(ANTAZOLINE HYDROCHLORIDE 0.05%W/V + TETRAHYDROZOLINE –

HYDROCHLORIDE 0.04%W/V)

 COMPOSITION

Each ml of Antallerge®  Sterile Ophthalmic Solution contains  0.5mg Antazoline Hydrochloride and 0.4mg Tetrahydrozoline Hydrochloride.

ACTIONS

Antazoline is the anti-allergic active substance in Antallerge®  Eye Drops. It is responsible for competitive blocking of the H1 receptors of the effector cells and thus reduces the following effects of the histamine released in the tissue: increase in permeability and expansion of the capillaries and to a certain extent, contraction of smooth muscles, formation of oedema, itching and lacrimation.

Tetrahydrozoline is a vasoconstrictor causing contraction of the conjunctival arterioles through alpha-adrenergic stimulation, thereby reducing the inflammatory irritation and swelling of the conjunctiva.

Antallerge® Eye Drops therefore is suitable for the treatment of allergic symptoms which are mainly induced by the release of histamine.

PHARMACO-KINETICS

Like all alpha-sympathomimetics, Tetrahydrozoline is absorbed systemically via the blood vessels. However, after topical administration of Antallerge® Eye Drops in the eye, the amounts absorbed are extremely small.

H1 antihistamine agents such as Antazoline are generally absorbed rapidly and readily.

INDICATIONS

Allergic inflammatory conditions of the conjunctiva, particularly hay fever conjunctivitis and vernal conjunctivitis. Non-infectious irritative conjunctivitis.

DOSAGE AND ADMINISTRATION

In the acute phase, 1 drop every three hours; for continuous use, 1 drop 2 – 3 times daily is sufficient.

In severe cases, Antallerge® Eye Drops can be used as frequently as every hour without any side effects being observed.

For Children, 1 –2 drops should be administered daily.

CONTRA-INDICATIONS

  • Hypersensitivity to the ingredients in Antallerge® Eye Drops.
  • In patients with narrow angle glaucoma, application is in general not recommended.
  • Contact lenses should be removed before administration of the product. The lenses can be placed back into the eye after at least 15minutes.

PRECAUTIONS

  • Use with care in children.
  • For a treatment longer than 2 – 3 days, it should be prescribed and

monitored by a physician.

  • Due to systemic sympathomimetic effects, care should be exercised when treating diabetics or patients suffering from severe heart disease, hypertension.
  • In pregnancy, the drug should be used in those cases where the potential benefit exceeds the risk to the foetus or that of the infant.

KEEP OUT OF THE REACH OF CHILDREN!

 ADVERSE REACTIONS

A mild burning sensation may occur for a short time directly after instillation of the eye drops. Headache, and tachycardia may occur in isolated cases, especially in infants.

Drug – Drug Interactions:

Preparations containing Tetrahydrozoline may not be used in patients receiving MAO inhibitors until ten days after the last treatment with such active ingredients (increase in blood pressure resulting from the concomitant use of MAO   inhibitors and tricyclic anti-depressives).

Shelf – Life:

Close the bottle immediately after use. Do not use longer than 28 days after first opening.

If the pack is unopened, Antallerge® Eye Drops can be used until the expiry date.

STORAGE CONDITIONS

Store below 25oC protected from light. Replace cap immediately after use.

PRESENTATION

Antallerge® Eye Drops is available in sterile lupolen bottles containing 10ml of the sterile drops.