Advair Diskus

Name: Advair Diskus

Fluticasone Salmeterol Dosage

Salmeterol may increase the risk of asthma-related death. Use only the prescribed dose of fluticasone and salmeterol, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits of using this medicine.

Fluticasone and salmeterol is not a rescue medicine. It will not work fast enough to treat an asthma attack. Use only a fast acting inhalation medicine for an asthma attack.

Advair Diskus is a powder form of fluticasone and salmeterol that comes with a special inhaler device pre-loaded with blister packs containing measured doses of the medicine. The device opens and loads a blister each time you use the inhaler. This device is not to be used with a spacer.

Advair HFA is an aerosol form of fluticasone and salmeterol that comes in a canister that is used with an actuator inhaler device. Use only the inhaler device provided with Advair HFA. This device is not to be used with a spacer.

Shake the Advair HFA inhaler for at least 5 seconds before each spray.

To reduce the chance of developing a yeast infection in your mouth, rinse your mouth with water after using this medicine.

Keep track of the number of sprays you have used and throw away the Advair HFA canister after 120 sprays, even if it feels like there is still medicine in it.

If you also use an oral steroid medication, do not stop using it suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about tapering your steroid dose before stopping completely. Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. If you use a peak flow meter at home, call your doctor if your numbers are lower than normal.

Do not change your doses or medication schedule without advice from your doctor.

Store fluticasone and salmeterol at room temperature away from moisture, heat, and direct light. Keep the Advair HFA canister away from high heat, such as open flame or in a car on a hot day. The canister may explode if it gets too hot.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include angina or chest pain, fast or irregular heartbeats, seizures, tremor, weakness, headache, nausea, and vomiting.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What is the dosage for Advair Diskus, Advair HFA (fluticasone propionate and salmeterol oral inhaler)?

  • The recommended Advair Diskus regimen for asthma in individuals 12 years and older is one inhalation twice daily (morning and evening) approximately 12 hours apart.
  • The lowest effective strength should be used and the maximum dose is 500/50 mcg twice daily.
  • For children 4 to 11 years old the recommended treatment is one inhalation of 100/50 mcg twice daily.
  • The recommended regimen of Advair Diskus for COPD is one inhalation of 250/50 mcg twice daily. Higher doses are not more effective.
  • The recommended dose for Advair HFA is 2 inhalations twice daily. The lowest effective dose should be used.

The Diskus device is held in one hand with the thumb of the other hand placed on the thumb-grip. The thumb is then pulled away as far as the device allows until the mouthpiece seems to click into position. With the Diskus then held horizontally and with the mouthpiece towards the patient, the lever is then slid away as far as it can go until it clicks. The patient breathes out as far as comfortable, then placing his mouth to the mouthpiece, breathes in quickly and deeply and holds his breath for about ten seconds. The patient then washes his or her mouth without swallowing after inhalation.

Uses of Advair Diskus

Advair Diskus is a prescription medication used to treat asthma and chronic obstructive pulmonary disease (COPD). The condition COPD is a group of lung diseases that includes chronic bronchitis and emphysema.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Advair Diskus and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Advair Diskus falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems.  No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Before Using Advair Diskus

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Advair® Diskus® to treat asthma in children older than 4 years of age. Safety and efficacy have not been established in children younger than 4 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of Advair® HFA oral inhalation or Airduo™ Respiclick® in children younger than 12 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluticasone and salmeterol combination in the elderly. However, elderly people with heart and blood vessel problems may require special caution when receiving fluticasone and salmeterol combination.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Desmopressin
  • Fluconazole
  • Posaconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfuzosin
  • Amiodarone
  • Amprenavir
  • Apomorphine
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Atazanavir
  • Azithromycin
  • Bemiparin
  • Boceprevir
  • Bupropion
  • Ceritinib
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clozapine
  • Cobicistat
  • Conivaptan
  • Darunavir
  • Dasabuvir
  • Dasatinib
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Droperidol
  • Fingolimod
  • Flecainide
  • Fosamprenavir
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Ibutilide
  • Idelalisib
  • Iloperidone
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lapatinib
  • Lopinavir
  • Lumacaftor
  • Lumefantrine
  • Mefloquine
  • Mifepristone
  • Nadroparin
  • Nefazodone
  • Nelfinavir
  • Netupitant
  • Nilotinib
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Ombitasvir
  • Ondansetron
  • Paliperidone
  • Paritaprevir
  • Pixantrone
  • Posaconazole
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Quinidine
  • Quinine
  • Ranolazine
  • Ritonavir
  • Saquinavir
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sunitinib
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Tetrabenazine
  • Tipranavir
  • Toremifene
  • Trazodone
  • Trifluoperazine
  • Vardenafil
  • Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Erythromycin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma attack, acute or
  • Bronchospasm (difficulty with breathing), acute or
  • COPD flare-up or
  • Milk protein allergy, severe—Should not be used in patients with these conditions.
  • Blood vessel disease (eg, Churg-Strauss syndrome) or
  • Bone problems (eg, osteoporosis) or
  • Cataracts or
  • Diabetes or
  • Glaucoma or
  • Heart disease or
  • Heart rhythm problems (eg, arrhythmia) or
  • Hypertension (high blood pressure) or
  • Hyperthyroidism (overactive thyroid) or
  • Hypokalemia (low potassium in the blood) or
  • Ketoacidosis (high ketones in the blood) or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Chickenpox (including recent exposure) or
  • Herpes simplex (virus) infection of the eye or
  • Infections (virus, bacteria, or fungus) or
  • Measles or
  • Tuberculosis, active or history of—Inhaled fluticasone can reduce the body's ability to fight off these infections.
  • Infection or
  • Stress or
  • Surgery or
  • Trauma—Supplementary oral corticosteroids may be needed. Check with your doctor.
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Advair Diskus Side Effects

