Buy Spiolto Respimat Other 2.5 μg + 2.5 μg/dose 4 ml cart. 1 pc., With ing.
  • Buy Spiolto Respimat Other 2.5 μg + 2.5 μg/dose 4 ml cart. 1 pc., With ing.

Spiolto Respimat®

Boehringer Ingelheim
652 Items
2019-09-19
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$139.94
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Clinical Pharmacology

Combined bronchodilator ((two beta - long-acting adrenergic agonist + m-holinoblokator)

Indications

The drug Spiolto Respimat taken 1 time / day is indicated for;

- long-term maintenance therapy for patients with COPD, chronic bronchitis, pulmonary emphysema,

- reduction of airway obstruction and concomitant dyspnea;

- reduce the frequency of exacerbations; improve exercise tolerance and quality of life.

Composition

Excipients: benzalkonium chloride solution - 0.0022 mg (respectively benzalkonium chloride - 0.0011 mg), disodium edetate - 0.0011 mg, anhydrous citric acid 1M - to pH 2.9, purified water - up to 11.05 mg.

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Spiolto Respimat®

Dosage and Administration

The recommended therapeutic dose is 2 spray inhalations from Respimat inhaler (5 mcg / therapeutic dose of tiotropium bromide and 5 mcg / therapeutic dose of olodaterol) 1 time / day, at the same time of day (see instructions for use).

In elderly patients, the drug Spiolto Respimat can be used at the recommended dose.

In patients with mild to moderate hepatic insufficiency, Spiolto Respimat can be used at the recommended dose.

Data on the use of olodaterol in patients with severe hepatic insufficiency is not available.

In patients with impaired renal function, Spiolto Respimat can be used at the recommended dose.

Patients with moderate to severe renal insufficiency who use Spiolto Respimat must be under the close supervision of a physician.

Adverse reactions

Infections and invasions: nasopharyngitis.

Metabolism and nutrition: dehydration.

Of the nervous system: dizziness, insomnia.

On the part of the organ of vision: increased intraocular pressure, glaucoma; blurred vision.

Since the cardiovascular system: atrial fibrillation, palpitations, tachycardia, supraventricular tachycardia, increased blood pressure.

From the organ of respiration, organs of the chest and mediastinum: cough, nosebleeds, pharyngitis, dysphonia, bronchospasm, laryngitis, sinusitis.

On the part of the gastrointestinal tract: slight dry mouth, constipation, oral candidiasis, dysphagia, gastroesophageal reflux, gingivitis, glossitis, stomatitis; intestinal obstruction, including paralytic intestinal obstruction.

On the part of the skin: skin infections and ulcers on the skin, dry skin.

Allergic reactions: rash, pruritus, angioedema, urticaria, hypersensitivity, including immediate type reactions.

Musculoskeletal system and connective tissue diseases related to it: arthralgia, swelling in the joints, back pain *.

On the part of the kidneys and urinary system: dysuria, urinary retention (more often in men with the presence of predisposing factors), urinary tract infection.

Contraindications

- patients with hypersensitivity to olodaterol, tiotropium bromide, or to any component of the drug;

- patients who have previously experienced hypersensitivity to atropine or its derivatives, such as ipratropium and oxitropium;

- not recommended for use in children under 18 years (due to lack of data on efficacy and safety).

Carefully

In patients with acute glaucoma, prostatic hyperplasia and bladder neck obstruction.

In patients with cardiovascular diseases, including coronary insufficiency, heart rhythm disturbances, lengthening of the QT interval, hypertrophic obstructive cardiomyopathy, arterial hypertension, thyrotoxicosis, convulsions. In patients with a history of such diseases as myocardial infarction or hospitalization for heart failure (during the previous year), life-threatening arrhythmia, paroxysmal tachycardia with heart rate> 100 were noted.

In patients with unusual reactions to sympathomimetic amines.

Drug interactions

Although there were no special studies of drug interactions, tiotropium bromide was used in conjunction with other drugs to treat COPD, including methylxanthines, steroids for oral administration and inhalation, with no clinical signs of drug interactions.

Long-term combined use of tiotropium bromide with other m-anticholinergic drugs has not been studied. Therefore, long-term joint use of the drug Spiolto Respimat with other m-anticholinergic drugs is not recommended.

The simultaneous use of other adrenergic drugs may enhance the unwanted effects of the drug Spiolto Respimat.

The simultaneous use of xanthine derivatives, steroids or diuretics (not belonging to the group of potassium-sparing) can enhance the hypokalemic effect of adrenomimetics.

Beta-blockers may weaken the effect of olodaterol or counteract this effect. In this case, preferably running1-blockers, although they should be used with caution.

MAO inhibitors, tricyclic antidepressants or other drugs that can lengthen the QTc interval, can enhance the effect of Spiolto Respimat on the cardiovascular system.

The combined use of olodaterol with ketoconazole led to an increase in systemic exposure to olodaterol by 1.7 times. However, this did not affect safety. Dose change is not required.

