Budate Uses

• Budate indications
• Uses of Budate in details
• Budate description
• Budate dosage
• Budate interactions
• Budate side effects
• Budate contraindications

What is Budate?

Budate is used to help prevent the symptoms of asthma. When used regularly every day, inhaled Budate decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Budate 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 Budate may be used with other asthma medicines such as bronchodilators, which are also used to open up narrowed breathing passages in the lungs.

Budate is available only with your doctor's prescription.

Budate indications

Budate (Budate) is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age or older. It is also indicated 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.

Budate (Budate) is NOT indicated for the relief of acute bronchospasm.

How should I use Budate?

Use Budate foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Budate foam. Talk to your pharmacist if you have questions about this information.
• Budate foam is for rectal use only. Do not take Budate foam by mouth.
• Before using Budate foam, use the bathroom to empty your bowels.
• If you need more lubricant for the applicator, you may use petrolatum or petroleum jelly.
• Warm Budate foam before use by holding the can in your hands and shaking it for 10 to 15 seconds.
• You can use Budate foam while standing, lying down, or sitting.
• If you are using Budate foam in the evening, use right before bedtime. After using Budate foam, try to avoid emptying your bowels until the next morning.
• Budate foam is flammable. Avoid fire, flame, and smoking while you use Budate foam and right after using it.
• Use Budate foam on a regular schedule to get the most benefit from it.
• Do not eat grapefruit or drink grapefruit juice while you use Budate foam.
• If you miss a dose of Budate foam, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Budate foam.

Uses of Budate in details

Use: Labeled Indications

Crohn disease, mild to moderate (capsules): Treatment of active Crohn disease (mild to moderate) involving the ileum and/or the ascending colon in patients ≥8 years of age; maintenance of clinical remission (for up to 3 months) of Crohn disease (mild to moderate) involving the ileum and/or the ascending colon in adults

Ulcerative colitis (tablets): Induction of remission in patients with active ulcerative colitis (mild to moderate)

Off Label Uses

Eosinophilic esophagitis

Data from controlled trials and meta-analyses indicate that inhalational Budate, when swallowed rather than inhaled, is effective at improving the clinicopathologic features of eosinophilic esophagitis. Guidelines from the American College of Gastroenterology (ACG) and consensus recommendations from the American Gastroenterological Association (AGA)/North American Society of Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) regarding diagnosis and management of eosinophilic esophagitis recommend that oral administration of inhalational corticosteroids (eg, fluticasone, Budate) be considered as first-line therapy for eosinophilic esophagitis and that the corticosteroid type and duration of therapy be individualized. Symptoms often recur upon discontinuation, and steroid resistance has been reported.

Microscopic (lymphocytic and collagenous) colitis

Data from multiple small randomized, double-blind, placebo-controlled trials support the use of Budate as an effective treatment for induction of clinical remission and histological improvement in patients with active lymphocytic colitis.

Based on the American Gastroenterological Association Institute Guideline on the Medical Management of Microscopic Colitis, Budate is recommended as first line therapy for the induction and maintenance of clinical remission in patients with symptomatic microscopic colitis.

Budate description

Turbuhaler: One metered dose contains Budesonide 100 micrograms or 200 micrograms.

Respules: Each single-dose unit of 2 ml contains 0.5 mg or 1 mg Budate.

Respules: The active ingredient, Budate, is a non-halogenated glucocorticoid structurally related to 16-α- hydroxyprednisolone. The chemical name is 16α, 17α -22R, S-propylmethylenedioxy-pregna-1, 4-diene-11ß, 21-diol-3, 20-dione; MW 430.5.

Budate is a white to off-white powder, freely soluble in chloroform, sparingly soluble in ethanol and practically insoluble in water and heptane. Budate melts with decomposition between 224°C and 231.5°C.

Budate RESPULES nebulising suspension for inhalation is a white to off-white suspension in plastic single dose units. Budate RESPULES contain Budate 0.5 mg/2 mL or 1.0 mg/2 mL as the active ingredient plus disodium edetate, sodium chloride, polysorbate 80 (E 433) citric acid - anhydrous (E 330), sodium citrate (E 331) and water for injections.

Excipients/Inactive Ingredients: Turbuhaler: Budate contains no excipients.

Respules: Disodium edetate, sodium chloride, polysorbate 80 (E 433) citric acid anhydrous (E 330), sodium citrate (E 331) and water for injections.

