NDC 54868-4082 Ipratropium Bromide

NDC Product Code 54868-4082

NDC CODE: 54868-4082

Proprietary Name: Ipratropium Bromide What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Ipratropium is used to control and prevent symptoms (wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Controlling symptoms of breathing problems can decrease time lost from work or school. For preventing symptoms of lung disease, this medication must be used regularly to be effective. Use your quick-relief inhaler or nebulized solution (such as albuterol, also called salbutamol in some countries) for wheezing or sudden shortness of breath unless otherwise directed by your doctor. Ipratropium does not work as fast as your quick-relief medication, but may sometimes be used together with your quick-relief medication to relieve symptoms of wheezing or sudden shortness of breath if so prescribed by your doctor.

NDC Code Structure

NDC 54868-4082-0

Package Description: 12 POUCH in 1 CARTON > 5 VIAL in 1 POUCH > 2.5 mL in 1 VIAL

NDC 54868-4082-1

Package Description: 5 POUCH in 1 CARTON > 5 VIAL in 1 POUCH > 2.5 mL in 1 VIAL

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Ipratropium Bromide with NDC 54868-4082 is a product labeled by Physicians Total Care, Inc.. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 836358.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Physicians Total Care, Inc.
Labeler Code: 54868
Start Marketing Date: 12-03-1998 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Ipratropium Oral Inhalation

Ipratropium Oral Inhalation is pronounced as (i pra troe' pee um)

Why is ipratropium oral inhalation medication prescribed?
Ipratropium oral inhalation is used to prevent wheezing, shortness of breath, coughing, and chest tightness in people with chronic obstructive pulmonary disease (COPD; a ...
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Ipratropium Bromide Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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PRESCRIBING INFORMATIONFOR INHALATION USE ONLY–NOT FOR INJECTION.

Description

The active ingredient in Ipratropium Bromide Inhalation Solution
is ipratropium bromide monohydrate. It is an anticholinergic bronchodilator
chemically described as
8-azoniabicyclo[3.2.1]-octane,3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-,
bromide, monohydrate (endo, syn)-,(±)-; a synthetic
quaternary ammonium compound, chemically related to atropine.Ipratropium bromide is a white crystalline substance, freely soluble in water
and lower alcohols. It is a quaternary ammonium compound and thus exists in an
ionized state in aqueous solutions. It is relatively insoluble in non-polar
media.Ipratropium Bromide Inhalation Solution is administered by oral inhalation
with the aid of a nebulizer. Each mL contains ipratropium bromide 0.02%
(anhydrous basis) in a sterile, preservative-free, isotonic saline solution, pH
adjusted to 3.4 (3 to 4) with hydrochloric acid.

