Omeprozale 20mg & Domperidone 10mg Capsules
Omeprazole belongs to a class of antisecretory compounds, the substituted Benzimidazoles, that do not exhibit anti cholinergic or H2 histamine antagonistic properties, but that suppress gastric acid secretion by specific inhibition of the H/K ATP ase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is the “acid (proton) pump” within the gastric mucosa, omeprazole has been characterized as a gastric acid pump inhibitor: It blocks the final step of acid production. The effect is dose related & inhibits both basal & stimulated acid secretion regardless of the stimulus.
Domperidone acts as a gastrointestinal emptying (delayed) adjunct and peristaltic stimulant. The gastroprokinetic properties of domperidone are related to its peripheral dopamine receptor blocking properties. Domperidone facilitates gastric emptying and decreases small bowel transit time by increasing esophageal and gastric peristalsis and by lowering esophageal sphincter pressure. Antiemetic: The antiemetic properties of domperidone are related to its dopamine receptor blocking activity at both the chemoreceptor trigger zone and at the gastric level.
Each hard gelatin capsule contains:
Omeprozole BP 20mg
(As enteric coated pellets)
Domperidone BP 10mg
(As film coated pellets)
Approved colours used in capsule shells
MECHANISM OF ACTION
OMEDOM acts by suppressing gastric acid secretion by inhibiting the parietal cell H+/K+ ATP pump and it has strong affinities for the D2 and D3 dopamine receptors. It is a specific blocker of dopamine receptors. It speeds gastrointestinal peristalsis, causes prolactin release, and is used as antiemetic.
Onset of antisecretory action: Oral within 1 hour
Peak effect: 2 hours
Duration: 72 hours
Protein binding: 95%
Metabolism: Extensive in the liver
Half-life: 0.5 – 1 hour
Short-term (4-8 weeks) treatment of severe-erosive esophogitis (grade 2 or above), diagnosed by endoscopy and short-term treatment of symptomatic gastroesophogeal reflux disease (GERD) poorly responsive to customary medical treatment; treatment of heartburn and other symptoms associated with GERD; pathological hypersecretory conditions; peptic ulcer disease; gastric ulcer therapy; maintenance of healing of erosive esophogitis; approved for combination use in the eradication of H. pylori in patients with active duodenal ulcer, acute nausea and vomiting, dyspepsia, functional dyspepsia, gastric distention pain due to pressure on the stomach, gastro-oesophageal reflux disease, nausea and vomiting, nausea and vomiting (chemotherapy induced), nausea and vomiting (L-dopa induced), Non-ulcer dyspepsia, reflux oesophagitis.
Hypersensitivity, GI haemorrhage, obstruction and perforation, patients with prolactin releasing pituitary hormone, chronic admin or routine prophylaxis of postoperative nausea and vomiting.
The side effects reported most frequently with OMEDOM capsules have been diarrhoea, skin rashes, and headache; they have been sometimes been severe enough to require discontinuation of treatment. Effects on the central nervous system, including reversible confessional states in severely ill patients, have occurred. Other adverse effects reported rarely include arthalgia and myalgia, blood disorders including leucopenia and thrombocytopenia, interstitial nephritis, and hepatotoxicity.
CYP2C8, 2C9, 2C18, 2C19, and 3A3/4 enzyme substrate; CYP1A2 enzyme inducer; CYP2C19, 2C8, 2C9, and 2C19 enzyme inhibitor, CYP3A3/4 enzyme inhibitor (weak)
Increased toxicity: Diazepam may increase half-life; increased digoxin, increased phenytoin, increased warfarin. Reduces absorption of digoxin. Increases absorption of aspirin, paracetamol and oral diazepam. Enhances CNS depression by phenothiazine. Antimuscarinic agents and opioids antagonise GI effects. May antagonise hypoprolactinaemic effect of drugs such as bromocriptine. Increased effects when used with CYP3A4 inhibitors such as erythromycin or ritonavir.
Adults: Two Capsules 3 to 4 times per day, 15 to 30 minutes before meals
WARNING AND PRECAUTIONS
In long-term (2-year) studies in rats, OMEDOM capsules produces a dose-related increase in gastric carcinoid tumors. While available endoscopic evaluations and histologic examinations of biopsy specimens from human stomachs have not detected a risk from short-term exposure to omeprazole, further human data on the effect of sustained hypochlorhydria and hypergastrinemia are needed to rule out the possibility of an increased risk for the development of tumors in humans receiving long-term therapy. Bioavailability may be increased in the elderly.
OMEDOM capsule should be swallowed whole and not opened, chewed or crushed.
Store below 25°C in a dry place, Protect from light & moisture.
KEEP OUT OF REACH OF CHILDREN
1 X 10, 3 X 10 Capsules Packing.
ZADIP PHARMA NIG. LTD.
488, Town Planning Way, llupeju, Lagos.
NEST LIFESCIENCE Pvt. Ltd.
Comed Chemicals Limited
359, Rania, Taluka-Savli, District-Baroda, Gujarat, India.