NDC 47335-706 Ipratropium Bromide

Ipratropium Bromide

NDC Product Code 47335-706

NDC CODE: 47335-706

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.

Non-Proprietary Name: Ipratropium Bromide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

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 (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 inhaler, but may sometimes be used to relieve symptoms of wheezing or sudden shortness of breath if so prescribed by your doctor.

NDC Code Structure

NDC 47335-706-49

Package Description: 5 POUCH in 1 CARTON > 5 VIAL in 1 POUCH (47335-706-48) > 2.5 mL in 1 VIAL

NDC 47335-706-52

Package Description: 6 POUCH in 1 CARTON > 5 VIAL in 1 POUCH > 2.5 mL in 1 VIAL

NDC 47335-706-54

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

NDC Product Information

Ipratropium Bromide with NDC 47335-706 is a a human prescription drug product labeled by Sun Pharmaceutical Industries, Inc.. The generic name of Ipratropium Bromide is ipratropium bromide. The product's dosage form is solution and is administered via respiratory (inhalation) form.

Labeler Name: Sun Pharmaceutical Industries, Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Ipratropium Bromide Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • IPRATROPIUM BROMIDE .5 mg/2.5mL

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.

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

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Anticholinergic - [EPC] (Established Pharmacologic Class)
  • Cholinergic Antagonists - [MoA] (Mechanism of Action)

Product Labeler Information

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

Labeler Name: Sun Pharmaceutical Industries, Inc.
Labeler Code: 47335
FDA Application Number: ANDA207903 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-04-2020 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: 12-31-2021 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: N 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. Values = ‘Y’ or ‘N’.

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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

Description

The active ingredient in Ipratropium Bromide Inhalation Solution is ipratropium bromide monohydrate, USP. 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, USP 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 to 2 hours and persisted for periods of 4 to 5 hours in the majority of patients, with about 25 to 38% of the patients demonstrating increases of 15% or more for at least 7 to 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 to 7 hours, compared with 3 to 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.

General

Ipratropium bromide should be used with caution in patients with narrow angle glaucoma, prostatic hypertrophy or bladder neck obstruction.

Information For Patients

Patients should be advised that mydriasis, 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 Interactions

Ipratropium 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 Fertility

Two-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.

Pregnancy

Teratogenic Effects Pregnancy Category BOral 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 Mothers

It 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 Use

Safety 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 postmarketing 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, mydriasis, 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 COPDAll adverse events, regardless of drug relationship, reported by the three percent or more patients in the 12-week controlled clinical trials. PERCENT OF PATIENTSIpratropiumBromide(500 mcgt.i.d.)n = 219Metaproterenol(15 mg t.i.d.)n = 212IpratropiumBromide/ Metaproterenol(500 mcg t.i.d./15 mgt.i.d.)n = 108Albuterol(2.5 mgt.i.d.)n = 205IpratropiumBromide/ Albuterol(500 mcg t.i.d./2.5mg t.i.d.)n = 100Body as a Whole-General DisordersHeadache6.45.26.56.39Pain4.13.30.92.95Influenza-like symptoms3.74.76.50.51Back Pain3.21.91.92.40Chest Pain3.24.25.621Cardiovascular DisordersHypertension/hypertension Aggravated0.91.90.91.54Central & Peripheral Nervous SystemDizziness2.33.31.93.94Insomnia0.90.54.611Tremor0.97.18.310Nervousness0.54.76.511Gastrointestinal System DisordersMouth Dryness3.201.923Nausea4.13.81.92.92Constipation0.903.711Musculo-skeletal System DisordersArthritis0.91.40.90.53Respiratory System Disorders (Lower)Coughing4.686.55.46Dyspnea9.613.216.712.79Bronchitis14.624.515.716.620Bronchospasm2.32.84.65.45Sputum Increased1.41.44.63.40Respiratory Disorder06.16.524Respiratory System Disorders (Upper)Upper Respiratory TractInfection13.211.39.312.216Pharyngitis3.74.25.62.94Rhinitis2.34.21.92.40Sinusitis2.32.80.95.44

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 1,001 and 2,010 mg/kg in mice; between 1,667 and 4,000 mg/kg in rats; and between 400 and 1,300 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, USP 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 47335-706-49    carton of 25 vials (5 vials per foil pouch)NDC 47335-706-52    carton of 30 vials (5 vials per foil pouch)NDC 47335-706-54    carton of 60 vials (5 vials per foil pouch) Each vial is made from a low density polyethylene (LDPE) resin. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light. Store in pouch until time of use.

Patient's Instructions For Use

Ipratropium Bromide (IH-pruh-TROE-pee-uhm BROE-mide)  Inhalation Solution 0.02%Read complete instructions carefully before using.1. Remove vial from the foil pouch. 2. Twist open the top of one unit dose vial and squeeze the contents into the nebulizer reservoir (Figure 1). 3. Connect the nebulizer reservoir to the mouthpiece or face mask (Figure 2).4. Connect the nebulizer to the compressor.5. 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, pupil enlargement, precipitation or worsening of narrow-angle glaucoma, or eye pain may occur if the solution comes into direct contact with the eyes.6. Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 15 minutes). At this point, the treatment is finished.7. 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 at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light. Store in pouch until time of use.ADDITIONAL INSTRUCTIONS: __________________________________________  Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512   Manufactured by: Sun Pharmaceutical Medicare LimitedBaska Ujeti Road, UjetiHalol-389350, Gujarat, IndiaPHPI0036AISS. 09/2016

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