- COMPOSITION:

Each capsule contains:

Chlorpheniramine Maleate    4mg.

Calcium Ascorbate 36mg = 30mg (Vit.C)

Caffeine Anhydrous            10mg.

Paracetamol                       300mg.

Excipient      S.Q. for one capsule.

 

- PHARMACODYNAMICS:
This drug is a combination between paracetamol and Chlorpheniramine maleate as an antihistamine, and vitamin C, and anhydrous caffeine.
- Chlorpheniramine maleate: antihistamine H1-receptors, structurally it is a propylamine and possessing an anticholenergic activity which is the origin of the adverse reactions. Antihistamine H1-receptors are generally oppose reversibly & competitively the effects of histamine on skin, bronchi, intestine, and blood vessels.
Due to its passage into the blood-brain barrier, the sedative effects of the product are originate as a result to the histaminic effect and due to the nature of adrenolytic effect, whereas the maintenance of hymodynamic plan is due to the last property (risk of orthostatic hypotension).
- Anhydrous caffeine: it stimulates all levels of the CNC, therapeutic doses of caffeine increase blood pressure only slightly, and causing transient increases in heart rate, it also stimulates gastric acid secretion from parietal cells. Caffeine increase renal blood flow, resulting in mild diuresis.

- INDICATIONS:

Symptomatic treatment of nasal hypersecretions that accompanies acute rhinopharyngeal affections with headaches and / or fever.

Note: to overcome the general clinical signals of bacterial infection, an antibiotic by general route should be considered.

 

Related to Paracetamol: Some rare cases of allergic accidents may happen, which manifested by simple cutaneous rashes and associated with erythema or urticaria, in these cases it's necessary to discontinue treatment immediately.

Very exceptional cases of thrombopenia were reported.

Related to Chlorpheniramine maleate: The pharmacological characteristics of Chlorpheniramine molecule are the origin of the adverse reactions and its appearance is dose related.

 

If fever elevation persist or if signs of superinfection had occurred, or if symptoms are still present for more than 5 days after initiating therapy, a reevaluation of the therapeutic program should be consider.

Paracetamol and its metabolites are essentially excreted in the urine, in case of severe renal insufficiency the intervals between doses should be 8 hours at least.

Chlorpheniramine maleate should be used with caution in the following cases:

It is not recommended to drink alcoholic beverages or taking medicaments containing alcohol during treatment (see Drug Interactions).

Caffeine should be used with caution in the presence of cardiac disease, particularly in the presence of cardiac arrhythmias.

Administration of paracetamol may produce wrong results when blood uric acid was titrated by phosphotungestic acid method, also administration of paracetamol affects the results of blood glucose by glucose-oxidase-peroxydase method.

Caffeine produces false-positive elevations of serum urate as measured by the Bittner method, it also produces slight increases in urine levels of vanillylmandelic acid (VMA), catecholamines, and 5-hydroxyindoleacetic acid. Because high urine levels of (VMA) or catecholamines may result in false-positive diagnosis of pheochromocytoma or neuroblastoma, caffeine intake should be avoided during tests of these disorders.

 

 ILVICON should not be given to a pregnant woman unless it is clearly needed.

 ILVICON is not recommended to be used during lactation.

Attention is required in drivers and machinery operators, for fear of somnolence risk that associated with the use of this medicament, chiefly at the beginning of treatment, this phenomenon accentuated by administering alcoholic beverages or medicaments containing alcohol, therefore it is preferable to start therapy at night.

 

It is apprehend from intoxication in small age children; (therapeutic overdosage or accidental intoxication which is more frequent) that it may cause death in this age group; the symptoms will be arranged according to each component of the product:

-Overdosage related to Chlorpheniramine maleate: risk of convulsions, consciousness disturbances, coma.

- Overdosage related to paracetamol: nausea, vomiting, anorexia, pallor, abdominal pains appears during the first 24 hours of intoxication by an overdose.

Administration of an overdosage, of 10 g of paracetamol in a single dose in adults and 150mg/kg of body weight in children will cause hepatic cytolysis and complete irreversible heppatic necrosis, manifested by hepatocellular insufficiency with metabolic acidosis, and encephalopathy that may reach the step of coma and death; with an increase in hepatic transaminase enzymes, and in lacticodehydrogenase and bilirubin, also prothrombin time will be decreased, all these signs and symptoms usually appear within 12 to 48 hours after ingestion of overdosage.

- Overdosage related to anhydrous caffeine: acute toxicity has been reported rarely, mild delirium, insomnia, diuresis, dehydration, and fever commonly occur with overdosage, more serious symptoms of overdosage include cardiac arrhythmias and convulsions.

 

 

Dose is limited to one capsule per dose to be renewed if necessary every 4 hours without exceeding 5 capsules per day.

In case of renal insufficiency (creatinine clearance inferior to 10ml/min), the interval between two doses should be 8 hours as minimum.

In case of fever or pain persistence, the course of treatment should be revaluated.

For the reason of sedative effects of Chlorpheniramine maleate, the vespertine doses are more convenient.