1.1 Duodenal Ulcer:
(omeprazole/sodium bicarbonate) is indicated for short-term treatment of active duodenal
ulcer. Most patients heal within four weeks. Some patients may require an additional four
weeks of therapy.
1.2 Gastric Ulcer
SOICARBY is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer
1.3 Treatment of Gastroesophageal Reflux Disease (GERD)
Symptomatic GERD SOICARBY is indicated for the treatment of heartburn and other
symptoms associated with GERD for up to 4 weeks. Erosive Esophagitis SOICARBY is
indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been
diagnosed by endoscopy. The efficacy of SOICARBY used for longer than 8 weeks in
these patients has not been established. If a patient does not respond to 8 weeks of
treatment, it may be helpful to give up to an additional 4 weeks of treatment. If there is
recurrence of erosive esophagitis or GERD symptoms (e.g., heartburn), additional 4-8
week courses of SOICARBY may be considered.
1.4 Maintenance of Healing of Erosive Esophagitis
SOICARBY is indicated to maintain healing of erosive esophagitis. Controlled studies do
not extend beyond 12 months.

SOICARBY (omeprazole/sodium bicarbonate) is available as a hard gelatin capsule 40 mg /
1100 mg strengths of omeprazole / sodium bicarbonate for adult use. Directions for use for
each indication are summarized in Table 1. All recommended doses throughout the labeling
are based upon omeprazole. Since the 40 mg capsules contain the same amount of sodium bicarbonate (1100 mg), two
capsules of 20 mg are not equivalent to one capsule of SOICARBY 40 mg; therefore, two 20
mg capsules of SOICARBY should not be substituted for one capsule of SOICARBY 40 mg.
SOICARBY should be taken on an empty stomach at least one hour before a meal. For
patients receiving continuous Nasogastric (NG)/ Orogastric (OG) tube feeding, enteral feeding
should be suspended approximately 3 hours before and 1 hour after administration of
SOICARBY Powder for Oral Suspension.

Special Populations:
Hepatic Insufficiency Consider dose reduction, particularly for maintenance of healing of
erosive esophagitis.

Administration of Capsules:
SOICARBY Capsules should be swallowed intact with water. DO NOT USE OTHER LIQUIDS.
DO NOT OPEN CAPSULE AND SPRINKLE CONTENTS INTO FOOD.
If SOICARBY is to be administered through a nasogastric (NG) or orogastric (OG) tube, the
suspension should be constituted with approximately 20 mL of water. DO NOT USE OTHER
LIQUIDS OR FOODS. Stir well and administer immediately. An appropriately-sized syringe
should be used to instill the suspension in the tube. The suspension should be washed through
the tube with 20 mL of water.

4.4.1 Concomitant Gastric Malignancy:
Symptomatic response to therapy with omeprazole does not preclude the presence of gastric
malignancy.
4.4.2 Atrophic gastritis
Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated
long-term with omeprazole.
4.4.3 Acute Interstitial Nephritis:
Acute interstitial nephritis has been observed in patients taking PPIs including SOICARBY.
Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed
to an idiopathic hypersensitivity reaction. Discontinue SOICARBY if acute interstitial nephritis
develops.
4.4.4 Cyanocobalamin (vitamin B-12) Deficiency:
Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer
than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B-12) caused by hypoor
achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing
therapy have been reported in the literature. This diagnosis should be considered if clinical
symptoms consistent with cyanocobalamin deficiency are observed.
4.4.5 Buffer Content:
The sodium content of SOICARBY products should be taken into consideration when
administering to patients on a sodium restricted diet. Because SOICARBY products contain
sodium bicarbonate, they should be used with caution in patients with Bartter’s syndrome,

