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Albuterol Sulfate (Albuterol Sulfate)

Trade Name : Albuterol Sulfate

Mylan Pharmaceuticals Inc.

TABLET, FILM COATED, EXTENDED RELEASE

Strength 4 mg/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 Mylan Pharmaceuticals Inc.. It is available in strength of 4 mg/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

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
  • Albuterol extended-release tablets, USP contain albuterol sulfate, the racemic form of albuterol and a relatively selective beta-adrenergic bronchodilator, in an extended-release formulation. Albuterol sulfate has the chemical name (u00b1) a-[(-butyl-amino)methyl]-4-hydroxy--xylene-a, au00b4-diol sulfate (2:1) (salt), and the following structural formula:
  • Albuterol sulfate has a molecular weight of 576.7, and the molecular formula is (CHNO)u2022HSO. Albuterol sulfate, USP is a white crystalline powder, soluble in water and slightly soluble in ethanol.
  • The World Health Organization recommended name for albuterol base is salbutamol.
  • Each tablet for oral administration contains 4 mg or 8 mg of albuterol as 4.8 mg or 9.6 mg, respectively, of albuterol sulfate, USP. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, triacetin and xanthan gum. The 8 mg tablets also contain the following coloring agents: FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake.
  • In vitron- in vivo
  • The pharmacologic effects of beta-adrenergic agonist drugs, including albuterol, are at least in part attributable to stimulation through beta-adrenergic receptors on intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3u00b4, 5u00b4-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
  • Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects.
  • Albuterol is longer acting than isoproterenol in most patients by any route of administration because it is not a substrate for the cellular uptake processes for catecholamines nor for catechol-O-methyl transferase.
  • Albuterol extended-release tablets, USP are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.
  • Albuterol extended-release tablets are contraindicated in patients with a history of hypersensitivity to albuterol or any of its components.
  • Immediate hypersensitivity reactions may occur after administration of albuterol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema.
  • No data
  • The adverse reactions to albuterol are similar in nature to reactions to other sympathomimetic agents.
  • The most frequent adverse reactions to albuterol are nervousness, tremor, headache, tachycardia, and palpitations.
  • Less frequent adverse reactions are muscle cramps, insomnia, nausea, weakness, dizziness, drowsiness, flushing, restlessness, irritability, chest discomfort, and difficulty in micturition.
  • Rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema have been reported after the use of albuterol.
  • In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vomiting, vertigo, central nervous system stimulation, unusual taste, and drying or irritation of the oropharynx.
  • In controlled clinical trials of adult patients conducted in the United States, the following incidence of adverse events was reported:
  • A trend was observed among patients treated with albuterol extended-release tablets toward increasing frequency of muscle cramps with increasing patient age (12 to 20 years, 1.2%; 21 to 30 years, 2.6%; 31 to 40 years, 6.9%; 41 to 50 years, 6.9%), compared with no such events in the placebo group. Also observed was an increasing frequency of tremor with increasing patient age (12 to 20 years, 29.4%; 21 to 30 years, 29.9%; 31 to 40 years, 27.6%; 41 to 50 years, 37.9%), compared to 2.9% or less in the placebo group.
  • The reactions are generally transient in nature, and it is usually not necessary to discontinue treatment with albuterol extended-release tablets.
  • 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. Hypokalemia may also occur. As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of albuterol extended-release tablets.
  • Treatment consists of discontinuation of albuterol extended-release tablets 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 extended-release tablets.
  • The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg, (approximately 250 times the maximum recommended daily oral dose for adults on a mg/m basis, or, approximately 200 times the maximum recommended daily oral 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 110 times the maximum recommended daily oral dose for adults on a mg/m basis, or, approximately 90 times the maximum recommended daily oral dose for children on a mg/m basis). In small young rats, the subcutaneous median lethal dose is approximately 2000 mg/kg, (approximately 500 times the maximum recommended daily oral dose for adults on a mg/m basis, or, approximately 400 times the maximum recommended daily oral dose for children on a mg/m basis).
  • The following dosages of albuterol extended-release tablets are expressed in terms of albuterol base:
  • Albuterol Extended-release Tablets, USP are available containing 4.8 mg or 9.6 mg of albuterol sulfate, USP equivalent to 4 mg or 8 mg of albuterol, respectively.
  • The 4 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:
  • NDC 0378-4122-01bottles of 100 tablets
  • The 8 mg tablets are blue, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:
  • NDC 0378-4124-01bottles of 100 tablets
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • Mylan Pharmaceuticals Inc.
  • REVISED MARCH 2015ALBER:R2
  • NDC 0378-4122-01
  • Albuterol n- Extended-releasen- Tabletsn- 4 mgn- (oral)
  • Rx only u00a0u00a0u00a0u00a0u00a0100 Tablets
  • Each film-coated tablet contains 4.8 mg of albuterol sulfate, USP equivalent to 4 mg of albuterol.
  • Dispense in a tight, light-resistant container asdefined in the USP using a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medication out of then- reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USPn- Controlled Room Temperature.]
  • Usual Adult Dosage:
  • Do not chew or crush.
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM4122A4
  • NDC 0378-4124-01
  • Albuterol n- Extended-releasen- Tabletsn- 8 mgn- (oral)
  • Rx only u00a0u00a0u00a0u00a0u00a0100 Tablets
  • Each film-coated tablet contains 9.6 mg of albuterol sulfate, USP equivalent to 8 mg of albuterol.
  • Dispense in a tight, light-resistant container asdefined in the USP using a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medication out of then- reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USPn- Controlled Room Temperature.]
  • Usual Adult Dosage:
  • Do not chew or crush.
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM4124A3

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