Drug: Atrovent Nasal Spray .06

The active ingredient in ATROVENT Nasal Spray is ipratropium bromide (as the monohydrate). It is an anticholinergic agent chemically described as 8-azoniabicyclo[3.2.1] octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide monohydrate, (3-endo, 8-syn)-: a synthetic quaternary ammonium compound, chemically related to atropine. The structural formula is: C20H30BrNO3•H2O ipratropium bromide Mol. Wt. 430.4 Ipratropium bromide is a white to off-white crystalline substance, freely soluble in water and methanol, sparingly soluble in ethanol, and insoluble in non-polar media. In aqueous solution, it exists in an ionized state as a quaternary ammonium compound. ATROVENT Nasal Spray 0.06% is a metered-dose, manual pump spray unit which delivers 42 mcg ipratropium bromide (on an anhydrous basis) per spray (70μL) 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 165 sprays.

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Adverse reaction information on ATROVENT Nasal Spray 0.06% in patients with the common cold was derived from two multicenter, vehicle-controlled clinical trials involving 1,276 patients (195 patients on ATROVENT Nasal Spray 0.03%, 352 patients on ATROVENT Nasal Spray 0.06%, 189 patients on ATROVENT Nasal Spray 0.12%, 351 patients on vehicle and 189 patients receiving no treatment). Table 1 shows adverse events reported for patients who received ATROVENT Nasal Spray 0.06% at the recommended dose of 84 mcg per nostril, or vehicle, administered three or four times daily, where the incidence is 1% or greater in the ATROVENT group and higher in the ATROVENT group than in the vehicle group. Table 1 - % of Patients with Common Cold Reporting Events1
  Atrovent®
(ipratropium bromide)
Nasal Spray
0.06% Vehicle Control No. of Patients 352 351 Epistaxis2 8.2% 2.3% Nasal Dryness 4.8% 2.8% Dry Mouth/Throat 1.4% 0.3% Nasal Congestion 1.1% 0.0% 1This table includes adverse events for which the incidence was 1% or greater in the ATROVENT group and higher in the ATROVENT group than in the vehicle group.
2Epistaxis reported by 5.4% of ATROVENT patients and 1.4% of vehicle patients, blood-tinged nasal mucus by 2.8% of ATROVENT patients and 0.9% of vehicle patients. ATROVENT Nasal Spray 0.06% was well tolerated by most patients. The most frequently reported adverse events were transient episodes of nasal dryness or epistaxis. The majority of these adverse events (96%) were mild or moderate in nature, none was considered serious, and none resulted in hospitalization. No patient required treatment for nasal dryness, and only three patients ( < 1%) required treatment for epistaxis, which consisted of local application of pressure or a moisturizing agent (e.g., petroleum jelly). No patient receiving ATROVENT Nasal Spray 0.06% was discontinued from the trial due to either nasal dryness or bleeding. Adverse events reported by less than 1% of the patients receiving ATROVENT Nasal Spray 0.06% during the controlled clinical trials that are potentially related to ATROVENT's local effects or systemic anticholinergic effects include: taste perversion, nasal burning, conjunctivitis, coughing, dizziness, hoarseness, palpitation, pharyngitis, tachycardia, thirst, tinnitus, and blurred vision. No controlled trial was conducted to address the relative incidence of adverse events for three times daily versus four times daily therapy. Nasal adverse events seen in the clinical trial with seasonal allergic rhinitis (SAR) patients (see Table 2) were similar to those seen in the common cold trials. Additional events were reported at a higher rate in the SAR trial due in part to the longer duration of the trial and the inclusion of Upper Respiratory Tract Infection (URI) as an adverse event. In common cold trials, URI was the disease under study and not an adverse event. Table 2 - % of Patients with SAR Reporting Events1
  Atrovent®
(ipratropium bromide)
Nasal Spray
0.06% Vehicle Control No. of Patients 218 211 Epistaxis2 6.0% 3.3% Pharyngitis 5.0% 3.8% URI 5.0% 3.3% Nasal Dryness 4.6% 0.9% Headache 4.1% 0.5% Dry Mouth/Throat 4.1% 0.0% Taste Perversion 3.7% 1.4% Sinusitis 2.8% 2.8% Pain 1.8% 0.9% Diarrhea 1.8% 0.5% 1This table includes adverse events for which the incidence was 1% or greater in the ATROVENT group and higher in the ATROVENT group than in the vehicle group.
2Epistaxis reported by 3.7% of ATROVENT patients and 2.4% of vehicle patients, blood-tinged nasal mucus by 2.3% of ATROVENT patients and 1.9% of vehicle patients. There were no reports of allergic-type reactions in the controlled clinical common cold and SAR trials. 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 Nasal Spray 0.06% 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, ocular irritation, wheezing, dryness of the oropharynx, tachycardia, 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 .06 (ipratropium bromide nasal spray .06) Side Effects Center for a complete guide to possible side effectsLearn More »