hypokalemia, hypocalcemia, and problems with acid-base balance. Long-term administration
of bicarbonate with calcium or milk can cause milk-alkali syndrome. Chronic use of sodium
bicarbonate may lead to systemic alkalosis and increased sodium intake can produce edema
and weight increase.
4.4.6 Clostridium difficile Associated Diarrhea:
Published observational studies suggest that PPI therapy like SOICARBY may be associated
with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized
patients. This diagnosis should be considered for diarrhea that does not improve.
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the
condition being treated.
4.4.7 Interaction with Clopidogrel:
Avoid concomitant use of SOICARBY with clopidogrel. Clopidogrel is a prodrug. Inhibition of
platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of
clopidogrel to its active metabolite can be impaired by use with concomitant medications, such
as omeprazole, that interfere with CYP2C19 activity. Concomitant use of clopidogrel with 80
mg omeprazole reduces the pharmacological activity of clopidogrel, even when administered
12 hours apart. When using SOICARBY, consider alternative anti-platelet therapy.
4.4.8 Bone Fracture:
Several published observational studies suggest that proton pump inhibitor (PPI) therapy may
be associated with an increased risk for osteoporosis related fractures of the hip, wrist, or
spine. The risk of fracture was increased in patients who received high-dose, defined as
multiple daily doses, and long term PPI therapy (a year or longer). Patients should use the
lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Patients at risk for osteoporosis-related fractures should be managed according to the
established treatment guidelines.
4.4.9 Hypomagnesemia:
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients
treated with PPIs for at least three months, in most cases after a year of therapy. Serious
adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of
hypomagnesemia required magnesium replacement and discontinuation of the PPI. For
patients expected to be on prolonged treatment or who take PPIs with medications such as
digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals
may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
4.4.10 Concomitant Use of ZEGERID with St John’s Wort or Rifampin:
Drugs which induce CYP2C19 OR CYP34A (such as St John’s Wort or rifampin) can
substantially decrease omeprazole concentrations. Avoid concomitant use of SOICARBY with
St John’s Wort or rifampin.

4.4.11 Interactions with Investigations for Neuroendocrine Tumors:
Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric
acidity. The increased CgA level may cause false positive results in diagnostic investigations
for neuroendocrine tumors. Providers should temporarily stop omeprazole treatment before
assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial
tests are performed (e.g. for monitoring), the same commercial laboratory should be used for
testing, as reference ranges between tests may vary.
4.4.12 Concomitant Use of SOICARBY with Methotrexate:
Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose;
see methotrexate prescribing information) may elevate and prolong serum levels of
methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose
methotrexate administration, a temporary withdrawal of the PPI may be considered in some
patients.

4.5.1 Drugs for Which Gastric pH Can Affect Bioavailability:
Due to its effects on gastric acid secretion, omeprazole can reduce the absorption of drugs
where gastric pH is an important determinant of their bioavailability. Like with other drugs that
decrease the intragastric acidity, the absorption of drugs such as ketoconazole, atazanavir,
iron salts, erlotinib, and mycophenolate mofetil (MMF) can decrease, while the absorption of
drugs such as digoxin can increase during treatment with omeprazole.
Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects
increased the bioavailability of digoxin by 10% (30% in two subjects). Coadministration of
digoxin with SOICARBY is expected to increase the systemic exposure of digoxin. Therefore,
patients may need to be monitored when digoxin is taken concomitantly with SOICARBY.
Co-administration of omeprazole in healthy subjects and in transplant patients receiving MMF
has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA),
possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance
of reduced MPA exposure on organ rejection has not been established in transplant patients
receiving SOICARBY and MMF. Use SOICARBY with caution in transplant patients receiving
MMF.
4.5.2 Drugs Metabolized by Cytochrome P450 (CYP):
Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin, drugs that are
metabolized by oxidation in the liver. There have been reports of increased INR and
prothrombin time in patients receiving proton pump inhibitors, including omeprazole, and
warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding
and even death. Patients treated with proton pump inhibitors and warfarin may need to be
monitored for increases in INR and prothrombin time.

