Isopto hyoscine

Overdose

No information provided.

Contraindications

Contraindicated in persons with primary glaucoma or a tendency toward glaucoma, e.g., narrow anterior chamber angle; and in those showing hypersensitivity to any component of this preparation.

Undesirable effects

Prolonged use may produce local irritation, characterized by follicular conjunctivitis, vascular congestion, edema, exudate, and an eczematoid dermatitis. Somnolence, dryness of the mouth, or visual hallucinations may occur.

Therapeutic indications

For mydriasis and cycloplegia in diagnostic procedures. For some pre- and postoperative states when a mydriatic and cycloplegic is needed in treatment of iridocyclitis.

Name of the medicinal product

Isopto Hyoscine

Qualitative and quantitative composition

In 5 mL and 15 mL plastic DROP-TAINER® dispensers.

    5 mL NDC 0998-0331-05 15 mL NDC -15

STORAGE: Store at 46° to 80°F. Protect from light.

Special warnings and precautions for use

WARNINGS

Do not touch dropper tip to any surface, as this may contaminate the solution. For topical use only-not for injection. In infants and small children, use with extreme caution.

PRECAUTIONS

To avoid excessive absorption, the lacrimal sac should be compressed by digital pressure for two to three minutes after instillation. To avoid inducing angle closure glaucoma, an estimation of the depth of the angle of the anterior chamber should be made.

PATIENT WARNING: Patient should be advised not to drive or engage in other hazardous activities when drowsy or while pupils are dilated. Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not, to get this preparation in their child†s mouth and to wash their own hands and the child†s hands following administration.

Dosage (Posology) and method of administration

For refraction, administer one or two drops topically in the eye(s) one hour before refracting. For uveitis, administer one or two drops topically in the eye(s) up to four times daily.

Interaction with other medicinal products and other forms of interaction

SIDE EFFECTS

Prolonged use may produce local irritation, characterized by follicular conjunctivitis, vascular congestion, edema, exudate, and an eczematoid dermatitis. Somnolence, dryness of the mouth, or visual hallucinations may occur.

DRUG INTERACTIONS

No Information Provided