Class: Vasoconstrictors
VA Class: NT100
CAS Number: 522-48-5
Brands: Murine Plus, Optigene 3, Tyzine, Visine, Visine A.C.
Introduction
Vasoconstrictor; an imidazoline-derivative sympathomimetic amine.101 a
Uses for Tetrahydrozoline Hydrochloride
Nasal Congestion
Temporary relief of nasal congestion.101 a
As effective as other topical vasoconstrictors.a
Nasal decongestants often preferred for short-term treatment; oral agents preferred for prolonged treatment.a (See Overuse under Cautions.)
Reduce swelling and facilitate visualization of nasal and pharyngeal membranes prior to surgery or diagnostic procedures.a
Open obstructed eustachian ostia in ear inflammation.a
Conjunctival Congestion
Temporary relief of conjunctival congestion, itching, and minor irritation.102 a
Used alone or in fixed combination with astringents (i.e., zinc sulfate).a c
Controls hyperemia in patients with superficial corneal vascularity.a
Ineffective in the treatment of delayed hypersensitivity reactions such as contact dermatoconjunctivitis.a
Used for vasoconstrictor effect during some ocular diagnostic procedures; phenylephrine may be preferred.a
Tetrahydrozoline Hydrochloride Dosage and Administration
Administration
Apply topically to nasal mucosa 101 a or to conjunctiva.102 a c
Avoid contamination of the dropper tip or spray dispenser.102 a c
Intranasal Administration
Apply topically to the nasal mucosa as drops or spray.101 a
Nasal sprays preferable due to a decreased risk of swallowing the drug and resultant systemic absorption; however, drops are easier to administer to young children.a
Apply nasal drops to the dependent (lower) nostril with the patient in a lateral, head-low position.101 a Remain in the same position for 5 minutes, then apply drops to the other nostril in a similar manner.a Alternatively, instill drops while in a reclining position, with head tilted back as far as possible.a
Administer nasal spray into each nostril while head is erect.101 a Squeeze bottle quickly and firmly and sniff briskly;101 blow nose thoroughly after 3–5 minutes.a
Rinse tips of dispensers or droppers thoroughly with hot water following use.a
Ophthalmic Administration
Apply ophthalmic solution topically to the conjunctiva.a
Remove contact lenses before administering ophthalmic solution;102 c wait ≥15 minutes to reinsert contact lenses.b
Do not administer discolored or cloudy solution.102 c
Dosage
Available as tetrahydrozoline hydrochloride; dosage expressed in terms of the salt.a
Pediatric Patients
Nasal Congestion
Intranasal
Children 2–5 years of age: 2–3 drops of a 0.05% solution in each nostril every 3–6 hours (typically 4–6 hours) as needed.101
Children ≥6 years of age: 2–4 drops or 3–4 sprays of a 0.1% solution in each nostril every 3–8 hours (typically 4–8 hours) as needed.101
Conjunctival Congestion
Ophthalmic
Children ≥6 years of age: 1–2 drops of a 0.05% ophthalmic solution in the affected eye(s) up to 4 times daily.102 a c
Adults
Nasal Congestion
Intranasal
2–4 drops or 3–4 sprays of 0.1% solution in each nostril every 3–8 hours (typically 4–8 hours) as needed.101 a
Conjunctival Congestion
Ophthalmic
1–2 drops of a 0.05% ophthalmic solution in the affected eye(s) up to 4 times daily.102 a c
Prescribing Limits
Pediatric Patients
Nasal Congestion
Intranasal
Maximum of every 3 hours;101 a maximum duration of 3–5 days.a
Conjunctival Congestion
Ophthalmic
For self-medication: Maximum of 4 times daily; maximum duration of 3–4 days, unless directed by a clinician.102 a
Adults
Nasal Congestion
Intranasal
Maximum of every 3 hours;101 a maximum duration 3–5 days.a
Conjunctival Congestion
Ophthalmic
For self-medication: Maximum of 4 times daily; maximum duration of 3–4 days, unless directed by a clinician.102 a
Special Populations
No special population dosage recommendations at this time.a
Cautions for Tetrahydrozoline Hydrochloride
Contraindications
Known hypersensitivity to tetrahydrozoline or any ingredient in the formulation.101 a
Nasal solution: Use in infants <2 years of age.101 a
Nasal solution: Use of 0.1% solution in children <6 years of age.101 a
Nasal solution: Concomitant use of MAO inhibitors.101 (See Specific Drugs under Interactions.)
Warnings/Precautions
Warnings
Glaucoma
Patients with narrow-angle glaucoma or other serious eye disease should consult a clinician before using ophthalmic solution.102 a c
General Precautions
Overuse
Possible irritation of nasal mucosa or conjunctiva and adverse systemic effects (particularly in children) with excessive dosage and/or prolonged or too frequent use.a Possible rebound congestion (rhinitis, chronic redness, and swelling of the nasal mucosa) or ocular hyperemia (redness); avoid prolonged use.101 102 a c (See Advice to Patients.)
