Spiriva 18 mcg

Generic Name: Tiotropium Rotacaps 18 mcg
Spiriva 18 mcg Image

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Spiriva Facts

Boehringer Ingelheim Pharmaceuticals, Inc., markets and distributes SPIRIVA.

In clinical trials for SPIRIVA, 2,663 patients were treated with the drug.

SPIRIVA was evaluated in two six-month and four one-year controlled clinical trials.

SPIRIVA obtained its first approval from the FDA on January 30, 2004.


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Spiriva General Information

Spiriva is an anticholinergic agent that works by enlarging the airway passages to enable easier breathing. It used by people who are symptomatic for emphysema, COPD (chronic obstructive pulmonary disease) and bronchitis to prevent narrowing of the airways in the lungs called bronchospasm.

How does Spiriva work?

Spiriva belongs to a class of medications known as antimuscarinics or anticholinergics. Spiriva helps to relax the smooth muscle in the airway by binding to specific receptors called muscarinc receptors. By relaxing the smooth muscle in the airways it opens them up which in turn makes breathing easier. It provides long term relief for symptoms such as wheezing and shortness of breath due to emphysema and chronic bronchitis.

When/How is Spiriva taken/used/applied?

Spiriva comes in a gelatin capsule that is taken once daily. The capsule is not swallowed but is placed in a special device made specifically for the pill called a Handihaler. The contents of the capsule, which are in powder form, are punctured by the inhaler and inhaled by the patient.

Side Effects of Spiriva

There are several side effects associated with taking Spiriva but not all of the side effects are felt by everyone taking this medication.Emergency medical help should be sought if any of the following side effects are felt: difficulty breathing, swelling of the lips, throat, tongue or face and hives.

The doctor should be called at once if there is: redness of the tongue, urinating less than usual or none at all and sores or patches on the lips, tongue or mouth.

Other less serious side effects include: nausea, constipation, upset stomach, drowsiness, blurred vision, fast heart rate, trouble swallowing, dry mouth and coughing.

Other Brand Names for Spiriva:

Spiriva is also known as Tiotropium.

Safety Information:

Spiriva should not be taken by anyone who has an allergic reaction to atropine or to atropine-like medications (e.g., ipratropium, oxitropium) or has an allergy to any of the ingredients in the Spiriva medication.

Dosage:

The Spiriva dose is a gelatin capsule (18mcg) taken once daily through a special Spiriva inhaler called a Handhaler.

Visual Description:

Spiriva comes in the form a light green hard gelatin capsule with the Boehringer Ingelheim company logo on one side of the capsule and T1 01 on the other side.

About Spiriva

What Spiriva is used for

SPIRIVA is a long acting bronchodilator for maintenance treatment of bronchospasm associated with Chronic Obstructive Pulmonary Disease (COPD).

What is COPD?

COPD (Chronic Obstructive Pulmonary Disease) is a type of lung disease in which there is a progressive narrowing of the airways, leading to breathing difficulties. In many patients, this narrowing of the airways may be the result of many years of cigarette smoking; others may have a genetic predisposition. Smoking cessation produces symptomatic benefits and will slow the progression of chronic bronchitis (which is a form of COPD). COPD can be helped by medication as well.

What Spiriva does

Tiotropium bromide is one of a group of medicines called “bronchodilators”.

SPIRIVA makes breathing easier by opening your narrowed airways and keeping them open for 24 hours.

When Spiriva should not be used

SPIRIVA should not be used by patients with a history of allergy to atropine or its derivatives (ipratropium or oxitropium) or to any component of this formulation.

SPIRIVA should not be used as a rescue medication.

What the medicinal ingredient is

Tiotropium bromide monohydrate.

What the important nonmedicinal ingredients for Spiriva are

Lactose monohydrate.

