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|Product Name:||Amoxicillin For Oral Suspension||Composition:||Each 5 ML Oral Suspension Contains: Ampicillin 250MG|
|Indications:||Amoxycillin Is Indicated In The Treatment Of All Infections Caused By Susceptible (non-penicillinase Producing) Micro-organisms||Storage Instructions:||Store Below 25°C. Protect From Moisture. The Potency Of Reconstituted Suspensions Will Be Maintained For One Week At Temperatures Not Exceeding 25°C And For Two Weeks Under Refrigeration(2°C –8°C)|
|Expiration Date:||3 Years|
Amoxicillin For Oral Suspension Drugs 250MG / 5ML 100ML
The powder contains amoxycillin trihydrate equivalent to 250 mgamoxycillin per 5 mL and 0,1% m/v sodium benzoate as preservative when reconstituted.
Amoxycillin is a semi-synthetic, broad-spectrum penicillin derived from the 6-amino- penicillanic acid nucleus. Chemically it is 6-[D(-)-alpha-amino-p-hydroxyphenyl -acetamido] penicillanic acid trihydrate.
Amoxycillin is rapidly absorbed after oral administration and provides high blood levels and very high concentrations in the tissues and urine. Amoxycillin does not readily diffuse into the brain and spinal fluid except when the meninges are inflamed.
The ingestion of food does not greatly reduce the absorption of amoxycillin. Amoxycillin does not appear to be metabolized in the body. Urinary excretion is rapid, and only unchanged amoxycillin is recovered in the urine. Its excretion can be delayed by concurrent administration of probenecid. Approximately 17% of amoxycillin is bound by serum proteins.
Amoxycillin does not resist destruction by penicillinase and is thus not effective against penicillinase-producing bacteria, particularly resistant Staphylococci. All strains of Pseudomonas and most strains of Klebsiella, indole-positive Proteus, Serratia, Acinetobacter and Enterobacter are resistant to amoxycillin.
Amoxycillin is particularly effective in-vitro against the following organisms; Gram-positive cocci, Strep. agalactiae,Strep. faecalis, Strep. pneumoniae and penicillin-sensitive N. gonorrhoea, Gram-negative bacilli, Listeria monocytogenes. Amoxycillin is also effective in-vitro against the following organisms (penicillin G is preferred for routine use): Penicillin-sensitive Staph. aureus, Strep. pyogenes, Strep. viridans, group N. meningitidis. Amoxycillin is also active in-vitro against the following organisms (sensitivity tests must be performed as these organisms may produce beta-lactamase); E. coli, Proteus mirabilis, Salmonella, Shigella and Haemophilus influenzae. In-vitro sensitivity does not necessarily imply in-vivo efficacy.
Amoxycillin may be effective against the following organisms (Sensitivity tests must be performed): Bordetella pertussis, Bacteroides fragilis and Nocardia.
Amoxycillin is indicated in the treatment of all infections caused by susceptible (non-penicillinase producing) micro-organisms.
Respiratory infections such as:-
Acute typical pneumonia, acute and chronic bronchitis and epiglottitis, tonsillitis, pharyngitis, laryngitis, otitis media, and sinusitis.
Urinary tract infections and uncomplicated gonococcal infections. Bacteraemia, enteric fever. Meningitis (sensitivity tests must be performed).
Skin and soft tissue infections such as:-Pyoderma, erysipelas, lymphangitis, cellulitis.
Gastro-intestinal infections such as:-
Typhoid, Salmonella (uncomplicated gastro-enteritis). Indicated surgical procedures should be performed.
Patients hypersensitive to penicillins and cephalosporins. Patients with infectious mononucleosis are susceptible to skin rashes.
DOSAGE AND DIRECTIONS FOR USE:Adults and children with a mass of more than 40 kg:-
500 mg three times per day. The latter dosage is for the more severe infections.
|Age and Mass||% of Adult Dose||Usual Total Daily
|Adults (65 kg)||100%||750 mg - 1,5 g|
|12 years (40 kg)||75%||525 mg - 1,125 mg|
|7 years (23 kg)||50%||375 mg - 750 mg|
|1 year (10 kg)||25%||187 mg - 375 mg|
|* Administered in divided doses three times per day.|
For in-between ages, in-between percentages are used, e.g. at 10 years 66% and at three years 33% of the adult dose. The above percentage method of calculating dosage is based on the formula:-
|Surface area of child||X 100 = Percentage of Adult dose|
|Surface area of adult|
The recommended dosage is 20 mg/kg/day in three equally divided doses.
In the case of severe infections the dosage should be doubled. Treatment should be continued for a minimum
of forty-eight to seventy-two hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. A MINIMUM OF TEN DAYS' TREATMENT IS RECOMMENDED FOR ANY INFECTION CAUSED BY GROUP A BETA-HAEMOLYTIC STREPTOCOCCI.
Chronic urinary tract infections may require prolonged, intensive therapy with continued bacteriological and clinical follow-up.
For the treatment of gonorrhoea:-
3 g as a single oral dose. In the treatment of complications of gonococcal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended.
Patients with gonorrhoea in whom syphilis is suspected should have darkfield examinations before receiving treatment and monthly serological tests for a minimum of four months.
Reconstitution of powders:-
The 250 mg/5 mL powder are reconstituted with 59 mL of water to yield 100 mL of suspension.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Adverse events associated with amoxycillin are allergic reactions which commonly include urticarial or maculopapular skin rashes.
Amoxycillin may cause reactions typical of penicillin allergy in patients sensitive to penicillin. See under "Warnings".
Gastro-intestinal adverse effects particularly diarrhoea and also nausea and vomiting occur quite frequently, usually following administration by mouth. Glossitis, stomatitis and black-"hairy" tongue have been reported. Pseudomembranous colitis has also been reported. Supra-infections with non-susceptible organisms may occur particularly with prolonged use.
Amoxycillin should not be given to patients with infectious mononucleosis, lymphatic leukaemia and patients with hyperuricaemia being treated with allopurinol, since these patients appear to have a higher incidence of skin rashes.
Anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis have been reported during therapy with the penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
Periodic assessment of organ system function including renal, hepatic and haematopoietic, should be made during prolonged therapy.
A moderate rise in serum glutamic oxaloacetic transaminase (SGOT) has been noted particularly in infants but the significance of this finding is unknown.
On account of the slow physiological renal development in newborns, amoxycillin is excreted slowly in infants aged between two and three weeks.
The use of this antibiotic may lead to appearance of resistant strains of organisms and sensitivity testing should therefore be carried out wherever possible to ensure the appropriateness of the therapy.
Amoxycillin may decrease the efficacy of oestrogen-containing oral contraceptives and it may also affect the absorption of other drugs due to its effect on the gastro-intestinal flora.
Safety of use during pregnancy has not been established.
Store below 25°C. Protect from moisture.
The potency of reconstituted suspensions will be maintained for one week at temperatures not exceeding 25°C and for two weeks under refrigeration(2°C –8°C).
KEEP OUT OF REACH OF CHILDREN.