Ipratropium Bromide Spray
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Questions & Answers
Side Effects & Adverse Reactions
Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal edema.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Ipratropium bromide nasal solution 0.06% (Nasal Spray) is indicated for the symptomatic relief of rhinorrhea associated with the common cold for adults and children age 5 years and older. Ipratropium bromide nasal solution 0.06% (Nasal Spray) does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis.
The safety and effectiveness of the use of ipratropium bromide nasal solution 0.06% (Nasal Spray) beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.
History
There is currently no drug history available for this drug.
Other Information
The active ingredient in Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is ipratropium bromide 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 (endo,syn)-, (±)-: a synthetic quaternary ammonium compound, chemically related to atropine. Its structural formula is:
ipratropium bromide monohydrate
C20H30BrNO3 • H2O
Mol. Wt. 430.4
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 insoluble in non-polar media.
Ipratropium bromide nasal solution 0.06% (Nasal Spray) is a metered-dose, manual pump spray unit which delivers 42 mcg ipratropium bromide (on an anhydrous basis) per spray (70 μL) 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.
Sources
Ipratropium Bromide Spray Manufacturers
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Physicians Total Care, Inc.
![Ipratropium Bromide Spray, Metered [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ipratropium Bromide Spray | Physicians Total Care, Inc.
For Symptomatic Relief of Rhinorrhea Associated with the Common Cold: The recommended dose of ipratropium bromide nasal solution 0.06% (Nasal Spray) 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 ipratropium bromide nasal solution 0.06% (Nasal Spray) 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 ipratropium bromide nasal solution 0.06% (Nasal Spray) 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 ipratropium bromide nasal solution 0.06% (Nasal Spray) 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 ipratropium bromide nasal solution 0.06% (Nasal Spray) 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.
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Physicians Total Care, Inc.
Ipratropium Bromide Spray | Physicians Total Care, Inc.
The recommended dose of ipratropium bromide nasal solution 0.03% (Nasal Spray) 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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Roxane Laboratories, Inc
Ipratropium Bromide Spray | Roxane Laboratories, Inc
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Roxane Laboratories, Inc
Ipratropium Bromide Spray | Cardinal Health
Instructions for Use/Handling Ondansetron Orally Disintegrating TabletsDo not attempt to push ondansetron orally disintegrating tablets, USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.
Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy
The recommended adult oral dosage of ondansetron hydrochloride is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.
Pediatric Use
There is no experience with the use of a 24 mg dosage in pediatric patients.
Geriatric Use
The dosage recommendation is the same as for the general population.
Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy
The recommended adult oral dosage is one 8-mg ondansetron orally disintegrating tablet, USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron orally disintegrating tablet, USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
Pediatric Use
For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron orally disintegrating tablet, USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron orally disintegrating tablet, USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
Geriatric Use
The dosage is the same as for the general population.
Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen
The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet, USP given 3 times a day.
For total body irradiation
One 8-mg ondansetron orally disintegrating tablet, USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
For single high-dose fraction radiotherapy to the abdomen
One 8-mg ondansetron orally disintegrating tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen
One 8-mg ondansetron orally disintegrating tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
Pediatric Use
There is no experience with the use of, ondansetron orally disintegrating tablets, USP, in the prevention of radiation-induced nausea and vomiting in pediatric patients.
Geriatric Use
The dosage recommendation is the same as for the general population.
Postoperative Nausea and Vomiting
The recommended dosage is 16 mg given as two 8-mg ondansetron orally disintegrating tablets, USP 1 hour before induction of anesthesia.
Pediatric Use
There is no experience with the use of ondansetron orally disintegrating tablets, USP in the prevention of postoperative nausea and vomiting in pediatric patients.
Geriatric Use
The dosage is the same as for the general population.
Dosage Adjustment for Patients With Impaired Renal Function
The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.
Dosage Adjustment for Patients With Impaired Hepatic Function
In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.
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Rebel Distributors Corp
Ipratropium Bromide Spray | Rebel Distributors Corp
For Symptomatic Relief of Rhinorrhea Associated with the Common Cold: The recommended dose of ipratropium bromide nasal solution 0.06% (Nasal Spray) 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 ipratropium bromide nasal solution 0.06% (Nasal Spray) 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 ipratropium bromide nasal solution 0.06% (Nasal Spray) 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 ipratropium bromide nasal solution 0.06% (Nasal Spray) 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 ipratropium bromide nasal solution 0.06% (Nasal Spray) 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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Bausch & Lomb Incorporated
Ipratropium Bromide Spray | Northstar Rx Llc
Valacyclovir tablets may be given without regard to meals. Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from 500 mg valacyclovir tablets for use in pediatric patients for whom a solid dosage form is not appropriate [see Dosage and Administration (2.3)]. 2.1 Adult Dosing RecommendationsCold Sores (Herpes Labialis): The recommended dosage of valacyclovir tablets for treatment of cold sores is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning).
