OMEPRAZOL

Indication & Oral

Dosage Peptic ulcer
Adult: 20 mg daily as a single dose or 40 mg daily in severe cases.
Treatment duration: Duodenal ulcers: 4 wk; gastric ulcers: 8 wk.
Maintenance: 10-20 mg once daily.
Hepatic impairment: Dose reduction may be necessary.
Oral
NSAID-associated ulceration
Adult: 20 mg daily. Same dose may also be used for prophylaxis of
ulceration in patients who require continued NSAID therapy.
Hepatic impairment: Dose reduction may be necessary.
Oral
H.pylori infection
Adult: Dose varies with regimen. As triple therapy: 20 mg bid or 40 mg
once daily; requires combination therapy with antibiotics. Therapy is
given for 1 wk. Omeprazole may be continued for another 4-8 wk on its
own.
Hepatic impairment: Dose reduction may be necesary.
Oral
Gastro-oesophageal reflux disease
Adult: 20 mg once daily for 4 wk, may continue for another 4-8 wk if
necessary. Maintenance: 10 mg daily.
Child: Neonate, 1 mth-2 yr: 700 mcg/kg/day, may increase up to 3
mg/kg/day, or 20 mg daily. >2 yr: <20 kg: 10 mg once daily; 20 kg: 20
mg daily. Doses may be doubled if necessary.
Hepatic impairment: Dose reduction may be necessary.
Oral
Zollinger-Ellison syndrome
Adult: Initially, 60 mg once daily, adjust according to response.
Maintenance: 20-120 mg daily. Doses >80 mg are administered usually in
2 divided doses.
Hepatic impairment: Dose reduction may be necessary.
Oral
Prophylaxis of acid aspiration during general anaesthesia
Adult: Initially, 40 mg given the evening before surgery and another 40
mg 2-6 hr before the procedure.
Hepatic impairment: Dose reduction may be necessary.
Oral
Acid-related dyspepsia
Adult: 10 or 20 mg daily for 2-4 wk.
Hepatic impairment: Dose reduction may be necessary.
Oral
Erosive oesophagitis
Adult: 20 mg/day for 4-8 wk. Maintenance of healing: 20 mg/day for up
to 12 mth of total therapy (including treatment period).
Hepatic impairment: Dose reduction may be necessary.
 Intravenous
Reflux oesophagitis
Adult: By infusion over 20-30 minutes or slow inj over 5 minutes: 40 mg
once daily until oral admin is possible.
Hepatic impairment: Dose adjustment is required; a daily dose of 10-20
mg may be sufficient.
Intravenous
Gastric and duodenal ulcers
Adult: By infusion over 20-30 minutes or slow inj over 5 minutes: 40 mg
once daily until oral admin is possible.
Hepatic impairment: Dose adjustment is required; a daily dose of 10-20
mg may be sufficient.
Intravenous
Prophylaxis of acid aspiration during general anaesthesia
Adult: 40 mg, to be given and completed 1 hr before the surgery. May be
given via inj over 5 minutes or infusion over 20-30 minutes.
Hepatic impairment: Dose adjustment is required; a daily dose of 10-20
mg may be sufficient.

