FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
RESUSCITATIVE EQUIPMENT AND DRUGS SHOULD BE IMMEDIATELY AVAILABLE WHENEVER ANY LOCAL ANESTHETIC DRUG IS USED.
Large doses of local anesthetics should not be used in patients with heartblock.
Reactions resulting in fatality have occurred on rare occasions with the use of local anesthetics, even in the absence of a history of hypersensitivity.
Contains acetone sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
PONTOCAINE is indicated for the production of spinal anesthesia for procedures requiring two to three hours.
History
There is currently no drug history available for this drug.
Other Information
Tetracaine hydrochloride is 2-(Dimethylamino)ethyl p-(butylamino)benzoate monohydrochloride. It is a white crystalline, odorless powder that is readily soluble in water, physiologic saline solution, and dextrose solution. It has the following structural formula:
Tetracaine hydrochloride is a local anesthetic of the ester-linkage type, related to procaine.
PONTOCAINE® hydrochloride is supplied in two forms for prolonged spinal anesthesia: Niphanoid® and 1% Solution.
NIPHANOID: A sterile, instantly soluble form consisting of a network of extremely fine, highly purified particles, resembling snow.
1% Solution: A sterile, isotonic, isobaric solution, each 1 mL containing 10 mg tetracaine hydrochloride, 6.7 mg sodium chloride, and not more than 2 mg acetone sodium bisulfite. The air in the ampuls has been displaced by nitrogen gas or carbon dioxide gas. The pH is 3.2 to 6.
Tetracaine hydrochloride is supplied for prolonged spinal anesthesia as: 1% Tetracaine Hydrochloride Injection, USP: A sterile, isotonic, isobaric solution, each 1 mL containing 10 mg tetracaine hydrochloride, 6.7 mg sodium chloride, and not more than 2 mg acetone sodium bisulfite. The air in the ampuls has been displaced by nitrogen gas or carbon dioxide gas. The pH is 3.2 to 6.
These formulations do not contain preservatives.
Sources
Niphanoid Manufacturers
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Hospira, Inc.
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