2.2 Pediatric Dosing Recommendations
Genital Herpes: Initial Episode: The recommended dosage of valacyclovir tablets for treatment of initial genital herpes is 1 gram twice daily for 10 days. Therapy was most effective when administered within 48 hours of the onset of signs and symptoms.
Recurrent Episodes: The recommended dosage of valacyclovir tablets for treatment of recurrent genital herpes is 500 mg twice daily for 3 days. Initiate treatment at the first sign or symptom of an episode.
Suppressive Therapy: The recommended dosage of valacyclovir tablets for chronic suppressive therapy of recurrent genital herpes is 1 gram once daily in patients with normal immune function. In patients with a history of 9 or fewer recurrences per year, an alternative dose is 500 mg once daily.
In HIV-infected patients with a CD4+ cell count ≥100 cells/mm3, the recommended dosage of valacyclovir tablets for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.
Reduction of Transmission: The recommended dosage of valacyclovir tablets for reduction of transmission of genital herpes in patients with a history of 9 or fewer recurrences per year is 500 mg once daily for the source partner.
Herpes Zoster: The recommended dosage of valacyclovir tablets for treatment of herpes zoster is 1 gram 3 times daily for 7 days. Therapy should be initiated at the earliest sign or symptom of herpes zoster and is most effective when started within 48 hours of the onset of rash.Cold Sores (Herpes Labialis): The recommended dosage of valacyclovir tablets for the treatment of cold sores in pediatric patients ≥12 years of age is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning).
2.3 Extemporaneous Preparation of Oral Suspension
Chickenpox: The recommended dosage of valacyclovir tablets for treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age is 20 mg/kg administered 3 times daily for 5 days. The total dose should not exceed 1 gram 3 times daily. Therapy should be initiated at the earliest sign or symptom [see Use in Specific Populations (8.4), Clinical Pharmacology (12.3), Clinical Studies (14.4)].Ingredients and Preparation per USP-NF: Valacyclovir tablets 500 mg, cherry flavor, and Suspension Structured Vehicle USP-NF (SSV). Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) should be prepared in lots of 100 mL.
Prepare Suspension at Time of Dispensing as Follows:
Prepare SSV according to the USP-NF. Using a pestle and mortar, grind the required number of valacyclovir 500 mg tablets until a fine powder is produced (5 valacyclovir tablets for 25 mg/mL suspension; 10 valacyclovir tablets for 50 mg/mL suspension). Gradually add approximately 5 mL aliquots of SSV to the mortar and triturate the powder until a paste has been produced. Ensure that the powder has been adequately wetted. Continue to add approximately 5 mL aliquots of SSV to the mortar, mixing thoroughly between additions, until a concentrated suspension is produced, to a minimum total quantity of 20 mL SSV and a maximum total quantity of 40 mL SSV for both the 25 mg/mL and 50 mg/mL suspensions. Transfer the mixture to a suitable 100 mL measuring flask. Transfer the cherry flavor* to the mortar and dissolve in approximately 5 mL of SSV. Once dissolved, add to the measuring flask. Rinse the mortar at least 3 times with approximately 5 mL aliquots of SSV, transferring the rinsing to the measuring flask between additions. Make the suspension to volume (100 mL) with SSV and shake thoroughly to mix. Transfer the suspension to an amber glass medicine bottle with a child-resistant closure. The prepared suspension should be labeled with the following information "Shake well before using. Store suspension between 2° to 8°C (36° to 46°F) in a refrigerator. Discard after 28 days."*The amount of cherry flavor added is as instructed by the suppliers of the cherry flavor.
2.4 Patients With Renal ImpairmentDosage recommendations for adult patients with reduced renal function are provided in Table 1 [see Use in Specific Populations (8.5, 8.6), Clinical Pharmacology (12.3)]. Data are not available for the use of valacyclovir tablets in pediatric patients with a creatinine clearance <50 mL/min/1.73 m2.
