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Albuterol Sulfate (Albuterol Sulfate)

Trade Name : Albuterol Sulfate

Actavis Pharma, Inc.

SOLUTION

Strength 0.63 mg/3mL

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

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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 Actavis Pharma, Inc.. It is available in strength of 0.63 mg/3mL 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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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.

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
  • u00a0
  • Albuterol sulfate inhalation solution is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate is a relatively selective beta -adrenergic bronchodilator (see ). The chemical name for albuterol sulfate is u03b1 [(tert-butylamino) methyl]-4-hydroxy-m-xylene-u03b1, u03b1'-diol sulfate (2:1) (salt), and its established chemical structure is as follows:
  • The molecular weight of albuterol sulfate is 576.7 and the empirical formula is (CHNO)u2022HSO. Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol is salbutamol.
  • Albuterol sulfate inhalation solution is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.75 mg of albuterol sulfate (equivalent to 0.63 mg of albuterol) or 1.50 mg of albuterol sulfate (equivalent to 1.25 mg of albuterol) with sodium chloride and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution and sulfuric acid is added to adjust pH of the solution to 4.0 (see ).
  • Albuterol sulfate inhalation solution does not require dilution prior to administration by nebulization. For albuterol sulfate inhalation solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plusu2122 nebulizer (with face mask or mouthpiece) connected to a Pari PRONEBu2122 compressor, under conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Albuterol sulfate inhalation solution should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see ).
  • 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. studies and 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 predominant receptors in bronchial smooth muscle, recent data indicate that 10% to 50% of the beta-receptors in the human heart may be beta -receptors. The precise function of these receptors, however, is not yet established. Controlled clinical studies and other clinical experience have shown that inhaled albuterol, like other beta-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes. 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 sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).
  • Albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to any of its components.
  • No data
  • No data
  • Clinical Trial Experience: Adverse events reported in >1% of patients receiving albuterol sulfate and more frequently than in patients receiving placebo in a four-week double-blind study are listed in the following table.
  • There was one case of ST segment depression in the 1.25 mg albuterol sulfate treatment group.
  • No clinically relevant laboratory abnormalities related to albuterol sulfate administration were seen in this study.
  • Postmarketing Experience:
  • To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
  • The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of symptoms such as 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, insomnia, and exaggeration of the pharmacological effects listed in . Hypokalemia may also occur. As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of albuterol sulfate. Treatment consists of discontinuation of albuterol sulfate 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.
  • The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 580 times the maximum recommended daily inhalation dose of albuterol sulfate on a mg/m basis). The subcutaneous median lethal dose of albuterol sulfate in mature rats and small young rats is approximately 450 mg/kg and 2000 mg/kg, respectively (approximately 260 and 1200 times the maximum recommended daily inhalation dose of albuterol sulfate on a mg/m basis). The inhalation median lethal dose has not been determined in animals.
  • The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of albuterol sulfate inhalation solution administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended.
  • To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial [3 mL of 0.042% (1.25 mg) or 0.021% (0.63 mg) inhalation solution] by nebulization. Adjust nebulizer flow rate to deliver albuterol sulfate over 5 to 15 minutes.
  • The use of albuterol sulfate inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.
  • Patients 6 to 12 years of age with more severe asthma (baseline FEV less than 60% predicted), weight >40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.
  • Albuterol sulfate inhalation solution has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.
  • If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.
  • The drug compatibility (physical and chemical), clinical efficacy and safety of albuterol sulfate inhalation solution, when mixed with other drugs in a nebulizer have not been established.
  • The safety and efficacy of albuterol sulfate inhalation solution have been established in clinical trials when administered using the Pari LC Plusu2122 nebulizer and Pari PRONEBu2122 compressor. The safety and efficacy of albuterol sulfate inhalation solution when administered with other nebulizer systems have not been established.
  • Albuterol sulfate inhalation solution should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.
  • Albuterol sulfate inhalation solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.021% (0.63 mg) and 0.042% (1.25 mg) of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of albuterol sulfate inhalation solution is available in a shelf carton containing multiple foil pouches.
  • Albuterol sulfate inhalation solution, 0.021% (0.63 mg/3 mL)
  • NDC 0591-3467-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton
  • Albuterol sulfate inhalation solution, 0.042% (1.25 mg/3 mL)
  • NDC 0591-3468-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton
  • Store between 20u00b0 to 25u00b0 C (68u00b0 to 77u00b0 F). [See USP Controlled Room Temperature]. u00a0Protect from light and excessive heat.
  • Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial(s) within one week. Discard the vial if the solution is not colorless.
  • Keep out of the reach of children.
  • Manufactured by: Cipla Ltd.Verna Goa, INDIA
  • Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA
  • Revised: January 2017
  • 21060786
  • No data
  • Read this patient information completely every time your prescription is filled as information may have changed. Keep these instructions with your medication, as you may want to read them again.
  • Albuterol sulfate inhalation solution should only be used under the direction of a physician. Your physician and pharmacist have more information about albuterol sulfate inhalation solution and the condition for which it has been prescribed. Contact them if you have additional questions.
  • Storing your Medicine
  • Store albuterol sulfate inhalation solution between 20u00b0 and 25u00b0 C (68u00b0 and 77u00b0 F). [See USP Controlled Room Temperature]. Vials should be protected from light before use, therefore, keep unused vials in the foil pouch. Do not use after the expiration (EXP) date printed on the vial.
  • Dose
  • Albuterol sulfate inhalation solution is supplied as a single-dose, ready-to-use vial containing 3 mL of solution. No mixing or dilution is needed. Use one new vial with each nebulizer treatment.
  • 1.u00a0u00a0u00a0u00a0Remove one vial from the foil pouch. Place remaining vials back into foil pouch for storage.
  • 2.u00a0u00a0u00a0u00a0Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir (Figure 1).
  • 3.u00a0u00a0u00a0u00a0Connect the nebulizer to the mouthpiece or face mask (Figure 2).n n n
  • 4.u00a0u00a0u00a0u00a0Connect the nebulizer to the compressor
  • 5.u00a0u00a0u00a0u00a0Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 3) or put on the face mask (Figure 4); and turn on the compressor.
  • 6.u00a0u00a0u00a0u00a0Breathe as calmly, deeply and evenly as possible through your mouth until no more mist is formed in the nebulizer chamber (about 5-15 minutes). At this point, the treatment is finished.
  • 7.u00a0u00a0u00a0u00a0Clean the nebulizer (see manufacturer's instructions).
  • Manufactured by:Cipla Ltd.Verna Goa, INDIA
  • Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA
  • Revised: January 2017
  • Albuterol Sulfate Inhalation Solutionn n- 0.042% (1.25 mg*/3 mL) and 0.021% (0.63 mg*/3 mL)n n- (*Potency expressed as albuterol, equivalent to 1.5 mg n- and 0.75 mg albuterol sulfate)n- Array
  • Read the patient information that comes with albuterol sulfate inhalation solution before using it and each time you get a refill for your child. There may be new information. This leaflet does not take the place of talking to your childu2019s doctor about your childu2019s medical condition or treatment.
  • What is albuterol sulfate inhalation solution?
  • Albuterol sulfate inhalation solution is a medicine that is used for the relief of bronchospasms caused by asthma in children ages 2 to 12 years. Bronchospasm is the tightening and swelling of the muscles around the airways. Albuterol sulfate inhalation solution can help relax these airway muscles for up to 6 hours so that your child may breathe more easily.
  • Who should not use albuterol sulfate inhalation solution?
  • Do not give your child albuterol sulfate inhalation solution if he or she is allergic to any of its ingredients. The active ingredient is albuterol sulfate. See the end of this leaflet for a complete list of ingredients.
  • What should I tell my childu2019s doctor before giving albuterol sulfate inhalation solution?
  • Tell your childu2019s doctor about all of your childu2019s medical conditions including if your child has:n
  • Tell your childu2019s doctor about all the medicines your child takes, including prescription and non-prescription medicines, vitamins and herbal supplements. Albuterol sulfate inhalation solution and some other medicines can affect each other and may cause serious side effects. Especially tell your childu2019s doctor if your child is taking or using:
  • Know the medicines your child takes. Keep a list of them and show it to your childu2019s doctor and pharmacist each time your child gets a new medicine.
  • How should albuterol sulfate inhalation solution be given?
  • Read the Patientu2019s Instructions for Use that comes with albuterol sulfate inhalation solution. Ask your pharmacist for these instructions if they are not with your medicine. Keep the instructions with albuterol sulfate inhalation solution because you may want to read them again.
  • What are the side effects with albuterol sulfate inhalation solution?
  • Albuterol sulfate inhalation solution may cause the following serious side effects:
  • The most common side effects with albuterol sulfate inhalation solution include a fast or irregular heartbeat, chest pain, shakiness, or nervousness.
  • How should albuterol aulfate inhalation solution be stored?
  • General Information about albuterol sulfate inhalation solution
  • Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflets. Do not use albuterol sulfate inhalation solution for a condition for which it was not prescribed. Do not give albuterol sulfate inhalation solution to other people, even if they have the same symptoms your child has. It may harm them.
  • This leaflet summarizes the most important information about albuterol sulfate inhalation solution. If you would like more information, talk with your childu2019s doctor. You can ask your childu2019s doctor or pharmacist for information about albuterol sulfate inhalation solution that is written for health professionals. You can also call Actavis toll free at 1-800-272-5525.
  • What are the ingredients in albuterol sulfate inhalation solution?
  • Active Ingredient:n- Inactive Ingredients:
  • Manufactured by:Cipla Ltd.Verna, Goa INDIA
  • Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA
  • Revised: January 2017
  • NDC 0591-3467-53
  • Albuterol SulfateInhalation Solution0.021% (0.63 mg*/3mL)n
  • 0.021% (0.63mg*/3mL) 25 VialsSterile Unit-Dose VialsFor Inhalation Only
  • Carton contains:5 pouches of 5 x 3mL vials each
  • Rx onlyn n n
  • NDC 0591-3468-53
  • Albuterol SulfateInhalation Solution0.042% (1.25 mg*/3mL)n
  • 0.042% (1.25mg*/3mL) 25 VialsSterile Unit-Dose VialsFor Inhalation Only
  • Carton contains:5 pouches of 5 x 3mL vials eachn
  • Rx onlyn n n n n

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