Carcinogenesis, Mutagenesis, Impairment Of Fertility
Allegro propionate demonstrated no tumorigenic potential in mice at oral doses up to 1,000 mcg/kg (approximately 20 times the MRHDID in adults and approximately 10 times the MRHDID in children on a mcg/m² basis) for 78 weeks or in rats at inhalation doses up to 57 mcg/kg (approximately 2 times the MRHDID in adults and approximately equivalent to the MRHDID in children on a mcg/m² basis) for 104 weeks.
Allegro propionate did not induce gene mutation in prokaryotic or eukaryotic cells in vitro. No significant clastogenic effect was seen in cultured human peripheral lymphocytes in vitro or in the mouse micronucleus test.
No evidence of impairment of fertility was observed in male and female rats at subcutaneous doses up to 50 mcg/kg (approximately 2 times the MRHDID in adults on a mcg/m² basis). Prostate weight was significantly reduced at a subcutaneous dose of 50 mcg/kg.
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Allegro is a preventer inhaler. Use it every day to prevent your symptoms from developing. Steroids like Allegro work by reducing the inflammation in your airways. When the inflammation has gone, your airways are much less likely to become narrow and cause symptoms such as wheezing.
Allegro is available on its own in an inhaler, and also in combination with other medicines, such as salmeterol, formoterol or vilanterol. These are medicines which also help to control the symptoms of asthma.
The recommended starting dosage in adults is 2 sprays (50 mcg of Allegro propionate each) in each nostril once daily (total daily dose, 200 mcg). The same total daily dose, 1 spray in each nostril administered twice daily (e.g., 8 a.m. and 8 p.m.) is also effective. After the first few days, patients may be able to reduce their dose to 1 spray in each nostril once daily for maintenance therapy.
Maximum total daily doses should not exceed 2 sprays in each nostril (total dose, 200 mcg/day). There is no evidence that exceeding the recommended dose is more effective.
Coadministration of orally inhaled Allegro propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma Allegro propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol.
In addition to adverse events reported from clinical trials, the following adverse events have been identified during postapproval use of intranasal Allegro propionate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to Allegro propionate or a combination of these factors.
General Disorders and Administration Site Conditions : Hypersensitivity reactions, including angioedema, skin rash, edema of the face and tongue, pruritus, urticaria, bronchospasm, wheezing, dyspnea, and anaphylaxis/anaphylactoid reactions, which in rare instances were severe.
Ear and Labyrinth Disorders : Alteration or loss of sense of taste and/or smell and, rarely, nasal septal perforation, nasal ulcer, sore throat, throat irritation and dryness, cough, hoarseness, and voice changes.
Eye Disorders : Dryness and irritation, conjunctivitis, blurred vision, glaucoma, increased intraocular pressure, and cataracts.
Cases of growth suppression have been reported for intranasal corticostero > .
Other Uses for Allegro
Allegro is also available (under other brand names) as an aerosol inhaled by mouth, and as a topical cream or ointment applied to the skin.
Flovent (Allegro oral inhalation) helps people with asthma breathe more easily and reduces tightness in the chest. It can also treat asthma-related wheezing and coughing.
There is research suggesting that inhaled steroids such as Allegro may benefit people with stable chronic obstructive pulmonary disease (COPD).
A study published in the International Journal of Chronic Obstructive Pulmonary Disease in 2014 found that a once-daily dry powder inhaler combination therapy could improve people's adherence to long-term inhaled therapy as well as their prognosis.
In the United States, GlaxoSmithKline markets Allegro as Flovent for the treatment of asthma, as well as the combination of Allegro and salmeterol as Advair for the treatment of asthma and COPD.
Additionally, doctors prescribe topical Allegro to reduce inflammation and relieve symptoms associated with certain skin conditions, including:
PharmaDerm, a division of Fougera Pharmaceuticals, manufactures topical Allegro and sells it under the brand name Cutivate.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In controlled US clinical trials, more than 3,300 subjects with allergic and nonallergic rhinitis received treatment with intranasal Allegro propionate. In general, adverse reactions in clinical trials have been primarily associated with irritation of the nasal mucous membranes, and the adverse reactions were reported with approximately the same frequency by subjects treated with placebo. Less than 2% of subjects in clinical trials discontinued because of adverse reactions; this rate was similar for vehicle placebo and active comparators.
The safety data described below are based on 7 placebo-controlled clinical trials in subjects with allergic rhinitis. The 7 trials included 536 subjects (57 girls and 108 boys aged 4 to 11 years, 137 female and 234 male adolescents and adults) treated with FLONASE 200 mcg once daily over 2 to 4 weeks and 2 placebo-controlled clinical trials which included 246 subjects (119 female and 127 male adolescents and adults) treated with FLONASE 200 mcg once daily over 6 months (Table 1). Also included in Table 1 are adverse reactions from 2 trials in which 167 children (45 girls and 122 boys aged 4 to 11 years) were treated with FLONASE 100 mcg once daily for 2 to 4 weeks.
Table 1: Adverse Reactions with FLONASE Nasal Spray with > 3% Incidence and More Common than Placebo in Subjects ≥ 4 Years with Allergic Rhinitis
Other adverse reactions with FLONASE Nasal Spray observed with an incidence less than or equal to 3% but greater than or equal to 1% and more common than with placebo included: blood in nasal mucus, runny nose, abdominal pain, diarrhea, fever, flu-like symptoms, aches and pains, dizziness, and bronchitis.
Allegro Brand Names
Allegro may be found in some form under the following brand names:
How to use a Allegro inhaler
- Before you start this treatment, read the manufacturer's printed information leaflet from ins >
Why it's used
Allegro/salmeterol contains two drugs that work in different ways to treat asthma and chronic obstructive pulmonary disease (COPD).