Hydra-C (cyclosporine/chondroitin sulfate A sodium)
Ophthalmic - Anti-Inflammatory, Immunomodulators Ophthalmic (Eye) Drops
Last reviewed · Source: First Databank (FDB) drug data
Overview
Cyclosporine is a systemic immunosuppressive agent that appears to act as a partial immunomodulator with anti-inflammatory effects after ophthalmic administration.
Cyclosporine exhibits immunosuppressive activity when administered systemically. Although the exact mechanism of action of cyclosporine ophthalmic emulsion has not been fully elucidated, the drug is thought to act as a partial immunomodulator with anti-inflammatory effects when administered topically to the eye.
Chronic dry eye disease (e.g., keratoconjunctivitis sicca) is thought to result from an underlying cytokine- (released from T cells) and receptor-mediated inflammatory process that affects the lacrimal gland acini and ducts, resulting in tear film abnormalities and disruptions in ocular surface homeostasis. Topical application of cyclosporine to the eye reduces cell-mediated inflammatory responses associated with inflammatory ocular surface diseases.
Following topical application to the eye of cyclosporine 0.05% emulsion twice daily for up to 12 months, blood concentrations of the drug were determined using a specific high-pressure liquid chromatographic-mass spectrometric assay and found to be below the level of quantitation (0.1 ng/mL) in all samples collected. There was no evidence that cyclosporine accumulated in blood following repeated ophthalmic administration over a period of 12 months.
Generic name: cyclosporine/chondroitin sulfate A sodium
Drug class: Ophthalmic - Anti-Inflammatory, Immunomodulators
Therapeutic class: Ophthalmic Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
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Indications
No indications are available for this drug.
Dosing
No dosing information is available for this tab.
For topical ophthalmic use only. Not for injection. Not for subconjunctival injection or introduction directly into the anterior chamber.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
No formal drug interaction studies involving cyclosporine ophthalmic emulsion have been performed.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
Known hypersensitivity to cyclosporine or any ingredient in the formulation. Cyclosporine ophthalmic emulsion also is contraindicated in patients with active ocular infections.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- No disease contraindications
Adverse reactions
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.
Rare or Very Rare
- Bacterial keratitis
More Frequent
- Ocular irritation
- Ocular pain
Less Frequent
- Blurred vision
- Conjunctival hyperemia
- Cough
- Eye tearing
- Eyelid edema
- Headache disorder
- Ocular discharge
- Ocular redness
- Visual changes
Rare or Very Rare
- Blepharitis
- Foreign body sensation of eye
- Herpes zoster
- Ocular itching
- Upper respiratory infection
Precautions
No enhanced messaging available.
Safety and efficacy not established in children younger than 16 years of age.
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.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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