Cizia

Cyclosporine Eye Drops IP 0.09% w/v.

Composition:

Cyclosporine IP 0.09% w/v
Sterile Aqueous Buffered Vehicle q.s.
(Preserved with Ionic Buffer System)

Pharmaceutical Form:

Eye drops

Therapeutic Indication:

Increase tear production in patients with keratoconjunctivitis sicca (dry eye)
Treatment for moderate to severe dry eye

Dosage and Administration:

Posology
The recommended dose is Instill one drop into the affected eye(s) 2 times a day (every 12 hours).

Method of administration - For ocular use

Contraindications:

None.

Effects on Ability to Drive and Use Machines:

None

Incompatibility:

Not known.

Shelf Life:

See on the carton

Storage:

Store at a temperature not exceeding 25°C.
Protect from light & moisture.
Do not freeze.
NOT FOR INJECTION, FOR EXTERNAL USE ONLY
Keep out of reach of children.

Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials, 769 subjects received at least 1 dose of cyclosporine ophthalmic solution. The majority of the treated subjects were female (83%).
The most common adverse reactions reported in greater than 5% of subjects were pain on instillation of drops (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of the patients were blepharitis, eye irritation, headache, and urinary tract infection.

Potential for Eye Injury and Contamination

To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces.

Use with Contact Lenses

Cyclosporine should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of Cyclosporine ophthalmic solution.

Use in Specific Population:

Pregnancy

Risk Summary
There are no adequate and well-controlled studies of Cyclosporine administration in pregnant women to inform a drug-associated risk. Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses.

Data
Animal Data Oral administration of cyclosporine oral solution (USP) to pregnant rats or rabbits was teratogenic at maternally toxic doses of 30 mg/kg/day in rats and 100 mg/kg/day in rabbits, as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations. These doses (normalized to body weight) were approximately 3200 and 21000 times higher than the maximum recommended human ophthalmic dose (MRHOD) of 1.5 mcg/kg/day, respectively. No adverse embryofetal effects were observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively (approximately 1800 and 6400 times higher than the MRHOD, respectively). An oral dose of 45 mg/kg/day cyclosporine (approximately 4800 times higher than MRHOD) administered to rats from Day 15 of pregnancy until Day 21 postpartum produced maternal toxicity and an increase in postnatal mortality in offspring. No adverse effects in dams or offspring were observed at oral doses up to 15 mg/kg/day (approximately 1600 times greater than the MRHOD).

Lactation

Risk Summary
Cyclosporine blood concentrations are low following topical ocular administration of Cyclosporine. There is no information regarding the presence of cyclosporine in human milk following topical administration or on the effects of Cyclosporine on the breastfed infants and milk production. Administration of oral cyclosporine to rats during lactation did not produce adverse effects in offspring at clinically relevant doses. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Cyclosporine and any potential adverse effects on the breast-fed child from cyclosporine.

Pediatric Use

The safety and efficacy of Cyclosporine ophthalmic solution have not been established in pediatric patients below the age of 18.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.

Pharmacological Properties:

Mechanism of action

Cyclosporine is a calcineurin inhibitor immunosuppressant agent when administered systemically. In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, topical administration of cyclosporine is thought to act as a partial immunomodulator. The exact mechanism of action is not known.

Pharmacokinetic properties

Blood concentrations of cyclosporine after twice daily topical ocular administration of Cyclosporine into each eye of healthy subjects for up to 7 days, and once on Day 8, were either not detectable or were marginally above the lower limit of assay quantitation of 0.100 ng/mL (range 0.101 to 0.195 ng/mL) for up to 2 hours after a single dose, and up to 4 hours after multiple doses.

Presentation:

CIZIA Eye Drops is available in a 5 ml pack.