A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Robinul Indications, Dosage, Storage, Stability - Glycopyrrolate
Robinul Indications, Dosage, Storage, Stability - Glycopyrrolate
INDICATIONS
In Anesthesia: Glycopyrrolate injection
is indicated for use as a preoperative antimuscarinic
to reduce salivary, tracheobronchial,
and pharyngeal secretions;
to reduce the volume
and free acidity of gastric secretions; and, to block
cardiac vagal
inhibitory reflexes during induction of anesthesia
and intubation. When indicated, glycopyrrolate
injection may be used intraoperatively to counteract
drug-induced or vagal
traction reflexes with the associated arrhythmias. Glycopyrrolate
protects against the peripheral
muscarinic effects
(e.g., bradycardia
and excessive secretions) of cholinergic
agents such as neostigmine
and pyridostigmine given to reverse the neuromuscular
blockade due to nondepolarizing
muscle relaxants.
In Peptic Ulcer: For use in adults as adjunctive
therapy for the treatment
of peptic ulcer
when rapid anticholinergic
effect is desired or
when oral medication
is not tolerated.
DOSAGE AND ADMINISTRATION
Glycopyrrolate injection
may be administered intramuscularly, or intravenously, without dilution,
in the following indications:
Adults
Preanesthetic Medication: The recommended dose
of glycopyrrolate injection is 0.002 mg
(0.01 mL) per pound
of body weight by intramuscular
injection, given 30 to 60 minutes prior to the anticipated time
of induction of anesthesia
or at the time the preanesthetic
narcotic and or sedative
are administered.
lntraoperative Medication: Glycopyrrolate injection
may be used during surgery to counteract
drug induced
or vagal traction
reflexes with the associated arrhythmias (e.g., bradycardia). It
should be administered intravenously as single doses of 0.1 mg
(0.5 mL) and repeated, as needed, at intervals of 2 to 3 minutes.
The usual attempts should be made to determine the etiology of the
arrhythmia, and the surgical
or anesthetic manipulations
necessary to correct parasympathetic
imbalance should be
performed.
Reversal of Neuromuscular Blockade: The recommended
dose of glycopyrrolate
injection is 0.2 mg
(1.0 mL) for each 1.0 mg
of neostigmine or 5.0 mg
of pyridostigmine. In order
to minimize the appearance
of cardiac side effects, the drugs may be administered simultaneously
by intravenous injection and may be mixed
in the same syringe.
Peptic Ulcer: The usual recommended dose
of glycopyrrolate injection is 0.1 mg
(0.5 mL) administered at 4-hour intervals, 3 or 4 times daily intravenously
or intramuscularly. Where more profound effect
is required, 0.2mg (1.0 mL) may be given. Some patients may need
only a single dose, and frequency of administration
should be dictated by patient
response up to a maximum
of four times daily.
Children
Preanesthetic Medication: The recommended dose
of glycopyrrolate injection in children to 12 years of age
is 0.002 mg (0.01 mL) per
pound of body weight
intramuscularly, given 30 to 60 minutes prior to the anticipated
time of induction
of anesthesia or
at the time the preanesthetic
narcotic and/or sedative
are administered.
Children under 2 years of age
may require up to 0.004 mg
(0.02 mL) per pound of body weight.
lntraoperative Medication: Because of the long duration
of action of glycopyrrolate
injection, if used as preanesthetic
medication, additional glycopyrrolate
injection for anticholinergic
effect intraoperatively
is rarely needed; in the event it is required the recommended pediatric
dose is 0.002 mg (0.01 mL)
per pound
of body weight intravenously,
not to exceed 0.1 mg (0.5
mL) in a single dose which
may be repeated, as needed, at intervals of 2 to 3 minutes. The
usual attempts should be made to determine the etiology of the arrhythmia,
and the surgical or
anesthetic manipulations
necessary to correct parasympathetic
imbalance should be
performed.
Reversal of Neuromuscular Blockade: The recommended
pediatric dose of glycopyrrolate
injection is 0.2 mg
(1.0 mL) for each 1.0 mg
of neostigmine or 5.0 mg
of pyridostigmine. In order
to minimize the appearance of cardiac
side effects, the drugs
may be administered simultaneously by intravenous injection
and may be mixed in the
same syringe.
Peptic Ulcer: Glycopyrrolate injection
is not recommended for peptic
ulcers in children under 12 years of age. (See PRECAUTIONS).
NOTE: Parenteral drug
products should be inspected visually for particulate matter
and discoloration prior to administration
whenever solution and container
permit.
Incompatibilities
Glycopyrrolate injection
stability is generally dependent upon pH. The pH of the USP product
ranges between 2.0 and 3.0. Stability decreases rapidly above pH
6.0.
Glycopyrrolate injection
is stable for 48 hours
in I.V. infusion solutions
of 5% Dextrose, 10% Dextrose, 0.45% Sodium Chloride, 0.9% Sodium
Chloride or Ringer’s Injection.
Glycopyrrolate injection
is generally physcially compatible
with drugs having an acid
pH (below 6.0) however, this
would also be dependent on concentration of the drugs and temperature
as well as pH. Glycopyrrolate injection would be expected to be
incompatible with
drugs having a more alkaline pH
(greater than 6.0) such as the barbiturates, diazepam
or buffered Lactated Ringer’s Injection. The latter may be used
for administration via the tubing of a running I.V. infusion.
HOW SUPPLIED
| NDC-0517-4601-25 0.2mg |
Glycopyrrolate per
mL with 0.9% Benzyl Alcohol. lmL fill in 2mL single dose vials
packaged in boxes of 25. |
| NDC-0517-4602-25 0.2mg |
Glycopyrrolate per
mL with 0.9% Benzyl Alcohol. 2mL fill in 2mL single dose vials
packaged in boxes of 25. |
| NDC-0517-4605-25 0.2mg |
Glycopyrrolate per
mL with 0.9% Benzyl Alcohol. 5mL fill in 5mL multiple dose vials
packaged in boxes of 25. |
| NDC-0517-4620-25 0.2mg |
Glycopyrrolate per
mL with 0.9% Benzyl Alcohol. 20mL multiple
dose vials packaged in boxes of 25. |
Store at controlled room
temperature, 15°- 30° C( 59°- 86° F).
CAUTION: Federal (USA) wlaw
prohibits dispensing without prescription.
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