Symbicort

DRUG DESCRIPTION

SYMBICORT (budesonide and formoterol fumarate dihydrate) 80/4.5 and SYMBICORT (budesonide and formoterol fumarate dihydrate) 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only.

Each SYMBICORT (budesonide and formoterol fumarate dihydrate) 80/4.5 and SYMBICORT (budesonide and formoterol fumarate dihydrate) 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing either 60 or 120 actuations [see Dosage Forms and Strengths and HOW SUPPLIED]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. SYMBICORT (budesonide and formoterol fumarate dihydrate) also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant.

SYMBICORT (budesonide and formoterol fumarate dihydrate) should be primed before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds before each spray and releasing two test sprays into the air away from the face.

One active component of SYMBICORT (budesonide and formoterol fumarate dihydrate) is budesonide, a corticosteroid designated chemically as (RS)-11?, 16?, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is:

Budesonide Structural Formula Illustration

Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103.

The other active component of SYMBICORT (budesonide and formoterol fumarate dihydrate) is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-()-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is:

Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25C is 7.9 for the phenolic group and 9.2 for the amino group.

What are the possible side effects of budesonide and formoterol inhalation (Symbicort)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • worsening asthma symptoms;
  • chest pain, fast or pounding heartbeats, tremors, nervousness;
  • wheezing, throat irritation, choking, or other breathing problems after using this medication;
  • signs of infection such as fever, chills, sore...

Read All Potential Side Effects and See Pictures of Symbicort

What are the precautions when taking budesonide and formoterol fumarate dihydrate (Symbicort)?

Before using this medication, tell your doctor or pharmacist if you are allergic to budesonide or formoterol; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your 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.

Formoterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can...

Read All Potential Precautions of Symbicort


Symbicort Consumer (continued)

SIDE EFFECTS: Headache, throat irritation, or stomach upset may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

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.

Tell your doctor right away if any of these unlikely but serious side effects occur: 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).

Get medical help right away if any of these rare but serious side effects occur: chest pain, fast/slow/irregular heartbeat, severe dizziness, fainting, seizures.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, sudden trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to budesonide or formoterol; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your 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.

Formoterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in 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 affect the heart rhythm. Before using this product, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: 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. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using this medication safely.

This medication may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Therefore, 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 immediately 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).

This medication 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.

Budesonide passes into breast milk. It is unknown if formoterol passes into breast milk. Consult your doctor before breast-feeding.


Symbicort Patient Information Including Side Effects

Brand Names: Symbicort

Generic Name: budesonide and formoterol inhalation (Pronunciation: bue DES oh nide and for MOE te rol)

  • What is budesonide and formoterol inhalation (Symbicort)?
  • What are the possible side effects of budesonide and formoterol inhalation (Symbicort)?
  • What is the most important information I should know about budesonide and formoterol inhalation (Symbicort)?
  • What should I discuss with my healthcare provider before using budesonide and formoterol inhalation (Symbicort)?
  • How should I use budesonide and formoterol inhalation (Symbicort)?
  • What happens if I miss a dose (Symbicort)?
  • What happens if I overdose (Symbicort)?
  • What should I avoid while using budesonide and formoterol inhalation (Symbicort)?
  • What other drugs will affect budesonide and formoterol (Symbicort)?
  • Where can I get more information?

What is budesonide and formoterol inhalation (Symbicort)?

Budesonide is a steroid that reduces inflammation in the body.

Formoterol is a long-acting bronchodilator that relaxes muscles in the airways to improve breathing.

The combination of budesonide and formoterol is used to prevent bronchospasm in people with asthma or chronic obstructive pulmonary disease (COPD).

Budesonide and formoterol inhalation may also be used for other purposes not listed in this medication guide.

What are the possible side effects of budesonide and formoterol inhalation (Symbicort)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • worsening asthma symptoms;
  • chest pain, fast or pounding heartbeats, tremors, nervousness;
  • wheezing, throat irritation, choking, or other breathing problems after using this medication;
  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding, unusual weakness;
  • blurred vision, eye pain, or seeing halos around lights;
  • white patches or sores in your mouth or throat; or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • headache;
  • back pain;
  • nausea, vomiting, diarrhea, upset stomach;
  • back pain, muscle cramps;
  • sore throat, stuffy nose;
  • joint or muscle pain; or
  • changes in your voice.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about budesonide and formoterol inhalation (Symbicort)?

Do not use budesonide and formoterol inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use only a fast-acting inhalation medicine to treat an asthma attack.

Budesonide and formoterol inhalation may increase the risk of asthma-related death. It is critical that you use only the prescribed dose of this medicine and follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits in using budesonide and formoterol inhalation.

Asthma is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor.

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.

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