 500-750 mg every 12 hours.
Child: Based on amoxicillin dose: 125-250 mg every 8 hours.
Children weighing Infants
Disclaimer:To be taken only after consulting with the doctor.

PHARMACOLOGY

Mechanism of Action

Amoxicillin exerts a bactericidal action against sensitive organisms during the stage of active multiplication through the inhibition of the biosynthesis of bacterial cell wall mucopeptides. Clavulanic acid inhibits specific β-lactamases of some microorganisms and allows amoxicillin to inhibit amoxicillin (ampicillin) resistant organisms which produce clavulanic acid sensitive β-lactamases.

Pharmacodynamic Properties

It is an antibacterial combination consisting of the antibiotic. Amoxycillin and the Beta-lactamase inhibitor Clavulanic acid. Amoxycillin has a broad spectrum of bactericidal activity against many gram-positive &gram-negative microorganisms but it is susceptible to degradation by beta-lactamases and therefore the spectrum of activity does not include microorganisms, which produce these enzymes. Clavulanic acid possesses the ability to inactivate a wide range of beta-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins. Thus Clavulanic acid in Moxaclav protects Amoxycillin from degradation by beta-lactamase enzymes and effectively extends the antibiotic spectrum to embrace a wide range of microorganisms.

Gram-positive:
Aerobes: Enterococcus faecalis, Enterococcus faecium, Streptococcus pyogenes, Streptococcus viridans, Staphylococcus aureus, Coagulase negative staphylococci (including Staphylococcus epidermidis), Corynebacterium species, Bacillus anthracis, Listeria monocytogenes.
Anaerobes: Clostridium species, Peptococcus species, Peptostreptococcus.

Gram-negative:
Aerobes: Haemophilus influenzae, Moraxella catarrhalis, Escherichia coli, Proteus mirabilis, Proteus vulgaris, Klebsiella species, Salmonella species, Shigella species, Bordetella pertussis, Brucella species, Neisseria gonorrhoeae, Neisseria meningitidis, Vibrio cholerae, Pasteurella multocida.
Anaerobes: Bacteroides species including B fragilis.

Pharmacokinetic Properties

Peak serum levels of both occur about one hour after oral administration. Absorption is optimised at the start of a meal. Both clavulanate and amoxycillin have low levels of serum binding; about 70% remains free in the serum. Doubling the dosage approximately doubles the serum levels achieved.

INTERACTIONS

• Allopurinol or probenecid (for treatment of gout)
• Anticoagulants (used to prevent blood clots) such as warfarin
• Mycophenolate mofetil (suppressed the immune system)

Patients should be informed that amoxicillin and clavulanic acid tablets may be taken every 8 hours or every 12 hours, depending on the dose prescribed. Each dose should be taken with a meal or snack to reduce the possibility of gastrointestinal upset.
Patients should be counseled that antibacterial drugs, including amoxicillin and clavulanic acid tablets, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When amoxicillin and clavulanate potassium tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin and clavulanate potassium tablets or other antibacterial drugs in the future.
Counsel patients that diarrhea is a common problem caused by antibacterials, and it usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibacterial. If diarrhea is severe or lasts more than 2 or 3 days, patients should contact their physician.
Patients should be aware that amoxicillin and clavulanic acid tablets contain a penicillin class drug product that can cause allergic reactions in some individuals.

It is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid).

Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S•3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(phydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:

Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as: