What is Afrin

Afrin nasal spray is used for the temporary relief of nasal congestion associated with acute and chronic rhinitis or stuffiness caused by hay fever or other allergies and common colds. Afrin is also used to relieve sinus congestion and pressure. Afrin active ingredient is called Oxymetazoline hydrochloride. Afrin (Oxymetazoline) nasal spray should not be used to treat children younger than 6 years of age unless it is recommended by a doctor. Children 6 to 12 years of age should only use Afrin (Oxymetazoline) nasal spray carefully and under adult supervision.

Afrin (Oxymetazoline) may also be used for other conditions as determined by your doctor.

Afrin (Oxymetazoline) is available without a prescription.

Afrin Nasal Spray

• Active ingredients: Oxymetazoline hydrochloride 0.05%
• Inactive ingredients: benzalkonium chloride solution, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Afrin Pump Mist

• Active ingredients: Oxymetazoline hydrochloride 0.05%
• Inactive ingredients: benzalkonium chloride solution, benzyl alcohol, edetate disodium, flavor, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Afrin Uses

• Temporarily relieves nasal congestion due to:
  • the common cold
  • hay fever
  • upper respiratory allergies
• Temporarily relieves sinus congestion and pressure
• Helps clear nasal passages
• Shrinks swollen membranes so you can breathe more freely

Afrin (Oxymetazoline) is available in the following dosage forms:

• Nasal Pump Mist
• Nasal Spray

Directions of use

• Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• Children under 6 years of age: Ask a doctor

To use Afrin Pump Mist:

• Shake well before use. Hold white tabs, press grooved area of cap firmly and turn counter clockwise. Before using the first time, prime metered pump by
  depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Secure cap after use.

To use Afrin Nasal Spray:

• Push firmly down on cap and turn counter clockwise.
• Place tip of nozzle just past nasal opening (approximately 1/8″)
• To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying.
• Sniff deeply.
• Wipe nozzle clean after use
• Secure cap after use.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

How does Afrin work?

Afrin (Oxymetazoline) is a selective α_2A-adrenergic receptor agonist a sympathomimetic amine in a class of medications called nasal decongestants. It is used as a topical vasoconstrictor. Afrin (Oxymetazoline) works by narrowing the blood vessels (vasoconstriction) in the nasal passages, thus decreasing nasal blood flow and nasal congestion.

Before using Afrin – Precautions

• tell your doctor and pharmacist if you are allergic to Afrin (Oxymetazoline), or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate).
• Afrin (Oxymetazoline) is contra-indicated with monoamine oxidase inhibitor (MAOI) medicine used for the treatment of depression
• tell your doctor if you have or have ever had high blood pressure, diabetes, difficulty urinating due to an enlarged prostate gland, or thyroid or heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using Afrin (Oxymetazoline) nasal spray, call your doctor.

Pediatric patients

Children may be especially sensitive to the effects of Afrin (Oxymetazoline). This may increase the chance of side effects during treatment.

Geriatric patients

Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information about the use of Afrin (Oxymetazoline) in the elderly.

Afrin and Pregnancy

Safe use of Afrin (Oxymetazoline) during pregnancy has not been established. Oxymetazoline hydrochloride ophthalmic or nasal solutions should be used during pregnancy only when instructed by a clinician ¹⁾.

• The effects of repeated use of Afrin (Oxymetazoline) nasal spray in a 20-yr-old woman, with uncomplicated pregnancy, resulting in nonreactive nonstress test, late decelerations and fetal heart rate abnormalities, were reported ²⁾.
• This investigation ³⁾ studied the effects of Afrin (Oxymetazoline) on the maternal and fetal circulations. Twelve healthy gravid patients in the third trimester (27-39 weeks) underwent flow velocity measurements by the same sonographer using a pulsed Doppler system (ATL Ultramark 4 machine). Maternal and fetal indices were recorded 15 min before dosing, immediately thereafter, and at 15 min intervals during the first 2 hr after the drug was given. No significant changes were found in either the maternal blood pressures or pulse rates. Blood flow velocities did not change significantly from baseline for the uterine arcuate artery, fetal aorta, or umbilical artery circulations. In no case did absolute blood flow velocity decrease significantly or systolic/diastolic ratios elevate to worrisome values. For uncomplicated pregnancies, it was concluded there are no significant acute changes in the maternal and fetal circulations after a single dose of intranasal Afrin (Oxymetazoline) ⁴⁾.