Along with its needed effects, a medicine 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:

More common
  • Black, tarry stools
  • blindness
  • blurred vision
  • burning, tingling, numbness, or pain in the hands, arms, feet, or legs
  • chills
  • cough
  • decreased vision
  • difficulty with breathing or swallowing
  • eye pain
  • fast heartbeat
  • fever
  • headache
  • hives or welts, skin itching, rash, or redness
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • nausea or vomiting
  • noisy breathing
  • painful or difficult urination
  • sensation of pins and needles
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stabbing pain in the arms or legs
  • swelling of the face, throat, or tongue
  • swollen glands
  • tearing
  • unusual bleeding or bruising
Incidence not known
  • Abdominal or stomach pain
  • backache
  • bruising
  • darkening of the skin
  • decrease in height
  • diarrhea
  • difficulty with moving
  • dizziness
  • facial hair growth in females
  • fainting
  • fast, slow, pounding, or irregular heartbeat or pulse
  • flushed, dry skin
  • fractures
  • fruit-like breath odor
  • full or round face, neck, or trunk
  • heavy bleeding
  • increased hunger
  • increased thirst or urination
  • irritability
  • large, flat, blue, or purplish patches in the skin
  • loss of sexual desire or ability
  • menstrual irregularities
  • mental depression
  • muscle pain or stiffness
  • muscle wasting
  • pain in the back, ribs, arms, or legs
  • pain in the joints
  • sweating
  • troubled breathing
  • unexplained weight loss
  • unusual tiredness or weakness
  • weight gain

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

Symptoms of overdose
  • Chest pain or tightness
  • confusion
  • convulsions (seizures)
  • decreased urine output
  • dry mouth
  • faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • general feeling of discomfort or illness
  • high blood pressure
  • loss of appetite
  • mood changes
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • sudden sweating
  • tremors
  • trouble with sleeping

Some side effects 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:

More common
  • Body aches or pain
  • choking
  • congestion
  • dryness of the throat
  • high-pitched noise when breathing
  • hoarseness
  • runny nose
  • sneezing
  • trouble with swallowing
  • voice changes
Less common
  • Cough-producing mucus
  • flu-like symptoms
  • irritation or inflammation of the eye
  • muscle pain
  • pain or tenderness around the eyes and cheekbones
  • sleep disorders
  • stuffy nose
  • white patches in the mouth or throat or on the tongue

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
  • Chest pain or pressure or a fast heartbeat.
  • Feeling nervous and excitable.
  • Shakiness.
  • Change in how you act.
  • Change in eyesight.
  • A burning, numbness, or tingling feeling that is not normal.
  • Choking.
  • Change in voice.
  • Seizures.
  • Bone pain.
  • Very bad dizziness.
  • Very bad headache.
  • Not able to sleep.
  • Feeling very tired or weak.
  • Vaginal itching or discharge.
  • Weight gain.
  • Mouth irritation or mouth sores.
  • Redness or white patches in mouth or throat.
  • This medicine can cause very bad breathing problems right after you take a dose. Sometimes, this may be life-threatening. If you have trouble breathing, breathing that is worse, wheezing, or coughing after using this medicine (Advair Diskus), use a rescue inhaler and get medical help right away.

How Supplied/Storage and Handling

Advair Diskus 100/50 is supplied as a disposable purple plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0695-00). Advair Diskus 100/50 is also supplied in an institutional pack containing 14 blisters (NDC 0173-0695-04).

Advair Diskus 250/50 is supplied as a disposable purple plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0696-00). Advair Diskus 250/50 is also supplied in an institutional pack containing 14 blisters (NDC 0173-0696-04).

Advair Diskus 500/50 is supplied as a disposable purple plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0697-00). Advair Diskus 500/50 is also supplied in an institutional pack containing 14 blisters (NDC 0173-0697-04).

Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children.

Advair Diskus should be stored inside the unopened moisture-protective foil pouch and only removed from the pouch immediately before initial use. Discard Advair Diskus 1 month after opening the foil pouch or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.

What is the most important information i should know about fluticasone and salmeterol (advair diskus, advair hfa)?

Do not use fluticasone and salmeterol to treat an asthma attack that has already begun.

Salmeterol may increase the risk of asthma-related death. Use only the prescribed dose of fluticasone and salmeterol, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits of using this medication.

Before using fluticasone and salmeterol, tell your doctor if you have a food or drug allergy, heart disease, high blood pressure, a seizure disorder, an infection, a weak immune system, diabetes, glaucoma, tuberculosis, osteoporosis, a thyroid disorder, or liver disease.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. If you use a peak flow meter at home, call your doctor if your numbers are lower than normal.

What should i avoid while using fluticasone and salmeterol (advair diskus, advair hfa)?

Do not use a second form of salmeterol (such as Serevent) or use a similar inhaled bronchodilator such as formoterol (Foradil) unless your doctor has told you to.

Fluticasone and salmeterol can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medicines.

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