| 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. |