Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)
Ritedose Pharmaceuticals, LLC
ALBUTEROL SULFATE
ALBUTEROL 2.5 mg in 3 mL
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm. Albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to any of its components. Albuterol Sulfate Inhalation Solution 0.083% 3 Note: This is a unit-dose vial. No dilution is required. Read complete instructions carefully before using. - Remove the vial from the foil pouch. - Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir (Figure 1). - Connect the nebulizer reservoir to the mouthpiece or face mask (Figure 2). - Connect the nebulizer to the compressor. - Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 3) (or put on the face mask); and turn on the compressor. - Breathe as calmly, deeply and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 15 minutes). At this point, the treatment is finished. - Clean the nebulizer (see manufacturer's instructions). Note: Use only as directed by your physician. More frequent administration or higher doses are not recommended . Store Albuterol Sulfate Inhalation Solution 0.083% 3 between 2° and 25° C (36° and 77° F). Store in pouch until time of use. ADDITIONAL INSTRUCTIONS: Manufactured by: The Ritedose Corporation Columbia, SC 29203 for Ritedose Pharmaceuticals, LLC Columbia, SC 29203 To report SUSPECTED ADVERSE REACTIONS, contact Ritedose Pharmaceuticals, LLC at 1-855-806-3300 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch RPIN0052 March 2014
Unit-dose plastic vial containing Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3 mL 2. Equivalent to 0.5 mL albuterol (as the sulfate) 0.5% (2.5 mg albuterol) diluted to 3 mL. Supplied in cartons as listed below. NDC 76204-200-25 25 vials per carton / 25 vials per foil pouch NDC 76204-200-30 30 vials per carton / 30 vials per foil pouch NDC 76204-200-01 30 vials per carton / 1 vial per foil pouch NDC 76204-200-60 60 vials per carton / 30 vials per foil pouch PROTECT FROM LIGHT. Store in pouch until time of use. Store between 2° and 25° C (36° and 77° F). Rx only.
Abbreviated New Drug Application
ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION RITEDOSE PHARMACEUTICALS, LLC ---------- ALBUTEROL SULFATE INHALATION SOLUTION, 0.083% 2.5 MG/3 ML (RDP) ALBUTEROL SULFATE INHALATION SOLUTION 0.083% 1 PRESCRIBING INFORMATION FOR INHALATION USE ONLY-NOT FOR INJECTION DESCRIPTION Albuterol sulfate inhalation solution is a relatively selective beta -adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic form of albuterol, has the chemical name α -[( _tert_-Butylamino)methyl]-4- hydroxy- _m_-xylene-α,α'-diol sulfate (2:1) (salt), and the following structural formula: Albuterol sulfate has a molecular weight of 576.70 and the molecular formula (C H NO ) • H SO . Albuterol sulfate is a white or practically white powder, freely soluble in water and slightly soluble in alcohol. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol sulfate inhalation solution 0.083% requires no dilution before administration. Each milliliter of albuterol sulfate inhalation solution 0.083% contains 0.83 mg of albuterol (as 1 mg of albuterol sulfate) in an isotonic, sterile, aqueous solution containing sodium chloride; sulfuric acid is used to adjust the pH to between 3 and 5. Albuterol sulfate inhalation solution 0.083% contains no sulfiting agents or preservatives. Albuterol sulfate inhalation solution is a clear, colorless to light yellow solution. CLINICAL PHARMACOLOGY The prime action of beta-adrenergic drugs is to stimulate adenyl cyclase, the enzyme which catalyzes the formation of cyclic-3',5'-adenosine monophosphate (cyclic AMP) from adenosine triphosphate (ATP). The cyclic AMP thus formed mediates the cellular responses. _In vitro _studies and _in vivo _pharmacologic studies have demonstrated that albuterol has a preferential effect on beta -adrenergic receptors compared with isoproterenol. While it is recognized that beta -adrenergic receptors are the 1 (Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate) 2 1 13 21 3 2 2 4 2 2 pr Perskaitykite visą dokumentą