PYRIDOSTIGMINE BROMIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Pyridostigmine bromide (UNII: KVI301NA53) (Pyridostigmine - UNII:19QM69HH21)

Available from:

Valeant Canada Limited

INN (International Name):

Pyridostigmine bromide

Pharmaceutical form:

TABLET

Composition:

30 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pyridostigmine bromide is indicated for pretreatment against the lethal effects of Soman nerve agent poisoning. Pyridostigmine is intended for use in conjunction with protective garments, including a mask. At the first sign of nerve agent poisoning, pyridostigmine should be stopped, and atropine and pralidoxime therapy started immediately. The evidence for the effectiveness of pyridostigmine as pretreatment against Soman-induced toxicity was derived from animal studies alone [see Nonclinical Toxicology (13.2) ]. FOR MILITARY MEDICAL USE ONLY - Mechanical intestinal or urinary obstruction - Known hypersensitivity to anticholinesterase agents Pregnancy Category B Pyridostigmine produced no teratogenic effects in rats given up to 30 mg/kg/day and in rabbits given up to 45 mg/kg/day orally during the period of organogenesis. These doses are 3 and 10 times, respectively, the recommended human dose of 90 mg on a mg/m2 basis. In rats, a slight degree of delayed skeletal ossification was seen at 30 mg/kg, a dose wh

Product summary:

Pyridostigmine bromide tablets, USP, 30 mg, are round, white tablets imprinted with the letters "PBT". Immediate Container: Twenty-one (21) tablets individually sealed in a blister or strip package which is supplied in a protective sleeve. NDC: 46594-750-01 NSN 6505-01-178-79031 Storage Store refrigerated between 2 and 8°C (36-46°F). Protect from light. Do not dispense the content of unit packages (10 blister packs) and shipping containers (10 packages of 10 each blister packs) after removal from refrigeration for more than a total of 3 months. Do not use after the 10 year expiration date provided on the package. Military personnel should be advised to discard the contents of the individual unit packages of pyridostigmine 3 months after issue.

Summary of Product characteristics

PYRIDOSTIGMINE BROMIDE- PYRIDOSTIGMINE BROMIDE TABLET
VALEANT CANADA LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
CAUTION: USE AS A PRETREATMENT ONLY - USE ATROPINE AND 2-PAM AFTER
SOMAN EXPOSURE
- USE PROTECTIVE GARMENT(S)
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
PYRIDOSTIGMINE BROMIDE IS FOR USE AS A PRETREATMENT FOR EXPOSURE TO
THE CHEMICAL NERVE AGENT SOMAN.
PYRIDOSTIGMINE ALONE WILL NOT PROTECT AGAINST EXPOSURE TO SOMAN. THE
EFFICACY OF PYRIDOSTIGMINE IS
DEPENDENT UPON THE RAPID USE OF ATROPINE AND PRALIDOXIME (2-PAM) AFTER
SOMAN EXPOSURE.
PRIMARY PROTECTION AGAINST EXPOSURE TO CHEMICAL NERVE AGENTS IS THE
WEARING OF PROTECTIVE GARMENTS.
PYRIDOSTIGMINE MUST NOT BE TAKEN AFTER EXPOSURE TO SOMAN. IF TAKEN
IMMEDIATELY BEFORE SOMAN
EXPOSURE (E.G., WHEN THE GAS ATTACK ALARM IS GIVEN) OR AT THE SAME
TIME AS POISONING BY SOMAN, IT IS NOT
EXPECTED TO BE EFFECTIVE, AND MAY EXACERBATE THE EFFECTS OF A
SUB-LETHAL EXPOSURE TO SOMAN.
INDICATIONS AND USAGE
Pyridostigmine bromide is a reversible cholinesterase inhibitor
indicated for pretreatment against the lethal effects of
soman nerve agent poisoning. (1)
Pyridostigmine bromide is for use in conjunction with
Protective garments, including a gas mask, and
Immediate atropine and pralidoxime therapy at the first sign of nerve
agent poisoning. (1)
DOSAGE AND ADMINISTRATION
One 30 mg tablet every 8 hours. (2)
Start at least several hours prior to exposure to Soman. (2)
At the first sign of Soman poisoning pyridostigmine must be stopped,
and atropine and 2-PAM be administered. (2)
Use beyond 14 consecutive days should be evaluated in the context of
the likelihood of Soman exposure. (2)
Store refrigerated between 2 and 8°C (36-46°F). Protect from light.
Do not dispense after removal from refrigeration
for more than a total of 3 months. (16)
DOSAGE FORMS AND STRENGTHS
30 mg tablets (round, white imprinted with letters "PBT") (3)
CONTRAINDICATIONS
Mechanical intestinal or urinary obstruction. (4)
Known hypersensitivity to anticholinesterase ag