Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder)

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Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder)

Budecort Rotacaps (Generic Budesonide Inhalation
Powder) are 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. Many of those patients may be able to reduce
or eliminate their requirement for oral corticosteroids
over time.
Budecort Rotacaps are not used for the relief of acute
bronchospasm.

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

Chemical Structure
The structure of Budesonide is given below:

Budecort Rotacaps are manufactured by Cipla Limited, India.
(Website: www.cipla.com)
URL: https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html

Budesonide Inhalation Powder – Brand Names
Budesonide Inhalation Powder is
available as Pulmicort Flexhaler,
Budecort Rotacaps, Budamate
Transcaps, Budenase AQ, Bubate,
Derinide Rotacaps, Budate Transcaps,
Bunase Rotacaps and Budvent Easecaps.

Uses of Budecort 100mcg, 200mcg and 400mcg Rotacaps
Budecort Rotacaps (Generic Budesonide Inhalation Powder) are
used to help prevent the symptoms of asthma. When used
regularly every day, inhaled Budesonide decreases the number
and severity of asthma attacks. However, it will not relieve an
asthma attack that has already started.
Budesonide is a corticosteroid or steroid (cortisone-like medicine).
It works by preventing inflammation (swelling) in the lungs, which
makes the asthma attack less severe. Inhaled budesonide may be
used with other asthma medicines such as bronchodilators, which
are also used to open up narrowed breathing passages in the
lungs.

Budecort Rotacaps Dosage
The dosage of Budecort Rotacaps (Generic Budesonide
Inhalation Powder) for adults including the elderly and Children
Over 12 Years is given below:
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 Budecort Rotacaps (Generic Budesonide Inhalation
Powder) for Children 5 to 12 Years is given below:
200 mcg to 800 mcg daily, in divided doses. The dose should be
reduced to the minimum needed to maintain good asthma
control.

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.

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.

Storage Instructions
Budecort Rotacaps by Cipla
(Generic Budesonide Inhalation
Powder) have to be stored at
controlled room temperature i.e.
from 20°C to 25°C (68°F to 77°F)
with excursions permitted
between 15° to 30°C (59° to 86°F).
Keep this as well as all other
medicines away from children
and pets.

Warnings
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.

Warnings
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.

Warnings
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.

Warnings
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.
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.

Side Effects
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

Side Effects
The following side effects have been reported during post-approval use of
Budesonide Inhalation Powder (Budecort Rotacaps). Because these
reactions are reported voluntarily from a population of uncertain size, it is not
always possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.
Immune system disorders: immediate and delayed hypersensitivity reactions
including anaphylactic reaction, angioedema, bronchospasm, rash, contact
dermatitis, urticaria, and cough, wheezing or bronchospasm in patients with
severe milk protein hypersensitivity.
Endocrine disorders: symptoms of hypocorticism and hypercorticism.
Eye disorders: cataracts, glaucoma, increased intraocular pressure.
Psychiatric disorders: psychiatric symptoms including psychosis, depression,
aggressive reactions, irritability, nervousness, restlessness, and anxiety
Respiratory, thoracic,and mediastinal disorders: throat irritation
Skin and subcutaneous tissue disorders: skin bruising.

Budecort Rotacaps Overdose
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.

Budecort Rotacaps During Pregnancy
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.

Budecort Rotacaps During Nursing
Budesonide (Budecort Rotacaps), like other corticosteroids, is
secreted in human milk. However, at therapeutic doses of
Budesonide (Budecort Rotacaps) no effects on the suckling child
are anticipated. Budesonide can be used during breast feeding.
Maintenance treatment with inhaled Budesonide (200 or 400
micrograms twice daily) in asthmatic nursing women results in
negligible systemic exposure to Budesonide in breast-fed infants.
Based on data from inhaled Budesonide and the fact that
budesonide exhibits linear PK properties within the therapeutic
dosage intervals after nasal, inhaled, oral and rectal administrations,
at therapeutic doses of Budesonide, exposure to the breast-fed child
is anticipated to be low.

Budecort Rotacaps (Generic Budesonide
Inhalation Powder) is manufactured by Cipla
Limited, India.

Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder)

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