SIGUENT HYCOR 1% eye ointment

MIMS Revision Date: 01 April 2020

1 Name of Medicine

Hydrocortisone acetate.

2 Qualitative and Quantitative Composition

Siguent Hycor eye ointment contains 1% hydrocortisone acetate as the active ingredient in a sterile oculentum base. It is a preservative-free preparation.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

A soft, yellowish-white, clear eye ointment with an odour faintly of paraffin and lanolin.

4 Clinical Particulars

4.1 Therapeutic Indications

Inflammatory conditions of the eye, including allergic conjunctivitis, nonpurulent conjunctivitis and/or blepharitis, iritis, herpes zoster ophthalmicus, recurrent marginal ulceration.

4.2 Dose and Method of Administration

Apply two to four times daily.

4.3 Contraindications

Hypersensitivity to any ingredient including excipients.
Acute herpes simplex, vaccinia, varicella and most other viral diseases of the cornea and conjunctiva; ocular tuberculosis; fungal diseases of the eye; purulent conjunctivitis and blepharitis and other acute purulent untreated infections of the eye which may be masked or enhanced by the presence of a steroid.

4.4 Special Warnings and Precautions for Use

Extended use of the topical steroid therapy may cause increased intraocular pressure in certain individuals. Ophthalmologic examinations, especially tonometry and slit lamp examinations should be performed 2 to 3 weeks following onset of chronic therapy; subsequent examinations should be performed at intervals as determined by patient status or risk factors.
Risk/ benefit should be considered when the following medical problems exist: cataracts (may be exacerbated); diabetes mellitus (patient may be predisposed toward increase in intraocular pressure and/or cataract formation); diseases causing thinning of the cornea or sclera (use may result in perforation); glaucoma, chronic open angle or family history of glaucoma (may be precipitated or exacerbated); infections of the cornea or conjunctiva (risk of exacerbation or development of secondary infections).
There have been reports of bacterial keratitis associated with the use of multiple dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or the surrounding structures.
Patients should be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
Patients should also be advised that if they develop an intercurrent ocular condition (e.g. trauma, ocular surgery or infection) or any ocular reactions, particularly conjunctivitis and lid reactions, they should immediately seek their physician's advice concerning the continued use of the product.
If more than one topical ophthalmic drug is being utilised, the drugs should be administered at least 10 minutes apart.
To minimise systemic absorption of the active ingredient, pressure should be applied to the tear duct for one minute immediately after application.
Visual disturbance. Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Use in the elderly. No geriatric specific problems have been documented.
Paediatric use. Corticosteroids should be used with caution in children 2 years of age or younger because the different dose/weight ratio for children increases the risk of adrenal suppression. This risk increases with the length of therapy, which, therefore, should be limited to the shortest possible time (preferably less than 5 days).
Effects on laboratory tests. No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Anti-glaucoma agents. Chronic or prolonged use of corticosteroids may raise intraocular pressure and decrease the efficiency of the anti-glaucoma agents.
Anticholinergics (especially atropine and related compounds). Prolonged corticosteroid therapy may increase risk of intraocular hypertension which may be more likely to occur during treatment with anticholinergics in patients predisposed to acute angle closure.
Interactions with therapeutic devices. Contact lenses: risk of infection is increased.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. No data available.
Use in pregnancy. (Category A)
Systemically absorbed hydrocortisone is classified category A in Australia. Problems in humans have not been documented with ophthalmologically applied hydrocortisone, however, well controlled studies have not been performed. Studies in pregnant mice have shown that hydrocortisone drops, when applied to both eyes five times a day on days 10-13 of gestation, caused a significant increase in foetal cleft palate. Studies in rabbits have shown that corticosteroids produce foetal resorptions and multiple abnormalities, including those of the head, ears, limbs and palate. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
Use in lactation. Problems in humans have not been documented.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Reporting suspected adverse effects. Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.
Frequent or intensive use of ophthalmic corticosteroids may retard corneal healing.
Common. Ophthalmological. Temporary blurred vision (particularly after application of the eye ointment).
Uncommon to rare. Ophthalmological. Burning, stinging, redness or watering of the eyes; corneal thinning and/or globe perforation (decreased vision, watering of the eyes); glaucoma; ocular hypertension; optic nerve damage; posterior subcapsular cataract; visual acuity and field defects (gradual blurring or loss of vision, eye pain, nausea, vomiting); secondary ocular infection.
Post marketing. Eye disorders. Blurred vision.

4.9 Overdose

Dilution with water and other fluids is the usual response to accidental or deliberate overdose.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Hydrocortisone is the main glucocorticoid secreted by the adrenal cortex. It is an anti-inflammatory hormone. Hydrocortisone acetate is the acetate salt of hydrocortisone.
Mechanism of action. Corticosteroids diffuse across cell membranes and complex with specific cytoplasmic receptors. These then enter the cell nucleus, bind to DNA and stimulate transcription of mRNA and subsequent protein synthesis of enzymes ultimately responsible for anti-inflammatory effects of topical applications of corticosteroids to the eye.
In high concentrations, which may be achieved after topical application, corticosteroids may exert direct membrane effects. Corticosteroids decrease cellular and fibrinous exudation and tissue infiltration, inhibit fibroblastic and collagen-forming activity, retard epithelial regeneration, diminish postinflammatory neovascularization and reduce toward normal levels the excessive permeability of inflamed capillaries.
Clinical trials. No data available.

5.2 Pharmacokinetic Properties

Absorption. Hydrocortisone and its acetate salt are absorbed into the aqueous humour, cornea, iris, choroid, ciliary body and retina. Systemic absorption occurs, but may be significant only at higher dosages or in extended paediatric delivery. The biological half-life is about 100 minutes.
Distribution. It is more than 90% bound to plasma proteins.
Metabolism. Hydrocortisone is metabolised in the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol.
Excretion. These are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone.

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. Long-term studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity or mutagenicity attributable to oral administration of corticosteroids. Long-term animal studies have not been performed to evaluate the carcinogenic potential of topical corticosteroids. Studies to determine mutagenicity with hydrocortisone have revealed negative results.

6 Pharmaceutical Particulars

6.1 List of Excipients

White soft paraffin, liquid paraffin and wool fat.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Discard 4 weeks after opening.

6.5 Nature and Contents of Container

Aluminium tube with a HDPE nozzle. Pack sizes of 2.5 g or 5 g.
(Note: not all pack sizes are available.)

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Hydrocortisone acetate is a white or almost white, odourless crystalline powder. 112 mg of hydrocortisone acetate is approximately equivalent to 100 mg of hydrocortisone. It is insoluble in water, soluble 1 in 230 of alcohol, 1 in 200 in chloroform. Formula: C₂₃H₃₂O₆. Molecular weight: 404.5.
Chemical structure.

CAS number. 50-03-3.

7 Medicine Schedule (Poisons Standard)

S4.

Date of First Approval

04 September 2007

Date of Revision

06 February 2020

Summary Table of Changes