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Ospamox

Composition

Ospamox 100mg/ml: 1 ml contains:

Amoxycillin, 100 mg; Sodium Benzoate, 6.7 mg; Saccharin Sodium, 0.3 mg; Sucrose, appr. 0.6 g

Ospamox 125mg/5ml: 5 ml (1 measuring spoonful) contains:

Amoxycillin, 125 mg; Sodium Benzoate, 25 mg; Saccharin Sodium, 3.3 mg; Sucrose, appr. 1.2 g

Ospamox 250mg/5ml: 5 ml (1 measuring spoonful) contains:

Amoxycillin, 250 mg; Sodium Benzoate, 25 mg; Saccharin Sodium, 3.3 mg; Sucrose, appr. 1.6 g

Ospamox 375mg/5ml: 5 ml (1 measuring spoonful) contains:

Amoxycillin, 375 mg; Sodium Benzoate, 25 mg; Saccharin Sodium, 3.3 mg; Sucrose, appr. 2.0 g

Ospamox 250mg: 1 capsule contains: Amoxycillin, 250 mg

Ospamox 375mg: 1 capsule contains: Amoxycillin, 375 mg

Ospamox 500mg: 1 capsule contains: Amoxycillin, 500 mg

Ospamox 500mg: 1 tablet contains: Amoxycillin, 500 mg

Ospamox 750mg: 1 tablet contains: Amoxycillin, 750 mg

Ospamox 1000mg: 1 tablet contains: Amoxycillin, 1000 mg

Properties and action

Amoxycillin is a highly potent, broad-spectrum penicillin with a particularly rapid onset and a broad spectrum of action. Like other penicillins, it acts by inhibiting cell wall synthesis.

Thanks to its broad action spectrum, it is active against both gram-positive and gram-negative micro-organisms. Clinically relevant gram-negative pathogens covered by amoxycillin are Escherichia coli, Proteus mirabilis, Salmonella, Shigella, Campylobacter, Hemophilus influenzae, Bordetella pertussis as well as Leptospira and Chlamydia. Other micro-organisms responding to amoxycillin include all those susceptible to penicillin G, eg group A, B, C, G, H, L and M streptococci, Streptococcus pneumoniae, non-penicillinase-producing staphylococci and Neisseria, Erysipelothrix rhusiopathiae, Corynebacterium, Bacillus anthracis, Actinomycetes, streptobacilli, Spirillium minus, Pasteurella multocida, Listeria and spirochetal organisms ( Leptospira, Treponema, Borrelia and other Spirochetes ) as well as numerous anaerobic organisms ( among them peptococci, peptostreptococci, Clostridia and Fuso-bacteria ).

Pharmacokinetics

The absorption of amoxycillin is unaffected by meals. The drug is almost completely absorbed from the small intestine. Peak serum levels are reached within 1 to 2 hours after ingestion. Amoxycillin readily distributes in body tissues and fluids including the sputum and purulent bronchial secretions. If liver function is intact, high biliary drug concentrations are reached.

Amoxycillin is eliminated at a half-life of approximately 1 to 2 hours. Elimination is predominantly renal. More than half of the oral dose is excreted with the urine in a therapeutically active form.

Fields of application

Ospamox is useful in the treatment of infections caused by amoxycillin-susceptible organisms:

Respiratory tract infections

-- Upper airways and ENT infections

-- Lower airways infections, eg acute and chronic bronchitis, pneumonia, lung abscesses, pertussis ( incubation period and early stages )

Urogenital infections

-- Acute and chronic pyelonephritis, pyelitis, prostatitis, epididymitis

-- Cystitis, urethritis, asymptomatic bacteriuria during pregnancy

-- Gonorrhea

Gynecologic infections ( septic abortion, adnexitis, endometritis, etc )

Gastro-intestinal infections

-- Typhoid fever, paratyphoid, particularly if complicated by septicemia ( in combination with an aminoglycoside antibiotic ); control of Salmonella carriers

