Each tablet contains
Chlorpheniramine Maleate ... 4mg
An orange, biconvex, round tablet 8 mm in diameter with KOTRA logo on one
side and a single score line on the other side.
For allergic conditions including hay fever, urticaria, angioedema,
vasomotor rhinitis, allergic, eczema, atopic and contact dermatitis, drug
and serum reactions, insect bites, pruritus.
MECHANISMS OF ACTION
Chlorpheniramine Maleate is an alkylamine derivative with antihistamine and
anticholinergic effects. The antihistamine acts by competing with histamine
for H1 receptor sites on the effector cells to the exclusion of agonist
molecules, without itself initiating a response. This antagonism is
competitive and reversible. It does not prevent the production of
Chlorpheniramine Maleate is readily absorbed from gastrointestinal tract and
parenteral sites of administration. Following oral administration the
effects may start within 15 to 30 minutes, reaching peak within 1 hour, and
may last about 4-6 hours. It is extensively metabolised in the liver, and
excreted mainly as metabolites in the urine.
Adults: 1 tablet 3 or 4 times daily.
Children 6-12 years: 1/2 tablet (2mg) 3-4 times daily.
Contraindicated in patients with known sensitivity to antihistamines.
The most common side effect is sedation, varying from drowsiness to deep
sleep, and including inability to concentrate, lassitude, dizziness,
hypotension, muscular weakness and inco-ordination. Sedative effects, when
they occur, may diminish after a few day. Other side effects include
gastrointestinal disturbances, such as nausea, vomiting, diarrhea or
constipation, colic, and epigastric pain. It may also produce headache,
blurred vision, tinnitus, elation or depression, irritability, nightmares,
anorexia, difficulty in micturition, dryness of mouth, tightness of chest,
tingling, heaviness and weakness of the hands. It may potentiate CNS
depressants. Large doses may precipitate fits in epileptics.
May cause drowsiness and hence may impair ability to drive vehicles or
operate machinery. MAO inhibitors may prolong some of its actions. Patients
should be warned that antihistamine may enhance the sedative effects of CNS
depressants including alcohol, barbiturates, hypnotics, narcotic analgesics,
sedatives and tranquillisers. Use with caution in patients with narrow angle
glaucoma, history of bronchial asthma, hyperthyroidism, cardiovascular
disease and prostatic hypertrophy. Use is not recommended in nursing
mothers, pregnancy, newborn and premature infants. Safety and efficacy of
the drug in children younger than 2 years of age have not been established.
MAO inhibitors may enhance the antimuscarinic effects of chlorpheniramine
while CNS depressants including alcohol, barbiturates, hypnotics, narcotic
analgesics, sedatives and tranquillisers may enhance the sedative effects.
It is also important to note that chlorpheniramine may mask the warning
signs of damage caused by ototoxic drugs such as aminoglycoside antibiotics.
TREATMENT FOR OVERDOSAGE
If the drug has been taken recently by mouth, the stomach should be emptied
by aspiration and lavage. Emetics are generally of little value. The
patients should be kept quiet to minimise the excitation which occurs
particularly in children. Convulsions and marked CNS stimulation should
preferably be treated with diazepam or phenobarbitone intramuscularly,
paraldehyde, thiopentone sodium, and chlorpromazine have also been
recommended. Severe hypotension may require fluid replacement, and assisted
respiration may be necessary. Forced diuresis is of little value since
antihistamines are rapidly metabolised and only traces are recovered in the
Keep container well closed. Store below 30°C. Protect from light.
Available in plastic container of
1000 tablets and blister pack of 100 x 10's & 10 x 10's.