Rhinocort Aqua

DRUG DESCRIPTION

Budesonide, the active ingredient of RHINOCORT AQUA (budesonide) Nasal Spray, is an anti-inflammatory synthetic corticosteroid.

It is designated chemically as (RS)-11-beta, 16-alpha, 17, 21-tetrahydroxypregna-l,4-diene-3,20-dione cyclic 16, 17-acetal with butyraldehyde.

Budesonide is provided as the 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:

RHINOCORT AQUA 32 mcg (budesonide) Nasal Spray  Structural Formula Illustration

Budesonide is a white to off-white, odorless powder that 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 5 is 1.6 x103.

RHINOCORT AQUA (budesonide) Nasal Spray is an unscented, metered-dose, manual-pump spray formulation containing a micronized suspension of budesonide in an aqueous medium. Microcrystalline cellulose and carboxymethyl cellulose sodium, dextrose anhydrous, polysorbate 80, disodium edetate, potassium sorbate, and purified water are contained in this medium; hydrochloric acid is added to adjust the pH to a target of 4.5.

RHINOCORT AQUA Nasal Spray delivers 32 mcg of budesonide per spray.

Each bottle of RHINOCORT AQUA (budesonide) Nasal Spray 32 mcg contains 120 metered sprays after initial priming.

Prior to initial use, the container must be shaken gently and the pump must be primed by actuating eight times. If used daily, the pump does not need to be reprimed. If not used for two consecutive days, reprime with one spray or until a fine spray appears. If not used for more than 14 days, rinse the applicator and reprime with two sprays or until a fine spray appears.

What are the possible side effects of budesonide nasal (Rhinocort Aqua)?

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:

  • severe or ongoing nose bleed;
  • sores in the nose that won't heal;
  • wheezing, trouble breathing;
  • vision problems; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • dry or sore...

Read All Potential Side Effects and See Pictures of Rhinocort Aqua

What are the precautions when taking budesonide (Rhinocort Aqua)?

Before using nasal budesonide, tell your doctor or pharmacist if you are allergic to it; 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: eye problems (such as glaucoma, cataracts), infections (including tuberculosis), recent nose problems (such as injury, ulcers, surgery).

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.

Rarely, using corticosteroid medications for a long time can make it more difficult...

Read All Potential Precautions of Rhinocort Aqua


Rhinocort Aqua Consumer (continued)

SIDE EFFECTS: Nose/throat dryness or irritation, cough, sneezing, nosebleeds, and unpleasant taste/smell may occur. If any of these side effects persist or worsen, tell your doctor or pharmacist 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.

Tell your doctor immediately if any of these rare but serious side effects occur: loss of taste or smell, pain/sores in your nose.

Rarely, it is possible that corticosteroids given in the nose will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time and in high doses. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

Corticosteroids may weaken the body's ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. This effect might also rarely occur with corticosteroids inhaled through the nose (such as budesonide). The risk may be increased if high doses are used, especially when used for a long time. Tell your doctor immediately if you have any signs of infection (such as ear pain, persistent sore throat, fever, chills, white patches inside the nose or on the back of the throat).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, wheezing/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 nasal budesonide, tell your doctor or pharmacist if you are allergic to it; 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: eye problems (such as glaucoma, cataracts), infections (including tuberculosis), recent nose problems (such as injury, ulcers, surgery).

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.

Rarely, using corticosteroid medications for a long time can make it 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 this medication within the past few months.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

Tell your doctor if you are pregnant before using nasal budesonide. Rarely, infants born to mothers who have been using corticosteroids (including budesonide) for a long time may have low levels of corticosteroid hormone. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn. Discuss the risks and benefits with your doctor.

It is unknown if nasal budesonide passes into breast milk. However, similar drugs pass into breast milk. Nasal budesonide might also pass into breast milk in very small amounts that are unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Rhinocort Aqua Patient Information Including Side Effects

Brand Names: Rhinocort Aqua

Generic Name: budesonide nasal (Pronunciation: byoo DEH so nide)

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

What is budesonide nasal (Rhinocort Aqua)?

Budesonide is a steroid. It prevents the release of substances in the body that cause inflammation.

Budesonide nasal is used to treat nasal symptoms such as congestion, sneezing, and runny nose caused by seasonal or year-round allergies. Budesonide is also used to keep nasal polyps from coming back after surgery to remove them.

Budesonide may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of budesonide nasal (Rhinocort Aqua)?

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:

  • severe or ongoing nose bleed;
  • sores in the nose that won't heal;
  • wheezing, trouble breathing;
  • vision problems; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • dry or sore throat, cough;
  • irritation in your nose;
  • pain, swelling, burning, itching, or irritation in your throat;
  • sores or white patches inside or around your nose.

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 nasal (Rhinocort Aqua)?

Before using budesonide, tell your doctor if you have been sick or had an infection of any kind. Also tell your doctor if you have liver disease, glaucoma or cataracts, herpes simplex infection of your eyes, tuberculosis, sores or ulcers in your nose, or if you have recently had injury of or surgery on your nose.

It may take up to 2 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after a week of treatment.

To be sure this medication is not causing harmful effects on your nose or sinuses, your doctor may want to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.

Budesonide nasal 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 budesonide nasal.

Avoid getting this medication in your eyes. If this does happen, rinse with water and call your doctor.

Steroid medicines can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using budesonide nasal.

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