Pregnancy and Lactation

There are no clinical data on the effect of olodaterol / tiotropium bromide on pregnancy. In preclinical studies using high doses of olodaterol, several times higher than therapeutic doses, effects typical for beta have been established.2- adrenomimetics. Consider the inhibitory effect of olodaterol on uterine contractility. Spiolto Respimat should not be used in pregnant women, unless the potential benefit to the mother does not exceed the potential risk to the fetus.

There are no clinical data on the use of olodaterol / tiotropium bromide in women who are breastfeeding. Spiolto Respimat should not be used in breastfeeding women, unless the potential benefit to the mother does not exceed the potential risk to the baby.

For the period of use of the drug it is necessary to stop breastfeeding

Special instructions

Spiolto Respimat should not be used for bronchial asthma. The efficacy and safety of Spiolto Respimat in bronchial asthma has not been studied.

Acute bronchospasm

Spiolto Respimat is not indicated for the treatment of acute episodes of bronchospasm, i.e. as a means of first aid.

Hypersensitivity

After the use of the drug Spiolto Respimat, the development of immediate-type hypersensitivity reactions is possible.

Paradoxical bronchospasm

The use of the drug Spiolto Respimat, as well as other inhalation drugs, can lead to paradoxical bronchospasm, sometimes life-threatening. In the case of the development of paradoxical bronchospasm, the use of the drug Spiolto Respimat should be immediately discontinued and alternative therapy should be prescribed.

Patients with impaired renal function

Since tiotropium bromide is excreted primarily by the kidneys, patients with moderate to severe renal failure (CK

Violations by the organ of vision

Patients should be informed about the correct use of the drug Spiolto Respimat. Do not allow the solution or spray in the eyes. Pain or discomfort in the eyes, blurred vision, visual halos around light sources in combination with redness of the eye caused by swelling of the conjunctiva and cornea can be symptoms of acute angle-closure glaucoma. With the development of any combination of these symptoms should immediately consult a specialist. Eye drops with a miotic effect are not considered an effective treatment.

Cardiovascular effects

Olodaterol, like other beta-adrenomimetics, may have a clinically significant effect on the cardiovascular system in some patients (increased heart rate, increased blood pressure and / or the appearance of relevant symptoms). If such symptoms occur, discontinuation of treatment may be necessary. In addition, beta has been reported2-adrenomimetics led to such ECG changes as flattening of the T wave and depression of the ST segment, although the clinical significance of these changes is unknown.

Hypokalemia

Beta2-adrenomimetics in some patients may lead to the development of hypokalemia, which creates prerequisites for the occurrence of undesirable effects on the cardiovascular system. The decrease in serum potassium concentration is usually short-lived and does not require its completion. In patients with severe COPD, hypokalemia may increase due to hypoxia and concomitant treatment and increase the risk of developing arrhythmias.

Hyperglycemia

Inhalation use of large doses of beta2β-adrenomimetics can lead to an increase in plasma glucose concentration.

Spiolto Respimat should not be used in combination with any other drug containing beta.2- long-acting adrenomimetics.

Patients who often use inhaled beta2- short-acting adrenomimetics (for example, 4 times / day), it is necessary to instruct that these drugs are used only to alleviate the acute symptoms of bronchospasm.

Spiolto Respimat is intended for the maintenance treatment of patients with COPD. Due to the fact that in the general population of COPD, patients over the age of 40 years predominate significantly. When prescribing the drug to patients younger than 40 years old, a spirometric confirmation of the diagnosis of COPD is required.

The effect of the drug on the ability to drive vehicles and mechanisms

Studies on the effect on the ability to drive vehicles and mechanisms have not been conducted. Care should be taken when performing these activities, because may develop dizziness or blurred vision.

Overdosage

Overdose of olodaterol can lead to pronounced effects typical of beta.2-adrenomimetikov, such as myocardial ischemia, an increase or decrease in blood pressure, tachycardia, arrhythmia, palpitations, dizziness, nervousness, insomnia, anxiety, headache, tremor, dry mouth, muscle spasm, nausea, fatigue, malaise, hypokalemia, hyperglycemia and metabolic acidosis.

When using high doses of tiotropium bromide, manifestations of m-anticholinergic action are possible. After a 14-day inhalation use of tiotropium bromide in doses up to 40 μg, no significant adverse events were observed in healthy individuals, except for a feeling of dryness of the mucous membranes of the nose and oropharynx, the frequency of which depended on the dose (10-40 μg / day). The exception was a clear decrease in salivation, starting from day 7 of the drug.

Treatment

Spiolto Respimat should be discontinued. Showing supportive and symptomatic treatment. In severe cases, hospitalization is necessary. Beta may be recommended.1-blockers, but only with the utmost care, because the use of these drugs can cause bronchospasm.

  • Brand name: Spiolto Respimat
  • Active ingredient: Olodaterol, Tiotropium bromide
  • Dosage form: Dosed inhalation solution
  • Manufacturer: Boehringer Ingelheim
  • Country of Origin: Austria

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