Kroger Nitetime Flu Plus Severe Cold And Cough
Loading...Kroger Nitetime Flu Plus Severe Cold And Cough Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
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
PROAIR RESPICLICK (albuterol sulfate) inhalation powder is indicated for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease.
PROAIR RESPICLICK is indicated for the prevention of exercise-induced bronchospasm in patients 12 years of age and older.
History
There is currently no drug history available for this drug.
Other Information
The active ingredient of PROAIR RESPICLICK inhalation powder is albuterol sulfate, a racemic salt of albuterol. Albuterol sulfate is a beta2-adrenergic agonist. It has the chemical name α1-[(tert-butylamino) methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt), and the following chemical structure:
The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C13H21NO3)2•H2SO4. Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official U.S. Adopted Name in the United States, and salbutamol sulfate is the recommended World Health Organization international nonproprietary name.
PROAIR RESPICLICK is an inhalation-driven, multi-dose inhalation powder (dry powder inhaler) for oral inhalation only. It contains a formulation blend of albuterol sulfate with alpha-lactose monohydrate. Each actuation provides a metered dose of 2.6 mg of the formulation containing 117 mcg of albuterol sulfate (equivalent to 97 mcg of albuterol base) and lactose from the device reservoir. Under standardized in vitro test conditions with fixed flow rates ranging from 58 to 71 L/min, and with a total air volume of 2 L, the PROAIR RESPICLICK inhaler delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) with lactose from the mouthpiece. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. In a study that investigated the peak inspiratory flow rate (PIFR) in asthma (n=27, ages 12 to 17 years old and n=50, ages 18 to 45 years old) and COPD (n=50, over 50 years old) patients, the mean PIFR achieved by subjects was >60 L/min (range = 31 to 110 L/min.), indicating that patients would be able to achieve the required inspiratory flow to operate the MDPI device correctly. The inhaler is provided for 200 actuations (inhalations).
Sources
Kroger Nitetime Flu Plus Severe Cold And Cough Manufacturers
-
Kroger Company
![Kroger Nitetime Flu Plus Severe Cold And Cough (Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride) Powder, For Solution [Kroger Company]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Kroger Nitetime Flu Plus Severe Cold And Cough | Teva Respiratory, Llc
2.1 BronchospasmFor treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the recommended dosage for adults and adolescents 12 years and older is 2 inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, 1 inhalation every 4 hours may be sufficient.
2.2 Exercise-Induced BronchospasmFor prevention of exercise-induced bronchospasm, the recommended dosage for adults and adolescents 12 years of age or older is 2 inhalations 15 to 30 minutes before exercise.
2.3 Administration InformationAdminister PROAIR RESPICLICK by oral inhalation only.
Priming:PROAIR RESPICLICK inhaler does not require priming.
Do not use PROAIR RESPICLICK with a spacer or volume holding chamber.
Cleaning:
• Keep the inhaler clean and dry at all times. Never wash or put any part of your inhaler in water. • Routine maintenance is not required. If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed.Dose Counter: The PROAIR RESPICLICK inhaler has a dose counter attached to the actuator. When the patient receives the inhaler, the number 200 will be displayed. The dose counter will count down each time the inhaler is actuated. When the dose counter reaches 20, the color of the numbers will change to red to remind the patient to contact their pharmacist for a refill of medication or consult their physician for a prescription refill. When the dose counter reaches 0, the background will change to solid red. Discard PROAIR RESPICLICK 13 months after opening the foil pouch, when the dose counter displays 0 or after the expiration date on the product, whichever comes first [see Patient Counseling Information (17.8)].
Login To Your Free Account