Reconstitution: The solution for IV inj is obtained by adding to the vial

10 ml of the solvent provided. (No other solvent should be used). The
solution should be given over a period of at least 2.5 min at a max rate of
4 ml/minute; use within 4 hr of reconstitution. The solution for IV
infusion is obtained by dissolving 1 vial in 100 ml saline for infusion or
100 ml 5% dextrose for infusion. The solution should be used within 12
hr when dissolved in saline and within 6 hr when dissolved in 5%
dextrose. After reconstitution, start the infusion immediately. The
constituted solution should not be mixed or co-administered in the same
infusion set with any other drug. Infusion should be given over a period
of 20-30 minutes.
Administration MUPS tab: May be taken with or without food.
Powd for oral susp: Should be taken on an empty stomach. Take on an
empty stomach at least 1 hr before a meal.
Cap: Should be taken with food. Take immediately before a meal.
Overdosage Confusion, drowsiness, blurred vision, tachycardia, nausea, flushing,
diaphoresis, headache, and dry mouth. Treatment is supportive; not
dialysable.
Special Exclude malignancy, prolonged use, hepatic impairment. Pregnancy,
Precautions lactation, children <1 yr. Elderly and Asians (increased bioavailability).
Adverse Drug Diarrhoea, nausea, fatigue, constipation, vomiting, flatulence, acid
Reactions regurgitation, taste perversion, arthralgia, myalgia, urticaria, dry mouth,
dizziness, headache, paraesthesia, abdominal pain, skin rashes, weakness,
back pain, upper respiratory infection, cough.
Potentially Fatal: Anaphylaxis.
Drug Interactions Decreases absorption of itraconazole, ketoconazole, dasatinib, oral iron
salts. Decreases levels of nelfinavir. Increases levels of benzodiazepines
(e.g. diazepam, midazolam, triazolam), HMG-CoA reductase inhibitor,
CYP2C19 substrates (e.g. citalopram, diazepam, methsuximide,
 phenytoin, propranolol, and sertraline), and CYP2C9 substrates (e.g.
bosentan, dapsone, fluoxetine, glimepiride, glipizide, losartan,
montelukast, nateglinide, paclitaxel, phenytoin, warfarin, and zafirlukast).
Decreased levels/effects with CYP2C19 inducers (e.g.
aminoglutethimide, carbamazepine, phenytoin, and rifampin). Decreases
excretion of methotrexate. Enhances the adverse/toxic effect of cilostazol.
May alter the concentrations/effects of clozapine. Avoid concurrent use
with clopidogrel.
Potentially Fatal: Decreases absorption of itraconazole, ketoconazole,
dasatinib, oral iron salts. Decreases levels of nelfinavir. Increases levels
of benzodiazepines (e.g. diazepam, midazolam, triazolam), HMG-CoA
reductase inhibitor, CYP2C19 substrates (e.g. citalopram, diazepam,
methsuximide, phenytoin, propranolol, and sertraline), and CYP2C9
substrates (e.g. bosentan, dapsone, fluoxetine, glimepiride, glipizide,
losartan, montelukast, nateglinide, paclitaxel, phenytoin, warfarin, and
zafirlukast). Decreased levels/effects with CYP2C19 inducers (e.g.
aminoglutethimide, carbamazepine, phenytoin, and rifampin). Decreases
excretion of methotrexate. Enhances the adverse/toxic effect of cilostazol.
May alter the concentrations/effects of clozapine. Avoid concurrent use
with clopidogrel.
Food Interaction Absorption may be delayed. St John's wort decreases omeprazole levels.
Avoid ethanol (may cause gastric mucosal irritation).
Lab Interference False negative results in the urea breath test.
Pregnancy
Category (US
FDA) Category C: Either studies in animals have revealed adverse effects on
the foetus (teratogenic or embryocidal or other) and there are no
controlled studies in women or studies in women and animals are not
available. Drugs should be given only if the potential benefit justifies the
potential risk to the foetus.
Storage Intravenous: Store at 15-30 C. Protect from light. Oral: Store at 15-30
C. Protect from light.
Mechanism of Omeprazole suppresses gastric acid secretion by specific inhibition of the
Action enzyme system hydrogen/potassium adenosine triphosphatase (H+/K+
ATPase) present on the secretory surface of the gastric parietal cell.
Onset: Antisecretory: approx 1 hr; peak effect:0.5-3.5 hr.
Duration: 72 hr.
Absorption: Rapid but variable (oral); dose-dependent. Bioavailability:
Oral: approx 30-40%.
Distribution: Protein-binding: 95%.
Metabolism: Extensively hepatic; converted to hydroxyomeprazole and
omeprazole sulfone.
Excretion: Via urine (77%) and bile. Elimination half-life: 0.5-3 hr.
MIMS Class Antacids, Antireflux Agents & Antiulcerants
ATC A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors.
Classification Used in the treatment of peptic ulcer and gastro-oesophageal reflux
disease (GERD).
FAMOTIDINE

Indication & Oral

Dosage Benign gastric and duodenal ulceration
Adult: 40 mg daily at bedtime for 4-8 wk or 20 mg bid. To prevent
recurrence of duodenal ulceration: 20 mg at bedtime may be taken.
CrCl (ml/min) Dosage Recommendation
<50 Halve the dose or increase dosing interval to 36-48 hr.

