Orciprenaline (AA Pharma): Uses, Side Effects and Dosage

What is ORCIPRENALINE used for?

ORCIPRENALINE syrup used in adults and children (4 years of age or older) to treat symptoms from the following lung problems:

• bronchial asthma (widespread narrowing of the airways in the lungs);
• chronic bronchitis (consistent irritation or inflammation of the air tubes in the lungs);
• pulmonary emphysema (airflow blockage in the lungs);

• bronchospasm (reduced airflow from the tightening of the lung muscles) in sarcoidosis

  (growth of inflammatory cells in the lungs), silicosis (lung inflammation from breathing in silica), lung cancer, or tuberculosis (TB -infection caused by bacteria).

How does ORCIPRENALINE work?

ORCIPRENALINE belongs to a group of medicines called bronchodilators. It relaxes the muscles in the walls of the small air passages in the lungs. This helps to open up the airways so that you can breathe more easily by reducing the frequency and severity of your:

• involuntary lung contraction episodes (bronchospastic attacks), and
• lung problem symptoms (e.g., wheezing, chest congestion and shortness of breath).

What are the ingredients in ORCIPRENALINE?

Medicinal ingredient: Orciprenaline sulfate

Non-medicinal ingredients: Artificial grape flavour, edetate disodium, glycerin, hydroxyethyl cellulose, methylparaben, propylparaben, purified water, and sorbitol.

ORCIPRENALINE comes in the following dosage forms:

Syrup: 2 mg/mL

Do not use ORCIPRENALINE if:

• you are allergic to orciprenaline sulfate or any of the other ingredients in the

  ORCIPRENALINE.

• you are allergic to a type of medications known as sympathomimetic amines (e.g., epinephrine, norepinephrine, ephedrine, etc.).
• you have heart problems.
• you have hypertrophic obstructive cardiomyopathy (the muscular wall between the two bottom chambers of the heart is thicker than normal and blocks blood flow out of the heart).
• you have abnormal heart rhythms (arrhythmias).

• you are pregnant and are at risk for premature labour or miscarriage.

• you are taking medications known as beta blockers (e.g., propranolol).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ORCIPRENALINE. Talk about any health conditions or problems you may have, including if you:

• are taking anti inflammatory medications,
• have heart problems or blood problems (e.g., arrhythmias, myocardial infarction, heart disorders, and high blood pressure),
• have diabetes,
• have glaucoma,
• have high thyroid hormone levels (hyperthyroidism),
• have phaeochromocytoma (a noncancerous tumor that develops in the adrenal gland),
• are pregnant or planning to become pregnant,
• have asthma,
• are taking medications known as xanthine derivatives, steroids, and diuretics (water pills),
• are breastfeeding or planning to breastfeed. It is not known if ORCIPRENALINE can pass into breast milk.

Other warnings you should know about:

Serious hypokalemia (low levels of potassium in the blood): Treatment with ORCIPRENALINE can cause serious hypokalemia if you have asthma. The risk is higher if you are also taking xanthine derivatives, steroids, and diuretics (water pills). Ask your healthcare professional if you are unsure. Your healthcare professional will monitor your potassium levels in these situations. However, if you notice an acute or rapidly worsening shortness of breath (dyspnea), you should tell your healthcare professional right away.

If your ORCIPRENALINE treatment does not improve your condition or if your condition gets worse, you should also tell your healthcare professional. A new treatment plan may be necessary.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with ORCIPRENALINE:

• medications known as sympathomimetic agents (e.g., epinephrine).
• antidepressant medications known as monoamine oxidase inhibitors and tricyclic antidepressants (used to treat depression).
• inhaled anaesthetics known as halogenated hydrocarbon anaesthetics (e.g., halothane, trichloroethylene and enflurane).
• medications known as beta blockers (used to reduce blood pressure).
• anti-inflammatory medications known as corticosteroids.
• medications that belong to a group called methylxanthines.
• medications known as diuretics or the water pill (used to increase the amount of water released in your urine, and reduce blood pressure).

If you are unsure, ask your healthcare professional.

How to take ORCIPRENALINE:

• Take ORCIPRENALINE orally and exactly as prescribed by your doctor.
• The syrup should be measured using a teaspoon to ensure the appropriate dose.

Usual dose:

Your doctor will tell you how much and how often to take the syrup each day. This will depend on your condition, other medications you are taking, and how you respond to the treatment. The usual doses are as follows:

• Adults (18 years of age and older): Two teaspoons (10 mL) of syrup (20 mg) three or four times a day.

• Adolescents (12 to 17 years of age): Two teaspoons (10 mL) of syrup (20 mg) three times a day.

• Children (4 to 11 years of age): One teaspoon (5 mL) of syrup (10 mg) three times a day.

Overdose:

The symptoms of an overdose can include any of the side effects listed. The most common side effects of an overdose include:

• high or low blood pressure,
• irregular or rapid heartbeats,
• chest pain,
• trembling,
• flushing of the face.

If an overdose occurs, your healthcare professional will stop your treatment and an appropriate intervention may be considered.

If you think you, or a person you are caring for, have taken too much ORCIPRENALINE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If you forget to take your dose, take it as soon as you remember. But if it is almost time for your next dose, do not take the missed dose. Instead, take the next scheduled dose. Do not try to make up for the missed dose by taking two doses at the same time.

What are possible side effects from using ORCIPRENALINE?

These are not all the possible side effects you may have when taking ORCIPRENALINE. If you experience any side effects not listed here, tell your healthcare professional. Side effects may include:

• nervousness,
• shaking,
• sweating,
• muscle weakness or pain,
• psychological changes.

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting

  (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store ORCIPRENALINE at room temperature (15°C to 30°C) Protect from light.

Keep out of reach and sight of children.

If you want more information about ORCIPRENALINE:

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html). Find the Patient Medication Information on the manufacturer’s website (https://www.aapharma.ca/en/), or by calling 1-877-998-9097.

AA Pharma Inc.

1165 Creditstone Road Unit #1

Vaughan, Ontario

L4K 4N7

Date of Revision: OCT 11, 2022