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Omeprazole
Overview
What is Omeprazole Delayed-Release?
The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1 -benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is CHNOS, with a molecular weight of 345.42. The structural formula is:
Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions.
Omeprazole delayed-release capsules are supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: cellulose, disodium hydrogen phosphate, hydroxypropyl cellulose, hypromellose, lactose, mannitol, sodium lauryl sulfate and other ingredients. The capsule shells have the following inactive ingredients: gelatin-NF, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, synthetic black iron oxide, isopropanol, butyl alcohol, FD&C Blue #2, D&C Red #7 Calcium Lake, and, in addition, the 40 mg capsule shells also contain D&C Yellow #10.
What does Omeprazole Delayed-Release look like?
What are the available doses of Omeprazole Delayed-Release?
Omeprazole delayed-release capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 1740 on cap and 40 mg on the body.
What should I talk to my health care provider before I take Omeprazole Delayed-Release?
Hepatic Impairment:
Asian Patients:
How should I use Omeprazole Delayed-Release?
Omeprazole delayed-release capsules is indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
Omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with infection and duodenal ulcer disease (active or up to 1-year history) to eradicate in adults.
Omeprazole delayed-release capsules in combination with clarithromycin is indicated for treatment of patients with infection and duodenal ulcer disease to eradicate in adults.
Eradication of has been shown to reduce the risk of duodenal ulcer recurrence [].
Among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted. [ ], and the clarithromycin package insert, Microbiology section.)
Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole delayed-release capsules.
Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.
For patients unable to swallow an intact capsule, alternative administration options are available [ ].
What interacts with Omeprazole Delayed-Release?
Sorry No Records found
What are the warnings of Omeprazole Delayed-Release?
Sorry No Records found
What are the precautions of Omeprazole Delayed-Release?
Sorry No Records found
What are the side effects of Omeprazole Delayed-Release?
Sorry No records found
What should I look out for while using Omeprazole Delayed-Release?
Omeprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, and urticaria [
].
What might happen if I take too much Omeprazole Delayed-Release?
Reports have been received of overdosage with omeprazole in humans. Doses ranged up to 2400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience. [ ] Symptoms were transient, and no serious clinical outcome has been reported when omeprazole delayed-release capsules were taken alone. No specific antidote for omeprazole overdosage is known. Omeprazole is extensively protein bound and is, therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive.
As with the management of any overdose, the possibility of multiple drug ingestion should be considered. For current information on treatment of any drug overdose, contact a Poison Control Center at 1-800-222-1222.
Single oral doses of omeprazole at 1350, 1339, and 1200 mg/kg were lethal to mice, rats, and dogs, respectively. Animals given these doses showed sedation, ptosis, tremors, convulsions, and decreased activity, body temperature, and respiratory rate and increased depth of respiration.
How should I store and handle Omeprazole Delayed-Release?
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .Omeprazole delayed-release capsules, 40 mg, are opaque, hard gelatin, apricot and amethystcolored capsules, coded 1740 on cap and 40 mg on the body. They are supplied as follows:NDC 63304-445-30 unit of use bottles of 30NDC 63304-445-01 bottles of 100NDC 63304-445-10 bottles of 1000.StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store between 15 C and 30C (59F and 86F).Omeprazole delayed-release capsules, 40 mg, are opaque, hard gelatin, apricot and amethystcolored capsules, coded 1740 on cap and 40 mg on the body. They are supplied as follows:NDC 63304-445-30 unit of use bottles of 30NDC 63304-445-01 bottles of 100NDC 63304-445-10 bottles of 1000.StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store between 15 C and 30C (59F and 86F).Omeprazole delayed-release capsules, 40 mg, are opaque, hard gelatin, apricot and amethystcolored capsules, coded 1740 on cap and 40 mg on the body. They are supplied as follows:NDC 63304-445-30 unit of use bottles of 30NDC 63304-445-01 bottles of 100NDC 63304-445-10 bottles of 1000.StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store between 15 C and 30C (59F and 86F).Omeprazole delayed-release capsules, 40 mg, are opaque, hard gelatin, apricot and amethystcolored capsules, coded 1740 on cap and 40 mg on the body. They are supplied as follows:NDC 63304-445-30 unit of use bottles of 30NDC 63304-445-01 bottles of 100NDC 63304-445-10 bottles of 1000.StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store between 15 C and 30C (59F and 86F).Omeprazole delayed-release capsules, 40 mg, are opaque, hard gelatin, apricot and amethystcolored capsules, coded 1740 on cap and 40 mg on the body. They are supplied as follows:NDC 63304-445-30 unit of use bottles of 30NDC 63304-445-01 bottles of 100NDC 63304-445-10 bottles of 1000.StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store between 15 C and 30C (59F and 86F).Omeprazole delayed-release capsules, 40 mg, are opaque, hard gelatin, apricot and amethystcolored capsules, coded 1740 on cap and 40 mg on the body. They are supplied as follows:NDC 63304-445-30 unit of use bottles of 30NDC 63304-445-01 bottles of 100NDC 63304-445-10 bottles of 1000.StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store between 15 C and 30C (59F and 86F).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H /K ATPase enzyme system at the secretory surface of the gastric parietal cell. 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. Animal studies indicate that after rapid disappearance from plasma, omeprazole can be found within the gastric mucosa for a day or more.
