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Nembutal Sodium Solution CII
(pentobarbital sodium injection, USP)
Principal Display Panel Text for Carton Label:
NDC 76478-501-20 20 mL Sterile Solution
For Intravenous or Intramuscular Use.
Multiple-dose Vial. LATEX-FREE.

SKU: insomnia Category:

Description

nembutal pentobarbital sodium solution

nembutal pentobarbital sodium solution (pentobarbital sodium injection) is a sterile solution for intravenous or intramuscular injection. Each mL contains pentobarbital sodium 50 mg, in a vehicle of propylene glycol, 40%, alcohol, 10% and water for injection, to volume.

Barbiturates are substituted pyrimidine derivatives in which the basic structure common to these drugs is barbituric acid, a substance which has no central nervous system (CNS) activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring.

NEMBUTAL Sodium Solution (pentobarbital sodium injection) is a sterile solution for intravenous or intramuscular injection. Each mL contains pentobarbital sodium 50 mg, in a vehicle of propylene glycol, 40%, alcohol, 10% and water for injection, to volume. The pH is adjusted to approximately 9.5 with hydrochloric acid and/or sodium hydroxide.

CLINICAL PHARMACOLOGY

Barbiturates are capable of producing all levels of CNS mood alteration from excitation to mild sedation, to 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 physiological sleep.

Sleep laboratory studies have demonstrated that barbiturates reduce the amount of time spent in the rapid eye movement (REM) phase of sleep or 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.

INDICATIONS AND USAGE nembutal pentobarbital sodium

Parenteral:

  • Sedatives.
  • Hypnotics, for the short-term treatment of insomnia, since they appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks (See “Clinical Pharmacology” section.)
  • Preanesthetics.
  • Anticonvulsant, in anesthetic doses, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics.

CONTRAINDICATIONS

Barbiturates are contraindicated in patients with known barbiturate  sensitivity. Barbiturates are also contraindicated in patients with a history of manifest or latent porphyria.

HOW SUPPLIED nembutal pentobarbital

nembutal pentobarbital Sodium Solution (pentobarbital sodium injection, USP) is available in the following sizes:
20-mL multiple-dose vial, 1 g per vial (NDC 76478-501-20); and 50-mL multiple-dose vial, 2.5 g per vial (NDC 76478-501-50). Each mL contains:

Pentobarbital Sodium, derivative of barbituric acid ……………….. 50 mg
Propylene glycol ………………………………………………… 40% v/v
Alcohol ………………………………………………………….. 10%
Water for Injection ………………………………………………. qs
(pH adjusted to approximately 9.5 with hydrochloric acid and/or sodium hydroxide.) Vial stoppers are latex free.
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at 20° to 25°C (68° to 77°F), however, brief excursions are permitted between 15° to 30°C (59° to 86°F). See USP controlled room temperature.

DOSAGE AND ADMINISTRATION

Dosages of barbiturates must be individualized with full knowledge of their particular characteristics and recommended rate of administration. Factors of consideration are the patient’s age, weight, and condition. Parenteral routes should be used only when oral administration is impossible or impractical. Intramuscular Administration: IM injection of the sodium salts of barbiturates should be made deeply into a large muscle, and a volume of 5 mL should not be exceeded at any one site because of possible tissue irritation. After IM injection of a hypnotic dose, the patient’s vital signs should be monitored.

The usual adult dosage of NEMBUTAL Sodium Solution is 150 to 200 mg as a single IM injection; the recommended pediatric dosage ranges from 2 to 6 mg/kg as a single IM injection not to exceed 100 mg. Intravenous Administration: NEMBUTAL Sodium Solution should not be admixed with any other medication or solution. IV injection is restricted to conditions in which other routes are not feasible, either because the patient is unconscious (as in cerebral hemorrhage, eclampsia, or status epilepticus), or because the patient resists (as in delirium), or because prompt action is imperative.

Slow IV injection is essential, and patients should be carefully observed during administration. This requires that blood pressure, respiration, and cardiac function be maintained, vital signs be recorded, and equipment for
resuscitation and artificial ventilation be available. The rate of IV injection should not exceed 50 mg/min for pentobarbital sodium.

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