- OPHTHALMOLOGICAL DRUGS
- Pharmaceutical Form : Single Dose Ophthalmic Solutions
- Composition : Each ml CYCLOMED 0.5 % -1% ophthalmic solution contains: Cyclopentolate Hcl 5mg-10 mg
- Active Substance : Cyclopentolate Hcl
Each ml CYCLOMED 0.5 % -1% ophthalmic solution contains: Cyclopentolate Hcl 5mg-10 mg
Each unit (0.5mL) of CYCLOMED 0.5% single dose ophthalmic solution contains: Cyclopentolate Hcl 2.5 mg
Each unit (0.5mL) of CYCLOMED 1% single dose ophthalmic solution contains: Cyclopentolate Hcl 5 mg
MECHANISM OF ACTION: Cyclopentolate hydrochloride is a competitive antagonist of acetylcholine at the parasympathetic nerve endings.
As a topical mydriatic and cycloplegic agent. Preoperative use in ophthalmic surgery. Refraction and treatment of iritis and iridocyclitis.
Do not use in patients with a known hypersensitivity to cyclopentolate or to any of the excipients.
Should not be used in neonates except where, on expert evaluation, the need is considered to be compelling.
Do not use in patients with paralytic ileus.
Do not use in patients with narrow-angle glaucoma.
Do not use in geriatric patients and other patients who may be predisposed to an increased intraocular pressure.
Common: Eye irritation, ocular stinging on instillation. Not known: Ocular hyperaemia, eye oedema, conjunctivitis.
Common: Gastrointestinal hypomotility leading to constipation. Not known: Necrotising colitis (in preterm infants).
General disorders and administration site
Immune system disorders:
Rare: Allergic reaction.
Nervous system disorders:
Not known: Drowsiness, seizures (especially in children), ataxia.
Common: Confusion, hallucinations. Not known: Psychotic reactions, abnormal behavior especially in children.
Skin and subcutaneous tissue disorders:
Not known: Skin rash.
Common: Facial flushing.
Not known: Intraocular pressure increased.
Interaction with other medicinal products:
Pregnancy and lactation: This product should only be used in pregnancy and lactation if considered essential by the physician.
Effects on ability to drive and use machines: May cause transient blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery until vision is clear.
Adults (including the elderly)
Instill dropwise into eye according to the recommended dosage.
For mydriasis: the recommended dosage in adults is one drop of the 1% solution.
For refraction: 1 drop of solution, which may be repeated after five minutes, is usually sufficient. For iritis and iridocyclitis: 1-2 drops are instilled every six to eight hours.
Children and adolescents
3 months – 18 years: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated five to ten minutes later by a second application of 0.5% or 1% solution if necessary.
Small Infants: A single instillation of one drop of 0.5% in the eye. To minimize absorption, apply pressure over the nasolacrimal sac for two to three minutes.
Method of administration: Ocular use.
Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. This blocks the passage of the drops via the nasolacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially
Advisable in children.
Caution is also advised in inflamed or hyperaemic eye as increased systemic absorption may occur.
Contact lenses: It is advised to remove contact lenses prior to the administration of the drops. There is no information on the effect of this product on contact lenses. Therefore, contact lenses should not be worn until the effects of the drops have completely worn off.
Overdose: For a unit dose presentation for topical application to the eye, overdosage by this route is unlikely to occur.
Excessive dosage may produce behavioral disturbances, tachycardia, hyperpyrexia, hypertension, elevated intraocular pressure, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Patients exhibiting signs of overdosage should receive supportive care and monitoring.
STORAGE CONDITIONS: Ophthalmic solution:
Single dose sterile ophthalmic solution:
PACKAGING: ophthalmic solution: 10 mL
Single dose sterile ophthalmic solution: 10-30 PE plastic ampoules (0.5 mL)