Terbutaline Sulfate (Terbutaline Sulfate)

Trade Name : Terbutaline Sulfate

West-Ward Pharmaceuticals Corp

INJECTION

Strength 1 mg/mL

TERBUTALINE SULFATE

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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 Terbutaline Sulfate (Terbutaline Sulfate) which is also known as Terbutaline Sulfate and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 1 mg/mL per ml. Read more

Terbutaline Sulfate (Terbutaline 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
  • A sterile aqueous solution for subcutaneous injection
  • Rx Only
  • No data
  • Terbutaline Sulfate, USP, the active ingredient of Terbutaline Sulfate Injection, USP, is a betau2011adrenergic agonist bronchodilator available as a sterile, nonpyrogenic, aqueous solution in vials, for subcutaneous administration. Each milliliter of solution contains 1 mg of Terbutaline Sulfate, USP (0.82 mg of the free base), sodium chloride for isotonicity, 0.055% edetate disodium dihydrate as a stabilizing agent, and hydrochloric acid for adjustment to a target pH of 4. Terbutaline sulfate isu00a0(u00b1)-a-[(u2011butylamino)u00a0methyl]-3,5-dihydroxybenzyI alcohol sulfate (2:1) (salt). The molecular formula is (CHN0)u2022HSOu00a0and the structural formula is:u00a0
  • Terbutaline Sulfate, USP is a white to gray-white crystalline powder. It is odorless or has a faint odor of acetic acid. It is soluble in water and in 0.1N hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform. Its molecular weight is 548.65.
  • Terbutaline sulfate injection is a beta-adrenergic receptor agonist. and pharmacologic studies have demonstrated that terbutaline exerts a preferential effect on betau2011adrenergic receptors. While it is recognized that beta-adrenergic receptors are the predominant receptors in bronchial smooth muscle, data indicate that there is a population of beta-receptors in the human heart, existing in a concentration between 10% to 50%. The precise function of these receptors has not been established (see ). Controlled clinical studies in patients given terbutaline subcutaneously have not revealed a preferential beta-adrenergic effect.
  • The pharmacologic effects of beta-adrenergic agonists, including terbutaline, are at least in part attributable to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic 3u2019,5u2019-adenosine monophosphate (cAMP). Increased cAMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
  • Controlled clinical studies have shown that terbutaline sulfate injection relieves bronchospasm in acute and chronic obstructive pulmonary disease by significantly increasing pulmonary flow rates (e.g., an increase of 15% or more in FEV). After subcutaneous administration of 0.25 mg of terbutaline sulfate injection, a measurable change in expiratory flow rate usually occurs within 5 minutes, and a clinically significant increase in FEVu00a0occurs within 15 minutes. The maximum effect usually occurs within 30 to 60 minutes, and clinically significant bronchodilator activity may continue for 1.5 to 4 hours. The duration of clinically significant improvement is comparable to that observed with equimilligram doses of epinephrine.
  • Terbutaline Sulfate Injection, USP is indicated for the prevention and reversal of bronchospasmu00a0in patients 12 years of age and older with asthma and reversible bronchospasm associatedu00a0with bronchitis and emphysema.
  • 1. Prolonged Tocolysisn n- Array
  • 2. Hypersensitivityn
  • No data
  • No data
  • Adverse reactions observed with terbutaline sulfate injection are similar to those commonly seen with other sympathomimetic agents. All these reactions are transient in nature and usually do not require treatment.
  • The following table compares adverse reactions seen in patients treated with terbutaline sulfate injection (0.25 mg and 0.5 mg), with those seen in patients treated with epinephrine injection (0.25 mg and 0.5 mg), during eight double-blind crossover studies involving a total of 214 patients.u00a0
  • Note:
  • To report SUSPECTED ADVERSE REACTIONS,u00a0contact West-ward Pharmaceutical Corp. at 1-877-233-2001, or theu00a0FDA at 1-800-FDA-1088 or .
  • The median sc lethal dose of terbutaline sulfate in mature rats was approximately 165u00a0mg/u200ckg (approximately 2,700 times the maximum recommended daily sc dose for adults on a mg/u200cmu00a0basis). The median sc lethal dose of terbutaline sulfate in young rats was approximately 2,000u00a0mg/kg (approximately 32,000 times the maximum recommended daily sc dose for adults on a mg/m basis).
  • The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/u200cor 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. There is no specific antidote. Treatment consists of discontinuation of terbutaline sulfate injection 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 terbutaline sulfate injection.
  • Vials should be used only for subcutaneous administration and not intravenous infusion.
  • Sterility and accurate dosing cannot be assured if the vials are not used in accordance with n n
  • Discard unused portion after single patient use.
  • The usual subcutaneous dose of terbutaline sulfate injection is 0.25 mg injected into the lateral deltoid area. If significant clinical improvement does not occur within 15 to 30 minutes, a second dose of 0.25 mg may be administered. If the patient then fails to respond within another 15 to 30u00a0minutes, other therapeutic measures should be considered. The total dose within 4 hours should not exceed 0.5 mg.
  • Note:
  • Terbutaline Sulfate Injection, USP, 1 mg/mL, is supplied at a volume of 1 mL contained in a 2 mL amber glass vial. Each vial contains 1 mg of terbutaline sulfate per 1u00a0mL of solution; 0.25 mL of solution will provide the usual clinical dose of 0.25 mg.
  • NDC 0143-9746-10
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Protect from light by storing vials in original carton until dispensed.
  • Do not use if solution is discolored.
  • Discard unused portion after single patient use.u00a0
  • Manufactured by:
  • Distributed by:n
  • Revised: Aprilu00a0 2011
  • NDC 0143-9746-01Terbutaline Sulfate Injection, USP1 mg/mLFOR SUBCUTANEOUS USE ONLY
  • NDCu00a00143-9746-10Terbutaline Sulfate Injection, USP10 x 1 mL Single Dose Vials1 mg/mLFOR SUBCUTANEOUS USE ONLY
  • No data

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