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A SPIRIVA HandiHaler
(tintrnpiiim bromide inhalation powder)
SPIRIVA® HandiHaler®
(botropjum bromide inhalation powder)
For Oral Mutation Only
Brief Summary of Prescribing Information
INDICATIONS AND USAGE
SPIRIVA HandSttter itwtropium hromide inhalation powder) is indicated tor the long-term once darty,
maintenance treatment of hroochospasm associated with chronic obstructive pulmonary disease
(COPD) including chrome bronchitis and emphysema
CONTRAINDICATIONS
SPIRIVA Handsaw ibobopium bromide inhalation powder) is contraindicated r patients with a history of
hypersensitivity to atropine or its derivatives including ipratropium, or to any component of this product
WARNINGS
SPIRIVA HandiHaler (twtropium Bromide inhalation powder) is intended as a once-daily maintenance
treatment tor COPD and is not indicated tor the ritial treatment of acute episodes ot bronchospasm,
ie. rescue therapy
Immediate hypersensitivity reactions mciudmg angioedema may occia after administration of SPIRIVA
If such a reaction occurs, therapy with SPIRIVA should be stopped at once and alternative treatments
should be considered
Inhaled medicines mcludmg SPIRIVA, may cause paradoxical bronchospasm 1 this occurs treatment
with SPIRIVA should be stopped and other treatments considered
PRECAUTIONS
General
As an antichohnergic drug, SPIRIVA itwtropium bromide inhalation powden may potentially wot sen
symptoms and signs associated with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck
obstruction and should be used with caution in patients with any ot these conditions
As a piedommanfty renatty excreted diug. patients with moderate to severe renal impairment
icreatmme clearance of <SO nH/rntn) treated with SPIRIVA should be monitored closely isee
CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations Penally impaired Patient#
Information for Patients
It is important (or patients to understand how to correctly admrnrstei SPIRIVA capsules using the
Handtfaier mhatabon device tsee Patient’s Instructions for Use) SPIRIVA capsules should only be
administered via the HarehHaier device and the HandiHaler device should not be used for admsusleting
other medications
Capsules should always be stored m sealed blisters and only removed immediately before use The
blister ship should be carefuly opened to expose only one capsule at a time Open the Mister toil as tar
as the STOP line to remove only one capsule at a time The drug should be used unmedately after the
packaging over an mdwiduai capsule is opened or else rts effectiveness may be reduced Capsules that
are inadvertently exposed to a» |i e.. not intended for immediate use) should be discarded
Eye paw or discomfort blurred vision, visual halos 01 cokxed images in association with red eyes from
coniunchval congestion and comeal edema may be signs of acute narrow-angle glaucoma Should any
ot these sgre. and symptoms develop consult a physician immediately Miotic eye drops atone are not
constoered to be effective treatment
Care must be taken not to allow the powder to enter into the eyes as this may cause blurring of vision
and pupil dilation
SPIRIVA HandiHaler is a once dady maintenance bionchodilator and should not be used lor immediate
retet of breathing problems i e, as a rescue medication
Drug Interactions
SPIRIVA has been used concomitantly with other drugs commonly used w COPD without increases w
adverse drug reactions These include sympathomimetic bronchodilators. methylxanthmes and oral and
mlialed steroids However the co-admmistration ot SPIRIVA with other anbcholmeigic-containing drugs
le g ipratropium) has not been shirked and is therefore not recommended
Drug/laboratory Test Interactions
None known
Carcinogenesis, Mutagenesis, Impairment of Fertility
No evidence of tumongenicity was observed m a 104 week inhalation study m rats at tiotropium doses
up to 0 059 mg/kg/day >n an 83-week rhalation study in female mice at doses up to 0145 mg/kg/day.
