SPIRIVA (Spiriva)

     Synonym : Tiotropiya bromide, Tiotropium bromide

     The composition and the form of : Capsule powder inhalation 1 CBSA. , Tiotropiya bromide 18 µ g (corresponding to 22.5 ug tiotropiya bromide monohydrate), auxiliary substances : lactose Monohydrate

in contour yacheykovoy packing 10 pieces. ; in the stack of cardboard 1, 3 or 6 packages complete with asthma HandiHaler or without asthma.

     Description pharmaceutical form : Solid gelatine capsules light greenish-blue opaque.

The contents of the capsules - white powder.

     The drugs act : Holinoliticheskoe, bronhodilatiruyuschee.

The result of inhibition M3- receptors in the respiratory passages is to relax the bronchial smooth musculature. The high affinity for M3- receptors and the slow dissociation from them and make long expressed bronhodilatiruyuschee of an inhalation application in patients with chronic obstructive pulmonary (COPD).

     Pharmacokinetics : The inhalation method of absolute bioavailability tiotropiya bromide is 19.5%, which provides a high concentration of light and little effect on the organism as a whole. Based on the chemical structure (Quaternary ammonievoe connection), tiotropiya bromide poorly absorbed from the digestive tract. For the same reason, eating does not affect the absorption tiotropiya bromide. Cmax after inhalation powder dose of 18 µ g is achieved through five minutes and is in patients with COPD 17-19 pg / ml, equilibrium concentration in plazme3-4 pg / ml. Linking plasma proteins 72%, the volume of 32 l / kg. It permeates through the GEB.

Biotransformation negligible, as evidenced by the fact that after the on / in the preparation of young healthy volunteers found in the urine of 74% tiotropiya unchanged. Tiotropy split nefermentativnym way to alcohol and N-metilskopina ditienilglikolevoy acid, which is not associated with muskarinovymi receptors. Even in excessive doses tiotropy not igibiruet Cytochrome R450, 1-A1, 1-A2, 2 V6, 2 S9, S19 2, 2D6, 2 or 3 E1 A mikrosomah in human liver.

After inhalation terminal T1 / 2 days at 5-6, displayed kidneys (14% of dose), the remainder (neabsorbirovavshayasya in the gut) part from faeces.

     Farmakodinamika : Bronhodilatiruyuschy effect is the result of local, not systemic action depends on the dose and maintained for at least 24 h. The studies showed that the drug significantly increases the lung function (forced expiratory volume in 1) and life-size light after 30 minutes after a single dose for 24 hours Farmakodinamicheskoe balance achieved during the first week, and expressed bronhodilatiruyuschy effect was observed on the third day. Evaluation bronhodilatiruyuschego effect for a year did not identify manifestations of tolerance. The drug reduces the number of exacerbations, increases until the first deterioration compared to placebo, improves the quality of life throughout the period of treatment, reduces the incidence of hospitalization related to the exacerbation of COPD, and increases the time until the first hospitalization.

     Indication : A maintenance therapy in patients with COPD, including chronic bronchitis and emphysema (with the persistent cough and to prevent relapses).

     Contraindications : Giperchuvstvitelnost (incl. to atropine or its derivatives, such as ipratropiyu or oksitropiyu), I trimester of pregnancy, up to 18 years.

     Application of pregnancy and breastfeeding : Protivopokazano I trimester of pregnancy. In other periods of pregnancy and breastfeeding-only if the expected benefits exceed any potential risk to the fetus or infant.

     Side Effects : So part of the digestive tract : dry mouth (usually light degree of gravity, often disappearing for continuing treatment) lock.

From the respiratory system : cough, local irritation may develop bronchospasm, as well as the admission of other inhalants.

Other : tachycardia, impede or delay urination (men with predisposing factors), angionevrotichesky swelling, blurred vision, severe glaucoma (associated with antiholinergicheskim action).

     Networking : Not recommended simultaneous application antiholinergicheskimi other means.

Perhaps tiotropiya bromide use in combination with other drugs normally used to treat COPD, simpatomimetikami, metilksantinami, oral and inhaled steroids.

     Overdosing : Symptoms : possible dry mouth, a breach of accommodation, increased CHSS.

Treatment : symptomatic therapy.

     Dosing and Administration : Ingalyatsionno with apparatus HandiHaler, 1 CBSA. a day in the same time. Capsules should not ingest.

The elderly, patients with impaired kidney or liver function can be used in the preparation of recommended doses.

Instruction on the use of the device HandiHaler

HandiHaler device has been specially designed for Spirivy used within 1 year. It should not be used for the reception of other medicines.

The device HandiHaler includes :

1) Dust cap;

2) Mouthpiece;

3) The base;

4) prokalyvayuschuyu button;

5) central chamber.

Using the device HandiHaler

Open Dust cap, lifting it.

Then open Mouthpiece.

Obtaining capsule Spirivy from roubles (to use) and put it in a central chamber. No matter which side capsule placed in a cell.

Tightly close Mouthpiece until the snap, Dust cap is left open.

Holding HandiHaler Mouthpiece up prokalyvayuschuyu press the button again until the end of January and then released. Thus, a openings through which drug released from the capsules in the breath.

Make a full breath, not palm in Mouthpiece, then take HandiHaler in the mouth and tightly compressed lips around Mouthpiece. Holding the head straight, breathing slowly and deeply, but at the same time strong enough to hear the vibration capsules. Make a deep breath; Then hold breath to feel discomfort while removing HandiHaler of mouth. Continue breathing quietly.

Repeat procedure for the full devastation capsules.

Re-open Mouthpiece. Obtaining and throw the used capsule.

Close Mouthpiece and Dust cap.

Cleaning HandiHalera to 1 per month.

Open Mouthpiece and Dust cap. Then open ground equipment, raising prokalyvayuschuyu button. Rinse thoroughly with warm water pump to remove the powder. HandiHaler wipe with a paper towel and open Mouthpiece, ground and Dust cap left drying in the air for 24 h. After cleaning device according to the instructions he was ready for the next use. If necessary, outside of the Mouthpiece be cleared through damp, but not wet cloth.

Autopsies blisters

To separate strip blisters.

Revealing strip blisters to use so that the one capsule was fully visible.

Obtaining capsule.

Neither device or blisters capsules should not be exposed to high temperatures, i.e. Effects of solar radiation, etc.

     Precautions : There is a need for careful monitoring of patients with moderate or severe renal insufficiency receiving the drug in combination with other drugs, eksretiruyuschimisya, mainly kidneys.

Be wary designate uzkougolnoy patients with glaucoma, prostate gland hyperplasia, or bladder neck obstruction.

     Special instructions : The drug should not be used as a primary therapy in acute stroke bronchospasm (ie, in emergency situations).

As for other inhaled drugs, after inhalation may develop immediate hypersensitivity reactions.

It should not be allowed into powder in the eyes.

The drug should only apply to the device HandiHaler.

     Shelf life : 24 months

     Storage conditions : List B. When temperature is not above 25 ° C (not freezing). Do not be frozen.

Materials allowed to copy only with the active hyperlink to the handbook of medicines