Budate dosage

The recommended starting dosage for adults and children 6 years of age and older is 64 mcg per day administered as one spray per nostril of Budate (Budate) Nasal Spray 32 mcg once daily. Some patients who do not achieve symptom control at the recommended starting dosage may benefit from an increased dosage. The maximum recommended dosage for adults (12 years of age and older) is 256 mcg per day administered as four sprays per nostril once daily of Budate (Budate) Nasal Spray 32 mcg and the maximum recommended dose for pediatric patients (6 to < 12 years of age) is 128 mcg per day administered as two sprays per nostril once daily of Budate (Budate) Nasal Spray 32 mcg.

It is always desirable to titrate an individual patient to the minimum effective dosage to reduce the possibility of side effects. An improvement in nasal symptoms may be noted in patients within 10 hours of first using Budate (Budate) Nasal Spray, however, clinical improvement usually takes 1 -2 days with maximum benefit in approximately 2 weeks. When the maximum benefit has been achieved and symptoms have been controlled, reducing the dosage may be effective in maintaining control of the allergic rhinitis symptoms in patients who were initially controlled on higher dosages.

Prior to initial use, the container must be shaken gently and the pump must be primed by actuating eight times. If used daily, the pump does not need to be reprimed. If not used for two consecutive days, reprime with one spray or until a fine spray appears. If not used for more than 14 days, rinse the applicator and reprime with two sprays or until a fine spray appears. Shake the container gently before each use.

Illustrated Patient's Instructions for Use accompany each package of Budate (Budate) Nasal Spray 32 mcg.

How supplied

Dosage Forms and Strengths

Budate (Budate) Nasal Spray is a nasal spray suspension. Each spray delivers 32 mcg of Budate. Each bottle of Budate (Budate) Nasal Spray 32 mcg contains 120 metered sprays after initial priming.

Budate (Budate) Nasal Spray 32 mcg is available in an amber glass bottle with a metered-dose pump spray and a green protection cap. Budate (Budate) Nasal Spray 32 mcg (NDC 0186-1070-08) provides 120 metered sprays after initial priming; net fill weight 8.6 g. The Budate (Budate) Nasal Spray 32 mcg bottle has been filled with an excess to accommodate the priming activity. The bottle should be discarded after 120 sprays following initial priming, since the amount of Budate delivered per spray thereafter may be substantially less than the labeled dose. Each spray delivers 32 mcg of Budate to the patient.

Budate (Budate) Nasal Spray should be stored at controlled room temperature, 20 to 25°C (68 to 77°F) with the valve up. Do not freeze. Protect from light. Shake gently before use. Do not spray in eyes.

Distributed by: AstraZeneca LP, Wilmington, DE 19850. Revised: 12/2010

Budate interactions

See also:
What other drugs will affect Budate?

Budate:

Oral ketoconazole 200 mg once daily increased the plasma concentrations of oral Budate (3 mg) on average 6-fold when administered simultaneously. When ketoconazole was administered 12 hrs after Budate, the concentration increased on average of 3-fold. Information on this interaction is lacking for nasal Budate, but greatly increased plasma levels are expected too. Since there is an absence of data to permit dosage recommendations for nasal administration, the combination should be avoided. If this is not possible, the interval between administration of ketoconazole and Budate should be as long as possible. A reduction of the Budate dose must also be considered. Other potent inhibitors of CYP3A4 probably also cause a marked increase in the plasma levels of Budate.

Rhinocort Turbuhaler: Budate has not been observed to interact with any drug used for the treatment of rhinitis.

The metabolism, of Budate is primarily mediated by CYP3A4. Inhibitors of this enzyme, eg, ketoconazole and itraconazole, may therefore increase systemic exposure to Budate several times.

Oral ketoconazole 200 mg once daily increased the plasma concentrations of oral Budate (3 mg in a single dose) on average 6-fold when administered simultaneously. When oral ketoconazole was administered 12 hrs after Budate, the concentration increased on average 3-fold. There is no information about this interaction for nasal Budate, but also in such cases greatly increased plasma levels are expected. Since there are no data that support a dosage recommendation to be given in cases of nasal administration the combination must be avoided. If this is not possible, the time interval between treatments must be as long as possible and a reduction of the Budate dose may also be considered. Other potent inhibitors of CYP3A4 also probably cause a marked increase in the plasma levels of Budate.

Elevated plasma concentrations and increased effects of corticosteroids have been observed in women who were also treated with oestrogens and contraceptive steroids, but no effect has been observed with Budate and concomitant intake of combined low dose contraceptive pills.

