Drug: Atrovent Nasal Spray

The active ingredient in ATROVENT® Nasal Spray is ipratropium bromide monohydrate. It is an anticholinergic agent chemically described as 8-azoni-abicyclo (3.2.1) octane,3-(3-hydroxy-1-oxo-2-phenyl-propoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo,syn)-, (±)- :a synthetic quaternary ammonium compound, chemically related to atropine. Its structural formula is: Ipratropium bromide is a white to off-white, crystalline substance. It is freely soluble in lower alcohols and water, existing in an ionized state in aqueous solutions, and relatively in soluble in non-polar media. ATROVENT (ipratropium bromide) Nasal Spray 0.03% is a metered-dose, manual pump spray unit which delivers 21 mcg(70µL) ipratropium bromide per spray on an anhydrous basis in an isotonic, aqueous solution with pH adjusted to 4.7. It also contains benzalkonium chloride, edetate disodium, sodium chloride, sodium hydroxide, hydrochloric acid, and purified water. Each bottle contains 345 sprays.

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Adverse reaction information on ATROVENT Nasal Spray 0.03% in patients with perennial rhinitis was derived from four multicenter, vehicle-controlled clinical trials involving 703 patients (356 patients on ATROVENT and 347 patients on vehicle), and a one-year, open-label, follow-up trial. In three of the trials, patients received ATROVENT Nasal Spray (ipratropium bromide nasal spray) 0.03% three times daily, for eight weeks. In the other trial, ATROVENT Nasal Spray (ipratropium bromide nasal spray) 0.03% was given to patients two times daily for four weeks. Of the 285 patients who entered the open-label, follow-up trial, 232 were treated for 3 months, 200 for 6 months, and 159 up to one year. The majority ( > 86%) of patients treated for one year were maintained on 42 mcg per nostril, two or three times daily, of ATROVENT Nasal Spray (ipratropium bromide nasal spray) 0.03%. Table 1 shows adverse events, and the frequency that these adverse events led to the discontinuation of treatment, reported for patients who received ATROVENT Nasal Spray 0.03% at the recommended dose of 42 mcg per nostril, or vehicle two or three times daily for four or eight weeks. Only adverse events reported with an incidence of at least 2.0% in the ATROVENT group and higher in the ATROVENT group than in the vehicle group are shown. Table 1 - % of Patients Reporting Events +
  Atrovent®
(ipratropium bromide)
Nasal Spray 0.03%
(n=356) Vehicle Control
(n=347) Incidence % Discontinued % Incidence % Discontinued % Headache 9.8 0.6 9.2 0.0 Upper respiratory tract infection 9.8 1.4 7.2 1.4 Epistaxis1 9.0 0.3 4.6 0.3 Rhinitis*    Nasal dryness 5.1 0.0 0.9 0.3    Nasal irritation2 2.0 0.0 1.7 0.6    Other nasal symptoms3 3.1 1.1 1.7 0.3 Pharyngitis 8.1 0.3 4.6 0.0 Nausea 2.2 0.3 0.9 0.0 + This table includes adverse events which occurred at an incidence rate of at least 2.0% in the ATROVENT group and more frequently in the ATROVENT group than in the vehicle group.
1 Epistaxis reported by 7.0% of ATROVENT patients and 2.3% of vehicle patients, blood-tinged mucus by 2.0% of ATROVENT patients and 2.3% of vehicle patients.
2Nasal irritation includes reports of nasal itching, nasal burning, nasal irritation, and ulcerative rhinitis.
3 Other nasal symptoms include reports of nasal congestion, increased rhinorrhea, increased rhinitis, posterior nasal drip, sneezing, nasal polyps, and nasal edema.
*All events are listed by their WHO term; rhinitis has been presented by descriptive terms for clarification. ATROVENT Nasal Spray (ipratropium bromide nasal spray) 0.03% was well tolerated by most patients. The most frequently reported nasal adverse events were transient episodes of nasal dryness or epistaxis. These adverse events were mild or moderate in nature, none was considered serious, none resulted in hospitalization and most resolved spontaneously or following a dose reduction. Treatment for nasal dryness and epistaxis was required infrequently (2% or less) and consisted of local application of pressure or a moisturizing agent (e.g., petroleum jelly or saline nasal spray). Patient discontinuation for epistaxis or nasal dryness was infrequent in both the controlled (0.3% or less) and one-year, open-label (2% or less) trials. There was no evidence of nasal rebound (i.e., a clinically significant increase in rhinorrhea, posterior nasal drip, sneezing or nasal congestion severity compared to baseline) upon discontinuation of double-blind therapy in these trials. Adverse events reported by less than 2% of the patients receiving ATROVENT Nasal Spray 0.03% during the controlled clinical trials or during the open-label follow-up trial, which are potentially related to ATROVENT's local effects or systemic anticholinergic effects include: dry mouth/throat, dizziness, ocular irritation, blurred vision, conjunctivitis, hoarseness, cough, and taste perversion. There were infrequent reports of skin rash in both the controlled and uncontrolled clinical studies. Post-Marketing Experience Allergic-type reactions such as skin rash, angioedema of the throat, tongue, lips and face, generalized urticaria (including giant urticaria), laryngospasm, and anaphylactic reactions have been reported with Atrovent® (ipratropium bromide) Nasal Spray 0.03% and for other ipratropium bromide-containing products, with positive rechallenge in some cases. Additional side effects identified from the published literature and/or post-marketing surveillance on the use of ipratropium bromide-containing products (singly or in combination with albuterol), include: urinary retention, prostatic disorders, mydriasis, cases of precipitation or worsening of narrow-angle glaucoma, acute eye pain, wheezing, dryness of the oropharynx, sinusitis, tachycardia, palpitations, pain, edema, gastrointestinal distress (diarrhea, nausea, vomiting), bowel obstruction, and constipation. After oral inhalation of ipratropium bromide in patients suffering from COPD/Asthma supraventricular tachycardia and atrial fibrillation have been reported. Read the Atrovent Nasal Spray (ipratropium bromide nasal spray) Side Effects Center for a complete guide to possible side effectsLearn More »

