ISOPTO CARPINE STERILE OPHTHALMIC SOLUTION 2% [SIN04712P]

Product Info

ISOPTO CARPINE STERILE OPHTHALMIC SOLUTION 2%

[SIN04712P]

4.1 Therapeutic indications
ISOPTO CARPINE ophthalmic solution contains pilocarpine hydrochloride, a miotic (parasympathomimetic).

ISOPTO CARPINE ophthalmic solution is used to control intraocular pressure in chronic simple glaucoma. In acute glaucoma it may be used alone prior to emergency surgery, or in combination with other miotics or carbonic anhydrase inhibitors. Patients can be maintained on ISOPTO CARPINE ophthalmic solution as long as intraocular tension is controlled and there is no visual deterioration as indicated by changes in the visual field.

4.2 Dosage regimen and administration
Dosage regimen
2 drops should be instilled in the eye(s) 3 times daily or as directed by a physician.

Use in children
The safety and efficacy of ISOPTO CARPINE ophthalmic solution in children have not been established. Due to a lack of pharmacokinetic data for the pediatric population, it is not possible to make particular evidence-based dose recommendations for children.

Use in patients with hepatic or renal impairment
The safety and efficacy of ISOPTO CARPINE ophthalmic solution in patients with hepatic or renal impairment have not been established.

Geriatric patients (65 years of age or above)
No overall differences in safety and efficacy have been observed between elderly and younger patients.

Method of administration

• For ocular use.

• After cap is removed, if tamper evident snap collar is loose, it should be removed before using the product.

• To avoid contamination, the dropper tip should not touch any surface. The dropper tip should also not come into contact with the eye as this may cause injury to the eye. Patients should be instructed to keep the bottle tightly closed when not in use.

• If more than one topical ophthalmic product is being used, the products must be administered at least 5 minutes apart. Eye ointments should be administered last.

• Nasolacrimal occlusion or gently closing the eyelid for 2 minutes after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Miotics are contraindicated in conditions where pupillary constriction is undesirable such as acute iritis or anterior uveitis.