Afrin and Breastfeeding

Although no information exists on the use of Afrin (Oxymetazoline) specifically during breastfeeding, very little should reach the infant through breastmilk because of the local administration and limited absorption into the maternal bloodstream ⁵⁾. It is recommended over oral systemic decongestants such as pseudoephedrine during breastfeeding ⁶⁾. Topical use on the face is unlikely to present a risk to the nursing infant. However, weigh the potential benefits against the potential risks before taking Afrin (Oxymetazoline) while breastfeeding.

• Maternal Drug Levels. Relevant published information was not found.
• Infant Drug Levels. Relevant published information was not found.
• Effects in Breastfed Infants: Relevant published information was not found.
• Effects on Lactation and Breastmilk: Relevant published information was not found.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking Afrin (Oxymetazoline), it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using Afrin (Oxymetazoline) with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Carteolol
• Carvedilol
• Clomipramine
• Desipramine
• Dibenzepin
• Doxepin
• Fentanyl Citrate
• Furazolidone
• Imipramine
• Iproniazid
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Lofepramine
• Melitracen
• Methylene Blue
• Metipranolol
• Moclobemide
• Nadolol
• Nialamide
• Nortriptyline
• Opipramol
• Oxprenolol
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Protriptyline
• Rasagiline
• Safinamide
• Selegiline
• Sotalol
• Tianeptine
• Timolol
• Tranylcypromine
• Trimipramine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Dryness in nose or
• High blood pressure or
• Tachycardia (fast heart rate) or
• Trouble urinating from an enlarged prostate—May make these conditions worse.

How should Afrin be used?

Afrin (Oxymetazoline) nasal spray comes as a solution (liquid) to spray into your nose. Afrin (Oxymetazoline) nasal spray is usually used every 10 to 12 hours as needed, but not more often than twice in a 24-hour period. Follow the directions on the package label or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use Afrin (Oxymetazoline) nasal spray exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor or directed on the label.

If you use Afrin (Oxymetazoline) nasal spray for more often or for longer than the recommended period of time, your congestion may get worse or may improve but come back. Do not use Afrin (Oxymetazoline) nasal spray for longer than 3 days. If your symptoms do not get better after 3 days of treatment, stop using Afrin (Oxymetazoline) and call your doctor.

Afrin (Oxymetazoline) nasal spray is only for use in the nose. Do not swallow the medication.

To prevent the spread of infection, do not share your spray dispenser with anyone else. Rinse the tip of the dispenser with hot water or wipe it clean after you use it.

Follow the directions for using the Afrin (Oxymetazoline) nasal spray that appear on the package label. If you are using a product that comes in a pump dispenser, press down on the rim several times before using your first dose to prime the pump, according to the directions on the label. When you are ready to use the spray, hold your head upright without tilting and place the tip of the bottle in your nostril. For the Afrin (Oxymetazoline) nasal spray, squeeze the bottle quickly and firmly. For products that come in a pump dispenser, press down on the rim with a firm, even stroke and breathe in deeply.

To use Afrin pump mist:

• Shake well before use.
• Hold white tabs, press grooved area of cap firmly and turn counter clockwise.
• Before using the first time, prime metered pump by depressing pump firmly several times.
• To spray, hold bottle with thumb at base and nozzle between first and second fingers.
• Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply.
• Wipe nozzle clean after use.
• Secure cap after use.

Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for longer than 3 days without checking with your doctor. To do so may make your runny or stuffy nose worse and may increase the chance of side effects.

To use Afrin Nasal Spray:

• Push firmly down on cap and turn counter clockwise.
• Place tip of nozzle just past nasal opening (approximately 1/8″)
• To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying.
• Sniff deeply.
• Wipe nozzle clean after use
• Secure cap after use.

Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for longer than 3 days without checking with your doctor. To do so may make your runny or stuffy nose worse and may increase the chance of side effects.

