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 64950-424-30||Bottles of 30 tablets||YOSPRALA 81/40|
|NDC 64950-424-90||Bottles of 90 tablets||YOSPRALA 81/40|
|NDC 64950-425-30||Bottles of 30 tablets||YOSPRALA 325/40|
|NDC 64950-425-90||Bottles of 90 tablets||YOSPRALA 325/40|
Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59 to 86°F) [see USP Controlled Room Temperature]. Store in the original container with desiccant and keep the bottle tightly closed to protect from moisture. Dispense in a tight container if package is subdivided.
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.
Advise patients to inform their health care provider if they experience any unanticipated, prolonged or excessive bleeding or bleeding time (e.g. bruising, nose bleed) [see Warnings and Precautions (5.1)].
GI Adverse Reactions
Advise patients to stop taking YOSPRALA and call their health care provider right away if they have any of the following signs or symptoms: 1) black, bloody, or tarry stools; 2) coughing up blood or vomit that looks like coffee grounds; 3) severe nausea, vomiting, or stomach pain [see Warnings and Precautions (5.2)].
Bleeding Risk with Use of Alcohol
Advise patients to avoid heavy alcohol use (three or more drinks every day) during treatment with YOSPRALA during treatment with YOSPRALA [see Warnings and Precautions (5.3)].
Advise patients to report to their healthcare provider before starting treatment with any of the following:
- Rilpivirine-containing products [see Contraindications (4)].
- Clopidogrel, ticagrelor, St. John’s Wort or rifampin; or, if they take high-dose methotrexate [see Warnings and Precautions (5.4, 5.5, 5.15, 5.17)].
Advise patients to report to their health care provider if they develop kidney problems (e.g. changes in urination, swelling, skin rash/itching, ammonia breath) [see Warnings and Precautions (5.6)].
Advise patients to return to their healthcare provider if they have gastric symptoms while taking YOSPRALA or after completing treatment [see Warnings and Precautions (5.7)].
Acute Interstitial Nephritis
Advise patients to call their healthcare provider immediately if they experience signs and/or symptoms associated with acute interstitial nephritis [see Warnings and Precautions (5.8)].
Clostridium difficile -Associated Diarrhea
Advise patients to call their health care provider immediately if they experience diarrhea that does not improve [see Warnings and Precautions (5.9)].
Advise patients to report any fractures, especially of the hip, wrist or spine, to their health care provider [see Warnings and Precautions (5.10)].
Cutaneous and Systemic Lupus Erythematosus
Advise patients to immediately call their health care provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus [see Warnings and Precautions (5.11)].
Advise patients to report to their health care provider if they develop liver problems (e.g. skin and eyes that appear yellowish, abdominal pain and swelling, itchy skin, dark urine color) [see Warnings and Precautions (5.12)].
Cyanocobalamin (Vitamin B-12) Deficiency
Advise patients to report any clinical symptoms that may be associated with cyanocobalamin deficiency to their health care provider if they have been receiving YOSPRALA for longer than 3 years [see Warnings and Precautions (5.13)].
Advise patients to report any clinical symptoms that may be associated with hypomagnesemia to their health care provider, if they have been receiving YOSPRALA for at least 3 months [see Warnings and Precautions (5.14)].
Inform pregnant women to avoid use of YOSPRALA and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closure of the fetal ductus arteriosus [see Warnings and Precautions (5.18) and Use in Specific Populations (8.1)].
Advise women that breastfeeding is not recommended during treatment with YOSPRALA [see Use in Specific Populations (8.2)].
Advise females of reproductive potential that NSAIDs, including YOSPRALA, may be associated with reversible infertility [see Use in Specific Populations (8.3)].
Administration [see Dosage and Administration (2.2)]
- To take YOSPRALA once daily at least 60 minutes before a meal.
- The tablets are to be swallowed whole with liquid. Do not split, chew, crush or dissolve the tablet.
- If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose, unless advised by their health care provider.
- Not to stop taking YOSPRALA suddenly as this could increase the risk of heart attack or stroke.
Genus Lifesciences Inc.Allentown, PA 18102
|This Medication Guide has been approved by the U.S. Food and Drug Administration.||Revised: September 2018 r1|
MEDICATION GUIDEYOSPRALA™ (yo SPRA lah)(aspirin and omeprazole)delayed-release tablets
You should take YOSPRALA exactly as prescribed, at the lowest dose possible and for the shortest time needed.
YOSPRALA may help reduce the risk of stomach ulcers from aspirin use, but you could still have bleeding and stomach or intestine ulcers, or other serious stomach or intestine problems. Talk with your doctor.
Tell your doctor if you have unexpected bleeding, if you bleed more than usual, or if your bleeding lasts longer than is normal for you, such as increased bruising or more frequent nose bleeds.
YOSPRALA contains aspirin, a nonsteroidal anti-inflammatory drug (NSAID) and omeprazole, a proton pump inhibitor (PPI) medicine. Before taking YOSPRALA, tell your doctor if you take:
Do not stop taking YOSPRALA without talking with your doctor. Stopping YOSPRALA suddenly could increase your risk of having a heart attack or stroke.
YOSPRALA can cause serious side effects, including:
Talk to your doctor about your risk of these serious side effects.
YOSPRALA can have other serious side effects. See “What are the possible side effects of YOSPRALA?“
What is YOSPRALA?
YOSPRALA is a prescription medicine used:
The aspirin in YOSPRALA is used:
The omeprazole in YOSPRALA is used:
YOSPRALA should not be used to treat sudden signs and symptoms of a heart attack or stroke. YOSPRALA should only be used as directed by your doctor to help reduce the risk of further heart problems or strokes.
It is not known if YOSPRALA is safe and effective in children.
YOSPRALA has not been shown to reduce the risk of bleeding in the stomach or intestines that is caused by aspirin.
You should not take an aspirin tablet and an omeprazole tablet together instead of taking YOSPRALA, because they will not work the same way.
Do not take YOSPRALA if you:
Do not give YOSPRALA to a child who has a suspected viral infection, even if they do not have a fever. There is a risk of Reye’s syndrome with YOSPRALA because it contains aspirin.
Before taking YOSPRALA, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. YOSPRALA and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your doctor first.
Especially tell your doctor if you take:
How should I take YOSPRALA?
What should I avoid while taking YOSPRALA?
Avoid heavy alcohol use during treatment with YOSPRALA. People who drink three or more drinks that contain alcohol every day have a higher risk of bleeding during treatment with YOSPRALA because it contains aspirin.
YOSPRALA can cause serious side effects, including:
The most common side effects of YOSPRALA include: indigestion or heartburn and stomach-area pain, nausea, diarrhea, and chest pain behind the breastbone, for example, with eating.
These are not all the possible side effects of YOSPRALA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store YOSPRALA?
Keep YOSPRALA and all medicines out of the reach of children.
General information about the safe and effective use of YOSPRALA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use YOSPRALA for a condition for which it was not prescribed. Do not give YOSPRALA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about YOSPRALA that is written for health professionals.
What are the ingredients in YOSPRALA?
Active ingredients: aspirin and omeprazole
Inactive ingredients: 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.
Manufactured for: Genus Lifesciences Inc., 514 North 12th Street, Allentown, PA 18102YOSPRALA® is a trademark of Genus Lifesciences Inc.
For more information, go to www.genuslifesciences.com or call 1-866-511-6754.
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