Tetrahydrozoline Nasal

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using tetrahydrozoline nasal and call your doctor at once if you have:

• ongoing or worsening symptoms;
• severe burning or stinging in your nose after using the nasal spray;
• pounding heartbeats or fluttering in your chest;
• slow heartbeats; or
• severe headache, buzzing in your ears, anxiety, confusion, or feeling short of breath.

Common side effects may include:

• mild burning or stinging of the nose;
• sneezing; or
• dryness of your nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• It is used to treat nose stuffiness.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure, a fast heartbeat, or passing out.
• A heartbeat that does not feel normal.
• Shakiness.
• Very bad headache.
• Very bad dizziness.
• Pale skin.
• Sweating a lot.
• Feeling sleepy.
• Feeling very tired or weak.
• Not able to sleep.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Do not use if solution changes color.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take tetrahydrozoline or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to tetrahydrozoline. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Stimulates alpha-adrenergic receptors in the arterioles of the nasal mucosa to produce vasoconstriction

Nasal congestion: Intranasal: Instill 2-4 drops or 3-4 sprays of 0.1% solution into each nostril every 3-4 hours as needed, no more frequently than every 3 hours

Blood pressure, heart rate, symptom response

Animal reproduction studies have not been conducted.

Applies to tetrahydrozoline nasal: nasal solution, nasal spray

Respiratory

Rhinitis medicamentosa (RM) is attributed to chronic swelling of the nasal mucosa resulting in redness, swelling, and rhinitis. RM has been reported after too frequent, prolonged, or excessive doses. Treatment consists of gradual or abrupt withdrawal of therapy and substituting an orally administered decongestant in the interim (if indicated and appropriate).[Ref]

Respiratory side effects have included rhinitis medicamentosa (rebound nasal congestion), transient burning, stinging, or dryness of the mucosa, and sneezing.[Ref]

Nervous system

Nervous system side effects have included headache, weakness, drowsiness, tremors, light-headedness, insomnia, and sweating. Overdosage has resulted in drowsiness in adults.[Ref]

Cardiovascular

Cardiovascular side effects have included palpitations. Overdosage has resulted in hypertension, bradycardia, rebound hypotension, and a shock-like syndrome.[Ref]

Local

Local side effects have included transient burning, stinging, or dryness of the mucosa, and sneezing.[Ref]

Some side effects of tetrahydrozoline nasal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.