Advair HFA (combination), Serevent Diskus

Name: Advair HFA (combination), Serevent Diskus

Uses for Advair HFA (combination), Serevent Diskus

Bronchospasm in Asthma

Salmeterol is used only concomitantly with long-term asthma controller therapy (e.g., inhaled corticosteroids) for treatment of asthma and prevention of bronchospasm in patients with reversible obstructive airway disease, including symptoms of nocturnal asthma.156 188 221 222 263

Long-acting β2-adrenergic agonists (e.g., salmeterol) increase the risk of asthma-related death and may increase risk of asthma-related hospitalization in children and adolescents.188 221 248 257 Use of salmeterol for treatment of asthma without concomitant use of long-term asthma controller therapy (e.g., inhaled corticosteroids) is contraindicated.188 248 (See Boxed Warning and also Asthma-related Death and Life-threatening Events under Cautions.)

Salmeterol is used only as additional therapy in patients with asthma currently receiving long-term asthma controller therapy (e.g., inhaled corticosteroids) but whose disease is inadequately controlled with such therapy.188 222 263

Salmeterol in fixed combination with fluticasone is used only in patients with asthma not responding adequately to long-term asthma controller therapy (e.g., inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a long-acting β2-adrenergic agonist.221 257

Once asthma control achieved and maintained, assess patient at regular intervals and step down therapy (e.g., discontinue salmeterol or salmeterol in fixed combination with fluticasone) if possible without loss of asthma control, and maintain patient on long-term asthma controller therapy (e.g., inhaled corticosteroids).188 221 248 257

Salmeterol is not a substitute for corticosteroids; corticosteroid therapy should not be stopped or reduced in dosage when salmeterol is initiated.1 188 226 (See Concomitant Anti-inflammatory Therapy under Cautions.)

Do not use salmeterol alone or in fixed combination with fluticasone in patients with asthma adequately controlled on low or medium dosage of inhaled corticosteroids.188 221 257

In children and adolescents with asthma requiring addition of a long-acting β2-adrenergic agonist to an inhaled corticosteroid, generally use a fixed-combination preparation containing both an inhaled corticosteroid and a long-acting β2-adrenergic agonist to ensure compliance with both drugs.188

When separate administration of long-term asthma controller therapy (e.g., inhaled corticosteroids) and a long-acting β2-adrenergic agonist is clinically indicated, take appropriate steps to ensure compliance with both drugs.188 If compliance cannot be ensured, a fixed-combination preparation containing both an inhaled corticosteroid and a long-acting β2-adrenergic agonist is recommended.188

Salmeterol alone or in fixed combination with fluticasone not indicated for relief of acute bronchospasm.154 188 221 257 (See Deterioration of Disease and Acute Episodes under Cautions.)

Exercise-induced Bronchospasm

Prevention of exercise-induced bronchospasm.1 12 21 91 105 172 188 214 222 263

Use as a single agent for prevention of exercise-induced bronchospasm may be clinically indicated in patients without persistent asthma.188

Use for prevention of exercise-induced bronchospasm may be clinically indicated in patients with persistent asthma; however, treatment of asthma should include long-term asthma controller therapy (e.g., inhaled corticosteroids).188

Bronchospasm in COPD

Long-term symptomatic treatment of reversible bronchospasm associated with moderate to severe COPD (e.g., FEV1 less than 80% of predicted), including chronic bronchitis and emphysema.1 182 183 188 223 224 225 238 239

Fixed combination with fluticasone as the inhalation powder (Advair Diskus) is used for maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and/or emphysema; also used to reduce COPD exacerbations in patients with a history of exacerbations.221

Not indicated for relief of acute bronchospasm.154 188 221 Use a short-acting inhaled β2-agonist intermittently (as needed) for acute symptoms of COPD.238 239 (See Deterioration of Disease and Acute Episodes under Cautions.)

