INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo OMEZ 10 (capsule)
OMEZ 20 (capsule)
OMEZ 40 (capsule)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

OMEZ 10 (capsule)
OMEZ 20 (capsule)
OMEZ 40 (capsule)

COMPOSITION:
OMEZ 10: Each capsule contains omeprazole 10 mg
OMEZ 20: Each capsule contains omeprazole 20 mg
OMEZ 40: Each capsule contains omeprazole 40 mg

PHARMACOLOGICAL CLASSIFICATION
A 11.4.3 Medicines acting on the gastrointestinal tract –Other

PHARMACOLOGICAL ACTION
Omeprazole is an inhibitor of the gastric proton pump (H+, K+-ATPase). It inhibits both basal and stimulated gastric acid secretion by parietal cells, whether induced by acetylcholine, gastrin or histamine.
Omeprazole has no effect on acetylcholine, histamine or gastric receptors.
Pharmacokinetics
Orally administered omeprazole is well absorbed but to a variable extent. Absorption of omeprazole takes place in the small intestine and is usually completed within three to six hours. Bioavailability depends on dose and gastric pH and may reach 70% with repeated administration. Food has no influence on the bioavailability of omeprazole.
Omeprazole is more than 95% bound to plasma proteins. Clearance from the circulation is by hepatic metabolism with a plasma half-life of 30 to 90 minutes.
Hepatic metabolism occurs primarily via the cytochrome P450 (CYP) isoform (CYP2C19). The inactive metabolites are excreted mainly in the urine (80%) whilst the remaining 20% are excreted via the faeces. The average half-life of the terminal phase of the plasma concentration-time curve is approximately 40 minutes. There is no change in plasma half- life during treatment. The inhibition of acid secretion is related to the area under the plasma concentration - time curve (AUC) and not to the actual plasma concentration at a given time.

INDICATIONS
OMEZ is indicated in:
Adults
• Treatment of duodenal ulcer, including prevention of relapse gastric ulcer and reflux oesophagitis.
• Long-term management of reflux oesophagitis and Zollinger-Ellison Syndrome.
• Symptomatic relief of heartburn in patients with gastro-oesophageal reflux disease (GORD) and the short-term relief of functional dyspepsia.
• Helicobacter pylori-positive duodenal ulcers as part of an eradication programme with appropriate antibiotics.
• Treatment of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric and/or duodenal ulcer/erosions.
• Reduction of the risk to develop gastric and/or duodenal ulcer/erosions and reduction of the risk of relapse for previously healed gastric and/or duodenal ulcer/erosions in patients on NSAID treatment.
Children
  Short-term (up to 3 months) treatment of severe ulcerative reflux oesophagitis resistant to previous medical treatment.

CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients
Safety in pregnancy and lactation has not been established

WARNINGS
Symptomatic response to OMEZ therapy does not preclude the presence of gastric ulcer or malignancy or a malignant disease of the oesophagus. The administration of OMEZ in this situation may delay diagnosis (see Special Precautions).
Hepatic impairment may require a reduction in dose (see DOSAGE AND DIRECTIONS FOR USE).
THERE IS VERY LIMITED EXPERIENCE WITH THE USE OF OMEZ IN CHILDREN.
THE LONG-TERM SAFETY OF OMEZ IN PATIENTS WITH RENAL AND/OR HEPATIC IMPAIRMENT HAS NOT BEEN ESTABLISHED.
THIS MEDICINE MAY LEAD TO DROWSINESS AND IMPAIRED CONCENTRATION THAT MAY BE AGGRAVATED BY THE SIMULTANEOUS INTAKE OF ALCOHOL OR OTHER CENTRAL NERVOUS SYSTEM DEPRESSANTS. PATIENTS SHOULD BE ADVISED, PARTICULARLY AT THE INITIATION OF THERAPY, AGAINST TAKING CHARGE OF VEHICLES OR MACHINERY OR PERFORMING POTENTIALLY HAZARDOUS TASKS WHERE LOSS OF CONCENTRATION COULD LEAD TO ACCIDENTS.