Oral
Gastro-oesophageal reflux disease
Adult: 20 mg bid for 6-12 wk or up to 40 mg bid if there is oesophageal
ulceration. Maintenance dose: 20 mg bid may be given to prevent
recurrence.
Child: 1-16 yr: 1-2 mg/kg/day divided bid up to 40 mg bid.
CrCl (ml/min) Dosage Recommendation
<50 Halve the dose or increase dosing interval to 36-48 hr.

Oral
Zollinger-Ellison syndrome
Adult: Initially, 20 mg every 6 hr, up to 800 mg daily if necessary.
Child: 1-16 yr: 0.5-1 mg/kg/day up to 40 mg/day, given once at bedtime
or taken bid.
CrCl (ml/min) Dosage Recommendation
<50 Halve the dose or increase dosing interval to 36-48 hr.

Oral
Non-ulcer dyspepsia
Adult: 10 mg bid.
CrCl (ml/min) Dosage Recommendation
<50 Halve the dose or increase dosing interval to 36-48 hr.

Oral
Heartburn
Adult: 10 mg bid.
CrCl (ml/min) Dosage Recommendation
<50 Halve the dose or increase dosing interval to 36-48 hr.

Intravenous
Benign gastric and duodenal ulceration
 Adult: 20 mg every 12 hr, as an inj over at least 2 minutes or as an
infusion over 15-30 minutes.
CrCl (ml/min) Dosage Recommendation
<50 Halve the dose or increase dosing interval to 36-48 hr.
Administration May be taken with or without food.
Contraindications Hypersensitivity; lactation.
Special Impaired renal function, liver cirrhosis; pregnancy. Possibility of
Precautions malignancy should be considered prior to initiating treatment as drug may
mask symptoms and delay diagnosis. No safety and efficacy data is
available for children <1 yr.
Adverse Drug Headache, dizziness, constipation, diarrhoea, nausea, rash, GI discomfort,
Reactions fatigue, gynaecomastia, impotence.
Drug Interactions Reduced absorption of famotidine with antacids hence admin should be
separated by 2 hr. Reduced absorption of ketoconazole and itraconazole.
Avoid ethanol (may cause gastric mucosal irritation).
Potentially Fatal: Reduced absorption of famotidine with antacids hence
admin should be separated by 2 hr. Reduced absorption of ketoconazole
and itraconazole. Avoid ethanol (may cause gastric mucosal irritation).
Pregnancy
Category (US
FDA) Category B: Either animal-reproduction studies have not demonstrated a
foetal risk but there are no controlled studies in pregnant women or
animal-reproduction studies have shown an adverse effect (other than a
decrease in fertility) that was not confirmed in controlled studies in
women in the 1st trimester (and there is no evidence of a risk in later
trimesters).
Storage Intravenous: Refrigerate at 2-8C. Do not freeze. Oral: Store below
25C.
Mechanism of Famotidine competitively blocks histamine H2-receptors thus reducing
Action basal, nocturnal and stimulated gastric acid secretion. Pepsin secretion is
reduced resulting in decreased peptic activity. It effectively heals
duodenal and gastric ulcers and prevents recurrence.
Absorption: Readily but incompletely absorbed from the GI tract; peak
plasma concentrations after 1-3 hr (oral).
Distribution: Enters the breast milk. Protein-binding: 15-20%.
Metabolism: Hepatic (small proportion); converted to famotidine S-
oxide.
Excretion: Urine (as unchanged) within 24 hr; 2.5-3.5 hr (elimination
half-life).
MIMS Class Antacids, Antireflux Agents & Antiulcerants
ATC A02BA03 - famotidine ; Belongs to the class of H2-receptor antagonists.
Classification Used in the treatment of peptic ulcer and gastro-oesophageal reflux
disease (GERD).
Ranitidine

Indication & Oral

Dosage Benign gastric and duodenal ulceration
Adult: Initially, 300 mg as a single daily dose at bedtime or 150 mg bid;
300 mg bid for 4 wk may be used in duodenal ulcer to improve healing).
Treatment duration: 4-8 wk for benign gastric and duodenal ulceration; up
to 8 wk in NSAID-associated ulceration. For prevention of NSAID-
associated ulceration: 150 mg bid.
Child: 3-12 yr: 2-4 mg/kg (max: 150 mg) bid for 4-8 wk.
Renal impairment: Dosage reduction is required in severe renal
impairment.
CrCl (ml/min) Dosage Recommendation
20 Dosage should be halved.

