Budoneb 0.5mg Repsules 2ml

BUDONEB 0.5MG REPSULES 2ML by EVONEXT HEALTHCARE DIV.

BUDONEB 0.5MG REPSULES 2ML is a corticosteroid medication formulated for inhalation, primarily used for the long-term management of respiratory conditions.

• Name:

  • Brand Name: BUDONEB 0.5MG REPSULES 2ML
  • Common Name: Budesonide Inhalation Suspension 0.5 mg/2 mL

• Composition:

  • Active Ingredient: Budesonide 0.5 mg.
  • Excipients: Each 2.0 ml respule contains Budesonide IP 0.5 mg in a sterile aqueous vehicle. Similar formulations also include disodium edetate, sodium chloride, sodium citrate, citric acid, polysorbate 80, and Water for Injection.

• Uses: BUDONEB is prescribed to control and prevent symptoms associated with various respiratory conditions.

  • Asthma: It is indicated for the maintenance treatment of asthma to prevent symptoms such as wheezing, shortness of breath, and chest tightness, by reducing inflammation and swelling in the airways. It is a "controller" medication and should not be used for sudden asthma attacks.
  • Croup: It is also recommended for the treatment of croup (acute viral laryngotracheobronchitis) in infants and children where hospitalization is indicated.
  • Other Uses: It may also be used for lung diseases such as bronchitis and emphysema, and in some cases, for eosinophilic esophagitis.

• Dosage and Administration: BUDONEB is for inhalation only and must be administered using a jet nebulizer.

  • Adults (including the elderly and children 12 years and older): Typically 0.5 - 1 mg twice daily. The dose may be increased in very severe cases.
  • Children (3 months to 12 years): Usually 0.25 - 0.5 mg twice daily. In severe cases, up to 1 mg twice daily for limited periods.
  • Croup (Infants and Children): A usual dose of 2 mg, given as a single administration or as two 1 mg doses separated by 30 minutes. Dosing can be repeated every 12 hours for a maximum of 36 hours or until clinical improvement.
  • Administration: Breathe calmly and deeply until the mist stops, usually over 5 to 10 minutes. Avoid getting the medication in the eyes. Rinse mouth with water and spit out after each use to prevent oral thrush. Do not mix this medication with other medications in your nebulizer.

• Side Effects:

  • Common Side Effects: Dry/irritated throat, hoarseness, voice changes, bad taste in the mouth, runny nose, nosebleeds, cough, sore throat, headache, indigestion, and oral thrush (yeast infection in the mouth).
  • Serious Side Effects: Sudden breathing problems or worsening asthma immediately after use, severe allergic reactions (rash, itching/swelling of the face/tongue/throat, severe dizziness, trouble breathing), increased risk of infection, unusual tiredness, vision problems (such as cataracts or glaucoma), and in prolonged or high-dose use, bone loss (osteoporosis) or adrenal insufficiency.

• Precautions:

  • BUDONEB is not for immediate relief of sudden asthma attacks; a fast-acting "reliever" inhaler should be used for acute symptoms.
  • Rinse your mouth with water after each use to minimize the risk of oral yeast infections (thrush).
  • As a corticosteroid, it can weaken the immune system, making individuals more susceptible to infections. Avoid exposure to easily spread infections (e.g., chickenpox, measles, flu, COVID-19).
  • Inform your doctor about any existing medical conditions such as eye disease (cataracts, glaucoma), high blood pressure, liver disease, thyroid problems, diabetes, stomach/intestinal problems, bone loss (osteoporosis), or current/past infections (e.g., tuberculosis, herpes, fungal infections).
  • Discuss with your doctor if you are pregnant or breastfeeding.
  • Long-term use in children may temporarily slow growth; regular monitoring of height is recommended.
  • This medication may interact with certain drugs, particularly potent CYP3A inhibitors (e.g., itraconazole, ketoconazole). Consult your doctor about all medications you are taking.
  • Carry a warning card or medical ID bracelet stating you use (or have used) corticosteroid medications.

• Storage: Store BUDONEB respules upright at room temperature, between 68°F to 77°F (20°C to 25°C). Keep them in the foil envelope to protect from light. Do not refrigerate or freeze. Once the foil envelope is opened, discard any unused ampules after 2 weeks. Once an individual ampule is opened, its contents should be used immediately, and any remaining solution discarded.

BUDONEB 0.5MG REPSULES 2ML is a medicine containing Budesonide, an inhaled corticosteroid used for respiratory conditions. Below are some frequently asked questions about this medicine.

What is BUDONEB 0.5MG REPSULES 2ML used for?

