DESCRIPTION
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| Ophthalmic solution Ethiatropine (Atropine sulphate) is a topical solution
containing atropine sulphate 1% in a buffer system. Benzalkonium chloride
0.01% is added as preservative. Atropine sulphate is Bis(1R,3r,5S)-3-[(RS)-(3-hydroxy-2-phenylpropionyl)oxy]-8-methyl-8-azabicyclo[3.2.1]octane
sulphate. Its empirical formula is C34H48N2O10S × H2O. Atropine sulphate
is a white, crystalline powder or colorless crystals, very soluble in water,
reely soluble in alcohol, practically insoluble in ether. Its molecular
weight is 695. |
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ACTIONS/CLINICAL PHARMACOLOGY |
* Atropine sulphate is an antimuscarinic alkaloid with both central and
peripheral actions. It first stimulates and then depresses the central nervous
system and has antispasmodic actions on smooth muscle and reduces secretions.
It is used as eye drops to produce cycloplegia and mydriasis. Dilation of
the pupil occurs in half an hour following one local application and lasts
for a week or more; marked paralysis of accommodation is obtained in 1 to
3 hours with recovery in 3 to 7 days. It is used in the treatment of iritis
and uveitis to immobilize the ciliary muscle and iris and to prevent or
break down adhesions.
* Because of its powerful cycloplegic action atropine sulphate is also used
in the determination of refraction in children below the age of 6 and in
children with convergent trabismus.
* Atropine sulphate eye drops give releif from pain in eye injuries.
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INDICATIONS AND USAGE |
| Acute iritis; cycloplegia for refractometry. |
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CONTRAINDICATIONS |
| Narrow-angle glaucoma; soft lenses |
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WARNINGS |
| Ethiatropine should not be given to patients with closed-angle glaucoma
or to patients with a narrow angle between the iris and the cornea. Due
to the risk of provoking hyperpyrexia it should not be given to patients,
especially children, when the ambient temperature is high. It should also
be used cautiously in patients with fever. |
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PRECAUTIONS |
| Ethiatropine should be used with caution in children and in geriatric
patients, who may be more susceptible to its adverse effects. It is contraindicated
in patients with prostatic enlargement. It should be cautiously given to
patients with diarrhoea. It should be used with extreme caution myasthenia
gravis. Ethiatropine should be used with caution in conditions characterized
by tachycardia. |
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ADVERSE REACTIONS |
| Dryness of the mouth with difficulty in swallowing and talking; thirst;
dilation of pupils with loss of accommodation; photophobia; flushing and
dryness of the skin; transient bradycardia followed by tachycardia; may
cause temporary irritation. |
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DOSAGE AND ADMINISTRATION |
Adults
For refraction, 1 to 2 drops of Ethiatropine 1% solution 30 to 60 min
before examination.
For iritis 1 drop t.i.d.
Children
For refraction, 1 drop bi.d. of Ethiatropine 1% solution 1 to 2 days
before examination and 1
drop solution 30 to 60 min before examination. For iritis 1 drop t.i.d. |
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HOW SUPPLIED |
15 mL in plastic dropper bottle (Sterile).
REFRIGERATE UNTIL DISPENSED. |
