Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 30 January 2017

Indication(s)

INDICATIONS AND USAGE Tyzine® Nasal Solution is indicated for decongestion of nasal and nasopharyngeal mucosa.

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Advisory information

contraindications

CONTRAINDICATIONS Tyzine® Nasal Solution is contraindicated for patients who have shown previous hypersensitivity to its components.

The 0.1 % solution is contraindicated in children under six years of age.

Tyzine® Nasal Solution is not to be used for infants under two years of age.

Tyzine® Pediatric Nasal Drops (0.05 %) should be used for children between the ages of 2 and 6 years (See " Dosage and Administration ").

Tyzine® Nasal Solution should not be used by patients under treatment with Monoamine Oxidase (MAO) Inhibitors.

Adverse reactions

ADVERSE REACTIONS Local application of Tyzine® Nasal Solution can be associated with burning, stinging, sneezing or dryness of the mucosa.

Occasionally, systemic sympathomimetic effects can occur, including headaches, drowsiness, weakness, tremors, light-headedness, insomnia, and palpitations.

Rebound congestion can also occur, and is characterized by chronic swelling of the nasal mucosa resulting in chronic redness, swelling and rhinitis.

If adverse reactions occur, discontinue use.

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION Adults and Children 6 Years and Over Tyzine® 0.1 % Nasal Solution It is recommended that 2 to 4 drops of Tyzine® 0.1 % Nasal Solution be instilled in each nostril as needed, never more often than every three hours.

Less frequent administration is usually sufficient since relief is maintained for four hours or longer in most cases, and often for as long as eight hours.

Bedtime instillation usually assures sleep undisturbed by the need for remedication before morning, or by insomnia from central stimulation.

Tyzine® 0.1 % Nasal Spray It is recommended to squeeze quickly and firmly three or four times Tyzine® 0.1 % Nasal Spray in each nostril as needed, never more often than every three hours.

Less frequent administration is usually sufficient since relief is maintained for four hours or longer in most cases, and often for as long as eight hours.

Bedtime instillation usually assures sleep undisturbed by the need for remedication before morning, or by insomnia from central stimulation.

Children 2 to 6 Years of Age Tyzine® 0.05 % Pediatric Nasal Drops Note:

Do not use Tyzine® 0.1 % Nasal Solution or Tyzine® 0.1 % Nasal Spray It is recommended that 2 to 3 drops of Tyzine® 0.05 % Pediatric Nasal Drops be instilled in each nostril as needed, and never more often than every three hours.

Relief usually lasts for several hours, so that instillation is usually needed only every four to six hours.

Instillation of nose drops can be most conveniently accomplished with the patient in the lateral head-low position.

Pregnancy and lactation
Nursing Mothers It is not known whether this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Tyzine® Nasal Solution is administered to a nursing woman.

Interactions

Drug Interactions DRUG EFFECT Monoamine Oxidase (MAO) Inhibitors Hypertension

More information

Category Value
Authorisation number ANDA086576
Orphan designation No
Product NDC 10337-477,10337-476
Date Last Revised 25-09-2013
Type HUMAN PRESCRIPTION DRUG
RXCUI 1232718
Storage and handling Recommended Storage Store below 86°F (30°C).
Marketing authorisation holder PharmaDerm A division of Fougera Pharmaceuticals Inc.