BUDONEB 0.5MG REPSULES 2ML is primarily used as a "controller" or "preventer" medicine for the maintenance treatment of asthma to prevent symptoms such as wheezing and shortness of breath. It is also indicated for prophylactic therapy in children aged 12 months to 8 years and for the treatment of croup in infants and children. It is not intended for the rapid relief of sudden asthma attacks.

How does BUDONEB 0.5MG REPSULES 2ML work?

BUDONEB 0.5MG REPSULES 2ML contains budesonide, which is an inhaled corticosteroid. It works by decreasing inflammation and swelling in the airways of the lungs, which helps improve airflow and makes breathing easier. This action helps to prevent asthma symptoms from flaring up.

What is the usual dosage for BUDONEB 0.5MG REPSULES 2ML?

The dosage varies depending on the patient's age and the severity of their condition. For adults and children over 12 years, the usual starting dose can range from 0.5 mg to 2.0 mg daily, often divided into twice-daily doses. For children aged 3 months to 12 years, initial doses are typically 0.5 mg to 1 mg twice daily, or 0.25 mg to 1.0 mg daily. Maintenance doses are generally lower and should be adjusted to the lowest dose that keeps symptoms under control. For croup in infants and children, a common dose is 2 mg, given as a single administration or as two 1 mg doses separated by 30 minutes. It is crucial to follow your doctor's specific instructions.

What are the possible side effects of BUDONEB 0.5MG REPSULES 2ML?

Common side effects may include respiratory tract infection, ear infection, runny or stuffy nose, cough, sore throat, stomach pain, headache, and oral thrush (a fungal infection in the mouth or throat). To help prevent oral thrush, rinse your mouth with water and spit it out (do not swallow) after each dose. Serious but less common side effects can include severe allergic reactions, worsening breathing problems right after use, eye problems like cataracts or glaucoma, reduced adrenal function, and a weakened immune system making you more susceptible to infections.

Is BUDONEB 0.5MG REPSULES 2ML safe during pregnancy or breastfeeding?

Pregnancy: It is important to manage asthma during pregnancy, as uncontrolled asthma can pose risks to both the mother and the developing baby. Inhaled corticosteroids like budesonide are considered a preferred treatment for asthma during pregnancy. While it is not known if or how budesonide could affect an unborn baby, research suggests inhaled corticosteroids may not increase the risk of harm. Discuss the risks and benefits with your healthcare provider. Breastfeeding: Budesonide passes into breast milk in small amounts. While there is generally a low concern for adverse effects in breastfed infants, it is advisable to discuss with your doctor whether to use this medication while breastfeeding.

Can BUDONEB 0.5MG REPSULES 2ML be taken with other medications?

It is important to inform your doctor about all prescription, over-the-counter, herbal, and vitamin supplements you are taking. Budesonide is metabolized by an enzyme called CYP3A4 in the liver. Medications that inhibit this enzyme, such as ketoconazole, itraconazole, clarithromycin, and erythromycin, can increase the levels of budesonide in your body, potentially leading to more side effects. Grapefruit juice can also inhibit CYP3A4 and is generally not recommended. Do not mix BUDONEB 0.5MG REPSULES 2ML with other medicines in the nebulizer unless specifically instructed by your healthcare provider.

What precautions should be taken while using BUDONEB 0.5MG REPSULES 2ML?

• Do not use BUDONEB 0.5MG REPSULES 2ML to treat a sudden asthma attack; use your prescribed rescue inhaler for acute symptoms.
• Rinse your mouth with water and spit it out after each inhalation to prevent oral thrush and throat irritation.
• Avoid getting the medication in your eyes. If using a face mask, ensure it fits properly, and wash your face after use to prevent skin irritation.
• Inform your doctor about any pre-existing medical conditions, such as glaucoma, cataracts, bone problems (osteoporosis), liver disease, or current/past infections (e.g., tuberculosis, herpes, fungal infections).
• Long-term use of corticosteroids can weaken the immune system, making you more susceptible to infections. Avoid contact with people who are sick or have infections like chickenpox or measles.
• Prolonged use in children may affect growth; your doctor may monitor your child's height regularly.
• If you are switching from oral corticosteroids to BUDONEB 0.5MG REPSULES 2ML, do not stop the oral medication suddenly, as it can lead to withdrawal symptoms or worsening of your condition. Your doctor will provide a plan for gradual reduction.

What happens if a dose of BUDONEB 0.5MG REPSULES 2ML is missed?

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should BUDONEB 0.5MG REPSULES 2ML be stored?

Store BUDONEB 0.5MG REPSULES 2ML upright at controlled room temperature, typically between 20°C and 25°C (68°F and 77°F). Protect it from light by keeping the ampules sealed in their original foil pouch. Do not refrigerate or freeze the solution. Once a foil envelope has been opened, unused ampules should be kept within the envelope and discarded after 2 weeks. An opened ampule should be used promptly.