Restor Eye Drops
Cyclosporine Eye prep
50 mg/100 ml
Apex Pharma Limited.
| Pack size | 5ml bot |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 200 AED |
Indications
Restor Eye Drops is used for:
Dry eye, Keratoconjunctivitis Sicca,
This drug is indicated to increase tear production in patients whose tear production is suppressed due to ocular inflammation associated with dry eye syndrome (keratoconjunctivitis sicca).
Adult Dose
Keratoconjuntivitis Sicca
1 drop twice daily approximately 12 hours apart in each eye
May be used with artificial tears; allow 15-minute interval between products
Child Dose
<16 years
Safety and efficacy not established
>16 years
Keratoconjuntivitis Sicca
1 drop twice daily approximately 12 hours apart in each eye
May be used with artificial tears; allow 15-minute interval between products
Renal Dose
Administration
Ophthalmic Administration
Ophthalmic use only
Single-use solution or emulsion: After opening for administration to one or both eyes use immediately, and discard remaining contents immediately
Do not administer while wearing contact lenses; remove contacts prior to administration; contacts may reinsert 15 minutes following administration
Contra Indications
Cyclosporine is contraindicated in patients with active ocular infections and in patients with known or suspected hypersensitivity to any of the ingredients in the formulation.
Precautions
Cyclosporine eye drop should not be administered while wearing contact lenses.
Patients with decreased tear production typically should not wear contact lenses.
If contact lenses are worn, they should be removed prior to the administration of this formulation.
Lenses may be reinserted 15 minutes following administration of Cyclosporine eye drop.
Pregnancy-Lactation
Pregnancy
There are no adequate and well-controlled studies of administration in pregnant females to inform a drug-associated risk
Infertility
No data are available on drug effects on human fertility
No impairment of fertility reported in animals receiving intravenous cyclosporine
Animal data
Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses
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; doses (normalized to body weight) were ~320 times higher than the daily maximum recommended human ophthalmic dose of 0.015 mg/kg/day
Lactation
There is no information regarding drug presence in human milk following topical administration or on effects on breastfed infants and milk production
Administration of oral cyclosporine to rats during lactation did not produce adverse effects in offspring at clinically relevant doses
Interactions
Increased ciclosporin level by diltiazem, doxycycline, erythromycin, ketoconazole, methylprednisolone (high doses), nicardipine, verapamil, oral contraceptives.
Drugs which reduce ciclosporin level are carbamazepine, isoniazid, phenobarbitone, phenytoin and rifampicin.
Increased risk of convulsion when used concurrently with high-dose methylprednisolone.
Potentially Fatal: Additive nephrotoxicity when used with aminoglycosides, amphotericin B, ciprofloxacin, colchicine, melphalan, co-trimoxazole and NSAIDs.
Adverse Effects
Side effects of Cyclosporine Eye prep :
1-5%
Conjunctival hyperemia
Discharge
Epiphora
Eye pain
Foreign body sensation
Stinging
Visual disturbance (eg, blurring)
Mechanism of Action
Ciclosporin is a strong immunosuppressant that acts mainly on the helper T-cells. It inhibits the activation of calcineurin and production of interleukin-2, thus reducing cell-mediated immune response. May act as immunomodulator to suppress tear production in keratoconjunctivitis sicca
Note
Restor 50 mg/100 ml Eye Drops manufactured by Apex Pharma Limited.. Its generic name is Cyclosporine Eye prep. Restor is availble in Bangladesh.
Farmaco BD drug index information on Restor Eye Drops is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.