BUDESONIDE-FORMOTEROL INHALATION

Rarely, serious (sometimes fatal) asthma-related breathing problems may occur in people with asthma who are treated with drugs similar to formoterol (long-acting beta agonists). In people with asthma, this product should only be used when one long-term medication (such as inhaled corticosteroids) does not control breathing problems. Before using this medication, it is important to learn how to use it properly. Discuss the risks and benefits of this medication with your doctor.

• Minor side effects (if these symptoms persist or worsen, inform your doctor)
  • Headache, throat irritation, or stomach upset
  • May increase blood pressure
  • Infrequently, this medication may cause severe sudden worsening of breathing problems/asthma immediately after use. If you have sudden worsening of breathing, use your quick-relief inhaler and get medical help right away.
• Serious side effects (inform your doctor immediately)
  • White patches on tongue/in mouth, signs of infection (such as fever, persistent sore throat), mental/mood changes (such as nervousness), trouble sleeping, vision problems (such as blurred vision), increased thirst/urination, muscle cramps, shaking (tremors)
  • Chest pain, fast/slow/irregular heartbeat, severe dizziness, fainting, seizures
• Severe allergic reactions are rare. Get immediate medical help if you notice the following:
  • Rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing

Precautions

• Inform your doctor
  • Allergy to to budesonide or formoterol; or to arformoterol or any allergies
  • Medical History, especially of:
    • current/past infections (such as tuberculosis, herpes), high blood pressure, heart disease (such as chest pain, heart attack, irregular heartbeat), overactive thyroid (hyperthyroidism), seizures, bone loss (osteoporosis), eye problems (such as cataracts, glaucoma), diabetes, liver disease, swelling of an artery (aneurysm), a certain tumor of the adrenal gland (pheochromocytoma).
• Formoterol may cause QT prolongation, a condition that affects the heart rhythm
  • can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
  • The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation:
    • certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
    • Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation.
      • Usage of such as diuretics/”water pills” or presence of conditions such as severe sweating, diarrhea, or vomiting.
• May mask signs of infection and/or make you more likely to get infections or may worsen any current infections.
  • Practice proper handwashing to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu)
• Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.
• Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
• May slow down a child’s growth if used for a long time, but poorly controlled asthma can also slow down growth. The effect on final adult height is unknown. See the doctor regularly so your child’s height can be checked.
• During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Babies born to mothers who have used corticosteroids for a long time may develop hormone problems. Tell your doctor right away if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn
• Passes into breast milk
  • It is unknown if formoterol passes into breast milk. Before breast-feeding, consult your physician.

Interactions

Taking multiple drugs may affect how medications work and/or cause unwanted side effects. List down all the medications you are taking and inform your physician and pharmacist. Do not take, discontinue, or alter any dose of medications without prior approval of your physician.

• Products that may interact with this medication include:
  • aldesleukin, mifepristone.

Overdose

If overdose is suspected, contact a poison control center or emergency room right away.

• Laboratory and/or medical tests (such as lung function tests, blood pressure, bone density tests) may be performed to monitor your progress or check for side effects. Consult your doctor for more details.
• Learn to use a peak flow meter, use it daily, and promptly report worsening asthma or other breathing problems (such as readings in the yellow/red range or increased use of quick-relief inhalers).
• Avoid allergens/irritants such as smoke, pollen, pet dander, dust, and molds that may worsen asthma and other breathing problems. Because the flu virus can also worsen breathing problems, ask your doctor or pharmacist if you should have a flu shot every year.
• In adults, this medication can increase the risk of bone loss (osteoporosis) if used for a long time. Talk with your doctor about your risk, and about available treatments for osteoporosis. Lifestyle changes that reduce the risk of bone loss include doing weight-bearing exercise, getting enough calcium and vitamin D, stopping smoking, and limiting alcohol. To help prevent osteoporosis later in life, encourage children to exercise and eat a healthy diet (including calcium).

Missed Dose

If you miss a dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

• Room temperature
• Do not expose to light and moisture
• Do not store in the bathroom
• Keep all medications away from pets and children
• Do not flush medications down the toilet or pour them into a drain unless instructed to do so
• Properly discard this product when it is expired or no longer needed
  • Consult your pharmacist or local waste disposal company for more details about how to safely discard your product

Brands

 Available Brands:

• Symbicort