Zicam

What is Zicam

Zicam 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. Zicam is also used to relieve sinus congestion and pressure. Zicam active ingredient is called Oxymetazoline hydrochloride. Zicam (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 Zicam (Oxymetazoline) nasal spray carefully and under adult supervision.

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

Zicam (Oxymetazoline) is available without a prescription.

Zicam 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

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

Nasal Solution
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 pump:

to open, hold the actuator to squeeze and turn cap
hold with thumb at bottom of bottle and nozzle between fingers
before using the first time, prime pump by depressing several times
place tip of nozzle just past nasal opening (approximately 1/8″)
pump 2 or 3 times in each nostril without tilting your head. Sniff deeply.
wipe nozzle clean after use
to close, turn cap until it ‘clicks’

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Do not keep outdated medicine or medicine no longer needed.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 much zinc is in Zicam?

Zicam (Oxymetazoline) nasal spray does not contain any zinc.

Active ingredients: Oxymetazoline hydrochloride 0.05%

Inactive ingredients: aloe barbadensis gel, benzalkonium chloride, benzyl alcohol, disodium EDTA, disodium phosphate, glycerin, hydroxyethylcellulose, hydroxylated lecithin, monosodium phosphate, purified water

How does Zicam work?

Zicam (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. Zicam (Oxymetazoline) works by narrowing the blood vessels (vasoconstriction) in the nasal passages, thus decreasing nasal blood flow and nasal congestion.

Before using Zicam – Precautions

tell your doctor and pharmacist if you are allergic to Zicam (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).
Zicam (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 Zicam (Oxymetazoline) nasal spray, call your doctor.

Pediatric patients

Children may be especially sensitive to the effects of Zicam (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 Zicam (Oxymetazoline) in the elderly.

Zicam and Pregnancy

Safe use of Zicam (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 Zicam (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 Zicam (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 Zicam (Oxymetazoline) ³.

Zicam and Breastfeeding

Although no information exists on the use of Zicam (Oxymetazoline) specifically during breastfeeding, very little should reach the infant through breastmilk because of the local administration and limited absorption into the maternal bloodstream ⁴. It is recommended over oral systemic decongestants such as pseudoephedrine during breastfeeding ⁴. 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 Zicam (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 Zicam (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 Zicam (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 Zicam be used?

Zicam (Oxymetazoline) nasal spray comes as a solution (liquid) to spray into your nose. Zicam (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 Zicam (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 Zicam (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 Zicam (Oxymetazoline) nasal spray for longer than 3 days. If your symptoms do not get better after 3 days of treatment, stop using Zicam (Oxymetazoline) and call your doctor.

Zicam (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 Zicam (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 Zicam (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.

How to use the Zicam nose spray

Blow your nose gently. With the head upright, spray the medicine into each nostril. Sniff briskly while squeezing the bottle quickly and firmly. If needed, blow the nose gently again and repeat the spray process until the total dose is used.
Rinse the tip of the spray bottle with hot water, taking care not to suck water into the bottle, and dry with a clean tissue. Replace the cap right after use.
To avoid spreading a cold or infection, do not use the container for more than one person and throw the container away after your cold is better.

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 the Zicam nose drops

Blow your nose gently. Tilt the head back while standing or sitting up, or lie down on a bed and hang the head over the side. Place the drops into each nostril and keep the head tilted back for a few minutes to allow the medicine to spread throughout the nose.
Rinse the dropper with hot water and dry with a clean tissue. Replace the cap right after use.
To avoid spreading a cold or infection, do not use the container for more than one person and throw the container away after your cold is better.

Zicam Dosing

The dose of Zicam (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 Zicam (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 Zicam (Oxymetazoline) nasal dosage form (nose drops or 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 Zicam (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.

Zicam Nasal Spray

Active ingredients: Oxymetazoline hydrochloride 0.05%

Purpose: Nasal decongestant

Other information

store between 15-29°C (59-84°F)
retain carton for future reference on full labeling

Zicam 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

Zicam 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.

Zicam Nasal Spray Directions of Use

To use pump:

to open, hold the actuator to squeeze and turn cap
hold with thumb at bottom of bottle and nozzle between fingers
before using the first time, prime pump by depressing several times
place tip of nozzle just past nasal opening (approximately 1/8″)
pump 2 or 3 times in each nostril without tilting your head. Sniff deeply.
wipe nozzle clean after use
to close, turn cap until it ‘clicks’

Zicam 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

Zicam side effects

Zicam (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 ¹.

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 ⁵.

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 ⁶.

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 ¹. 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 ¹.

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 ⁷.

A patient prescribed oxymetazoline hydrochloride nasal drops presented with recurrent ventricular tachycardia of fascicular origin ⁸. 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 ⁸.

A case of chronic use of nasal oxymetazoline associated with thunderclap headache due to reversible segmental intracranial vasoconstriction is reported ⁹. The patient had been using a nasal spray that contains oxymetazoline, regularly for the previous 6 months ⁹. 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 ⁹. 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 ¹⁰.

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 ¹¹. 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 ¹¹.

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 ¹².

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