Although in normal subjects no interaction with theophylline or propranolol was found, there
have been clinical reports of interaction with other drugs metabolized via the cytochrome P-
450 system (e.g., cyclosporine, disulfiram, and benzodiazepines). Patients should be
monitored to determine if it is necessary to adjust the dosage of these drugs when taken
concomitantly with SOICARBY.
Concomitant administration of omeprazole and voriconazole (a combined inhibitor of
CYP2C19 and CYP3A4) resulted in more than doubling of the omeprazole exposure. Dose
adjustment of omeprazole is not normally required. When voriconazole (400 mg every 12
hours for one day, then 200 mg for 6 days) was given with omeprazole (40 mg once daily for
7 days) to healthy subjects, it significantly increased the steady-state Cmax and AUC024 of
omeprazole, an average of 2 times (90% CI: 1.8, 2.6) and 4 times (90% CI: 3.3, 4.4)
respectively as compared to when omeprazole was given without voriconazole.
Drugs known to induce CYP2C19 or CYP3A4 (such as rifampin) may lead to decreased
omeprazole serum levels. In a cross-over study in 12 healthy male subjects, St John’s wort
(300 mg three times daily for 14 days), an inducer of CYP3A4, decreased the systemic
exposure of omeprazole in CYP2C19 poor metabolisers (Cmax and AUC decreased by 37.5%
and 37.9%, respectively) and extensive metabolisers (Cmax and AUC decreased by 49.6%
and 43.9%, respectively). Avoid concomitant use of St. John’s Wort or rifampin with
omeprazole.

4.5.3 Antiretroviral Agents:
 

Concomitant administration of atazanavir and proton pump inhibitors is not recommended.
Co-administration of atazanavir with proton pump inhibitors is expected to substantially
decrease atazanavir plasma concentrations and thereby reduce its therapeutic effect.
Omeprazole has been reported to interact with some antiretroviral drugs. The clinical
importance and the mechanisms behind these interactions are not always known. Increased
gastric pH during omeprazole treatment may change the absorption of the antiretroviral drug.
Other possible interaction mechanisms are via CYP2C19. For some antiretroviral drugs, such
as atazanavir and nelfinavir, decreased serum levels have been reported when given together
with omeprazole. Following multiple doses of nelfinavir (1250 mg, twice daily) and omeprazole
(40 mg, daily), AUC was decreased by 36% and 92%, Cmax by 37% and 89% and Cmin by
39% and 75% respectively for nelfinavir and M8. Following multiple doses of atazanavir (400
mg, daily) and omeprazole (40 mg, daily, 2 hours before atazanavir), AUC was decreased by
94%, Cmax by 96%, and Cmin by 95%. Concomitant administration with omeprazole and
drugs such as atazanavir and nelfinavir is therefore not recommended.
Increased Concentration of Saquinavir:
For other antiretroviral drugs, such as saquinavir, elevated serum levels have been reported
with an increase in AUC by 82%, in Cmax by 75% and in Cmin by 106% following multiple
dosing of saquinavir/ritonavir (1000/100 mg) twice daily for 15 days with omeprazole 40 mg
daily co-administered days 11 to 15. Dose reduction of saquinavir should be considered from
the safety perspective for individual patients. There are also some antiretroviral drugs of which
unchanged serum levels have been reported when given with omeprazole.

4.5.4 Combination Therapy with Clarithromycin
Concomitant administration of clarithromycin with other drugs can lead to serious adverse
reactions due to drug interaction. Because of these drug interactions, clarithromycin is
contraindicated for co-administration with certain drugs.
4.5.5 Clopidogrel:
Omeprazole is an inhibitor of CYP2C19 enzyme. Clopidogrel is metabolized to its active
metabolite in part by CYP2C19. Concomitant use of omeprazole 80 mg results in reduced
plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet
inhibition. Avoid concomitant administration of SOICARBY with clopidogrel. When using
SOICARBY, consider use of alternative anti-platelet therapy.
4.5.6 Tacrolimus
Concomitant administration of omeprazole and tacrolimus may increase the serum levels of
tacrolimus.
4.5.7 Interactions with Investigations of Neuroendocrine Tumors:
Drug-induced decrease in gastric acidity results in enterochromaffin-like cell hyperplasia and
increased Chromogranin A levels which may interfere with investigations for neuroendocrine
tumors.
4.5.8 Methotrexate
Case reports, published population pharmacokinetic studies, and retrospective analyses
suggest that concomitant administration of PPIs and methotrexate (primarily at high dose; see
methotrexate prescribing information) may elevate and prolong serum levels of methotrexate
and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of
methotrexate with PPIs have been conducted.