Oral
H.pylori infection
Adult: 300 mg once daily or 150 mg bid in combination with amoxicillin
750 mg tid and metronidazole 500 mg tid given for 2 wk. Treatment with
ranitidine may be continued for a further 2 wk.
Renal impairment: Dosage reduction is required in severe renal
impairment.
CrCl (ml/min) Dosage Recommendation
20 Dosage should be halved.

Oral
Gastro-oesophageal reflux disease
Adult: 150 mg bid or 300 mg at bedtime for up to 8 wk, may increase to
150 mg four times daily for 12 wk in severe cases.
Child: 5-10 mg/kg daily, given in 2 divided doses.
Renal impairment: Dosage reduction is required in severe renal
impairment.
CrCl (ml/min) Dosage Recommendation
20 Dosage should be halved.

Oral
Hypersecretory conditions
Adult: Initially, 150 mg bid/tid increased to 6 g daily if necessary.
Renal impairment: Dosage reduction is required in severe renal
impairment.
CrCl (ml/min) Dosage Recommendation
20 Dosage should be halved.
Oral
Acid aspiration during general anaesthesia
Adult: 150 mg given 2 hr before induction of anaesthesia and preferably,
an additional dose on the previous evening.
Renal impairment: Dosage reduction is required in severe renal
impairment.
CrCl (ml/min) Dosage Recommendation
20 Dosage should be halved.

Oral
Dyspepsia
Adult: 75 mg repeated if necessary up to 4 doses daily. Max: 2 wk of
continuous use at each time. For chronic episodic dyspepsia: 150 mg bid
for up to 6 wk.
Renal impairment: Dosage reduction is required in severe renal
impairment.
CrCl (ml/min) Dosage Recommendation
20 Dosage should be halved.

Parenteral
Prophylaxis of acid aspiration during general anaesthesia
Adult: 50 mg IV/IM given 45-60 minutes before the induction of
anaesthesia.
Renal impairment: Dosage reduction is required in severe renal
impairment.
CrCl (ml/min) Dosage Recommendation
20 Doses should be halved.

Intravenous
Hypersecretory conditions
Adult: Initially, 1 mg/kg/hr IV infusion, may increase by increments of
0.5 mg/kg/hr starting after 4 hr if necessary.
Renal impairment: Dosage reduction is required in severe renal
impairment.
CrCl (ml/min) Dosage Recommendation
20 Dosage should be halved.

Intravenous
Stress ulceration of upper gastrointestinal tract
Adult: 50 mg by slow IV Inj as priming dose followed by 125-250
mcg/kg/hr as continuous IV infusion then transfer to oral dose of 150 mg
bid once oral feeding is resumed.
Renal impairment: Dosage reduction is required in severe renal
impairment.
CrCl (ml/min) Dosage Recommendation
 20 Dosage should be halved.
Administration May be taken with or without food.
Overdosage May lead to muscular tremors, vomiting and rapid respiration.
Contraindications Porphyria.
Special Exclude malignancy before treating gastric ulcer. Renal and hepatic
Precautions impairment. Infants, pregnancy and lactation.
Adverse Drug Headache, dizziness. Rarely hepatitis, thrombocytopaenia, leucopaenia,
Reactions hypersensitivity, confusion, gynaecomastia, impotence, somnolence,
vertigo, hallucinations.
Potentially Fatal: Anaphylaxis, hypersensitivity reactions.
Drug Interactions Antacids may interfere with absorption. May decrease the GI absorption
of ketoconazole. Smoking may decrease the plasma levels of ranitidine.
May cause an increase in the bioavailability of furosemide.
Potentially Fatal: Antacids may interfere with absorption. May decrease
the GI absorption of ketoconazole. Smoking may decrease the plasma
levels of ranitidine. May cause an increase in the bioavailability of
furosemide.
Pregnancy
Category (US
FDA) Category B: Either animal-reproduction studies have not demonstrated a
foetal risk but there are no controlled studies in pregnant women or
animal-reproduction studies have shown an adverse effect (other than a
decrease in fertility) that was not confirmed in controlled studies in
women in the 1st trimester (and there is no evidence of a risk in later
trimesters).
Mechanism of Ranitidine blocks histamine H2-receptors in the stomach and prevents
Action histamine-mediated gastric acid secretion. It does not affect pepsin
secretion, pentagastrin-stimulated factor secretion or serum gastrin.
Absorption: 50% with peak plasma concentrations after 2-3 hr (oral);
rapid with peak plasma concentrations after 15 min (IM).
Distribution: Widely distributed. Crosses the placental barrier and enters
breast milk. Protein-binding: 20%
Metabolism: Hepatic; converted to N-oxide, S-oxide and
desmethylranitidine.
Excretion: Urine (as unchanged drug) within 24 hr; faeces; 2-3 hr
(elimination half-life).
MIMS Class Antacids, Antireflux Agents & Antiulcerants
ATC A02BA02 - ranitidine ; Belongs to the class of H2-receptor antagonists.
Classification Used in the treatment of peptic ulcer and gastro-oesophageal reflux
disease (GERD).
Cimetidine

