Albuterol Sulfate (Albuterol Sulfate)

Trade Name : Albuterol Sulfate

Par Pharmaceutical Inc.

AEROSOL, METERED

Strength 108 ug/1

ALBUTEROL SULFATE Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Albuterol Sulfate (Albuterol Sulfate) which is also known as Albuterol Sulfate and Manufactured by Par Pharmaceutical Inc.. It is available in strength of 108 ug/1 per ml. Read more

Albuterol Sulfate (Albuterol Sulfate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

FOR ORAL INHALATION ONLY
Prescribing Information

The active component of Albuterol Sulfate Inhalation Aerosol is albuterol sulfate, USP racemic u03b1 [(Butylamino)methyl]-4-hydroxy--xylene-u03b1,u03b1'-diol sulfate (2:1)(salt), a relatively selective beta-adrenergic bronchodilator having the following chemical structure:
Albuterol sulfate is the official generic name in the United States. The World Health Organization recommended name for the drug is salbutamol sulfate. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (CHNO)u2022HSO. Albuterol sulfate is a white to off-white crystalline solid. It is soluble in water and slightly soluble in ethanol. Albuterol Sulfate Inhalation Aerosol is a pressurized metered-dose aerosol unit for oral inhalation. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane), ethanol, and oleic acid.
Each actuation delivers 120 mcg albuterol sulfate, USP from the valve and 108 mcg albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Each canister provides 200 inhalations. It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four u201ctest spraysu201d into the air, away from the face.
This product does not contain chlorofluorocarbons (CFCs) as the propellant.

No data

Albuterol Sulfate Inhalation Aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.n

Albuterol Sulfate Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any other Albuterol Sulfate Inhalation Aerosol components.n

No data

No data

Adverse reaction information concerning Albuterol Sulfate Inhalation Aerosol is derived from a 12-week, double-blind, double-dummy study which compared Albuterol Sulfate Inhalation Aerosol, a CFC 11/12 propelled albuterol inhaler, and an HFA-134a placebo inhaler in 565 asthmatic patients. The following table lists the incidence of all adverse events (whether considered by the investigator drug related or unrelated to drug) from this study which occurred at a rate of 3% or greater in the Albuterol Sulfate Inhalation Aerosol treatment group and more frequently in the Albuterol Sulfate Inhalation Aerosol treatment group than in the placebo group. Overall, the incidence and nature of the adverse reactions reported for Albuterol Sulfate Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler were comparable.
Adverse events reported by less than 3% of the patients receiving Albuterol Sulfate Inhalation Aerosol, and by a greater proportion of Albuterol Sulfate Inhalation Aerosol patients than placebo patients, which have the potential to be related to Albuterol Sulfate Inhalation Aerosol include: dysphonia, increased sweating, dry mouth, chest pain, edema, rigors, ataxia, leg cramps, hyperkinesia, eructation, flatulence, tinnitus, diabetes mellitus, anxiety, depression, somnolence, rash. Palpitation and dizziness have also been observed with Albuterol Sulfate Inhalation Aerosol.
Adverse events reported in a 4-week pediatric clinical trial comparing Albuterol Sulfate Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler occurred at a low incidence rate and were similar to those seen in the adult trials.
In small, cumulative dose studies, tremor, nervousness, and headache appeared to be dose related.
Rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema have been reported after the use of inhaled albuterol. In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, insomnia, headache, metabolic acidosis, and drying or irritation of the oropharynx.

The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under , e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia.n
Hypokalemia may also occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of Albuterol Sulfate Inhalation Aerosol. Treatment consists of discontinuation of Albuterol Sulfate Inhalation Aerosol together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Albuterol Sulfate Inhalation Aerosol.n
The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 6800 times the maximum recommended daily inhalation dose for adults on a mg/m basis and approximately 3200 times the maximum recommended daily inhalation dose for children on a mg/m basis). In mature rats, the subcutaneous median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 3000 times the maximum recommended daily inhalation dose for adults on a mg/m basis and approximately 1400 times the maximum recommended daily inhalation dose for children on a mg/m basis). In young rats, the subcutaneous median lethal dose is approximately 2000 mg/kg (approximately 14,000 times the maximum recommended daily inhalation dose for adults on a mg/m basis and approximately 6400 times the maximum recommended daily inhalation dose for children on a mg/m basis). The inhalation median lethal dose has not been determined in animals.n

For treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, the usual dosage for adults and children 4 years of age and older is two inhalations repeated every 4 to 6u00a0hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient. Each actuation of Albuterol Sulfate Inhalation Aerosol delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) from the mouthpiece. It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four u201ctest spraysu201d into the air, away from the face.n
Exercise Induced Bronchospasm Prevention:
To maintain proper use of this product, it is important that the mouthpiece be washed and dried thoroughly at least once a week. The inhaler may cease to deliver medication if not properly cleaned and dried thoroughly (see section). Keeping the plastic mouthpiece clean is very important to prevent medication buildup and blockage. The inhaler may cease to deliver medication if not properly cleaned and air dried thoroughly. If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage.n
If a previously effective dose regimen fails to provide the usual response, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.n

Albuterol Sulfate Inhalation Aerosol is supplied as a pressurized aluminum canister, with an attached dose indicator, a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations (NDC 0254-1007-52).
Rx only. Store between 15u00b0-25u00b0C (59u00b0-77u00b0F). Store the inhaler with the mouthpiece down. For best results, canister should be at room temperature before use.
SHAKE WELL BEFORE USING.
The yellow actuator supplied with Albuterol Sulfate Inhalation Aerosol should not be used with any other product canisters, and actuator from other products should not be used with a Albuterol Sulfate Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations and when the dose indicator display window shows zero, even though the canister is not completely empty the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.
WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120u00b0F may cause bursting. Keep out of reach of children.
Albuterol Sulfate Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.
u00a0 u00a0 u00a0 u00a0 Manufactured for:u00a0 u00a0 u00a0 u00a0 Par Pharmaceuticalu00a0 u00a0 u00a0 u00a0 Chestnut Ridge, NY 10977, U.S.A.
u00a0 u00a0 u00a0 u00a0 Developed and Manufactured by:u00a0 u00a0 u00a0 u00a0 3M Health Care Limitedu00a0 u00a0 u00a0 u00a0 Loughborough UK
u00a0 u00a0 u00a0 u00a0 or
u00a0 u00a0 u00a0 u00a0 3M Drug Delivery Systemsu00a0 u00a0 u00a0 u00a0 Northridge, CA 91324, USA

INSTRUCTIONS FOR USEAlbuterol SulfateInhalation Aerosol with Dose Indicator
Read this Instructions for Use before you start using Albuterol Sulfate Inhalation Aerosol and eachtime you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment. Your doctor should show you how your child should use Albuterol Sulfate Inhalation Aerosol.
Important Information:
Albuterol Sulfate Inhalation Aerosol comes as a canister with a dose indicator. The dose indicator is located on the top of the canister that fits into an actuator (See ). The dose indicator display window will show you how many puffs of medicine you have left. A puff of medicine is released each time you press the center of the dose indicator.
Figure A
Before you use Albuterol Sulfate Inhalation Aerosol for the first timen- (See )
Each canister of Albuterol Sulfate Inhalation Aerosol contains 200 puffs of medicine. This does not include the sprays of medicine used for priming your inhaler.
Figure B
Before using your Albuterol Sulfate Inhalation Aerosol for the first time, you should prime your inhaler.n- 2 weeks
Using your Albuterol Sulfate Inhalation Aerosol inhaler:
Step 1: Shake the inhaler well before each use.n- See n
Figure C
Step 2:n- See n
Figure D
Step 3:n- See n
Step 4:
Step 5: If your doctor has prescribed additional puffs of Albuterol Sulfate Inhalation Aerosoln- Repeat steps 3 through 5n- u201cu201d.
Step 6:
Cleaning your Albuterol Sulfate Inhalation Aerosol inhaler:
It is very important that you keep the mouthpiece clean so that medicine will not build up and block the spray through the mouthpiece. or if your mouthpiece becomes blocked ().
Step 1:n- Do not clean the metal canister or let it get wet.
Step 2:n- See n
Figure E
Step 3
Step 4:n- See n n- u201cu201d.
Figure F
Step 5:n- Figure Gn- Do not
Figure G
Step 6:
Note: If you need to use your Albuterol Sulfate Inhalation Aerosol inhaler before it is completely dry,n- 2 spraysn- u201cu201d.
How should I store Albuterol Sulfate Inhalation Aerosol?
Manufactured for:Par PharmaceuticalChestnut Ridge, NY 10977, U.S.A.
Developed and Manufactured by:n- 3M Health Care Limitedn- Loughborough UK
or
3M Drug Delivery Systemsn- Northridge, CA 91324, USA
Copyright u00a9 1996, 2011, 2012, 2017, 2018Par PharmaceuticalAll rights reserved.This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Principal Display Panel u2013 Canister
NDC 0254--52
Albuterol SulfateInhalation Aerosol HFAWith Dose Indicator
FOR ORAL INHALATION WITHPAR PHARMACEUTICALALBUTEROL SULFATE INHALATIONAEROSOL HFA ACTUATOR ONLY
Rx only
200 METERED INHALATIONSNET CONTENTS 6.7G

Principal Display Panel u2013 Carton
NDC 0254--52
Albuterol SulfateInhalation Aerosol HFAWith Dose Indicator
FOR ORAL INHALATION WITHPAR PHARMACEUTICALALBUTEROL SULFATE INHALATIONAEROSOL HFA ACTUATOR ONLY
Rx only
200 METEREDINHALATIONSNET CONTENTS 6.7G
CONTAINS NOCHLOROFLUOROCARBONS (CFCs)
PARPharmaceutical

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Albuterol Sulfate (Albuterol Sulfate)

Trade Name : Albuterol Sulfate

AEROSOL, METERED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Albuterol Sulfate (Albuterol Sulfate)

Trade Name : Albuterol Sulfate

AEROSOL, METERED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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