Pregnancy Category C
Risk Summary There are no adequate and well-controlled studies on the use of SOICARBY
in pregnant women. Available epidemiologic data fail to demonstrate an increased risk of
major congenital malformations or other adverse pregnancy outcomes with first trimester
omeprazole use. Teratogenicity was not observed in animal reproduction studies with
administration of oral esomeprazole magnesium in rats and rabbits with doses about 68 times
and 42 times, respectively, an oral human dose of 40 mg (based on a body surface area basis
for a 60 kg person). However, changes in bone morphology were observed in offspring of rats
dosed through most of pregnancy and lactation at doses equal to or greater than
approximately 33.6 times an oral human dose of 40 mg. Because of the observed effect at
high doses of esomeprazole magnesium on developing bone in rat studies, SOICARBY
should be used during pregnancy only if the potential benefit justifies the potential risk to the
fetus.

SOICARBY not likely to affect the ability to drive or use machines. Adverse drug reactions
such as dizziness and visual disturbances may occur, if affected, patients should not drive or
operate machinery.

Clinical Trials Experience Because clinical trials are conducted under widely varying
conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly
compared to rates in the clinical trials of another drug and may not reflect the rates observed
in clinical practice. In the U.S. clinical trial population of 465 patients, the adverse reactions
summarized in Table 2 were reported to occur in 1% or more of patients on therapy with
omeprazole. Numbers in parentheses indicate percentages of the adverse reactions
considered by investigators as possibly, probably or definitely related to the drug.

Post marketing Experience the following adverse reactions have been identified during postapproval
use of omeprazole. Because these reactions are voluntarily reported from a
population of uncertain size, it is not always possible to reliably estimate their actual frequency
or establish a causal relationship to drug exposure
Body as a Whole: Hypersensitivity reactions, including anaphylaxis, anaphylactic shock,
angioedema, bronchospasm, interstitial nephritis, urticaria (see also Skin below), fever, pain,
fatigue, malaise.
Cardiovascular: Chest pain or angina, tachycardia, bradycardia, palpitation, elevated blood
pressure, and peripheral edema.
Gastrointestinal: Pancreatitis (some fatal), anorexia, irritable colon, flatulence, fecal
discoloration, esophageal candidiasis, mucosal atrophy of the tongue, dry mouth, stomatitis
and abdominal swelling. During treatment with omeprazole, gastric fundic gland polyps have
been noted rarely. These polyps are benign and appear to be reversible when treatment is
discontinued. Gastroduodenal carcinoids have been reported in patients with ZollingerEllison
syndrome on long-term treatment with omeprazole. This finding is believed to be a
manifestation of the underlying condition, which is known to be associated with such tumors.
Hepatic: Mild and, rarely, marked elevations of liver function tests [ALT (SGPT), AST (SGOT),
γ-glutamyl Trans-peptidase, alkaline phosphatase, and bilirubin (jaundice)]. In rare instances,
overt liver disease has occurred, including hepatocellular, cholestatic, or mixed hepatitis, liver
necrosis (some fatal), hepatic failure (some fatal), and hepatic encephalopathy.
Infections and Infestations: Clostridium difficile associated diarrhea.
Metabolism and Nutritional Disorders: Hyponatremia, hypoglycemia, hypomagnesemia,
and weight gain.
Musculoskeletal: Muscle cramps, myalgia, muscle weakness, joint pain, bone fracture, and
leg pain.
Nervous System/Psychiatric: Psychic disturbances including depression, agitation,
aggression, hallucinations, confusion, insomnia, nervousness, tremors, apathy, somnolence,
anxiety, dream abnormalities; vertigo; paresthesia; and hemifacial dysesthesia.
Respiratory: Epistaxis, pharyngeal pain.
Skin: Severe generalized skin reactions including toxic epidermal necrolysis (TEN; some
fatal), Stevens-Johnson syndrome, and erythema multiforme (some severe); purpura and/or
petechiae (some with rechallenge); skin inflammation, urticaria, angioedema, pruritus,
photosensitivity, alopecia, dry skin, and hyperhidrosis.
Special Senses: Tinnitus, taste perversion. Ocular: Blurred vision, ocular irritation, dry eye
syndrome, optic atrophy, anterior ischemic optic neuropathy, optic neuritis and double vision.
Urogenital: Interstitial nephritis (some with positive rechallenge), urinary tract infection,
microscopic pyuria, urinary frequency, elevated serum creatinine, proteinuria, hematuria,
glycosuria, testicular pain, and gynecomastia.
Hematologic: Rare instances of pancytopenia, agranulocytosis (some fatal),
thrombocytopenia, neutropenia, leukopenia, anemia, leucocytosis, and hemolytic anemia
have been reported.