Indication & Oral

Dosage Benign gastric and duodenal ulceration
Adult: Initially, 800 mg as a single daily dose given at bedtime for at
least 4 wk for duodenal ulcers and 6 wk for gastric ulcers. Maintenance:
400 mg once daily at bedtime or bid.
CrCl (ml/min) Dosage Recommendation
30-50 200 mg 4 times daily.
15-30 200 mg tid.
0-15 200 mg bid.

Oral
Stress ulceration of upper gastrointestinal tract
Adult: 200-400 mg every 4-6 hr.
CrCl (ml/min) Dosage Recommendation
30-50 200 mg 4 times daily.
15-30 200 mg tid.
0-15 200 mg bid.

Oral
Prophylaxis of acid aspiration during general anaesthesia
Adult: 400 mg is given orally 90-120 minutes before induction of
anaesthesia or at the start of labour and up to 400 mg may be given every
4 hr if necessary.
CrCl (ml/min) Dosage Recommendation
30-50 200 mg 4 times daily.
15-30 200 mg tid.
0-15 200 mg bid.

Oral
Gastro-oesophageal reflux disease
Adult: 400 mg 4 times daily or 800 mg bid for 4-8 wk.
CrCl (ml/min) Dosage Recommendation
30-50 200 mg 4 times daily.
15-30 200 mg tid.
0-15 200 mg bid.

Oral
 Zollinger-Ellison syndrome
Adult: 300-400 mg 4 times daily, increase dose if necessary.
CrCl (ml/min) Dosage Recommendation
30-50 200 mg 4 times daily.
15-30 200 mg tid.
0-15 200 mg bid.

Oral
Non-ulcer dyspepsia
Adult: Up to 200 mg 4 times daily.
CrCl (ml/min) Dosage Recommendation
30-50 200 mg 4 times daily.
15-30 200 mg tid.
0-15 200 mg bid.

Oral
Prophylaxis of nocturnal heartburn
Adult: 100 mg at night.
CrCl (ml/min) Dosage Recommendation
30-50 200 mg 4 times daily.
15-30 200 mg tid.
0-15 200 mg bid.

Oral
Pancreatic insufficiency
Adult: 800-1600 mg daily in 4 divided doses, to be taken 60-90 minutes
before meals.
CrCl (ml/min) Dosage Recommendation
30-50 200 mg 4 times daily.
15-30 200 mg tid.
0-15 200 mg bid.

