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WIXELA INHUB is a brand name for Salmeterol, supplied as a powder. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview The type and severity of adverse reactions associated with fluticasone propionate and salmeterol xinafoate may be expected with Wixela® Inhub®. There are no additional adverse reactions attributed to the combination product when compared to the adverse event profiles of the individual components.
Adverse drug reactions based on the frequency of reported events from pooled clinical trial data (23 asthma and 7 COPD studies) are listed in Table 2 below. Frequencies are defined as: very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000).
The frequency of adverse drug reactions based on spontaneous adverse event reporting data is presented separately (see Post-Market Adverse Drug Reactions). Table 2 Adverse Drug Reactions based on the frequency of reported events from pooled clinical trial data (23 asthma and 7 COPD studies) MedDRA preferred term Frequency Cardiac disorders Atrial fibrillation uncommon Tachycardia uncommon Palpitations uncommon Cardiac arrhythmia rare Supraventricular tachycardia rare Supraventricular extrasystoles rare Ventricular extrasystoles rare Eye disorders Cataract uncommon Glaucoma rare Infections and Infestations Oral candidiasis common Pneumonia common (COPD patients) Immune system disorders Cutaneous hypersensitivity reactions uncommon Dyspnoea uncommon Anaphylactic reaction rare Metabolism and nutrition disorders Hyperglycemia uncommon Musculoskeletal and connective tissue disorders Arthralgia common Muscle spasms common Nervous system disorders Headache (see Warnings and Precautions) very common Tremor (see Warnings and Precautions) uncommon Psychiatric disorders Page 15 of 63 MedDRA preferred term Frequency Anxiety uncommon Sleep disorder uncommon Psychomotor hyperactivity rare Irritability rare Abnormal behaviour rare Respiratory, thoracic and mediastinal disorders Dysphonia/Hoarseness common Throat irritation uncommon Skin and subcutaneous tissue disorders Contusion uncommon In addition to the pooled data above, symptoms of laryngeal spasm, irritation, or swelling, such as stridor and choking, have been reported rarely in patients receiving salmeterol.
Clinically significant hypokalemia has also been seen rarely during long-term administration of salmeterol at recommended doses. In rare cases, patients on inhaled fluticasone propionate may present with systemic eosinophilic conditions, with some patients presenting with clinical features of vasculitis consistent with EGPA, a condition that is often treated with systemic corticosteroid therapy (see WARNINGS AND PRECAUTIONS, Hematologic, Eosinophilic Conditions).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Salmeterol in Canada.
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Clinical Trial Adverse Drug Reactions By Indication Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Asthma Use of LABA monotherapy increases the risk of serious asthma-related events (death, hospitalizations, and intubations) (see WARNINGS AND PRECAUTIONS, General).
Fluticasone Propionate and Salmeterol Inhalation Powder In clinical trials involving 1824 adult and adolescent patients with asthma, the most commonly reported adverse events with the combination fluticasone propionate/salmeterol xinafoate inhalation powder were: hoarseness/dysphonia, throat irritation, headache, candidiasis of mouth and throat and palpitations as detailed in the table below: Table 3 Number (and percentage) of patients with drug-related adverse events (incidence ≥ 1%1) (Safety Population) Page 16 of 63 Adverse events Fluticasone propionate/ salmeterol xinafoate combination product Fluticasone propionate and salmeterol xinafoate concurrent therapy Fluticasone propionate alone Salmeterol xinafoate alone Placebo Number of patients 644 486 339 180 175 Any event 110 (17%) 81 (17%) 50 (15%) 9 (5%) 5 (3%) Hoarseness/dysphonia 15 (2%) 11 (2%) 8 (2%) 1 (<1%) 0 Throat irritation 14 (2%) 10 (2%) 8 (2%) 1 (<1%) 1 (<1%) Candidiasis of mouth and throat 15 (2%) 9 (2%) 5 (1%) 0 0 Headaches 16 (2%) 11 (2%) 3 (<1%) 0 0 Asthma2 9 (1%) 11 (2%) 3 (<1%) 0 0 Palpitations 7 (1%) 4 (<1%) 2 (<1%) 1 (<1%) 0 Cough 6 (<1%) 2 (<1%) 5 (1%) 1 (<1%) 0 Breathing disorders 6 (<1%) 2 (<1%) 4 (1%) 0 0 Candidiasis-unspecified site 6 (<1%) 3 (<1%) 4 (1%) 0 2 (1%) Upper respiratory tract infection 5 (<1%) 5 (1%) 2 (<1%) 0 0 1 in any integrated treatment group 2 asthma was not recorded as an adverse event in those studies which included treatment with salmeterol xinafoate alone or placebo (unless it was a serious adverse event) In the Fluticasone Propionate and Salmeterol Inhalation Powder group, there was no apparent relationship to fluticasone propionate dose for drug-related adverse events (15% with 100/50 mcg, 19% with 250/50 mcg and 17% with 500/50 mcg).
Use in children A total of 257 pediatric patients participated in the clinical development programme and received either the combination 100 mcg fluticasone propionate/50 mcg salmeterol xinafoate inhalation powder or concurrent therapy (with fluticasone propionate and salmeterol administered via separate inhalers).
Only one drug-related adverse event, candidiasis, was reported with an incidence of 2% or more in the Fluticasone Propionate and Salmeterol Inhalation Powder group. The combination product was generally well tolerated and the safety profile was comparable to that observed in the concurrent therapy group.
There have been very rare reports of anxiety, sleep disorders and behavioural changes including hyperactivity and irritability (predominantly in children and adolescents). COPD Clinical trial adverse drug reaction data is provided for two 24-week studies, a 52-week study and a 3-year study.
24-week […]