and m a 101 week whaiabon study in male mce at doses up to 0 00? mg/kg/day These doses
correspond to 25, 35 and 0 5 tries the Recommended Human Daily Dose (RHOOi on a mg'm basis
respectively These dose multiples may be over estimated due to drtficulties m measuring deposited
doses m animal whaiation studies
lot/opwm bromide demonstrated no evidence at mutagenicity or dastogencity m the blowing assays
the bacterial gene mutation assay the V 79 Chinese hamster cel mutagenesis assay the chromosomal
aberration assays w human lymphocytes in vitro and mouse mrcronucfeus formation tn two and the
unscheduled DNA synthesis w pnmary rat hepatoeyfes m vitro assay
to rats decreases m the number of corpora lutea and the percentage ot implants were noted at
inhalation tiotropium doses of 0 078 mg/kg/day or greater (approximately 35 tones the RHOD on a
mg/m basis) No such effects were observed at 0009 mg/kg/day (approximately 4 tunes than the
RHOO on a mg/m basis) The ferttity index, however was not affected at inhalation doses up to 1 689
mgdig/day (approximately 760 tones the RHOD on a mg/m basis) These dose muitiptes may be over
estimated due to drfhcutties m measimng deposited doses m animal inhalation studies
Pregnancy
Pregnancy Category C
No ewdence of structural alterations was observed w rats and rabbits at whaiation twtropium doses ot
up to 1471 and 0 007 mg/kg/day respectively these doses correspond to approximately 660 and
6 times the recommended human daily dose (RHOO) on a mg/m basis However, in rats, fetal
resorption. Mter toss, decreases w the number ot tore pups at birth and the mean pup weights and a
delay in pup sexual maturation were observed at whaiation twtropium doses of 20078 mg/kg
iapproximately 35 tones the RHOO on a mgm basis), to rabbits, an increase to post impiantaton loss
was observed at an whaiation dose of 0.4 mg/kg/day (approximately 360 tones the RHOO on a mgm
base) Such effects were not observed at whaiation doses at 0 009 and up to 0 088 mg/kg/day w rats
and rabbits respectively These doses correspond to approximately 4 and 80 times the RHOO on a
mg'm basis respectively These dose multiples may be over-estimated due to difficulties in measuring
deposited doses in animal whaiation studies
There are no adequate and we* controlled studies in pregnant women SPIRIVA should be used during
pregnancy only 4 the potential benefit justifies the potential risk to the fetus
Us* in Labor and Delivery
The safety and effectiveness of SPHVA has not been studied dunrig labor and delivery
Nurang Mothers
Ckrecal data from nursing women exposed to twtropium are not available Based on ladatmg rodent
shakes. twtropwm is excreted into breast ntok R is nos known whether twtropium is excreted w human
m4k. hut because many drugs are excreted w human mrtk and gwen these findings m rats caubon
should be exercised if SPIRIVA is admwistered to a nursing woman
Hi only
5P2775368
Copyright ©2006. Boehnnger Ingetheim Pharmaceuticals. Inc All rights lesetved
Pediatric Use
SPIRIVA HandiHaler is approved for use in the maintenance treatment of bronchospasm associated
with chronic obstructive pulmonary disease including chronic bronchitis and emphysema This
disease does not normally occur in children The safety and effectiveness of SPIRIVA w pediatric
patients have not been established
Geriatric Use ’
Ot the total number o( patients who received SPIRIVA m the I year cluneal trials. 426 were < 65 years
375 were 65-74 years and 105 were ’75 years of age Within each age subgroup there were no
differences between the proportion ol patients with adverse events in the SPIRIVA and the comparator
groups for most events Dry mouth increased with age w the SPIRIVA group idrtferenr.es bom placebo
were 90% 171%, and 16.2% in the aforementioned age subgroups) A higher frequency ot
constipation and urwaiy tract wtections with increasing age was observed in the SPIRIVA group in the
placebo-controlled studies The differences from placebo tor constipation were 0%. l 8%. and 7 8% tor
each of the age groups The differences from placebo for unnary tract infections were -0 6% 4 6% and
4 5% No overall differences m effectiveness were observed among these groups Based on available
data no adjustment ot SPtRIVA dosage w geriatric patients is warranted
ADVERSE REACTIONS
Of the 2,663 patterns m the four 1 year and two 6 month controlled clinical trials. I 308 were treated
with SPIRIVA (tiotropium bromide inhalation powder) at the recommended dose ot 18 meg once a day
Patients with narrow angle glaucoma, or symptomatic prostatic hypertrophy or bladder outlet
obstruction were excluded from these trials
The most commonly reported adverse drug reaction was dry mouth Dry mouth was usually nutd and
often resolved during continued treatment Other reactions reported in individual patients and consistent
with possible anticholineigic effects aid tided constipation, increased heart rate. Wuued vision,
glaucoma unnary difficulty and unnary retention
Four multicenter 1 -year controlled studies evaluated SPWVA in patients with COPO Table i shows al
adverse events that occuned with a frequency ol >3% in the SPRIVA group m the 1 yea
placebo-controlled Inals where the rates in the SPIRIVA group exceeded placebo by *l% The frequency
ol corresponding events in the ipratropium controlled trials is included lor comparison
Table 1: Adverse Experience Incidence (% Patients) in One-Ylear-COPO Clinical Tnals
Body System (Event) Placebo-Controlled Tnals Ipratropium-Controfled Tnals
SPIRIVA Placebo SPIRIVA Ipratropium
Body as a Whole
Accidents 13 n 5 8
Chest Pm inon-specific) 7 5 5 2
Edema, Dependent 5 4 3 5
Gastrointestinal System Disorders
Abdominal Pam 5 3 6 6
Constipation 4 ? i i
Oiy Mouth 16 3 12 6
Dyspepsia 6 5 t i
Vomiting 4 2 1 2
Musculoskeletal System
Myalgia 4 3 4 3
Resistance Mechanism Disorders
Infection 4 3 1 3
Moniliasis 4 2 3 2
Respiratory System (upper)
Eptstaxis 4 2 l i
Pharyngrtis 9 7 7 3
Rhtodis 6 5 3 2
Sinusitis U 9 3 2
Uppei Respiratory Traci totection 41 37 43 35
Skin and Appendage Disorders
Rash 4 2 2 2
Unnary System
Urinary Tract Infection 7 5 4 2
Arthritis, coughing, and influenza hke symptoms occurred at a rate ot -3% m the SPIRIVA treatment
group, but were < 1 % in excess of the placebo gioig)
Other events that occurred m the SPIRIVA group at a frequency ot 1 3% in the placebo conboled trials
where the rates exceeded that in the placebo group include Body as a Whole anergic reaction leg pain.
