Treatment of mild non‐infectious allergic or inflammatory conjunctival diseases.
What is Zoftacot?
- Zoftacot are eye drops, solution in single-dose container.
- The solution is a practically clear, colourless to slightly yellow solution, practically free from particles.
What is Zoftacot used for?
- Treatment of mild non‐infectious allergic or inflammatory conjunctival diseases.
- The recommended dosage is 2 drops 2 to 4 times daily in the affected eye.
- The duration of this dosing regimen will generally vary from a few days to a maximum of 14 days.
- Gradual tapering off up to one administration every other day may be recommended in order to avoid a relapse.
- In case of insufficient response, a more potent corticosteroid should be used.
Method of administration
A single‐dose container contains enough solution to treat both eyes. For single use only.
This medicinal product is a sterile solution that does not contain a preservative. The solution from one individual single‐dose container is to be used immediately after opening for administration to the affected eye(s).
Patients should be instructed:
- to avoid contact between the dropper tip and the eye or eyelids,
- to use the eye drops, solution immediately after first opening of the single‐dose container and to discard the single‐dose container after use.
In case of concomitant treatment with other eye drops, solution, instillations should be spaced out by 5 minutes.
- Hypersensitivity to the active substance or to any of the excipients;
- Known glucocorticosteroid‐induced ocular hypertension and other forms of ocular hypertension;
- Acute herpes simplex virus infection and most of the other corneal viral infections at the acute stage of ulceration (except when combined with specific chemiotherapeutic agents for herpes virus); conjunctivitis with ulcerative keratitis even at the initial stage (positive fluorescein test);
- Ocular tuberculosis;
- Ocular mycosis;
- Acute ocular purulent infection, purulent conjunctivitis and purulent blepharitis, stye and herpes infection that may be masked or aggravated by anti‐inflammatory drugs.
Precautions for use
- Topical steroids should never be given for an undiagnosed red eye.
- Use of this medicinal product is not recommended for the treatment of viral herpes keratitis, but it may be used if required only with a combined antiviral treatment and under close supervision of an ophthalmologist.
- Thinning of the cornea and sclera (caused by diseases) may increase the risk of perforations with the use of topical steroids.
- Any fungal infection should be suspected in cases of corneal ulceration where a steroid has or had been used for a long period.
- Patients should be monitored at frequent intervals during treatment with hydrocortisone eye drops. Prolonged use of corticosteroid treatment has shown to cause ocular hypertension/glaucoma especially for patients with previous IOP increase induced by steroids or with pre‐existing high IOP or glaucoma, and also cataract formation, especially in children and elderly population.
The use of corticosteroids may also result in opportunistic ocular infections due to the suppression of host response or to the delay of their healing. In addition, topical ocular corticosteroids may promote, aggravate or mask signs and symptoms of opportunistic eye infections.
Wearing of contact lenses during treatment with corticosteroid eye drops should be avoided.
Interaction with other medicinal products
- No interaction studies have been performed.
Fertility, pregnancy and lactation
- ZOFTACOT is not recommended during pregnancy, unless clearly necessary.
- Systemically administered glucocorticoids are excreted in breast milk and may cause suppression of growth or of endogenous corticosteroid production or may have other undesirable effects.
- It is unknown whether ZOFTACOT is excreted in human milk.
- A risk to the newborns/infants cannot be excluded.
- There are no data on potential effects of hydrocortisone sodium phosphate 3.35 mg/ml on fertility.
Effects on ability to drive and use machines
- No studies on the effects on the ability to drive and use machines have been performed.
- Temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs, the patient must wait until the vision is clear before driving or using machines.
- Burning and stinging may occur immediately after instillation. These events are usually mild and transient and have no consequences.