Budespid 0.5 Respu

Here is a detailed product description for BUDESPID 0.5 RESPU, based on information regarding Budesonide 0.5 mg/2 mL Inhalation Suspension:

BUDESPID 0.5 RESPU

• Name:

  • Common Name: Budesonide 0.5 mg/2 mL Inhalation Suspension
  • Brand Names: Similar products are often marketed under names such as Pulmicort Respules or Budecort Respules. BUDESPID 0.5 RESPU by ALLET LIFESCIENCES contains the same active ingredient and strength.

• Composition:

  • Active Ingredient: Each 2 mL Respule contains 0.5 mg of Budesonide.
  • Other Ingredients: Disodium edetate, sodium chloride, polysorbate 80, citric acid monohydrate, sodium citrate dehydrate, and water for injections.

• Uses: Budesonide Inhalation Suspension is a corticosteroid used to reduce and prevent swelling and inflammation in the lungs, making breathing easier. It is prescribed for:

  • Asthma: Long-term management to control and prevent symptoms like wheezing and shortness of breath. It is not for sudden asthma attacks.
  • Chronic Obstructive Pulmonary Disease (COPD): To manage symptoms by reducing airway inflammation and improving lung capacity.
  • Croup: In infants and children, especially when hospitalization is indicated.

• Dosage and Administration: Budesonide Inhalation Suspension is administered via a nebulizer, which turns the liquid medicine into a fine mist to be inhaled through a face mask or mouthpiece. The dosage is individualized by a healthcare professional.

  • Asthma (Adults and Children 12+ years): Typically 0.5 mg to 2 mg, once or twice daily.
  • Asthma (Children 1-12 years): Ranges from 0.25 mg to 1 mg, once or twice daily, depending on prior treatment and severity.
  • Croup (Infants and Children): A usual dose is 2 mg, given as a single administration or two 1 mg doses separated by 30 minutes, repeatable every 12 hours up to 36 hours.
  • Rinse your mouth with water after each use to prevent oral thrush and wash your face if a face mask was used to avoid skin irritation.

• Side Effects:

  • Common Side Effects: Mild sore throat, coughing, hoarse voice, runny or stuffy nose, headache, stomach pain, and mouth thrush (less likely if mouth is rinsed after use).
  • Serious Side Effects (Seek immediate medical attention): Sudden worsening of breathing/bronchospasm, severe allergic reactions (swelling of face, lips, tongue, throat), signs of infection (fever, chills, increased mucus), changes in vision (glaucoma, cataracts), and adrenal insufficiency (severe tiredness, muscle weakness, nausea). Long-term use may rarely cause growth velocity reduction in children and decreased bone mineral density.

• Precautions:

  • Do not use if allergic to budesonide or any other ingredients.
  • Inform your doctor about any existing lung infections, tuberculosis, fungal or viral infections.
  • Use with caution if switching from oral corticosteroids, as abrupt withdrawal can lead to adrenal insufficiency.
  • Avoid exposure to individuals with infections like chickenpox or measles if not immune.
  • Inform your doctor about all other medications, especially antifungal medicines (like ketoconazole, itraconazole) and HIV protease inhibitors (like ritonavir), as they can interact with budesonide.
  • Regular medical check-ups are important, particularly for children, to monitor growth and potential side effects.

• Storage:

  • Store in an upright position at room temperature, between 68°F to 77°F (20°C to 25°C), and protect from light by keeping Respules in their original foil envelope and carton.
  • Do not refrigerate or freeze.
  • Once a foil envelope is opened, use the Respules within 3 months. Mark the opening date.
  • Any unused suspension in an opened Respule should be discarded immediately after use.

Here are frequently asked questions about BUDESPID 0.5 RESPU, which contains Budesonide Inhalation Suspension 0.5 mg/2ml:

What is BUDESPID 0.5 RESPU used for?

BUDESPID 0.5 RESPU is primarily used for the maintenance treatment of asthma to prevent symptoms like wheezing and shortness of breath. It is also used as a prophylactic therapy in children aged 12 months to 8 years where other inhaler formulations are not suitable. Additionally, it is recommended for treating croup (an acute viral upper respiratory tract infection) in infants and children. It may also be used to manage symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults.

How does BUDESPID 0.5 RESPU work?

BUDESPID 0.5 RESPU contains budesonide, a corticosteroid that works by reducing and preventing swelling and inflammation in the airways of the lungs. This action helps to improve airflow and make breathing easier.

What is the usual dosage of BUDESPID 0.5 RESPU?

The dosage is individualized based on the severity of the condition and patient response. For asthma, the recommended starting dose for adults and children over 12 years is typically 1 mg to 2 mg, twice a day. Children under 12 years are usually prescribed a lower dose of 0.5 mg to 1 mg, twice a day. For croup in infants and children, the usual dose is 2 mg per day, given either as a single administration or as two 1 mg doses separated by 30 minutes. It is administered via a nebulizer. Your doctor may adjust the dose as your symptoms improve.

What are the possible side effects of BUDESPID 0.5 RESPU?

Common side effects can include a mild sore throat, coughing, hoarse voice, runny nose, and oral thrush (a fungal infection in the mouth). Rinsing your mouth with water after each use can help prevent thrush. More serious but rare side effects can include sudden wheezing after inhalation, allergic reactions (rash, itching, swelling of the face/tongue/throat), and changes in bone mineral density with long-term use.

Is BUDESPID 0.5 RESPU safe during pregnancy or breastfeeding?

If you are pregnant or planning to become pregnant, you should discuss the risks and benefits with your doctor. While animal studies have shown potential for malformations, studies in pregnant women have not shown an increased risk of abnormalities when inhaled budesonide is used during pregnancy. Budesonide does pass into breast milk, but at therapeutic doses, no adverse effects on the breastfed infant are anticipated, and it can be used during breastfeeding.

Can BUDESPID 0.5 RESPU be taken with other medications?

It is important to inform your doctor about all medications, supplements, and herbal products you are taking. Certain medications can interact with budesonide. Strong inhibitors of CYP3A4 enzymes, such as some antifungal medications (e.g., ketoconazole, itraconazole) and HIV medications (e.g., nelfinavir, ritonavir), can increase budesonide levels in the body, potentially leading to more side effects. Antacids should generally be taken with a gap of at least 1-2 hours.

What precautions should be taken while using BUDESPID 0.5 RESPU?

BUDESPID 0.5 RESPU is not for immediate relief of acute asthma attacks; a fast-acting reliever should be used for sudden breathing difficulties. People with existing infections (like tuberculosis, fungal, or viral infections) should use it with caution. Long-term use, especially at high doses, may affect bone mineral density, slow growth in children, and potentially suppress adrenal function. It's important to rinse your mouth and wash your face after using the nebulizer, particularly if using a face mask, to prevent oral thrush and skin irritation. Avoid people who are sick or have contagious infections like chickenpox or measles.

What happens if a dose of BUDESPID 0.5 RESPU is missed?

If you miss a dose, skip the missed dose and take the next dose at your regularly scheduled time. Do not double the dose to catch up. Consistency is key for effectiveness.

How should BUDESPID 0.5 RESPU be stored?

BUDESPID 0.5 RESPU (Budesonide Inhalation Suspension) should be stored upright at room temperature, typically between 68°F to 77°F (20°C to 25°C), and protected from light. Do not store it above 30°C and do not freeze it. Keep the Respules in their original foil envelope to protect them from light. Once a foil envelope has been opened, the Respules inside should be used within 3 months. Any unused suspension in an opened Respule should be thrown away immediately.