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YOSPRALA
Overview
What is YOSPRALA?
The active ingredients of YOSPRALA are aspirin which is an antiplatelet agent and omeprazole which is a PPI.
YOSPRALA (aspirin and omeprazole) is an oval, blue-green, multi-layer film-coated, delayed-release tablet consists of an enteric coated delayed-release aspirin core surrounded by an immediate-release omeprazole layer for oral administration. Each delayed-release tablet contains either 81 mg aspirin and 40 mg omeprazole printed with 81/40, or 325 mg aspirin and 40 mg omeprazole printed with 325/40.
The excipients used in the formulation of YOSPRALA are all inactive and United States Pharmacopeia/National Formulary (USP/NF) defined. The inactive ingredients in YOSPRALA include: carnauba wax, colloidal silicon dioxide, corn starch, FD&C Blue #2, glyceryl monostearate, hydroxypropyl methycellulose, methacrylic acid copolymer dispersion, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, povidone, pre-gelatinized starch , sodium phosphate dibasic anhydrous, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate, yellow iron oxide.
Aspirin is acetylsalicylic acid and is chemically known as benzoic acid, 2-(acetyloxy). Aspirin is an odorless white needle-like crystalline or powdery substance. When exposed to moisture, aspirin hydrolyzes into salicylic and acetic acids and gives off a vinegary odor. It is highly lipid soluble and slightly soluble in water. Aspirin irreversibly inhibits platelet COX-1.
Omeprazole is a white to off-white crystalline powder which 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 is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H- benzimidazole, a compound that inhibits gastric acid secretion.
Structural Formula
Aspirin
Omeprazole
Molecular Formula
The empirical formula of aspirin is CHO .
The empirical formula of omeprazole is CHNOS .
Molecular Weight
The molecular weight of aspirin is 180.16.
The molecular weight of omeprazole is 345.4.
What does YOSPRALA look like?
What are the available doses of YOSPRALA?
Delayed-Release Tablets ():
What should I talk to my health care provider before I take YOSPRALA?
How should I use YOSPRALA?
YOSPRALA, a combination of aspirin and omeprazole, is indicated for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers.
The aspirin component of YOSPRALA is indicated for:
The omeprazole component of YOSPRALA is indicated for decreasing the risk of developing aspirin-associated gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers due to age (≥ 55) or documented history of gastric ulcers.
Limitations
of Use
:
Recommended dosage: One tablet daily at least 60 minutes before a meal. (, )
Do not split, chew, crush or dissolve the tablet. ()
What interacts with YOSPRALA?
Sorry No Records found
What are the warnings of YOSPRALA?
Sorry No Records found
What are the precautions of YOSPRALA?
Sorry No Records found
What are the side effects of YOSPRALA?
Sorry No records found
What should I look out for while using YOSPRALA?
YOSPRALA is contraindicated in:
What might happen if I take too much YOSPRALA?
There is no clinical data on overdosage with YOSPRALA.
Aspirin
Salicylate toxicity may result from acute ingestion (overdose) or chronic intoxication. The early signs of salicylic overdose (salicylism), including tinnitus (ringing in the ears), occur at plasma concentrations approaching 200 mg/mL. Plasma concentrations of aspirin above 300 mg/mL are clearly toxic. Severe toxic effects are associated with levels above 400 mg/mL. A single lethal dose of aspirin in adults is not known with certainty but death may be expected at 30 g.
Signs and Symptoms:
Treatment:
Severity of aspirin intoxication is determined by measuring the blood salicylate level. Serial salicylate levels should be obtained every 1 to 2 hours until concentrations have peaked and are declining. Acid-base status should be closely followed with serial blood gas and serum pH measurements. Fluid and electrolyte balance should also be maintained.
In severe cases, hyperthermia and hypovolemia are the major immediate threats to life. Children should be sponged with tepid water. Replacement fluid should be administered intravenously and augmented with correction of acidosis. Plasma electrolytes and pH should be monitored to promote alkaline diuresis of salicylate if renal function is normal. Infusion of glucose may be required to control hypoglycemia.
Hemodialysis and peritoneal dialysis can be performed to reduce the body drug content. In patients with renal impairment or in cases of life-threatening intoxication, dialysis is usually required. Exchange transfusion may be indicated in infants and young children.
O
meprazole
Reports have been received of overdosage with omeprazole in humans. Doses ranged up to 2400 mg. 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 with recommended doses of omeprazole see
. Symptoms were transient, and no serious clinical outcome has been reported when omeprazole was 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.
If overexposure to YOSPRALA occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.
How should I store and handle YOSPRALA?
