Omeprazole

Therapeutic Indications

Omeprazole is classified as a proton pump inhibitor (PPI) as it works by reduces the amount of acid produced in the stomach. By doing so, it relieves the effects of the acid and enables healing of damage that is a result of the stomach acid. Omeprazole is used in the management and treatment of a number of conditions that include:

• Gastroesophageal reflux disease (GERD)
• Gastric ulcers
• Duodenal ulcers
• Ulcers due to H.pylori (Omeprazole is concurrent with antibiotics such as clarithromycin and amoxicillin).
• Dyspepsia
• Upper gastrointestinal tract bleeding
• Hypersecretory pathological conditions such as Zollinger –Ellison syndrome, systemic mastocytosis, and multiple endocrine adenomas.
• Heartburn
• Indigestion

Do I need a Prescription?

Omeprazole can be bought from pharmacies close to you and also from online drug stores. It exists as a prescription medication where the doctor’s prescription is mandatory. Omeprazole also can be bought as an over the counter product that is mainly used to manage heartburn.

Dosage

The dosage of omeprazole may differ from one person to another. The dosage is determined by the disease being treated, how severe it is, body weight, age, reaction to the initial dose and other medications in use if any. The recommended dosage for Omeprazole for different conditions include:

• Duodenal Ulcer

Adult dose: 20 mg once a day for four weeks.

• Ulcer due to H.pylori

Adult dose: 40 mg once a day concomitant with clarithromycin for two weeks (dual therapy) or 20 mg taken two times a day concomitant with 1000 mg amoxicillin and 500 mg clarithromycin for a period of ten days (triple therapy). In the case that an active ulcer is present at the beginning of treatment, 20 mg should be taken for a continued period of 14 days and 18 days for both dual and triple therapy respectively.

• Gastric Ulcer

Adult dose:  20 mg once a day for four to eight weeks.

• Erosive Esophagitis

Adult dose: 20 mg once a day for four to eight weeks.

Pediatric dose:

1 month to 1 year:

3 kg to 5 kg: 2.5 mg once a day for six weeks.

5kg to 10 kg: 5 mg once a day for six weeks.

10 kg and above: 10 mg once a day for six weeks.

1 to 18 years:

5 kg to 10 kg: 5 mg once a day for four to eight weeks.

10 kg to 20 kg: 10 mg once a day for four to eight weeks.

20 kg and above: 20 mg once a day for four to eight weeks

• Multiple Endocrine Adenomas, Systemic Mastocytosis, and Zollinger- Ellison Syndrome.

Adult dose: 60 mg once a day, with a maximum dose of up to 360 mg a day divided three times. Any dose above 80 mg a day should be divided up. The medication should be taken for as it is necessary clinically.

• Gastroesophageal Reflux Disease(GERD)

Adult dose: 20 mg once a day for four weeks.

Pediatric dose:

1 to 18 years:

5kg – 10 kg: 5 mg once a day for four weeks

10 kg – 20 kg: 10 mg once a day for four weeks

20 kg and above: 20 mg once a day for four weeks

• Dyspepsia

Adult dose: Use over the counter omeprazole. 20 mg once a day, preferably in the morning for a period of 14 days. This may be repeated after every four months.

Chemical Composition

The active ingredient in omeprazole is:

                                     Omeprazole magnesium.

The tablets also contain other ingredients that include titanium dioxide, gelatin, red iron oxide, mannitol, lactose, magnesium hydroxide, povidone triethyl citrate, and eudragit. These ingredients may differ in some tablets.

Mechanism of Action (MOA)

Omeprazole is a proton inhibitor. It works by reducing or controlling the release of stomach acid by the stomach gastric cells. Omeprazole inhibits the hydrogen ion/ potassium ion ATPase pumps found on the parietal cells in the gastric gland. It acts directly on the pump in the process preventing the final step in the production of the acid.

Contraindications

The use of Omeprazole is contraindicated in a number of conditions as it might worsen the pre-existing condition or make it prone to side effects occurring. Inform your doctor if you have any of the following conditions as they might influence the prescription. The conditions include:

• Allergy to the active ingredient and other contents of Omeprazole.
• Liver disease.
• Vitamin B-12 deficiency
• Osteoporosis
• Low blood magnesium levels
• Pregnant women
• Breastfeeding women
• Older adults (The kidneys have reduced efficiency and may lower drug clearance).
• Do not use omeprazole if you have the followings signs as they could indicate a serious underlying disease; nausea, vomiting, bloody stools, heartburn accompanied with wheezing, pain while swallowing food, chest pain that is reoccurring and have had heartburn for over three months. Seek medical assistance immediately.

Facts on Omeprazole

• Omeprazole is classified as category C in pregnancy as it has not been shown to harm the growing fetus.
• Omeprazole may cause an imbalance in the electrolytes levels, a frequent laboratory test to check their levels is necessary.
• Omeprazole contains gelatin thus not suitable for use by vegans and vegetarians.
• Omeprazole does not cause dependency.
• Once taken orally, the effects of Omeprazole are felt within one hour.
• Omeprazole should not be used in Asian patients whose CYP2C19 is unknown.