What dosage forms Spiriva comes in

Capsules for oral inhalation. DO NOT SWALLOW. Each capsule contains a dry powder blend of 18 μg tiotropium (equivalent to 22.5 μg tiotropium bromide monohydrate) with lactose monohydrate as the carrier. SPIRIVA capsules are light green, with TI 01 printed on one side of the capsule and the Boehringer Ingelheim company logo on the other side. Ten SPIRIVA capsules are packaged in an aluminum/PVC/aluminum blister card. One blister card consists of two 5-cavity strips joined along a perforated line.

SPIRIVA capsules are partially filled but contain exact amount of medication as declared on the label.


Warnings and Precautions

BEFORE you use SPIRIVA, talk to your doctor or pharmacist if:

  • You may be pregnant or wish to become pregnant;

  • You are a breast-feeding mother;

  • You are taking any medications including eye drops, this includes those you can buy without prescription;

  • You have any other medical problems such as difficult urination or enlarged prostate;

  • You have eye problems, such as glaucoma or eye pain;

  • You have any allergies to food or drugs;

  • You are allergic to lactose (milk sugar).

These capsules are intended for inhalation only. DO NOT SWALLOW!

SPIRIVA should not be used more frequently than once daily. Do not exceed the prescribed dose.

This medication has been prescribed for you and should not be given to other people.

Avoid getting the drug powder into your eyes. This may result in eye pain and/or discomfort, temporary blurring of vision, and/or colored images in association with red eyes. Should any of these symptoms develop, consult a doctor immediately.

Remember to tell any other doctor, dentist or pharmacist you consult that you are taking this medication.

If you have any questions about SPIRIVA or the HandiHaler device, contact your doctor or pharmacist.


Interactions with Spiriva

Other medications may be affected by SPIRIVA or may affect how SPIRIVA works. Tell your doctor or pharmacist if you are taking other medications.


Proper Use of Spiriva

SPIRIVA should be administered once daily by inhalation only through the HandiHaler inhalation device. The HandiHaler enables you to inhale the medicine contained in the SPIRIVA capsule that your doctor has prescribed for your breathing problems. The HandiHaler is especially designed for SPIRIVA; you must not use it to take any other medication. Likewise, you should not take your SPIRIVA capsules with any device other than the HandiHaler. You can use your HandiHaler for up to one year to take your medication before needing a replacement. Before starting treatment with SPIRIVA, be certain that you are completely familiar with the use and proper care of the HandiHaler device.

If you are unable to inspire through the HandiHaler to make the SPIRIVA capsule vibrate, consult your physician.

Usual dose

One (1) SPIRIVA capsule is to be taken once daily, preferably at the same time each day, only with the HandiHaler inhalation device. DO NOT SWALLOW!

Do not use another type of inhaler with the SPIRIVA capsules. Do not use other capsules in the HandiHaler inhalation device.

How to Use SPIRIVA through the HandiHaler Inhalation Device:

(See package insert for illustrations.)

  1. Become familiar with the HandiHaler device:

    1. Dust cap

    2. Mouthpiece

    3. Mouthpiece ridge

    4. Base

    5. Piercing button

    6. Centre chamber

    7. Air intake vents

  2. To release the dust cap, press the green piercing button completely in and let go.

  3. Open the dust cap completely by pulling it upwards, then open the mouthpiece by pulling it upwards.

  4. Blister Handling:

    1. The blister card contains two blister strips joined along a perforated line. Prior to removing the first capsule from the blister card, separate the blister strips by tearing along the perforation.

    2. Immediately before use, peel the aluminum back foil until one capsule is fully visible. After opening a strip, the in-use shelf life of the remaining capsules in the strip is 5 days.

    3. Remove one SPIRIVA capsule from the blister. Do not expose more than one capsule. If more than one capsule is exposed, you should discard the exposed unused capsules. Do not store the capsule in the HandiHaler device.

  5. Place the capsule in the centre chamber. It does not matter which end of the capsule is placed in the chamber.

  6. Close the mouthpiece firmly until you hear a click, leaving the dust cap open.

  7. Hold the HandiHaler with the mouthpiece upwards and press the green piercing button completely in only once, and release. This makes holes in the capsule and allows the medication to be released when you breathe in.