Advair HFA (combination), Serevent Diskus Dosage and Administration

General

  • When initiating salmeterol alone or in fixed combination with fluticasone, discontinue regular use of short-acting, oral or inhaled β2-agonists;97 188 221 257 use a short-acting, inhaled β2-agonist, not salmeterol (alone or in fixed combination with fluticasone), to relieve acute symptoms such as shortness of breath.97 188 221 257

  • Increasing use of short-acting, inhaled β2-agonists is a marker of deteriorating asthma and failure to respond to a previously effective dosage is often a sign of asthma destabilization.1 111 112 154 188 221 222 257 Extra/increased doses of salmeterol alone or in fixed combination with fluticasone are not recommended.1 111 112 154 188 221 222 257 (See Deterioration of Disease and Acute Episodes under Cautions.) Consult clinician.1 113 188

Administration

Oral Inhalation

Administer by oral inhalation using a special oral inhaler (Diskus device) that delivers powdered salmeterol xinafoate alone (Serevent Diskus) or in fixed combination with fluticasone (Advair Diskus) from foil-wrapped blisters or using an inhalation aerosol containing salmeterol in fixed combination with fluticasone (Advair HFA) via an oral aerosol inhaler with hydrofluoroalkane (HFA) propellant.188 221 257

Administer twice daily, approximately every 12 hours (morning and evening).1 188 221 257

Inhalation Powder

Hold the Diskus device in one hand, put the thumb of the other hand on the thumbgrip, and push the thumbgrip until the mouthpiece appears and snaps into position.189 253 254 255

To release powdered drug into the exit port, hold the inhaler in a level, horizontal position and depress the lever on the Diskus in a direction away from the patient.189 253 254 255

To avoid releasing and wasting additional doses of the drug, do not close the Diskus device, play with the lever, or advance the lever more than once.189 253 254 A dose counter will advance each time the lever is depressed.189 253 254 255

Exhale completely, place the mouthpiece of the inhaler between the lips, and inhale deeply and rapidly through the inhaler with a steady, even breath.189 190 253 254 255 Remove the inhaler from the mouth and hold the breath for 10 seconds before slowly exhaling.189 253 254 255

Do not exhale into the Diskus device.189 190 221 253 254 255

Do not use another dose from the Diskus device if the patient does not feel or taste the drug.253 254

Spacer devices are not recommended with the Serevent or Advair Diskus inhaler.188 221 253 254

Close the inhalation device and reset for the next dose by sliding the thumbgrip toward the patient as far as it will go.189 253 254 255 Do not wash the inhaler.189 253 254 255 Do not take inhaler apart.188 190 221 253 254 255

Discard the inhaler when every blister of salmeterol alone or in fixed combination with fluticasone has been used.188 190 221 253 254 Alternatively, discard the inhaler 6 or 4 weeks after removal of salmeterol alone or in fixed combination with fluticasone, respectively, from its foil overwrap pouch.188 190 221 253 254

Rinse the mouth without swallowing after inhalation of salmeterol in fixed combination with fluticasone propionate.221 254 255

Salmeterol-fluticasone Inhalation Aerosol

Use the inhalation aerosol only with the actuator supplied with the product.258

Shake the oral aerosol inhaler well for 5 seconds before each inhalation.257 258 Test spray inhaler 4 times into the air (away from face) before initial use, and shake well for 5 seconds before each spray.257 258 If inhaler not used for >4 weeks or if inhaler was dropped, test spray inhaler twice into the air (away from face) and shake well for 5 seconds before each spray.257 258

Remove cap covering mouthpiece of the aerosol inhaler.258 Look for foreign objects inside inhaler prior to use and check to see that canister is fully seated within actuator.258

After exhaling as completely as possible, place mouthpiece of inhaler well into mouth and close lips firmly around it.258 Inhale deeply through mouth while actuating inhaler.258 Remove mouthpiece from mouth and hold breath for as long as possible (up to 10 seconds) and exhale slowly.258 It is recommended that 30 seconds elapse between inhalations.258 After inhalation, rinse mouth and spit out water.257 258

Clean the aerosol inhaler by wiping the opening where medicine sprays out of metal canister and mouthpiece with a dry cotton swab and dampened tissue, respectively, at least once a week after evening dose.257 258 Allow actuator to air-dry overnight.258

When dose counter on the aerosol inhaler reads “020,” recommend that the patient contact the pharmacy for a refill or consult clinician to determine need for a refill.257 Discard inhaler when the dose counter reads “000.”257 Never alter or remove dose counter from canister.257

Dosage

Available as salmeterol xinafoate; dosage expressed in terms of salmeterol.1

Each blister in the Serevent Diskus device contains 50 mcg of salmeterol inhalation powder; however, precise amount of drug delivered to lungs with each activation of the device depends on factors such as patient’s inspiratory flow.188

Each blister in the Advair Diskus device contains 50 mcg of salmeterol and 100, 250, or 500 mcg of fluticasone propionate; however, precise amount of each drug delivered to lungs with each activation of device depends on factors such as patient’s inspiratory flow.221

