Dulera inhalers contain a combination of formoterol and mometasone. Formoterol is a prolonged-acting bronchodilator which relaxes muscles in the airways to improve breathing. Mometasone is a steroid which prohibits the release of substances in the body that cause inflammation. Dulera inhalers are used as a maintenance treatment for asthma in adults and children who are at least 12 years old. Dulera is not for use in treating an asthma or bronchospasm attack. Dulera may also be used for purposes not listed in this medication guide.
Possible side effects of Durela
A side effect is an unwanted response to a medication when it is taken in proper doses. Side effects can be temporary or permanent, mild or severe. In this light the following side effects of Durela include:
- Stuffy nose
- Dry mouth or throat irritation may be experienced
- Abdominal or stomach pain
- Dry mouth
- Feeling of warmth
- Feeling sad or
- Empty feeling
- Unusually cold
- Overall feeling of illness or discomfort
- Heartburn irritability
- Itching of the skin
- Joint pain
- Loss of appetite
- Loss of interest or pleasure
- Loss of strength or weakness
- Muscle aches and pains nausea
- Redness of the face
- Arms and occasionally upper chest
- Runny nose
- Skin rash
- Sleepiness or unusual drowsiness
- Stuffy nose
- Unusual feeling of excitement
If any of these side effects of Durela persist or worsen, tell your physician promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of Durela side effects. Many people using this treatment do not have serious Durela side effects. This medication may increase your blood pressure. Check your blood pressure constantly and tell your doctor if the outcomes are high. Infrequently, this treatment may cause intense sudden worsening of breathing problems/asthma rapidly after use. If you witness a sudden worsening of breathing, apply your quick-relief inhaler and pursue medical help right away.
Tell your doctor right away if any of these common but serious side effects of Durela occur:
- White patches on tongue/in mouth
- Signs of infection (such as persistent sore throat and fever)
- Mental/mood changes (such as nervousness)
- Trouble sleeping
- Vision difficulties (such as blurred sight)
- Increased thirst/urination
- Muscle cramps
- Shaking (tremors)
Get medical assistance straightaway should any of these rare but serious side effects of Durela occur:
- Chest pain
- Fast/irregular heartbeat
- Severe dizziness, fainting
A very serious allergic reaction to this product is difficult. However, get medical assistance straight away if you notice any symptoms of a serious allergic reaction, amongst which we have:
- Rash, itching/swelling (especially of the face/tongue/throat)
- Severe dizziness
- Sudden trouble breathing
Furthermore signs of Durela side effects include:
- Overactive reflexes
- Poor coordination
- Acting or talking with excitement you cannot control
- Trembling or shaking
- difficulty breathing
- swelling of your face, tongue, or throat, tips
Durela is not for use in children. Solicit emergency medical attention if a child has taken this medicine and has; sighing, noisy breathing, slow breathing with long pauses between breaths, being unusually sleepy or hard to wake up, blue colored lips.
Call your doctor at once if you have: seizure (convulsions), weak or shallow breathing, infertility, missed menstrual periods, impotence, sexual problems, loss of interest in sex or low cortisol levels, nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness, or severe skin reaction, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: hallucinations, fever, shivering, agitation, sweating, fast heart rate, loss of coordination, muscle stiffness, nausea, twitching, diarrhea or vomiting
This is not a complete list of possible side effects Durela. If you notice other side effects Durela not listed above, call your physician or pharmacist. In the US-Call your physician for medical counsel about side effects Durela. You may report Durela side effects to FDA at 1-800-FDA-1088 or the website www.fda.gov/medwatch. In Canada call your physician for medical advice about side effects Durela. You may report side effects Durela to Health Canada at 1-866-234-2345.
i). Asthma-related death
Patients should be informed that formoterol, one of the active components in Durela, increases the risk of asthma-related death. In adolescent patients and pediatric, formoterol may increase the risk of asthma-related hospitalization. They should also be told that data are not adequate to determine whether the concurrent uses of Durela inhaled corticosteroids, the other component of Durela, or other long-term asthma-control therapy mitigates or eliminates this risk.
ii). Not for acute symptoms
Dulera is not indicated to relieve acute asthma symptoms and extra doses should not be used for that purpose. Acute signs should be treated alongside an inhaled, short-acting, beta2-agonist (the health care provider should prescribe the patient with such medication and instruct the patient in how it should be used).Patients should be instructed to seek medical attention immediately if they experience any of the following:
• If their symptoms worsen
• Significant reduction in lung function as outlined by the physician
• If they require more inhalations of a short-acting beta2-agonist than usual.
