...................... 60 mg/tab
........................ 30 mg/5 ml
Dexchlorpheniramine Maleate is an anti-histamine with anti-cholinergic
properties. It is capable of producing a slight to moderate sedative effect.
It appears to compete with histamine for receptor sites on effector cells
and are of value clinically in the prevention and relief of many allergic
It has been demonstrated that the predominant activity of the optically
active isomers of chlorpheniramine is the dextro-isomer. The dextro-isomer
is approximately two times more active than the racemic compound. Since
dexchlorpheniramine is the dextro-isomer and active moiety of
chlorpheniramine, its action and uses are similar to those of
Peak blood levels were achieved at an average time of 3 hours after
administration. The half life of Dexchlorpheniramine Maleate ranged from 20
to 24 hours. The drug when given is found to be extensively metabolized. The
drug and metabolites were primarily excreted in the urine, with 19% of the
dose appearing in 24 hours and a total of 34% in 48 hours.
Pseudoephedrine is a physiologically active stereoisomer of ephedrine that
acts directly on alpha-adrenergic receptors and to a lesser degree,
beta-adrenergic receptors. The alpha-adrenergic effects are believed to
result from the reduced production of cyclic adenosine 3', 5' monophosphate
(cyclic 3',5' AMP) by inhibition of the enzyme adenyl cyclase, whereas
beta-adrenergic effects appear to be caused by the stimulation of adenyl
Pseudoephedrine acts on alpha-adrenergic receptors in the nasal mucosa and
releases norepinephedrine, hence producing vasoconstriction of the dilated
nasal arterioles resulting in shrinkage of swollen nasal mucous membranes,
reduction of tissue hyperemia, oedema and nasal decongestion and an increase
in nasal airway patency. Drainage of sinus secretions is increased and
obstructed eustachian ostia may be opened. Relaxation of bronchial smooth
muscle by stimulation of beta-adrenergic receptors may also occur. Following
oral administration of 30 mg of pseudoephedrine hydrochloride effects are
noted within 30 minutes with peak activity occurring at approximately one
hour after administration and the effect persists for 4 to 6 hours.
Pseudoephedrine is absorbed from the gastrointestinal tract. It is resistant
to metabolism by monoamine oxidase and is largely excreted unchanged in the
urine together with small amounts of its hepatic metabolite. It has
half-life of several hours; elimination is enhanced and half-life
accordingly shorter in acidic urine.
It is indicated in nasal and upper respiratory tract congestion, common
cold, acute sinusitis, allergic rhinitis.
This formula is contraindicated in patients exhibiting hypersensitivity to
any of the components. Antihistamines are contraindicated in patients
receiving monoamine oxidase inhibitors since these agents prolong and
intensify the anticholinergic effects of anti-histamines. Antihistamines
should not be used to treat lower respiratory tract symptoms.
Sympathomimetic preparations are contraindicated in patients with severe
hypertension, severe coronary artery disease and patients receiving MAO
inhibitor therapy due to potentiation of the pressor effects of
Side effects/Adverse reactions
General:- Urticaria, drug rash, anaphylactic shock, photosensitivity,
excessive perspiration, chills, dryness of mouth, nose and throat.
Cardiovascular system:- Hypotension, headache, palpitation, tachycardia,
Hematologic system:- Hemolytic
anemia, thrombocytopenia, agranulocytosis.
Nervous system:- Sedation, sleepiness, dizziness, disturbed coordination,
fatigue, confusion, restlessness, excitation, nervousness, tremor,
irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia,
vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions, CNS
Gastrointestinal system:- Epigastric distress, anorexia, nausea, vomiting,
Urinary system:- Urinary
frequency, difficult urination, urinary retention.
Respiratory system:- Thickening of bronchial secretions, tightness of chest,
wheezing, nasal stuffiness.
Sympathomimetics should be used with caution in patients with hypertension,
hyperthyroidism, diabetes mellitus and cardiovascular disease.
Antihistamines should be used with caution in patients with narrow angle
glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic
prostatic hypertrophy and bladder neck obstruction.
Patients should be warned about
engaging in activities requiring mental alertness such as driving a car or
Not recommended for children below 2 years.
Use with caution and on doctor's/pharmacist's advice in children 2 to 6
years of age.
Use in pregnancy and lactation
Safety during pregnancy has not been established.
It is not known whether Polarine Syrup is excreted in human milk and
therefore caution should be exercised when administered to nursing mothers.
Use in children
Safety and effectiveness of Polarine Syrup have not been established in
children below 2 years.
Use in elderly
Antihistamines may cause dizziness, sedation and hypotension in patients
above 60 years. These patients are also more likely to have adverse
reactions to sympathomimetics.
|Children 6 to 12 years
||Half a tablet 3 times daily
||Half teaspoonful 6 hourly 3 times daily
||One tablet 3 times daily
||One teaspoonful 6 hourly 3 times daily
Anti-histamines have additive effects with alcohol and other CNS depressants
(hypnotics, sedatives, tranquilisers). Monoamine oxidase inhibitors prolong
and intensify the anticholinergic effects of antihistamines and potentiate
the pressor effects of sympathomimetics. Sympathomimetics may reduce the
antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum
Symptoms and Treatment for overdosage and antidote(s)
Overdosage reactions may vary from central nervous system depression to
stimulation. Stimulation is particularly likely in children. Atropine-like
signs and symptoms: dry mouth, fixed, dilated pupils, flushing, and
gastrointestinal symptoms may also occur. If vomiting has not occurred
spontaneously the conscious patient should be induced to vomit. This is best
done by having the patient drink a glass of water or milk after which they
should be made to gag. Precautions against aspiration must be taken,
especially in infants and children.
If vomiting is unsuccessful, gastric lavage is indicated within 3 hours
after ingestion and even later if large amounts of milk or cream were given
beforehand. Isotonic and half isotonic saline is the lavage solution of
choice. Saline cathartics, such as milk of magnesia, by osmosis draw water
into the bowel and therefore, are valuable for their action in rapid
dilution of bowel content.
Vasopressors may be used to treat hypotension.
Tablet : A bottle of 90 tablets.
Blister pack : A box of 100 x 10 tablets per strip.
Alu-alu pack : A box of 10 x 10, 50 x 10 and 100 x 10 tablets per strip.
Syrup : A bottle of
60ml,100ml and 120ml.
Pack sizes (export/tender only)
Tablet : A bottle of 1000 tablets.
Syrup : A bottle of 3.6 litres and 3.8 litres.
Store at or below 25°C.
Tablet: Oval, deep convex, white, plain tablets without markings.
Syrup: A clear, dark brown syrup
with plum flavour.