Phenylephrine Nasal

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For phenylephrine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to phenylephrine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Children may be especially sensitive to the effects of nasal phenylephrine. This may increase the chance of side effects during treatment.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Geriatric

Many medicines have not been studied specifically 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 comparing use of nasal phenylephrine in the elderly with use in other age groups.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

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 phenylephrine, 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 phenylephrine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Linezolid
• Rasagiline
• Selegiline

Using phenylephrine 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.

• Amitriptyline
• Amoxapine
• Clomipramine
• Desipramine
• Dothiepin
• Doxepin
• Fentanyl Citrate
• Imipramine
• Iobenguane I 123
• Lofepramine
• Midodrine
• Nortriptyline
• Opipramol
• Protriptyline
• Trimipramine

Interactions with Food/Tobacco/Alcohol

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

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

• Type 2 diabetes mellitus or
• Heart or blood vessel disease or
• High blood pressure or
• Overactive thyroid—Nasal phenylephrine may make the condition worse

To use the nose drops:

• Blow your nose gently. Tilt the head back while standing or sitting up, or lie down on a bed and hang 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 the infection, do not use the container for more than one person.

To use the 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. For best results, spray once or twice into each nostril and wait 3 to 5 minutes to allow the medicine to work. Then, blow your nose gently and thoroughly. Repeat until the complete 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 the infection, do not use the container for more than one person.

To use the nose jelly:

• Blow your nose gently. Wash your hands before applying the medicine. With your finger, place a small amount of jelly (about the size of a pea) up each nostril. Sniff it well back into the nose.
• Wipe the tip of the tube with a clean, damp tissue and replace the cap right after use.

Use phenylephrine 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 first checking with your doctor. To do so may make your runny or stuffy nose worse and may also increase the chance of side effects.

Dosing

The dose of phenylephrine 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 phenylephrine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine 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 stuffy nose:
  • For nose jelly dosage form:
    • Adults—Use a small amount in the nose every three or four hours as needed.
    • Children—Use is not recommended.
  • For nose drops dosage form:
    • Adults and children 12 years of age and older—Use two or three drops of a 0.25 to 0.5% solution in the nose every four hours as needed.
    • Children 6 to 12 years of age—Use two or three drops of a 0.25% solution in the nose every four hours as needed.
    • Children 4 to 6 years of age—Use two or three drops of a 0.125 or 0.16% solution in the nose every four hours as needed.
    • Children and infants up to 4 years of age—Use is not recommended .
  • For nose spray dosage form:
    • Adults and children 12 years of age and older—Use two or three sprays of a 0.25 to 0.5% solution in the nose every four hours as needed.
    • Children 6 to 12 years of age—Use two or three sprays of a 0.25% solution in the nose every four hours as needed.
    • Children 4 to 6 years of age—Use and dose must be determined by your doctor.
    • Children and infants up to 4 years of age—Use is not recommended .

Missed Dose

If you miss a dose of phenylephrine, 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.

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.

(fen il EF rin)

There are no dosage adjustments provided in manufacturer’s labeling.

For intranasal use only. Blow nose to clear nostrils before use; spray or drop solution into each nostril while gently occluding the other. Wipe nozzle clean after each use.

Frequency not defined.

Nasal: Burning, nasal discharge, sneezing, stinging

You should not use phenylephrine nasal if you are allergic to it.

Do not use phenylephrine nasal if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, especially:

• heart disease, heart rhythm disorder;

• high blood pressure;

• diabetes;

• glaucoma;

• a thyroid disorder; or

• an enlarged prostate or urination problems.

It is not known whether phenylephrine nasal will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

It is not known whether phenylephrine nasal passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe dizziness or drowsiness, slow heart rate, and fainting.

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

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

• severe sneezing, runny or stuffy nose, redness or swelling in your nose, or other worsening nasal symptoms (may be a sign of overuse of phenylephrine nasal);

• severe stinging, burning, or irritation inside your nose;

• severe dizziness, restless feeling, nervousness, or insomnia;

• mood changes, unusual thoughts or behavior;

• tremors or shaking; or

• little or no urination.

Side effects may be more likely in older adults.

Common side effects may include:

• temporary sneezing;

• mild burning, dryness, cold feeling, or irritation inside your nose;

• headache, dizziness, weakness;

• feeling excited or restless (especially in children); or

• mild sleep problems.

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.

Before using this nasal decongestant, tell your doctor or pharmacist if you are allergic to it; or to other sympathomimetics (e.g., pseudoephedrine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have any of the following health problems, consult your doctor or pharmacist before using this product: heart/blood vessel disease (e.g., coronary artery disease), overactive thyroid (hyperthyroidism), diabetes, high blood pressure, difficulty urinating (due to enlarged prostate).

Before having surgery, tell your doctor or dentist that you are using this medication.

Caution is advised when using this drug in children because they may be more sensitive to the effects of the drug. Check the product package or consult with your doctor or pharmacist about whether these nasal drops can be used in children.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.