Patient Medication Information: uses, side effects, how to take - PMS-Ipratropium (Pharmascience, 125 mcg, 250 mcg)
ABOUT THIS MEDICATION
What the medication is used for:
pms-IPRATROPIUM is used to treat the wheezing or shortness of breath caused by COPD (chronic obstructive pulmonary disease which includes chronic bronchitis and emphysema). For the treatment of asthma, pms-IPRATROPIUM must be used in conjunction with some other bronchodilating medication.
What it does:
pms-IPRATROPIUM belongs to a group of medicines known as “bronchodilators” which make breathing easier by opening your narrowed airways.
When it should not be used:
pms-IPRATROPIUM should not be used by patients with allergic reactions to ipratropium bromide, atropinics or any component of the drug.
If you do not get the expected relief from your treatment, you should contact your doctor.
What the medicinal ingredient is:
Ipratropium bromide
What the non-medicinal ingredients are:
Hydrochloric Acid, Nitrogen, Sodium Chloride, Sodium Hydroxide, Water
What dosage forms it comes in:
Inhalation Solution: 250 mcg of ipratropium bromide in 1 mL, 125 mcg of ipratropium bromide in 2 mL, 250 mcg of ipratropium bromide in 2 mL.
WARNINGS AND PRECAUTIONS
The solution is intended for inhalation only. Do not inject or drink.
Do not let the nebulized mist get into your eyes as this may cause blindness known as acute angle glaucoma. This may present as eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes. If any combination of these symptoms occurs, seek immediate medical attention. Patients with glaucoma should use swimming goggles or a nebulizer with a mouthpiece to prevent nebulized solution getting into the eyes.
BEFORE you use pms-IPRATROPIUM talk to your doctor or pharmacist if you:
are pregnant or intend to become pregnant;
- are breast feeding;
- are having treatment for a thyroid or adrenal gland condition;
- are having treatment for high blood pressure, angina or a heart problem;
- have diabetes;
have low levels of potassium in your blood (hypokalemia), especially if you are taking:
- drugs known as xanthine derivatives (such as theophylline)
- steroids to treat asthma
- water pills (diuretics)
- have eye problems, such as glaucoma or eye pain;
- are taking any other medications, including eye drops or any medications you can buy without a prescription;
- have difficulty in urination;
- have enlarged prostate;
- have any allergies or reactions to foods or drugs;
- have a history of convulsions (uncontrolled shaking or seizures);
- have liver or kidney disease.
Contact your doctor immediately if:
- you require more than one dose to relieve your breathing problems;
- your shortness of breath becomes worse;
- you don’t get the same benefit from your medicine as you did before;
- you have breathing difficulties and chest pain;
- you experience difficulty with urination.
pms-IPRATROPIUM may cause dizziness, difficulty in focusing the eyes, dilated pupils, and blurred vision. You should not drive or operate machinery if this occurs.
INTERACTIONS WITH THIS MEDICATION
As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
The following may interact with pms-IPRATROPIUM:
- digitalis;
other anticholinergic drugs, such as ipratropium bromide and other beta2- adrenergic agents such as salbutamol;
Do not mix pms-IPRATROPIUM with other drugs in the same nebulizer.
- beta blockers, such as propranolol;
- xanthine derivatives such as theophylline;
- monoamine oxidase inhibitors such as isocarboxazid;
- tricyclic antidepressants such as amitriptyline;
- epinephrine;
- certain diuretics or “water pills” such as furosemide, hydrochlorothiazide.
PROPER USE OF THIS MEDICATION
pms-IPRATROPIUM should only be inhaled from a nebulizer. It must not be injected or swallowed.
Do not let the pms-IPRATROPIUM or the mist produced by the nebulizer, get in your eyes.
Use your nebulizer in a well ventilated room. Some of the mist will be released into the air and may be breathed in by others.