Cential and Peripheral Nervous System dysphoma. paresthesia; Gastrointestinal System Disorders
gastnxntestmai disorder not otherwise specified (NOS), gastroesophageal reflux, stomatitis (mdudmg
ulcerative stomatitis), Metadobc and Nutritional Disorders hypercholesterolemia, hyperglycemia
Musculoskeletal System Disorders skeletal pam Cardiac Events angina pectons (including aggravated
angina pectonsi Psychiatric Disorder depression infections herpes zoster Respiratory System
Disorder iUppen laryngitis; Vision Disordei cataract In addition, among the adverse events observed
in the clmcal trials with an incidence ot <l% were atrial fibrillation, supiaveiitnculai tachycardia
angwedema, and unnary retention
to the 1 year tnals. the incidence ot dry mouth, constipation and urinary tract infection increased with
age tsee PRECAUTIONS, Genatnc Use)
Two multicenter, 6-month, controlled studies evaluated SPIWVA in patients with COPD Tlie adverse
events and the incidence rales were similar lo those seen in the 1 - year controlled tnals
The following adverse reactions have been identified during worldwide post appiova! use ot SPIRIVA
dizziness, epistaxis. hoarseness palpitations, pruritus tachycarika. throat irritation and urticaria
DOSAGE AND ADMINISTRATION
The recommended dosage ol SPIRIVA HandiHaler (twtropium bromide inhalation powder) is the
whaiation ol the contents of one SPWVA capsule, once daily, with the Hand!Haler whaiation device (see
Patient's Instructions tor Uaei
No dosage adwstment is required tor genatnc. hepatwally-impaired or renaHy-impaired patients
However patients with moderate to severe renal impairment given SPIRIVA should be monitored closely
(see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and PRECAUTIONS.
SPIRIVA capsules are for mhalatioii only and must not be swallowed
HOW SUPPLIED
The following packages are available
carton contaimng 6 SPIRIVA capsules (1 blister card) and i HandiHaiei inhalation device
(NDC 0597-0075-06)
carton containing 30 SPtRIVA capsules (b buster cardsi and 1 HandiHaler inhalation device
(NDC 0597-0075 37)
SV-BS (10/05)
59873/US/3 October 2005
®Boeh ringer
Ingelheim
(09/061 5V12385Q
Health
Dietary
Guidelines
for Diabetics
Whether you’re trying to
prevent diabetes, better manage your disease
or slow complications from developing, the
American Diabetes Association (ADA) has
developed guidelines to help you choose the
right meal plan to meet your goals.
Tlie guidelines, published in the Septem
ber issue ot Diabetes Can, offer nutrition advice
based on a person’s medical condition.
“When you're talking about diabetes,
there is no ‘one-size-fits-all’ diet," says Ann
Albright, an ADA spokeswoman. “For people
with diabetes and those at risk for type 2
diabetes, medical nutrition therapy should
be tailored to a person’s specific health issues
and personal preferences to help maintain
optimum health.”
For people who are at risk for diabetes, the
guidelines call for a diet high in fiber and
nutrient-rich foods, with whole grains mak
ing up half of all grain consumed.
For people who already have diabetes, tlie
guidelines recommend obtaining carbohy
drates from fruits, vegetables, whole grains,
legumes and low-fat milk; eating fiber-rich
fixxls; keeping saturated fats to less titan 7
percent of total caloric inrake; eating at least
two servings of non-tfied fish per week;
limiting trans fats; and restricting cholesterol
intake.
Specific dietary recommendations also are
included for people with type l diabetes,
pregnant or nursing mothers with diabetes,
older adults, and those living in long-term
tare facilities or managing acute illnesses. Tlie
recommendarions note that altering a persons
diet cannot prevent type 1 diabetes.
Tlie guidelines emphasize the importance
of sustained, moderate weight loss for people
who are overweight or obese and increased
physical activity for all people at risk for or
living with diabetes. In addition, they urge
people with diabetes to avoid fed diets, such as
those that promote extreme low-carbohydrate
or high-protein intake.
“Fad diets come and go,” Albright says.
“We want people to be provided with sound
nutrition advice tliat will help them in mak
ing choices for maintaining good health for
the long term.”
Visit www.diabetes.org or call (800)
342-2383 for more information.
www.americanprofile.com •
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