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ARISTOMOX

Amoxycillin

 

Description:

Aristomox (Amoxycillin) is a semi-synthetic antibiotic, an analog of Ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically it is d-(-) alpha amino-P-hydroxy benzyl penicillin trihydrate.

Clinical Pharmacology:

Amoxycillin is stable in the presence of gastric acid and may be given without regard to meals. It is better absorbed when taken orally and produces a higher blood level.

Microbiology:

Aristomox (Amoxycillin) is similar to Ampicillin in its bactericidal action against susceptible organisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell wall mucopeptides. In vitro studies have demonstrated the susceptibility of most strains of the following Gram-positive bacteria: alpha-and beta-hemolytic streptococci, Streptococcus pneumoniae (formerly Diplococcus pneumoniae), non-penicillinase producing staphylococci and Streptococcus faecalis.

It is active in vitro against many strains of Haemophilus influenzae, Neisseria gonorrhoeae, Escherichia coli and Proteus mirabilis.

Composition:

Aristomox Capsule: Each capsule contains Amoxycillin Trihydrate BP equivalent to Amoxycillin 250 mg.

Aristomox-500 Capsule: Each capsule contains Amoxycillin Trihydrate BP equivalent to Amoxycillin 500 mg.

Aristomox Powder for Suspension: After reconstitution each 5 ml contains Amoxycillin Trihydrate BP equivalent to Amoxycillin 125 mg.

Indications:

Aristomox is indicated in the following bacterial infections:

Infections of the Respiratory tract & ear: Laryngitis, pharyngitis, tonsillitis, sinusitis, chronic & acute bronchitis, pneumonia, otitis.

Infections of biliary and G.I. tract: Salmonellosis including the carrier stage, cholecystitis, peritonitis.

Infections of the Genito-urinary tract: Nephritis, pyelitis, pyelonephritis, cystitis, urethritis and gonorrhoea, bacteriuria in pregnancy.

Gynaecological infections: Puerperal sepsis and septic abortion.

Skin and soft tissue infection: Boils, curbuncles, cellulitis, pre and post-operative prophylaxis and treatment of infections.

Septicaemia.

Osteomyelitis.

Prophylaxis of endocarditis: Aristomox may be used for the prevention of bacterimia associated with procedures such as dental extraction in patients at risk of developing bacterial endocarditis.

Dosage & Administration:

Adult (including elderly patients): Usual dose is 250 mg three times daily, increasing to 500 mg three times daily for more severe infections for 5-7 days or as advised by the physician.

Typhoid and Para-typhoid: 4 g daily in divided doses for 14-21 days.

Typhoid carrier states: 3-4 g in divided doses for a minimum of 1 month or as advised by the physician.

Gonorrhoea/Uncomplicated urinary tact infections: A single dose of 3 g (generally employed with 1 g of Probenecid)

Simple acute urinary tract infection: Two 3 g doses with10-12 hours between the doses.

Syphillis: A dose of 250 mg every 6 hours for 1 month to 5 months according to the stage of the disease and serological response.

Prophylaxis of endocarditis in susceptible patients: Single dose of 3 g about 1 hour before procedures such as dental extraction.

Severe or recurrent purulent infection of the respiratory tract: A dose of 3 g twice daily is recommended in appropriate cases. Maximum recommended oral dose is 6 g daily in divided doses.

Children:

Under 2 years: 1/4 adult dosage.

2-10 years: 1/2 adult dosage.

In severe infections the dosage may safely be increased.

Children up to 10 years of age may be given the equivalent of 125 to 250 mg three times daily. Under 20 Kg body weight a dose of 20 to 40 mg per Kg daily has been suggested.

Children weight 20 Kg or more should be dosed according to the adult recommendation.

Typhoid & Para-typhoid: 100 mg/Kg/day in divided doses for 14-21 days. In prophylaxis of endocarditis, children may be given half the adult dose. i.e., 1.5 g about 1 hour before procedure such as dental extraction.

Contraindication:

The use of this drug is contraindicated in individuals with a history of an allergic reaction to any of the penicillins.

Side-effects:

Side effects as with other penicillins are rare and are usually of mild and transient in nature. If skin rash appears then treatment should be discontinued after informing the physicians. Rarely diarrhoea has been reported. Such cases disappear in continuation of the treatment. But all reactions must be reported to the physician.

Warnings:

In presence of diarrhoea or vomiting the absorption of Aristomox is doubtful. Superinfections may appear with the use of broad-spectrum antibiotics. Treatment should be discontinued if superinfection appears with the use of Aristomox and necessary treatment should be taken for the superinfection.

Direction for reconstitution:

Add 70 ml (14 tea-spoonfuls) of boiled and cooled water using the supplied cap to the dry powder in the bottle. For ease of preparation add water to the bottle in two portions. Shake well after each addition until all the powder is in suspension.

Note: Shake the oral suspension well before use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool place, preferably in a refrigerator and use within 7 days of preparation.

Packing:

Aristomox Capsule: Box containing 10x10's capsules in blister pack.

Aristomox-500 Capsule: Box containing 5x10's capsules in blister pack.

Aristomox Powder for Suspension: Bottle containing dry powder for reconstitution of 100 ml oral suspension.

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