Patients should be advised not to increase the dose or frequency of Durela. The daily dosage of Durela should not exceed two inhalations twice daily. If they miss a dose, they should be guided to take their next dose at the same time they normally do. Durela, provides bronchodilation for up to 12 hours. Patients should not stop or reduce the Durela therapy without physician/provider guidance since symptoms may recur after discontinuation.
iii). Do not use additional long-acting beta2-agonists
When patients are given Durela, other long-acting beta2-agonists should not be used.
iv). Local Effects
Patients should be advised that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis forms, it should be treated with precise local or systemic (i.e., oral) antifungal treatment, while still continuing with Durela therapy, but at times therapy with Durela may need to be temporarily interrupted under close medical control. Rinsing the mouth after inhalation is very advisable.
Dosage of Durela
i). Dosage information:
Durela should be taken as two inhalations twice daily every day (morning and evening) by the orally inhaled route. Shake well prior to each inhalation. After each dosage of Durela, the patient should be advised to rinse his/her mouth with water without swallowing. The cap from the mouthpiece of the actuator should be removed before using Durela. Durela should be primed before using for the first time by releasing 4 test sprays into the air, away from the face, shaking thoroughly before each spray. In situations where the inhaler has not been used for more than five days, prime the inhaler again by making four test sprays into the air, away from the face, shaking thoroughly before each spray. The Durela canister should only be used with the Durela actuator. The Durela actuator should not be the uses of Durela with any other inhalation drug product. Actuators from other products should not be used with the Durela canister.
ii). Recommended dosage:
Adults and adolescents 12 years of age and older. The dosage of Durela is either 2 inhalations twice daily of Durela 100 mcg/5 mcg or Durela 200 mcg/5 mcg. The maximum recommended dose of Durela is two inhalations of Durela 200 mcg/5 mcg twice daily (maximum daily dosage 800 mcg/20 mcg). When choosing the starting dosage strength of Durela, strength, consider the patients’ disease severity, based on their past asthma therapy, incorporating the inhaled corticosteroid dosage, as well as the patients’ current control of asthma symptoms and risk of future exacerbation. The maximum benefit may not be achieved for 1 week or longer after beginning treatment. Individual patients may witness a variable time to onset and degree of symptom relief. For patients who do not respond properly after 2 weeks of therapy with two inhalations of Durela 100 mcg/5 mcg twice daily (morning and evening), increasing the dosage of Durela to two inhalations of Durela 200 mcg/5 mcg twice daily (morning and evening) may provide additional asthma control. Do not use more than two inhalations twice daily of the prescribed strength of Durela as some patients are more likely to experience adverse effects with higher doses of formoterol. If signs arise among doses, an inhaled short-acting beta2-agonist should be taken for immediate relief.
If a previously effective dosage regimen of Durela fails to provide adequate control of asthma, the therapeutic regimen should be re-assessed and additional therapeutic options, e.g., replacing the present strength of Durela with a greater strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids, have to be accepted.
Storage conditions of Durela
Store at controlled room temperature 20–25°C (68–77°F); excursions permitted to 15–30°C (59–86°F). The 120-inhalation inhaler does not require a specific storage guide. For the 60-inhalation inhaler, after priming, keep the inhaler with the mouthpiece down or in a horizontal position. For best results, the canister should be at room temperature before use. Shake thoroughly and take off the cap from the mouthpiece of the actuator before applying. Put out of the reach of children. Avoid using in eyes. Do not block. Do not store near heat or open flame or use. Exposure to temperatures beyond 120°F could cause bursting. Never throw off container into incinerator or fire.
