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Pentothal (Thiopental Sodium) - Warnings and Precautions

 
 



WARNINGS

KEEP RESUSCITATIVE AND ENDOTRACHEAL INTUBATION EQUIPMENT AND OXYGEN READILY AVAILABLE. MAINTAIN PATENCY OF THE AIRWAY AT ALL TIMES.

This drug should be administered only by persons qualified in the use of intravenous anesthetics.

Avoid extravasation or intra-arterial injection.

PRECAUTIONS

Observe aseptic precautions at all times in preparation and handling of Pentothal (Thiopental Sodium for Injection) solutions.

If used in conditions involving relative contraindications, reduce dosage and administer slowly.

Care should be taken in administering the drug to patients with advanced cardiac disease, increased intracranial pressure, ophthalmoplegia plus, asthma, myasthenia gravis and endocrine insufficiency (pituitary, thyroid, adrenal, pancreas).

Drug interactions: The following drug interactions have been reported with thiopental.

Drug

Effect

Probenecid      

Prolonged action of thiopental

Diazoxide

Hypotension

Zimelidine

Thiopental antagonism

Opioid analgesics

Decreased antinociceptive action

Aminophylline

Thiopental antagonism

Midazolam

Synergism

Nursing Mothers: Thiopental sodium readily crosses the placental barrier and small amounts may appear in the milk of nursing mothers following administration of large doses.

Pregnancy Category C. Animal reproduction studies have not been conducted with Pentothal. It is also not known whether Pentothal can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pentothal should be given to a pregnant woman only if clearly needed.

WARNINGS

Intravenous administration of Sterile Water for Injection, USP without a solute may result in hemolysis.

Use aseptic technique for preparing Pentothal solutions during withdrawal from reconstituted single -use containers.

Administer only clear reconstituted solutions.

Use within 24 hours after reconstitution. Discard unused portions.

PRECAUTIONS

Do not use unless solution is clear and container is undamaged.

Inspect reconstituted (mixed) solutions of Pentothal (Thiopental Sodium for Injection) for clarity and freedom from precipitation or discoloration prior to administration. Use reconstituted solution only if it is clear, free from precipitate and not discolored.

Pregnancy Category C. Animal reproduction studies have not been conducted with sterile water for injection or sodium chloride injection. It is also not known whether sterile water or sodium chloride injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile water for injection or sodium chloride injection with additives should be given to a pregnant woman only if clearly needed.

Page last updated: 2010-05-28

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