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
Prevacid Indications, Dosage, Storage, Stability - Lansoprazole
Prevacid Indications, Dosage, Storage, Stability - Lansoprazole
INDICATIONS
Short-term Treatment of Active Duodenal Ulcer
Lansoprazole is indicated for short-term treatment
(up to 4 weeks) for healing and symptom
relief active duodenal
ulcer.
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy (Lansoprazole/Amoxicillin/Clarithromycin):
Lansoprazole delayed-release capsules, in combination with amoxicillin
plus clarithromycin as triple
therapy, are indicated for the treatment of patients with H. pylori infection
and duodenal ulcer
disease (active or one-year
history of a duodenal ulcer)
to eradicate H. pylori. Eradication of H. pylori has been shown to reduce
the risk of duodenal
ulcer recurrence. (See CLINICAL
STUDIES and DOSAGE AND ADMINISTRATION
).
Dual Therapy (Lansoprazole/Amoxicillin): Lansoprazole delayed-release
capsules, in combination with amoxicillin
as dual therapy, are indicated for the treatment
of patients with H. pylori infection
and duodenal ulcer disease
(active or one-year history of a duodenal
ulcer) who are either allergic
or intolerant to clarithromycin or in whom resistance to clarithromycin
is known or suspected. (See Clarithromycin,
Microbiology). Eradication of H. pylori has been shown to reduce
the risk of duodenal ulcer recurrence.
(See CLINICAL STUDIES and DOSAGE
AND ADMINISTRATION).
Maintenance of Healed Duodenal Ulcers
Lansoprazole delayed-release capsules are indicated to maintain healing
of duodenal ulcers. Controlled
studies do not extend beyond
12 months.
Short-Term Treatment of Active Benign Gastric Ulcer
Lansoprazole delayed-release capsules are indicated for short-term treatment
(up to 8 weeks) for healing
and symptom relief
of active benign gastric ulcer.
Gastroesophageal Reflux Disease (GERD)
Short-term Treatment of Symptomatic GERD: Lansoprazole
delayed-release capsules are indicated for the treatment
of heartburn and other symptoms
associated with GERD.
Short-term Treatment of Erosive Esophagitis: Lansoprazole
are indicated for short-term treatment
(up to 8 weeks) for healing
and symptom relief of all grades
of erosive esophagitis.
For patients who do not heal
with lansoprazole for
8 weeks (5-10%) it may be helpful to give an additional 8 weeks of treatment.
If there is a recurrence
of erosive esophagitis
an additional 8 week course of lansoprazole
may be considered.
Maintenance of Healing of Erosive Esophagitis
Lansoprazole delayed-release capsules are indicated to maintain healing
of erosive esophagitis. Controlled
studies did not extend beyond
12 months.
Pathological Hypersecretory Conditions Including Zollinger-Ellison
Syndrome
Lansoprazole are indicated for the long-term treatment
of pathological hypersecretory conditions, including Zollinger-Ellison
syndrome.
DOSAGE AND ADMINISTRATION
Short Term Treatment of Duodenal Ulcer
The recommended adult oral
dose is 15 mg daily before eating
for 4 weeks. (See INDICATIONS
AND USAGE).
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy: Lansoprazole/amoxicillin/clarithromycin:
The recommended adult oral
dose is 30 mg lansoprazole, 1
gram amoxicillin, and 500 mg
clarithromycin, all given twice daily (q 12h) for 10 or 14 days. (See
INDICATIONS
AND USAGE).
Dual Therapy: Lansoprazole/amoxicillin: The recommended
adult oral dose
is 30 mg lansoprazole
and 1 gram amoxicillin, each
given three times daily (q 8h) for 14 days. (See INDICATIONS
AND USAGE).
Please refer to amoxicillin and clarithromycin
for CONTRAINDICATIONS
and WARNINGS, and for information
regarding dosing in elderly and renally-impaired patients.
Maintenance of Healed Duodenal Ulcers
The recommended adult oral
dose is 15 mg once daily. (See
CLINICAL STUDIES.)
Short Term Treatment of Gastric Ulcer
The recommended adult oral
dose is 30 mg once daily for
up to eight weeks. (See CLINICAL STUDIES.)
Gastroesophageal Reflux Disease (GERD)
Short Term Treatment of Symptomatic GERD: The recommended
adult oral dose
is 15 mg once daily for up to 8 weeks.
Short Term Treatment of Erosive Esophagitis
The recommended adult oral
dose is 30 mg once daily for
up to 8 weeks. For patients who do not heal
with lansoprazole for
8 weeks (5-10%) it may be helpful to give an additional 8 weeks of treatment.
(See INDICATIONS
AND USAGE)
If there is a recurrence
of erosive esophagitis, an
additional 8 week course of lansoprazole
may be considered.
Maintenance of Healing of Erosive Esophagitis
The recommended adult oral
dose is 15 mg once daily. (See
CLINICAL STUDIES)
Pathological Hypersecretory Conditions Including Zollinger-Ellison
Syndrome
The dosage of lansoprazole
in patients with pathologic
hypersecretory conditions varies with the individual patient. The recommended
adult oral starting dose
60 mg once a day. Doses should be adjusted to individual patient needs
and should continue for as long as clinically indicated. Dosages up to
90 mg bid have been administered. Daily dosages of greater than 120 mg
should be administered in divided doses. Some patients with Zollinger-Ellison
syndrome have been treated
continuously with lansoprazole for more than four years.
No dosage adjustment
is necessary in patients with renal
insufficiency or the elderly. For patients with severe liver
disease, dosage adjustment
should be considered.
Lansoprazole delayed-release capsules should be taken before eating.
In the clinical trials, antacids
were used concomitantly with lansoprazole. For patients who have difficulty
swallowing capsules, lansoprazole
delayed-release capsules can be opened, and the intact granules contained
within can be sprinkled on one tablespoon
of applesauce and swallowed immediately. The granules should not be chewed
or crushed. The granules have also been shown in vitro to remain
intact when exposed to apple, cranberry, grape, orange, pineapple, prune,
tomato, and V-8® vegetable
juice and stored up to 30 minutes.
For patients who have a nasogastric
tube in place, lansoprazole
delayed-release capsules can be opened and the intact granules mixed
in 40 ml of apple juice and injected
through the nasogastric
tube into the stomach. After
administering the granules, the nasogastric
tube should be flushed with additional
apple juice to clear the tube.
HOW SUPPLIED
Prevacid delayed-release capsules, 15 mg, are opaque, hard gelatin, colored
pink and green. The 30 mg are opaque, hard gelatin, pink and black colored
capsules.
Storage: Lansoprazole capsules should be stored in a tight
container protected from moisture. Store between (15-30°C) 59-86°F
PRODUCT LISTING
| Capsule, Enteric Coated - Oral
- 15 mg |
| 30's |
Prevacid, TAP Pharm |
00300-1541-30 |
| 1000's |
Prevacid, TAP Pharm |
00300-1541-19 |
| Capsule, Enteric Coated - Oral
- 30 mg |
| 100's |
Prevacid, TAP Pharm |
00300-3046-13 |
| 1000's |
Prevacid, TAP Pharm |
00300-3046-19 |
REFERENCES
1. National Committee for Clinical Laboratory Standards.
Summary Minutes, Subcommittee on Antimicrobial Susceptibility Testing,
Tampa, FL, January 11-13, 1998.
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