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For Symptomatic Relief of Rhinorrhea Associated with the Common Cold The recommended dose of ATROVENT Nasal Spray 0.06% is two sprays (84 mcg) per nostril three or four times daily (total dose 504 to 672 mcg/day) in adults and children age 12 years and older. Optimum dosage varies with response of the individual patient. The recommended dose of ATROVENT Nasal Spray 0.06% for children age 5-11 years is two sprays (84 mcg) per nostril three times daily (total dose of 504 mcg/day). The safety and effectiveness of the use of ATROVENT Nasal Spray 0.06% beyond four days in patients with the common cold have not been established. For Symptomatic Relief of Rhinorrhea Associated with Seasonal Allergic Rhinitis The recommended dose of ATROVENT Nasal Spray 0.06% is two sprays (84 mcg) per nostril four times daily (total dose 672 mcg/day) in adults and children age 5 years and older. The safety and effectiveness of the use of ATROVENT Nasal Spray 0.06% beyond three weeks in patients with seasonal allergic rhinitis have not been established. 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 0.06% is minimally absorbed into the systemic circulation; nonetheless, there is some potential for an additive interaction with other concomitantly administered medications with anticholinergic properties, including ATROVENT for oral inhalation. 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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ATROVENT Nasal Spray 0.06% is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. ATROVENT Nasal Spray 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. The safety and effectiveness of the use of Atrovent® (ipratropium bromide) Nasal Spray 0.06% beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.

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ATROVENT Nasal Spray 0.06% 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 two bottles of Atrovent® (ipratropium bromide) Nasal Spray 0.06%) 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 6,000 and 2,900 times the maximum recommended daily intranasal dose in adults and children, respectively, on a mg/m² basis), 1,663 mg/kg in rats (approximately 20,000 and 9,500 times the maximum recommended daily intranasal dose in adults and children, respectively, on a mg/m² basis) and 400 mg/kg in dogs (approximately 16,000 and 7,600 times the maximum recommended daily intranasal dose in adults and children, respectively, on a mg/m² basis).

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ATROVENT Nasal Spray 0.06% 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 16.6 g of product formulation, 165 sprays, each delivering 42 mcg of ipratropium bromide per spray (70 μL), or 10 days of therapy at the maximum recommended dose (two sprays per nostril four times a day) (NDC 0597-0086-76). 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: April 2008. FDA rev date: 10/14/2008 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

General
  1. Effects Seen with Anticholinergic Drugs: ATROVENT Nasal Spray 0.06% 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 0.06% 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 0.06% comes into direct contact with the eyes. Patients should be instructed to avoid spraying ATROVENT Nasal Spray 0.06% 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 70 and 35 times the maximum recommended daily intranasal dose in adults, respectively, and approximately 35 and 15 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 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 6,000 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, 1,000 mg/kg in rats and 125 mg/kg in rabbits. These doses correspond, in each species respectively, to approximately 60, 12,000, and 3,000 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 20 and 45 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 1,100 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 0.06% 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 0.06% is administered to a nursing mother. Pediatric Use The safety of Atrovent® (ipratropium bromide) Nasal Spray 0.06% at a dose of two sprays (84 mcg) per nostril three times a day (total dose 504 mcg/day) for two to four days has been demonstrated in two clinical trials involving 362 pediatric patients 5-11 years of age with naturally acquired common colds. In this pediatric population ATROVENT Nasal Spray 0.06% had an adverse event profile similar to that observed in adolescent and adult patients. When ATROVENT Nasal Spray 0.06% was concomitantly administered with an oral decongestant (pseudoephedrine HCl) in 122 children ages 5-12 years, and concomitantly administered with an oral decongestant/antihistamine combination (pseudoephedrine HCl/chlorpheniramine maleate) in 123 children ages 5-12 years, adverse event profiles were similar to ATROVENT Nasal Spray 0.06% alone. The safety of ATROVENT Nasal Spray 0.06% at a dose of two sprays (84 mcg) per nostril four times a day (total dose 672 mcg/day) for three weeks in pediatric seasonal allergic rhinitis patients down to 5 years is based upon the safety demonstrated in the pediatric common cold trials and the trial in adult and adolescent patients 12 to 75 years of age with seasonal allergic rhinitis. The effectiveness of ATROVENT Nasal Spray 0.06% for the treatment of rhinorrhea associated with the common cold and seasonal allergic rhinitis in this pediatric age group is based on extrapolation of the demonstrated efficacy of ATROVENT Nasal Spray 0.06% in adolescents and adults with the conditions and the likelihood that the disease course, pathophysiology, and the drug's effects are substantially similar to that of adults. The recommended dose for common cold for the pediatric population is based on cross-study comparisons of the efficacy of ATROVENT Nasal Spray 0.06% in adult and pediatric patients and on its safety profile in both adults and pediatric common cold patients. The recommended dose for seasonal allergic rhinitis for the pediatric population down to 5 years is based upon the efficacy and safety of ATROVENT Nasal Spray 0.06% in adults and adolescents 12 years of age and above with seasonal allergic rhinitis and the safety profile of this dose in both adult and pediatric common cold patients. The safety and effectiveness of ATROVENT Nasal Spray 0.06% in pediatric patients under 5 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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