10 ML

DUCIDROP

Hypromellose Ophthalmic Solution USP 0.3% w/v.

It is indicated for temporary relief of discomfort due to minor irritation of the eye from exposure to wind, sun or other irritants, for use as a protectant against further irritation and to relieve dryness of the eyes.

Composition:

Each ml contains:
Hydroxypropyl Methylcellulose IP 3.0 mg
Sodium Perborate BP 0.028% w/v (As preservative)
Aqueous Buffered Vehicle q.s.

Inactive ingredients: Dextran 70 USP, Glycerin, Polysorbate 80 IP, Sodium Chloride IP, Boric Acid IP, Calcium Chloride IP, Potassium Chloride IP, Magnesium Chloride IP, Zinc Chloride IP.

Pharmaceutical Form:

Ophthalmic Solution

Therapeutic Indication:

Temporary relief of discomfort due to minor irritation of the eye from exposure to wind, sun or other irritants, protectant against further irritation and relief from dryness of the eyes.

Dosage & Administration:

Adults, children and elderly: 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.

If more than one topical ophthalmic product is being used, the products should be administered at least 5 to 15 minutes apart.

Contraindication:

It is contraindicated in patients with a known hypersensitivity to the active substance, hypromellose or to any of the excipients.

Storage:

Store at temperature not exceeding 25°C, protected from light.

Adverse events which have been associated with Hypromellose are given below, listed by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

The following adverse reactions have been reported following administration of Hypromellose:

Eye disorders: Not known: transient mild stinging or vision blurred, eye pain, foreign body sensation in eyes, eye irritation, and ocular hyperaemia.

May cause transient mild stinging or temporary blurred vision.
If irritation persists or worsens, discontinue use and consult physician.
Remove contact lenses before use.
Reinsert lenses after 15 minutes.
Avoid touching bottle tip to eyes or surrounding surfaces.
Keep bottle tightly closed when not in use.
Shake bottle well before use.
Keep out of reach of children.

Drug Interactions:

Hydroxypropyl methylcellulose or hypromellose prolongs the contact time of topically applied drugs commonly used in ophthalmology.

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.

Nursing Mothers:

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.

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.

Effects on Ability to Drive And Use Machines:

This may cause blurring of vision on instillation, which may impair the ability to drive or to use machinery. The patient should wait until these symptoms have cleared before driving or operating machinery.

Overdose:

Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product. It is not systemically absorbed.

Pharmacological Properties:

Pharmacodynamic properties
Pharmacotherapeutic Group: Ophthalmologicals: other ophthalmologicals.

Hydroxypropyl methylcellulose or Hypromellose is a soothing emollient solution with properties and uses similar to those of methylcellulose. Its advantages over methylcellulose are that mucilages of hypromellose have greater clarity and fewer undispersed fibres 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.

Pharmacokinetic:

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

Incompatibilities:

Not known.

Packing Information:

Ducidrop Eye Drops available in a 10 ml pack.