Cledomox

CLEDOMOX 375: Each film-coated tablet contains: Amoxicillin Trihydrate BP equivalent to Amoxicillin 250 mg; Diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 125 mg.
CLEDOMOX 625: Each film-coated tablet contains: Amoxicillin Trihydrate BP equivalent to Amoxicillin 500 mg; Diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 125 mg.
CLEDOMOX 1000: Each film-coated tablet contains: Amoxicillin Trihydrate BP equivalent to Amoxicillin 875 mg; Diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 125 mg.
CLEDOMOX 156.25: Each 5 mL oral suspension contains: Amoxicillin Trihydrate BP equivalent to Amoxicillin 125 mg; Diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 31.25 mg.
Amoxicillin and Clavulanic Acid is a combination of beta-lactam antibacterial penicillin with a beta-lactamase inhibitor.

CLEDOMOX is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the condition listed as follows: Lower Respiratory Tract Infections: caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis.
Otitis Media: caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis.
Sinusitis: caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis.
Skin and Skin Structure Infections: caused by β-lactamase-producing strains of S.aureus, E.coli, and Klebsiella spp.
Urinary tract infections: caused by β-lactamase-producing strains of E.coli, Klebsiella spp., and Enterobacter spp.

CLEDOMOX is administered orally. Treatment should not usually exceed 14 days.
Adult: The usual recommended adult dose is: One tablet of CLEDOMOX 375 every 8 hours; OR One tablet of CLEDOMOX 625 every 12 hours.
For more severe infections and infections of the respiratory tract: The recommended oral dose is: One tablet of CLEDOMOX 625 every 8 hours; OR One tablet of CLEDOMOX 1000 every 12 hours.
Administration in renal impairment: In patients with severe renal impairment the CLEDOMOX dosage should be reduced according to the glomerular filtration rate as follows: See Table 1.

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Children: See Table 2.

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CLEDOMOX is contraindicated in patients with a history of allergic reactions to any penicillin.
It is also contraindicated with a previous history of jaundice or hepatic dysfunction associated with CLEDOMOX.

CLEDOMOX should be given with caution to patients with lymphatic leukaemia since they are especially susceptible to amoxicillin induced skin rashes.
After administration of CLEDOMOX, if any allergic reactions occur, treatment should be discontinued and the appropriate therapy instituted.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including CLEDOMOX, and has ranged in severity from mild to life-threatening. Mild cases of Pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. difficile colitis.
Change in liver function tests have been observed in some patients receiving CLEDOMOX. CLEDOMOX is contraindicated in patients with a previous history of cholestatic jaundice or hepatic dysfunction associated with CLEDOMOX. The onset of signs and symptoms of hepatic dysfunction may occur during or several weeks after treatment has been discontinued. The hepatic dysfunction which may be severe, is usually reversible.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.

Pregnancy: Women treated with CLEDOMOX during pregnancy increase the risk of neonatal necrotising enterocolitis.
Breast-Feeding: Amoxicillin is excreted in breast milk, therefore caution is advised when CLEDOMOX is administered to a nursing mother.

Gastrointestinal disorders, including diarrhea, nausea and vomiting, hepatitis and cholestatic jaundice, skin and subcutaneous tissue disorders, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and exfoliative dermatitis. Tooth discoloration has also been reported.

Store below 25°C in a cool dry place. Protect from light.

Penicillins

J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.

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