Uses of Durela
i). Treatment of asthma
Durela uses apply to the treatment of asthma in patients twelve years of age and above. Prolonge-acting beta2-adrenergic agonists, such as formoterol, one of the active components in Durela uses, increase the risk of asthma related death. Available information from managed clinical trials suggests that prolonge-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related hospitalization in pediatric and adolescent patients. As a result, when treating patients with asthma, Durela uses should only be applied for patients not adequately controlled on a long-term asthma control treatment, such as an inhaled corticosteroidor whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and (LABA). Once asthma control is arrived and kept, assess the patient at frequent occasions and step down therapy (e.g., discontinue Durela) if possible without loss of asthma control, and keep the patient on a future asthma control treatment, such as an inhaled corticosteroid. Do not apply Durela for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
ii). Important limitation of use
Durela uses are not effective in the relief of acute bronchospasm
Durela contains both mometasonefuroate and formoterol fumarate; therefore, the risks associated with overdose for the individual components described below apply to Durela. Mometasone Furoate: Chronic overdosage may result in signs/symptoms of hypercorticism. Single oral doses up to 8000 mcg of mometasonefuroate have been studied in human volunteers with no adverse reactions reported.
Formoterol Fumarate: The expected signs and symptoms with overdosage of formoterol are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the following signs and signs: hypertension or hypotension, angina, tachycardia, with rates up to 200 beats/min., nausea, arrhythmias, seizures, nervousness, tremor, muscle cramps, dry mouth, palpitation, headache, dizziness, fatigue, malaise, hypokalemia, insomnia and hyperglycemia,. Metabolic acidosis may also happen. Cardiac arrest and even death may be linked with an overdose of formoterol.
The minimum acute lethal inhalation dose of formoterol fumarate in rats is 156 mg/kg (exactly 63,000 times the MRHD on a mcg/m2 basis). The average lethal oral doses in Chinese rats, hamsters, and mice offer even higher multiples of the MRHD.
Treatment for Durela Overdose
Durela: Treatment of overdosage consists of discontinuation of Durela together with institution of appropriate symptomatic and/or supportive therapy. The judicious uses of Durela of a cardioselective beta-receptor blocker may be considered, having in mind that such treatment can produce bronchospasm. There is inadequate evidence to determine if dialysis is beneficial for overdosage of Durela. Cardiac monitoring is recommended in cases of overdosage.
Use in specific populations
Pregnancy category C
There are no adequate and well-controlled researches on Durela, mometasonefuroate solely or formoterol fumarate only in pregnant women. Animal reproduction studies of mometasonefuroate and formoterol in mice, rats, and/or rabbits showed evidence of teratogenicity as well as other developmental toxic effects. Because animal reproduction researches are not always predictive of human response, uses of Durela should be applied during pregnancy only if the potential benefit justifies the potential risk to the fetus.
ii). Mometasonefuroate: teratogenic effects
When administered to pregnant mice, rats, and rabbits, mometasonefuroate increased fetal malformations and decreased fetal growth (measured by lower fetal weights and/or delayed ossification). Dystocia and associated complications were also observed when mometasonefuroate was administered to rats late in gestation. However, witness with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroid exposure than humans.
In a mouse reproduction study, subcutaneous mometasonefuroate produced cleft palate at approximately one-third of the maximum recommended daily human dose (MRHD) on a mcg/m2 basis and decreased fetal survival at approximately 1 time the MRHD. No toxicity was noticed at approximately one-tenth of the MRHD on a mcg/m2 basis.
In a rat reproduction study, mometasonefuroate produced umbilical hernia at topical dermal doses approximately 6 times the MRHD on a mcg/m2 basis and delays in ossification at approximately 3 times the MRHD on a mcg/m2 basis.
In another study, rats received subcutaneous doses of mometasonefuroate throughout pregnancy or late in gestation. Treated animals had lengthy and difficult labor, lower birth weight, fewer live births, and decreased early pup survival at a dose that was approximately 8 times the MRHD on an area under the curve (AUC) basis. Similar effects were not noticed at approximately 4 times MRHD on an AUC basis.
