Yosprala (Yosprala)

Trade Name

Yosprala

Active Ingredient

Power

81; 40 mg/1; mg/1

Type / form

Tablets

Status

Manufacturer

NuCare Pharmaceuticals,Inc.

Storage and handling for Yosprala

ASPIRIN; OMEPRAZOLE Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Yosprala (Yosprala) which is also known as Yosprala and Manufactured by NuCare Pharmaceuticals,Inc.. It is available in strength of 81; 40 mg/1; mg/1 per ml. Read more

Yosprala (Yosprala) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

About GNH

GNH India a Global Orphan Drug specialist renowned for its adherence to stringent quality standards. GNH India holds ISO 9001:2015 certification and WHO Good Storage and Distribution Practices (GSDP) compliance, ensuring the highest levels of safety and reliability in our operations.

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  • 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 (u2265 55) or documented history of gastric ulcers.
  • Limitations of Use:
  • YOSPRALA is a combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI), 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 (u2265 55) or documented history of gastric ulcers. (n n n )n nn
  • Limitations of Use:
  • No data
  • Recommended dosage: One tablet daily at least 60 minutes before a meal. (n n n , n n n )n n n
  • Do not split, chew, crush or dissolve the tablet. (n n n )n n n
  • Oval, blue-green, film-coated, delayed-release tablets for oral administration containing either:
  • Delayed-Release Tablets (n n n ):n nn
  • 81 mg delayed-release aspirin/40 mg immediate-release omeprazole
  • 325 mg delayed-release aspirin/40 mg immediate-release omeprazole
  • YOSPRALA is contraindicated in:
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. (n n n )n n n
  • In pediatric patients with suspected viral infections, with or without fever, because of the risk of Reye's Syndrome. (n n n )n n n
  • Known hypersensitivity to aspirin, omeprazole, substituted benzimidazoles or to any of the excipients of YOSPRALA. (n n n )n n n
  • Patients receiving rilpivirine-containing products. (n n n , n n n )n n n
  • No data
  • Coagulation Abnormalities
  • GI Adverse Reactions (including ulceration and bleeding)
  • Bleeding Risk with Use of Alcohol
  • Reduction in Antiplatelet Activity with Clopidogrel due to Interference with CYP2C19 Metabolism
  • Reduction in Efficacy of Ticagrelor
  • Renal Failure
  • Gastric Malignancy
  • Acute Interstitial Nephritis
  • Arrayn- -Associated Diarrhea
  • Bone Fracture
  • Cutaneous and Systemic Lupus Erythematosus
  • Hepatic Impairment
  • Cyanocobalamin (Vitamin B-12) Deficiency
  • Hypomagnesemia
  • Reduced Effect of Omeprazole with St. John's Wort or Rifampin
  • Interactions with Diagnostic Investigations for Neuroendocrine Tumors
  • Bone Marrow Toxicity with Methotrexate, especially in the elderly or renally impaired
  • Premature closure of the ductus arteriosus
  • Abnormal Laboratory Tests
  • Fundic Gland Polyps
  • Most common adverse reactions in adults (u2265 2%) are: gastritis, nausea, diarrhea, gastric polyps, and non-cardiac chest pain. (n n n )n nn
  • To report SUSPECTED ADVERSE REACTIONS, contact Pharm-Olam at 1-866-511-6754 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Tables 2 and 3 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with YOSPRALA and instructions for preventing or managing them.
  • Consult the labeling of concomitantly used drugs to obtain further information about interactions with omeprazole or aspirin.
  • See full prescribing information for a list of clinically important drug interactions. (n n n )n nn
  • No data
  • Lactation
  • Females and Males of Reproductive Potential Infertility
  • There is no clinical data on overdosage with 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 155u00b0C. 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]-1n n n - benzimidazole, a compound that inhibits gastric acid secretion.n nn
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  • YOSPRALA (aspirin 81 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 68071-5102-03 BOTTLES OF 30
  • Storage:
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Inform patients, families, or caregivers of the following before initiating therapy with YOSPRALA and periodically during the course of ongoing therapy.
  • Manufactured for:n n n Innovida Pharmaceutique Corporationn n n Charleston, WV 25301n nn
  • 70037927
  • No data

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