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The recommended dose of ATROVENT Nasal Spray (ipratropium bromide nasal spray) 0.03% is two sprays (42 mcg) per nostril two or three times daily (total dose 168 to 252 mcg/day) for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. Optimum dosage varies with the response of the individual patient. Initial pump priming requires seven sprays of the pump. If used regularly as recommended, no further priming is required. If not used for more than 24 hours, the pump will require two sprays, or if not used for more than seven days, the pump will require seven sprays to reprime. Avoid spraying into eyes.

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No controlled clinical trials were conducted to investigate potential drug-drug interactions. ATROVENT Nasal Spray (ipratropium bromide nasal spray) 0.03% is minimally absorbed into the systemic circulation; nonetheless, there is some potential for an additive interaction with other concomitantly administered medications with antichloinergic properties including ATROVENT for oral inhalation. Read the Atrovent Nasal Spray Drug Interactions Center for a complete guide to possible interactions Learn More »

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ATROVENT Nasal Spray (ipratropium bromide nasal spray) 0.03% is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. ATROVENT Nasal Spray (ipratropium bromide nasal spray) 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis.

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Atrovent® (ipratropium bromide) Nasal Spray 0.03% is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any of the other ingredients.Last reviewed on RxList: 12/5/2008
This monograph has been modified to include the generic and brand name in many instances.

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Acute overdosage by intranasal administration is unlikely since ipratropium bromide is not well absorbed systemically after intranasal or oral administration. Following administration of a 20 mg oral dose (equivalent to ingesting more than four bottles of ATROVENT Nasal Spray 0.03%) to 10 male volunteers, no change in heart rate or blood pressure was noted. Following a 2 mg intravenous infusion over 15 minutes to the same 10 male volunteers, plasma ipratropium concentrations of 22-45 ng/mL were observed ( > 100 times the concentrations observed following intranasal administration). Following intravenous infusion these 10 volunteers had a mean increase of heart rate of 50 bpm and less than 20 mmHg change in systolic or diastolic blood pressure at the time of peak ipratropium levels. Oral median lethal doses of ipratropium bromide were greater than 1,001 mg/kg in mice (approximately 16,000 and 9,500 times the maximum recommended daily intranasal dose in adults and children, respectively, on a mg/m² basis), 1,663 mg/kg in rats (approximately 53,000 and 32,000 times the maximum recommended daily intranasal dose in adults and children, respectively, on a mg/m² basis), and 400 mg/kg in dogs (approximately 43,000 and 25,000 times the maximum recommended daily intranasal dose in adults and children, respectively, on a mg/m² basis).