Afrin Dosing

The dose of Afrin (Oxymetazoline) will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of Afrin (Oxymetazoline) that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For Afrin (Oxymetazoline) nasal dosage form (pump mist or nasal spray):

• For nasal congestion or stuffiness:
  • Adults and children 6 years of age and older—Use 2 or 3 drops or sprays of 0.05% solution in each nostril every ten to twelve hours. Do not use more than two times in twenty four hours.
  • Children up to 6 years of age—Use and dose must be determined by your doctor.

What if I forget to take it?

If you miss a dose of Afrin (Oxymetazoline), take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Afrin Nasal Spray

Active ingredients: Oxymetazoline hydrochloride 0.05%

Purpose: Nasal decongestant

Inactive ingredients: benzalkonium chloride solution, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Other information

• store between 20° to 25°C (68° to 77°F)
• retain card for future reference on full labeling
• SAFETY SEALED: Do not use if “Afrin Security Seal” imprinted on bottle is broken or missing

Afrin Nasal Spray Uses

• temporarily relieves nasal congestion due to:
  • the common cold
  • hay fever
  • upper respiratory allergies
• temporarily relieves sinus congestion and pressure
• helps clear nasal passages
• shrinks swollen membranes so you can breathe more freely

Afrin Nasal Spray Warnings

Ask a doctor before use if you have:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

When using this product:

• do not use more than directed
• do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
• temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may result
• use of this container by more than one person may spread infection

Stop use and ask a doctor if symptoms persist

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Afrin Nasal Spray Directions of Use

To use Afrin Nasal Spray:

• Push firmly down on cap and turn counter clockwise.
• Place tip of nozzle just past nasal opening (approximately 1/8″)
• To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying.
• Sniff deeply.
• Wipe nozzle clean after use
• Secure cap after use.

Afrin Nasal Spray Dose

• Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• Children under 6 years of age: Ask a doctor

Afrin Pump Mist

Active ingredients: Oxymetazoline hydrochloride 0.05%

Purpose: Nasal decongestant

Inactive ingredients: benzalkonium chloride solution, benzyl alcohol, edetate disodium, flavor, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Other information

• store between 20° to 25°C (68° to 77°F)
• retain card for future reference on full labeling
• SAFETY SEALED: Do not use if “Afrin Security Seal” imprinted on bottle is broken or missing

Afrin Pump Mist Uses

• temporarily relieves nasal congestion due to:
  • the common cold
  • hay fever
  • upper respiratory allergies
• temporarily relieves sinus congestion and pressure
• helps clear nasal passages
• shrinks swollen membranes so you can breathe more freely

Afrin Pump Mist Warnings

Ask a doctor before use if you have:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

When using this product:

• do not use more than directed
• do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
• temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may result
• use of this container by more than one person may spread infection

Stop use and ask a doctor if symptoms persist

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Afrin Pump Mist Directions of Use

To use pump mist:

• Shake well before use.
• Hold white tabs, press grooved area of cap firmly and turn counter clockwise.
• Before using the first time, prime metered pump by depressing pump firmly several times.
• To spray, hold bottle with thumb at base and nozzle between first and second fingers.
• Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply.
• Wipe nozzle clean after use.
• Secure cap after use.

Afrin Pump Mist Dose

• Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• Children under 6 years of age: Ask a doctor

Afrin side effects

Afrin (Oxymetazoline) may cause side effects.

Common side effects

• Transient burning, stinging, increased nasal discharge
• Dryness inside the nose
• Sneezing
• Difficulty falling asleep or staying asleep
• Rebound congestion with prolonged use (4-5 days)
• Rebound congestion is associated with overuse and may take several weeks to reverse

Tell your doctor if any of these symptoms are severe or do not go away.

Uncommon side effects

• Hypertension
• Nausea
• Nervousness
• Dizziness
• Drowsiness
• Insomnia
• Headache
• CNS (central nervous system) effects are more common in children

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• fast heartbeat
• slow heartbeat

Oxymetazoline nasal spray may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

Human Toxicity Reports

Intranasal use of oxymetazoline may occasionally cause systemic sympathomimetic effects such as hypertension, nervousness, nausea, dizziness, headache, insomnia, palpitation, or reflex bradycardia ⁷⁾.