Table 1. Valacyclovir Tablets Dosage Recommendations for Adults With Renal Impairment Indications
Normal Dosage
Regimen
(Creatinine
Clearance ≥50 mL/min)
Creatinine Clearance (mL/min)
30-49
10-29
<10
Cold sores (Herpes labialis)
Do not exceed 1 day of treatment. Two 2 gram
doses taken
12 hours apart
Two 1 gram
doses taken
12 hours apart
Two 500 mg
doses taken
12 hours apart
500 mg
single dose
Genital herpes:
Initial episode 1 gram every
12 hours
no reduction
1 gram every
24 hours
500 mg every
24 hours
Genital herpes:
Recurrent episode 500 mg every
12 hours
no reduction
500 mg every
24 hours
500 mg every
24 hours Genital herpes:
Suppressive therapy
Immunocompetent patients
Alternate dose for
immunocompetent
patient with
≤9 recurrences/year
HIV-infected patients
1 gram every
24 hours
500 mg every
24 hours
500 mg every
12 hours
no reduction
no reduction
no reduction
500 mg every
24 hours
500 mg every
48 hours
500 mg every
24 hours
500 mg every
24 hours
500 mg every
48 hours
500 mg every
24 hours
Herpes zoster 1 gram every
8 hours
1 gram every
12 hours
1 gram every
24 hours
500 mg every
24 hours
Hemodialysis: Patients requiring hemodialysis should receive the recommended dose of valacyclovir tablets after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir tablets is approximately 4 hours. About one third of acyclovir in the body is removed by dialysis during a 4-hour hemodialysis session.
Peritoneal Dialysis: There is no information specific to administration of valacyclovir tablets in patients receiving peritoneal dialysis. The effect of chronic ambulatory peritoneal dialysis (CAPD) and continuous arteriovenous hemofiltration/dialysis (CAVHD) on acyclovir pharmacokinetics has been studied. The removal of acyclovir after CAPD and CAVHD is less pronounced than with hemodialysis, and the pharmacokinetic parameters closely resemble those observed in patients with end-stage renal disease (ESRD) not receiving hemodialysis. Therefore, supplemental doses of valacyclovir tablets should not be required following CAPD or CAVHD. -
Bausch & Lomb Incorporated
Ipratropium Bromide Spray | Woonsocket Prescription Center,incorporated
take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 times in 24 hours
adults and children
1 to 2 tablets children 6 to under
12 years of age and over
12 years
1 tablet children under 6 years do not use -
Remedyrepack Inc.
Ipratropium Bromide Spray | Remedyrepack Inc.
For Symptomatic Relief of Rhinorrhea Associated with the Common Cold:
The recommended dose of ipratropium bromide nasal solution 0.06% (Nasal Spray) 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 ipratropium bromide nasal solution 0.06% (Nasal Spray) 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 ipratropium bromide nasal solution 0.06% (Nasal Spray) 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 ipratropium bromide nasal solution 0.06% (Nasal Spray) 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 ipratropium bromide nasal solution 0.06% (Nasal Spray) 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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Remedyrepack Inc.
Ipratropium Bromide Spray | Remedyrepack Inc.
The recommended dose of Ipratropium Bromide 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 Ipratropium Bromide Nasal Spray 0.06% for children age 5 to 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 Ipratropium Bromide Nasal Spray 0.06% beyond four days in patients with the common cold have not been established.
The recommended dose of Ipratropium Bromide 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 Ipratropium Bromide 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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Remedyrepack Inc.
Ipratropium Bromide Spray | Remedyrepack Inc.
The recommended dose of Ipratropium Bromide 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 Ipratropium Bromide Nasal Spray 0.06% for children age 5 to 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 Ipratropium Bromide Nasal Spray 0.06% beyond four days in patients with the common cold have not been established.
The recommended dose of Ipratropium Bromide 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 Ipratropium Bromide 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.
![Ipratropium Bromide Spray, Metered [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=78f71505-6e1f-4d74-bfb6-faf4e3a4864e&name=packagelabel.jpg)
![Ipratropium Bromide Spray [Roxane Laboratories, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=05c56190-e346-4674-a4f8-049ce632ce2d&name=e39e571b-47a1-48d1-853c-c51acb6af663-06.jpg)
![Ipratropium Bromide Spray [Roxane Laboratories, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7eed9b3a-207f-49ca-83cd-8172357363d3&name=image-01.jpg)
![Ipratropium Bromide Spray, Metered [Rebel Distributors Corp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=09ab5bc2-645f-415d-ad76-246385690176&name=09ab5bc2-645f-415d-ad76-246385690176-06.jpg)
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![Ipratropium Bromide Spray [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8f48dde9-753a-439a-8684-a7c25acd0b91&name=MM6.jpg)
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