Intravenous
Stress ulceration of upper gastrointestinal tract
Adult: 200 mg every 4-6 hr.
Administration Should be taken with food.
Overdosage Overdosage may lead to respiratory failure and tachycardia that may be
controlled by assisted respiration and admin of a -blocker.
Contraindications Hypersensitivity, lactation.
Special Impaired renal and hepatic function. Age >50 yr; CV impairment.
Precautions Pregnancy.
Adverse Drug Diarrhoea, dizziness, tiredness, rash, headache, CNS disturbances,
Reactions arthralgia, myalgia, gynaecomastia, alopoecia, blood dyscrasias, nephritis,
hepatitis, pancreatitis, granulocytopenia, hypersensitivity reactions.
Drug Interactions Absorption reduced by antacids. May potentiate anticoagulants,
phenytoin, theophylline, benzodiazepines, -blockers, lidocaine.
Procainamide clearance is reduced. Reduced absorption of ketoconazole
and itraconazole. May enhance gastric mucosal irritation when taken with
ethanol. Avoid concurrent use with clopidogrel.
Potentially Fatal: Absorption reduced by antacids. May potentiate
anticoagulants, phenytoin, theophylline, benzodiazepines, -blockers,
lidocaine. Procainamide clearance is reduced. Reduced absorption of
ketoconazole and itraconazole. May enhance gastric mucosal irritation
when taken with ethanol. Avoid concurrent use with clopidogrel.
Food Interaction Absorption delayed.
Pregnancy
Category (US
FDA) Category B: Either animal-reproduction studies have not demonstrated a
foetal risk but there are no controlled studies in pregnant women or
animal-reproduction studies have shown an adverse effect (other than a
decrease in fertility) that was not confirmed in controlled studies in
women in the 1st trimester (and there is no evidence of a risk in later
trimesters).
Mechanism of Cimetidine competitively inhibits histamine at H2-receptors of the gastric
Action parietal cells resulting in decreased gastric acid secretion, gastric volume
and hydrogen ion concentration. It is a potent inhibitor of metabolism in
the hepatic mixed-function oxidase systems. It is also used in patients
with pancreatic insufficiency to reduce the breakdown of pancreatic
enzyme supplements.
Onset: 1 hr.
Duration: 4-6 hr.
Absorption: Readily absorbed from the GI tract; peak plasma
concentrations after 1-3 hr. Food delays the rate and slightly decreases
extent of absorption.
Distribution: Widely distributed in the body; crosses the placental barrier
and appears in breast milk. Protein-binding: 20%.
Metabolism: Partially hepatic; converted to the sulfoxide and to
hydroxymethylcimetidine.
Excretion: Urine (as unchanged); 2 hr (elimination half-life).
MIMS Class Antacids, Antireflux Agents & Antiulcerants
ATC A02BA01 - cimetidine ; Belongs to the class of H2-receptor antagonists.
Classification Used in the treatment of peptic ulcer and gastro-oesophageal reflux
disease (GERD).
Omeprazole
Obat Bermerek :

Contral, Dudencer, Inhipump, Lokev, Loklor, Losec, Meisec, Norsec, Omevell, OMZ, Onic,
Opm, Oprezol, Ozid, Prilos, Prohibit, Promezol, Protop, Pumpitor, Redusec, Regasec, Rocer,
Socid, Stomacer, Ulzol, Zepral, Zollocid.

KOMPOSISI

Omeprazole 20 mg : Tiap kapsul mengandung Omeprazole 20 mg.

Omeprazole 10 mg : Tiap kapsul mengandung Omeprazole 10 mg.

FARMAKOLOGI

Omeprazole bekerja menghambat sekresi asam lambung dengan cara berikatan pada pompa
H+K+ATPase (pompa proton) dan mengaktifkannya sehingga terjadi pertukaran ion kalium
dan ion hydrogen dalam lumen sel. Omeprazole berikatan pada enzim ini secara irreversibel,
tetapi reseptor-H2 tidak dipengaruhi. Secara klinis, tidak terdapat efek farmakodinamik yang
berarti selain efek obat ini terhadap sekresi asam. Pemberian melalui oral dari obat ini
menghambat sekresi asam lambung dan stimulasi pentagastrik.

CARA KERJA :

Omeprazol menghambat sekresi asam lambung dengan cara berikatan pada pompa H + K +
ATPase dan mengaktifkannya sehingga terjadi pertukaran ion kalium dan ion hydrogen dalam
lumen sel. Omeprazole berikatan pada enzim ini secara irreversibel, tetapi reseptor-H2 tidak
dipengaruhi. Secara klinis, tidak terdapat efek farmakodinamik yang berarti selain efek obat
ini terhadap sekresi asam. Pemberian melalui oral dari obat ini menghambat basal dan sekresi
asam yang distimulasi oleh pentagastrin.IndikasiOmeprazol diindikasikan untuk pengobatan
jangka pendek tukak lambung, tukak duodenum dan refluks esofagitis; pengobatan sindroma
Zollinger-Ellison.