-- Shigellosis

-- Infections of the biliary system ( cholangitis, cholecystitis )

Skin and soft tissue infections

Leptospirosis

Acute and latent listeriosis

Unless parenteral treatment ( eg with ampicillin ) is required, Ospamox is also active in the conditions below:

-- Short-term ( 24 to 48 hours ) prophylactic treatment of patients undergoing surgery ( eg in the oral cavity )

-- Endocarditis, eg enterococcal endocarditis ( alone or in combination with an aminoglycoside antibiotic )

-- Bacterial meningitis ( pending the outcome of susceptibility tests; particularly in children )

-- Septicemias caused by amoxycillin-susceptible pathogens.

Infections caused by pathogens with established penicillin G susceptibility should preferentially be treated with penicillin G.

Mode of application

To be taken with abundant fluid.

Dosage

The dose depends on the susceptibility of the offending organism and on the site of the infection. In general, the total daily dose should be divided into 2 ( 3 to 4 ) fractions.

Doses for children, which were calculated relative to kg body weight, should not exceed maximal adult doses.

Average dosage levels for

-- children:                       30 - 60/kg by.wght./day

-- adolescents and adults: 1,500 - 2,000 mg/day

Specific dosing recommendations:

250 mg/375 mg granules for oral suspension may be replaced by capsules of the same strength.

500 mg film-coated tablets are interchangeable with 500 mg capsules.

As Ospamox is highly effective and excellently absorbed, even severe infections will respond to oral drug treatment. In severe disease daily doses should, however, be increased:

Children: 100mg/kg by.wght.daily

Adults:     up to 6,000 mg daily

Dosages of 200 mg/kg by.wght. and 8,000 mg daily have been tolerated by children and adults, respectively, without any complications. For acute febrile infections of the gastro-intestinal tract ( typhoid fever, paratyphoid ) and the biliary system or for gynecologic infections adults should be given 1,500 to 2,000 mg t.i.d. or 1,000 to 1,500 mg q.i.d.

Leptospirosis:

Adults: 500 to 750 mg q.i.d. for 6 to 12 days

Chronic Salmonella carriers:

Adults: 1,500 to 2,000 mg t.i.d. for 2 to 4 weeks

Prevention of endocarditis secondary to dental extractions:

Adults should receive 3,000 to 4,000 mg 1 hour prior to extractions followed, if necessary, by another dose 8 to 9 hours later, Children are given half this dose.

Treatment should be continued for 2 to 5 days after symptoms have subsided. To prevent sequels, streptococcal infections should be treated for at least 10 days ( WHO recommendation ).

Dosage in patients with reduced elimination:

In patients with reduced renal function or plasma creatinine levels above 4 mg ( creatinine clearance below 30 ml/minute ) as well as in premature or newborn infants dosage levels and/or dosage intervals should be adjusted to match the reduced renal elimination. If creatinine clearances are between 15 and 40 ml/minute, amoxycillin should be dosed at approximately 12-hourly intervals. Anuric patients should not be given more than 2,000 mg within 24 hours. Urinary tract infections require normal dosage levels.

Contraindications

Known and suspected hypersensitivity to penicillins. Potential cross allergy should be considered in patiens with cephalosporin hypersensitivity.

Because of the increased incidence of side effects ( rashes ) amoxycillin should not be administered to patients with mononucleosis and lymphatic leukemia.

Severe gastro-intestinal infections with persistent diarrhea or vomiting should not be treated with oral amoxycillin because of the risk of reduced absorption.

Antibiotics have no place in trivial infections.

Special caution should be exercised in patients with allergic diatheses or bronchial asthma and hay fever.

Pregnancy and lactation:

There is no current evidence to suggest any embryotoxic, teratogenic or mutagenic effects of Ospamox during pregnancy. it should, however, be borne in mind that amoxycillin diffuses into breast milk.

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