Clinical Pharmacology

Ipratropium Bromide Inhalation Solution is an anticholinergic
(parasympatholytic) agent that, based on animal studies, appears to inhibit
vagally-mediated reflexes by antagonizing the action of acetylcholine, the
transmitter agent released from the vagus nerve.Anticholinergics prevent the increases in intracellular concentration of
cyclic guanosine monophosphate (cyclic GMP) which are caused by interaction of
acetylcholine with the muscarinic receptor on bronchial smooth muscle.The bronchodilation following inhalation of Ipratropium Bromide Inhalation
Solution is primarily a local, site-specific effect, not a systemic one. Much of
an administered dose is swallowed but not absorbed as shown by fecal excretion
studies. Following nebulization of a 2 mg dose, a mean 7% of the dose was
absorbed into the systemic circulation either from the surface of the lung or
from the gastrointestinal tract. The half-life of elimination is about 1.6 hours
after intravenous administration. Ipratropium bromide is minimally (0 to 9% in
vitro) bound to plasma albumin and α1-acid glycoproteins.
It is partially metabolized. Autoradiographic studies in rats have shown that
ipratropium bromide does not penetrate the blood-brain barrier. Ipratropium
Bromide Inhalation Solution has not been studied in patients with hepatic or
renal insufficiency. It should be used with caution in those patient
populations.In controlled twelve-week studies in patients with bronchospasm associated
with chronic obstructive pulmonary disease (chronic bronchitis and emphysema)
significant improvements in pulmonary function (FEV1
increases of 15% or more) occurred within 15 to 30 minutes, reached a peak in
1-2 hours and persisted for periods of 4-5 hours in the majority of patients,
with about 25-38% of the patients demonstrating increases of 15% or more for at
least 7-8 hours. Continued effectiveness of ipratropium bromide was demonstrated
throughout the 12-week period. In addition, significant increases in forced
vital capacity (FVC) have been demonstrated. However, ipratropium bromide did
not consistently produce significant improvement in subjective symptom scores
nor in quality of life scores over the 12-week duration of study.Additional controlled 12-week studies were conducted to evaluate the safety
and effectiveness of Ipratropium Bromide Inhalation Solution administered
concomitantly with the beta adrenergic bronchodilator solutions metaproterenol
and albuterol compared with the administration of each of the beta agonists
alone. Combined therapy produced significant additional improvement in FEV1 and FVC. On combined therapy, the median duration of 15%
improvement in FEV1 was 5-7 hours, compared with 3-4
hours in patients receiving a beta agonist alone.

Indications And Usage

Ipratropium Bromide Inhalation Solution administered either alone or with other
bronchodilators, especially beta adrenergics, is indicated as a bronchodilator
for maintenance treatment of bronchospasm associated with chronic obstructive
pulmonary disease, including chronic bronchitis and emphysema.

Contraindications

Ipratropium bromide is contraindicated in known or suspected cases of
hypersensitivity to ipratropium bromide, or to atropine and its derivatives.

Warnings

The use of Ipratropium Bromide Inhalation Solution as a single
agent for the relief of bronchospasm in acute COPD exacerbation has not been
adequately studied. Drugs with faster onset of action may be preferable as
initial therapy in this situation. Combination of Ipratropium Bromide Inhalation
Solution and beta agonists has not been shown to be more effective than either
drug alone in reversing the bronchospasm associated with acute COPD
exacerbation.Immediate hypersensitivity reactions may occur after administration of
ipratropium bromide, as demonstrated by rare cases of urticaria, angioedema,
rash, bronchospasm and oropharyngeal edema.

Precautions

GeneralIpratropium bromide should be used with caution in patients with
narrow angle glaucoma, prostatic hypertrophy or bladder neck obstruction.Information for PatientsPatients should be advised that temporary blurring of vision,
precipitation or worsening of narrow-angle glaucoma or eye pain may result if
the solution comes into direct contact with the eyes. Use of a nebulizer with
mouthpiece rather than face mask may be preferable, to reduce the likelihood of
the nebulizer solution reaching the eyes. Patients should be advised that
Ipratropium Bromide Inhalation Solution can be mixed in the nebulizer with
albuterol or metaproterenol if used within one hour. Drug stability and safety
of ipratropium bromide inhalation solution when mixed with other drugs in a
nebulizer have not been established. Patients should be reminded that
Ipratropium Bromide Inhalation Solution should be used consistently as
prescribed throughout the course of therapy.Drug InteractionsIpratropium bromide has been shown to be a safe and effective
bronchodilator when used in conjunction with beta adrenergic bronchodilators.
Ipratropium bromide has also been used with other pulmonary medications,
including methylxanthines and corticosteroids, without adverse drug
interactions.Carcinogenesis, Mutagenesis, Impairment of
FertilityTwo-year oral carcinogenicity studies in rats and mice have
revealed no carcinogenic potential at dietary doses up to 6 mg/kg/day of
ipratropium bromide.Results of various mutagenicity studies (Ames test, mouse dominal lethal
test, mouse micronucleus test and chromosome aberration of bone marrow in
Chinese hamsters) were negative.Fertility of male or female rats at oral doses up to 50 mg/kg/day was
unaffected by ipratropium bromide administration. At doses above 90 mg/kg,
increased resorption and decreased conception rates were observed.PregnancyTERATOGENIC EFFECTSPregnancy Category B. Oral
reproduction studies performed in mice, rats and rabbits at doses of 10, 100,
and 125 mg/kg respectively and inhalation reproduction studies in rats and
rabbits at doses of 1.5 and 1.8 mg/kg ( or approximately 38 and 45 times the
recommended human daily dose) respectively, have demonstrated no evidence of
teratogenic effects as a result of ipratropium bromide. However, no adequate or
well controlled studies have been conducted in pregnant women. Because animal
reproduction studies are not always predictive of human response, ipratropium
bromide should be used during pregnancy only if clearly needed.Nursing MothersIt is not known whether ipratropium bromide is excreted in human
milk. Although lipid-insoluble quaternary bases pass into breast milk, it is
unlikely that ipratropium bromide would reach the infant to a significant
extent, especially when taken by inhalation since ipratropium bromide is not
well absorbed systemically after inhalation or oral administration. However,
because many drugs are excreted in human milk, caution should be exercised when
ipratropium bromide is administered to a nursing woman.Pediatric UseSafety and effectiveness in pediatric patients below the age of
12 have not been established.

