BUDESONIDE suspension

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X)

Beszerezhető a:

Aurobindo Pharma Limited

Az alkalmazás módja:

RESPIRATORY (INHALATION)

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use : - Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm. The use of budesonide is contraindicated in the following conditions: - Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. - Hypersensitivity to budesonide or any of the ingredients of budesonide inhalation suspension [see Warnings and Precautions (5.3), Description (11), Adverse Reactions (6.2)] . Risk Summary There are no adequate well-controlled studies of budesonide in pregnant women.  However, there are published studies on the use of budesonide, the active ingredient in budesonide, in pregnant women. In animal reproduction studies, budesonide, administered by the subcutaneous route, caused structural abnormalities, was embryocidal, and reduced fetal weights in rats and rabbits at less than the maximum recommended human daily inhalation dose (MRHDID), but these effects were not seen in rats that received inhaled doses approximately 2 times the MRHDID (see Data) . Studies of pregnant women have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. Experience with oral corticosteroids suggests that rodents are more prone to structural abnormalities from corticosteroid exposure than humans. The estimated background risk of major birth defects and miscarriage of the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal risk In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control. Labor or Delivery There are no well-controlled human studies that have investigated the effects of budesonide during labor and delivery. Data Human Data Studies of pregnant women have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. The results from a large population-based prospective cohort epidemiological study reviewing data from three Swedish registries covering approximately 99% of the pregnancies from 1995 to 1997 (i.e., Swedish Medical Birth Registry; Registry of Congenital Malformations; Child Cardiology Registry) indicate no increased risk for congenital malformations from the use of inhaled budesonide during early pregnancy. Congenital malformations were studied in 2014 infants born to mothers reporting the use of inhaled budesonide for asthma in early pregnancy (usually 10 to 12 weeks after the last menstrual period), the period when most major organ malformations occur. The rate of recorded congenital malformations was similar compared to the general population rate (3.8% vs. 3.5%, respectively). In addition, after exposure to inhaled budesonide, the number of infants born with orofacial clefts was similar to the expected number in the normal population (4 children vs. 3.3, respectively). These same data were utilized in a second study bringing the total to 2534 infants whose mothers were exposed to inhaled budesonide. In this study, the rate of congenital malformations among infants whose mothers were exposed to inhaled budesonide during early pregnancy was not different from the rate for all newborn babies during the same period (3.6%). Animal Data In a fertility and reproduction study, male rats were subcutaneously dosed for 9 weeks and females for 2 weeks prior to pairing and throughout the mating period. Females were dosed up until weaning of their offspring. Budesonide caused a decrease in prenatal viability and viability in the pups at birth and during lactation, along with a decrease in maternal body-weight gain, at doses 0.2 times the MRHDID (on a mcg/m2 basis at maternal subcutaneous doses of 20 mcg/kg/day and above). No such effects were noted at a dose 0.05 times the MRHDID (on a mcg/m2 basis at a maternal subcutaneous dose of 5 mcg/kg/day). In an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6 to 18, budesonide produced fetal loss, decreased fetal weight, and skeletal abnormalities at doses 0.5 times the MRHDID (on a mcg/m2 basis at a maternal subcutaneous dose of 25 mcg/kg/day). In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 6 to 15, budesonide produced similar adverse fetal effects at doses approximately 5 times the MRHDID (on a mcg/m2 basis at a maternal subcutaneous dose of 500 mcg/kg/day). In another embryo-fetal development study in pregnant rats, no structural abnormalities or embryocidal effects were seen at doses approximately 2 times the MRHDID (on a mcg/m2 basis at maternal inhalation doses up to 250 mcg/kg/day). In a peri-and post-natal development study, rats dosed from gestation day 15 to postpartum day 21, budesonide had no effects on delivery, but did have an effect on growth and development of offspring. Offspring survival was reduced and surviving offspring had decreased mean body weights at birth and during lactation at doses less than 0.2 times the MRHDID and higher (on a mcg/m2 basis at maternal subcutaneous doses of 20 mcg/kg/day and higher). These findings occurred in the presence of maternal toxicity. Risk Summary There are no available data on the effects of budesonide on the breastfed child or on milk production. Budesonide, like other inhaled corticosteroids, is present in human milk [see Data] . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for budesonide and any potential adverse effects on the breastfed infant from budesonide or from the underlying maternal condition. Data Human data with budesonide delivered via dry powder inhaler indicates that the total daily oral dose of budesonide available in breast milk to the infant is approximately 0.3% to 1% of the dose inhaled by the mother [see Clinical Pharmacology (12.3)] . Safety and effectiveness in children six months to 12 months of age has been evaluated but not established. Safety and effectiveness in children 12 months to 8 years of age have been established [see Clinical Pharmacology (12.2), Adverse Reactions (6.1)] . A 12-week study in 141 pediatric patients 6 to 12 months of age with mild to moderate asthma or recurrent/persistent wheezing was conducted. All patients were randomized to receive either 0.5 mg or 1 mg of budesonide or placebo once daily. Adrenal-axis function was assessed with an ACTH stimulation test at the beginning and end of the study, and mean changes from baseline in this variable did not indicate adrenal suppression in patients who received budesonide versus placebo. However, on an individual basis, 7 patients in this study (6 in the budesonide treatment arms and 1 in the placebo arm) experienced a shift from having a normal baseline stimulated cortisol level to having a subnormal level at Week 12 [see Clinical Pharmacology (12.2)] . Pneumonia was observed more frequently in patients treated with budesonide than in patients treated with placebo, (N = 2, 1, and 0) in the budesonide 0.5 mg, 1 mg, and placebo groups, respectively. A dose dependent effect on growth was also noted in this 12-week trial. Infants in the placebo arm experienced an average growth of 3.7 cm over 12 weeks compared with 3.5 cm and 3.1 cm in the budesonide 0.5 mg and 1 mg arms respectively. This corresponds to estimated mean (95% CI) reductions in 12-week growth velocity between placebo and budesonide 0.5 mg of 0.2 cm (-0.6 to 1.0) and between placebo and budesonide 1 mg of 0.6 cm (-0.2 to 1.4). These findings support that the use of budesonide in infants 6 to 12 months of age may result in systemic effects and are consistent with findings of growth suppression in other studies with inhaled corticosteroids. Controlled clinical studies have shown that inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients. In these studies, the mean reduction in growth velocity was approximately one centimeter per year (range 0.3 to 1.8 cm per year) and appears to be related to dose and duration of exposure. This effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA)-axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA-axis function. The long-term effects of this reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final adult height, are unknown. The potential for “catch up” growth following discontinuation of treatment with orally inhaled corticosteroids has not been adequately studied. In a study of asthmatic children 5 to 12 years of age, those treated with budesonide administered via a dry powder inhaler 200 mcg twice daily (n=311) had a 1.1-centimeter reduction in growth compared with those receiving placebo (n=418) at the end of one year; the difference between these two treatment groups did not increase further over three years of additional treatment. By the end of four years, children treated with the budesonide dry powder inhaler and children treated with placebo had similar growth velocities. Conclusions drawn from this study may be confounded by the unequal use of corticosteroids in the treatment groups and inclusion of data from patients attaining puberty during the course of the study. The growth of pediatric patients receiving inhaled corticosteroids, including budesonide, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the risks and benefits associated with alternative therapies. To minimize the systemic effects of inhaled corticosteroids, including budesonide, each patient should be titrated to his/her lowest effective dose [see Dosage and Administration (2), Warnings and Precautions (5.8)] . Of  the 215 patients in 3 clinical trials of budesonide in adult patients, 65 (30%) were 65 years of age or older, while 22 (10%) were 75 years of age or older. No overall differences in safety were observed between these patients and younger patients, and other reported clinical or medical surveillance experience has not identified differences in responses between the elderly and younger patients. Formal pharmacokinetic studies using budesonide have not been conducted in patients with hepatic impairment. However, since budesonide is predominantly cleared by hepatic metabolism, impairment of liver function may lead to accumulation of budesonide in plasma. Therefore, patients with hepatic disease should be closely monitored. Budesonide (bue  des' oh nide) Inhalation Suspension 2 mL ampules containing 0.5 mg For inhalation only. Do not swallow. Only use budesonide inhalation suspension with a jet nebulizer machine that is connected to an air compressor. Do not use with an ultrasonic nebulizer. Read the Patient Information that comes with budesonide inhalation suspension before your child starts using it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your child’s medical condition or treatment. If you have any questions about budesonide inhalation suspension, ask your healthcare provider or pharmacist. What is budesonide inhalation suspension? Budesonide inhalation suspension is an inhaled corticosteroid medicine. Budesonide inhalation suspension is a long-term maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years. Inhaled corticosteroids help to decrease inflammation in the lungs. Inflammation in the lungs can lead to asthma symptoms. Budesonide inhalation suspension helps reduce swelling and inflammation in the lungs, and helps keep the airways open to reduce asthma symptoms. Budesonide inhalation suspension does not treat the sudden symptoms (wheezing, cough, shortness of breath, and chest pain or tightness) of an asthma attack. Always have a short-acting beta2 -agonist medicine (rescue inhaler) with you to treat sudden symptoms. If your child does not have an inhaled, short-acting bronchodilator, ask your healthcare provider to have one prescribed for your child. It is not known if budesonide inhalation suspension is safe or effective in children younger than 12 months or older than 8 years. Who should not use budesonide inhalation suspension? Do not use budesonide inhalation suspension: - to treat sudden symptoms of asthma - if your child is allergic to budesonide or any of the ingredients in budesonide inhalation suspension. See the end of this leaflet for a complete list of ingredients in budesonide inhalation suspension. What should I tell my healthcare provider before using budesonide inhalation suspension? Before your child uses budesonide inhalation suspension, tell your healthcare provider if your child: - has an allergy. See the section "Who should not use budesonide inhalation suspension?" There is a complete list of ingredients in budesonide inhalation suspension at the end of this leaflet. - has or recently had chicken pox or measles, or has recently been near anyone with chicken pox or measles. - has or had tuberculosis of the respiratory tract. - has certain kinds of infections that have not been treated, including:             o fungal infections             o bacterial infections             o viral infections             o parasitic infections             o herpes simplex infection of the eye (ocular herpes simplex) Budesonide inhalation suspension may not be right for children who have had any of these types of infections. - has decreased bone mineral density (bone strength). Your child is at risk for decreased bone mineral density if he or she:             o is inactive for a long period of time             o has a family history of osteoporosis             o does not eat well (poor nutrition)             o takes bone thinning medicines (such as anticonvulsant medicines or corticosteroids) for a long time. - has an eye problem such as increased pressure in the eye, glaucoma or cataracts. - has liver problems. - is planning to have surgery. - has any other medical conditions. - is pregnant or plans to become pregnant. It is not known if budesonide inhalation suspension will harm your unborn baby. - is breast-feeding or plans to breast-feed. Budesonide can pass into breast milk. You and your healthcare provider should decide if you will use budesonide inhalation suspension or breast-feed. Tell your healthcare provider about all the medicine your child takes, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using budesonide inhalation suspension with certain other medicines may affect each other causing side effects. Especially tell your healthcare provider if your child takes: - corticosteroids - anti-seizure medicine (anticonvulsants) - medicines that suppress the immune system (immunosuppressant) - ketoconazole (Nizoral) - certain medicines that can affect how your liver breaks down medicine Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Know the medicines your child takes. Keep a list of them and show it to your healthcare provider and pharmacist when your child gets a new medicine. How should I use budesonide inhalation suspension? - Use budesonide inhalation suspension exactly as prescribed by your healthcare provider. Your child must use budesonide inhalation suspension regularly for it to work. - Budesonide inhalation suspension comes in three strengths. Your healthcare provider has prescribed the strength that is best for your child. - Do not stop using budesonide inhalation suspension, and do not change your child’s dose of budesonide inhalation suspension without talking to your healthcare provider. - Budesonide inhalation suspension is for inhaled use only. Use budesonide inhalation suspension with a jet nebulizer connected to an air compressor set up with a mouthpiece or face mask. Do not use an ultrasonic nebulizer to give budesonide inhalation suspension. - Do not mix budesonide inhalation suspension with other nebulizer medicines. If your child uses another medicine by inhalation to treat asthma, talk with your healthcare provider for instructions on when to use the other medicine. - If your child misses a dose, just give the next regularly scheduled dose when it is due. Do not use budesonide inhalation suspension more often than has been prescribed. - Improvement in the control of asthma symptoms with budesonide inhalation suspension can occur within 2 to 8 days.  It may take up to 4 to 6 weeks before maximum improvement is seen. - Make sure your child always has a short-acting beta2 -agonist medicine with him or her. Your child should use the short-acting beta2 -agonist medicine for breathing problems between doses of budesonide inhalation suspension or if a sudden asthma attack happens. Call your healthcare provider right away if:             o the short-acting rescue medicine does not work as well for relieving asthma symptoms.             o your child needs to use the short-acting rescue medicines more often than usual.             o your child's breathing problems worsen with budesonide inhalation suspension - Rinse your child's mouth with water and have him or her spit the water out after each budesonide inhalation suspension treatment. Do not swallow the water. This will lessen the chance of getting a fungal infection (thrush) in the mouth. - If your child has used long-term corticosteroids and the dose is now being lowered or stopped, a warning card should be carried stating that your child may need corticosteroids during times of stress or during an asthma attack that does not get better with bronchodilator medicines. - Your healthcare provider may check your child’s blood, breathing and do eye exams while using budesonide inhalation suspension. - Read the Patient Information and Instructions for Use at the end of this leaflet for detailed instructions about how to use budesonide inhalation suspension. What are the possible side effects of budesonide inhalation suspension? Budesonide inhalation suspension may cause serious side effects including: - Thrush (candida), a fungal infection in your mouth and throat. Tell your healthcare provider if your child has any redness or white colored patches in the mouth or throat. - Worsening of asthma or sudden asthma attacks. - Allergic reactions. Tell your healthcare provider or get medical help right away if your child has:              o skin rash, redness or swelling              o severe itching              o swelling of the face, mouth and tongue              o trouble breathing or swallowing              o chest pain              o anxiety (feeling of doom) - Immune system effects and a higher chance of infections. Your child is more likely to get infections when taking medicines that weaken the immune system. Symptoms of infection may include: fever, pain, aches, chills, feeling tired, nausea and vomiting. Tell your healthcare provider about any signs of infection while your child uses budesonide inhalation suspension. - Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency include tiredness, weakness, nausea and vomiting, and low blood pressure. - Decrease in bone mineral density (bone strength). Your healthcare provider may want to check your child for this during treatment with budesonide inhalation suspension. - Slowed or delayed growth problems. Your child's healthcare provider may want to monitor your child's growth while using budesonide inhalation suspension. - Eye problems, including glaucoma and cataracts. Your child's healthcare provider may suggest eye exams while using budesonide inhalation suspension. - Increased wheezing right after taking budesonide inhalation suspension. Always have a fast-acting inhaled bronchodilator medicine with you to treat sudden wheezing. Call your healthcare provider or get medical help right away if your child has any of the serious side effects listed above. The most common side effects of budesonide inhalation suspension include: - respiratory infections. Symptoms may include stuffy nose, sore nose and throat. - runny nose - cough - viral infections - viral irritation and inflammation of the stomach and intestine (gastroenteritis). Gastroenteritis symptoms may include: stomach area pain, diarrhea, nausea and vomiting, and loss of appetite. - ear infections - nosebleed - pink eye (conjunctivitis) - rash Tell your healthcare provider if your child has any side effect that bothers him or her or that does not go away. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to www.aurobindousa.com at 1-866-850-2876 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. How should I store budesonide inhalation suspension? - Store budesonide inhalation suspension in an upright position between 68°F to 77°F (20°C to 25°C). - Keep budesonide inhalation suspension in the aluminium foil pouch to protect from light until ready to use. - After a budesonide inhalation suspension ampule is opened it should be used right away. - Budesonide inhalation suspension ampules can be stored for 2 weeks after opening the protective aluminium foil pouch. - Throw away budesonide inhalation suspension ampules if not used within 2 weeks of opening the protective aluminium foil pouch. - Do not refrigerate or freeze. Keep budesonide inhalation suspension and all medicines out of the reach of children. General Information about budesonide inhalation suspension Medicines are sometimes prescribed for conditions other than those listed in a Patient Information leaflet. Do not use budesonide inhalation suspension for a condition for which it was not prescribed. Do not give budesonide inhalation suspension to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information leaflet summarizes the most important information about budesonide inhalation suspension. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about budesonide inhalation suspension that is written for health professionals. For more information, go to www.aurobindousa.com or call 1-866-850-2876. What are the ingredients in budesonide inhalation suspension? Active ingredient: budesonide Inactive ingredients: disodium edetate, sodium chloride, sodium citrate, citric acid, polysorbate 80 and water for injection. Patient Instructions for Use Important: Budesonide inhalation suspension is only for use with a jet nebulizer machine. Make sure you know how to use your jet nebulizer machine before your child uses budesonide inhalation suspension. Budesonide inhalation suspension is a liquid that is turned into a mist by a nebulizer and inhaled into the lungs. The face mask should be properly adjusted to optimize delivery and to avoid exposing the eyes to the nebulized medication. Corticosteroid effects on the skin can be avoided if the face is washed after the use of a face mask. 1.   Budesonide inhalation suspension come in a sealed protective aluminium foil pouch. - Do not open the sealed pouch until you are ready to use a dose of budesonide inhalation suspension. - Open the sealed foil pouch along the dotted line and take out 1 single-dose ampule from the strip. See Figure 1. - Record the date that you opened the foil on the back of the pouch in the space provided. Return the unopened budesonide inhalation suspension ampules on the strip back into the foil pouch before storing. Figure 1 2.   Gently shake the budesonide inhalation suspension ampule using a circular motion as shown in Figure 2. Figure 2 3.   Hold the budesonide inhalation suspension ampule upright without squeezing the ampule and open by twisting off the top as shown in Figure 3. Figure 3 4.   Place the open end of the budesonide inhalation suspension ampule into the nebulizer cup (reservoir) and slowly squeeze all of the medicine from the ampule into the nebulizer medicine cup as shown in Figure 4. Throw away the empty ampule. Figure 4 5.   Use your jet nebulizer as directed. All brands listed are the trademarks of their respective owners and are not trademarks of Eugia Pharma Specialities Limited. This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised: December 2022

Termék összefoglaló:

Budesonide inhalation suspension is a white to almost white colored suspension and is supplied in sealed aluminum foil pouches containing one plastic strip of five single-dose ampules together with patient instructions for use. There are 30 ampules in a carton. Each single-dose ampule contains 2 mL of sterile liquid suspension. Budesonide inhalation suspension is available in one strength containing 2 mL: NDC 59651-585-30                0.5 mg/2 mL Budesonide inhalation suspension should be stored upright at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature], and protected from light. When a pouch has been opened, the shelf life of the unused ampules is 2 weeks when protected. After opening the aluminum foil pouch, the unused ampules should be returned to the aluminum foil pouch to protect them from light. Any opened ampule must be used promptly. Gently shake the ampule using a circular motion before use. Keep out of reach of children. Do not freeze.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

BUDESONIDE - BUDESONIDE SUSPENSION
AUROBINDO PHARMA LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUDESONIDE INHALATION
SUSPENSION SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR BUDESONIDE INHALATION SUSPENSION.
BUDESONIDE INHALATION SUSPENSION
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Budesonide inhalation suspension is an inhaled corticosteroid
indicated for:
• Maintenance treatment of asthma and as prophylactic therapy in
children 12 months to 8 years of age
(1)
Limitations of Use:
Not indicated for the relief of acute bronchospasm (1)
DOSAGE AND ADMINISTRATION
Recommended dosing based on previous therapy (2). Start with the
lowest recommended dose:
Bronchodilators alone: 0.5 mg once daily or 0.25 mg twice daily
Inhaled corticosteroids: 0.5 mg once daily or 0.25 mg twice daily up
to 0.5 mg twice daily
Oral corticosteroids: 0.5 mg twice daily or 1 mg once daily
In symptomatic children not responding to non-steroidal therapy, a
starting dose of 0.25 mg once
daily may be considered
If once-daily treatment does not provide adequate control, the total
daily dose should
be increased and/or administered as a divided dose. Once asthma
stability is achieved, titrate the dose
downwards
For inhalation use via compressed air driven jet nebulizers only (not
for use with ultrasonic devices). Not
for injection. (2.2)
DOSAGE FORMS AND STRENGTHS
Inhalation suspension: 0.5 mg/2 mL (3)
CONTRAINDICATIONS
Primary treatment of status asthmaticus or other acute episodes of
asthma where intensive measures
are required (4)
Hypersensitivity to any of the ingredients in budesonide (4)
WARNINGS AND PRECAUTIONS
Localized Infections: _Candida albicans_ infection of the mouth and
throat may occur. Monitor patients
periodically for signs of adverse effects on the oral cavity. Advise
patients to rinse the mouth following
inhalation (5.1)
Deterioration of Disease and Acute Asthma Episodes: Do not use for the
relief of acute bronchospasm
(5.2)
H