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Home » Eye & Ear Problems »Spersallerg
Spersallerg
Brand names: Spersallerg
Generic name: Antazoline 0.05% Tetryzoline 0.04%
Manufacturer: Novartis
Contents: 10 ml
COMPOSITION:
Each 1 ml contains:
Antazoline HCI...................................................................0,5 mg
Tetryzoline HCI..................................................................0,4 mg
Hydroxypropylmethylcellulose…………………………3,0 mg
Benzalkonium chloride....................................................0,005 % m/v
(as preservative)
PHARMACOLOGICAL CLASSIFICATION:
A 15.4 Ophthalmic preparations. Other
PHARMACOLOGICAL ACTION:
Antazoline, an antihistamine acts by blocking the action of histamine through competitive inhibition of H1 receptors.
Tetryzoline a sympathomimetic agent with alpha-adrenergic activity, acts as a local vasoconstrictor.
SPERSALLERG INDICATIONS:
Hay-fever conjunctivitis. Allergic conjunctivitis as consequence of drug sensitivity. Conjunctivitis vernalis. Conjunctivitis ecchymotosa.
SPERSALLERG CONTRA-INDICATIONS:
1. Hypersensitivity to any of the ingredients.
2. Patients with dry eyes , especially keratoconjunctivitis sicca.
3. Patients at a risk of narrow angle glaucoma.
4. Patients receiving monoamine oxidase inhibitors or within 14 days of its treatment
5. Not recommended for children under two years of age, due to the greater incidence of systemic absorption and effects.
WARNINGS:
1. 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 ophthalmological preparations cannot be excluded, regular ophthalmological examination is required.
2. Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.
3. Soft contact lenses should not be worn during instillation of Spersallerg Eye Drops. They can be reinserted after an interval of at least 5 minutes.
4. Use with caution in patients with increased intra-ocular pressure, hypertension, cardiac irregularities, hyperthyroidism and diabetes mellitus.
5. Safety in pregnancy and lactation has not been established.
6. Rebound congestion may follow continued use.
DOSAGE AND DIRECTIONS FOR USE:
Adult: Instill 1 drop, 3 or 4 times daily, into the lower eyelid.
Children 2 - 12 years: Instill 1 drop daily or twice daily.
Not recommended for children under the age of 2 years.
If redness or irritation continues, gets worse or lasts for more than 3 days consult your doctor.
SPERSALLERG SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Transient irritation may occur immediately after instillation.
Systemic reactions may occur after the use of these eye drops, such as headache, drowsiness, and tachycardia. Children and the elderly are more susceptible to these systemic reactions.
Antimuscarinic effects, including blurred vision, have been described after systemic absorption of Spersallerg Eye Drops.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS
TREATMENT:
After accidental ingestion, especially in children, overdosage is associated with antimuscarinic, extrapyramidal and CNS stimulation and depression. CNS stimulation, causes ataxia, excitement, tremors, psychoses, hallucinations, convulsions, hyperpyrexia may also occur. Deepening coma and cardiorespiratory collapse may follow. CNS depression causes drowsiness, coma, convulsions, progressing to respiratory failure or possible cardiovascular collapse.
Treatment is symptomatic and supportive, including artificial respiration if necessary. If patient is conscious and has not lost the gag reflex and not having seizures, emesis should be induced. If emesis cannot be induced, gastric lavage is indicated.
IDENTIFICATION:
Clear , colourless, odourless solution.
PRESENTATION:
Plastic dropper bottle of 10 ml
STORAGE INSTRUCTIONS:
Store in a cool place below 25°C. Discard
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