Adverse Reactions

Adverse reaction information concerning Ipratropium Bromide
Inhalation Solution is derived from 12-week active-controlled clinical trials.
Additional information is derived from foreign post-marketing experience and the
published literature.All adverse events, regardless of drug relationship, reported by three
percent or more patients in the 12-week controlled clinical trials appear in the
table.Additional adverse reactions reported in less than three percent of the
patients treated with ipratropium bromide include tachycardia, palpitations, eye
pain, urinary retention, urinary tract infection and urticaria. Cases of
precipitation or worsening of narrow-angle glaucoma and acute eye pain have been
reported.Lower respiratory adverse reactions (bronchitis, dyspnea and bronchospasm)
were the most common events leading to discontinuation of ipratropium bromide
therapy in the 12-week trials. Headache, mouth dryness and aggravation of COPD
symptoms are more common when the total daily dose of ipratropium bromide equals
or exceeds 2,000 mcg.Allergic-type reactions such as skin rash, angioedema of tongue, lips and
face, urticaria, laryngospasm and anaphylactic reaction have been reported. Many
of the patients had a history of allergies to other drugs and/or foods.All Adverse Events, From a Double-blind, Parallel, 12-week Study of Patients with COPD*PERCENTOF PATIENTSIpratropiumBromide(500 mcg t.i.d.)n = 219Metaproterenol(15
mg t.i.d.)n = 212Ipratropium Bromide/Metaproterenol(500 mcg t.i.d./15 mg t.i.d.)n =
108Albuterol(2.5 mg t.i.d.)n = 205Ipratropium Bromide/Albuterol(500 mcg t.i.d./2.5 mg t.i.d.)n = 100Body as a Whole-General DisordersHeadache6.45.26.56.39.0Pain4.13.30.92.95.0Influenza-like symptoms3.74.76.50.51.0Back Pain3.21.91.92.40.0Chest Pain3.24.25.62.01.0Cardiovascular DisordersHypertension/hypertension0.91.90.91.54.0AggravatedCentral & Peripheral Nervous SystemDizziness2.33.31.93.94.0Insomnia0.90.54.61.01.0Tremor0.97.18.31.00.0Nervousness0.54.76.51.01.0Gastrointestinal System DisordersMouth Dryness3.20.01.92.03.0Nausea4.13.81.92.92.0Constipation0.90.03.71.01.0Musculo-skeletal System DisordersArthritis0.91.40.90.53.0Respiratory System Disorders (Lower)Coughing4.68.06.55.46.0Dyspnea9.613.216.712.79.0Bronchitis14.624.515.716.620.0Bronchospasm2.32.84.65.45.0Sputum Increased1.41.44.63.40.0Respiratory Disorder0.06.16.52.04.0Respiratory System Disorders (Upper)Upper Respiratory Tract Infection13.211.39.312.216.0Pharyngitis3.74.25.62.94.0Rhinitis2.34.21.92.40.0Sinusitis2.32.80.95.44.0*      All adverse events, regardless of drug relationship, reported by the three percent or more patients in the 12-week controlled clinical trials

