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
Compazine Indications, Dosage, Storage, Stability - Prochlorperazine
Compazine Indications, Dosage, Storage, Stability - Prochlorperazine
INDICATIONS
AND USES
For control of severe nausea and vomiting.
For management of the manifestations of psychotic disorders.
Compazine (prochlorperazine) is effective for the short-term treatment of generalized
non-psychotic anxiety. However, Compazine is not the first drug to be
used in therapy for most patients with non-psychotic anxiety, because certain
risks associated with its use are not shared by common alternative treatments
(e.g., benzodiazepines).
When used in the treatment of non-psychotic anxiety, Compazine should
not be administered at doses of more than 20 mg per day or for longer than 12
weeks, because the use of Compazine at higher doses or for longer intervals
may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS
).
The effectiveness of Compazine as treatment for non-psychotic anxiety
was established in 4-week clinical studies of outpatients with generalized anxiety
disorder. This evidence does not predict that Compazine will be useful
in patients with other non-psychotic conditions in which anxiety, or signs that
mimic anxiety, are found (e.g., physical illness, organic mental conditions,
agitated depression, character pathologies, etc.).
Compazine has not been shown effective in the management of behavioral
complications in patients with mental retardation.
DOSAGE AND ADMINISTRATION
Notes on Injection: Stability This solution should
be protected from light. This is a clear, colorless to pale yellow solution;
a slight yellowish discoloration will not alter potency. If markedly discolored,
solution should be discarded.
Compatibility It is recommended that Compazine (prochlorperazine)
Injection not be mixed with other agents in the syringe.
DOSAGE AND ADMINISTRATION
ADULTS
(For children's dosage and administration, see below.) Dosage should be increased
more gradually in debilitated or emaciated patients.
Elderly Patients: In general, dosages in the lower range
are sufficient for most elderly patients. Since they appear to be more susceptible
to hypotension and neuromuscular reactions, such patients should be observed
closely. Dosage should be tailored to the individual, response carefully monitored
and dosage adjusted accordingly. Dosage should be increased more gradually in
elderly patients.
- To Control Severe Nausea and Vomiting: Adjust dosage
to the response of the individual. Begin with the lowest recommended dosage.
Oral Dosage Tablets: Usually one 5 mg or 10 mg tablet
3 or 4 times daily. Daily dosages above 40 mg should be used only in resistant
cases.
Spansule capsules: Initially, usually one
15 mg capsule on arising or one 10 mg capsule q12h. Daily doses above 40 mg
should be used only in resistant cases.
Rectal Dosage: 25 mg twice daily.
I.M. Dosage: Initially 5 to 10 mg (1 to 2 mL) injected
deeply into the upper outer quadrant of the buttock. If necessary,
repeat every 3 or 4 hours. Total I.M. dosage should not exceed 40 mg per day.
I.V. Dosage: 2 1 / 2 to 10 mg ( 1
/ 2 to 2 mL) by slow I.V. injection or infusion at a rate
not to exceed 5 mg per minute. Compazine Injection may be administered
either undiluted or diluted in isotonic solution. A single dose of the drug
should not exceed 10 mg; total I.V. dosage should not exceed 40 mg per day.
When administered I.V., do not use bolus injection. Hypotension is a possibility
if the drug is given by I.V. injection or infusion.
Subcutaneous administration is not advisable because of local irritation.
- Adult Surgery (for severe nausea and vomiting):
Total parenteral dosage should not exceed 40 mg per day. Hypotension is
a possibility if the drug is given by I.V. injection or infusion.
I.M. Dosage: 5 to 10 mg (1 to 2 mL) 1 to 2 hours before
induction of anesthesia (repeat once in 30 minutes, if necessary), or to control
acute symptoms during and after surgery (repeat once if necessary).
I.V. Dosage: 5 to 10 mg (1 to 2 mL) as a slow I.V. injection or infusion
15 to 30 minutes before induction of anesthesia, or to control acute symptoms
during or after surgery. Repeat once if necessary. Compazine (prochlorperazine)
may be administered either undiluted or diluted in isotonic solution, but
a single dose of the drug should not exceed 10 mg. The rate of administration
should not exceed 5 mg per minute. When administered I.V., do not use bolus
injection.
- In Adult Psychiatric Disorders: Adjust dosage
to the response of the individual and according to the severity of the condition.
Begin with the lowest recommended dose. Although response ordinarily is seen
within a day or 2, longer treatment is usually required before maximal improvement
is seen.
Oral Dosage: Non-Psychotic Anxiety Usual
dosage is 5 mg 3 or 4 times daily; by Spansule capsule, usually
one 15 mg capsule on arising or one 10 mg capsule q12h. Do not administer
in doses of more than 20 mg per day or for longer than 12 weeks.
Psychotic Disorders In relatively mild conditions, as seen in
private psychiatric practice or in outpatient clinics, dosage is 5 or 10 mg
3 or 4 times daily.
In moderate to severe conditions, for hospitalized or adequately supervised
patients, usual starting dosage is 10 mg 3 or 4 times daily. Increase dosage
gradually until symptoms are controlled or side effects become bothersome.
When dosage is increased by small increments every 2 or 3 days, side effects
either do not occur or are easily controlled. Some patients respond satisfactorily
on 50 to 75 mg daily.
