Omepral
Omeprazole pellets eq. to 20 mg
Company Name
Memphis
Therapeutic Group
ACID PUMP INHIBITORS
Pharmaceutical form
Capsule
Package
box containing 14 capsules
Indications
"*Treatment of oesophageal reflux disease. In
reflux oesophagitis the majority of patients are
healed after 4 weeks. Symptom relief is rapid.
*Treatment of duodenal and benign gastric ulcers
including those complicating NSAID therapy.
*Relief of associated dyspeptic symptoms.
*Helicobacter pylori eradication:
Omeprazole should be used in combination with
antibiotics for eradication of Helicobacter pylori
(Hp) in peptic ulcer disease.
*Prophylaxis of acid aspiration.
*Zollinger-Ellison syndrome.
*Relief of reflux-like symptoms (e.g. heartburn)
and/or ulcer-like symptoms (e.g. epigastric pain)
associated with acid-related dyspepsia.
*Treatment and prophylaxis of NSAID-associated
benign gastric ulcers, duodenal ulcers and
gastroduodenal erosions in patients with a previous
history of gastroduodenal lesions who require
continued NSAID treatment.
*Children over 1 year of age and 10 kg: Reflux
oesophagitis. Symptomatic treatment of heartburn
and acid regurgitation in gastroesophageal reflux
disease."
Warning & Precautions
"WARNINGS AND PRECAUTIONS: 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. Decreased gastric acidity due to any means, including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with acid-reducing drugs may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter. Some children with chronic illnesses may require long-term treatment although it is not recommended. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose - galactose malabsorption should not take this medicine. Omepral may cause low serum magnesium levels if taken for prolonged periods of time (longer than one year). PREGNANCY AND LACTATION : - There are no adequate or well-controlled studies in pregnant women and Omepral should only be used when potential benefits outweigh the potential hazards to the fetus. - It is not known whether omeprazole is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from omeprazole, patients taking omeprazole should not breast feed. PAEDIATRIC USE: Safety and effectiveness in children have not been established."
Product Type
Human
Dosage
"*Duodenal ulcers, benign gastric ulcers,
postoperative ulcers, recurring ulcers:
Usual dosage:
For short-term management the normal daily
dose is 20 mg increasing to 40 mg once daily in
severe or refractory cases. A single daily dose of
20 mg before breakfast or before the evening
meal produces effective gastric suppression for
16 to18 hours. This dose can be doubled when
the respond is not satisfactory.
Duration of treatment:
Duodenal ulcers: at least 4 weeks.
gastric ulcer: at least 6-8 weeks.
*Duodenal ulcers associated with helicobacter
pylori: Usual dose: 40 mg daily with amoxicillin
1.5 g (750 mg b.d.) for 2 weeks Up to 2 g/day of
amoxicillin has been used in clinical trials.
*gastroesophageal reflux/ erosive
oesophagitis: Usual daily dosage:
20 to 40 mg depending on the severity of the lesion.
Duration of treatment:
Duodenal ulcers :4 to 8 weeks, depending on
the severity of the lesion. At the beginning of
treatment, and in case of continuing pain, antacids
may be prescribed. Both in recurrent peptic ulcer and
chronic gastroesophageal reflux, pulsed
maintenance treatment giving 20 mg of omeprazole
for 3 days each week, instead of continuous H2-
blocker maintenance therapy, is a promising
alternative.
*gastritis, hyperacidity:
The current recommended adult dosage:
20-40 mg twice a day.
Duration of treatment: 1-2 weeks is usually sufficient.
*aspiration syndrome:
40 mg given the night before and again on the
morning of elective caesarian section effectively
increases gastric PH and reduces gastric volume.
*Zollinger-Ellison syndrome:
Daily dosage: 60 mg dosages should be adjusted
to individual patient needs and should continue as
long as clinically indicated. A dosage range of 20
mg to 120 mg/day may be employed depending
on the severity of the disease. Dosages of up to
360 mg/day have been employed in patients with
severe disease. With doses in excess of 80 mg daily,
the dose should be equally divided and given
twice daily.
Special dosage instructions:
Omepral will be most effective when taken with or
shortly before meals; effectiveness is likely to be
significantly compromised if taken during
a prolonged fasting period.
Omepral should not be co-administered with
another anti-secretory agent. Higher dosages or
more frequent administration is indicated if greater
antisecretory effectiveness is required.
Renal impairment: No dose adjustment is needed.
Hepatic impairment:
The dose should be adjusted, maximum daily dose
is 20 mg. In most subjects, the 20 mg dosage will
not become fully effective until after about 4 days
of therapy. Continuing H2-blockers will be counter-
productive. In the elderly, safety and efficacy
appear similar to those of younger age."
Adverse Reactions
"Omepral is well tolerated and adverse reactions have generally been mild and reversible. The following have been reported as adverse events
in clinical trials or reported from routine use, but in many cases a relationship to treatment with omeprazole has not been established. The
following definitions of frequencies are used:
COMMON ≥ 1/100
UNCOMMON ≥ 1/1000 and < 1/100
RARE < 1/1000
COMMON Central and peripheral nervous system
Headache
Gastrointestinal
Diarrhoea, constipation, abdominal
pain, nausea/vomiting and flatulence
UNCOMMON Central and peripheral nervous system
Dizziness,paraesthesia,light headedness
feelingfaint,somnolence,insomnia and
Vertigo.
Hepatic
Increased liver enzymes
Skin
Rash, dermatitis and/or pruritus. Urticaria
Other
Malaise
RARE Central and peripheral nervous system
Reversible mental confusion, agitation,
Aggression, depression and hallucinations,
Predominantly in severely ill patients
Endocrine
Gynaecomastia
Gastrointestinal
Dry mouth, stomatitis and gastrointestinal
candidiasis.
Haematological
Leukopenia, thrombocytopenia
agranulocytosis and pancytopenia
Encephalopathy in patients with pre-existing
Severe liver disease; hepatitis with or without Jaundice, hepatic failure.
Musculoskeletal
Arthritic and myalgic symptoms and muscular weakness
Reproductive system and breast disorders Impotence
Skin
Photosensitivity, bullous eruption, erythema
multiforme, Stevens-Johnson syndrome,
Toxic epidermal necrolysis (TEN), alopecia
Other
Hypersensitivity reactions e.g. angioedema Fever, broncho - spasm, interstitial nephritis,And anaphylactic shock, Increased sweating,Peripheral oedema, blurred vision, taste,Disturbance and hyponatraemia. The safety of omeprazole has been assessed in a total of 310 children aged 0 to 16 years with acid-related disease. There are limited long term safety data from 46 children who received maintenance therapy of omeprazole during a clinical study for severe erosive oesophagitis for up to 749 days. The adverse event profile was generally the same as for adults in short-term as well as in long-term treatment. There are no long-term data regarding the effects of omeprazole treatment on puberty and growth. "
Contra Indications
"There are no known contraindications to the use of Omepral."
Drug Interactions
" Omepral can prolong the elimination of Diazepam, Phenytoin, and Warfarin, drugs that are metabolized
by oxidation in the liver by subsets of the cytochrome P-450 enzyme system. This effect is minor at clinically
relevant doses. However, monitoring of patients also receiving Warfarin or Phenytoin also is recommended
and a reduction of dose of Phenytoin and Warfarin may be necessary. No interaction with Propranolol or
Theophylline has been found, but interactions with other drugs also metabolized by the cytochrome P- 450 enzyme system can not be excluded. No interaction with concomitantly administered antacids has been found."
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