Isopto Hyoscine

What is Isopto Hyoscine and how is it used?

Isopto Hyoscine is a prescription medicine used to treat the symptoms of Nausea, Vomiting, and as prophylaxis to Motion Sickness and Nausea or Vomiting associated with Anesthesia. Isopto Hyoscine may be used alone or with other medications.

Isopto Hyoscine belongs to a class of drugs called Antiemetic Agents.

It is not known if Isopto Hyoscine is safe and effective in children.

What are the possible side effects of Isopto Hyoscine?

Isopto Hyoscine may cause serious side effects including:

• hives,
• difficulty breathing, a
• swelling of your face, lips, tongue, or throat,
• mood changes,
• confusion,
• hallucinations,
• memory problems,
• nausea,
• vomiting,
• difficulty urination,
• muscle spasms,
• eye pain or swelling,
• vision changes, and
• seeing halos around lights

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Isopto Hyoscine include:

• temporary burning, stinging, or redness of the eye,
• blurred vision,
• sensitivity to light,
• drowsiness, and
• dry mouth

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Isopto Hyoscine. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

ISOPTO^® HYOSCINE (Scopolamine Hydrobromide) is an anticholinergic prepared as a sterile topical ophthalmic solution.

Structure

Established name: Scopolamine Hydrobromide

Chemical name: Benzeneacetic acid , a-(hydroxymethyl)- , 9-methyl-3-oxa-9azatricyclo[3 .3. 1 .O2 -4]non-7-yl ester, hydrobromide, trihydrate, [7(S)-(1 a,2b,4b,5a,7b)]-.

Each ml contains:

Active: Scopolamine Hydrobromide 0.25%.

Preservative: Benzalkonium Chloride 0.01%.

Vehicle: Hydroxypropyl Methylcellulose 0.5%.

Inactive: Sodium Chloride, Glacial Acetic Acid, Sodium Acetate (to adjust pH), Purified Water.

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.

DOSAGE AND 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.

HOW SUPPLIED

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.

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

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.

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.

CLINICAL PHARMACOLOGY

This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia).

PATIENT INFORMATION

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.

See WARNINGS, CONTRAINDICATIONS and PRECAUTIONS.