Each actuation of the Advair HFA oral aerosol inhaler delivers 25 mcg of salmeterol and 50, 125, or 250 mcg of fluticasone propionate from the valve.257 Dosages in the fixed-combination inhalation aerosol are expressed in terms of drug delivered from the mouthpiece; each actuation of the inhaler delivers 21 mcg of salmeterol and 45, 115, or 230 mcg of fluticasone propionate from the mouthpiece.257

Commercially available Advair HFA inhalation aerosol delivers 60 or 120 metered sprays per 8- or 12-g canister, respectively.257

Pediatric Patients

Asthma Salmeterol Oral Inhalation Powder

Children ≥4 years of age: 50 mcg (1 inhalation) twice daily.188

Salmeterol/Fluticasone Fixed-combination Oral Inhalation Aerosol

Children ≥12 years of age: 42 mcg of salmeterol and 90, 230, or 460 mcg of fluticasone propionate (2 inhalations) twice daily;257 258 265 recommended initial dosage is based on patient’s current asthma therapy.257

If control of asthma is inadequate after 2 weeks of therapy at the initial dosage, replacing the current strength of the fixed combination with a higher strength (higher strengths contain higher dosages of fluticasone only) may provide additional asthma control.257

Oral Inhalation Powder

Children 4–11 years of age: 50 mcg of salmeterol and 100 mcg of fluticasone propionate (1 inhalation) twice daily in those inadequately controlled on an inhaled corticosteroid.221

Children ≥12 years of age: 50 mcg of salmeterol and 100, 250, or 500 mcg of fluticasone propionate (1 inhalation) twice daily;221 265 recommended initial dosage is based on patient’s asthma severity.221

If control of asthma is inadequate after 2 weeks of therapy at the initial dosage, replacing the current strength with a higher strength (higher strengths contain higher dosages of fluticasone only) may provide additional asthma control.221

Exercise-induced Bronchospasm Salmeterol Oral Inhalation Powder

Children ≥4 years of age: 50 mcg (1 inhalation) administered at least 30 minutes before exercise.188

Adults

Asthma Salmeterol Oral Inhalation Powder

50 mcg (1 inhalation) twice daily.188

Salmeterol/Fluticasone Fixed-combination Oral Inhalation Aerosol

42 mcg of salmeterol and 90, 230, or 460 mcg of fluticasone propionate (2 inhalations) twice daily;257 258 265 recommended initial dosage is based on patient’s current asthma therapy.257

If control of asthma is inadequate after 2 weeks of therapy at the initial dosage, replacing the current strength with a higher strength (higher strengths contain higher dosages of fluticasone only) may provide additional asthma control.257

Oral Inhalation Powder

50 mcg of salmeterol and 100, 250, or 500 mcg of fluticasone propionate (1 inhalation) twice daily;221 265 recommended initial dosage is based on patient’s asthma severity.221

If control of asthma is inadequate after 2 weeks of therapy at the initial dosage, replacing the current strength with a higher strength (higher strengths contain higher dosages of fluticasone only) may provide additional asthma control.221

Exercise-induced Bronchospasm Salmeterol Oral Inhalation Powder

50 mcg (1 inhalation) administered at least 30 minutes before exercise.188

COPD Salmeterol Oral Inhalation Powder

50 mcg (1 inhalation) twice daily.188

Salmeterol/Fluticasone Fixed-combination Oral Inhalation Powder

50 mcg of salmeterol and 250 mcg of fluticasone propionate (1 inhalation) twice daily.221

Use of higher dosages produces no additional improvement in lung function.221

Prescribing Limits

Pediatric Patients

Asthma Salmeterol Oral Inhalation Powder

Children ≥4 years of age: Maximum 50 mcg (1 inhalation) twice daily.188

Salmeterol/Fluticasone Fixed-combination Oral Inhalation Aerosol

Children or adolescents ≥12 years of age: Maximum 42 mcg of salmeterol and 460 mcg of fluticasone propionate (2 inhalations) twice daily.257

Oral Inhalation Powder

Children 4–11 years of age: Maximum 50 mcg of salmeterol and 100 mcg of fluticasone propionate (1 inhalation) twice daily.221

Children or adolescents ≥12 years of age: Maximum 50 mcg of salmeterol and 500 mcg of fluticasone propionate (1 inhalation) twice daily.221

Exercise-induced Bronchospasm Salmeterol Oral Inhalation Powder

Children ≥4 years of age: Maximum 50 mcg (1 inhalation) twice daily (every 12 hours).188