Non-Clinical Toxicology
Omeprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, and urticaria [ ].CNS Drugs - Given the primary CNS effects of citalopram, caution should be used when it is taken in combination with other centrally acting drugs.
Alcohol - Although citalopram did not potentiate the cognitive and motor effects of alcohol in a clinical trial, as with other psychotropic medications, the use of alcohol by depressed patients taking citalopram hydrobromide is not recommended.
Monoamine Oxidase Inhibitors (MAOIs) - See and .
Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.)- Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate the risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored when citalopram hydrobromide is initiated or discontinued.
Cimetidine - In subjects who had received 21 days of 40 mg/day citalopram hydrobromide, combined administration of 400 mg/day cimetidine for 8 days resulted in an increase in citalopram AUC and C of 43% and 39%, respectively. The clinical significance of these findings is unknown.
Digoxin - In subjects who had received 21 days of 40 mg/day citalopram hydrobromide, combined administration of citalopram hydrobromide and digoxin (single dose of 1 mg) did not significantly affect the pharmacokinetics of either citalopram or digoxin.
Lithium - Coadministration of citalopram hydrobromide (40 mg/day for 10 days) and lithium (30 mmol/day for 5 days) had no significant effect on the pharmacokinetics of citalopram or lithium. Nevertheless, plasma lithium levels should be monitored with appropriate adjustment to the lithium dose in accordance with standard clinical practice. Because lithium may enhance the serotonergic effects of citalopram, caution should be exercised when citalopram hydrobromide and lithium are coadministered.
Pimozide - In a controlled study, a single dose of pimozide 2 mg co-administered with citalopram 40 mg given once daily for 11 days was associated with a mean increase in QTc values of approximately 10 msec compared to pimozide given alone. Citalopram did not alter the mean AUC or C of pimozide. The mechanism of this pharmacodynamic interaction is not known.
Theophylline - Combined administration of citalopram hydrobromide (40 mg/day for 21 days) and the CYP1A2 substrate theophylline (single dose of 300 mg) did not affect the pharmacokinetics of theophylline. The effect of theophylline on the pharmacokinetics of citalopram was not evaluated.
Sumatriptan - There have been rare postmarketing reports describing patients with weakness, hyperreflexia, and incoordination following the use of a SSRI and sumatriptan. If concomitant treatment with sumatriptan and an SSRI (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram) is clinically warranted, appropriate observation of the patient is advised.
Warfarin - Administration of 40 mg/day citalopram hydrobromide for 21 days did not affect the pharmacokinetics of warfarin, a CYP3A4 substrate. Prothrombin time was increased by 5%, the clinical significance of which is unknown.
Carbamazepine - Combined administration of citalopram hydrobromide (40 mg/day for 14 days) and carbamazepine (titrated to 400 mg/day for 35 days) did not significantly affect the pharmacokinetics of carbamazepine, a CYP3A4 substrate. Although trough citalopram plasma levels were unaffected, given the enzyme-inducing properties of carbamazepine, the possibility that carbamazepine might increase the clearance of citalopram should be considered if the two drugs are coadministered.
Triazolam - Combined administration of citalopram hydrobromide (titrated to 40 mg/day for 28 days) and the CYP3A4 substrate triazolam (single dose of 0.25 mg) did not significantly affect the pharmacokinetics of either citalopram or triazolam.
Ketoconazole - Combined administration of citalopram hydrobromide (40 mg) and ketoconazole (200 mg) decreased the C and AUC of ketoconazole by 21% and 10%, respectively, and did not significantly affect the pharmacokinetics of citalopram.
CYP3A4 and 2C19 Inhibitors - studies indicated that CYP3A4 and 2C19 are the primary enzymes involved in the metabolism of citalopram. However, coadministration of citalopram (40 mg) and ketoconazole (200 mg), a potent inhibitor of CYP3A4, did not significantly affect the pharmacokinetics of citalopram. Because citalopram is metabolized by multiple enzyme systems, inhibition of a single enzyme may not appreciably decrease citalopram clearance.
Metoprolol - Administration of 40 mg/day citalopram hydrobromide for 22 days resulted in a two-fold increase in the plasma levels of the beta-adrenergic blocker metoprolol. Increased metoprolol plasma levels have been associated with decreased cardioselectivity. Coadministration of citalopram hydrobromide and metoprolol had no clinically significant effects on blood pressure or heart rate.
Imipramine and Other Tricyclic Antidepressants (TCAs) - studies suggest that citalopram is a relatively weak inhibitor of CYP2D6. Coadministration of citalopram hydrobromide (40 mg/day for 10 days) with the TCA imipramine (single dose of 100 mg), a substrate for CYP2D6, did not significantly affect the plasma concentrations of imipramine or citalopram. However, the concentration of the imipramine metabolite desipramine was increased by approximately 50%. The clinical significance of the desipramine change is unknown. Nevertheless, caution is indicated in the coadministration of TCAs with citalopram hydrobromide.
Electroconvulsive Therapy (ECT) - There are no clinical studies of the combined use of electroconvulsive therapy (ECT) and citalopram hydrobromide.
Symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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