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Albuterol Sulfate - Hfa (Ventolin)

Trade Name : VENTOLIN

GlaxoSmithKline LLC

AEROSOL, METERED

Strength 90 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 - Hfa (Ventolin) which is also known as VENTOLIN and Manufactured by GlaxoSmithKline LLC. It is available in strength of 90 ug/1 per ml. Read more

Albuterol Sulfate - Hfa (Ventolin) 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

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • VENTOLIN HFA is a beta-adrenergic agonist indicated for:
  • No data
  • Inhalation aerosol: Blue plastic inhaler with a blue strapcap containing a pressurized metered-dose aerosol canister containing 60 or 200 metered inhalations and fitted with a counter. Each actuation delivers 108 mcg of albuterol sulfate (90 mcg of albuterol base) from the mouthpiece.
  • Inhalation aerosol: Inhaler containing 108 mcg albuterol sulfate (90 mcg albuterol base) as an aerosol formulation for oral inhalation. ()
  • VENTOLIN HFA is contraindicated in patients with a history of hypersensitivity to any of the ingredients .
  • Hypersensitivity to any ingredient. ()
  • No data
  • 5.4n- 5.7
  • 5.7n- 5.8
  • Use of VENTOLIN HFA may be associated with the following:
  • Most common adverse reactions (incidence u22653%) are throat irritation, viral respiratory infections, upper respiratory inflammation, cough, and musculoskeletal pain. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Other short-acting sympathomimetic aerosol bronchodilators should not be used concomitantly with albuterol. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.
  • No data
  • The expected signs and symptoms with overdosage of albuterol are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms of beta-adrenergic stimulation (e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200u00a0beats/min, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, metabolic acidosis).
  • As with all inhaled sympathomimetic medicines, cardiac arrest and even death may be associated with an overdose of VENTOLIN HFA Inhalation Aerosol.
  • Treatment consists of discontinuation of VENTOLIN HFA 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 VENTOLIN HFA.
  • The active component of VENTOLIN HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta-adrenergic bronchodilator. Albuterol sulfate has the chemical name u03b1-[(-butylamino)methyl]-4-hydroxy--xylene-u03b1, u03b1u2032-diol sulfate (2:1)(salt) and the following chemical structure:
  • Albuterol sulfate is a white crystalline powder with a molecular weight of 576.7, and the empirical formula is (CHNO)u2022HSO. It is soluble in water and slightly soluble in ethanol.
  • The World Health Organization recommended name for albuterol base is salbutamol.
  • VENTOLIN HFA is a blue plastic inhaler with a blue strapcap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients.
  • After priming, each actuation of the inhaler delivers 120u00a0mcg of albuterol sulfate, USP in 75u00a0mg of suspension from the valve and 108u00a0mcg of albuterol sulfate, USP from the mouthpiece (equivalent to 90u00a0mcg of albuterol base from the mouthpiece).
  • Prime VENTOLIN HFA before using for the first time, when the inhaler has not been used for more than 2u00a0weeks, or when the inhaler has been dropped. To prime VENTOLIN HFA, release 4 sprays into the air away from the face, shaking well before each spray.
  • No data
  • No data
  • No data
  • VENTOLIN HFA Inhalation Aerosol is supplied in the following boxes of 1 as a pressurized aluminum canister fitted with a counter and supplied with a blue plastic actuator with a blue strapcap:
  • NDC 0173-0682-20u00a0u00a0u00a0u00a0u00a018-g canister containing 200 actuations
  • NDC 0173-0682-24u00a0u00a0u00a0u00a0u00a08-g canister containing 60 actuations
  • Each inhaler is sealed in a moisture-protective foil pouch with a desiccant that should be discarded when the pouch is opened. Each inhaler is packaged with a Patient Information leaflet.
  • The blue actuator supplied with VENTOLIN HFA should not be used with any other product canisters, and actuators from other products should not be used with a VENTOLIN HFA canister.
  • VENTOLIN HFA has a counter attached to the canister. The counter starts at 204 or 64 and counts down each time a spray is released. The correct amount of medication in each actuation cannot be assured after the counter reads 000, even though the canister is not completely empty and will continue to operate. The inhaler should be discarded when the counter reads 000 or 12 months after removal from the moisture-protective foil pouch, whichever comes first.
  • Keep out of reach of children. Avoid spraying in eyes.
  • Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120u00b0F may cause bursting. Never throw canister into fire or incinerator.
  • Store at room temperature between 68u00b0F and 77u00b0F (20u00b0C and 25u00b0C); excursions permitted from 59u00b0F to 86u00b0F (15u00b0C to 30u00b0C) [See USP Controlled Room Temperature]. Store the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use. SHAKE WELL BEFORE EACH SPRAY.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Frequency of Use
  • Inform patients that the action of VENTOLIN HFA should last up to 4 to 6u00a0hours. Do not use VENTOLIN HFA more frequently than recommended. Instruct patients not to increase the dose or frequency of doses of VENTOLIN HFA without consulting the physician. Instruct patients to seek medical attention immediately if treatment with VENTOLIN HFA becomes less effective for symptomatic relief, symptoms become worse, and/or they need to use the product more frequently than usual.
  • Priming
  • Instruct patients to prime VENTOLIN HFA before using for the first time, when the inhaler has not been used for more than 2u00a0weeks, or when the inhaler has been dropped. To prime VENTOLIN HFA, release 4 sprays into the air away from the face, shaking well before each spray.
  • Cleaning
  • To ensure proper dosing and to prevent actuator orifice blockage, instruct patients to wash the actuator with warm water and let it air-dry completely at least once a week. Inform patients that detailed cleaning instructions are included in the Patient Information leaflet.
  • Paradoxical Bronchospasm
  • Inform patients that VENTOLIN HFA can produce paradoxical bronchospasm. Instruct them to discontinue VENTOLIN HFA if paradoxical bronchospasm occurs.
  • Concomitant Drug Use
  • Advise patients that while they are using VENTOLIN HFA, other inhaled drugs and asthma medications should be taken only as directed by the physician.
  • Common Adverse Effects
  • Common adverse effects of treatment with inhaled albuterol include palpitations, chest pain, rapid heart rate, tremor, and nervousness.
  • Pregnancy Exposure Registry
  • Inform women there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications, including VENTOLIN HFA, during pregnancy and that they can enroll in the Pregnancy Exposure Registry by calling 1-877-311-8972 or by visiting https://mothertobaby.org/ongoing-study/asthma .
  • VENTOLIN is owned by or licensed to the GSK group of companies.
  • The other brands listed are trademarks owned by or licensed to their respective owners and are not owned by or licensed to the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • u00a92019 GSK group of companies or its licensor.
  • VNT:11PI
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0This Patient Information has been approved by the U.S. Food and Drug Administrationu00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised: December 2019
  • u00a0u00a0u00a0u00a0u00a0u00a0This Instructions for Use has been approved by the U.S. Food and Drug Administrationu00a0u00a0u00a0u00a0u00a0u00a0Revised: December 2019
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0682-20
  • Arrayn- Ventolin HFA
  • Arrayn- (albuterol sulfate)
  • Arrayn- Inhalation Aerosol
  • Arrayn- 90 mcg per actuation
  • Arrayn- 200 Metered Inhalations
  • FOR ORAL INHALATION ONLY
  • For use with Ventolin HFA actuator only.
  • Discard when the counter reads 000 or 12 months after removal from the moisture-protective foil pouch.
  • Pouch opened: ____ Use by: ____
  • Arrayn- Net Wt. 18 g
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • Made in United Kingdom
  • R only
  • Contents:
  • Important:
  • WARNING: Do not exceed the dose prescribed by your doctor.
  • If difficulty in breathing persists, get immediate medical help.
  • Contents Under Pressure:
  • Shake the inhaler well before each spray.
  • Store at room temperature between 68F and 77F (20C and 25C). with the mouthpiece down.

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