Celsus Naphazoline HCl + Pheniramine Maleate Ophthalmic Solution

Naphazoline hydrochloride, pheniramine maleate.

Naphazoline Hydrochloride: The hydrochloride salt form of naphazoline, an imidazole derivative and a direct-acting sympathomimetic amine with vasoconstrictive properties. Upon ocular administration, Naphazoline hydrochloride exerts its effect by acting on alpha-adrenergic receptors in the arterioles of the conjunctiva to produce vasoconstriction, resulting in decreased conjunctival congestion and diminished itching, irritation, and redness.
Pheniramine Maleate: The maleate salt form of pheniramine, an alkylamine derivative with antihistaminic and vasodilatory properties. Pheniramine maleate binds to histamine H1 receptors, thereby inhibiting phospholipids A2 and production of endothelium-derived relaxing factor, nitric oxide. Subsequent lack of activation of gauntly cycles through nitric oxide results in decreased cyclic GMP camp levels, thereby inhibiting constriction of smooth muscle tissue, and decreased capillary permeability and histamine-activated allergic reactions.
Each mL of solution contains: Naphazoline (as HCl) 0.1 mg; Pheniramine (as maleate) 2.2 mg.
Excipients/Inactive Ingredients: Boric Acid, Sodium Chloride, Potassium Chloride, Edetate Sodium, Purified Water.
Preservative: 0.01% Benzalkonium Chloride.

Pharmacology: Pharmacokinetics: Systemic absorption has been reported after topical use of solutions of Naphazoline Hydrochloride and Pheniramine Maleate. It is not given systematically, but it is readily absorbed from the gastrointestinal tract. Naphazoline hydrochloride and Pheniramine maleate instilled into the eye causes conjunctival vasoconstriction within 10 minutes and effects can last up to 6 hours.

For the treatment of allergic or inflammatory ocular conditions accompanied by itchiness and relief of ocular congestion or redness and other ocular irritations.

Apply 1 to 2 drops in the affected eye up to 4 times a day.

Narrow angle glaucoma, benign prostatic hyperplasia, cardiovascular diseases, and diabetes mellitus.

When using this product, pupils may become enlarged temporarily. Overuse may cause more redness of the eye(s). If the patient is sensitive to any ingredient in this product, do not use.
Do not use this product if the patient has heart disease, high blood pressure, narrow angle glaucoma or trouble urinating unless directed by a physician.
Accidental swallowing by infants and children may lead to coma and marked reduction in body temperature. Before using in children under 6 years of age, consult the physician.
If swallowed, get medical help right away. Remove contact lenses before using.

Dilation of pupil, increased intraocular pressure, mydriasis.

Increased pressure effects with maprotiline or TCA. Possibility of severe hypertensive reaction with MAOI.
Narrow Angle Glaucoma: The agents stimulate both alpha-1 and alpha-2 adrenergic receptors that can increase intraocular pressure.
Benign Prostatic Hyperplasia: Urinary difficulty may develop or worsen smooth muscle contraction in the bladder neck via stimulation of alpha-1 adrenergic receptors.
Cardiovascular Disease: These agents may produce positive chronotropic and inotropic effects via stimulation of beta-1 adrenergic receptors, possibility to severe hypertensive reaction.
Diabetes Mellitus: May occur slight increases in blood glucose concentrations.

Directions For Use: To apply eye drops, wash the hands first. To avoid contamination, be careful not to touch the dropper or let it touch the eye. Tilt the head back, gaze upward and pull down the lower eyelid to make a pouch. Place dropper directly over eye and administer the prescribed number of drops. Look downward and gently close the eye for 1 to 2 minutes. Place one finger at the corner of the eye near the nose and apply gentle pressure. This will prevent the medication from draining away from the eye. Try not to blink and do not rub the eye. Do not rinse the dropper. If patient is using another kind of eye drop, wait at least minutes before applying other eye medications.

Store at temperature not exceeding 30°C. Keep away from sunlight and moisture. Do not freeze.

Ophthalmic Decongestants, Anesthetics, Anti-Inflammatories

S01GA51 - naphazoline, combinations ; Belongs to the class of sympathomimetics used as ophthalmologic decongestants.

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