Ethiatropine

 
     
 

DESCRIPTION

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.
 

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.
 

INDICATIONS AND USAGE

Acute iritis; cycloplegia for refractometry.
 

CONTRAINDICATIONS

Narrow-angle glaucoma; soft lenses
 

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.
 

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.
 

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.
 

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.

 

HOW SUPPLIED

15 mL in plastic dropper bottle (Sterile).

REFRIGERATE UNTIL DISPENSED.