The incidence of clinical adverse experiences in patients greater than 65 years of age was
similar to that in patients 65 years of age or less.
Additional adverse reactions that could be caused by sodium bicarbonate include metabolic
alkalosis, seizures, and tetany

Reports have been received of overdosage with omeprazole in humans. Doses ranged up to
2400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but
included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis,
flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal
clinical experience [See Adverse Reactions (6)]. Symptoms were transient, and no serious
clinical outcome has been reported when omeprazole was taken alone. No specific antidote
for omeprazole overdosage is known. Omeprazole is extensively protein bound and is,
therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic
and supportive. As with the management of any overdose, the possibility of multiple drug
ingestion should be considered. For current information on treatment of any drug overdose, a
certified Regional Poison Control Center should be contacted. Telephone numbers are listed
in the Physicians’ Desk Reference (PDR) or local telephone book. Single oral doses of
omeprazole at 1350, 1339, and 1200 mg/kg were lethal to mice, rats, and dogs, respectively.
Animals given these doses showed sedation, ptosis, tremors, convulsions, and decreased
activity, body temperature, and respiratory rate and increased depth of respiration. In addition,
a sodium bicarbonate overdose may cause hypocalcemia, hypokalemia, hypernatremia, and
seizures.

Antisecretory Activity
Results from a separate PK/PD study of antisecretory effect on repeated once-daily dosing of
40 mg/1100 mg of SOICARBY Capsules in healthy subjects show similar effects in general
on the above three PD parameters.
The antisecretory effect lasts longer than would be expected from the very short (1 hour)
plasma half-life, apparently due to irreversible binding to the parietal H+/K+ ATPase enzyme.
Enterochromaffin-like (ECL) Cell Effects
In 24-month carcinogenicity studies in rats, a dose-related significant increase in gastric
carcinoid tumors and ECL cell hyperplasia was observed in both male and female animals.
Carcinoid tumors have also been observed in rats subjected to fundectomy or long-term
treatment with other proton pump inhibitors or high doses of H2-receptor antagonists. Human
gastric biopsy specimens have been obtained from more than 3000 patients treated with
omeprazole in long-term clinical trials. The incidence of ECL cell hyperplasia in these studies
increased with time; however, no case of ECL cell carcinoids, dysplasia, or neoplasia has
been found in these patients. These studies are of insufficient duration and size rule out the
possible influence of long-term administration of omeprazole on the development of any
premalignant or malignant conditions.
Serum Gastrin Effects
In studies involving more than 200 patients, serum gastrin levels increased during the first 1
to 2 weeks of once-daily administration of therapeutic doses of omeprazole in parallel with
inhibition of acid secretion. No further increase in serum gastrin occurred with continued
treatment. In comparison with histamine H2-receptor antagonists, the median increases
produced by 20 mg doses of omeprazole were higher (1.3 to 3.6 fold vs. 1.1 to 1.8 fold
increase). Gastrin values returned to pretreatment levels, usually within 1 to 2 weeks after
discontinuation of therapy.
Increased gastrin causes enterochromaffin-like cell hyperplasia and increased serum
Chromogranin A (CgA) levels. The increased CgA levels may cause false positive results in
diagnostic investigations for neuroendocrine tumors.
Other Effects
Systemic effects of omeprazole in the CNS, cardiovascular and respiratory systems have not
been found to date. Omeprazole, given in oral doses of 30 or 40 mg for 2 to 4 weeks, had no
effect on thyroid function, carbohydrate metabolism, or circulating levels of parathyroid
hormone, cortisol, estradiol, testosterone, prolactin, cholecystokinin or secretin. No effect on
gastric emptying of the solid and liquid components of a test meal was demonstrated after a