Use pms-IPRATROPIUM only as directed by your doctor. During administration your doctor may want to monitor your blood.
pms-IPRATROPIUM has been prescribed to treat your current condition. DO NOT give it to other people. Always use pms-IPRATROPIUM exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
pms-IPRATROPIUM should be used only in a properly functioning and regularly maintained nebulizer or an intermittent positive pressure ventilator. Before starting treatment, be certain that you are completely familiar with the use and proper care of your nebulizer. The content of the vial does not need to be diluted for nebulization.
pms-IPRATROPIUM (Ipratropium Bromide) Solution:
2 mL Polynebs®
125 mcg/mL
Each plastic Polynebs® contains 2 mL pms-IPRATROPIUM solution. Each millilitre (mL) of solution contains 125mcg (0.0125%) ipratropium bromide in an isotonic solution.
250 mcg/mL
Each plastic Polynebs® contains 2 mL pms-IPRATROPIUM solution. Each millilitre (mL) of solution contains 250 mcg (0.025%) ipratropium bromide in an isotonic solution.
1 mL Polynebs®
250 mcg/mL
Each plastic Polynebs® contains 1 mL pms-IPRATROPIUM solution. Each millilitre (mL) of solution contains 250 mcg (0.025%) ipratropium bromide in an isotonic solution.
Usage Instructions
Your doctor or pharmacist will tell you how to prepare your pms-IPRATROPIUM inhalation solution. Your doctor or pharmacist might instruct you to use sterile sodium chloride solution (0.9%) to dilute the pms-IPRATROPIUM solution. If you are told to dilute pms-IPRATROPIUM, you must do so immediately before you plan to use the solution. If necessary, doses may be diluted to a total nebulization volume of 3-5 mL with preservative free 0.9% sterile sodium chloride solution and used immediately. Discard any unused solution. Nebulize over 10- 15 minutes at gas flow of 6-10L/min. Repeat every 4-6 hours as necessary.
- 1. The contents of pms-IPRATROPIUM Polynebs® are to be inhaled from a nebulizer. Do not open the foil pack until the Polynebs® are required.
- 2. To open the foil pack, lift the foil at the black arrow and peel (Diagram 1). Do not peel the lid off completely. Remove the vials.
- 3. To detach a pms-IPRATROPIUM Polynebs®, push one Polynebs® downwards and away while holding the remaining vials securely (Diagram 2). Record the date when the foil pouch is first opened using a regular ballpoint pen. Return the remaining Polynebs® to the foil tray, cover the tray with the foil lid and place the tray back in the carton.
- 4. Holding the top of the Polynebs® securely, twist the body to open (Diagram 3). It is important that you use the contents of the Polynebs® as soon as possible after opening it.
- 5. Place the open end of the Polynebs® well into the nebulizer cup and squeeze slowly (Diagram 4). Squeeze the contents of the Polynebs® into your nebulizer chamber. If your doctor has instructed you to use less than one complete Polynebs®, use a syringe to withdraw the prescribed dose. Any solution left in the Polynebs® must be thrown away.
- 6. If your doctor has instructed you to use another inhalation solution in combination with pms-IPRATROPIUM solution, you should add the appropriate amount of that solution to the nebulizer chamber as well.
- 7. Using a syringe, add sodium chloride solution to the chamber if you have been directed to do so by your pharmacist or physician.
- 8. Gently shake the nebulizer chamber and connect it to the mouthpiece or face mask. Then connect the nebulizer tube to the air or oxygen pump and begin therapy.
- 9. Breathe calmly and deeply through the mask or mouthpiece until no more mist is formed in the nebulizer chamber. This usually takes 10 to 15 minutes. It is very important to adjust the face mask, if required, to prevent the mist from getting in your eyes.
- 10. Follow the instructions provided by the nebulizer and air pump manufacturers for the proper care and maintenance of the equipment. Keep the nebulizer, nebulizer tube and face mask clean to minimize microbial contamination.