INDIKASI

Pengobatan jangka pendek tukak duodenal dan yang tidak responsif terhadap obat-obat
antagonis reseptor H2.
Pengobatan jangka pendek tukak lambung.
Pengobatan refluks esofagitis erosif / ulseratif yang telah didiagnosa melalui endoskopi.
Pengobatan jangka lama pada sindroma Zollinger Ellison.

KONTRAINDIKASI

Omeprazole sebaiknya tidak diberikan pada penderita hipersensitif terhadap omeprazole.

DOSIS DAN ATURAN PAKAI

Dosis yang dianjurkan 20 mg atau 40 mg, sekali sehari.

 Penderita dengan gejala tukak duodenal : lama pengobatan memerlukan waktu 2
minggu, dan dapat diperpanjang sampai 2 minggu lagi.
Penderita dengan gejala tukak lambung atau refluks esofagitis erosif/ulseratif : lama
pengobatan memerlukan waktu 4 mimggu, dan dapat diperpanjang sampai 4 minggu
lagi.
Penderita yang sukar disembuhkan dengan pengobatan lain, diperlukan 40 mg sekali
sehari.
Penderita sindroma Zollinger Ellison dosis awal 20-160 mg sekali sehari, dosis ini harus
disesuaikan untuk masing-masing penderita. Untuk dosis lebih dari 80 mg sehari, dosis
harus dibagi 2 kali sehari.
Kapsul harus ditelan utuh dengan air (kapsul tidak dibuka, dikunyah, atau dihancurkan).
Sebaiknya diminum sebelum makan.

DOSIS :
Dewasa:

Tukak lambung dan tukak duodenum (termasuk yang komplikasi terapi AINS), 20 mg
satu kali sehari selama 4 minggu pada tukak duodenum atau 8 minggu pada tukak
lambung; pada kasus yang berat atau kambuh tingkatkan menjadi 40 mg sehari;
Pemeliharaan untuk tukak duodenum yang kambuh, 20 mg sehari; pencegahan kambuh
tukak duodenum, 10 mg sehari dan tingkatkan sampai 20 mg sehari bila gejala muncul
kembali.
Tukak lambung atau tukak duodenum karena AINS dan erosi gastroduodenum, 20 mg
sehari selama 4 minggu, diikuti 4 minggu berikutnya bila tidak sepenuhnya sembuh;
Profilaksis pada pasien dengan riwayat tukak lambung atau tukak duodenum, lesi
gastroduodenum, atau gejala dispepsia karena AINS yang memerlukan pengobatan
AINS yang berkesinambungan, 20 mg sehari.
Tukak duodenum karena H. Pylori menggunakan regimen eradikasi.
Sindrom Zollinger Ellison, dosis awal 60 mg sekali sehari; kisaran lazim 20-120 mg
sehari (di atas 80 mg dalam 2 dosis terbagi).
Pengurangan asam lambung selama anestesi umum (profilaksis aspirasi asam), 40 mg
pada sore hari, satu hari sebelum operasi kemudian 40 mg 2-6 jam sebelum operasi.
Penyakit refluks gastroesofagal, 20 mg sehari selama 4 minggu diikuti 4-8 minggu
berikutnya jika tidak sepenuhnya sembuh; 40 mg sekali sehari telah diberikan selama
8 minggu pada penyakit refluks gastroesofagal yang tidak dapat disembuhkan dengan
terapi lain; dosis pemeliharaan 20 mg sekalis sehari.
Penyakit refluks asam (Penatalaksanaan jangka panjang), 10 mg sehari meningkat
sampai 20 mg sehari jika gejala muncul kembali.
Dispepsia karena asam lambung, 10-20 mg sehari selama 2-4 minggu sesuai respons.
Esofagitis refluks yang menyebabkan kondisi tukak yang parah (obati selama 4-12
minggu) ANAK di atas 1 tahun, berat badan 10-20 kg, 10 mg sekali sehari, jika perlu
ditingkatkan menjadi 20 mg sekali sehari; Berat badan di atas 20 kg, 20 mg sekali sehari
jika perlu ditingkatkan menjadi 40 mg sehari; Pemberian harus diawali oleh dokter anak
di rumah sakit.
ANAK:

