Budecort Rotacaps (Budesonide Inhalation Powder) is used for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients five years of age or older. It is also used for patients requiring oral corticosteroid therapy for asthma

1. Budesonide Inhalation Powder
© Clearsky Pharmacy
Budecort Rotacaps (Budesonide Inhalation Powder) is
used for the maintenance treatment of asthma as
prophylactic therapy in adult and pediatric patients five
years of age or older. It is also used for patients
requiring oral corticosteroid therapy for asthma

2. Budecort Rotacaps
© Clearsky Pharmacy
Budecort Rotacaps are manufactured
by Cipla Ltd., India
(Website: www.cipla.com)

3. Budesonide Inhalation Powder – Brand Names
© Clearsky Pharmacy
Budesonide Inhalation Powder is
available as Pulmicort Flexhaler,
Budecort Rotacaps, Budamate
Transcaps, Budenase AQ, Bubate,
Budvent Easecaps.

4. Active Ingredient
© Clearsky Pharmacy
The active ingredient contained in Budecort
rotacaps is Budesonide.
Each capsule contains 100 mcg, 200 mcg or
400 mcg of Budesonide IP respectively.

5. Chemical Structure
© Clearsky Pharmacy
The structure of Budesonide is given below:

6. Uses of Budesonide Inhalation Powder
© Clearsky Pharmacy
Budecort Rotacaps (Budesonide Inhalation
Powder) is used in the long-term
management of asthma and chronic
obstructive pulmonary disease (COPD).
Budecort Rotacaps (Generic Pulmicort
Flexhaler ) is used for the maintenance
treatment of asthma as prophylactic therapy
in adult and pediatric patients 5 years and
above. It is also used for patients requiring
oral corticosteroid therapy for asthma.
Budecort Rotacaps must not be used for
the relief of acute bronchospasm.

7. Budesonide Inhalation Powder Dosage
© Clearsky Pharmacy
➢200 mcg to 1,600 mcg daily, in divided doses.
200 mcg twice daily, in the morning and in the
evening. During periods of severe asthma the daily
dosage can be increased up to 1600 mcg.
➢In patients whose asthma is well controlled, the
daily dose may be reduced below 400 mcg but
should not go below 200 mcg. Patients should be
maintained on the lowest dose that will effectively
control symptoms.
The dosage of Budecort Rotacaps (Budesonide
Powder For Inhalation) for adults including the
elderly and Children Over 12 Years is given
below:

8. Budecort Rotacaps Dosage
© Clearsky Pharmacy
➢200 mcg to 800 mcg daily, in divided doses. The
dose should be reduced to the minimum needed to
maintain good asthma control.
The dosage Budecort Rotacaps (Budesonide
Powder For Inhalation) for Children 5 to 12
Years is given below:

9. Budecort Rotacaps Dosage
© Clearsky Pharmacy
The patient must be transferred to once daily dosing at
the same equivalent total daily dose; the drug and
method of delivery should be considered.
The Budecort Rotacaps dose should subsequently be
reduced to the minimum needed to maintain good
asthma control.
Patients should be instructed to take the once daily
dose in the evening. It is important that the dose is
taken consistently and at a similar time each evening.
Patients, in particular those receiving once daily
treatment, should be advised that in case their asthma
deteriorates (e.g. increased frequency of bronchodilator
use or persistent respiratory symptoms) they should
double their steroid dose, by administering it twice
daily, and must contact their doctor immediately.

10. Storage Instructions
© Clearsky Pharmacy
Budecort Rotacaps (Budesonide
Inhalation Powder) has to be stored at
controlled room temperature i.e. from
20°C to 25°C (68°F to 77°F) in a dry
place with the cover tightly in place.
Keep this as well as all other medicines
away from children and pets.

11. Warnings
© Clearsky Pharmacy
Patients Not Dependent on Steroids:
Treatment with the recommended doses of
Budesonide inhalation powder usually gives
a therapeutic benefit within 10 days.
However, certain patients may have an
excessive collection of mucous secretion in
the bronchi. In these cases, a short course of
oral corticosteroids (usually 1 to 2 weeks)
must be given in addition to the aerosol.
After the course of the oral drug, the inhaler
alone should be sufficient therapy.

