Iliadin

Iliadin

oxymetazoline

Manufacturer:

P&G Health

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Oxymetazoline hydrochloride.
Description
Adult nasal drops: 1ml Iliadin 0.05% Decongestant Nasal Drops contains in an aqueous solution 0.5mg Oxymetazoline Hydrochloride.
Children nasal drops: 1ml Iliadin 0.025% Decongestant Nasal Drops contains in an aqueous solution 0.25mg Oxymetazoline Hydrochloride.
Infant nasal drops: 100ml Iliadin 0.01% metered drops contains 0.01g Oxymetazoline Hydrochloride in aqueous solution.
Excipients/Inactive Ingredients: Adult and children nasal drops: Citric acid monohydrate, benzalkonium chloride solution 50% (as a preservative), sodium citrate, glycerol 85%, purified water.
Infant nasal drops: Citric acid monohydrate, sodium citrate, glycerol (85%), purified water.
Action
Rhinological agents (chemically defined), α-sympathomimetic. The active ingredient of Iliadin 0.05% Decongestant Nasal Drops has a sympathomimetic, vasoconstrictive, and thus a decongestant effect on the mucous membranes.
Adult nasal drops: The effect of Iliadin 0.05% Decongestant Nasal Drops sets in within few seconds. In a clinical study, the median onset was found to be 25 seconds. The effect persists for up to 12 hours.
Children nasal drops: The effect of Iliadin 0.025% Decongestant Nasal Drops sets in within a few minutes. The effect persists for up to 12 hours.
Infant nasal drops: Pharmacology: Pharmacodynamics: Substance or indication group Rhinological agents (chemically defined), a-sympathomimetic.
Oxymetazoline has a sympathomimetic, vasoconstrictive and therefore a decongestant effect on mucous membranes. The application of Iliadin 0.01% Decongestant Nasal Drops into the nostrils decongests the inflamed nasal mucosa and causes excessive secretion to stop. The patient is able to breathe freely through the nose again. Also, decongestion of the nasal mucosa opens and dilates the efferent ducts of the paranasal sinuses and clears the auditory tube. This facilitates the discharge of secretion and combats bacterial invasion.
Pharmacokinetics: Investigations with radiolabelled oxymetazoline in healthy volunteers revealed that this intranasally applied rhinological agent has no systemic effect. Oral administration (double-blind studies) showed first unspecific ECG changes only after administration of 1.8mg oxymetazoline - this is equivalent to 3.6ml of a 0.05% solution. Neither blood pressure nor pulse rate were affected by the intake of this quantity of active substance. After intranasal application of doses higher than recommended the absorbed quantity can suffice to trigger systemic effects in the cardiovascular system. In rare cases the quantity absorbed after intranasal application can suffice to produce systemic effects in the central nervous system (cf. adverse reactions).
The half-life of terminal elimination after nasal application is 35 hours in humans. 2.1% is excreted via the kidneys and about 1.1% via the faeces. No information is available on the distribution of oxymetazoline in humans.
Iliadin 0.01% Decongestant Nasal Drops sets in within a few minutes. The effect persists for up to 12 hours.
Toxicology: Preclinical safety data: Acute toxicity: The LD50 of oxymetazoline hydrochloride was established as 0.9mg/kg (i.v.) and 1.3mg/kg (oral) in rats. Mice showed an LD50 of 9.2mg/kg (i.v.) and 26mg/kg (oral). Symptoms of acute intoxication included piloerection, exophthalmos, mydriasis and nosebleeds. At higher doses pallor, mild cyanosis and reduced motility were observed. In terminal conditions asphyctic convulsions occurred.
Subacute toxicity: 0.6ml of an 0.05% solution (0.3mg oxymetazoline hydrochloride) - instilled into each nostril 3 times daily for 13 weeks - was well tolerated by dogs. No toxic effects, systemically or in the nasal mucosa, occurred. No significant changes in the ECG or in the eyes were observed. The doses investigated amounted to up to 60 times the dosage recommended for humans.
Chronic toxicity: Dogs received nasal doses of 0.06ml and 0.24ml of 0.05% oxymetazoline hydrochloride solution twice daily for 1 year. No toxic effects developed. The doses investigated amounted to up to three times the dosage recommended for humans.
