Tiova Inhaler

Description

Tiova Inhaler (tiotropium bromide) is an M long-acting anticholinergic. It has the same affinity for various subtypes of muscarinic receptors from M1 to M5. The result of inhibition of M3 receptors in the airways is the relaxation of smooth muscles. The bronchodilating effect persists for at least 24 hours and depends on the dose of tiotropium bromide. The significant duration of action is probably due to the very slow dissociation of tiotropium bromide from M3 receptors compared to ipratropium bromide. With the inhalation route of administration of tiotropium bromide, as a N-quaternary anticholinergic agent, it has a local selective effect, while at therapeutic doses it does not cause systemic M anticholinergic adverse reactions. The dissociation of tiotropium bromide from M2 receptors is faster than from M3. High affinity for receptors and slow dissociation cause a pronounced and prolonged bronchodilatory effect in patients with chronic obstructive pulmonary disease (COPD). Bronchodilation after inhalation of tiotropium bromide is the result of a local rather than a systemic effect.

Tiotropium bromide significantly increases lung function 30 minutes after a single dose for 24 hours. Pharmacodynamic balance is achieved during the first week, and a bronchodilating effect is observed on the third day. Tiotropium bromide significantly increases the morning and evening peak expiratory flow rate (PEF). The use of Tiova Inhaler during the year does not cause a decrease in effectiveness in relation to bronchodilation.

Tiotropium bromide significantly reduces dyspnoea throughout the treatment period, significantly improves exercise tolerance, significantly reduces the number of COPD exacerbations and increases the period to the first exacerbation, and also significantly reduces the number of hospitalizations associated with a COPD exacerbation and increases the time to the first hospitalization. Tiotropium bromide results in a sustained improvement in FEV1 after four years of use without changing the rate of annual decline in FEV1.

There is evidence of a 16% reduction in the risk of death during treatment with tiotropium bromide, as well as evidence of an increase in time to first exacerbation with a 17% reduction in the risk of exacerbations with tiotropium bromide compared with salmeterol.

Also, the use of Tiova Inhaler reduces the annual number of moderate or severe (requiring hospitalization) exacerbations.

Composition

Tiova Inhaler contains tiotropium (9mcg) as an active ingredient.

Indications for use

• Asthma
• Bronchitis
• Bronchospasm
• Acute chronic obstructive pulmonary disease
• Emphysema

Contraindications

• Hypersensitivity to atropine or its derivatives (including ipratropium and oxitropium) and / or to other components of the drug
• I trimester of pregnancy
• age under 18 years

Use with caution

Tiova Inhaler should be used with caution in patients who have diseases such as angle-closure glaucoma, bladder neck obstruction, prostatic hyperplasia, moderate and severe renal insufficiency.

Pregnancy and breastfeeding

Data on the use of tiotropium bromide in human pregnancy are limited. In animal studies, no indications of direct or indirect adverse effects on pregnancy, embryonic/fetal development, childbirth or postnatal development have been obtained.

As a precautionary measure, it is preferable to refrain from using Tiova Inhaler during pregnancy.

There are no clinical data on the use of the product in women who are breastfeeding. In preclinical studies, data have been obtained that a small amount of tiotropium bromide is excreted in breast milk.

Tiova Inhaler should not be used in pregnant or breastfeeding women unless the expected benefit outweighs the potential risk to the fetus or child.

Dosage and instructions for use

Tiotropium is prescribed as inhalation, one inhalation per day at the same time.

The drug should not be swallowed.

Tiova Inhaler should be used no more than once a day.

Elderly and older patients and patients with impaired renal or hepatic function may use the drug at the recommended doses. However, patients with moderate or severe renal insufficiency who receive tiotropium in combination with other drugs excreted mainly by the kidneys should be carefully monitored.

Overdose

Overdose of tiotropium bromide may cause slight manifestations of systemic anticholinergic action and dry mouth.

Acute intoxication associated with accidental ingestion of the medicine is unlikely due to the low bioavailability of tiotropium bromide.

Side effects

• Digestive system: dry mouth, oral candidiasis; constipation, gastroesophageal reflux; in isolated cases – intestinal obstruction (including paralytic ileus), dysphagia.
• Respiratory system: dysphonia, bronchospasm, cough and local irritation of the pharynx; nose bleed.
• Cardiovascular system: tachycardia, palpitations; in isolated cases – supraventricular tachycardia, atrial fibrillation.
• Central nervous system: dizziness.
• Urinary system: difficulty urinating and urinary retention in men with predisposing factors, urinary tract infections.
• Allergic reactions: rash, urticaria, itching, hypersensitivity reactions, including immediate type reactions; in isolated cases – angioedema.
• Others: in isolated cases – blurred vision, increased intraocular pressure; glaucoma.

Most of the above adverse reactions may be associated with the anticholinergic effect of tiotropium bromide.

If any of the adverse reactions indicated in the instructions are aggravated, or you notice any other adverse reactions not listed in the instructions, contact your doctor.

Interaction with other drugs

Tiova Inhaler can be used in combination with other drugs commonly used to treat COPD: sympathomimetics, methylxanthines, oral and inhaled glucocorticosteroids.

Co-administration with long-acting β2 adrenomimetics, inhaled glucocorticosteroids and their combinations does not affect the action of tiotropium bromide.

It is not recommended to use the inhaler in combination with other anticholinergic medicinal products as their combination has not been studied.

Special instructions

Tiova Inhaler as a once-daily maintenance bronchodilator is not intended for initial therapy in acute attacks of bronchospasm, i.e. in urgent cases.

Inhalation of tiotropium may cause immediate hypersensitivity reactions. Like other inhalation drugs, it can cause paradoxical bronchospasm.

Patients should be familiar with the instructions for using Tiova Inhaler.

Do not allow the medicine to get into the eyes. Eye pain or discomfort, blurred vision, visual halos, combined with eye redness, conjunctival congestion, and corneal edema may indicate an acute attack of angle-closure glaucoma. If you develop any combination of these symptoms, you should immediately consult a doctor. The use of drugs that cause miosis is not an effective treatment in this case.

The use of the drug does not affect the results of doping tests in athletes.

The effect of tiotropium on the ability to drive vehicles and control mechanisms has not been conducted. If you have dizziness, headache and blurred vision after using this medicine, you should refrain from driving vehicles and operating mechanisms, as well as from engaging in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.