MilliOph Eye Drops

MilliOph Eye Drops

Manufacturer:

Millimed

Distributor:

Prosp Pharma
Full Prescribing Info
Contents
Antazoline hydrochloride, tetrahydrozoline hydrochloride, hydroxypropyl methyl-cellulose.
Description
Each 1 mL contains Antazoline hydrochloride 0.5 mg and tetrahydrozoline hydrochloride 0.4 mg.
Action
Pharmacology: Pharmacodynamics: Antazoline hydrochloride is an H1 receptor antagonist which also possesses some local anaesthetic properties. It can relieve any symptoms of allergic conjunctivitis mediated by histamine.
Tetrahydrozoline hydrohloride, a vasoconstrictor, is structurally and pharmacologically closely related to Naphazoline. It is a conjunctival congestion by stimulates α-adrenergic receptors of the sympathetic nervous system.
Antazoline hydrochloride and in combination with the vasoconctrictor was effective in the treatment of allergic conjunctivitis.
Hydroxypropyl methylcellulose have been added to increase the viscosity of eye drop to reduce the lacrimal clearance of ophthalmic solution. It can prolong the ocular contact time of Antazoline hydrochloride and Tetrayzoline hydrochloride.
Pharmacokinetics: The pharmacokinetic of Antazoline hydrochloride is incomplete data available. However, has a short duration of activity.
Tetrahydrozoline hydrochloride is a local vasoconstriction usually occurs within a few minutes and may persist for 4-8 hours.
Indications/Uses
Used topically for the treatment of allergic conjunctivitis.
Dosage/Direction for Use
Instill 1 or 2 drops in each eye 3-4 times daily, or as directed by physician.
Method of Administration: Ophthalmic route.
Overdosage
Antazoline hydrochloride: Poisoning is common but rarely severe. May occur via oral, parenteral, or dermal (patches or cream) routes. Somnolence, anticholinergic effects (ie, mydriasis, flushing, fever, dry mouth, and decreased bowel sounds), tachycardia, mild hypertension, nausea and vomiting are common after overdose.
Treatment:
The antihistamine overdoses requires only supportive care; give activated charcoal if patient presents shortly after ingestion. Gastric lavage may be of benefit, if the patient presents soon after a large ingestion.
Tetryzoline hydrochloride: The minimum toxic dose of tetryzoline hydrochloride has not been established in paditaric patients; however, ingestion of 2-5 mL of a 0.05% tetryzoline solution is capable of producing CNS depression and agitation or hyperactivity or coma.
The symptoms develop rapidly in children within 15 minutes to 4 hours following ingestion.
Treatment: There is no known specific antidote for tetryzoline hydrochloride. However, some clinicians have hypothesized that naloxone may be useful for the management of tetryzoline hydrochloride intoxication.
Contraindications
Contraindicated in narrow angle glaucoma.
Contraindicated in patient who are hypersensitive to antazoline hydrochloride or tetryzoline hydrochloride.
Contraindicated in children younger than 2 years of age.
Special Precautions
Should be used with caution in hypertension.
Should be used with caution in cardiac irregularities or cardiovascular disease.
Should be used with caution in hyperglycemia.
Should be used with caution in thyroid disease.
Should be used with caution in diabetes mellitus.
Should be used with caution in prostatic enlargement.
Should be used with caution in infection or injury.
Concomitant use with monoamine oxidase inhibitors or tricyclic antidepressant with caution.
Contact lens wear during ophthalmic use is not recommended.
Use In Pregnancy & Lactation
Teratogenicity/Effects in Pregnancy: Available evidence is inconclusive or is inadequate for determining fetal risk when used in pregnant women.
Lactation: Available evidence and/or expert concensus is inconclusive or is inadequate for determining infant risk when used during breastfeeding.
Adverse Reactions
Uncommon: Ophthalmic effects: Mydriasis, ocular hyperemia.
Nervous effects: Headache, sleepiness.
Cardiovascular effects: Tachycardia.
Unknown frequency: Ophthalmic effects: Burning sensation in eye.
Nervous effects: Tremor, agitation.
Dermatologic effects: Sweating.
Cardiovascular effects: Angina pectoris, increase arterial pressure.
Drug Interactions
Indirect sympathomimetics: Risk of vasoconstriction and/or hypersensitive episodes.
Dopaminergic ergot alkaloids: Risk of vasoconstriction and/or hypertensive episodes.
Non-selective MAO inhibitors: Hypertensive episodes (inhibition of metabolism of pressor amines. Due to the duration of MAO inhibitors, this interaction is still possible 15 days after the discontinuation of MAO inhibitors.
Vasoconstrictive ergot alkaloids: Risk of vasoconstriction and/or hypertensive episodes.
Caution For Usage
Sterile Eye drops and Cap with High German Technology: 1. Screw the cap to the right up until the white ring tears off.
2. Remove white plastic ring.
3. Screw the cap to the left to open.
Storage
Store below 30°C. Discard 30 days after first opening.
ATC Classification
S01GA52 - tetryzoline, combinations ; Belongs to the class of sympathomimetics used as ophthalmologic decongestants.
Presentation/Packing
Eye drops (clear, colorless sterile ophthalmic solution) 5 mL x 1's. 10 mL x 1's.
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