Reproduction toxicology: Reproduction in rats: Subcutaneous administration of 0.08mg/kg and 0.24mg/kg oxymetazoline from the 6th and 15th postcoital day did not cause any somatic abnormalities in the offspring. A slight difference in the number of resorptions was not statistically significant. The doses investigated amounted to up to 25 times and 75 times, respectively, the dosage recommended for humans.
Mutagenic and tumorigenic potential: No data are available on mutagenesis and carcinogenesis.
Indications/Uses
Adult and children nasal drops: Acute cold, paranasal sinusitis, syringitis, otitis media.
Infant nasal drops: Acute rhinitis, vasomotor rhinitis, allergic rhinitis, paranasal sinusitis, syringitis. For diagnostic decongestion of mucous membranes.
Dosage/Direction for Use
Adult nasal drops: Iliadin 0.05% Decongestant Nasal Drops is intended for intranasal application. Unless otherwise prescribed, instill 1-2 drops of Iliadin 0.05% Decongestant Nasal Drops into each nostril 2-3 times daily.
Iliadin 0.05% Decongestant Nasal Drops may only be administered to adults and children of 6 years and older and should not be used in small children and infants.
Children nasal drops: Iliadin 0.025 % Decongestant Nasal Drops may only be administered to children aged between one and six years and should not be used in infants under 1 year of age.
Iliadin 0.025% Decongestant Nasal Drops is intended for intranasal application. Unless otherwise prescribed, instill 1-2 drops of Iliadin 0.025% Decongestant Nasal Drops into each nostril 2-3 times daily.
Infant nasal drops: Iliadin 0.01% Decongestant Nasal Drops is intended for infants and small children. Up to the age of 4 weeks instill 1 drop of the 0.01% solution into each nostril 2-3 times daily.
From the 5th week of life until the age of 1 year, instill 1-2 drops into each nostril 2-3 times daily.
Instill the solution into each nostril. As the metered dropper bottle must be held in an upside-down position for application, Iliadin metered drops for infants can only be applied with the baby's head bent backwards.
Especially in the case of the 0.01% solution for infants 20 minutes may elapse before the onset of action.
0.01% decongestant nasal drops are intended for application in the nose only.
The single doses given for 0.01% decongestant nasal drops must not be administered more than 3 times daily.
Application for more than 10 consecutive days has to be prescribed by a physician.
A treatment-free period of several days should precede any repeated use.
Duration of treatment: Adult and children nasal drops: Unless specifically prescribed by the doctor, Iliadin 0.05% and 0.025% Decongestant Nasal Drops should only be used for short periods of time (up to 10 days). A treatment-free period of several days should precede any repeated use.
Permanent use of decongestant rhinological agents may attenuate their effect. The abuse of local rhinological agents may cause mucosal atrophy and reactive hyperaemia with rhinitis medicamentosa.
Longer use of oxymetazoline may cause damage to the mucosal epithelium with inhibition of ciliary activity. This may possibly result in irreversible damage to the mucosa with rhinitis sicca.
Long term use and overdosage must be avoided, especially in children. Medical supervision is indicated in patients with chronic rhinitis. Dosage higher than recommended may only be used under supervision.
Overdosage
Adult and children nasal drops: Overdosage may occur after nasal or accidental oral administration. The clinical picture following intoxication with imidazol-derivatives may be unclear due to the occurrence of episodes of hyperactivity alternated with episodes of depression of the central nervous system and of the cardiovascular and pulmonary system.
Symptoms of an overdose may be hypertension, tachycardia, palpitations, cardiac arrhythmia, cardiac arrest, sweating, agitation, convulsion, mydriasis, nausea, vomiting, cyanosis, fever, spasms, circulatory collapse, pulmonary oedema, respiratory and psychic disorders, drowsiness, paleness, miosis, decrease in body temperature, bradycardia, shock-like hypotension, apnoea and coma.
In children, in particular, overdose often causes dominating central nervous effects with convulsions and coma, bradycardia, apnoea as well as hypertension possibly followed by hypotension.