Side effects

Apart from the desired effects of Omeprazole, it can also cause some side effects. The side effects are not experienced by everyone. They depend on the body’s response to the first dose and duration of use. The side effects may be common and less serious while others are rare but very serious. Inform your doctor of any side effects you experience especially if they do not go away. Common side effects include:

• Headache
• Nausea
• Vomiting
• Diarrhea
• Gas
• Stomach pain
• Constipation
• Dizziness
• Dry mouth
• Sleepiness

Rare and more serious side effects; discontinue the use of Omeprazole and inform your doctor if you experience:

• Bloody or watery diarrhea with severe pain in the stomach.
• Seizure
• Decreased or no urine output, urine with blood and swelling indicating kidney problems.
• Decreased magnesium levels that may cause palpitations, being dizzy, movements being jerky, being jittery, muscles spasms and cramps and a choking feeling.
• Worsening signs of lupus or new signs; rashes on the cheeks or arms that worsen with exposure to sunlight.
• Allergic reactions. The signs include swelling of lips, tongue, face, and throat, difficulty breathing and hives.
• Vitamin B-12 deficiency signs such as numbness in the hands and feet, sore tongue, nervousness, neuritis, menstruation changes, and weakness.
• Dark urine and yellowing of the skin.
• Blisters that Redden, skin peeling and bleeding in the eyes, nose, and genitals (Stevens-Johnson syndrome).
• Fracture of the wrist, hip and spine bones.

The side effects can be minimized by taking plenty of water in small amounts, taking food rich in fiber and avoiding foods that cause gas.

If you accidentally take an overdose of Omeprazole, inform your doctor and rush to the emergency center of the nearest health center with the package for identification. An overdose of Omeprazole may cause drowsiness, confusion, dry mouth, nausea, vomiting, flushing, and blurred vision.

Drug interactions

Notify your doctor of any medications whether prescription drugs or over the counter drugs, vitamin supplements or herbal products that you might be using. This prevents drug interactions with Omeprazole. Drug interactions might interfere with the normal working of the medication or lead to severe side effects.  The following drugs and products interact with Omeprazole:

• Clopidogrel
• John’s Wort
• Methotrexate
• Celecozib
• Carbamazepine
• Carvedilol
• Inhibitors of tyrosine kinase such as nilotinib, bosutinib, and dasatinib
• Azole antifungals
• Amphetamines
• Aripiprazole
• Salts of iron
• Inhibitors of HIV protease
• Tricyclic antidepressants
• Warfarin
• Atazanavir
• Nelfinavir
• Rilpivirine
• Esters of ampicillin
• Mycophenolate mofetil(MMF)
• Erlotinib

What to do if you skip a dose?

If you skip a dose, take it as soon as you notice. If it is close to the next dose, skip it and continue with the normal schedule. Do not double the dose to compensate for the skipped dose. Frequent dose skipping makes the drug not to be effective. To avoid dose missing, set a reminder or have a family member remind you.

Precautions

A number of precautions should be considered before using Omeprazole. The precautions include:

• Notify your doctor if you are allergic to Omeprazole.
• Inform your doctor of any drugs and products you are using to prevent drug interactions.
• Liver disease. Dose adjustment may be required to prevent overworking of the liver.
• Omeprazole might cause diarrhea associated with Clostridium defficile, report to your doctor symptoms of diarrhea.
• Use of Omeprazole for extended periods may cause signs of lupus or worsen the condition. Discontinue use if you experience the signs.
• Use of Omeprazole for longer periods may result in fractures of the spine, hip, and wrist due to osteoporosis.
• Prolonged use of Omeprazole increases the risk of Vitamin B-12 deficiency, low levels of magnesium and development of fundic gland polyp.
• Omeprazole might interfere with diagnostic tests for tumors that are neuroendocrine, notify your doctor and laboratory specialist before taking the test. It is recommended to stop Omeprazole use for at least two weeks if you are to take the test.
• Omeprazole should be taken before meals.
• Omeprazole should be used in expecting women with caution when the benefits outweigh the risks. No human studies show Omeprazole to harm the growing fetus.
• Omeprazole should be used with caution in breastfeeding mothers as it passes into breast milk and might affect the nursing baby.
• Omeprazole inhibits the function of isoenzyme CYP2C19 and may disrupt the normal metabolism of drugs that are metabolized by the enzyme.
• Omeprazole should be stored away at room temperature away from moisture, light and excess heat.
• Avoid the use of alcohol while taking Omeprazole as it increases acid production and may worsen the symptoms. If you experience drowsiness or dizziness while on Omeprazole, avoid operating heavy machinery and driving.

Different Brands and Manufacturing Companies of the Drug

Omeprazole is manufactured as different companies and sold under different brand names. It is manufactured as tablets and oral suspensions. It comes in different strengths of 10mg, 20 mg, and 40 mg tablets or capsule and oral suspension of 2.5 mg or 10 mg. Omeprazole is sold under the following brand names:

• Prilosec
• Prilosec OTC
• Omesec – Sun Phamaceuticals Inc.
• Omeprazole
• Acichek – Saonafi Aventis Pharma India
• Acidus – Labindus Pharmaceuticals
• AIG – Pharmacopius Drugs Pvt. Ltd
• Biocid – Biochem Pharmaceuticals Industries Ltd
• Cozep – AHPL
• Lokit – Kopran Pharma Ltd

Substitutes Drugs

Substitutes drugs that be used in place of Omeprazole include:

• Zegerid contains omeprazole and sodium bicarbonate
• Nexium contains esomeprazole
• Protonix contains pantoprazole
• Zantac 75 contains ranitidine
• Pepcid contains famotidine
• Maalox contains aluminum, magnesium and simethicone
• Tums contains calcium carbonate
• Rolaids contains calcium carbonate and magnesium hydroxide

References

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