MONOKETO Gé 0,25 mg/ml Collyre sol en récipient unidose 60Unid/0,4ml

VIDAL
Medicines
Update of 23/04/2024

MONOKETO^® Ge
ketotifen

Forms and presentations

Eye drops in solution at 0,25 mg/ml (clear, colourless to slightly yellow-tinged): Single-dose containers of 0,4 ml, box of 60 (in sachets containing 2 strips of 5 single-dose containers).

Composition

	single-dose p
Ketotifen (INN)	0,100 mg
(as fumarate: 0,138 mg/single dose)

Excipients: glycerol, sodium hydroxide, water ppi.

Each drop contains 9,5 µg of ketotifen fumarate.

Indications

Symptomatic treatment of seasonal allergic conjunctivitis.

Dosage and administration

Adults, elderly people and children from 3 years of age: one drop of Monokéto Ge in the conjunctival sac, twice a day.

The contents of the single-dose container are sufficient for treating both eyes.

The eye drops are sterile until the single-dose container is first opened. To avoid any risk of contamination, do not touch any surface with the tip of the single-dose container.

The safety and efficacy of Monokéto Ge have not been established in children under 3 years of age.

Contraindications

Hypersensitivity to ketotifen or to any of the components of the eye drops.

Interactions

Drug interactions
In case of concomitant treatment with another eye drop, the eye drops must be instilled at least 5 minutes apart.
Oral use of ketotifen may potentiate the effects of central nervous system depressants, antihistamines and alcohol. Although this has not been observed with Monokéto Ge, the possibility of such interactions cannot be excluded.

Fertility, pregnancy and breastfeeding

Pregnancy:

There are no relevant clinical data on exposure of pregnant women to ketotifen in eye drop form. Animal studies using maternotoxic oral doses showed an increase in pre- and postnatal mortality, but no teratogenic effect. Systemic levels observed after ocular instillation are far lower than those observed after oral administration. Nevertheless, caution will be required when prescribing this medicine to pregnant women.

Breastfeeding:

Although animal studies after oral administration show passage into breast milk, topical administration in humans is unlikely to produce detectable amounts in breast milk. Monokéto Ge may be used during breastfeeding.

Driving and using machines

Patients with visual disturbance or signs of drowsiness must refrain from driving vehicles or operating machinery.

Adverse effects

Adverse effects are classified by frequency according to the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10 000, < 1/1000); very rare (< 1/10 000); frequency not known (cannot be estimated from the available data).

At the recommended dosage, the following adverse effects have been reported:

Eye disorders:

• Common: eye irritation, eye pain, punctate keratitis, punctate erosion of the corneal epithelium.
  
• Uncommon: blurred vision (during instillation), dry eye, eyelid irritation, conjunctivitis, photophobia, conjunctival haemorrhage.
  

Nervous system disorders:

• Uncommon: headache.
  

General disorders and administration site conditions:

• Uncommon: somnolence.
  

Skin and subcutaneous tissue disorders:

• Uncommon: skin rash, eczema, urticaria.
  

Gastrointestinal disorders:

• Uncommon: dry mouth.
  

Immune system disorders:

• Uncommon: hypersensitivity reaction.
  

The following adverse effects have been observed after marketing: hypersensitivity reactions including local allergic reactions (mainly contact dermatitis, swelling of the eyes, irritation and oedema of the eyelid), systemic allergic reactions including swelling/oedema of the face (sometimes associated with contact dermatitis), and exacerbation of pre-existing allergic conditions such as asthma and eczema.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.

Overdose

No cases of overdose have been reported.

Oral absorption of the contents of one single-dose unit is equivalent to 0,1 mg of ketotifen, which corresponds to 5% of the recommended daily oral dose for a child aged 3 years. Clinical results did not reveal any serious sign or symptom after oral absorption of doses up to 20 mg of ketotifen.

Pharmacodynamics

Pharmacotherapeutic class: Ophthalmological drugs, other antiallergics (ATC code: S01GX08).

Ketotifen is an antagonist of histamine H1 receptors. Studies carried out in vivo in animals and studies carried out in vitro suggest additional mechanisms of action such as stabilisation of the mast cell membrane and inhibition of the infiltration, activation and degranulation of eosinophils.

Pharmacokinetics

In a pharmacokinetic study conducted in 18 healthy volunteers treated with Monokéto Ge, plasma ketotifen levels after ocular instillation of repeated doses for 14 days were, in most cases, below the quantifiable limit (20 pg/ml). After oral administration, ketotifen is eliminated biphasically, with an initial distribution half-life of 3 to 5 hours and an elimination half-life of 21 hours. About 1% of the substance is eliminated unchanged in the urine within 48 hours, and 60 to 70% as metabolites. The main metabolite is glucuronide-N-ketotifen, which is practically inactive.

Preclinical safety

Non-clinical data from conventional safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenesis and reproductive and developmental studies revealed no particular risk for humans related to the use of Monokéto eye drops. Ge.

Storage conditions

HANDLING/DISPOSAL INSTRUCTIONS

Single-dose containers must be discarded after use.

Prescription, supply and reimbursement

LIST II

Marketing authorisation (AMM)

3400922214610 (2012, SmPC rev 29.09.2016).

Price:	6,10 euros (60 single-dose containers).
Social Security reimbursement at 30%. Collect.

HORUS PHARMA
22, Allée Camille-Muffat
INEDI 5. 06200 Nice
Tel: 04 93 19 54 03. Fax: 04 93 19 54 09
https://www.horus-pharma.com