Adults

Asthma Salmeterol Oral Inhalation Powder

Maximum 50 mcg (1 inhalation) twice daily.188

Salmeterol/Fluticasone Fixed-combination Oral Inhalation Aerosol

Maximum 42 mcg of salmeterol and 460 mcg of fluticasone propionate (2 inhalations) twice daily.257

Oral Inhalation Powder

Maximum 50 mcg of salmeterol and 500 mcg of fluticasone propionate (1 inhalation) twice daily.221

Exercise-induced Bronchospasm Salmeterol Oral Inhalation Powder

Maximum 50 mcg (1 inhalation) twice daily (every 12 hours).188

COPD Salmeterol Oral Inhalation Powder

Maximum 50 mcg (1 inhalation) twice daily.188

Salmeterol/Fluticasone Fixed-combination Oral Inhalation Powder

Maximum 50 mcg of salmeterol and 250 mcg of fluticasone propionate (1 inhalation) twice daily.221

Special Populations

The following information addresses dosage of salmeterol in special populations.188 When salmeterol is used in fixed combination with fluticasone propionate, dosage requirements for fluticasone propionate should be considered.221 257

Hepatic Impairment

No specific dosage recommendations at this time.188 (See Hepatic Impairment under Cautions.)

Renal Impairment

No specific dosage recommendations at this time.188 221

Geriatric Patients

Dosage adjustments not recommended solely because of age in geriatric patients.188 221 257

Interactions for Advair HFA (combination), Serevent Diskus

The following information addresses potential interactions with salmeterol.188 When used in fixed combination with fluticasone, consider interactions associated with fluticasone.221 257 No formal drug interaction studies have been performed to date with the fixed-combination.221 257

Salmeterol is a substrate for CYP3A4.221 257

Drugs Affecting Hepatic Microsomal Enzymes

Potential pharmacokinetic (increased peak plasma concentrations and AUC of salmeterol) and pharmacologic interactions (increased risk of adverse cardiovascular effects [e.g., QTc prolongation, palpitations, sinus tachycardia]) with concomitant use of CYP3A4 inhibitors.188 221 257 Concomitant use of potent CYP3A4 inhibitors with salmeterol alone or in fixed combination with fluticasone not recommended.188 221 257

Specific Drugs

Drug

Interaction

Comments

Atazanavir

Possible increased peak concentrations and AUC of salmeterol; possible increased risk of adverse cardiovascular effects188 221 257

Concomitant use not recommended188 221 257

β2-Adrenergic agonists, short-acting

Potential for increased adverse cardiovascular effects, but such effects less likely with a selective β2-adrenergic agonist like salmeterol110 115 116 117 118 120

Safety of concomitant use of >8 inhalations of supplemental, short-acting β2-agonist therapy with salmeterol inhalation therapy not established1 188

β-Adrenergic blocking agents

Potential for antagonism of pulmonary effects resulting in severe bronchospasm in patients with asthma or COPD154 156 188

If concomitant therapy required, consider cautious use of cardioselective β-adrenergic blocking agents188

Clarithromycin

Possible increased peak concentrations and AUC of salmeterol; possible increased risk of adverse cardiovascular effects188 221 257

Concomitant use not recommended188 221 257

Cromolyn sodium

No apparent alteration in safety profile of salmeterol oral inhalation when administered concurrently16 17 25 45 52 102 188

Diuretics, non-potassium-sparing

Potential for additive hypokalemia and/or ECG changes, especially when recommended β-agonist dose is exceeded1

Clinical importance unknown; however, use concomitantly with caution1 188

Indinavir

Possible increased peak concentrations and AUC of salmeterol; possible increased risk of adverse cardiovascular effects188 221 257

Concomitant use not recommended188 221 257

Itraconazole

Possible increased peak concentrations and AUC of salmeterol; possible increased risk of adverse cardiovascular effects188 221 257

Concomitant use not recommended188 221 257

Ketoconazole

Increased peak concentrations and AUC of salmeterol; possible increased risk of adverse cardiovascular effects 188 221 257

Concomitant use not recommended188 221 257

MAO inhibitors

Potential for increased effect of salmeterol on the vascular system1

Extreme caution recommended with concomitant therapy or within 2 weeks following discontinuance of an MAO inhibitor1

Nefazodone

Possible increased peak concentrations and AUC of salmeterol; possible increased risk of adverse cardiovascular effects188 221 257

Concomitant use not recommended188 221 257

Nelfinavir

Possible increased peak concentrations and AUC of salmeterol; possible increased risk of adverse cardiovascular effects188 221 257

