Pulmicort 0,5 mg/ml

Trade Name:

Pulmicort 0,5 mg/ml

20 sterile single dose units × 2 ml

Composition:

Active ingredient: budesonide (micronized)

Inactive ingredients:

disodium edetate, sodium chloride, sodium citrate, citric acid, polysorbate 80 and water

Properties:

Budesonide is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. This medication belongs to a class of drugs known as corticosteroids. It works directly in the lungs to make breathing easier by reducing the irritation and swelling of the airways.This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler as prescribed.

Indications

Pulmicort is indicated for the maintenance treatment of asthma and asprophylactic therapy in children 12 months to 8 years of age.

Pulmicort is not indicated for the relief of acute bronchospasm.

Dosage and administration:

The Pulmicort dosage your doctor prescribes will depend on several factors. These include:

-the severity of the condition you’re using Pulmicort;

-your age;

-the form of Pulmicort that you take

-other medical conditions you may have. Typically, your doctor will adjust your dose over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

• Pulmicort single doses are small plastic containers that hold a liquid form of Pulmicort. The respules should be taken using a jet nebulizer that’s connected to an air compressor. (A nebulizer turns the liquid medication that’s held in the respules into a mist that you can inhale.) With nebulizer treatments, the medication can be easily inhaled through the mouthpiece or face mask that’s connected to the nebulizer.

Side effects:

• common:cough, conjunctivitis,nosebleeds, rash, runny nose, stuffy nose, respiratory infections, such as the common cold, ear infections.
• rare/serious: paradoxical bronchospasm, 

increased risk of infections, reduced bone mineral density, slowed growth in children and teenagers.

• others: severe allergic reactions, glaucoma and cataracts, adrenal insufficiency.

Contraindications:

Pulmicort is contraindicated as the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

Hypersensitivity to budesonide or any of the ingredients of this preparation contraindicates the use of Pulmicort.

Warnings and precautions:

Before taking Pulmicort, talk with your doctor about your health history. Pulmicort may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

• An allergy to milk proteins;
• Tuberculosis (TB) infection in your lungs;
• Untreated bacterial, viral, fungal, or parasitic infections;
• Ocular herpes infections;
• Not being immunized for measles or chickenpox;
• Reduced bone mineral density (weak bones);
• Eye problems, such as raised pressure in your eye, glaucoma, or cataracts;
• Liver problems;
• Pregnancy;
• Breastfeeding.

Storage:

Store at a temperature not exceeding 25°C. Single dose respules can be kept for 2 weeks after the foil envelope is opened.

Package:

Carton box holds 20 vials × 2 ml (5 × 2 mL/envelope)