Penicillins

Amoxicillin and Clavulanate Potassium tablets are indicated for the treatment of the following infections in adults and children Lower Respiratory Infections : Caused by B-lactamase-producing strains of H. influenzae and M. catarrhalis Upper Respiratory tract infection e.g.,Otitis Media: Caused by B-lactamase-producing strains of H.influenzae and M. catarrhalis Skin and Skin Structure Infections: Caused by B-lactamase-producing strains of S. aureus, E. coil & Klebsiella spp. Urinary Tract Infections: Caused by B-lactamase-produciing strains of E. coil & Klebsiella spp. , and Enterobacter spp. Bone and Joint Infection e.g., osteomye litis

Each film - coated tablet contains Amoxicillin Trihydrate USP eq. to Amoxicillin 250 mg, Diluted
Potassium Clavulanate BP eq. to Clavulanic Acid 125 mg

1 x 10's/ Box

The dose of MEDIMOX-CV that is selected to treat an individual infect1on should take into account: •            The expected pathogens and their likely susceptibility to antibactenal agents. •            The severity and the site of the infection. •            The age,weight and renal function of the patient as shown below.

In patients with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins. Safety in pregnancy has not been established. There is limited mformation on the use of Amoxic1llin and Clavulanate Porassium in human pregnancy. Use should be avoided in pregnancy unless considered essential by the physician.Amoxicillin and Clavulanate Potassium is contra-indicated in patients with a previous history of Amoxicillin and Clavuanate Potassium associated jaundice/hepatic dysfunction

Serious and occasiona ly fatal hypersensitivity ( A'laphylactic) reaction have been reported in patients on penicillin terapy. although anaphylaxis is more frequent following parenteral therapy, it has occurred in pat1ents on oral penicillin. these reactions are more likely to occur in individuals with a history of Penicillins hypersensitivity, who have experienced severe reaction when treated with cephalosporins. before initiating therapy with any penicillin , careful inquiry should be made concerning previous hypersensitivity reactions to penicillins cephalosporins or other allergens. If an allergic reaction occurs, amoxicillin and clavulanate potass um should be discontinued and the appropriate therapy instituted: adrenaline, corticosteroids and antihistamines. MEDIMOX-CV should be avoided if infectious mononucleosis is suspected since thc. occurrence of a morbilliform rash has been associated w1th th1s condition following the use of amoxicill1n . Transient hepatitis and cholestatic jaundice has been reported. MEDIMOX-CV should be used with caution patients with ev1dence of hepatic dysfunction. In patients with renal impairment,dosage should be adjusted according to the degree of MED MOX-CV should not be used in patients with a glomerular filtration rate of less than 30 mllminute. Prolonged use may occasionally result in overgrowth of non-susceptible organisms.

Concomitant use of probenecid 1s not recommended. Probenecid decreases the renal tubular secretion of amoxicillin . Its use may result in increased and prolonged blood levels of amoxicillin but does not delay renal excretion of the clavulanacrd. Concomitant use of allopurinol during treatment with amoxicHiln can increase the likelihood of allergic Skin reactions. There are no data on the concomitant use of MEDIMOX-CV and allopurinol. As w1th other broad spectrum antibiotics, MEDIMOX-CV may affect the gut flora , leading to lower oestrogen reabsorption and reduced efficacy of combined oral contracept1"es

Medicef Pharma.,India