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
Imodium Indications, Dosage, Storage, Stability - Loperamide
Imodium Indications, Dosage, Storage, Stability - Loperamide
INDICATIONS
Loperamide hydrochloride is indicated for the control and symptomatic
relief of acute nonspecific diarrhea and of chronic diarrhea associated
with inflammatory bowel disease. Loperamide hydrochloride is also indicated
for reducing the volume of discharge from ileostomies.
DOSAGE AND ADMINISTRATION
(1 capsule= 2 mg)
Patients should receive appropriate fluid and electrolyte replacement
as needed.
Acute Diarrhea
Adults: The recommended initial dose is 4 mg (two capsules) followed
by 2mg (one capsule) after each unformed stool. Daily dosage should not
exceed 16 mg (eight capsules). Clinical improvement is usually observed
within 48 hours.
Children: Loperamide hydrochloride use is not recommended for
children under 2 years of age. In children 2 to 5 years of age (20 kg
or less), a non-prescription liquid formulation should be used; for ages
6 to 12, either loperamide hydrochloride capsules or liquid may be used.
For children 2 to 12 years of age, the following schedule for capsules
or liquid will usually fulfill initial dosage requirements:
Recommended First Day Dosage Schedule
|
Two to five years:
(13 to 20 kg)
|
1 mg t.i.d.
(3 mg daily dose)
|
|
Six to eight years:
(20 to 30 kg)
|
2 mg b.i.d.
(4 mg daily dose)
|
|
Eight to twelve years:
(greater than 30 kg)
|
2 mg t.i.d.
(6 mg daily dose)
|
Recommended Subsequent Daily Dosage
Following the first treatment day, it is recommended that subsequent
loperamide hydrochloride doses (1 mg/10 kg body weight) be administered
only after a loose stool. Total daily dosage should not exceed recommended
dosages for the first day.
Chronic Diarrhea
Children: Although loperamide hydrochloride has been studied in
a limited number of children with chronic diarrhea, the therapeutic dose
for the treatment of chronic diarrhea in a pediatric population has not
been established.
Adults: The recommended initial dose is 4mg (two capsules) followed
by 2 mg (one capsule) after each unformed stool until diarrhea is controlled,
after which the dosage of loperamide hydrochloride should be reduced to
meet individual requirements. When the optimal daily dosage has been established,
this amount may then be administered as a single dose or in divided doses.
The average daily maintenance dosage in clinical trials was 4 to 8 mg
(two to four capsules). A dosage of 16 mg (eight capsules) was rarely
exceeded. If clinical improvement is not observed after treatment with
16 mg per day for at least 10 days, symptoms are unlikely to be controlled
by further administration. Loperamide hydrochloride administration may
be continued if diarrhea cannot be adequately controlled with diet or
specific treatment.
HOW SUPPLIED
Loperamide Hydrochloride Capsules 2 mg are available as:
A light brown opaque body and dark brown opaque capsule, imprinted "93"
- "311" and packaged in bottles of 100 and 500.
Store at controlled room temperature 15°- 30° C (59°- 86° F).
Dispense in a well-closed container, as defined in the USP, with a child-resistant
closure (as required).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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