Infant nasal drops: Emergency measures, symptoms and antidotes: Overdosage may occur after nasal or accidental oral administration. The clinical picture following intoxication with imidazol-derivatives may be unclear due to the occurrence of episodes of hyperactivity alternated with episodes of depression of the central nervous system and of the cardiovascular and pulmonary system. Symptoms of an overdose may be: palpitations, paleness, miosis, mydriasis, nausea, vomiting, cyanosis, fever, spasms, tachycardia, cardiac arrhythmia, circulatory collapse, cardiac arrest, hypertension, pulmonary oedema, respiratory disorders, psychic disorders, sweating, agitation and convulsion. Futhermore, inhibition of central-nervous functions with drowsiness, decrease in body temperature, bradycardia, shock-like hypotension, apnoea and coma can possibly also develop. In children, in particular, overdose often causes dominating central nervous effects with convulsions and coma, bradycardia, apnoea as well as hypertension possibly followed by hypotension.
Therapeutic measures to be taken after overdosage: In-house intensive-care therapy is indicated in cases of severe overdose. Administration of medicinal charcoal (absorbent), sodium sulfate (laxative) or gastric lavage (in the case of large quantities) should be performed immediately as oxymetazoline may be absorbed rapidly.
A non-selective alpha-blocker can be given as antidote. If required, initiate fever lowering measures, anticonvulsive therapy and oxygen ventilation. Vasopressors are contraindicated.
Contraindications
Adult and children nasal drops: Rhinitis sicca, hypersensitivity to the active ingredient or to any of the excipients, children below six years of age.
Because of the benzalkonium chloride which is contained as preservative Iliadin 0.05% and 0.025% Decongestant Nasal Drops must not be used in known hypersensitivity to this substance.
Infant nasal drops: Rhinitis sicca, hypersensitivity to the active ingredient or one of the other ingredients.
Medical supervision is indicated in premature or underweight newborns to avoid the risk of overdosage.
Medical supervision is indicated in patients with chronic rhinitis.
In the following cases this drug may only be used after carefully weighing the risk-to-benefit ratio: Patients treated with monoamine oxidase inhibitors (MAO-inhibitors) and other drugs potentially increasing blood pressure.
Increased intraocular pressure, especially narrow-angle glaucoma.
Severe cardiovascular diseases (e.g. coronary heart disease, hypertension).
Phaeochromocytoma.
Metabolic disorders (e.g. hyperthyroidism, diabetes mellitus, porphyria).
Hyperplasia of the prostate.
Special Precautions
Adult and children nasal drops: In the following cases this drug may only be used after carefully weighing the risk-to benefit ratio: Patients treated with monoamine oxidase inhibitors (MAO inhibitors, tricyclic antidepressants) and other drugs potentially increasing blood pressure.
Increased intraocular pressure, especially narrow-angle glaucoma.
Severe cardiovascular diseases (e.g. coronary heart disease, hypertension).
Phaeochromocytoma.
Metabolic disorders (e.g. hyperthyroidism, diabetes mellitus, porphyria).
Hyperplasia of the prostate.
Long-term use and overdosage are to be avoided. The efficacy of decongestant rhinological agents may be reduced (tachyphylaxis) with long-term use or overdose. This may lead to use of higher doses or to more frequent usage which, in turn, can result in permanent use. If long term use or overdose occurs, treatment should be discontinued immediately. Continuous use may cause nasal congestion due to reactive hyperaemia of the nasal mucosa (rebound effect) and chronic swelling of the nasal mucosa (rhinitis medicamentosa) as well as mucosal atrophy or rhinitis sicca. Rebound effects and tachyphylaxis should stop once use of the product is discontinued. Patients are advised to use for a maximum of 10 consecutive days to avoid rebound effect and drug induced rhinitis.
Medical supervision is indicated in patients with chronic rhinitis. Dosages higher than recommended may only be used under medical supervision.
Benzalkonium chloride: irritant, may cause skin reactions.
Infant nasal drops: Permanent use of decongestant rhinological agents may attenuate their effect. The abuse of local rhinological agents may cause mucosal atrophy and reactive hyperaemia with rhinitis medicamentosa.
Longer use of oxymetazoline may cause damage to the mucosal epithelium with inhibition of ciliary activity. This may possibly result in irreversible damage to the mucosa with rhinitis sicca.
Long-term use and overdosage are to be avoided.