In rabbits, mometasonefuroate caused multiple malformations (e.g., gallbladder agenesis, hydrocephaly, flexed front paws, umbilical hernia,) at topical dermal doses approximately 3 times the MRHD on a mcg/m2 basis. In an oral study, mometasonefuroate accelerated resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at a dose less than the MRHD based on AUC. At a dose exactly 2 times the MRHD based on AUC, most litters were extinct or resorted
iii). Pediatric use
A safety and effectiveness of Durela have been established in patients 12 years of age and older in 3 clinical trials up to 52 weeks’ time frame. In the 3 clinical tests, 101 patients 12 to 17 years of age were treated with Durela. Patients in this age-group demonstrated meaningful results similar to those observed in patients 18 years of age and older. There were no normal differences in the type or frequency of adverse drug reactions reported in this age group compared to patients 18 years of age and older. Similar safety and effective outcomes were observed in an additional 22 patients 12 to 17 years of age who were treated with Durela in another clinical trial. The safety and effectiveness of Durela have not been established in children less than 12 years of age.
Warnings and Precautions
i). Excessive use of Durela and use with other long-acting beta2-agonists
As with other inhaled drugs containing beta2-adrenergic agents, Durela should not be used more often than approved, at higher doses than recommended, or in conjunction with other treatments containing long-acting beta2-agonists, as an overdose may result. Clinically important cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using Durela should not use an additional long-acting beta2-agonist (e.g., arformoterol tartrate, formoterol fumarate, salmeterol) for any reason, alongside prevention of exercise-induced bronchospasm (EIB) or the treatment of asthma.
ii). Paradoxical bronchospasm and upper airway symptoms
Durela may produce inhalation induced bronchospasm with an immediate increase in wheezing after dosing that may be life-threatening. If inhalation induced bronchospasm happens, it should be treated rapidly with an inhaled, brief-acting bronchodilator. Durela should be discontinued immediately and alternative therapy instituted.
iii). Immediate hypersensitivity reactions
Immediate hypersensitivity reactions may happen after administration of Durela, as demonstrated by cases of urticarial, flushing, allergic dermatitis, and bronchospasm.
iv). Cardiovascular and central nervous system effects
Excessive beta-adrenergic stimulation has been associated with seizures, angina, tachycardia hypertension or hypotension, with rates up to 200 beats/min, nervousness, arrhythmias, palpitation, headache, tremor, nausea, fatigue, dizziness, insomnia and malaise. Therefore, Durela should be used with caution in patients with cardiovascular disorders, particularly coronary inadequacy, cardiac arrhythmias, and hypertension. Formoterol fumarate, a component of Durela, can produce a clinically significant cardiovascular effect in some patients as measured by blood pressure, pulse rate, and/or the symptoms. Even though such effects are uncommon after administration of Durela at approved doses, if they happen, the drug may need to be discontinued. Furthermore, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, extension of the QTc interval, and ST segment setbacks. The clinical significance of these findings is not known. Fatalities have been released in association with excessive use of inhaled sympathomimetic drugs.
v). Asthma-related death
Long-acting beta2-adrenergic agonists, such as formoterol, one of the active components in Durela, increase the risk of asthma-related death. Presently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from (LABA). Available data from managed clinical trials suggest that (LABA) increase the risk of asthma-related hospitalization in pediatric and adolescent patients. As a result, when treating patients with asthma, physicians should only prescribe Durela for patients with asthma not adequately controlled on a long-term asthma control treatment, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and (LABA). Once asthma control is reached and maintained, assess the patient at constant intervals and step down therapy (e.g., discontinue Durela) if possible without loss of asthma control, and maintain the patient on a future asthma control treatment, such as an inhaled corticosteroid. Do not take Durela for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
vi). Hypokalemia and hyperglycemia
Beta2-agonist medications may produce significant hypokalemia in some patients, probably through intracellular shunting, which has the potential to trigger adverse cardiovascular effects. The reduction in serum potassium is obviously transient, not requiring supplementation. Clinically important changes in blood glucose and/or serum potassium were seen infrequently during clinical studies with Durela at recommended doses.
Dislaimer: The information in this article act as an important guide and should not in any way substitute or be given top priority over a doctor’s prescription.