Overdose in children may produce profound sedation, profuse sweating, hypotension, and/or shock.101
High concentrations of ophthalmic solution may liberate pigment granules; more common in the elderly.a
Sympathomimetic Effects
Possible headache, hypertension, weakness, sweating, cardiac irregularities (e.g., palpitations), tremors, drowsiness, lightheadedness, and insomnia.101 a Use with caution in patients with thyroid disease (e.g., hyperthyroidism), heart disease (e.g., coronary artery disease), hypertension, or diabetes mellitus.101 a
Use of Fixed Combinations
When used in fixed combination with astringents (i.e., zinc sulfate), consider the cautions, precautions, and contraindications associated with the concomitant drug.c
Specific Populations
Pregnancy
Category C.101
Lactation
Not known whether tetrahydrozoline is distributed into milk.101 a Caution if used in nursing women.101 a
Pediatric Use
Safety and efficacy of 0.05% nasal solution not established in children <2 years of age;101 safety and efficacy of 0.1% nasal solution not established in children <6 years of age.101
Safety and efficacy of ophthalmic solution not established in children <6 years of age.102
Common Adverse Effects
Intranasal: Mucosal burning, stinging, dryness, sneezing.101 a
Ophthalmic: Blurred vision, irritation, mydriasis.a
Interactions for Tetrahydrozoline Hydrochloride
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
MAO Inhibitors | Nasal solution: possible severe hypertensive reaction101 | Concomitant use contraindicated101 |
Tetrahydrozoline Hydrochloride Pharmacokinetics
Absorption
Bioavailability
Absorption may occasionally be sufficient to produce systemic effects.a
Onset
Following intranasal or ocular administration, local vasoconstriction usually occurs within minutes.a
Duration
Local vasoconstriction may persist for 4–8 hours.a
Stability
Storage
Nasal
Solution
Tight containersa at <30°C.101
Ophthalmic
Solution
Tight containersa at 15–25°C.102 a c
ActionsActions
Structurally and pharmacologically related to naphazoline, oxymetazoline, and xylometazoline.a
Directly stimulates α-adrenergic receptors; exerts little or no effect on β-adrenergic receptors.a
Intranasal application constricts dilated arterioles, reduces nasal blood flow and congestion, and may open obstructed eustachian ostia.101 a Temporarily improves nasal ventilation.a
Conjunctival application constricts small arterioles and temporarily relieves conjunctival congestion.a
Advice to Patients
With intranasal use, importance of discontinuing drug and consulting a clinician if nasal congestion worsens or persists for >3–5 days.a
With ophthalmic use, importance of discontinuing drug and consulting a clinician if ocular pain or visual changes occur or if ocular redness or irritation worsens or persists for >72 hours.102 a c
Overuse of nasal solution may cause recurrence or exacerbation of nasal congestion; overuse of ophthalmic solution may produce increased redness of the eye. 101 a
Importance of removing contact lenses prior to administration of ophthalmic solution; wait ≥15 minutes after instillation to replace lenses.102 b
Importance of avoiding contamination of the dropper or spray dispenser.102 a c Do not touch dropper tip to any surface;102 c rinse nasal spray dispenser tip with hot water.a To minimize risk of spreading infections, do not share dropper or spray dispenser with other individuals.a
Advise patients not to use ophthalmic solution if solution is cloudy.102 c
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.101
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.101 102 c
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Nasal | Solution | 0.05% | Tyzine (with benzalkonium chloride; drops) | Kenwood |
0.1% | Tyzine (with benzalkonium chloride; drops and spray) | Kenwood | ||
Ophthalmic | Solution | 0.05%* | Murine Plus (with benzalkonium chloride and povidone) | Prestige Brands |
Optigene 3 (with benzalkonium chloride and glycerin) | Pfeiffer | |||
Tetrahydrozoline Hydrochloride Eye Drops (with benzalkonium chloride) | Rugby | |||
Visine (with benzalkonium chloride) | McNeil | |||
Visine Advanced Relief (with benzalkonium chloride and povidone) | McNeil |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Solution | 0.05% with Zinc Sulfate 0.25% | Visine A.C. (with benzalkonium chloride) | McNeil |
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
References
Only references cited for selected revisions after 1984 are available electronically.
101. Tyzine (tetrahydrozoline hydrochloride) nasal solution prescribing information. Fairfield, NJ; 1999 Apr.
102. Pfizer. Visine (tetrahydrozoline hydrochloride 0.05%) product information. From Pfizer Visine website (). Accessed 2006 Oct 25.
a. AHFS drug information 2007. McEvoy GK, ed. Tetrahydrozoline hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2868-9.
b. McNeil-PPC, Inc. Frequently asked questions. Available at: . Accessed 2007 Nov 29.
c. McNeil-PPC, Inc. Visine A.C. (tetrahydrozoline hydrochloride 0.05% and zinc sulfate 0.25%) product information. From McNeil Visine website (. Accessed 2007 Nov 21.
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