Budasmal SF Uses

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What is Budasmal SF?

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

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

Budasmal SF is available only with your doctor's prescription.

Budasmal SF indications

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Budasmal SF (Budasmal SF) 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.

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

How should I use Budasmal SF?

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

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

Uses of Budasmal SF in details

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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 Budasmal SF, 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, Budasmal SF) 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 Budasmal SF 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, Budasmal SF is recommended as first line therapy for the induction and maintenance of clinical remission in patients with symptomatic microscopic colitis.

Budasmal SF description

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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 Budasmal SF.

Respules: The active ingredient, Budasmal SF, 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.

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

Budasmal SF RESPULES nebulising suspension for inhalation is a white to off-white suspension in plastic single dose units. Budasmal SF RESPULES contain Budasmal SF 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: Budasmal SF 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.

Budasmal SF dosage

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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 Budasmal SF (Budasmal SF) 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 Budasmal SF (Budasmal SF) 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 Budasmal SF (Budasmal SF) 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 Budasmal SF (Budasmal SF) 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 Budasmal SF (Budasmal SF) Nasal Spray 32 mcg.

How supplied

Dosage Forms and Strengths

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

Budasmal SF (Budasmal SF) Nasal Spray 32 mcg is available in an amber glass bottle with a metered-dose pump spray and a green protection cap. Budasmal SF (Budasmal SF) Nasal Spray 32 mcg (NDC 0186-1070-08) provides 120 metered sprays after initial priming; net fill weight 8.6 g. The Budasmal SF (Budasmal SF) 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 Budasmal SF delivered per spray thereafter may be substantially less than the labeled dose. Each spray delivers 32 mcg of Budasmal SF to the patient.

Budasmal SF (Budasmal SF) 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

Budasmal SF interactions

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What other drugs will affect Budasmal SF?

Budasmal SF:

Oral ketoconazole 200 mg once daily increased the plasma concentrations of oral Budasmal SF (3 mg) on average 6-fold when administered simultaneously. When ketoconazole was administered 12 hrs after Budasmal SF, the concentration increased on average of 3-fold. Information on this interaction is lacking for nasal Budasmal SF, 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 Budasmal SF should be as long as possible. A reduction of the Budasmal SF dose must also be considered. Other potent inhibitors of CYP3A4 probably also cause a marked increase in the plasma levels of Budasmal SF.

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

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

Oral ketoconazole 200 mg once daily increased the plasma concentrations of oral Budasmal SF (3 mg in a single dose) on average 6-fold when administered simultaneously. When oral ketoconazole was administered 12 hrs after Budasmal SF, the concentration increased on average 3-fold. There is no information about this interaction for nasal Budasmal SF, 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 Budasmal SF dose may also be considered. Other potent inhibitors of CYP3A4 also probably cause a marked increase in the plasma levels of Budasmal SF.

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 Budasmal SF 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).

Budasmal SF side effects

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What are the possible side effects of Budasmal SF?

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

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 Budasmal SF (Budasmal SF) (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 Budasmal SF (Budasmal SF)

Budasmal SF
Adverse Event Placebo

N=284

%

200 mcg

twice daily

N=286

%

400 mcg

twice daily

N=289

%

800 mcg

twice daily

N=98

%

Respiratory System
Respiratory infection 17 20 24 19
Pharyngitis 9 10 9 5
Sinusitis 7 11 7 2
Voice alteration 0 1 2 6
Body As A Whole
Headache 7 14 13 14
 Flu syndrome 6 6 6 14
Pain 2 5 5 5
Back pain 1 2 3 6
Fever 2 2 4 0
Digestive System

Oral candidiasis

2 2 4 4
Dyspepsia 2 1 2 4
Gastroenteritis 1 1 2 3
Nausea 2 2 1 3
Average Duration of Exposure (days) 59 79 80 80

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 Budasmal SF (Budasmal SF) group and were more common than in the placebo group. In considering these data, the increased average duration of exposure for Budasmal SF (Budasmal SF) patients should be taken into account.

