Nafcela

Therapeutic action

Decongestant for local ophthalmic application.

Indications

Nafcela is indicated for temporary relief from eye irritations caused by dust, environmental pollution, pool water, sun, prolonged use of computers and prolonged reading stages. Nafcela produces relief from conjunctival hyperemia, photophobia, blepharospasm, tearing and itching, leaving a refreshing feeling of relief without dry eyes.

Pharmacokinetics and pharmacodynamics in humans

Nafazolin belongs to the imidazoline family of sympathomimetics. It is a vasoconstrictor for local ophthalmic application. Its effect is due to the direct stimulation of alpha adrenergic receptors in the arterioles of the conjunctiva, resulting in a decrease in conjunctival congestion. In the case of Nafazolin, absorption after instillation is acceptable at the conjunctiva level, tear protein binding is reduced, and metabolism is established at the level of tear proteins and tissue enzymes.

Nafazolin constricts the dilated vascular system of the conjunctiva; the initial action occurs in less than 10 minutes and lasts from 2 to 6 hours.

Hypromellose maintains moisture and lubrication of the ocular surface, forming a stable and uniform film on the cornea and conjunctiva, avoiding the formation of dry spots. Provides the patient with a refreshing feeling of relief. Occasionally, a systemic distribution of this preparation may occur, through absorption by the nasal mucosa, or by transcorneal / transconjunctival absorption. The route of elimination of ocular drugs is not known with certainty and it is presumed that it may occur via the liver and / or kidneys after systemic absorption.


Drug and other interactions

Concomitant use with Naproline or tricyclic antidepressants and Nafazolin may potentiate the pressor effect of Nafazolin. Patients treated with MAO inhibitors may experience severe hypertensive crisis if they receive a sympathomimetic agent. Topically applied hypromellose is not known to cause drug interactions and can be administered concomitantly with antibiotics, steroids, and antiglaucomatous drugs. It increases the contact time of the medicines with the ocular tissues. No changes in laboratory tests caused by hypromellose have been reported.

Contraindications

Narrow-angle glaucoma. Hypersensitivity to the components of the formula.


Composition

Each ml contains:

Nafazolin Hydrochloride 1mg

Hypromellose 5mg

Excipients and purified water C.S.P. 1ml

Posology and administration

 

Administration route: Ophthalmic.

Adults: Two drops four times a day.

Children under 12 years: one drop three times a day.

Storage recommendations

Store at a temperature between 15 °C and 25 °C. Protect  from freezing.

 

Presentation

Dropper bottle with 15 ml of solution.

Precautions or restrictions on use during pregnancy and lactation

Its use in pregnant women is recommended only if it is considered strictly necessary. It is unknown whether nafazolin is excreted in human milk.

Side Effects

 

The following adverse reactions may occur: pupil dilation, increased intraocular pressure, and systemic effects due to drug absorption (eg, hypertension, cardiac abnormalities, hyperglycemia). Drowsiness may occur in some of the patients.

Laboratory test abnormalities

None known.