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Drug overview for RESTASIS (cyclosporine):
Generic name: CYCLOSPORINE (SYE-kloe-SPOR-in)
Drug class: Ophthalmic - Anti-Inflammatory, Immunomodulators
Therapeutic class: Ophthalmic Agents
Cyclosporine is a systemic immunosuppressive agent that appears to act as a partial immunomodulator with anti-inflammatory effects after ophthalmic administration.
No enhanced Uses information available for this drug.
Generic name: CYCLOSPORINE (SYE-kloe-SPOR-in)
Drug class: Ophthalmic - Anti-Inflammatory, Immunomodulators
Therapeutic class: Ophthalmic Agents
Cyclosporine is a systemic immunosuppressive agent that appears to act as a partial immunomodulator with anti-inflammatory effects after ophthalmic administration.
No enhanced Uses information available for this drug.
DRUG IMAGES
RESTASIS 0.05% EYE EMULSION
The following indications for RESTASIS (cyclosporine) have been approved by the FDA:
Indications:
Keratoconjunctivitis sicca
Professional Synonyms:
None.
Indications:
Keratoconjunctivitis sicca
Professional Synonyms:
None.
The following dosing information is available for RESTASIS (cyclosporine):
No enhanced Dosing information available for this drug.
For topical ophthalmic use only. Not for injection. Not for subconjunctival injection or introduction directly into the anterior chamber.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| RESTASIS 0.05% EYE EMULSION | Maintenance | Adults instill 1 drop into affected eye(s) by ophthalmic route every 12 hours |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| CYCLOSPORINE 0.05% EYE EMULS | Maintenance | Adults instill 1 drop into affected eye(s) by ophthalmic route every 12 hours |
The following drug interaction information is available for RESTASIS (cyclosporine):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for RESTASIS (cyclosporine):
Drug contraindication overview.
Known hypersensitivity to cyclosporine or any ingredient in the formulation. Cyclosporine ophthalmic emulsion also is contraindicated in patients with active ocular infections.
Known hypersensitivity to cyclosporine or any ingredient in the formulation. Cyclosporine ophthalmic emulsion also is contraindicated in patients with active ocular infections.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| No disease contraindications |
The following adverse reaction information is available for RESTASIS (cyclosporine):
Adverse reaction overview.
The most common adverse effect of cyclosporine ophthalmic emulsion is ocular burning, which occurred in approximately 17% of patients who received the drug in clinical trials. Other adverse effects occurring in 1-5% of patients receiving cyclosporine included conjunctival hyperemia, discharge, epiphora, ocular pain, foreign body sensation, pruritus, stinging, and visual disturbance (e.g., blurring). In clinical trials, no increase in bacterial or fungal ocular infections was reported following administration of cyclosporine ophthalmic emulsion.
The most common adverse effect of cyclosporine ophthalmic emulsion is ocular burning, which occurred in approximately 17% of patients who received the drug in clinical trials. Other adverse effects occurring in 1-5% of patients receiving cyclosporine included conjunctival hyperemia, discharge, epiphora, ocular pain, foreign body sensation, pruritus, stinging, and visual disturbance (e.g., blurring). In clinical trials, no increase in bacterial or fungal ocular infections was reported following administration of cyclosporine ophthalmic emulsion.
There are 1 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Bacterial keratitis |
There are 16 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Ocular irritation Ocular pain |
Blurred vision Conjunctival hyperemia Cough Eye tearing Eyelid edema Headache disorder Ocular discharge Ocular redness Visual changes |
| Rare/Very Rare |
|---|
|
Blepharitis Foreign body sensation of eye Herpes zoster Ocular itching Upper respiratory infection |
The following precautions are available for RESTASIS (cyclosporine):
Safety and efficacy not established in children younger than 16 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide.)
It is not known whether cyclosporine is distributed into milk following topical application to the eye; however, cyclosporine is distributed into milk following systemic administration. Although blood cyclosporine concentrations are undetectable after ophthalmic administration of cyclosporine 0.05% emulsion, caution is advised if cyclosporine ophthalmic emulsion is administered in nursing women.
No substantial differences in safety and efficacy relative to younger adults.
The following prioritized warning is available for RESTASIS (cyclosporine):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for RESTASIS (cyclosporine)'s list of indications:
| Keratoconjunctivitis sicca | |
| H16.22 | Keratoconjunctivitis sicca, not specified as sjogren's |
| H16.221 | Keratoconjunctivitis sicca, not specified as sjogren's, right eye |
| H16.222 | Keratoconjunctivitis sicca, not specified as sjogren's, left eye |
| H16.223 | Keratoconjunctivitis sicca, not specified as sjogren's, bilateral |
| H16.229 | Keratoconjunctivitis sicca, not specified as sjogren's, unspecified eye |
| M35.01 | Sjogren syndrome with keratoconjunctivitis |
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