single dose of omeprazole 90 mg. In healthy subjects, a single I.V. dose of omeprazole (0.35
mg/kg) had no effect on intrinsic factor secretion. No systematic dose-dependent effect has
been observed on basal or stimulated pepsin output in humans. However, when intragastric
pH is maintained at 4.0 or above, basal pepsin output is low, and pepsin activity is decreased.
As do other agents that elevate intragastric pH, omeprazole administered for 14 days in
healthy subjects produced a significant increase in the intragastric concentrations of viable
bacteria. The pattern of the bacterial species was unchanged from that commonly found in
saliva. All changes resolved within three days of stopping treatment.
The course of Barrett’s esophagus in 106 patients was evaluated in a U.S. double-blind
controlled study of omeprazole 40 mg b.i.d. for 12 months followed by 20 mg b.i.d. for 12
months or ranitidine 300 mg b.i.d. for 24 months. No clinically significant impact on Barrett’s
mucosa by antisecretory therapy was observed. Although neosquamous epithelium
developed during antisecretory therapy, complete elimination of Barrett’s mucosa was not
achieved. No significant difference was observed between treatment groups in development
of dysplasia in Barrett’s mucosa and no patient developed esophageal carcinoma during
treatment. No significant differences between treatment groups were observed in
development of ECL cell hyperplasia, corpus atrophic gastritis, corpus intestinal metaplasia,
or colon polyps exceeding 3 mm in diameter.

Absorption
In separate in vivo bioavailability studies, when SOICARBY Oral Suspension and Capsules
are administered on an empty stomach 1 hour prior to a meal, the absorption of omeprazole
is rapid, with mean peak plasma levels (% CV) of omeprazole being 1954 ng/mL (33%) and
1526 ng/mL (49%), respectively, and time to peak of approximately 30 minutes (range 10-90
min) after a single-dose or repeated-dose administration. The bioavailability of omeprazole
from SOICARBY increases upon repeated administration. When SOICARBY is administered
1 hour after a meal, the omeprazole AUC is reduced by approximately 24% relative to
administration 1 hour prior to a meal. Distribution Omeprazole is bound to plasma proteins.
Protein binding is approximately 95%.
Metabolism
Following single-dose oral administration of omeprazole, the majority of the dose (about 77%)
is eliminated in urine as at least six metabolites. Two metabolites have been identified as
hydroxyomeprazole and the corresponding carboxylic acid. The remainder of the dose was
recoverable in feces. This implies a significant biliary excretion of the metabolites of
omeprazole. Three metabolites have been identified in plasma – the sulfide and sulfone
derivatives of omeprazole, and hydroxyomeprazole. These metabolites have very little or no
antisecretory activity.

Excretion
Following single-dose oral administration of omeprazole, little if any, unchanged drug is
excreted in urine. The mean plasma omeprazole half-life in healthy subjects is approximately
1 hour (range 0.4 to 3.2 hours) and the total body clearance is 500-600 mL/min.
Concomitant Use with Clopidogrel
In a crossover clinical study, 72 healthy subjects were administered clopidogrel (300 mg
loading dose followed by 75 mg per day) alone and with omeprazole (80 mg at the same time
as clopidogrel) for 5 days. The exposure to the active metabolite of clopidogrel was decreased
by 46% (Day 1) and 42% (Day 5) when clopidogrel and omeprazole were administered
together. Results from another crossover study in healthy subjects showed a similar
pharmacokinetic interaction between clopidogrel (300 mg loading dose/75 mg daily
maintenance dose) and omeprazole 80 mg daily when coadministered for 30 days. Exposure
to the active metabolite of clopidogrel was reduced by 41% to 46% over this time period.
In another study, 72 healthy subjects were given the same doses of clopidogrel and 80 mg
omeprazole but the drugs were administered 12 hours apart; the results were similar,
indicating that administering clopidogrel and omeprazole at different times does not prevent
their interaction.
Concomitant Use with Mycophenolate Mofetil
Administration of omeprazole 20 mg twice daily for 4 days and a single 1000 mg dose of MMF
approximately one hour after the last dose of omeprazole to 12 healthy subjects in a crossover
study resulted in a 52% reduction in the Cmax and 23% reduction in the AUC of MPA.
Special Populations
Geriatric
The elimination rate of omeprazole was somewhat decreased in the elderly, and bioavailability
was increased. Omeprazole was 76% bioavailable when a single 40-mg oral dose of
omeprazole (buffered solution) was administered to healthy elderly subjects, versus 58% in
young subjects given the same dose. Nearly 70% of the dose was recovered in urine as
metabolites of omeprazole and no unchanged drug was detected. The plasma clearance of
omeprazole was 250 mL/min (about half that of young subjects) and its plasma half-life
averaged one hour, similar to that of young healthy subjects.
Pediatric
The pharmacokinetics of SOICARBY has not been studied in patients < 18 years of age.
Gender
There are no known differences in the absorption or excretion of omeprazole between males
and females.

