S2 (Inhalation)

Racepinephrine inhalation is used for temporary relief of mild symptoms of a weak type of asthma, known as intermittent asthma (for example, chest tightness, trouble breathing).

This medicine is available without a prescription.

It is very important that your doctor checks your or your child's progress at regular visits to make sure this medicine is working well and to look for any unwanted effects.

Talk to your doctor if your symptoms do not get better or if they worsen. Your asthma may be getting worse if:

• You do not feel better in 20 minutes.
• You need more than 12 inhalations in 24 hours.
• You use more than 9 inhalations in 24 hours for 3 or more days a week.
• You have more than 2 asthma attacks in a week.

Contact your doctor immediately if you have trouble sleeping, a fast heartbeat, tremors, nervousness, or seizures.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]) within the past 14 days.

This medicine may cause high blood pressure, which can increase your risk of heart attack or stroke. Contact your doctor right away if you have chest pain or discomfort, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, slurred speech, or weakness.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on the effects of racepinephrine inhalation in children younger than 4 years old. Safety and effectiveness have not been established.

Geriatric

There is no information available regarding the effects of racepinephrine inhalation in older patients.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. If an interaction might happen, your doctor may want to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Diabetes or
• Enlarged prostate or
• Glaucoma, narrow-angle or
• Heart disease, or history of or
• Hypertension (high blood pressure), or
• Seizures or
• Thyroid problems or
• Trouble urinating—Use with caution. May worsen these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may require medical attention.

Check with your doctor right away if you experience any of the following side effects:

Incidence not known

• Blurred vision
• chest pain or discomfort
• confusion
• difficulty in speaking
• dizziness
• double vision
• headache
• inability to move the arms, legs, or facial muscles
• inability to speak
• nausea
• nervousness
• pain or discomfort in the arms, jaw, back, or neck
• pounding in the ears
• seizures
• slow or fast heartbeat
• slow speech
• sweating
• tremors
• vomiting

Some side effects may happen that usually do not require medical attention. These side effects may go away as your body adjusts to the medicine. Your health care professional may also offer ways to prevent or lessen some of these side effects. Talk to your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Incidence not known

• Trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, consult your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Asthmanefrin
• S2
• S-2 Inhalant

In Canada

• Vaponefrin

Available Dosage Forms:

• Solution

Therapeutic Class: Bronchodilator

Pharmacologic Class: Racepinephrine

Follow the instructions on the medicine label if you are using this medicine without a prescription. Do not use more medicine or use it more often than instructed.

You will use this medicine with an inhaler device called a nebulizer. The nebulizer turns the medicine into a fine mist that you breathe in through your mouth and to your lungs. If you do not understand the directions or you are not sure how to use the nebulizer, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the nebulizer to make sure you are using it properly.

Do not use this medicine to treat other breathing problems, without first checking with your doctor.

Avoid food or drinks that contain caffeine.

Avoid supplements that contain, or claim to have, stimulant effects.

Dosing

The dose of this medicine 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 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 inhalation dosage form:For relief of asthma symptoms: Adults and children 4 years of age and older—1 to 3 inhalations for each dose. Wait at least 3 hours between doses. Do not use more than 12 inhalations in 24 hours. Children younger than 4 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep the vial in the foil pouch until you are ready to use it. Store this medicine in the refrigerator or at room temperature, away from heat and direct light. Do not freeze. An open vial of medicine must be used right away.