Keep out of reach of children.Protect from light, moisture, and excessive heat.Dispense in tight, light-resistant container with child-resistant closure.Keep out of reach of children.Protect from light, moisture, and excessive heat.Dispense in tight, light-resistant container with child-resistant closure.Keep out of reach of children.Protect from light, moisture, and excessive heat.Dispense in tight, light-resistant container with child-resistant closure.YOSPRALA (aspirin 81 mg/omeprazole 40 mg) and (aspirin 325 mg/omeprazole 40 mg) delayed-release tablets are oval, blue-green, film-coated tablets printed with 81/40 and 325/40 respectively in black ink. YOSPRALA tablets are packaged in high density polyethylene (HDPE) bottles with desiccants and are supplied as:NDC 70347-081-30 Bottles of 30 tablets YOSPRALA 81/40NDC 70347-081-90 Bottles of 90 tablets YOSPRALA 81/40NDC 70347-325-30 Bottles of 30 tablets YOSPRALA 325/40NDC 70347-325-90 Bottles of 90 tablets YOSPRALA 325/40StorageYOSPRALA (aspirin 81 mg/omeprazole 40 mg) and (aspirin 325 mg/omeprazole 40 mg) delayed-release tablets are oval, blue-green, film-coated tablets printed with 81/40 and 325/40 respectively in black ink. YOSPRALA tablets are packaged in high density polyethylene (HDPE) bottles with desiccants and are supplied as:NDC 70347-081-30 Bottles of 30 tablets YOSPRALA 81/40NDC 70347-081-90 Bottles of 90 tablets YOSPRALA 81/40NDC 70347-325-30 Bottles of 30 tablets YOSPRALA 325/40NDC 70347-325-90 Bottles of 90 tablets YOSPRALA 325/40StorageYOSPRALA (aspirin 81 mg/omeprazole 40 mg) and (aspirin 325 mg/omeprazole 40 mg) delayed-release tablets are oval, blue-green, film-coated tablets printed with 81/40 and 325/40 respectively in black ink. YOSPRALA tablets are packaged in high density polyethylene (HDPE) bottles with desiccants and are supplied as:NDC 70347-081-30 Bottles of 30 tablets YOSPRALA 81/40NDC 70347-081-90 Bottles of 90 tablets YOSPRALA 81/40NDC 70347-325-30 Bottles of 30 tablets YOSPRALA 325/40NDC 70347-325-90 Bottles of 90 tablets YOSPRALA 325/40StorageYOSPRALA (aspirin 81 mg/omeprazole 40 mg) and (aspirin 325 mg/omeprazole 40 mg) delayed-release tablets are oval, blue-green, film-coated tablets printed with 81/40 and 325/40 respectively in black ink. YOSPRALA tablets are packaged in high density polyethylene (HDPE) bottles with desiccants and are supplied as:NDC 70347-081-30 Bottles of 30 tablets YOSPRALA 81/40NDC 70347-081-90 Bottles of 90 tablets YOSPRALA 81/40NDC 70347-325-30 Bottles of 30 tablets YOSPRALA 325/40NDC 70347-325-90 Bottles of 90 tablets YOSPRALA 325/40StorageYOSPRALA (aspirin 81 mg/omeprazole 40 mg) and (aspirin 325 mg/omeprazole 40 mg) delayed-release tablets are oval, blue-green, film-coated tablets printed with 81/40 and 325/40 respectively in black ink. YOSPRALA tablets are packaged in high density polyethylene (HDPE) bottles with desiccants and are supplied as:NDC 70347-081-30 Bottles of 30 tablets YOSPRALA 81/40NDC 70347-081-90 Bottles of 90 tablets YOSPRALA 81/40NDC 70347-325-30 Bottles of 30 tablets YOSPRALA 325/40NDC 70347-325-90 Bottles of 90 tablets YOSPRALA 325/40StorageYOSPRALA (aspirin 81 mg/omeprazole 40 mg) and (aspirin 325 mg/omeprazole 40 mg) delayed-release tablets are oval, blue-green, film-coated tablets printed with 81/40 and 325/40 respectively in black ink. YOSPRALA tablets are packaged in high density polyethylene (HDPE) bottles with desiccants and are supplied as:NDC 70347-081-30 Bottles of 30 tablets YOSPRALA 81/40NDC 70347-081-90 Bottles of 90 tablets YOSPRALA 81/40NDC 70347-325-30 Bottles of 30 tablets YOSPRALA 325/40NDC 70347-325-90 Bottles of 90 tablets YOSPRALA 325/40Storage
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Aspirin (acetylsalicylic acid) is an inhibitor of both prostaglandin synthesis and platelet aggregation. The differences in activity between aspirin and salicylic acid are thought to be due to the acetyl group on the aspirin molecule. This acetyl group is responsible for the inactivation of cyclo-oxygenase via acetylation.
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.
Non-Clinical Toxicology
YOSPRALA is contraindicated in:Absorption of other oral medications may be decreased during concurrent use with anticholinergics due to decreased gastrointestinal motility and delayed gastric emptying. Drug interactions may occur when anticholinergics are used with the following medications: antacids, antidiarrheals (adsorbent), other anticholinergics, antimyasthenics, cyclopropane, haloperidol, ketoconazole, metoclopramide, opioid (narcotic) analgesics, and potassium chloride.
Even low doses of aspirin can inhibit platelet function leading to an increase in bleeding time. This can adversely affect patients with inherited (hemophilia) or acquired (liver disease or vitamin K deficiency) bleeding disorders. Monitor patients for signs of increased bleeding.
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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