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Atrovent® (ipratropium bromide) Nasal Spray 0.03% is supplied in a white high density polyethylene (HDPE) bottle fitted with a metered nasal spray pump, a green safety clip to prevent accidental discharge of the spray, and a clear plastic dust cap. It contains 31.1g of product formulation, 345 sprays, each delivering 21 mcg of ipratropium bromide per spray (70 μL), or 28 days of therapy at the maximum recommended dose (two sprays per nostril three times a day) (NDC 0597-0081-30). Store tightly closed at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Avoid freezing. Keep out of reach of children. Do not spray in the eyes. Address medical inquiries to: http://us.boehringer-ingelheim.com, (800) 542-6257 or (800)459-9906 TTY. Patients should be reminded to read and follow the accompanying “Patient's Instructions for Use”, which should be dispensed with the product. Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA. Rev: May 2007. FDA rev date: 11/30/2007Last reviewed on RxList: 12/5/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General
  1. Effects Seen with Anticholinergic Drugs: ATROVENT Nasal Spray (ipratropium bromide nasal spray) 0.03% should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder neck obstruction, particularly if they are receiving an anticholinergic by another route.
  2. Use in Hepatic or Renal Disease: ATROVENT Nasal Spray (ipratropium bromide nasal spray) 0.03% has not been studied in patients with hepatic or renal insufficiency. It should be used with caution in those patient populations.
Information for Patients Patients should be advised that temporary blurring of vision, precipitation or worsening of narrow-angle glaucoma, mydriasis, increased intraocular pressure, acute eye pain or discomfort, visual halos or colored images in association with red eyes from conjunctival and corneal congestion may result if ATROVENT Nasal Spray 0.03% comes into direct contact with the eyes. Patients should be instructed to avoid spraying ATROVENT Nasal Spray (ipratropium bromide nasal spray) 0.03% in or around their eyes. Patients who experience eye pain, blurred vision, excessive nasal dryness, or episodes of nasal bleeding should be instructed to contact their doctor. To ensure proper dosing, patients should be advised not to alter the size of the nasal spray opening. Patients should be reminded to carefully read and follow the accompanying Patient's Instructions for Use. Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year oral carcinogenicity studies in rats and mice have revealed no carcinogenic activity at doses up to 6 mg/kg. This dose corresponds in rats and mice to approximately 190 and 95 times the maximum recommended daily intranasal dose in adults, respectively, and approximately 110 and 55 times the maximum recommended daily intranasal dose in children, respectively, on a mg/m² basis. Results of various mutagenicity studies (Ames test, mouse dominant 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 (approximately 1,600 times the maximum recommended daily intranasal dose in adults on a mg/m² basis) was unaffected by ipratropium bromide administration. At an oral dose of 500 mg/kg (approximately 16,000 times the maximum recommended daily intranasal dose in adults on a mg/m² basis), ipratropium bromide produced a decrease in the conception rate. Pregnancy Teratogenic Effects: Pregnancy Category B. Oral reproduction studies were performed at doses of 10 mg/kg in mice, 1000 mg/kg in rats and 125 mg/kg in rabbits. These doses correspond, in each species, respectively, to approximately 160, 32,000, and 8,000 times the maximum recommended daily intranasal dose in adults on a mg/m² basis. Inhalation reproduction studies were conducted in rats and rabbits at doses of 1.5 and 1.8 mg/kg, respectively, (approximately 50 and 120 times, respectively, the maximum recommended daily intranasal dose in adults on a mg/m² basis). These studies demonstrated no evidence of teratogenic effects as a result of ipratropium bromide. At oral doses 90 mg/kg and above in rats (approximately 2,900 times the maximum recommended daily intranasal dose in adults on a mg/m² basis) embryotoxicity was observed as increased resorption. This effect is not considered relevant to human use due to the large doses at which it was observed and the difference in route of administration. However, no adequate or well controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, Atrovent® (ipratropium bromide) Nasal Spray 0.03% should be used during pregnancy only if clearly needed. Nursing Mothers It is known that some ipratropium bromide is systemically absorbed following nasal administration; however the portion which may be excreted in human milk is unknown. Although lipid-insoluble quaternary cations pass into breast milk, the minimal systemic absorption makes it unlikely that ipratropium bromide would reach the infant in an amount sufficient to cause a clinical effect. However, because many drugs are excreted in human milk, caution should be exercised when ATROVENT Nasal Spray (ipratropium bromide nasal spray) 0.03% is administered to a nursing mother. Pediatric Use The safety of Atrovent® (ipratropium bromide) Nasal Spray 0.03% at a dose of two sprays (42 mcg) per nostril two or three times daily (total dose 168 to 252 mcg/day) has been demonstrated in 77 pediatric patients 6-12 years of age in placebo-controlled, 4-week trials and in 55 pediatric patients in active-controlled, 6 month trials. The effectiveness of ATROVENT Nasal Spray (ipratropium bromide nasal spray) 0.03% for the treatment of rhinorrhea associated with allergic and nonallergic perennial rhinitis in this pediatric age group is based on an extrapolation of the demonstrated efficacy of ATROVENT Nasal Spray (ipratropium bromide nasal spray) 0.03% in adults with these conditions and the likelihood that the disease course, pathophysiology, and the drug's effects are substantially similar to that of the adults. The recommended dose for the pediatric population is based on within and cross-study comparisons of the efficacy of ATROVENT Nasal Spray 0.03% in adults and pediatric patients and on its safety profile in both adults and pediatric patients. The safety and effectiveness of ATROVENT Nasal Spray 0.03% in patients under 6 years of age have not been established.Last reviewed on RxList: 12/5/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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