PHENOXYMETHYL PENICILLIN

POTASSIUM
PACIPHEN
125mg/5ml
Granules for Oral Suspension
Antibacterial
FORMULATION
Each 5ml (1tsp) oral suspension contains:
Phenoxymethyl penicillin
potassium .................................................................. 320
mg
............................................................ 300 mg

The most common reactions to this product are

gastrointestinal effects and hypersensitivity reactions such
as nausea, vomiting, epigastric distress, diarrhoea and
black, hairy tongue.

PRODUCT DESCRIPTION
Phenoxymethyl penicillin potassium is a natural
penicillin antibacterial which is white, odorless crystalline
powder.
Paciphen 125mg/5ml is a granules for reconstitution
of oral suspension.
PHARMACOLOGY
PHARMACODYNAMICS
Phenoxymethylpenicillin has a mainly bactericidal
action against many gram-positive bacteria and some
gram-negative cocci. It acts through interference with the
final stage of synthesis of the bacterial cell wall. The action
depends on its ability to bind certain membrane-bound
proteins, (penicillin-binding proteins or PBPs) that are
located beneath the cell wall. These proteins are involved
in maintaining cell wall structure, in cell wall synthesis and
in cell division, and appear to possess transpeptidase and
carboxypeptidase activity.
PHAMACOKINETICS
Phenoxymethyl penicillin potassium is rapidly but
incompletely absorbed after oral administration, about
60% of an oral dose is absorbed. Calcium and potassium
salts are better absorbed than the free acid.. Absorption
appears to be more rapid in fasting than non-fasting
subjects. Blood concentration peak serum concentrations
of 3 to 5 micrograms /ml occur 30 to 60 minutes after a
dose of 500 mg. The biological half-life is about 30
minutes, increased to about 4 hours in severe renal
impairment. About 50% to 80% is to be plasma proteins
bound. Biotransformation is metabolised in the liver;
several metabolites have been identified, including
penicilloic acid. Elimination: Unchanged drug and
metabolites are excreted rapidly in the urine about 20% to
35% of an oral dose is excreted in the urine in 24 hours.
INDICATION
Phenoxymethyl penicillin potassium is used for the
treatment of mild to moderately severe infections
associated with micro-organisms whose susceptibility to
penicillin is within the range of serum levels attained with
the dosage form or for prophyalxis of certain streptococcal
infections.
CONTRAINDICATION
This product is contraindicated in patients known to
have hypersensitive and should be used with caution in
patients with known histories of allergy.
PRECAUTIONS
Paciphen should be reconstituted only with water and
at the volume stated. Administer with caution in the
presence of markedly impaired renal function, as safe
dosage may be lower than that usually recommended and
also to patients with hypersensitivity . It should not be used
for the initial treatment of severe infections and should not
be relied on in patients with nausea, vomiting, gastric
dilatation, esophageal achalasia or intestinal hypermotility.
If an allergic reaction occurs, the medicine should be
discontinued and the appropriate therapy instituted.
ADVERSE REACTION

DOSAGE AND MODE OF ADMINISTRATION

The dosage and frequency of Phenoxymethyl
penicillin depends on the severity and localisation of the
infection and expected pathogens. It should be taken at
least 30 minutes before or 2 hours after food.
Usual doses:
Adults and children over 12 years: 250mg - 500mg (24 tsp) every six hours
Children: Infants (up to 1 year): 62.5mg (1/2 tsp)
every 6 hours
1-5 years: 125mg (1tsp) every six hours
6-12 years: 250mg (2tsp) every six hours
Prophylactic Use:
Prophylaxis of rheumatic fever: 250mg (2tsp) twice
daily on a continuing basis
Prophylaxis of
pneumococcal infection (e.g. in asplenia and in sickle cell
disease):
Adults and children over 12
years: 500mg (4tsp) every 12 hours
Children 6-12 years: 250mg (1tsp) every 12 hours
Children below 5 years: 125mg (1/2tsp) every 12
hours.
SYMPTOMS AND TREATMENT OF OVERDOSAGE
A large overdosage of penicillin may cause nausea,
vomiting, stomach pain, diarrhea, and rarely, major motor
seizures. If other symptoms are present, consider the
possibility of an allergic reaction. Hyperkalaemia may
result from overdosage, particularly for patients with renal
insufficiency.
For the management there is no specific antidote
known. Symptomatic and supportive therapy is
recommended. Activated charcoal with a cathartic, such as
sorbitol may hasten drug elimination. Penicillin may be
removed by haemodialysis.
WARNING
All degrees of hypersensitivity, including fatal
anaphylaxis, have been observed with oral penicillin.
These reactions are more likely to occur in individuals
with a history of sensitivity to penicillins, cephalosporins
and other allergens.
INFORMATION FOR THE PATIENT
The product is an antibacterial agent. It must not be
given to patients with hypersensitivity to penicillins. You
should not exceed the recommended dose except on the
advice of your doctor.
Paciphen granules should be reconstituted at the time
of dispensing adequate amount of water and administered

orally. Unused reconstituted solution should be stored in a

refrigerator and discarded within 14 days.

NAME AND ADDRESS OF THE MANUFACTURER

Manufactured by:

AVAILABILITY
Granules for oral suspension: 125mg/5ml x 60ml
bottle.
STORAGE CONDITIONS
Keep the product out of reach and sight of children.
Store granules for reconstitution in tight containers at
temperatures 15- 30C.Reconstituted suspensions should
be refrigerated at 2-8 C. Discard any unused solution after
14 days.

MedPacific Laboratories
2110 Paciano, Calamba
Laguna, Philippines

DATE OF THE LATEST REVISION OF THE

PACKAGE INSERT: 0315-UST