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ADVAIR is a brand name for Salmeterol, supplied as a powder. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..................................................................................................... 3 CONTRAINDICATIONS ......................................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations COPD and Asthma ADVAIR/ADVAIR DISKUS should not be used to treat acute symptoms of asthma or COPD. It is crucial to inform patients of this. , salbutamol) to relieve the acute symptoms such as shortness of breath and advised to have this available for use at all times.
g. salbutamol). Rapid onset, short duration beta2- agonists should be used only to relieve acute symptoms of asthma and COPD (See WARNINGS AND PRECAUTIONS). Patients should be regularly reassessed so that the strength of ADVAIR/ADVAIR DISKUS they are receiving remains optimal and is only changed on medical advice.
The dose should be titrated to the lowest dose of fluticasone propionate at which effective control of symptoms is maintained. There is no need to adjust the dose in the otherwise healthy elderly or in patients with impaired renal function.
Because salmeterol is predominantly cleared by hepatic metabolism, patients with hepatic disease should be closely monitored. Asthma When treating patients with asthma, physicians should only prescribe ADVAIR/ADVAIR DISKUS for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants treatment with both an inhaled corticosteroid and LABA.
Page 28 of 70 Recommended Dose And Dosage Adjustment ADVAIR DISKUS Inhalation Powder Asthma COPD Children 4-11 years of age Adults and adolescents 12 years of age Adults 18 years of age ADVAIR DISKUS 100 One inhalation twice daily One inhalation twice daily -- OR ADVAIR DISKUS250 -- One inhalation twice daily One inhalation twice daily OR ADVAIR DISKUS 500 -- One inhalation twice daily One inhalation twice daily ADVAIR Pressurised Inhalation, Suspension Asthma Adults and adolescents 12 years of age ADVAIR 125 Two inhalations twice daily OR ADVAIR 250 Two inhalations twice daily It is intended that each prescribed dose of ADVAIR Pressurised Inhalation, Suspension be given by a minimum of two inhalations twice daily.
However, the prescribed dose of ADVAIR DISKUS Inhalation Powder may be given by a single inhalation twice daily. Use with Spacer Devices Spacer devices may be used in patients who have difficulty coordinating the actuation of a metered dose inhaler (MDI) with inhalation.
The dosage of ADVAIR pressurised inhalation, suspension should be adjusted according to individual response. For patients whose asthma has been stabilized without the use of a spacer device, continuation of therapy with a spacer may require a dosage adjustment.
ADVAIR DISKUS is not for the treatment of acute asthma attacks or sudden increase of breathlessness and wheezing in COPD. If you get a sudden attack of wheezing and breathlessness between your doses of ADVAIR DISKUS, you should use your fast acting ‘reliever’ medicine, such as salbutamol which your doctor has prescribed to you.
Use the medication as directed by your doctor. You may need to also take steroid tablets or syrup during a severe asthma attack, during other illnesses or during times of stress. Your doctor may give you some steroid tablets or syrup to carry with you as well as a steroid warning card, which will give you advice on when and how to use them.
Before and while you use ADVAIR DISKUS talk to your doctor or pharmacist if the following situations apply to you so that they can determine whether you should start or continue taking this medication: Have eye problems such as glaucoma, cataracts, blurry vision or other changes in vision.
Are suffering from any chest infection (cold, bronchitis). Have ever had to stop taking another medication for your breathing problems because you were allergic to it or it caused problems. Have been told you are allergic to lactose (milk sugar) or milk protein.
Ever had a yeast infection (thrush) in your mouth. Are having treatment for a thyroid condition. Have diabetes. Have high blood pressure. Have heart problems. Have had tuberculosis (TB) infections. Are taking other “steroids” by mouth or by inhalation.
Are pregnant, planning to become pregnant or breastfeeding. Are taking a medicine called ketoconazole, used to treat fungal infection. g. ritonavir, atazanavir, indinavir, nelfinavir, saquinavir and cobicistat containing products).
Have liver problems or cirrhosis. You should avoid coming into contact with anyone who has measles or the chicken pox while taking an ICS. If you or your child are exposed, tell your doctor right away.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Salmeterol in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Two small single dose pharmacokinetic studies were conducted in subjects with asthma to investigate the performance of various spacer devices. The studies showed that following the administration of ADVAIR pressurised inhalation, suspension, the exposure to both fluticasone propionate (FP) and salmeterol xinafoate (SAL) was significantly higher (up to 4 fold) when used with the AeroChamber Max spacer, compared to the MDI alone.
Exposure to FP and SAL was also increased with the use of the AeroChamber Plus and Ventahaler spacers, but to a lesser degree than that seen with the AeroChamber Max spacer. The long term safety and clinical effect of using a spacer device with ADVAIR pressurised inhalation, suspension was not evaluated in these studies.