A total of 307 patients with acute rhinitis entered a study to compare the difference between oxymetazoline with preservative and oxymetazoline without preservative. The treatment with oxymetazoline with preservative and oxymetazoline without preservative and xylometazoline with preservative was evaluated. This randomized, double-blind, multi-centered, tolerance study confirmed that the local sympathomimetics oxymetazoline and xylometazoline are well tolerated in the treatment of acute rhinitis. When evaluated according to the parameters “feeling of dryness in nasal mucosa” and “burning sensation”, a 0.05% spray, which contains the active agent oxymetazoline without preservatives, proved to be considerably superior to preparations containing the preservative benzalkonium chloride ⁸⁾.

A case report of an abrupt withdrawal in a healthy man of oxymetazoline nasal spray precipitated a prolonged panic disorder that required hospitalization with extensive evaluations ⁹⁾.

Excessive dosage and/or prolonged or too frequent intranasal use of oxymetazoline may irritate nasal mucosa and especially in children, cause adverse systemic effects. Excessive dosage or inadvertent ingestion in children may cause profound CNS (central nervous system) depression, possibly necessitating intensive supportive care ¹⁰⁾. CNS depression, shock-like hypotension, and coma have occurred following overdosage of naphazoline and tetrahydrozoline; the possibility that this may occur with oxymetazoline should be considered ¹¹⁾.

In this case report, oxymetazoline nasal spray 0.025% was administered to a 2-year-old patient during general anesthesia for nasal endoscopy. Severe hypertension with reflex bradycardia progressed to sinus arrest and was successfully treated with atropine and cardiopulmonary resuscitation ¹²⁾.

A patient prescribed oxymetazoline hydrochloride nasal drops presented with recurrent ventricular tachycardia of fascicular origin ¹³⁾. Cardiac ultrasound showed a calcified lesion, presumably a fibroma arising from the interventricular septum. Fascicular tachycardia related to the lesion and provoked by the use of a sympathomimetic agent is postulated ¹⁴⁾.

A case of chronic use of nasal oxymetazoline associated with thunderclap headache due to reversible segmental intracranial vasoconstriction is reported ¹⁵⁾. The patient had been using a nasal spray that contains oxymetazoline, regularly for the previous 6 months ¹⁶⁾. Although she was using the medication at recommended daily dosages (2–3 sprays twice daily), she was using it consistently. Two weeks before presentation she had noticed a pattern of headache starting 20 minutes after use of the nasal spray. The event had occurred immediately after its use. Thunderclap headache is a hyperacute, severe headache that is so named because of its sudden onset. It often heralds a serious intracranial vascular event such as subarachnoid hemorrhage, cerebral venous sinus thrombosis or pituitary apoplexy. However, it may also occur spontaneously or in the setting of cerebral vasoconstriction. Narcotic analgesics reduced the pain, but the nausea and vomiting responded to ondansetron only. The patient had no improvement in her headache with nimodipine, a calcium-channel antagonist that causes dilatation of arterial smooth muscle. Two weeks after discharge the headache had nearly resolved. A repeat angiogram at 6 weeks showed complete resolution of most areas of arterial narrowing ¹⁷⁾. This case report illustrates that oxymetazoline can cause reversible segmental cerebral vasoconstriction, resulting in thunderclap headache.

A case report of 43-year-old woman who was evaluated for sequential bilateral vision loss following the use of oxymetazoline nasal spray. Thorough investigation of possible causes causing the bilateral anterior ischemic optic neuropathy was negative. The patient had several predisposing risk factors for ischemic optic neuropathy, including diabetes mellitus, hypertension, and crowded optic nerve heads. Before each acute optic neuropathy, the patient used two to three puffs of oxymetazoline nasal spray ¹⁸⁾.

A case report of a young, otherwise healthy man presented with an acute retinal artery obstruction following excessive use of oxymethazolone hydrochloride 0.5% nasal spray ¹⁹⁾. Platelet coagulation studies indicated a platelet aggregation hypersensitivity to adenosine diphosphate and epinephrine. A predisposition for sympathomimetic drug-induced platelet fibrin embolus formation appears to be the cause of the retinal artery obstruction in this case ²⁰⁾.

A case is presented in which a 73-yr-old man who was using Afrin (oxymetazoline hydrochloride) nasal spray several times daily, for the treatment of nasal congestion, developed bradycardia, hypotension and dizziness associated with oxymetazoline hydrochloride ²¹⁾.