INTERACTIONS
OMEZ is metabolised via the hepatic P450 cytochrome enzyme system, which may affect the metabolism of other medications metabolised by these enzymes, when given concomitantly. The elimination of diazepam, warfarin and phenytoin may be prolonged when OMEZ is given concomitantly.
Monitoring of INR and phenytoin serum levels is recommended and dosage reductions may be necessary when OMEZ is given concomitantly. There is a possible interaction of OMEZ with digoxin and a 10% increase in digoxin bioavailability may be expected.
There may be interactions with other medicines, which are also metabolised via the cytochrome P450 enzyme system.

PREGNANCY AND LACTATION
Safety in pregnancy and lactation has not been established (see CONTRAINDICATIONS).

DOSAGE AND DIRECTIONS FOR USE
OMEZ is recommended to be given in the morning and swallowed whole with a half glass of liquid. The capsules should not be chewed or crushed.
RECOMMENDED DOSAGES FOR ADULTS
Duodenal ulcer
20 mg once daily for two to four weeks.
In some duodenal ulcer patients refractory to other treatment regimens, 40 mg once daily may be effective.
Prevention of relapse in patients with duodenal ulcer
10 mg once daily.
If necessary the dose can be increased to 20 –40 mg once daily.
The above recommended dosage regimens are inclusive of Helicobacter pylori-positive duodenal ulcers as part of the eradication programme with appropriate antibiotics.
Gastric ulcer and reflux oesophagitis
20 mg once daily for four to eight weeks.
In some gastric ulcer and reflux oesophagitis patients refractory to other treatment regimens, 40 mg once daily may be effective.
For the long-term management of patients with reflux oesophagitis the recommended dose is 20 mg once daily. If necessary the dose can be increased to 20 –40 mg once daily.
In patients with severe or symptomatic recurrent reflux oesophagitis treatment can be continued with OMEZ at a dosage of 20 mg once daily.
NSAID-associated gastro-duodenal lesions with or without continued NSAID treatment
20 mg once daily.
In most patients healing occurs within 4 weeks. For patients who may not be fully healed after the initial course healing usually occurs during a further 4 weeks of treatment.
Prevention of NSAID-associated gastro-duodenal lesions and dyspeptic symptoms
20 mg once daily.
Symptomatic gastro-oesophageal reflux disease
20 mg daily.
Patients may respond adequately to 10 mg daily, therefore individual dose adjustments should be considered.
If symptom control has not been achieved after 2 weeks of treatment with 20 mg daily further investigation is recommended.
Zollinger-Ellison Syndrome
60 mg once daily.
The dosage should be adjusted individually and treatment continued as long as it is clinically indicated. With doses above 80 mg daily the dose should be divided and given twice daily.
There is very limited experience with the use of OMEZ in children (see WARNINGS).
Severe ulcerative reflux oesophagitis in children from one year and older
Recommended dosages:
Weight: Dosage:        
10 –20 kg: 10 mg once daily. If needed increase to 20 mg once daily
>20 kg:        20 mg once daily. If needed increase to 40 mg once daily
Elderly
Dose reductions are not necessary in elderly patients.
The long-term safety of OMEZ in patients with renal and hepatic impairment has not been established (see WARNINGS).
Impaired renal function
Dose reductions are not necessary in renal impairment.
Impaired hepatic function
Bioavailability and plasma half-life of OMEZ are increased in patients with impaired hepatic function, therefore a daily dose of 10 –20 mg is generally sufficient.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-effects
Blood and lymphatic system disorders
Rare: Leucopenia, thrombocytopenia, agranulocytosis, pancytopenia
Endocrine disorders
Rare: Gynaecomastia
Metabolic and nutritional disorders
Rare: Hyponatraemia
Psychiatric disorders
Rare: Reversible mental confusion, agitation, aggression, depression and hallucinations (predominantly in severely ill patients)
Nervous system disorders
Common: Headache (severe enough to cause discontinuation in some patients)
Uncommon: Dizziness, somnolence, insomnia, parasthaesias
Eye disorders
Rare: Blurred vision
Vascular disorders
Rare: Peripheral oedema
Respiratory, thoracic and mediastinal disorders
Rare: Bronchospasm
Gastrointestinal disorders
Common: Diarrhoea (severe enough to require discontinuation of therapy in some patients), constipation, abdominal pain or colic, nausea, vomiting, flatulence
Rare: Dry mouth, stomatitis, oesophageal candidiasis, taste disturbances
Hepato-biliary disorders
Uncommon: Raised liver enzymes
Rare: Hepatitis with or without jaundice, hepatic encephalopathy
Skin and subcutaneous tissue disorders
Uncommon: Skin rash, urticaria, pruritus
Rare: Photosensitivity, bullous eruption, toxic epidermal necrolysis, Stevens-Johnson syndrome, alopecia, erythema multiforme
Musculoskeletal, connective tissue and bone disorders
Rare: Asthenia, arthralgia, myalgia
Renal and urinary disorders
Rare: Interstitial nephritis
Other
Uncommon: Malaise
Rare: Hypersensitivity reactions (e.g. fever, angioedema, bronchospasm, interstitial nephritis) and anaphylactic shock

