JANUVIA (Page 6 of 7)
16 HOW SUPPLIED/STORAGE AND HANDLING
Tablets: JANUVIA, 100 mg, are beige, round, film-coated tablets with “277” on one side.
They are supplied as follows:
Bottles of approximately 1350 tablets, NDC 55154-5042-8
Storage
Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.]
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Pancreatitis
Inform patients that acute pancreatitis has been reported during postmarketing use of JANUVIA. Inform patients that persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to promptly discontinue JANUVIA and contact their physician if persistent severe abdominal pain occurs [see Warnings and Precautions (5.1)].
Heart Failure
Inform patients of the signs and symptoms of heart failure. Before initiating JANUVIA, ask patients about a history of heart failure or other risk factors for heart failure including moderate to severe renal impairment. Instruct patients to contact their health care provider as soon as possible if they experience symptoms of heart failure, including increasing shortness of breath, rapid increase in weight or swelling of the feet [see Warnings and Precautions (5.2)].
Hypoglycemia
Inform patients that the incidence of hypoglycemia is increased when JANUVIA is added to a sulfonylurea or insulin. Explain to patients receiving JANUVIA in combination with these medications the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development [see Warnings and Precautions (5.4)].
Hypersensitivity Reactions
Inform patients that allergic reactions have been reported during postmarketing use of JANUVIA. If symptoms of allergic reactions (including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing) occur, patients must stop taking JANUVIA and seek medical advice promptly [see Warnings and Precautions (5.5)].
Severe and Disabling Arthralgia
Inform patients that severe and disabling joint pain may occur with this class of drugs. The time to onset of symptoms can range from one day to years. Instruct patients to seek medical advice if severe joint pain occurs [see Warnings and Precautions (5.6)].
Bullous Pemphigoid
Inform patients that bullous pemphigoid may occur with this class of drugs. Instruct patients to seek medical advice if blisters or erosions occur [see Warnings and Precautions (5.7)].
- Distributed by: Merck Sharp & Dohme LLC
Rahway, NJ 07065, USA
Distributed By:
Cardinal Health
Dublin, OH 43017
L7309 Rev. A
For patent information: www.msd.com/research/patent
- Copyright © 2006-2022 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights reserved.
uspi-mk0431-t-2207r028
| Medication Guide JANUVIA® (jah-NEW-vee-ah) (sitagliptin) tablets, for oral use | ||||||
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| This Medication Guide has been approved by the U.S. Food and Drug Administration. | ||||||
| Revised: 07/2022 | ||||||
| Read this Medication Guide carefully before you start taking JANUVIA and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about JANUVIA, ask your doctor or pharmacist. | ||||||
| What is the most important information I should know about JANUVIA? JANUVIA can cause serious side effects, including:
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| Stop taking JANUVIA and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis. | ||||||
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| What is JANUVIA?
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| Who should not take JANUVIA? Do not take JANUVIA if:
Symptoms of a serious allergic reaction to JANUVIA may include rash, raised red patches on your skin (hives), or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. | ||||||
| What should I tell my doctor before taking JANUVIA? Before you take JANUVIA, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. | ||||||
| How should I take JANUVIA?
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| What are the possible side effects of JANUVIA? JANUVIA may cause serious side effects, including:
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The most common side effects of JANUVIA include upper respiratory infection, stuffy or runny nose and sore throat, and headache. JANUVIA may have other side effects, including stomach upset and diarrhea, swelling of the hands or legs, when JANUVIA is used with metformin and rosiglitazone (Avandia). Rosiglitazone is another type of diabetes medicine.Tell your doctor if you have any side effect that bothers you or does not go away.These are not all the possible side effects of JANUVIA. For more information, ask your doctor or pharmacist.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 JANUVIA? Store JANUVIA at room temperature, between 68°F to 77°F (20°C to 25°C).Keep JANUVIA and all medicines out of the reach of children. | ||||||
| General information about the safe and effective use of JANUVIA. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use JANUVIA for a condition for which it was not prescribed. Do not give JANUVIA to other people, even if they have the same symptoms you have. It may harm them. This Medication Guide summarizes the most important information about JANUVIA. If you would like to know more information, talk with your doctor. You can ask your doctor or pharmacist for information about JANUVIA that is written for health professionals. | ||||||
| What are the ingredients in JANUVIA? Active ingredient: sitagliptin Inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, and sodium stearyl fumarate. The tablet film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide. | ||||||
Cardinal Health Dublin, OH 43017 L7309 Rev. A
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