Overdosage

Acute systemic overdosage by inhalation is unlikely since ipratropium bromide is
not well absorbed after inhalation at up to four-fold the recommended dose, or
after oral administration at up to forty-fold the recommended dose. The oral
LD50 of ipratropium bromide ranged between 1001 and 2010
mg/kg in mice; between 1667 and 4000 mg/kg in rats; and between 400 and 1300
mg/kg in dogs.

Dosage And Administration

The usual dosage of Ipratropium Bromide Inhalation Solution is 500 mcg (1
Unit-Dose Vial) administered three to four times a day by oral nebulization,
with doses 6 to 8 hours apart. Ipratropium Bromide Inhalation Solution Unit-Dose
Vials contain 500 mcg ipratropium bromide anhydrous in 2.5 mL normal saline.
Ipratropium Bromide Inhalation Solution can be mixed in the nebulizer with
albuterol or metaproterenol if used within one hour. Drug stability and safety
of ipratropium bromide inhalation solution when mixed with other drugs in a
nebulizer have not been established.

How Supplied

Ipratropium Bromide Inhalation Solution is a clear, colorless
solution supplied in a unit-dose vial containing 2.5 mL. Supplied in cartons as
listed below:NDC 54868-4082-1 25 vials per carton/5 vials per foil pouchNDC 54868-4082-0 60
vials per carton/5 vials per foil pouchEach vial is made from a low density polyethylene (LDPE) resin.Store between 15° and 30°C (59° and 86°F). Protect from
light. Store in pouch until time of use.ATTENTION PHARMACIST: Detach "Patient's Instructions for Use" from Package
Insert and dispense with solution.Rx only.DEY®, Napa, CA 9455803-343-22JAN 06

Patient's Instructions For Use

  • Ipratropium BromideInhalation Solution 0.02%Read complete instructions carefully before using.Remove vial pouch from the foil pouch.Twist open the top of one unit dose vial and squeeze the contents into the
  • Nebulizer reservoir ( Figure 1).Connect the nebulizer reservoir to the mouthpiece or face mask ( Figure 2).Connect the nebulizer to the compressor.Sit in a comfortable, upright position; place the mouthpiece in your mouth
  • ( Figure 3) or put on the face mask and turn on the
  • Compressor. If a face mask is used, care should be taken to avoid leakage around
  • The mask as temporary blurring of vision, precipitation or worsening of
  • Narrow-angle glaucoma, or eye pain may occur if the solution comes into direct
  • Contact with the eyes.Breathe as calmly, deeply, and evenly as possible
  • Until no more mist is formed in the nebulizer chamber (about 5-15 minutes). At
  • This point, the treatment is finished.
  • Clean the nebulizer (see manufacturer's instructions). Note: Use only as directed by your physician. More frequent
  • Administration or higher doses are not recommended. Ipratropium Bromide
  • Inhalation Solution can be mixed in the nebulizer with albuterol or
  • Metaproterenol if used within one hour but not with other drugs. Drug stability
  • And safety of Ipratropium Bromide Inhalation Solution when mixed with other
  • Drugs in a nebulizer have not been established.Store between 15° and 30°C (59° and 86°F). Protect from
  • Light. Store in pouch until time of use.ADDITIONAL INSTRUCTIONS:      DEY®, Napa, CA 9455803-343-22JAN 06

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