  8. If you feel that your chest is congested with mucus, try to cough to clear your lungs before you inhale SPIRIVA. Breathe out completely.

    Important: Do not breathe into the mouthpiece at any time.

  9. Hold the HandiHaler by the grey base. Do not block the air intake vents. Raise the HandiHaler to your mouth and close your lips tightly around the mouthpiece. Keep your head in an upright position and breathe in slowly and deeply but at a rate sufficient to hear or feel the capsule vibrate.

    Breathe in until your lungs are full; then hold your breath as long as comfortable (try counting to 10) and at the same time take the HandiHaler out of your mouth. Resume normal breathing.

  10. To ensure complete inhalation of capsule contents, you must repeat steps 8 and 9 once again.

  11. Open the mouthpiece again. Tip out the used capsule and dispose. Do not touch the used capsules. If the dry powder gets on your hands, make sure you wash your hands thoroughly.

  12. Close the mouthpiece and dust cap for storage of your HandiHaler device.

When and how should you clean the HandiHaler?

(See package insert for illustrations.)

It is important to clean the HandiHaler once a month as follows:

  1. Open the dust cap and mouthpiece.

  2. Open the base by lifting the piercing button.

  3. Rinse the complete inhaler with warm water to remove any powder.

  4. Dry the HandiHaler thoroughly by tipping excess of water out on a paper towel and air-dry afterwards, leaving the dust cap, mouthpiece and base open. It takes 24 hours to air dry, so clean it right after you used it and it will be ready for your next dose. The outside of the mouthpiece may be cleaned with a moist but not wet tissue if needed.

    Do not place HandiHaler in the dishwasher.

Overdose

If you take more SPIRIVA than you should—talk to your doctor immediately.

Missed dose

If you forget to take a dose, take one as soon as you remember but do not take two doses at the same time or on the same day. Then take your next dose as usual.


Side Effects for Spiriva and What to Do About Them

You should be aware that prescription medicines carry some risks and that all possible risks may not be known at this stage. Discuss with your doctor the risks of taking SPIRIVA against the expected benefits.

The most commonly reported undesirable effects of SPIRIVA are:

  • Dry mouth

  • Dizziness

  • Constipation

  • Cough

  • Irritation of mouth and/or throat

  • Hoarseness

  • Nosebleeds

  • Sensation of heart beat

  • Retention of urine

Some people can be allergic to medicines. If you have any of the following symptoms soon after taking SPIRIVA, stop taking this medicine and tell your doctor immediately or go to the nearest hospital.

  • Sudden wheeziness and chest pain or tightness.

  • Swelling of eyelids, face, lips, tongue or throat.

  • Lumpy skin rash or “hives” anywhere on the body.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

This is not a complete list of side effects. For any unexpected effects while taking SPIRIVA, contact your doctor or pharmacist immediately, so that these effects may be properly addressed.

If you experience dry mouth or bad taste, sucking on a sour candy or rinsing your mouth may help.

Check with your doctor if the dry mouth or bad taste persist or if you experience constipation.

If you do not get the expected relief from your treatment, you should contact your doctor.

Serious Side Effects, How Often They Happen and What to Do About Them
Symptom/Effect Talk with your doctor or pharmacist Stop taking drug and call your doctor or pharmacist
Only if severe In all cases
Common Persistent dry mouth, bad taste    
Constipation    
Uncommon Increased wheezing or tightness in the chest or sudden difficulty in breathing (bronchospasm)    
Swelling of the mouth and face    
Difficulty in swallowing    
Fast or irregular heart beat    
Blurred vision or pain in the eyes    
Difficult or painful urination    
Skin rash/hives    
Suspected infection    

This is not a complete list of side effects. For any unexpected effects while taking SPIRIVA contact your doctor or pharmacist.


Technical Information

What Others Are Saying About spiriva:

Marco A. Nassar on Wednesday July 8, 2009

Fall is a busy time for me, but also a challenging time health-wise for me, which is why I was glad to see my order of Spiriva in my mail box this morning. Thanks for the continued professional and promt service.

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