Moxypen Forte 500 mg

/ Salomon, Levin & Elstein Ltd

It is not affected by food and may therefore be administered without regard to meals. With the exception of gonorrhea, treatment should be continued for a minimum of 48-72 hours beyond the time at which the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. In the treatment of group A β-hemolytic streptococcal infections, therapy with this drug should be continued for at least 10 days to help prevent the occurrence of acute rheumatic fever or glomerulonephritis.
Upper Respiratory Tract and Chest Infections
Adults and Children over 10 Years of Age: The recommended dosage is 250-500 mg 3 times daily, every 8 hours.
Infants and Children under 10 Years of Age: In infants under 2 years of age, the dosage is 62.5 mg 3 times daily, every 8 hours. In children 2-10 years of age, the dosage is 125 mg 3 times daily, every 8 hours. For more severe infections, the dosage may be increased to 250 mg 3 times daily. The recommended dosage according to body weight is 20 mg/kg per day in divided doses every 8 hours. For more severe infections, the dosage may be increased to 40 mg/kg body weight per day every 8 hours.
Skin and Soft-tissue Infections: Treat as for upper respiratory tract and chest infections.
Uncomplicated Lower Urinary Tract Infections
Adults: A single dose of 3 g may be administered.
Children: A single dose of 100 mg/kg body weight may be administered.
Gonorrhea: A single dose of 3 g may be administered.
Prophylaxis of Bacterial Endocarditis (in dental procedures)
Adults and Children over 10 Years of Age: A single dose of 3 g about 1 hour prior to the procedure, to prevent bacteremia.
Children under 10 Years of Age: Half the adult dose.

Infections caused by amoxycillin – susceptible organisms. Prevention of bacteremia in patients at risk of developing bacterial endocarditis.

Penicillin hypersensitivity, babies born to mothers with a history penicillin hypersensitivity.

Prolonged use may occasionally result in overgrowth of non-susceptible organisms. Erythematous (morbilliform) rashes have been associated with glandular fever in patients receiving amoxicillin. In the treatment of group A β-hemolytic streptococcal infections, therapy with this drug should be continued for at least 10 days to help prevent the occurrence of acute rheumatic fever or glomerulonephritis. Following completion of treatment, cultures should be taken to determine whether streptococci have been eradicated. As with any potent drug, periodic assessment of renal, hepatic and hematopoietic functions should be made during prolonged therapy. All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients with amoxicillin should have a follow-up serologic test for syphilis after 3 months. The possibility of superinfection with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfection occurs, appropriate therapy should be instituted.
As with any potent drug, periodic assessment of renal, hepatic and haematopoietic function should be made during prolonged therapy. The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving Aerobacter, Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted. Penicillins are excreted largely unchanged by the kidney. Because renal function is incompletely developed in infants, the rate of elimination of the drug tends to be slow. Penicillin-type drugs should therefore be administered with caution, particularly in neonates, and organ system function (renal, hepatic, and hematological) should be evaluated frequently.
Serious and occasionally even fatal hypersensitivity reactions due to penicillin therapy have been reported. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients receiving oral penicillins. Such reactions are more likely to occur in individuals with a history of hypersensitivity to penicillins and/or a history of sensitivity to multiple allergens. There have also been reports of individuals with a history of penicillin hypersensitivity experiencing severe reactions when treated with cephalosporins.
Therefore before initiating therapy with this drug, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens, because of the risk of anaphylactoid reactions.
If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management including intubation, should also be administered as indicated. Amoxicillin should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.
Use in Pediatrics: Penicillins are excreted largely unchanged by the kidney. Because renal function is incompletely developed in infants, the rate of elimination of the drug tends to be slow. Penicillin-type drugs should therefore be administered with caution, particularly in neonates, and organ system function (renal, hepatic, and hematological) should be evaluated frequently.
Use in Patient with Impairment of Renal Function: In patients with renal impairment, the rate of excretion of amoxicillin will be reduced depending on the degree of impairment and it may be necessary to reduce the total daily unit amoxicillin dosage accordingly.
Use in Geriatrics: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.
Warnings: Prolonged use may occasionally result in overgrowth of non-susceptible organisms Erythematous (morbilliform) rashes have been associated with glandular fever in patients receiving amoxicillin.
See prescribing information for full details.

Diarrhoea and nausea, abdominal pain, skin rash.
See prescribing information for full details.

Penicillins/Chloramphenicol/Erythromycin/Tetracyclines/Sulfonamides: Since bacteriostatic drugs may interfere with the bactericidal effect of penicillins in the treatment of meningitis or other conditions where a rapid bactericidial effect is necessary, it is best to avoid concurrent therapy.
Amoxicillin/Probenecid: Probenecid may decrease renal tubular secretion of penicillin-type drugs including amoxicillin, resulting in increased blood levels pf amoxicillin.
Amoxicillin/Oral Contraceptives: In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
Amoxicillin/Allopurinol: Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. Similar reactions can be expected with amoxicillin.
Amoxicillin/Anticoagulants: Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.

Pregnancy: Reproduction studies have been performed in mice and rats at doses up to ten (10) times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to amoxicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. See prescribing information for full details.
Use during Labor and Delivery: Oral ampicillin-class antibiotics are poorly absorbed during labor. Studies in guinea pigs showed that intravenous administration of ampicillin slightly decreased the uterine tone and frequency of contractions but moderately increased the height and duration of contractions. However, it is not known whether use of amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary. See prescribing information for full details.
Lactation: Since penicillins are excreted in breast milk, administration of this drug to nursing mothers may lead to sensitization of their infants. Therefore, having taken into account the importance of the drug to the mother, either discontinue nursing or discontinue the drug.
See prescribing information for full details.

Overdose of penicillin drugs may cause neuromuscular hyperirritability or convulsive seizures. Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdose with amoxicillin. Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin.
Discontinue medication, treat symptomatically, and institute supportive measures as required. In patients with renal function impairment, the antibiotic may be removed from the circulation by hemodialysis, not by peritoneal dialysis.

Storage: Store in a dry place below 25°C.