ALOMIDE ophthalmic solution
(and dosage form):
ALOMIDE ophthalmic solution
ALOMIDE contains 1,78 mg lodoxamide tromethamine equivalent to 1 mg lodoxamide per mL and 0,007% (m/v) benzalkonium chloride as preservative in a sterile, buffered isotonic solution.
A.15.4 Ophthalmic preparations, other.
Lodoxamide is a mast cell stabilizer. In vitro it inhibits the type I immediate hypersensitivity reaction, preventing the antigen specific induced release of histamine and other mast cell inflammatory mediators by preventing the movement of calcium into the mast cell after stimulation. Lodoxamide has no intrinsic vasoconstrictor, antihistaminic, cyclo-oxygenase inhibition or other anti-inflammatory activity.
ALOMIDE is indicated in the treatment of non-infectious allergic conjunctivitis (allergic/atopic conjunctivitis, vernal conjunctivitis, giant papillary conjunctivitis) in which type I immediate hypersensitivity is a major factor. The aetiologic factors are unknown, but common airborne allergens and contact lenses have been implicated.
Hypersensitivity to any component of the medicament. Safety in pregnancy and lactation and safety and effectiveness in children below the age of four years has not been established.
ALOMIDE is not intended for injection. As with all preparations containing benzalkonium chloride, users of soft (hydrophilic) contact lenses should refrain from wearing lenses while under treatment with ALOMIDE. Lenses may be worn within a few hours of discontinuation of treatment.
The recommended frequency of administration should not be exceeded.
As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved preparations cannot be excluded, regular ophthalmological examination is required. Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.
DOSAGE AND DIRECTIONS FOR USE:
The dose for adults and children is one or two drops in each eye four times a day at regular intervals.
Patients should be advised that the effect of ALOMIDE therapy is dependant upon its administration at regular intervals, as directed.
Improvements in signs and symptoms in response to ALOMIDE therapy (decreased discomfort, itching, foreign body sensation, photophobia, acute ocular pain, tearing, discharge, erythema/swelling, bulbar conjunctivae, limbus, epithelial disease, ptosis) may be evident within three days, but longer treatment for up to four weeks is sometimes required. Efficacy for longer than six months has not been established. .
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects: The most common side-effect associated with the use of ALOMIDE is mild and transient discomfort upon instillation expressed as burning, stinging, itching or tearing.
No interactions with other medicines are known.
Other effects: Since ALOMIDE is not an antihistamine, it is unlikely to affect a patient's ability to drive or to use machinery. The safety and efficacy of prolonged use of ALOMIDE has not been established.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of a topical overdose, flush from the eye with running water. Side-effects reported following systemic administration, include a feeling of warmth or flushing, headache, diiness, fatigue, sweating, nausea, loose stools, urinary frequency/urgency. Consideration may be given by the physician to emesis.
A clear, colourless to pale yellow solution.
Low density polyethylene bottle with 10 mL fill.
Keep tightly closed. Store upright at room temperature, below 28°C.
KEEP OUT OF REACH OF CHILDREN
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Alcon Laboratories (SA) (Pty) Ltd
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23 September 1993
Updated on this site: March 2000
SAEPI HOME PAGE
TRADE NAME INDEX
GENERIC NAME INDEX
Information presented by Malahyde Information Systems © Copyright 1996-2003