ALLERMINE®

Composition: Each tablet contains:
Chlorpheniramine maleate . . . . . . . . . . . . . 4 mg
Presentation:
Box of 10 blisters x 20 tablets.
Indications:
Allermine is used for:
The treatment of respiratory tract diseases due to acute and chronic allergy: Seasonal rhinorrhea, rhinitis etc.
Other allergic symptoms such as contact dermatitis, urticaria, Quincke’s edema, food or drug allergy; itching caused by infections such as measles or chickenpox.

Category:

Additional information

Dosage and administration

Children under 6 years of age: Follow doctor’s instructions.
Children from 6 to 12 years of age: 1 tablet, 1-2 times daily.
Adults and children over 12 years of age: 1 tablet, 3-4 times daily.

Contraindications

Hypersensitivity to any component of this medicine.
Acute asthma attack.
Prostatic hypertrophy.
Narrow-angle glaucoma.
Bladder neck obstruction.
Stenosing peptic ulcer; pyloroduodenal obstruction.
This product should not be used in pregnant women, nursing mothers, newborn infants and premature infants.
Patients who are taking monoamine oxidase inhibitors (MAOIs) for depression or are within 14 days of discontinuing treatment with them. That is because anticholinergic property of chlorpheniramine is increased by MAOIs.

Warnings and precautions for use

Sedative effect of chlorpheniramine increases when taken concomitantly with alcohol or sedatives and tranquilizers.
Chlorpheniramine may cause drowsiness. Avoid giving it to people who are driving or operating machinery.
Chlorpheniramine may increase the risk of urinary retention due to its anticholinergic side effects, particularly in people with prostatic hypertrophy, urinary tract obstruction, duodenal obstruction, and myasthenia gravis aggravated.

Recommendation for pregnancy and breastfeeding

Pregnancy:
Chlorpheniramine should only be administered to pregnant woman if it is really needed. Allermine should not be used during the third trimester because it may lead to severe reactions such as seizures in a newborn or premature neonates.
Lactation:
Chlorpheniramine may be excreted into human milk and may inhibit lactation. Because antihistamines may cause serious reactions to nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Effects on ability to drive and use machines

This drug causes drowsiness. Caution should be taken when driving and operating machines.

Interactions, incompatibilities of medicine

MAOIs may prolong and intensify anticholinergic activity of antihistamines.
Ethanol or other sedative hypnotic medications may potentiate the inhibitory activity on the central nervous system of chlorpheniramine.
Chlorpheniramine inhibits phenytoin metabolism and may lead to phenytoin intoxication.

Undesirable effects (ADRs)

Sedative effects vary from slight drowsiness to deep sleep, dry mouth, vertigo, dizziness, anorexia, nausea.

Overdose and management

Overdose:
The estimated lethal dose of chlorpheniramine is 25 to 50 mg per kg body weight.
Symptoms of chlorpheniramine overdose include sedation, paradoxical CNS stimulation, psychosis, epilepsy, apnoea, convulsions, anticholinergic activity, dystonic reactions and cardiovascular collapse including arrhythmias.
Treatment:
Symptomatic and supportive measures should be provided with special attention to cardiac, respiratory, renal and hepatic functions and fluid and electrolyte balance. Treatment with activated charcoal or induction of emesis with ipecacuanha syrup should be considered. Thereafter, activated charcoal and purgative may be used to limit the absorption. If hypotension and arrhythmias occur, vigorous treatment is required. CNS convulsions may be treated with i.v. diazepam or phenytoin. Hemoperfusion may be used in severe cases.

Pharmacodynamic properties

Chlorpheniramine maleate is an antihistamine. Chlorphenamine acts by competing with histamine for histamine H1-receptor sites on effector cells.
Chlorpheniramine maleate has anticholinergic activity, thereby, it is used to treat runny nose, however, this effect varies greatly between individuals.

Pharmacokinetic properties

Chlorpheniramine is well absorbed from the gastrointestinal tract.
It is metabolized rapidly and extensively. The metabolites include desmethyl- and didesmethyl-chlorpheniramine and some unidentified substances, of which one or more have activity.
The drug is excreted primarily in the urine.

Storage conditions, shelf-life, quality specification of the medicine

Storage conditions: Protect from humidity and light, below 30 degrees C.
Shelf – life: 36 months from the manufacture date.
Quality specification: In house specification.