PYRIDOSTIGMINE BROMIDE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

PYRIDOSTIGMINE BROMIDE (UNII: KVI301NA53) (PYRIDOSTIGMINE - UNII:19QM69HH21)

זמין מ:

Surgeon General-Department of the Army (TSG-DA)

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Pyridostigmine bromide is indicated for pretreatment against the lethal effects of soman nerve agent poisoning. Pyridostigmine bromide is intended for use in conjunction with protective garments, including a mask. At the first sign of nerve agent poisoning, pyridostigmine bromide should be stopped, and atropine and pralidoxime therapy started immediately. The evidence for the effectiveness of pyridostigmine bromide 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 bromide 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 an mg/m2 basis. In rats, a slight degree of delayed skeletal ossification was seen at 30 mg/kg, a dose which caused maternal toxicity, and a slight increase in the incidence of hydronephrosis was seen at all dose levels (lowest dose tested was 3 mg/kg). In rabbits, a slight increase in the incidence of hydronephrosis was seen at 45 mg/kg, a dose that caused maternal toxicity and increased incidences of blood vessel variations were seen at all doses (lowest dose tested was 5 mg/kg). There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when pyridostigmine bromide is administered to a nursing woman. Safety and effectiveness in pediatric patients have not been established. Clinical studies of pyridostigmine bromide did not contain sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In the elderly (71 to 85 years of age) the elimination half-life, volume of distribution (central and steady state) were comparable with the young (21to 51 years of age). However, the systemic plasma clearance was significantly lower in the elderly compared to the young (6.7 ± 2.2 vs. 9.5 ± 2.7 mL/min/kg). This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Caution should be observed, and dosage be selected carefully, when administering pyridostigmine bromide to patients with impaired renal function. In anephric patients, a 3-fold increase in the elimination half-life and a 75% decrease in systemic clearance were observed. [See Clinical Pharmacology (12.3).] It may be useful to monitor renal function. No information is available on the pharmacokinetics of pyridostigmine bromide in hepatic impaired patients. Although the abuse potential of pyridostigmine bromide has not been specifically assessed, no abuse of, tolerance to, withdrawal from, or drug-seeking behavior was observed in patients who received pyridostigmine bromide in clinical trials. Cholinesterase inhibitors are not believed to be associated with drug abuse.

leaflet_short:

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: 72458-128-01 NSN 6505-01-178-7903 The NSN refers to the actual unit that is ordered from supply (if someone orders 1 of this stock number they will get one package of 10 blister packs). Storage Store in refrigerator (2° to 8°C) (36 to 46°F). Protect from light. Discard the contents of the blister package after removal from refrigerator for more than a total of 3 months. Do not use after the 10-year expiration date provided on the package.

מצב אישור:

New Drug Application

מאפייני מוצר

PYRIDOSTIGMINE BROMIDE- PYRIDOSTIGMINE BROMIDE TABLET
SURGEON GENERAL-DEPARTMENT OF THE ARMY (TSG-DA)
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PYRIDOSTIGMINE BROMIDE
TABLETS USP 30 MG SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
PYRIDOSTIGMINE BROMIDE TABLETS USP 30 MG.
PYRIDOSTIGMINE BROMIDE USP TABLETS 30 MG FOR ORAL USE
INITIAL U.S. APPROVAL: 1955
CAUTION: USE PYRIDOSTIGMINE BROMIDE AS PRETREATMENT ONLY. AFTER
EXPOSURE
TO SOMAN, USE ATROPINE AND 2-PAM. ALWAYS USE PROTECTIVE GARMENT(S)
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
Pyridostigmine bromide is for use as a pretreatment for exposure to
soman nerve agent.
Pyridostigmine bromide alone will not protect against exposure to
soman. The efficacy of
pyridostigmine bromide 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 bromide 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 one (1) hour 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)
S