Physostigmine Salicylate Injection

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Prescribing Information : Click here

Generic Name

Physostigmine salicylate
NDC

81284-831-05
Safety Data Sheet

Click Here PDF
Pack Size

5 x 5 mL Ampules
Strength

2 mg/5 mL (0.4 mg/mL) Injection for Intravenous Use
Form

Injection for IV
GTIN

00381284831055
Therapeutic Class

Cholinesterase Inhibitor
Container Closure is not made with natural rubber latex
Preservative Free

YES
Gluten Free

YES
Container Size

5 mL Ampule
ITEM CODES

Disclaimer: Physostigmine Salicylate Injection has not been found by FDA to be safe and effective, and its labeling has not been approved by FDA. For further information about unapproved drugs, <a href="https://www.fda.gov/drugs/enforcement-activities-fda/unapproved-drugs">click here.</a> Disclaimer: Anticholium® (physostigmine salicylate) is not FDA approved, but is imported with foreign, non-US labeling under a temporary importation license to address supply shortage. <a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b90b50e8-c8f1-4f2d-be6e-4d269b8c362c">For more information click here.</a>

<h3>Physostigmine Salicylate Injection (0.4 mg/mL solution)</h3> INDICATIONS AND IMPORTANT SAFETY INFORMATION Physostigmine Salicylate Injection has not been found by FDA to be safe and effective, and its labeling has not been approved by FDA. <a href="https://www.fda.gov/drugs/enforcement-activities-fda/unapproved-drugs">For further information about unapproved drugs, click here.</a> Disclaimer: Anticholium® (physostigmine salicylate) is not FDA approved, but is imported with foreign, non-US labeling under a temporary importation license to address supply shortage. <a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b90b50e8-c8f1-4f2d-be6e-4d269b8c362c">For more information click here.</a> Product Description <table class="MsoTableGrid" style="border-collapse:collapse; border:none"> <tbody> <tr> <td style="border-bottom:1px solid black; width:213px; padding:0in 7px 0in 7px; border-top:1px solid black; border-right:1px solid black; border-left:1px solid black" valign="top"> Product Description </td> <td style="border-bottom:1px solid black; width:213px; padding:0in 7px 0in 7px; border-top:1px solid black; border-right:1px solid black; border-left:none" valign="top"> Strength </td> <td style="border-bottom:1px solid black; width:213px; padding:0in 7px 0in 7px; border-top:1px solid black; border-right:1px solid black; border-left:none" valign="top"> Packaging </td> </tr> <tr> <td style="border-bottom:1px solid black; width:213px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black" valign="top"> Anticholium® (Physostigmine Salicylate) </td> <td style="border-bottom:1px solid black; width:213px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none" valign="top"> 2mg/5ml (0.4mg/ml) injection for intravenous use) NOTE: Please see Dosing and Administration:  concentration differs from the product previously distributed in the US market. </td> <td style="border-bottom:1px solid black; width:213px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:none" valign="top"> 5X5 mL Ampules </td> </tr> </tbody> </table> INDICATION To reverse the effect upon the central nervous system caused by clinical or toxic dosages of drugs capable of producing the anticholinergic syndrome. CONTRAINDICATIONS Physostigmine Salicylate Injection should not be used in the presence of asthma, gangrene, diabetes, cardiovascular disease, mechanical obstruction of the intestine or urogenital tract or any vagotonic state, and in patients receiving choline esters and depolarizing neuromuscular blocking agents (decamethonium, succinylcholine). For post-anesthesia, the concomitant use of atropine with physostigmine salicylate is not recommended, since the atropine antagonizes the action of physostigmine. WARNINGS AND PRECAUTIONS. Hypersensitivity Reactions: Contains 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 non-asthmatic people.Because of the possibility of hypersensitivity, atropine sulfate injection should always be at hand when administering physostigmine salicylate since it is an antagonist and antidote for physostigmine. Excessive symptoms of salivation, vomiting, urination, defecation: If excessive symptoms of salivation, vomiting, urination and defecation occur, the use of Physostigmine Salicylate Injection should be terminated. If excessive sweating or nausea occur, the dosage should be reduced. Rate of Administration: Intravenous administration should be at a slow, controlled rate, no more than 1 mg per minute (see dosage). Rapid administration can cause bradycardia, or hypersalivation leading to respiratory difficulties and possible convulsions. Overdose: An overdosage of Physostigmine Salicylate Injection can cause a cholinergic crisis. The appropriate antidote is atropine sulfate. In all cases of poisoning the usual supportive measures should be undertaken. ADVERSE REACTIONS Nausea, vomiting and salivation; can be offset by reducing dosage. Bradycardia and convulsions; may occur if intravenous administration is too rapid. SEE WARNINGS AND PRECAUTIONS ABOVE. Other adverse reactions of unknown frequency that have been reported include hypersensitivity reactions, tachycardia, bradycardia, sinoatrial block, hypotension, and sweating. DOSING AND ADMINISTRATION NOTE: This product consists of a 0.4mg/mL physostigmine solution. This differs from the product previously distributed in the US market. Post anesthesia care For the treatment of postoperative awakening disorders: Adults: Slowly inject physostigmine intravenously at a dose of 0.04 mg/kg bodyweight (approx. 1 mg/ min), the maximum individual dose is 2 mg. In case of insufficient effect, give subsequent injections after 5 to 20 minutes at the earliest, after a positive evaluation of the effect of the first injection. In cases of intoxication: Adults: Slowly inject 0.04 mg/kg bodyweight (2 mg) of physostigmine salicylate intravenously and subsequently inject 1-4 mg every 20 minutes. Repeat the effective dose if the intoxication symptoms recur, also in the form of a continuous infusion if deemed useful. Pediatric dosage Use in children and adolescents: In cases of intoxication: Infants: Start with a low dose of 0.5 mg of physostigmine salicylate administered intravenously, repeat this dose every 5 minutes up to the overall dose of 2 mg, as long as the toxic, anticholinergic symptoms continue to persist, and no cholinergic symptoms occur. METHOD OF ADMINISTRATION Intravenously slowly or as brief infusion in 50 ml physiological saline solution over 10-15 minutes. A general criterion for adequate physostigmine dosing is the recognizable recovery of mental abilities and responsiveness (e.g., specifying name, address, date). USE IN SPECIFIC POPULATIONS Pregnancy and breast-feeding Safe use in pregnancy and lactation has not been established; therefore, use in pregnant women, nursing mothers or women who may become pregnant requires that possible benefits outweigh possible hazards to mother and child. For additional Safety Information, please see Full Prescribing Information. You are encouraged to report adverse reactions to Provepharm at 1-833-727-6556 or to the FDA by visiting <a href="www.fda.gov/medwatch">www.fda.gov/medwatch</a> or by calling 1-800-FDA-1088.