openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 2 matching rows.
warnings
WARNINGS Overdose in children may produce profound sedation. This may be accompanied by profuse sweating, hypotension or even shock (See " Overdosage "). General Avoid doses greater or more frequent than those recommended below. Excessive dosage in children may, on rare occasions, cause severe drowsiness. Profuse sweating may accompany this effect. Overdosage may also cause marked hypotension or even shock. Use cautiously in patients with cardiovascular disease (e.g., coronary artery disease, hypertension), and metabolic-endocrine diseases (e.g., hyperthyroidism, diabetes). Information for Patients Patients should be advised to follow the prescribed dosage regimen. The spray should be administered with the head held upright. To spray, squeeze bottle quickly and firmly and sniff briskly. Instillation of the nose drops can be most conveniently accomplished with the patient in the lateral head-low position. Drug Interactions DRUG EFFECT Monoamine Oxidase (MAO) Inhibitors Hypertension Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Tyzine ® . It is also not known whether Tyzine ® Nasal Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tyzine ® Nasal Solution should be given to a pregnant woman only if clearly needed. 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.
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.