The following other adverse events occurred in these clinical trials using Budasmal SF (Budasmal SF) with an incidence of 1 to 3% and were more common on Budasmal SF (Budasmal SF) 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 Budasmal SF (Budasmal SF) 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 Budasmal SF (Budasmal SF) group and which occurred more frequently with Budasmal SF (Budasmal SF) than placebo are shown below (% Budasmal SF (Budasmal SF) and % placebo). In considering these data, the increased average duration of exposure for Budasmal SF (Budasmal SF) patients (78 days for Budasmal SF (Budasmal SF) vs. 41 days for placebo) should be taken into account.

Body As A Whole: asthenia (9% and 2%) headache (12% and 2%) pain (10% and 2%)
Digestive: dyspepsia (8% and 0%)nausea (6% and 0%)oral candidiasis (10% and 0%)
Musculoskeletal: arthralgia (6% and 0%)
Respiratory: cough increased (6% and 2%) respiratory infection (32% and 13%) rhinitis (6% and 2%) sinusitis (16% and 11%)

Patients Receiving Budasmal SF (Budasmal SF) Once Daily

The adverse event profile of once-daily administration of Budasmal SF (Budasmal SF) 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 Budasmal SF (Budasmal SF) 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 Budasmal SF (Budasmal SF) (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 Budasmal SF 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.

Budasmal SF contraindications

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What is the most important information I should know about Budasmal SF?

Before using Budasmal SF, 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.

Budasmal SF 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 Budasmal SF 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 Budasmal SF nasal.



Active ingredient matches for Budasmal SF:

Budesonide in Chile.


