Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder)

1. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) © Clearsky Pharmacy ( www.clearskypharmacy.biz )

2. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) © Clearsky Pharmacy ( www.clearskypharmacy.biz )

3. 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. © Clearsky Pharmacy ( www.clearskypharmacy.biz )

4. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) 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. © Clearsky Pharmacy ( www.clearskypharmacy.biz )

5. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) Chemical Structure The structure of Budesonide is given below: © Clearsky Pharmacy ( www.clearskypharmacy.biz )

6. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) Budecort Rotacaps are manufactured by Cipla Limited, India. (Website: www.cipla.com www.cipla.com) URL: URL: https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

7. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) 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. URL: URL: https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

8. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) 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. URL: URL: https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

9. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) Budecort Rotacaps Dosage The dosage of Budecort Rotacaps 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. URL: URL: https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

10. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) Budecort Rotacaps Dosage 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. URL: URL: https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

11. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) Budecort Rotacaps Dosage 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. URL: URL: https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

12. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) 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. URL: URL: https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

13. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) 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. © Clearsky Pharmacy ( www.clearskypharmacy.biz )

14. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) 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. URL: URL: https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

15. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) 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. URL: URL: https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

16. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) 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. © Clearsky Pharmacy ( www.clearskypharmacy.biz )

17. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) 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. URL: URL: https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

18. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) 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 URL: URL: https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

19. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) 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. © Clearsky Pharmacy ( www.clearskypharmacy.biz )

20. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) 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. URL: URL: https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

21. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) 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. URL: URL: https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

22. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) 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. URL: URL: https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

23. Budecort Rotacaps by Cipla (Generic Budesonide Inhalation Powder) Budecort Rotacaps Budecort Rotacaps (Generic Budesonide Inhalation Powder) is manufactured by Cipla Limited, India. URL: URL: https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html https://www.clearskypharmacy.biz/budecort-rotacaps-budesonide-inhalation-powder.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )