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Amobarbital Sodium (Amytal Sodium)

Trade Name : Amytal Sodium

Bausch Health US LLC

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 0.5 g/5mL

AMOBARBITAL SODIUM

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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 Amobarbital Sodium (Amytal Sodium) which is also known as Amytal Sodium and Manufactured by Bausch Health US LLC. It is available in strength of 0.5 g/5mL per ml. Read more

Amobarbital Sodium (Amytal Sodium) 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
  • The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act.
  • Amobarbital sodium is a white, friable, granular powder that is odorless, has a bitter taste, and is hygroscopic. It is very soluble in water, soluble in alcohol, and practically insoluble in ether and chloroform. Amobarbital sodium is sodium 5-ethyl-5-isopentylbarbiturate and has the empirical formula CHNNaOIts molecular weight is 248.26.
  • It has the following structural formula:
  • Amobarbital sodium is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity.
  • Vials of amobarbital sodium are for parenteral administration. The vials contain 500 mg (2 mmol) amobarbital sodium as a sterile lyophilized powder.
  • Barbiturates are capable of producing all levels of CNS mood alteration, from excitation to mild sedation, hypnosis, and deep coma. Overdosage can produce death. In high enough therapeutic doses, barbiturates induce anesthesia.
  • Barbiturates depress the sensory cortex, decrease motor activity, alter cerebellar function, and produce drowsiness, sedation, and hypnosis.
  • Barbiturate-induced sleep differs from physiologic sleep. Sleep laboratory studies have demonstrated that barbiturates reduce the amount of time spent in the rapid eye movement (REM) phase of sleep or the dreaming stage. Also, Stages III and IV sleep are decreased. Following abrupt cessation of barbiturates used regularly, patients may experience markedly increased dreaming, nightmares, and/or insomnia. Therefore, withdrawal of a single therapeutic dose over 5 or 6 days has been recommended to lessen the REM rebound and disturbed sleep that contribute to the drug withdrawal syndrome (for example, the dose should be decreased from 3 to 2 doses/day for 1 week).
  • In studies, secobarbital sodium and pentobarbital sodium have been found to lose most of their effectiveness for both inducing and maintaining sleep by the end of 2 weeks of continued drug administration, even with the use of multiple doses. As with secobarbital sodium and pentobarbital sodium, other barbiturates (including amobarbital) might be expected to lose their effectiveness for inducing and maintaining sleep after about 2 weeks. The short-, intermediate-, and to a lesser degree, long-acting barbiturates have been widely prescribed for treating insomnia. Although the clinical literature abounds with claims that the short-acting barbiturates are superior for producing sleep whereas the intermediate-acting compounds are more effective in maintaining sleep, controlled studies have failed to demonstrate these differential effects. Therefore, as sleep medications, the barbiturates are of limited value beyond short-term use.
  • Barbiturates have little analgesic action at subanesthetic doses. Rather, in subanesthetic doses, these drugs may increase the reaction to painful stimuli. All barbiturates exhibit anticonvulsant activity in anesthetic doses. However, of the drugs in this class, only phenobarbital, mephobarbital, and metharbital are effective as oral anticonvulsants in subhypnotic doses.
  • Barbiturates are respiratory depressants, and the degree of respiratory depression is dependent upon the dose. With hypnotic doses, respiratory depression produced by barbiturates is similar to that which occurs during physiologic sleep and is accompanied by a slight decrease in blood pressure and heart rate.
  • Studies in laboratory animals have shown that barbiturates cause reduction in the tone and contractility of the uterus, ureters, and urinary bladder. However, concentrations of the drugs required to produce this effect in humans are not reached with sedative-hypnotic doses.
  • Barbiturates do not impair normal hepatic function but have been shown to induce liver microsomal enzymes, thus increasing and/or altering the metabolism of barbiturates and other drugs ().
  • Barbiturates are absorbed in varying degrees following oral or parenteral administration. The salts are more rapidly absorbed than are the acids. The rate of absorption is increased if the sodium salt is ingested as a dilute solution or taken on an empty stomach.
  • The onset of action for oral administration of barbiturates varies from 20 to 60 minutes. For intramuscular (IM) administration, the onset of action is slightly faster. Following intravenous (IV) administration, the onset of action ranges from almost immediately for pentobarbital sodium to 5 minutes for phenobarbital sodium. Maximal CNS depression may not occur until 15 minutes or more after IV administration for phenobarbital sodium. Duration of action, which is related to the rate at which the barbiturates are redistributed throughout the body, varies among persons and in the same person from time to time. Amobarbital sodium, an intermediate-acting barbiturate, is a CNS depressant. For the oral form, the onset of sedative and hypnotic action is 3/4 to 1 hour, with a duration of action ranging from 6 to 8 hours. These values should serve as a guide but not be used to predict exact duration of effect. No studies have demonstrated that the different routes of administration are equivalent with respect to bioavailability.
  • Barbiturates are weak acids that are absorbed and rapidly distributed to all tissues and fluids, with high concentrations in the brain, liver, and kidneys. Lipid solubility of the barbiturates is the dominant factor in their distribution within the body. The more lipid soluble the barbiturate, the more rapidly it penetrates all tissues of the body. Barbiturates are bound to plasma and tissue proteins to a varying degree, with the degree of binding increasing directly as a function of lipid solubility.
  • Phenobarbital has the lowest lipid solubility, lowest plasma binding, lowest brain protein binding, the longest delay in onset of activity, and the longest duration of action. At the opposite extreme is secobarbital, which has the highest lipid solubility, highest plasma protein binding, highest brain protein binding, the shortest delay in onset of activity, and the shortest duration of action. Amobarbital sodium is classified as an intermediate barbiturate. The plasma half-life for amobarbital sodium in adults ranges between 16 and 40 hours, with a mean of 25 hours.
  • Barbiturates are metabolized primarily by the hepatic microsomal enzyme system, and the metabolic products are excreted in the urine and, less commonly, in the feces. Only a negligible amount of amobarbital sodium is eliminated unchanged in the urine.
  • No data
  • Amobarbital sodium is contraindicated in patients who are hypersensitive to barbiturates, in patients with a history of manifest or latent porphyria, and in patients with marked impairment of liver function or respiratory disease in which dyspnea or obstruction is evident.
  • No data
  • No data
  • The following adverse reactions and their incidence were compiled from surveillance of thousands of hospitalized patients who received barbiturates. Because such patients may be less aware of certain of the milder adverse effects of barbiturates, the incidence of these reactions may be somewhat higher in fully ambulatory patients.
  • More than 1 in 100 Patients
  • The most common adverse reaction, estimated to occur at a rate of 1 to 3 patients per 100, is the following:n Somnolenceu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0
  • Less than 1 in 100 Patients
  • Adverse reactions estimated to occur at a rate of less than 1 in 100 patients are listed below, grouped by organ system and by decreasing order of occurrence:n Agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, abnormality in thinkingn Hypoventilation, apnea, postoperative atelectasisn Bradycardia, hypotension, syncopen Nausea, vomiting, constipationn Headache, injection site reactions, hypersensitivity reactions (angioedema, skin rashes, exfoliative dermatitis), fever, liver damage, megaloblastic anemia following chronic phenobarbital use
  • To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • The toxic dose of barbiturates varies considerably. In general, an oral dose of 1 g of most barbiturates produces serious poisoning in an adult. Toxic effects and fatalities have occurred following overdoses of amobarbital sodium alone and in combination with other CNS depressants. Death commonly occurs after 2 to 10 g of ingested barbiturate. The sedated, therapeutic blood levels of amobarbital range between 2 to 10 mcg/mL; the usual lethal blood level ranges from 40 to 80 mcg/mL. Barbiturate intoxication may be confused with alcoholism, bromide intoxication, and various neurologic disorders. Potential tolerance must be considered when evaluating significance of dose and plasma concentration.
  • Solutions of amobarbital sodium should be made up aseptically with Sterile Water for Injection. The accompanying table will aid in preparing solutions of various concentrations. Ordinarily, a 10% solution is used. After Sterile Water for Injection is added, the vial should be rotated to facilitate solution of the powder. n
  • Several minutes may be required for the drug to dissolve completely, but under no circumstances should a solution be injected if it has not become absolutely clear within 5 minutes. Also, a solution that forms a precipitate after clearing should not be used. Amobarbital sodium hydrolyzes in solution or on exposure to air. Not more than 30 minutes should elapse from the time the vial is opened until its contents are injected. Prior to administration, parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution containers permit.
  • The dose of amobarbital sodium must be individualized with full knowledge of its particular characteristics and recommended rate of administration. Factors of consideration are the patientu2019s age, weight, and condition. The maximum single dose for an adult is 1 g.
  • Amytal Sodium Vials 0.5 g (dry powder) are available as follows:NDC 0187-4303-05Storage: Store at 59u00b0 to 86u00b0F (15u00b0 to 30u00b0C).Lyophilized
  • Amytal is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.u00a9Valeant Pharmaceuticals North America LLC
  • Manufactured for:
  • Manufactured by:
  • 9476202 PC3328F
  • PRINCIPAL DISPLAY PANEL
  • NDC 0187-4303-05
  • 1 Vial
  • AMYTAL SODIUM CIIn- (Amobarbital Sodium)n- FOR INJECTION, USP
  • 0.5 g/vial
  • For Intramuscular n- or Intravenous Use Only
  • Rx only
  • VALEANT

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