Neonatus 700 mcg/kg bb satu kali sehari, ditingkatkan jika perlu setelah 7-14 hari
menjadi 1,4 mg/kg bb, beberapa neonatus memerlukan hingga 2,8 mg/kg bb satu kali
sehari;
Usia 1 bulan 2 tahun: 700 mcg/kg bb satu kali sehari, ditingkatkan jika perlu menjadi
3 mg/kg bb (maks. 20 mg) satu kali sehari;
Berat badan 10-20 kg, 10 mg satu kali sehari ditingkatkan jika perlu menjadi 20 mg
satu kali sehari (pada kasus refluks esofagitis ulseratif yang parah, maks. 12 minggu
dengan dosis lebih tinggi);
Berat badan > 20 kg, 20 mg satu kali sehari ditingkatkan jika perlu menjadi 40 mg satu
kali sehari (pada kasus refluks esofagitis ulseratif, maks. 12 minggu dengan dosis lebih
tinggi)
Eradikasi H.pylori pada anak (dalam kombinasi dengan antibakteri:
Usia 1-12 tahun, 1-2 mg/kg bb (maks. 40 mg) satu kali sehari;
Usia 12-18 tahun: 40 mg satu kali sehari.
Injeksi intravena diberikan selama 5 menit atau melalui infus intravena; profilaksis
aspirasi asam, 40 mg harus telah diberikan seluruhnya, 1 jam sebelum operasi.
Refluks gastroesofagal, tukak duodenum dan tukak lambung, 40 mg sekali sehari
hingga pemberian oral dimungkinkan.
ANAK. Injeksi intravena selama 5 menit atau dengan infus intravena: Usia 1 bulan12
tahun: dosis awal 500 mikrogram/kg bb (maks. 20 mg) satu kali sehari, ditingkatkan
menjadi 2 mg/kg bb (maks. 40 mg) jika diperlukan.; Usia 12-18 tahun, 40 mg satu kali
sehari.
Saran: Telan seluruh kapsul, larutkan tablet dalam air atau campur isi kapsul dengan
sari buah atau yoghurt.
Pemberian pada anak: Oral, sama dengan dewasa.
Enteral: Buka kapsul omeprazol, larutkan omeprazol dalam sejumlah air secukupnya
atau dalam 10 mL Natrium bikarbonat 8,4% (1mmol Na+/mL). Biarkan selama 10
menit sebelum diberikan). Infus intermiten intravena, encerkan larutan rekonstitusi
pada kadar 400 mikrogram/mL dengan glukosa 5% atau natrium klorida 0,9%, berikan
selama 20-30 menit.

EFEK SAMPING

Diare, mual, sakit kepala, sembelit dan perut kembung pernah dilaporkan tetapi jarang.
Pada sejumlah pasien, ruam kulit mungkin terjadi. Efek samping yang terjadi biasanya
ringan. Omeprazole umumnya dapat ditoleransi dengan baik.
Pada dosis besar dan penggunaan yang lama, kemungkinan dapat menstimulasi
pertumbuhan sel ECL (enterochromaffin-likecells).
Pada penggunaan jangka panjang perlu diperhatikan adanya pertumbuhan bakteri yang
berlebihan di saluran pencernaan.

PERINGATAN DAN PERHATIAN

Kemungkinan malignansi sebaiknya dihindarkan sebelum penggunaan Omeprazole

pada pasien tukak lambung karena dapat menutupi gejala-gejalanya dan menghambat
diagnosis.
Belum ada pengalaman penggunaan Omeprazol untuk anak-anak.
 Obat ini sebaiknya tidak digunakan selama kehamilan dan menyusui kecuali memang
dianggap penting.

INTERAKSI OBAT

Omeprazol menghambat metabolisme obat-obat yang dimetabolisme oleh sistem enzim

sitokrom P450 hati dan memperpanjang waktu paruh diazepam, warfarin dan fenitoin.
Pada wanita hamil, wanita menyusui dan anakanak sebaiknya dihindari bila
penggunaannya dianggap tidak cukup penting.

KEMASAN

Omeprazole 20 mg, box, 3 strip x 10 kapsul.

Omeprazole 10 mg.