NEOTEAR Eye Drop

 HYPROMELLOSE Eye Drops BP 0.7 % w/v

(Hydroxypropylmethylcellulose Eye Drops)

COMPOSITION

Each ml contains:

Hypromellose (Hydroxypropylmethylcellulose)  BP        7 mg

Benzalkonium chloride                                      BP        0.01 % w/v

(as preservative)

Water for Injections                                           BP        q.s.

 DESCRIPTION

A Clear, colorless to almost colorless solution.

 PHARMACODYNAMIC

Pharmacotherapeutic group: Ophthalmological.

ATC code: SO1X A20

Hypromellose is a soothing emollient solution with properties and uses similar to those of methylcellulose. Its advantages over methylcellulose are that mucilage of Hypromellose have greater clarity and fewer undispersed fibers are usually present. It prolongs the action of medicated eye drops and is used as artificial tears to prevent damage to the cornea in dry eye syndromes.

 PHARMACOKINETICS

Not applicable to topical (ophthalmic) preparations.

Hypromellose is an inert substance. It has no pharmacological activity and not absorbed systemically. Hence, the pharmacokinetic properties have not been studied.

THERAPEUTIC INDICATION

Hypromellose is used as artificial tears to prevent damage to the cornea in patients with keratoconjunctivitis sicca accompanying rheumatoid arthritis, xerophthalmias or keratitis or during gonioscopy procedures. It is also used to moisten hard contact lenses and to lubricate artificial eyes.

 Hypromellose provides immediate relief of dry eye conditions (including dry eye conditions associated with the use of VDUs and TVs, infrequent blinking, certain medical treatments, atmospheric pollution and drying atmospheres e.g. air-conditioning, central heating, wind and sun).

 DOSAGE AND ADMINISTRATION

The recommended dosage for adults, children and elderly is one or two drops topically instilled into the eye three times daily as needed, or as directed by a physician.

Method of administration: For ocular use only.

 INSTRUCTION FOR USE

Apply NEOTEAR Eye Drops in the following way:

1. Wash your hands. Tilt your head back and look at the ceiling.
2. Gently pull the lower eyelid down until there is a small pocket.
3. Turn the bottle upside down and gently press the bottle to release drops into eyes that needs treatment.
4. Let go of the lower lid, and close your eye for 30 seconds.
5. To avoid contamination, do not let the tip of dropper touch your eye or anything else.
6. Replace and tighten the cap straight after use.

 OVERDOSE

Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product, nor in the event of accidental ingestion of the contents of one bottle.

CONTRAINDICATION

Hypersensitivity to the active substance, Hypromellose or to any of the excipients.

 WARNING AND PRECAUTIONS

• It is not for injection.
• Do not use the eye drop with contact lenses.
• May cause transient mild stinging or temporary blurred vision. If irritation persists or worsens, or headache, eye pain, vision changes or continued redness occur, patients should discontinue use and consult a physician or pharmacist.
• Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.

 FERTILITY, PREGNANCY AND LACTATION

Fertility

Studies have not been performed to evaluate the effect of topical ocular administration of Hypromellose on fertility. Hypromellose is a pharmacologically inert compound and it would not be expected to have any effect on fertility.

Pregnancy

There are no or limited amount of data from the use of ophthalmic Hypromellose in pregnant women. Systemic exposure to Hypromellose following topical ocular administration is negligible and the product has no pharmacological properties.

Lactation

It is unknown whether topical Hypromellose/metabolites are excreted in human milk. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding women to Hypromellose is negligible. In addition to this, Hypromellose is pharmacologically inert.

DRUG INTERACTION

Hypromellose prolongs the contact time of topically applied drugs commonly used in ophthalmology.

ADVERSE EFFECTS

Transient mild stinging or vision blurred, eye pain, foreign body sensation in eyes, eye irritation, ocular hyperaemia.

 PRESENTATION

NEOTEAR Eye Drops are supplied in 5 ml sterilized opaque plastic container with nozzle and cap

 STORAGE AND OTHER INFORMATION

Store at temperature below 30 °C. Keep this medicine out of the sight and reach of children. Do not touch the dropper tip or other dispensing tip to any surface since this may contaminate the solution. Use the solution within one month after opening the container.

 

 

 

 

NEOTEAR Eye Drop