Page 29 of 70 Missed Dose If a single dose is missed, instruct the patient to take the next dose when it is due. Administration ADVAIR/ADVAIR DISKUS are to be administered by oral inhalation only. The patient should be made aware that for optimum benefit ADVAIR/ADVAIR DISKUS should be taken regularly, even when asymptomatic.
As a general rule, rinsing the mouth and gargling with water after each inhalation can help in preventing the occurrence of candidiasis. Cleansing dentures has the same effect. OVERDOSAGE ADVAIR/ADVAIR DISKUS should not be used more frequently than twice daily (morning and evening) at the recommended dose.
Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs (See WARNINGS AND PRECAUTIONS - General). Large doses of inhaled or oral salmeterol (12 to 20 times the recommended dose) have been associated with clinically significant prolongation of the QTc interval, which has the potential for producing ventricular arrhythmias.
There are no data available from clinical trials on overdose with ADVAIR/ADVAIR DISKUS, however data on overdose with individual drugs is given below. Acute inhalation of fluticasone propionate doses in excess of those approved may lead to temporary suppression of the hypothalamic-pituitary-adrenal axis.
This does not usually require emergency action, as normal adrenal function typically recovers within a few days. The expected signs and symptoms of salmeterol overdosage are those typical of excessive beta2-adrenergic stimulation, including tremor, headache, tachycardia, increases in systolic blood pressure, cardiac arrhythmias, hypokalemia, hypertension and, in extreme cases, sudden death.
There is no specific treatment for an overdose of fluticasone propionate and salmeterol. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. The judicious use of a cardioselective beta- receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm.
If higher than approved doses are continued over prolonged periods, significant adrenocortical suppression is possible. There have been very rare reports of acute adrenal crisis occurring in children exposed to higher than approved dosages (typically 1000 mcg daily and above), over prolonged periods (several months or years); observed features included hypoglycemia […]
Drugs like ADVAIR DISKUS can cause eye disorders: Cataracts:
Clouding of the lens in the eye, blurry vision, eye pain; Glaucoma: An increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss; Central serous chorioretinopathy (CSCR): blurry vision or other changes in vision.
Contact your healthcare professional if you experience blurry vision or other vision problems. You should have regular eye exams.
Other warnings you should know about:
Asthma specific warnings: After you start taking ADVAIR DISKUS, your doctor may change the dosages of your other asthma medicines. Rarely, this may make a patient feel worse rather than better. This especially applies to oral corticosteroids (sometimes referred to as steroids), including prednisone.
If your doctor decreases your oral steroid dose, and you become unwell, tell your doctor immediately. You should have your asthma assessed at regular intervals as agreed upon with your doctor. Once control of your asthma is achieved and maintained, your doctor may further adjust your dose of ADVAIR DISKUS.
Do not stop or change the dose of your ADVAIR DISKUS unless your doctor has advised you to do so. When LABA medicines are used alone without an ICS, they increase the risk of hospitalization and death from asthma problems. ADVAIR DISKUS contains both an ICS and LABA.
Studies showed that when an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems. Tell your doctor immediately if: There is a change in your symptoms such as more coughing, attacks of wheezing, chest tightness, or an unusual increase in the severity of the breathlessness.
You wake up at night with chest tightness, wheezing or shortness of breath. You use increasing amounts of your fast acting ‘reliever’ medicine. These could be warning signs that your condition may be worsening. Do not stop taking ADVAIR DISKUS without talking to your doctor.
COPD specific warnings: Tell your doctor immediately if you notice symptoms of a ‘flare up”. Patients with COPD have a higher chance of getting pneumonia (a lung infection). Drugs like ADVAIR DISKUS may also increase your chance of getting pneumonia.
However, symptoms of pneumonia and COPD ‘flare ups’ frequently overlap. It is therefore important you tell your doctor immediately if you suspect an infection, as even mild chest infections should be treated immediately.
IMPORTANT:
PLEASE READ Page 57 of 70 Your doctor may also recommend that you receive a flu shot each year. You should avoid close contact with people who have colds or the flu (influenza). You should ask your doctor about flu vaccination. The following warning signs indicate that your COPD condition may be worsening.
You should contact your doctor as soon as possible if you notice: An unusual increase or decrease in the amount of phlegm. An unusual increase in the consistency and stickiness of the phlegm. The presence of blood in phlegm. A change in the colour of the phlegm to either brown, yellow or green.
An unusual increase in the severity of the breathlessness, cough or wheeze. , sore throat). Unexplained tiredness or fever. Chest tightness. Unexplained swelling. The necessity to increase the number of pillows in order to sleep in comfort.
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.
Drugs that may interact with ADVAIR DISKUS include: medicines similar to ADVAIR DISKUS used for your lung disease, as it may increase the risk of experiencing possible side effects. This includes other medicines containing a LABA or a corticosteroid.
g. ritonavir, atazanavir, indinavir, nelfinavir, […]