Naphazoline Hydrochloride

Naphazoline hydrochloride ophthalmic solutions should be protected from light and should be stored in tight, light-resistant containers. The drug is degraded in the presence of aluminum and, therefore, should not be stored in aluminum containers. ... Fixed combinations containing naphazoline hydrochloride and antazoline phosphate should be stored at temperatures less than 25 °C.

SRP: At the time of review, criteria for land treatment or burial (sanitary landfill) disposal practices are subject to significant revision. Prior to implementing land disposal of waste residue (including waste sludge), consult with environmental regulatory agencies for guidance on acceptable disposal practices.

Patients being treated with monoamine oxidase (MAO) inhibitors may experience a severe hypertensive reaction if administered with a sympathomimetic drug. Although this reaction has not specifically been reported with naphazoline, the possibility of such an interaction should be considered.

Concurrent use of maprotiline or tricyclic antidepressants with naphazoline hydrochloride may potentiate the pressor effects of naphazoline.

PENTOBARBITONE APPEARS TO ENHANCE HYPOTENSIVE ACTION OF ALPHA-SYMPATHOMIMETIC DRUGS, INCL NAPHAZOLINE HYDROCHLORIDE.

/SIGNS AND SYMPTOMS/ Overdosage of the drug may produce drowsiness, decreased body temperature, bradycardia, shock-like hypotension, and coma.

/SIGNS AND SYMPTOMS/ Excessive dosage of topically applied naphazoline hydrochloride may cause marked sedation in children, and, if severe, symptomatic and supportive therapy should be initiated. One manufacturer states that 0.1% naphazoline hydrochloride ophthalmic solution is contraindicated in infants and children, since CNS depression possibly progressing to coma and hypothermia may occur in children, especially infants.

/SIGNS AND SYMPTOMS/ Naphazoline, a sympathomimetic and an imidazoline derivative, is used as 0.05-0.1% solution for local decongestion of the nasal and ocular mucosa. In excessive dosage, or if ingested by accident, may cause depression of the central nervous system (disturbances of consciousness progressing to coma), hypothermia, bradycardia and sweating. These naphazoline effects are particularly strongly pronounced in children. Anglo-Saxon pharmacotherapy excludes the application of naphazoline nasal drops in children younger than six years, whereas the Croatian pharmacotherapeutic literature (and practice) allows its use even in infancy. At the Kantrida Pediatric Clinic, Clinical Hospital Center in Rijeka, 11 children with signs of intoxication with naphazoline nasal drops were hospitalized from 1990 to 1992. The symptoms pertaining to the central nervous system i.e. disturbances of consciousness in the form of somnolence were clearly marked in all children. Some children developed skin pallor, bradycardia, bradypnoea and hypothermia. Resolution occurred within 24 hours and the findings returned to normal values. Clinical picture followed by rapid resolution and normal findings, with a personal history of drug taking, is a safe indication for diagnosis. There are several reasons to account for intoxication (drops difficult to use with children, containers inadequate for proper dosage), but the major factor is the age of the patient--all hospitalized children were younger than six years.

/SIGNS AND SYMPTOMS/ It is reported that many accidental poisonings in Japan are the result of ingestion of dermatologic preparations containing naphazoline hydrochloride; symptoms include somnolence, elevation of blood pressure, and bradycardia.

For more Human Toxicity Excerpts (Complete) data for NAPHAZOLINE HYDROCHLORIDE (11 total), please visit the HSDB record page.

/OTHER TOXICITY INFORMATION/ In dogs, signs of intoxication may include vomiting, bradycardia, cardiac arrhythmias, poor capillary refill time, hypotension or hypertension, panting, increased upper respiratory sounds, depression, weakness, nervousness, hyperactivity, or shaking. These signs appear within 30 min to 4 hr postexposure. In general, imidazoline decongestant exposure may affect the GI, cardiopulmonary, and nervous systems. /Imidazoline decongestions/

Patients with glaucoma should be advised not to use naphazoline hydrochloride ophthalmic solutions except under the advice and supervision of a physician. Ophthalmic solutions of the drug should not be used in patients with angle-closure glaucoma.

One manufacturer states that 0.1% naphazoline hydrochloride ophthalmic solution is contraindicated in infants and children, since CNS depression possibly progressing to coma and hypothermia may occur in children, especially infants.

Naphazoline hydrochloride ophthalmic solution should be used with caution in patients with hypertension, cardiovascular abnormalities, diabetes mellitus, hyperthyroidism, ... .

/VET:/ Decontamination may not be practical due to the rapid absorption and onset of clinical signs. Heart rate and rhythm and blood pressure should be assessed, and an ECG obtained if needed. IV fluids should be given, along with atropine at 0.02 mg/kg, IV, if bradycardia is present. Diazepam (0.25-0.5 mg/kg, IV) can be given if CNS signs (eg, apprehension, shaking) are present. Serum electrolytes (ie, potassium, sodium, chloride) should be assessed and corrected as needed. Yohimbine, which is a specific a2-adrenergic antagonist, can also be used at 0.1 mg/kg, IV, and repeated in 2-3 hr if needed. /Imidazoline decongestants/

No specific antidote is available but a symptomatic drug therapy with intravenous administration of phentolamine, an alpha-adrenoceptor antagonist acts against the vasoconstrictive side effects. Because of the serious side effects and the narrow therapeutic to toxic window of naphazoline a strict observance of guidelines and contradictions, such as maximum dose, is necessary.

Nasal decongestant active ingredients. The active ingredient of the product consists of any of the following when used within the dosage limits and in the dosage forms established for each ingredient: ... Topical nasal decongestants: naphazoline hydrochloride.

Ophthalmic vasoconstrictors. The active ingredient of the product consists of one of the following, within the established concentration for each ingredient: ... Naphazoline hydrochloride, 0.01 to 0.03 percent.

The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies currently marketed prescription and over-the-counter drug products, incl naphazoline hydrochloride, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act.