Thursday, November 3, 2011

Important Safety Information for VENTOLIN


Prescription VENTOLIN HFA is used for the prevention and relief of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. VENTOLIN HFA is also used for the prevention of exercise-induced bronchospasm (EIB) in Spier patients 4 years of age and older.
Important Safety Information for VENTOLIN HFA 90 mcg
Do not use VENTOLIN HFA if you are allergic to albuterol sulfate or any of the ingredients of VENTOLIN HFA. Ask your doctor if you have questions.
If your symptoms become significantly worse when you use VENTOLIN HFA, call your doctor right away. This worsening of symptoms can be life threatening and frequently occurs with the first use of a new canister.
Take VENTOLIN HFA as directed by your doctor. Do not take extra doses or take more often without asking your doctor. Get medical help right away if VENTOLIN HFA no longer helps your symptoms, if your symptoms get worse, or if you are using your inhaler more often than usual. Your asthma may be getting worse.
Effects on the heart and blood vessels may occur with the use of VENTOLIN HFA. These effects may include fast heartbeat, irregular heartbeat, change in blood pressure, or chest pain. Other side effects include shakiness and nervousness.
Allergic reactions may occur including breathing problems; suddenly feeling weak or lightheaded; swelling of the face, mouth, tongue, and/or throat, including difficulty swallowing; rash; and hives. These may be serious. Stop taking VENTOLIN HFA right away and call your doctor if such reactions occur.
Before and while you are taking VENTOLIN HFA, tell your doctor if you have a heart, blood, or seizure disorder, high blood pressure, diabetes, or an overactive thyroid; also tell your doctor if you are pregnant or nursing.
Some medicines can interfere with how well asthma medications work. Before and while you are taking VENTOLIN HFA, tell your doctor about all medicines you are taking, especially heart medicines and drugs that treat depression, and use other inhaled medicines and asthma medicines only as directed by your doctor.
The most common side effects include throat irritation, viral respiratory infection, upper respiratory inflammation, cough, and musculoskeletal pain. The side effect profile in children is generally similar to that of adults.

How does it work?


Ventolin accuhaler, evohaler, nebules, respirator solution, syrup and injection all contain the active ingredient salbutamol, which is a type of medicine known as a short-acting beta 2 agonist. (NB. Salbutamol is also available without a brand name, ie as the generic medicine.)
Salbutamol works by acting on receptors in the lungs called beta 2 receptors. When salbutamol stimulates these receptors it causes the muscles in the airways to relax. This allows the airways to open.
In conditions where there is narrowing of the airways, such as asthma or chronic obstructive pulmonary disease (COPD, eg emphysema and chronic bronchitis), it is difficult for air to get in and out of the lungs. By opening the airways, salbutamol makes it easier to breathe.
Salbutamol is most commonly taken using an inhaler device. Inhaling the medicine allows it to act directly in the lungs where it is needed most. It also reduces the potential for side effects occurring in other parts of the body, as the amount absorbed into the blood through the lungs is lower than if it is taken by mouth.
Salbutamol when used as an inhaler is known as a reliever. This is because it works very quickly to relieve asthma attacks, wheezing, chest tightness or shortness of breath. Salbutamol inhalers can also be used to open the airways shortly before exercising to prevent wheezing.
Salbutamol is sometimes prescribed to be taken by mouth for people who cannot use inhalers very well. It must be taken regularly in this way to help keep the airways open all the time.
Nebuliser or respirator solutions of salbutamol are used to treat acute asthma attacks in hospital. A nebuliser is a machine that converts the liquid medicine inside the nebules, into particles that can be inhaled. It is used to deliver higher doses of the medicine than a standard inhaler.
People with severe asthma or COPD who have been shown to benefit from regular use of high doses of salbutamol are sometimes prescribed nebules to be used in a nebuliser at home.
Salbutamol may also be given by injection in hospital to treat severe asthma attacks.

What is it used for?

  • Asthma
  • Chronic obstructive pulmonary disease (COPD)

Warning!

  • Do not exceed the dose of salbutamol that your doctor has prescribed you to use.
  • If your inhaler doesn't relieve wheezing or chest tightness as well as usual, or for as long as usual, or you need to use it more often than usual, you should consult your doctor as soon as possible. It may be that your asthma or COPD is getting worse and your doctor might need to give you another medicine. The same applies if you are taking salbutamol by mouth or nebuliser and it doesn't seem to be working as well.
  • Inhalers may cause an unexpected increase in wheezing (paradoxical bronchospasm) straight after using them. If this happens, stop using the inhaler immediately and consult your doctor. The medicine should be stopped and an alternative treatment found.
  • People with severe asthma should have regular blood tests to monitor the amount of potassium in their blood. This is because low oxygen levels in the blood (hypoxia) and various asthma medicines, including this one, can lower blood potassium levels.

Use with caution in

  • Diabetes
  • Heart disease
  • High blood pressure (hypertension)
  • Hyperthyroidism
  • Irregular heart beats (arrhythmias)

Not to be used in

  • Known sensitivity or allergy to any ingredient
This medicine should not be used if you Neogra are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
  • It is important that asthma is well controlled in pregnant women. Wherever possible, asthma medications should be taken by inhaler, as this minimises the amount of medicine that enters the bloodstream and crosses the placenta. Seek medical advice from your doctor.
  • Salbutamol passes into breast milk in small amounts. The effect of this on the breastfed baby is unknown, therefore this medicine should be used with caution in breastfeeding mothers. However, in general, salbutamol inhalers can be used as normal during breastfeeding, because the amount of medicine that passes into the breast milk after using an inhaler is negligable and unlikely to harm the baby. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
  • Shaking, usually of the hands (tremor)
  • Nervous tension
  • Headache
  • Faster than normal heart beat (tachycardia)
  • Awareness of your heart beat (heart palpitations)
  • Muscle cramps
  • Low blood potassium level (hypokalaemia)
  • Unexpected narrowing of the airways (paradoxical bronchospasm)
The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.
This medicine should not be taken with beta-blockers, such as atenolol, propranolol or timolol. This is because beta-blockers have an opposite action to this medicine and cause the airways to narrow. This can result in breathing difficulties for people with asthma or COPD. This problem has sometimes been seen with eye drops containing beta-blockers, eg used for glaucoma.
Salbutamol can potentially cause a serious decrease in the levels of potassium in the blood (hypokalaemia), which may result in adverse effects. This effect can be increased by the following medicines, which can also lower potassium in the blood:
  • xanthine derivates, such as theophylline or aminophylline
  • corticosteroids, such as beclometasone and prednisolone
  • other beta 2 agonists, such as salmeterol
  • diuretics, such as bendroflumethiazide and furosemide.
This is why people with severe asthma or COPD, who may be taking several of these medicines, should have their blood potassium levels monitored regularly.