Concomitant use not recommended188 221 257

Ritonavir

Possible increased peak concentrations and AUC of salmeterol; possible increased risk of adverse cardiovascular effects188 221 257

Concomitant use not recommended188 221 257

Saquinavir

Possible increased peak concentrations and AUC of salmeterol; possible increased risk of adverse cardiovascular effects188 221 257

Concomitant use not recommended188 221 257

Telithromycin

Possible increased peak concentrations and AUC of salmeterol; possible increased risk of adverse cardiovascular effects188 221 257

Concomitant use not recommended188 221 257

Tricyclic antidepressants

Potential for increased effect of salmeterol on the vascular system1

Extreme caution recommended with concomitant therapy or in patients receiving salmeterol within 2 weeks of discontinuance of these agents1

Xanthine derivatives

Potential for increased cardiotoxic effects with concomitant administration of sympathomimetic agents and aminophylline but not theophylline1 123 124 154

No apparent alteration in safety profile of salmeterol oral inhalation observed when administered concurrently with theophylline in patients with asthma or COPD in clinical studies188

Advice to Patients

  • When used in fixed combination with fluticasone, importance of informing patients of important cautionary information about fluticasone.221 257

  • Provide a copy of the manufacturer's patient information (medication guide) for salmeterol alone or in fixed combination with fluticasone with each prescription.249 250 252 Importance of instructing patients to read the medication guide prior to initiation of therapy and each time prescription is refilled.253 254 258

  • Importance of informing patients that long-acting β2-adrenergic agonists, including salmeterol, increase the risk of asthma-related death and may increase the risk of asthma-related hospitalization in children and adolescents.188 221 257

    Importance of informing patients that salmeterol should not be the only therapy used for asthma treatment and must only be used as additional therapy when long-term asthma controller therapy (e.g., inhaled corticosteroids) does not adequately control symptoms.188 Importance of informing patients that long-term asthma controller drugs must be continued when salmeterol is added to the treatment regimen.188

  • Importance of children receiving therapy under adult supervision.253

  • Importance of adequate understanding of proper storage, preparation, and inhalation techniques, including use of the inhalation delivery system.1 25 188 189 221 257

  • Importance of adherence to dosing schedules, including not altering the dose or frequency of use unless otherwise instructed by a clinician.1 156 188 221 253 257

  • Importance of advising patient that if a dose of salmeterol alone or in fixed combination with fluticasone is missed, the next dose should be taken at the regularly scheduled time; the dose should not be doubled.253 254 258

  • Importance of all patients being provided with and instructed in the use of a short-acting, inhaled β2-agonist (e.g., albuterol) as treatment for acute symptoms (e.g., shortness of breath).97 188 221 257

  • Importance of discontinuing regular use of short-acting, oral or inhaled β-agonists when initiating salmeterol and using short-acting, inhaled β-agonists to relieve acute symptoms (e.g., shortness of breath).188 221 257

  • Importance of contacting a clinician if asthma symptoms do not improve after 1 week of therapy.253 254 258

  • Importance of contacting a clinician immediately if patient experiences decreasing effectiveness of short-acting inhaled β2-agonists, need for more inhalations than usual of short-acting inhaled β2-agonists, or clinically important decrease in lung function (as outlined by clinician).188 221 257

  • Importance of patients who are receiving salmeterol-containing preparations not to use additional salmeterol or other long-acting β2-adrenergic agonists for any reason, including prevention of exercise-induced bronchospasm or treatment of asthma or COPD.188 221 257

  • Importance of patients receiving corticosteroid therapy not to discontinue or alter dosage of corticosteroids without consulting a clinician, even if the patient feels better after initiating salmeterol.2 5 16 20 40 42 43 45 61 62 63 72 85 97 188 Importance of informing patients that salmeterol should not be used as a substitute for oral or inhaled corticosteroids.188

  • Importance of informing all patients with asthma that they must also continue regular maintenance treatment with an inhaled corticosteroid if they are receiving salmeterol.188

  • Importance of patients not discontinuing therapy with salmeterol without medical supervision, since symptoms may recur after discontinuance.188 221 257

  • Importance of administering salmeterol inhalation powder at least 30 minutes prior to exercise for prevention of exercise-induced bronchospasm.188 Importance of not using additional doses of salmeterol for exercise-induced bronchospasm for 12 hours.188 Importance of not using additional salmeterol for exercise-induced bronchospasm while receiving therapy (twice daily) with salmeterol.188

  • Importance of informing patients of adverse effects associated with β2-adrenergic agonists, such as palpitations, rapid heart rate, tremor, nervousness, or chest pain.154 156 188 221 257

  • Importance of informing a clinician of heart problems, high BP, seizures, thyroid disorders, diabetes mellitus, allergies to drugs or food (including milk proteins), or liver disorders prior to initiation of therapy.188 221 253 254 258

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.253 254 257 258

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, vitamins, and herbal supplements.253 254 258

  • Importance of informing patients of other important precautionary information.188 221 257 (See Cautions.)