Special precautions
Effects related to acid inhibition:
During long-term treatment gastric glandular cysts have been reported in increased frequency. These physiological changes result from pronounced inhibition of gastric acid secretion. Decreased gastric acidity increases gastric counts of bacteria normally present in the gastro-intestinal tract. Treatment with OMEZ may lead to an increased risk of gastro-intestinal infections such as Salmonella and Campylobacter.
In the presence of symptoms such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, or melaena, and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with OMEZ may alleviate symptoms and delay diagnosis.

KNOWN SYMPTOMS OF OVER-DOSAGE AND PARTICULARS OF ITS TREATMENT
Blurred vision, confusion, diaphoresis, flushing, headache, malaise, nausea and tachycardia have been reported from over-dosage with omeprazole. There is no specific antidote for overdose with omeprazole.
TREATMENT IS SYMPTOMATIC AND SUPPORTIVE.
Due to extensive protein binding omeprazole is not readily dialysable. Patients in whom overdose is confirmed or suspected should be referred for medical practitioner/ doctor consultation.

IDENTIFICATION
OMEZ 10: Off-white to pale yellow elliptical to spherical enteric-coated pellets, filled in a hard gelatin capsule with opaque lavender coloured cap and opaque yellow coloured body. “Omeprazole 10 mg”imprinted with black ink on cap and “R157”imprinted with black ink on body.
OMEZ 20: Off-white to pale yellow elliptical to spherical enteric-coated pellets, filled in a hard gelatin capsule with opaque lavender coloured cap and opaque iron grey coloured body. “Omeprazole 20 mg” imprinted with black ink on cap and “R158”imprinted with black ink on body.
OMEZ 40: Off-white to pale yellow elliptical to spherical enteric-coated pellets, filled in a hard gelatin capsule with opaque yellow coloured cap and opaque lavender coloured body. “Omeprazole 40 mg”imprinted with black ink on cap and “R159”imprinted with black ink on body.

PRESENTATION
OMEZ 10: Blister packaging containing 30 capsules
OMEZ 20: Blister packaging containing 30 capsules
  White plastic bottles containing 30 capsules
OMEZ 40: Blister packaging containing 14 capsules

STORAGE INSTRUCTIONS
Store below 25°C. Protect from light and moisture.
Store the blisters in the outer carton until required for use.
Store the container well closed.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
OMEZ 10: 34/11.4.3/0299
OMEZ 20: 34/11.4.3/0300
OMEZ 40: 34/11.4.3/0301

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Dr. Reddy’s Laboratories (Pty) Ltd
3rd Floor, TA Bank Building
160 Jan Smuts Avenue
Rosebank
2196 Johannesburg

DATE OF PUBLICATION OF THE PACKAGE INSERT
April 2007

New addition to this site: January 2008
Source: Pharmaceutical Industry

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