In more severe disturbances, optimum dosage is usually 100 to 150 mg
daily.
I.M. Dosage: For immediate control of severely disturbed
adults, inject an initial dose of 10 to 20 mg (2 to 4 mL) deeply into
the upper outer quadrant of the buttock. Many patients respond shortly after
the first injection. If necessary, however, repeat the initial dose every
2 to 4 hours (or, in resistant cases, every hour) to gain control of the patient.
More than three or four doses are seldom necessary. After control is achieved,
switch patient to an oral form of the drug at the same dosage level or higher.
If, in rare cases, parenteral therapy is needed for a prolonged period, give
10 to 20 mg (2 to 4 mL) every 4 to 6 hours. Pain and irritation at the site
of injection have seldom occurred.
Subcutaneous administration is not advisable because of local irritation.
DOSAGE AND ADMINISTRATION
CHILDREN
Do not use in pediatric surgery.
Children seem more prone to develop extrapyramidal reactions, even on moderate
doses. Therefore, use lowest effective dosage. Tell parents not to exceed prescribed
dosage, since the possibility of adverse reactions increases as dosage rises.
Occasionally the patient may react to the drug with signs of restlessness and
excitement; if this occurs, do not administer additional doses. Take particular
precaution in administering the drug to children with acute illnesses or dehydration
(see under Dystonias).
When writing a prescription for the 2 1 / 2 mg size suppository,
write "2 1 / 2 ," not "2.5"; this will help avoid confusion
with the 25 mg adult size.
- Severe Nausea and Vomiting in Children: Compazine (prochlorperazine)
should not be used in pediatric patients under 20 pounds in weight or 2 years
of age. It should not be used in conditions for which children's dosages have
not been established. Dosage and frequency of administration should be adjusted
according to the severity of the symptoms and the response of the patient.
The duration of activity following intramuscular administration may last up
to 12 hours. Subsequent doses may be given by the same route if necessary.
Oral or Rectal Dosage: More than 1 day's therapy is seldom
necessary.
|
Weight
|
Usual Dosage
|
Not to
Exceed
|
|
under 20 lbs not recommended
|
|
20 to 29 lbs
|
2 1 / 2 mg 1 or 2
times a day
|
7.5 mg
per day
|
|
30 to 39 lbs
|
2 1 / 2 mg 2 or 3
times a day
|
10 mg
per day
|
|
40 to 85 lbs
|
2 1 / 2 mg 3 times a day
or 5 mg 2 times a day
|
15 mg
per day
|
I.M. Dosage: Calculate each dose on the basis of 0.06 mg
of the drug per lb of body weight; give by deep I.M. injection. Control is
usually obtained with one dose.
- In Psychotic Children:
Oral or Rectal Dosage: For children 2 to 12 years, starting
dosage is 2 1 / 2 mg 2 or 3 times daily. Do not give
more than 10 mg the first day. Then increase dosage according to patient's
response.
FOR AGES 2 to 5, total daily dosage usually does not exceed 20 mg.
FOR AGES 6 to 12, total daily dosage usually does not exceed 25 mg.
I.M. Dosage: For ages under 12, calculate each dose on
the basis of 0.06 mg of Compazine (prochlorperazine) per lb of body weight;
give by deep I.M. injection. Control is usually obtained with one dose. After
control is achieved, switch the patient to an oral form of the drug at the
same dosage level or higher.
HOW SUPPLIED
Tablets 5 and 10 mg, in bottles of 100; in Single Unit Packages of
100 (intended for institutional use only).
5 mg 100's: NDC 0007-3366-20
5 mg SUP 100's: NDC 0007-3366-21
10 mg 100's: NDC 0007-3367-20
10 mg SUP 100's: NDC 0007-3367-21
Spansule capsules 10 and 15 mg, in bottles of 50.
10 mg 50's: NDC 0007-3344-15
15 mg 50's: NDC 0007-3346-15
Vials 2 mL (5 mg/mL), in boxes of 25 and 10 mL (5 mg/mL), in boxes
of 1.
2 mL (5 mg/mL), in boxes of 25: NDC 0007-3352-16
10 mL (5 mg/mL), in boxes of 1: NDC 0007-3343-01
Suppositories 2 1 / 2 mg (for young children),
5 mg (for older children) and 25 mg (for adults), in boxes of 12.
2 1 / 2 mg, in boxes of 12: NDC 0007-3360-03
5 mg, in boxes of 12: NDC 0007-3361-03
25 mg, in boxes of 12: NDC 0007-3362-03
Syrup 5 mg/5 mL (1 teaspoonful) in 4 fl o bottles.
5 mg/5 mL, 4 fl oz: NDC 0007-3363-44
Store Compazine (prochlorperazine) vials below 30°C (86°F). Do not freeze.
Other dosage forms can be stored between 15° and 30°C (59° and 86°F). Protect
from light.
Rx only
*norepinephrine bitartrate, Sanofi Pharmaceuticals.
** phenylephrine hydrochloride, Sanofi Pharmaceuticals.
*** phenytoin, Parke-Davis.
§metrizamide, Sanofi Pharmaceuticals.
ll diphenhydramine hydrochloride, Parke-Davis.
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