List of Budasmal SF substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Aerosol, Metered-Dose; Inhalation; Budesonide 200 mcg / dose (Laboratorios chile)
Budate 100mcg CAP / 200mdi (Lupin Laboratories Ltd.)$ 2.45
Budate 0.5mg RESP / 2mlx20 (Lupin Laboratories Ltd.)
Budate 1mg/2ml F-RESP / 2mlx20 (Lupin Laboratories Ltd.)
0.5 mg x 2mlx20 (Lupin Laboratories Ltd.)
1 mg x 2 mL x 2mlx20 (Lupin Laboratories Ltd.)
100 mcg x 200md (Lupin Laboratories Ltd.)$ 2.45
Budate 100 mcg Inhaler (Lupin Laboratories Ltd.)$ 0.02
BUDATE 0.5MG/2ML RESPULES 1 strip / 21 respuless each (Lupin Laboratories Ltd.)$ 6.83
BUDATE 100 MCG TRANSHALER 1 packet / 200 MDI transhaler each (Lupin Laboratories Ltd.)$ 3.08
BUDATE 200 MCG TRANSHALER 1 packet / 200 MDI transhaler each (Lupin Laboratories Ltd.)$ 3.80
BUDATE FORTE 1 MG TRANSPULES 1 packet / 7 transpuless each (Lupin Laboratories Ltd.)$ 2.66
BUDATE respules 0.5 mg x 2ml (Lupin Laboratories Ltd.)$ 0.32
BUDATE inhalation powd cap 100 mcg x 30's (Lupin Laboratories Ltd.)$ 0.62
BUDATE MDI 100 mcg x 1's (Lupin Laboratories Ltd.)$ 3.13
Budate 0.5mg Transpules (Lupin Laboratories Ltd.)$ 0.25
Budate 100mcg Transhaler (Lupin Laboratories Ltd.)$ 0.02
Budate 200mcg Transhaler (Lupin Laboratories Ltd.)$ 0.02
Budate 1mg Transpules (Lupin Laboratories Ltd.)$ 0.26
BUDATE FORTE respules 1 mg x 2 mL x 2ml (Lupin)$ 0.38
Capsule, Sustained Release; Oral; Budesonide 3 mg (Astrazeneca)
Enema; Kit; Tablet; Rectal; Budesonide 2.3 mg; Sodium Chloride 115 ml (Astrazeneca)
Powder; Inhalation; Budesonide 200 mcg / dose (AstraZeneca)
Budecort 100mcg R-CAP / 30 (AstraZeneca)$ 0.65
Budecort 200mcg R-CAP / 30 (AstraZeneca)$ 0.90
Budecort 400mcg R-CAP / 30 (AstraZeneca)$ 0.99
Budecort 100mcg/puff MDI / 200md (AstraZeneca)$ 2.87
Budecort 200mcg/puff MDI / 200md (AstraZeneca)$ 3.70
Budecort 64 mcg x 120 doses (AstraZeneca)$ 17.78
Budecort 200 mcg/1 dose x 100 doses (AstraZeneca)$ 25.11
Budecort 250 mcg/1 mL x 2 mL x 20's (AstraZeneca)$ 60.49
Budecort 500 mcg/1 mL x 2 mL x 20's (AstraZeneca)$ 81.51
100 mcg x 1 puff x 200md (AstraZeneca)$ 2.87
200 mcg x 1 puff x 200md (AstraZeneca)$ 3.70
100 mcg x 30's (AstraZeneca)$ 0.65
200 mcg x 30's (AstraZeneca)$ 0.90
400 mcg x 30's (AstraZeneca)$ 0.99
BUDECORT 0.5 MG RESPULES 1 strip / 10 respuless each (AstraZeneca)$ 2.50
BUDECORT 1 MG RESPULES 1 strip / 10 respuless each (AstraZeneca)$ 2.51
BUDECORT 100 MCG INHALER 1 packet / 200 MDI inhaler each (AstraZeneca)$ 3.09
BUDECORT 100 MG ROTACAP 1 packet / 30 rotacaps each (AstraZeneca)$ 0.87
BUDECORT 200 MG ROTACAP 1 packet / 30 rotacaps each (AstraZeneca)$ 1.14
BUDECORT 400 MCG ROTACAP 1 packet / 30 rotacaps each (AstraZeneca)$ 1.36
Budecort nasal spray 64 mcg 120 dose x 1's (AstraZeneca)$ 17.78
Budecort respules 250 mcg/mL 2 mL x 20 x 1's (AstraZeneca)$ 60.49
Budecort respules 500 mcg/mL 2 mL x 20 x 1's (AstraZeneca)$ 81.51
Budecort turbuhaler 200 mcg/dose 100 dose x 1's (AstraZeneca)$ 25.11
BUDECORT MDI 100 mcg x 1 puff x 200md (AstraZeneca)$ 2.62
BUDECORT MDI 200 mcg x 1 puff x 200md (AstraZeneca)$ 3.58
BUDECORT rotacap 100 mcg x 30's (AstraZeneca)$ 0.73
BUDECORT rotacap 200 mcg x 30's (AstraZeneca)$ 0.99
BUDECORT rotacap 400 mcg x 30's (AstraZeneca)$ 1.18
Budecort 0.5mg Respules (AstraZeneca)$ 0.25
Budecort 100mcg Inhaler (AstraZeneca)$ 3.14
Budecort 100mg Rotacap (AstraZeneca)$ 0.03
Budecort 1mg Respules (AstraZeneca)$ 0.26
Budecort 200mcg Inhaler (AstraZeneca)$ 3.87
Budecort 200mg Rotacap (AstraZeneca)$ 0.04
Budecort 400mcg Rotacap (AstraZeneca)$ 0.05
Budecort 100/200 Inhaler 100 mcg/1 actuation x 300 metered doses
Budecort 100/200 Inhaler 200 mcg/1 actuation x 300 metered doses
Budecort Aqueous Nasal Spray 64 mcg/1 dose x 120 doses (AstraZeneca)$ 17.78
Budecort Aqueous Nasal Spray nasal spray 64 mcg/dose 120 dose x 1's (AstraZeneca)$ 17.78
Budecort DP 100 mcg x 30's

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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