Dramoxilin® Dry Suspension and Capsules
(AMOXYCILLIN 250MG & 500MG)

COMPOSITION
Each teaspoonful (5ml) contains Amoxycillin (as Trihydrate) 125mg.
Each capsule contains Amoxycillin (as Trihydrate) 250mg.
Each capsule contains Amoxycillin (as Trihydrate) 500mg.

Amoxycillin is broad – spectrum semisynthetic penicillin which is stable in the presence of gastric acid.

Amoxycillin is rapidly absorbed following oral administration without regard to meals.
Amoxycillin diffuses readily into most body tissues and fluids but not into the brain and spinal fluid, except when meninges are inflamed. It is bactericidal against sensitive organisms during the stage of active multiplication and acts by inhibiting the biosynthesis of bacterial cell wall mucopeptides. Amoxycillin achieves good penetration into bronchial secretions and high urinary concentrations of unchanged antibiotic.

Amoxycilin dosage is particularly convenient; it is administered 3 times a day thus ensuring patient compliance necessary for therapeutic effectiveness. The wide range of organisms sensitive to the bacterial action of Amoxycilin includes:

Gram-positive: Streptococcus faecalis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridians Staphytoccus aureus (penicillin – sensitive). Listeria monocytogenes.

Gram-negative: Haemophillus influenzae, Escherichia coli, Proteus mirabilis, Salmonella species, Shigella species, Bordetella pertussis, Brucella species, Neisseria meningitis.

INDICATIONS
Infections caused by Amoxycilin-susceptible organisms including:
 Upper respiratory tract infections
 Chest infections
 Urinary tract infections
 Skin and soft tissues infections
Amoxycilin may be used for the prevention of bacteromia associated with procedures such as dental extraction in patient at risk of developing bacteria, endocarditis.

CONTRAINDICATIONS
Known hypersensitivity to Amoxycilin and/or other members of penicillin group. Babies born to mother with a history of such hypersensitivity.

WARNINGS
Before therapy with any penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens because of the risk of anaphylactoid reactions.

ADVERSE REACTIONS
As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena.
These are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillin and in those with a history of allergy, asthma, hay fever, or urticaria. Anaphylaxis is the most serious reaction experienced and has been associated with the parenteral dosage form. Note that urticaria, other skin rashes and serum sickness-like reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, the drug should be discontinued unless, in the opinion of the physicians, the condition being treated is life-threatening and amenable therapy. Serious anaphylactic reactions require the immediate use of adrenaline, oxygen and i.v. steroids.

PRECAUTIONS
In the treatment of group AB – hemolytic streptococcal infections, penicillin therapy should be continued for at least 10 days to help prevent the occurrence of acute rheumatic fever of glomerulonephritis

As with any potent drug, periodic assessment of renal, hepatic and hemapotic functions should be made during prolonged therapy. The possibility of superinfection with mycotic or bacteria pathogens should be kept in mind during therapy, if superinfection occurs, appropriate therapy should be instituted.

KEEP OUT OF THE REACH OF CHILDREN!
Drug Interactions
Penicillin / Chloramphenicol / Erythromycin / Tetracyclines Sulfonamides.
Since bacteriostatic drugs may interfere with the bactericidal effect of penicillin in the treatment of meningitis or other situations where a rapid bactericidal effect is necessary, it is best to avoid concurrent therapy.

DOSAGE AND ADMINISTRATION
Amoxycillin is effective in a wide range of dosage regimens. The recommendations given here are those commonly applied.

Infants under 2years of Age
62.5mg (half teaspoonful Amoxycillin Suspension) 3 times daily every 8 hours

Children 2-10 years of Age
125mg (1 teaspoonful Amoxycillin Suspension) 3 times daily every hours increasing to 250mg 3 times daily for more severe infections.

Adult
250-500mg every 8 hours or more frequently if necessary. Total daily dose in adults should not exceed 6g daily or 100mg/kg/day.

PRESENTATION
Syrup: Amoxycillin (as Trihydarte) 125mg per 5ml; dry powder for 100ml oral reconstitution.
Capsule: Amoxycillin (as Trihydrate) 250mg and 500mg in blister pack of 10 x 10’s and bulk pack of 500.

STORAGE
The Suspension should be stored below 30’c before and after reconstitution and be used within 7 days of reconstitution.
The capsules should be stored below 30oC