Hepatic Insufficiency
In patients with chronic hepatic disease, the bioavailability of omeprazole from a buffered
solution increased to approximately 100% compared to an I.V. dose, reflecting decreased firstpass
effect, and the mean plasma half-life of the drug increased to nearly 3 hours compared
to the mean half-life of 1 hour in normal subjects. Plasma clearance averaged 70 mL/min,
compared to a value of 500-600 mL/min in normal subjects. Dose reduction, particularly where
maintenance of healing of erosive esophagitis is indicated, for the hepatically impaired should
be considered.
Renal Insufficiency
In patients with chronic renal impairment, whose creatinine clearance ranged between 10 and
62 mL/min/1.73 m2, the disposition of omeprazole from a buffered solution was very similar to
that in healthy subjects, although there was a slight increase in bioavailability. Because urinary
excretion is a primary route of excretion of omeprazole metabolites, their elimination slowed
in proportion to the decreased creatinine clearance. No dose reduction is necessary in patients
with renal impairment.
Asian Population
In pharmacokinetic studies of single 20-mg omeprazole doses, an increase in AUC of
approximately four-fold was noted in Asian subjects compared to Caucasians. Dose
adjustment, particularly where maintenance of healing of erosive esophagitis is indicated, for
Asian subjects should be considered.

Pediatric Use
Safety and effectiveness of ZEGERID have not been established in pediatric patients less
than 18 years of age.
Juvenile Animal Data
In a juvenile rat toxicity study, esomeprazole was administered with both magnesium and
strontium salts at oral doses about 34 to 68 times a daily human dose of 40 mg on a body
surface area basis. Increases in death were seen at the high dose, and at all doses of
esomeprazole, there were decreases in body weight, body weight gain, femur weight and
femur length, and decreases in overall growth.
Geriatric Use
Omeprazole was administered to over 2000 elderly individuals (≥ 65 years of age) in clinical
trials in the U.S. and Europe. There were no differences in safety and effectiveness between
the elderly and younger subjects. Other reported clinical experience has not identified
differences in response between the elderly and younger subjects, but greater sensitivity of
some older individuals cannot be ruled out.

Pharmacokinetic studies with buffered omeprazole have shown the elimination rate was
somewhat decreased in the elderly and bioavailability was increased. The plasma clearance
of omeprazole was 250 mL/min (about half that of young subjects). The plasma half-life
averaged one hour, about twice that in nonelderly, healthy subjects taking SOICARBY.
However, no dosage adjustment is necessary in the elderly.

1. Croscarmellose Sodium (PRIMELLOSE)
2. Sodium Stearyl Fumarate
3. HARD GELATIN CAPSULE SIZE00

Not applicable.

Store below 30 ºC and keep in the original pack to protect from light, in a dry place.

SoiCarby 40/1100 Capsule: Hard-shell gelatin capsule with dark blue opaque cap and
white opaque body filled with white to yellowish powder, imprinted "JS58" on cap and
"40/1100" on body.
SoiCarby 40/1100 Capsule available in pack containing 28 Capsule per Pack (7 Capsules
per blister - 4 blister per pack).

Any unused medicinal product or waste material should be disposed of in accordance with
local requirements, Keep out of the reach & sight of children