For the Consumer

Applies to salmeterol: inhalation aerosol powder, inhalation disk, inhalation powder

Along with its needed effects, salmeterol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking salmeterol:

More common
  • Cough producing mucus
  • difficulty with breathing
  • headache
  • irritation of the throat
  • runny nose
  • shortness of breath
  • sneezing
  • stuffy nose
  • tightness in the chest
  • wheezing
Less common
  • Abdominal or stomach pain
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chills
  • colds
  • cough or hoarseness
  • diarrhea
  • difficulty breathing
  • dizziness
  • dry mouth
  • fever
  • flu-like symptoms
  • flushed, dry skin
  • fruit-like breath odor
  • general feeling of discomfort or illness
  • increased hunger
  • increased thirst
  • increased urination
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • nervousness
  • noisy breathing
  • pain
  • pain or tenderness around the eyes and cheekbones
  • pounding in the ears
  • shivering
  • slow or fast heartbeat
  • sore mouth or tongue
  • sore throat
  • sweating
  • swelling
  • trouble with sleeping
  • troubled breathing
  • unexplained weight loss
  • unusual tiredness or weakness
  • vomiting
  • white patches in the mouth or on the tongue

Get emergency help immediately if any of the following symptoms of overdose occur while taking salmeterol:

Symptoms of overdose
  • Arm, back, or jaw pain
  • confusion
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • fainting
  • fast or irregular heartbeat
  • fast, slow, pounding, or irregular heartbeat or pulse
  • seizures
  • shakiness in the legs, arms, hands, or feet
  • sleeplessness
  • trembling or shaking of the hands or feet
  • unable to sleep

Some side effects of salmeterol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Acid or sour stomach
  • anxiety
  • belching
  • blistering, burning, crusting, dryness, or flaking of the skin
  • bone pain
  • burning, dry, or itching eyes
  • difficulty with moving
  • discharge or excessive tearing
  • eye redness, irritation, or pain
  • headache, severe and throbbing
  • heartburn
  • hives or welts
  • indigestion
  • itching, scaling, severe redness, soreness, or swelling of the skin
  • mouth or tooth pain
  • muscle cramps and spasm
  • muscle stiffness or tightness
  • redness of the skin
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • skin rash
  • skin rash, encrusted, scaly and oozing
  • stomach discomfort, upset, or pain

Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Maintenance

50 mcg (1 inhalation) orally twice daily, approximately 12 hours apart

Use: Long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis

Usual Pediatric Dose for Asthma - Maintenance

Less than 4 years: Not approved.

4 years or older: 50 mcg (1 inhalation) orally twice a day, approximately 12 hours apart

Comments:
-For patients with asthma less than 18 years of age requiring addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and LABA should be used to ensure adherence with both drugs.
-If the use of a separate long-term asthma control medication (e.g., inhaled corticosteroid) and LABA is clinically indicated, take appropriate steps to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an inhaled corticosteroid and LABA is recommended.

Uses:
-Treatment of asthma and prevention of bronchospasm only as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma.

Salmeterol Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: -Physicians should be contacted if pregnancy occurs while taking this drug. -Beta-agonists, including this drug, may potentially interfere with uterine contractility due to a relaxant effect on uterine smooth muscle.

Studies in rats showed no teratogenic effects at doses approximately 160 times the maximum recommended daily inhalation dose (MRHDID). In pregnant Dutch rabbits administered oral doses approximately 50 times the MRHDID, fetal toxic effects were observed characteristically resulting from beta-adrenoceptor stimulation (e.g., precocious eyelid openings, cleft palate, sternebral fusion, limb and paw flexures, and delayed ossification of the frontal cranial bones). New Zealand White rabbits were less sensitive since only delayed ossification of the frontal cranial bones was seen at an oral dose approximately 1,600 times the MRHDID. This drug crossed the placenta following oral administration to mice and rats. There are no well-controlled human trials that have investigated effects of this drug on pregnancy, preterm labor, or labor at term. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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