DESCRIPTION
The World Health Organization recommended name for albuterol base
is salbutamol.
Inhalation Aerosol
The active component of
this formulation is albuterol racemic
(a1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-a,
a¢-diol) and a relatively selective beta2-adrenergic
bronchodilator. The molecular weight
is 239.3 and the empirical
formula is C13H21NO3. Albuterol
is a white to off-white crystalline
solid. It is soluble in ethanol,
sparingly soluble in water, and very soluble
in chloroform.
Ventolin inhalation aerosol
is a pressurized metered-dose aerosol
unit for oral inhalation. It
contains a microcrystalline
(95% £10 mm)
suspension of albuterol
in propellants (trichloromonofluoromethane and dichlorodifluoromethane)
with oleic acid. Each actuation
delivers 100 mcg of albuterol from the valve
and 90 mcg of albuterol from the
mouthpiece. Each 6.8-g canister provides 80
inhalations and each 17-g canister provides
200 inhalations.
Inhalation Solutions and Capsules for Inhalation
The active component in
these albuterol inhalation
formulations is albuterol sulfate, the racemic
form of albuterol and a relatively
selective beta2-adrenergic bronchodilator. It has the chemical
name (a1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-a,
a¢-diol) (2:1)(salt). Albuterol
sulfate has a molecular weight
of 576.7 and the empirical
formula is C13H21NO3·H2SO4.
Albuterol sulfate is a white
crystalline powder, soluble
in water and slightly soluble
in ethanol.
Ventolin Inhalation Solution, 0.5%: Ventolin inhalation
solution, 0.5% is in concentrated form. Dilute the appropriate
volume of the solution
(see DOSAGE AND ADMINISTRATION)
with sterile normal
saline solution
to a total volume of 3 ml
and administer by nebulization. Each milliliter
of Ventolin inhalation
solution contains 5 mg of
albuterol (as 6 mg of albuterol sulfate) in an aqueous
solution containing benzalkonium chloride; sulfuric acid
is used to adjust the pH to between 3 and 5. Ventolin inhalation
solution contains no sulfiting
agents and is a clear, colorless to light
yellow solution.
Ventolin Nebules Inhalation Solution, 0.083%: Ventolin
Nebules inhalation solution
requires no dilution before
administration by nebulization. Each milliliter
of Ventolin Nebules inhalation
solution 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. Ventolin Nebules inhalation
solution contains no sulfiting agents or preservatives and is a clear,
colorless solution.
Ventolin Rotacaps: Ventolin Rotacaps for inhalation
contain a dry powder presentation
of albuterol sulfate intended
for oral inhalation only. Each
light blue
and clear, hard gelatin capsule
contains a mixture of 200 mcg
of microfine (95% £10 mm)
albuterol (as the sulfate) with 25 mg of lactose. The contents of each
capsule are inhaled using a specially designed plastic
device for inhaling powder
called the Rotahaler. When turned, this device
opens the capsule and facilitates dispersion
of the albuterol sulfate into
the airstream created when the patient
inhales through the mouthpiece. Ventolin Rotacaps for inhalation
are an alternative inhalation
form of albuterol to the metered-dose
pressurized inhaler.
CATEGORIES, BRAND NAMES
CATEGORIES: Asthma; Pregnancy Category C; FDA Approval
Pre 1982; Patent Expiration 2014 Feb; Top 200 Drugs; WHO
Formulary
FDA Drug Classes: Antiasthmatics/Broncodilators
BRAND NAMES:
BRAND NAMES: Aerolin; Airet; Airomir; Albuterol
Sulfate; Almotex; Anebron; Asmadil; Asmalin; Asmanil; Asmasal;
Asmatol; Asmaven; Asmavent; Asmidon; Asmol Uni-Dose;
Asthalin; Broncho-Spray; Broncovaleas; Bronter;
Bugonol; Butamol; Buto-Asma; Butotal; Buventol; Cobutolin;
Dilatamol; Farcolin; Grafalin; Instavent; Libretin;
Medolin; Mozal; Novosalmol; Parasma; Proventil;
Respax; Salbetol; Salbron; Salbulin; Salbusian;
Salbutalan; Salbutamol; Salbutan; Salbutol; Salbuven;
Salbuvent; Salmaplon; Salomol; Sedalin; Sultanol;
Suprasma; Theosal; Tobybron; Vencronyl; Venetlin;
Ventilan; Ventimax; Ventolin; Ventoline; Ventolin
Rotacaps; Volmax
(Foreign Brand names outside U.S. in italics)
FOREIGN BRAND AVAILABILITY:
Aerolin (Brazil; Chile; Greece)
Airomir (Australia; Canada; France; Philippines; Thailand)
Almotex (Philippines)
Asmadil (Benin; Burkina-Faso; Ethiopia; Gambia; Ghana; Guinea; Ivory-Coast;
Kenya; Liberia; Malawi; Mali; Mauritania; Mauritius; Morocco; Niger; Nigeria;
Senegal; Seychelles; Sierra-Leone; Sudan; Tanzania; Tunia; Uganda; Zambia;
Zimbabwe)
Asmasal (Thailand)
Asmatol (Argentina)
Asmaven (England)
Asmidon (Japan)
Asmol Uni-Dose (New-Zealand)
Asthalin (India)
Broncho-Spray (Germany; South-Africa)
Broncovaleas (Italy)
Bronter (Colombia)
Bugonol (Colombia)
Buto-Asma (Spain)
Butotal (Chile)
Cobutolin (England)
Dilatamol (Indonesia)
Farcolin (Bahrain; Cyprus; Egypt; Iran; Iraq; Israel; Jordan; Kuwait;
Lebanon; Libya; Oman; Qatar; Republic-of-Yemen; Saudi-Arabia; Syria; United-Arab-Emirates)
Grafalin (Indonesia)
Libretin (Philippines)
Medolin (Thailand)
Mozal (Taiwan)
Novosalmol (Canada)
Parasma (Colombia)
Respax (Australia; New-Zealand)
Salbetol (India)
Salbron (Indonesia)
Salbulin (Costa-Rica; Dominican-Republic; El-Salvador; England; Guatemala;
Honduras; Panama)
Salbutalan (Mexico)
Salbutan (Venezuela)
Salbutol (Korea; Peru)
Salbuven (Indonesia)
Salbuvent (Norway)
Salmaplon (India)
Salomol (Taiwan)
Sedalin (Philippines)
Sultanol (Austria; Germany; Japan)
Suprasma (Indonesia)
Tobybron (Indonesia)
Vencronyl (Philippines)
Venetlin (Japan)
Ventilan (Colombia; Portugal)
Ventoline (Denmark; Finland; France; Norway; Sweden)
Administration route: INHALATION.