REGONOL- pyridostigmine bromide injection, solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Sandoz Inc

INN (Rahvusvaheline Nimetus):

PYRIDOSTIGMINE BROMIDE

Koostis:

PYRIDOSTIGMINE BROMIDE 5 mg in 1 mL

Manustamisviis:

INTRAVENOUS

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

REGONOL ® (pyridostigmine bromide injection, USP) is indicated as a reversal agent or antagonist to the neuromuscular blocking effects of nondepolarizing muscle relaxants. Known hypersensitivity to anticholinesterase agents; intestinal and urinary obstructions of mechanical type.

Toote kokkuvõte:

REGONOL ® (pyridostigmine bromide injection USP) for injection is available as 2 mL single-dose ampule containing 10 mg pyridostigmine bromide (5 mg/mL) and supplied as: NDC 0781-3040-95 - box of 10 x 2 mL Single-Dose Ampules CONTAINS BENZYL ALCOHOL. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) (see USP Controlled Room Temperature). Protect from light.

Volitamisolek:

New Drug Application

Toote omadused

REGONOL- PYRIDOSTIGMINE BROMIDE INJECTION, SOLUTION
SANDOZ INC
----------
REGONOL® (PYRIDOSTIGMINE BROMIDE INJECTION, USP)
RX ONLY
CONTAINS BENZYL ALCOHOL
THIS DRUG SHOULD BE ADMINISTERED BY ADEQUATELY TRAINED
INDIVIDUALS FAMILIAR WITH ITS ACTIONS, CHARACTERISTICS, AND
HAZARDS.
DESCRIPTION
REGONOL
(pyridostigmine bromide injection, USP) is an active cholinesterase
inhibitor
chemically designated as 3-hydroxy-1-methylpyridinium bromide
dimethyl-carbamate.
Its structural formula is:
REGONOL
is supplied as a sterile, isotonic, nonpyrogenic solution for
injection. Each
mL contains 5 mg of pyridostigmine bromide USP as active, 10 mg BENZYL
ALCOHOL
NF as preservative WHICH IS NOT INTENDED FOR USE IN NEWBORNS, 0.23 mg
sodium
citrate dihydrate USP and 0.1 mg anhydrous citric acid USP as
buffering agent, pH
adjusted with sodium hydroxide NF and anhydrous citric acid USP if
necessary and
water for injection USP.
CLINICAL PHARMACOLOGY
REGONOL
(pyridostigmine bromide injection, USP) an analogue of neostigmine,
facilitates the transmission of impulses across the myoneural junction
by inhibiting the
destruction of acetylcholine by cholinesterase. Currently available
data indicate that
pyridostigmine may have a significantly lower degree and incidence of
bradycardia,
salivation and gastrointestinal stimulation than does neostigmine.
Animal studies using
®
®
®
the injectable form of pyridostigmine and human studies using the oral
preparation have
indicated that pyridostigmine has a longer duration of action than
does neostigmine
measured under similar circumstances.
REGONOL
is effective in reversing the
neuromuscular blocking effects of nondepolarizing muscle relaxants.
Anticholinesterase agents such as REGONOL
and neostigmine may produce
depolarization block when administered at doses above their
recommended therapeutic
ranges. The therapeutic index of REGONOL
(ratio of reversal dose to blocking dose) is
approximately 1:6 (see OVERDOSAGE).
The antagonism of neuromuscular blockade by anticholinesterase agents
may be
influenc