- 11. The Polynebs® should be stored at room temperature (between 15° and 30°C). The Polynebs® should be protected from heat and light. Discard any unused Polynebs® in opened foil packs after 3 months.
Do not mix pms-IPRATROPIUM with other drugs in the same nebulizer.
Keep out of the reach of children.
Overdose:
Missed Dose:
If a dose is missed and no symptoms occur, the regular next dose according to the dosing schedule should be taken. If a dose is missed and respiratory symptoms are experienced, the missing dose should be taken and the dosing schedule according to the recommended dosage should be resumed.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects may include:
- wheezing after inhalation;
- headache, dizziness
- nausea (feeling sick), digestive problems like constipation, diarrhoea and vomiting;
- muscle problems such as cramps, weakness, pain, feeling weak, tremor (shaking);
- feeling nervous;
- mental disorder;
- impaired voice sounds;
- increased sweating;
- bronchitis and upper respiratory tract infection (a cold)
- throat irritation, cough, dry mouth or throat, bad taste-sucking on a sour candy or rinsing your mouth may help.
Check with your doctor if the dry mouth or bad taste persist or if you experience constipation for a prolonged period of time.
Stop taking the medication and tell your doctor immediately if you notice any of the following:
you are wheezy or have any other difficulties in breathing;
- you are having an allergic reaction – the signs may include skin rash, itching and nettle rash. In severe cases the signs include swelling of your tongue, lips and face, sudden difficulties in breathing and reduction of your blood pressure.
If you have any questions about pms-IPRATROPIUM or your nebulizer, contact your doctor or pharmacist.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and get immediate medical help | |||
| Only if severe | In all cases | ||||
| Un common | Bronchospasm: Increased wheezing or tightness in the chest, difficulty in breathing, coughing bouts | √ | |||
| Shortness of breath | √ | ||||
| Ra re | Hypotension or Hypertension, Changes in blood pressure: dizziness, fainting, lightheadedness | √ | |||
| Skin rash | √ | ||||
Allergic Reaction: rash, hives, swelling of the face, lips, mouth, tongue, or throat, difficulty swallowing or breathing, choking due to swelling of the muscles around the voice box | √ | ||||
| Fast or irregular heart beat / chest pain | √ | ||||
| Eye Disorders: new or worsened pressure in your eyes, eye pain, blurred vision, seeing halos or | √ | ||||
If you think you have taken too much pms-IPRATROPIUM, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
| rainbows around items or red eyes | ||||
| Urinary Retention: difficulty and pain when passing urine, urinating frequently, urination in a weak stream or drips | √ | |||
| Muscle pain, weakness or spasms; paralysis | √ | |||
| Myocardial Ischaemia: decreased blood flow to the heart leading to angina (chest pain), shortness of breath, or a heart attack | √ | |||
| Angina: Chest pain | √ | |||
| Decreased levels of potassium in the blood: irregular heartbeats, muscle weakness and generally feeling unwell | √ |
This is not a complete list of side effects. For any unexpected effects while taking pms-IPRATROPIUM contact your doctor or pharmacist.
HOW TO STORE IT
Keep this medication out of the reach and sight of children.
1 mL or 2 mL Polynebs®: Unopened Polynebs® of pms-IPRATROPIUM should be stored at controlled room temperature (between 15°and 30 °C) and protected from heat and light.
If required, the solution should be diluted with a preservative-free sterile sodium chloride solution 0.9% and used immediately. Any solution remaining in the Polynebs® must be discarded.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
FOR MORE INFORMATION
For more information, please contact your doctor, pharmacist or other healthcare professional.
This document plus the full product monograph, prepared for health professionals, can be obtained by contacting Pharmascience Inc. at 1-888-550-6060.
Pharmascience Inc.
Montréal Québec
H4P 2T4
www.pharmascience.com
Last revised: April 12, 2017
Polynebs® is a registered trade-mark owned by Pharmascience Inc.