Spiriva Inhaler

Instruction for Use

• Active substance: Tiotropium bromide.
• Drug form: hard gelatin capsules (HGC) of light – green — blue color, opaque.
• Contents of capsules: white powder.

Composition and Pharmaceutical Form

Capsules with powder for inhalation	1 caps
Tiotropium bromide (what is corresponded to 22,5 mcg of tiotropium bromide monohydrate)	18 mcg
Additive agent	Lactose monohydrate

Pharmachologic Effect

Spiriva Inhaler has bronchodilatory and cholinolytic mode of action.

As a result of inhibition M3 — receptor in airway provides bronchial smooth muscles relaxation. High affinity to M3 receptors and slow dissociation of them cause pronounced and long-lasting bronchodilatory effects by inhalation in patients with asthma and chronic obstructive pulmonary disease (COPD).

Pharmacodynamics

Bronchodilatory effect is a consequence of local, rather than systemic effect depending on dose and maintaining for at least 24 hours. Studies have shown that Spiriva Inhalers significantly increase pulmonary function (forced expiratory volume for 1 second) and vital lung capacity 30 minutes after a single dose per day.

Pharmacodynamic balance is achieved within the first week, and expressed bronchodilator effect was observed on the 3rd day. Bronchodilatory effect evaluation over the years did not reveal any tolerance manifestation. The drug reduces number of asthma and COPD exacerbations, increases period until the first exacerbation in comparison with placebo, improves quality of life throughout treatment period, reduces number of hospitalizations associated with COPD exacerbations and increases time until the first hospitalization.

Pharmacokinetics

At inhalation administration method, tiotropium bromide’s absolute bioavailability is 19.5%, which provides high concentration in lungs and a minor effect on body as a whole. Spiriva inhaler online is based on chemical structure (quaternary ammonium compound), tiotropium bromide is poorly absorbed. For this reason, food intake does not affect tiotropium bromide absorption. Cmax after a dose of 18 mcg inhalation is reached after 5 minutes and is comprised of 17-19 pg / ml in patients with asthma and COPD, equilibrium concentration in plazme is 3-4 in pg / ml. Plasma protein binding is 72%, distribution volume – 32 l / kg. It does not penetrate through hematoencephalic barrier.

Biotransformation is insignificant, as evidenced by the fact that after intravenous application by young healthy volunteers it was found in urine 74% of unchanged tiotropium. Tiotropium is decomposed in a nonenzymatic manner to alcohol N-methyl scopine thienyl glycolic acid which do not bind to muscarinic receptors. Even ultrahigh tiotropium dose does not inhibit cytochrome P450 1A1, 1A2, 2B6, 2C9, 2C19, 2D6, 2E1 and 3A in human liver microsomes.

After inhalation, terminal T1/2 is comprised of 5-6 days, and excreted by kidneys (14% of dose), remaining (non-absorbed in intestines) part – with feces.

Indications of Spiriva Inhaler Usage

Spiriva tiotropium inhaler is used as maintenance therapy in patients with asthma and COPD, including chronic bronchitis and emphysema (dyspnea at continuing and exacerbation prevention).

Contraindications

Hypersensitivity (including to atropine or its derivatives, eg ipratropium or oxitropium), the first trimester of pregnancy, age under 18 years old.

Pregnancy and Breast-Feeding

Spiriva is contraindicated in I trimester of pregnancy. The remaining stages of pregnancy and during breastfeeding – only if expected benefits outweigh any possible risk to fetus or infant.

Side Effects

• From digestive tract: dry mouth (usually mild degree, often disappears with continued treatment), constipation.
• From respiratory system: cough, local irritation, bronchospasm, as well as when taking other inhaled agents.
• Other: tachycardia, difficulty or urinary retention (in men with predisposing factors), angioneurotic edema, blurred vision, acute glaucoma (associated with anticholinergic effects).

Interaction

Simultaneous application is not recommended with other anticholinergic agents.

Perhaps tiotropium bromide application in combination with other drugs is commonly used to treat asthma and COPD – sympathomimetics, methylxanthines, oral and inhaled steroids.

Dosing and Administration

It is applied as inhalation using HandiHaler device, 1 caps. per day at one and the same time. The capsules should not be swallowed.

Older people, those with impaired renal or hepatic function may use drug at recommended doses. People of various ages may buy Spiriva Inhaler via Asthma Inhalers Online more affordable. It will be delivered to you without any delays.

Instructions for HandiHaler Device Use

The device HandiHaler has been specifically designed for Spiriva which is used for 1 year. Do not use it for taking other medications.

Device HandiHaler includes:

• dust cap;
• mouthpiece;
• base;
• piercing button;
• central chamber.

Using HandiHaler Device

• Open dust cap by lifting it up.
• Then open mouthpiece.
• Get Spiriva capsule from blister (immediately before use) and place it in central chamber. It does not matter which side of capsule is placed in chamber.
• Tightly close mouthpiece until until its clicking position, leaving dust cap open.
• Hold HandiHaler mouthpiece upwards and press piercing button 1 time until the end of time, and then release. Thus, opening is formed through which drug is released from capsules during inhalation.
• It is necessary to make a full breath without exhaling into mouthpiece, then take HandiHaler to your mouth and squeeze tight lips around mouthpiece. Keep your head straight, inhale slowly and deeply but at the same time with enough force to hear capsule vibration. Take a deep breath; then hold your breath until you feel discomfort while taking HandiHaler out of your mouth. Continue breathing quietly.
• Repeat procedure for complete emptying of capsule.
• Again open mouthpiece. Get and discard used capsule.
• Close mouthpiece and dust cap.

Cleaning

Clean HandiHaler 1 time per month.

Open mouthpiece and dust cap. Then open base of unit by lifting piercing button. Rinse thoroughly with warm water to completely remove powder. Wipe HandiHaler by means of paper towel and left to dry in air for 24 hours. After cleaning device according to instruction it is ready for the next use. If necessary, outer surface of mouthpiece can be cleaned with damp but not wet tissue.

Blister Opening

• Separate blister strip.
• Open blister strip immediately prior to use so that one capsule is completely visible.
• Take the capsule.
• Neither device nor in blister capsule should not be exposed to high temperatures, ie, to sunlight and other.

Overdose

Symptoms: Possible dry mouth, accommodation disorder, increased heart rate.

Treatment: symptomatic therapy.

Precautionary Measures

It is necessary to carefully monitor patients with moderate or severe renal impairment when receiving drug in combination with other drugs that are excreted mainly by kidneys.

Appoint with caution for patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction.

Special Instructions

Spiriva Inhaler should not be used as a means of initial treatment of bronchospasm acute attacks (ie, in case of emergency).

As with other inhaled drugs it may develop immediate hypersensitivity reactions.

Do not allow contact with eyes.

The drug should be used only with HandiHaler device.

Storage Conditions of Spiriva Inhaler Online

The temperature is not above 25 ° C (not to freeze). Do not subject to freezing. Keep out of the reach of children

Expiration Date of Spiriva: 24 months. Do not use beyond expiration date printed on package.