As adrenal function may be inhibited, an ACTH stimulation test for diagnosis of pituitary failure may show an incorrect result (low value).

Budate side effects

See also:
What are the possible side effects of Budate?

The following adverse reactions were reported in patients treated with Budate (Budate).

The incidence of common adverse events is based upon double-blind, placebo-controlled US clinical trials in which 1116 adult and pediatric patients age 6-70 years (472 females and 644 males) were treated with Budate (Budate) (200 to 800 mcg twice daily for 12 to 20 weeks) or placebo.

The following table shows the incidence of adverse events in patients previously receiving bronchodilators and/or inhaled corticosteroids in US controlled clinical trials. This population included 232 male and 62 female pediatric patients (age 6 to 17 years) and 332 male and 331 female adult patients (age 18 years and greater).

Adverse Events with ≥ 3% Incidence reported by Patients on Budate (Budate)

The table above includes all events (whether considered drug-related or non-drug-related by the investigators) that occurred at a rate of ≥3% in any one Budate (Budate) group and were more common than in the placebo group. In considering these data, the increased average duration of exposure for Budate (Budate) patients should be taken into account.

The following other adverse events occurred in these clinical trials using Budate (Budate) with an incidence of 1 to 3% and were more common on Budate (Budate) than on placebo.

Body As A Whole:neck pain

Cardiovascular: syncope

Digestive: abdominal pain, dry mouth, vomiting

Metabolic and Nutritional: weight gain

Musculoskeletal: fracture, myalgia

Nervous: hypertonia, migraine

Platelet, Bleeding and Clotting: ecchymosis

Psychiatric: insomnia

Resistance Mechanisms: infection

Special Senses: taste perversion

In a 20-week trial in adult asthmatics who previously required oral corticosteroids, the effects of Budate (Budate) 400 mcg twice daily (N=53) and 800 mcg twice daily (N=53) were compared with placebo (N=53) on the frequency of reported adverse events. Adverse events, whether considered drug-related or non-drug-related by the investigators, reported in more than five patients in the Budate (Budate) group and which occurred more frequently with Budate (Budate) than placebo are shown below (% Budate (Budate) and % placebo). In considering these data, the increased average duration of exposure for Budate (Budate) patients (78 days for Budate (Budate) vs. 41 days for placebo) should be taken into account.

Patients Receiving Budate (Budate) Once Daily

The adverse event profile of once-daily administration of Budate (Budate) 200 mcg and 400 mcg, and placebo, was evaluated in 309 adult asthmatic patients in an 18-week study. The study population included both patients previously treated with inhaled corticosteroids, and patients not previously receiving corticosteroid therapy. There was no clinically relevant difference in the pattern of adverse events following once-daily administration of Budate (Budate) when compared with twice-daily dosing.

Pediatric Studies: In a 12-week placebo-controlled trial in 404 pediatric patients 6 to 18 years of age previously maintained on inhaled corticosteroids, the frequency of adverse events for each age category (6 to 12 years, 13 to 18 years) was comparable for Budate (Budate) (at 100, 200 and 400 mcg twice daily) and placebo. There were no clinically relevant differences in the pattern or severity of adverse events in children compared with those reported in adults.

Adverse Event Reports From Other Sources: Rare adverse events reported in the published literature or from worldwide marketing experience with any formulation of inhaled Budate include: immediate and delayed hypersensitivity reactions including rash, contact dermatitis, urticaria, angioedema and bronchospasm; symptoms of hypocorticism and hypercorticism; glaucoma, cataracts; psychiatric symptoms including depression, aggressive reactions, irritability, anxiety and psychosis.

Budate contraindications

See also:
What is the most important information I should know about Budate?

Before using Budate, tell your doctor if you have been sick or had an infection of any kind. Also tell your doctor if you have liver disease, glaucoma or cataracts, herpes simplex infection of your eyes, tuberculosis, sores or ulcers in your nose, or if you have recently had injury of or surgery on your nose.

It may take up to 2 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after a week of treatment.

To be sure this medication is not causing harmful effects on your nose or sinuses, your doctor may want to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.

Budate nasal can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using Budate nasal.

Avoid getting this medication in your eyes. If this does happen, rinse with water and call your doctor.

Steroid medicines can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using Budate nasal.

Active ingredient matches for Budate:

Budesonide in India.

References

1. DailyMed. "BUDESONIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "budesonide". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "budesonide". http://www.drugbank.ca/drugs/DB01222 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology