What happens if I overdose Bronex?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include body discomfort; depression; difficulty breathing; dizziness; exhaustion; fainting; joint pain; loss of appetite; muscle aches; nausea.
Proper storage of Bronex spray:
Store Bronex spray at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in an upright position. Store away from heat, moisture, and light. Do not store in the bathroom. Do not freeze. Keep Bronex spray out of the reach of children and away from pets.
Overdose of Bronex in details
The potential for acute toxic effects following overdose of Bronex (Bronex) is low. If used at excessive doses for prolonged periods, systemic corticosteroid effects such as hypercorticism may occur. Bronex at twice the highest recommended dose (3200 mcg daily) administered for 6 weeks caused a significant reduction (27%) in the plasma cortisol response to a 6-hour infusion of ACTH compared with placebo (+1%). The corresponding effect of 10 mg prednisone daily was a 35% reduction in the plasma cortisol response to ACTH.
The minimal inhalation lethal dose in mice was 100 mg/kg (approximately 320 times the maximum recommended daily inhalation dose in adults and approximately 380 times the maximum recommended daily inhalation dose in children on a mcg/m basis).
Post-marketing experience showed that patients experiencing acute overdose of inhaled Bronex commonly remained asymptomatic. The use of excessive doses (up to 6400 mcg daily) for prolonged periods showed systemic corticosteroid effects such as hypercorticism.
What should I avoid while taking Bronex?
Avoid getting Bronex in your eyes. If this does happen, rinse with water and call your doctor.
Bronex 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 Bronex.
Bronex warnings
Entocort® EC (Bronex)Capsules
Read this information carefully before you begin treatment. Read the information you get whenever you get more medicine. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about Bronex (EN-toe-cort EE CEE), ask your health care provider (provider). Only your provider can determine if Bronex is right for you.
What is Bronex?
Bronex is a medicine to treat mild to moderate Crohn’ s Disease in many people. However, it does not work for everyone who takes it. Bronex is a nonsystemic corticosteroid, which means it works mainly in one area of the body. The medicine in Bronex is released in the intestine. Therefore, it controls the symptoms of Crohn’ s disease even though 90% of the drug does not go into the bloodstream. Because of this, it causes fewer severe side effects than other corticosteroids.
Who should not take Bronex?
Do not take Bronex if:
• you are breast feeding. Because Bronex is carried in human milk, it may harm the baby. Talk with your provider about whether you should stop breast feeding to take Bronex or should use another treatment
• you have had an allergic reaction to Bronex or any of its ingredients
To help your provider decide if Bronex is right for you, tell your provider:
• if you had an allergic reaction to any medicine in the past
• the names of all the prescription and nonprescription medicines you now take. Be sure to tell your provider if you take ketoconazole, which can affect processing of Bronex by the liver, steroids such as prednisone, or any other drug that suppresses your immune system
• if you are pregnant, think you may be pregnant, or plan to get pregnant. Your provider will talk about whether Bronex is right for you
• if you ever had liver problems. Liver problems affect the amount of Bronex that stays in your system, and dosage may need to be changed
• if you are about to have surgery for any reason. Your dosage may need to be changed
• if you have chicken pox or measles, or any other condition that suppresses the immune system
• if you or anyone in your family has had diabetes or glaucoma
• if you ever had tuberculosis, high blood pressure, osteoporosis, ulcers, or cataracts.
How should I take Bronex?
Take Bronex in the morning. Swallow each Bronex capsule whole.Do not open, chew, or crush Bronex capsules. Your provider will tell you how long to take Bronex.
What should I avoid while taking Bronex?
Patients who take medicines that suppress the immune system, such as Bronex, are more likely to get infections. Avoid people with infections. Also, if you never had chicken pox or measles, be careful to avoid people with these conditions. These conditions can be more serious if you get them while taking Bronex.
While you are taking Bronex, do not drink grapefruit juice regularly. Grapefruit juice can increase the amount of Bronex in your blood. Other juices, like orange juice or apple juice, do not have this effect.
What are the side effects of Bronex?
The most common side effects of Bronex are headache, infection in your air passages (respiratory infection), nausea, and symptoms of hypercorticism (too much steroids in your body).
These symptoms include an increase in the size of the face and neck, acne, and bruising. Most symptoms of too much steroids in your body occur less often with Bronex than with other steroids.
Call your provider right away if you notice itching, skin rash, fever, swelling of your face and neck, or trouble breathing while you are taking Bronex. These may be signs that you are allergic to the medicine and you may need emergency medical help.
Switching from a systemic medicine, like prednisone, to a nonsystemic medicine, such as Bronex, can cause allergies controlled by the systemic medicine to come back. These allergies may include eczema (a skin disease) or rhinitis (inflammation inside the nose).
Call your provider if
• your Crohn’ s disease symptoms worsen during treatment
• you notice any side effects or any other symptoms that concern you
These are not all the possible side effects of Bronex. Ask your provider or pharmacist for a complete listing of all possible side effects of Bronex.
What is Crohn’ s disease?
Crohn’ s disease is an inflammatory bowel disease. The inflammation caused by Crohn’ s disease is usually found in a part of the small intestine called the ileum and in the large intestine (colon). It may also occur in any part of the gastrointestinal tract (digestive system) from the mouth to the anus (rectum). The cause of Crohn’ s disease is not yet known.
There are many symptoms of Crohn’ s disease. These include diarrhea, crampy abdominal (stomach area) pain, fever, and sometimes bleeding from the rectum. Appetite loss followed by weight loss may occur. There may also be redness and soreness of the eyes, joint pain, and sores on the skin. These symptoms may range from mild to severe.
There is no cure yet for Crohn’ s disease. However, it is possible for the disease to quiet down (go into remission). During these periods of remission, there may be times when the symptoms get worse. In general, people with Crohn. s disease are able to lead productive lives.
General advice about prescription medicines
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Bronex for a condition for which it was not prescribed. Do not give Bronex to other people, even if they have the same symptoms you have. It may harm them. Keep Bronex and all medicines out of the reach of children.
This leaflet summarizes the most important information about Bronex. If you would like more information, talk with your provider. You can ask your pharmacist or provider for information about Bronex that is written for health professionals. You can also visit the Bronex Web site at (www. EntocortEC.com) or call the information center at AstraZeneca toll-free(1-800- 237-8898).
All trademarks are the property of the AstraZeneca grou © AstraZeneca 2005
Manufactured by: AstraZeneca AB S-151 85 Sodertalje, Sweden Distributed by: Prometheus Laboratories Inc San Diego, CA 92121 Product of Sweden 30029XX 04/05
What should I discuss with my healthcare provider before taking Bronex?
Some medical conditions may interact with Bronex spray. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a bacterial, viral, fungal, or parasitic infection; chickenpox; tuberculosis (TB); a positive TB skin test; measles; diarrhea; nasal ulcer, surgery, or trauma; or herpes infection in the eye; or if you have had a recent vaccine
Some MEDICINES MAY INTERACT with Bronex spray. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Clarithromycin, imidazoles (eg, ketoconazole), hormonal contraceptives (eg, birth control pills), or mifepristone because side effects, such as adrenal suppression effects, may occur
- Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease Bronex spray's effectiveness
- Live vaccines, mifepristone, or ritodrine because the risk of their side effects may be increased by Bronex spray
- Hydantoins (eg, phenytoin) because their effectiveness may be decreased by Bronex spray
This may not be a complete list of all interactions that may occur. Ask your health care provider if Bronex spray may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Bronex precautions
General
During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, eg, joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function.
In responsive patients, Bronex (Bronex) may permit control of asthma symptoms with less suppression of HPA-axis function than therapeutically equivalent oral doses of prednisone. Since Bronex is absorbed into the circulation and can be systemically active, the beneficial effects of Bronex (Bronex) in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose. Since individual sensitivity to effects on cortisol production exists, physicians should consider this information when prescribing Bronex (Bronex).
Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with Bronex (Bronex) should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response.
It is possible that systemic corticosteroid effects such as hypercorticism, reduced bone mineral density, and adrenal suppression may appear in a small number of patients, particularly at higher doses. If such changes occur, Bronex (Bronex) should be reduced slowly, consistent with accepted procedures for management of asthma symptoms and for tapering of systemic steroids.
Orally inhaled corticosteroids, including Bronex, may cause a reduction in growth velocity when administered to pediatric patients. A reduction in growth velocity may occur as a result of inadequate control of asthma or from use of corticosteroids for treatment. The potential effects of prolonged treatment on growth velocity should be weighed against the clinical benefits obtained and the risks associated with alternative therapies. To minimize the systemic effects of orally inhaled corticosteroids, including Bronex (Bronex), each patient should be titrated to his/her lowest effective dose.
Although patients in clinical trials have received Bronex (Bronex) on a continuous basis for periods of 1 to 2 years, the long-term local and systemic effects of Bronex (Bronex) in human subjects are not completely known. In particular, the effects resulting from chronic use of Bronex (Bronex) on developmental or immunological processes in the mouth, pharynx, trachea, and lung are unknown.
In clinical trials with Bronex (Bronex), localized infections with Candida albicans occurred in the mouth and pharynx in some patients. These infections may require treatment with appropriate antifungal therapy and/or discontinuance of treatment with Bronex (Bronex).
Inhaled corticosteroids should 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.
Rare instances of glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids.
Information for Patients
Patients being treated with Bronex (Bronex) should receive the following information and instructions. This information is intended to aid the patient in the safe and effective use of the medication. It is not a disclosure of all possible adverse or intended effects. For proper use of Bronex (Bronex) and to attain maximum improvement, the patient should read and follow the accompanying Patient's Instructions for Use carefully.
- Patients should use Bronex (Bronex) at regular intervals as directed since its effectiveness depends on regular use. The patient should not alter the prescribed dosage unless advised to do so by the physician.
- Patients should be advised that Bronex (Bronex) is not a bronchodilator and is not intended to treat acute or life-threatening episodes of asthma.
- Patients should be advised that the effectiveness of Bronex (Bronex) depends on proper use of the device and inhalation-administering technique:
- 1. Bronex (Bronex) must be in the upright position (mouthpiece on top) during loading in order to provide the correct dose.
- 2. Bronex (Bronex) must be primed when the unit is used for the very first time. To prime the unit, it must be held in an upright position and the brown grip turned fully to the right, then turned fully to the left until it clicks. Repeat.
- 3. To load the first dose, the grip must be turned fully to the right and fully to the left until it clicks.
- 4. After the first dose, it is not necessary to prime the unit. However, it must be loaded in the upright position immediately prior to use as described above.
- 5. Patients should be advised not to shake the inhaler.
- Patients should place the mouthpiece between the lips and inhale forcefully and deeply. The powder is then delivered to the lungs.
- Patients should not exhale through Bronex (Bronex).
- Due to the small volume of powder, the patient may not taste or sense the presence of any medication entering the lungs when inhaling from the TURBUHALER inhaler. This lack of sensation does not indicate that the patient is not receiving benefit from Bronex (Bronex).
- Patients should be advised that rinsing the mouth with water without swallowing after each dosing may decrease the risk of the development of oral candidiasis.
- Patients should be instructed that they will receive a new Bronex (Bronex) unit each time they refill their prescription. Patients should be advised to discard the whole device after the labelled number of inhalations has been used. When there are 20 doses remaining in Bronex (Bronex), a red mark will appear in the indicator window.
- Bronex (Bronex) should not be used with a spacer.
- The mouthpiece should not be bitten or chewed.
- The cover should be replaced securely after each opening.
- Patients should keep Bronex (Bronex) clean and dry at all times.
- Patients should be advised that improvement in asthma control following inhalation of Bronex (Bronex) can occur within 24 hours of beginning treatment although maximum benefit may not be achieved for 1 to 2 weeks, or longer. If symptoms do not improve in that time frame, or if the condition worsens, the patient should be instructed not to increase the dosage, but to contact the physician.
- Patients whose systemic corticosteroids have been reduced or withdrawn should be instructed to carry a warning card indicating that they may need supplemental systemic corticosteroids during periods of stress or an asthma attack that does not respond to bronchodilators.
- Patients should be advised not to stop the use of Bronex (Bronex) abruptly.
- Patients should be warned to avoid exposure to chicken pox or measles and if they are exposed, to consult their physicians without delay.
- Long-term use of inhaled corticosteroids, including Bronex, may increase the risk of some eye problems (cataracts or glaucoma). Regular eye examinations should be considered.
- Women considering the use of Bronex (Bronex) should consult with their physician if they are pregnant or intend to become pregnant, or if they are breast-feeding a baby.
- Patients considering use of Bronex (Bronex) should consult with their physician if they are allergic to Bronex or any other orally inhaled corticosteroid.
- Patients should inform their physician of other medications they are taking as Bronex (Bronex) may not be suitable in some circumstances and the physician may wish to use a different medicine.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies were conducted in rats and mice using oral administration to evaluate the carcinogenic potential of Bronex.
In a 104-week oral study in Sprague-Dawley rats, a statistically significant increase in the incidence of gliomas was observed in male rats receiving an oral dose of 50 mcg/kg/day (less than the maximum recommended daily inhalation dose in adults and children on a mcg/m basis).
Experience with oral corticosteroids since their introduction in pharmacologic as opposed to physiologic doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans.
Studies of pregnant women, however, have not shown that Bronex (Bronex) 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 1995-1997 (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 Bronex during early pregnancy. Congenital malformations were studied in 2,014 infants born to mothers reporting the use of inhaled Bronex for asthma in early pregnancy (usually 10-12 weeks after the last menstrual period), the period when most major organ malformations occur. The rate of recorded congenital malformations was similar compared with the general population rate (3.8 % vs. 3.5%, respectively). In addition, after exposure to inhaled Bronex, 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 2,534 infants whose mothers were exposed to inhaled Bronex. In this study, the rate of congenital malformations among infants whose mothers were exposed to inhaled Bronex during early pregnancy was not different from the rate for all newborn babies during the same period (3.6%).
Despite the animal findings, it would appear that the possibility of fetal harm is remote if the drug is used during pregnancy. Nevertheless, because the studies in humans cannot rule out the possibility of harm, Bronex (Bronex) should be used during pregnancy only if clearly needed.
Nonteratogenic Effects
Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully observed.
Nursing Mothers
Corticosteroids are secreted in human milk. Because of the potential for adverse reactions in nursing infants from any corticosteroid, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Actual data for Bronex are lacking.
Pediatric Use
Safety and effectiveness of Bronex (Bronex) in pediatric patients below 6 years of age have not been established.
In pediatric asthma patients the frequency of adverse events observed with Bronex (Bronex) was similar between the 6- to 12-year age group (N=172) compared with the 13- to 17-year age group (N=124).
Controlled clinical studies have shown that orally inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients. 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 5-12 years of age, those treated with Bronex (Bronex) 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 Bronex (Bronex) 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 orally inhaled corticosteroids, including Bronex (Bronex), should be monitored routinely (eg, 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 Bronex (Bronex), each patient should be titrated to his/her lowest effective dose.
Geriatric Use
One hundred patients 65 years or older were included in the US and non-US controlled clinical trials of Bronex (Bronex). There were no differences in the safety and efficacy of the drug compared with those seen in younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
What happens if I miss a dose of Bronex?
Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.
References
- DailyMed. "PSEUDOEPHEDRINE SULFATE: 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).
- DailyMed. "GUAIFENESIN; HYDROCODONE BITARTRATE: 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).
- 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).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