The efficacy of decongestant rhinological agents may be reduced (tachyphylaxis) with long-term use or overdose. This may lead to use of higher doses or to more frequent usage which, in turn, can result in permanent use. If long term use or overdose occurs, treatment should be discontinued immediately.
As with all nasal decongestant, Iliadin should not be used for longer than 10 consecutive days.
Effects on ability to drive and use machines: No impairment is to be expected if used as recommended. Systemic effects with involvement of the cardiovascular or central nervous system cannot be excluded after prolonged administration or intake of oxymetazoline containing cold remedies in dose higher than recommended. In these cases the ability to drive a vehicle or operate machinery can be impaired.
Use In Pregnancy & Lactation
Adult and children nasal drops: Iliadin 0.05% and 0.025% Decongestant Nasal Drops should only be used after the consultation with a physician during pregnancy and lactation. The recommended dosage must not be exceeded.
Infant nasal drops: Illiadin 0.01% Decongestant Nasal Drops should only be used after the consultation with a physician during pregnancy and lactation. The recommended dosage must not be exceeded. Medical supervision is indicated in premature or underweight newborns to avoid the risk of overdosage.
Medical supervision is indicated in patients with chronic rhinitis.
Dosage higher than recommended may only be used under medical supervision.
Adverse Reactions
Adult and children nasal drops: Adverse events from clinical trial data are both infrequent and based on small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/recommended dose and considered attributable are listed below. As most undesirable effects are based on post-marketing spontaneous reporting, precise frequency estimation is not possible.
Respiratory, thoracic and mediastinal disorders: nasal discomfort (burning of the nasal mucosa), nasal dryness, sneezing (especially in sensitive patients), after the effect has worn off increased swelling of the mucosa (reactive hyperaemia) & epistaxis.
Nervous system disorders: somnolence, sedation, headache, hallucinations (especially in children) & convulsions (especially in children).
Cardiac disorders: palpitations & tachycardia.
Vascular disorders: hypertension.
Immune system disorders: hypersensitivity reactions (angioedema, rash, pruritus).
Psychiatric disorders: insomnia & restlessness.
General disorders and administration site conditions: fatigue & tachyphylaxis (associated with long-term use or overdose).
Infant nasal drops: In especially sensitive patients, it might results in respiratory, thoracic and mediastinal disorder such as nasal discomfort (burning of nasal mucosa) or nasal dryness, or sneezing may occasionally occur. In rare cases after the effect has worn off - an intense sensation of "blocked" nose (reactive hyperaemia), epistaxis, and apnoea in newborns and in young infants (especially in case of overdosage).
With topical intranasal use, overdosage leads rarely to occasionally to systemic sympathomimetic effects like palpitations, accelerated pulse (tachycardia) and increase in blood pressure. Restlessness, insomnia, tiredness and headaches, somnolence, sedation, headache, hallucinations and convulsions (especially in children), hypersensitivity reactions (angioedema, rash, pruritus), tachyphylaxis (associated with long-term use or overdose) have been observed in very rare cases.
Drug Interactions
The concomitant use of oxymetazoline containing nasal drops and of medicines with a hypertensive effect (e.g. MAO inhibitors and tricyclic antidepressants) may lead to an increase in blood pressure due to their cardiovascular activity.
Overdose or swallowing of Iliadin 0.05% Decongestant Nasal Drops and use of tricyclic antidepressants or MAO inhibitors simultaneously or immediately prior to administration of Iliadin 0.05% Decongestant Nasal Drops can lead to an increase blood pressure.
Caution For Usage
Incompatibilities: Incompatibilities are unknown to date.
Storage
Adult and children nasal drops: Store at or below 30°C.
Infant nasal drops: Do not store above 30°C.
Patient Counseling Information
Please read the following instructions for use carefully, for they contain important information about what you should pay attention to when using this medication. If you have any questions please consult your doctor or pharmacist.
ATC Classification
R01AA05 - oxymetazoline ; Belongs to the class of topical sympathomimetic agents used as nasal decongestants.
Presentation/Packing
Adult nasal drops 0.05% (clear, colourless solution) x 10 mL. Childn nasal drops 0.025% (clear, colourless solution) x 10 mL. Infant nasal drops 0.01% (almost clear solution, almost colourless) x 5 mL.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in