12. Warnings
© Clearsky Pharmacy
Steroid-Dependent Patients:
Transfer of patients on oral steroids to treatment with Budesonide
inhalation powder necessitates special care, mainly due to the slow
restitution of the disturbed hypothalamic-pituitary-adrenal (HPA) axis
function, caused by extended treatment with oral corticosteroids.
When the Budesonide inhalation powder treatment is started, the
patient must be in a relatively stable phase. Budecort Rotacaps is
then given in combination with the previously used oral steroid dose
for about 10 days.
Patients requiring oral corticosteroids must be weaned gradually from
systemic corticosteroid use after transferring to Budecort Rotacaps.
Prednisone reduction can be accomplished by reducing the daily
prednisone dose by 2.5 mg or equivalent each month to the lowest
possible level during therapy with Budecort Rotacaps. Lung function,
beta-agonist use, and asthma symptoms should be carefully
monitored during withdrawal of oral corticosteroids. In addition to
monitoring asthma signs and symptoms, patients must be observed
for signs and symptoms of adrenal insufficiency such as fatigue,
lassitude, weakness, nausea and vomiting, and hypotension.

13. Warnings
© Clearsky Pharmacy
Reduced liver function can affect the elimination of
glucocorticosteroids. However, the plasma clearance following
an intravenous dose of Budesonide was similar in cirrhotic
patients and in healthy subjects.
Hypersensitivity reactions including anaphylaxis, rash, contact
dermatitis, urticaria, angioedema, and bronchospasm have
been observed with use of Budesonide. Discontinue
Budesonide inhalation powder in case such reactions occur.
Patients who are on medicines that suppress the immune
system are more susceptible to infection than healthy
individuals. Chicken pox and measles, for example, can have
a more serious or even fatal course in susceptible children or
adults using corticosteroids.
Inhaled corticosteroids must be used with caution, if at all, in
patients with active or quiescent tuberculosis infection of the
respiratory tract, untreated systemic fungal, bacterial, viral or
parasitic infections, or ocular herpes simplex.

14. Warnings
© Clearsky Pharmacy
Decreases in bone mineral density (BMD) have been
observed with long-term administration of products
containing inhaled corticosteroids like Budecort
Rotacaps. The clinical significance of small changes
in BMD with regard to long-term consequences such
as fracture is unknown.
Glaucoma, increased intraocular pressure, and
cataracts have been reported following the long-term
administration of inhaled corticosteroids, including
Budesonide Inhalation Powder. Therefore, close
monitoring is necessary in patients with a change in
vision or with a history of increased intraocular
pressure, glaucoma, and/or cataracts.

15. Warnings
© Clearsky Pharmacy
Budecort Rotacaps (Budesonide
Inhalation powder) is not intended for
rapid relief of acute episodes of asthma
or symptoms of asthma. In such cases
an inhaled short-acting bronchodilator is
required. Patients must be advised to
have such 'rescue' medication with them
at all times.

16. Budecort Rotacaps
© Clearsky Pharmacy
Contraindications
Budecort Rotacaps are contraindicated in
patients with a hypersensitivity to
Budesonide or any other component of
this medication.
Budecort Rotacaps are contraindicated in
the primary treatment of status asthmaticus
or other acute episodes of asthma where
intensive measures are necessary.

17. Budecort Rotacaps Side Effects
© Clearsky Pharmacy
➢Budecort Rotacaps (Budesonide Inhalation
Powder) side effects can include mild irritation in the
throat, Candida infection in the oropharynx,
hoarseness, coughing, nasopharyngitis, nasal
congestion, pharyngitis, allergic rhinitis, viral upper
respiratory tract infection, nausea, viral
gastroenteritis, otitis media, oral candidiasis,
respiratory infection, sinusitis, headache, pain, back
pain, fever, neck pain, syncope, abdominal pain, dry
mouth, vomiting, weight gain, fracture, myalgia,
hypertonia, migraine, ecchymosis, insomnia,
infection, taste perversion, voice alteration,
asthenia, dyspepsia, arthralgia, increased cough
and rhinitis

18. Budecort Rotacaps Overdose
© Clearsky Pharmacy
The only harmful effect that follows
inhalation of large amounts of this medicine
over a short period is suppression of the
HPA axis function.
No special emergency action is required to
be taken.
Treatment with Budecort Rotacaps
(Budesonide Inhalation Powder) must be
continued at the recommended dose to
control the asthma.

19. Budesonide During Pregnancy
© Clearsky Pharmacy
Budesonide (Budecort Rotacaps) has been
classified by the US FDA as Pregnancy Category B.
During controlled animal studies,
glucocorticosteroids have been shown to induce
malformations.
This is not likely to be relevant for humans given
recommended doses, but therapy with inhaled
Budesonide must be regularly reviewed and
maintained at the lowest effective dose.
Budecort Rotacaps should only be used during
pregnancy in case the expected benefits outweigh
the potential risks.

20. Budecort Rotacaps
For more details on
Budecort Rotacaps click here
© Clearsky Pharmacy
Budecort Rotacaps (Budesonide Inhalation
Powder) by Cipla Limited, India .