Pumpitor

Omeprazole.

Each capsule contains: Omeprazole 20 mg.
Product contains Tartrazine.

Pharmacology: PUMPITOR contains Omeprazole, a new class of antisecretory compounds, the substituted benzimidazole, which suppress gastric acid secretion by specific inhibition of H⁺/K⁺ ATPase enzyme system at the secretory surface of the gastric parietal cells.
Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, Omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.
PUMPITOR does not exhibit anticholinergic or H₂ histamine antagonistic properties. Animal studies indicate that after rapid disappearance from plasma, Omeprazole can be found within the gastric mucosa for a day or more.
Antisecretory Activity: After oral administration, the onset of the antisecretory effect of Omeprazole occurs within one hour, with the maximum effect occurring within 2 hours. Inhibition of secretion is about 50% of the maximum at 24 hours and the duration of inhibition lasts up to 72 hours.
The antisecretory effect of Omeprazole thus lasts for longer than would be expected from the very short plasma half-life (less than one hour), apparently due to prolonged binding of the parietal H⁺/K⁺ ATPase enzyme.
When the drug is discontinued, secretory activity returns gradually over 3 to 5 days. The inhibitory effect on acid secretion increases with repeated once-daily dosing, reaching the maximum effect after 4 days.
Results from numerous studies of the antisecretory effect of multiple doses of 20 mg and 40 mg of Omeprazole in normal volunteers and patients are shown below. The "max" value represents determinations at a time of maximum effect (2-6 hours after dosing), while "min" values are those 24 hours after the last dose of Omeprazole. (See table).

Click on icon to see table/diagram/image

PUMPITOR is rapidly absorbed and peak plasma level occurring within 0.5 hours to 3.5 hours.
Absolute bioavailability is about 30% - 40% at doses of 20-40 mg, due in large part to presystemic metabolism. Plasma half-life occurs within 0.5 to 1 hour and the total body clearance is 500-600 mL/minute.
Approximately 95% of Omeprazole is bound to protein plasma.
The bioavailability of Omeprazole increases slightly upon repeated administration.
Little if any unchanged drug was excreted in urine. About 77% was eliminated in urine as at least six metabolites, the remainder of the dose was recoverable in the feces.

PUMPITOR is indicated for: Short-term treatment of duodenal ulcer.
Short-term treatment of gastric ulcer.
Short-term treatment of erosive reflux esophagitis/ ulcerative.
Treatment of Zollinger-Ellison syndrome.

Usual doses for duodenal ulcer and benign gastric ulcer patients are 20 mg once daily. Healing can be attained within 4 weeks of treatment (for duodenal ulcer patients) and 8 weeks of treatment (for benign gastric ulcer). Doses can be increased to 40 mg once daily on severe cases.
For the patients with erosive reflux esophagitis, the recommended dosage is 20 mg once daily, given for 4 weeks. For those patients not fully healed after the initial course, healing usually occurs during a further 4-8 weeks of treatment.
For the patients with reflux esophagitis refractory to other therapy, it is used in a dose of 20 mg once daily.
The recommended initial dosage for patient with Zollinger-Ellison syndrome is 60 mg once daily. The dosage should be adjusted individually and treatment continued as long as clinically indicated. Patients with severe disease and inadequate response to other therapies have been effectively controlled on doses of 20 - 120 mg daily. With doses above 80 mg daily, the dose should be divided and given twice daily.
Dose adjustment is not required in patients with impaired renal or hepatic function, or in elderly.
There is no experience of the use of Omeprazole in children.

Hypersensitivity to Omeprazole.

Clostridium difficile-associated diarrhoea: Published observational studies suggest that proton pump inhibitor (PPI) therapy like PUMPITOR may be associated with an increased risk of Clostridium difficile-associated diarrhea (CDAD), especially in hospitalised patients. This diagnosis should be considered for diarrhoea that does not improve (see Adverse Reactions).
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
CDAD has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with PUMPITOR, refer to Warnings and Precautions sections of their respective prescribing information.
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 established treatment guidelines (see Dosage & Administration, and Adverse Reactions).
Concomitant use of PUMPITOR with Methotrexate: Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration a temporary withdrawal of the PPI may be considered in some patients (see Interactions).
If gastric ulcer was suspected, the possibility of malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate symptoms and delay diagnosis.
Hypomagnesaemia: Hypomagnesaemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrythmias, and seizures. In most patients, treatment of hypomagnesaemia required magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesaemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occured as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematosus cases were CLE.
The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly. Generally, histological findings were observed without organ involvement.
Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs. PPI associated SLE is usually milder than non-drug induced SLE. Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported.
Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving PUMPITOR, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks. Serological testing (e.g., Antinuclear antibody) may be positive and elevated serological test results may take longer to resolve than clinical manifestations.
Use in pregnancy: There is no evidence on the safety of Omeprazole in human pregnancy. Animal studies have revealed no teratogenic effect. Avoid of using this drug except in clinical circumstances where no alternative therapy is appropriate.

Use in pregnancy: There is no evidence on the safety of Omeprazole in human pregnancy. Animal studies have revealed no teratogenic effect. Avoid of using this drug except in clinical circumstances where no alternative therapy is appropriate.

Clostridium difficile-associated diarrhoea (CDAD); fractures.
PUMPITOR is well-tolerated.
The following adverse reactions have usually been mild and transient, and there has been no consistent relationship with treatment. Nausea, headache, diarrhea, constipation, flatulence, skin rashes, urticaria, pruritus have occurred rarely.
Postmarketing Experience: Immune system: systemic lupus erythematosus.
Skin and subcutaneous tissue: cutaneous lupus erythematosus.

Methotrexate: Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted (see Precautions).
Omeprazole can delay the elimination of diazepam, phenytoin and warfarin. Monitoring of patients receiving warfarin or phenytoin is recommended and a reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to treatment. There is no evidence of an interaction with theophylline, propranolol, metoprolol, lidocaine, quinidine, amoxicillin or antacids.
The absorption of Omeprazole is not affected by alcohol or food.

Store below 30°C.
Shelf-life: 36 months.

Antacids, Antireflux Agents & Antiulcerants

A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

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