Medication info
Janugluem XR Extended-Release Tablets 50/500 mg

Janugluem XR Extended-Release Tablets 50/500 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.69mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
삼천당제약(주)
Appearance
Pale blue, double convex, oval-shaped extended-release film-coated tablets
Packaging
Bottle - 100 tablets/bottle, Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 202300593 · Approved 2023.02.17 · Insurance code 651205960

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is taken once daily with food at dinner time and the dosage is gradually increased. The extended-release formulation of 100/1000 mg is taken once daily, one tablet per dose. For the 50/500 mg or 50/1000 mg extended-release tablets, one should take two tablets at once once daily. 1. For patients currently not undergoing treatment with Metformin: The initial dose is 100 mg of Sitagliptin and 1000 mg of Metformin.

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication assists patients with type 2 diabetes in effecting better blood sugar control. Sitagliptin and Metformin work together to allow for stable management of blood sugar levels when used along with dietary adjustments and exercise therapy. It is recommended as an adjunctive treatment for those who find it difficult to control their blood sugar levels. If taken consistently, it may provide positive assistance in blood sugar control.

How to take

Adult dose

This medication is taken once daily with food at dinner time and the dosage is gradually increased. The extended-release formulation of 100/1000 mg is taken once daily, one tablet per dose. For the 50/500 mg or 50/1000 mg extended-release tablets, one should take two tablets at once once daily. 1. For patients currently not undergoing treatment with Metformin: The initial dose is 100 mg of Sitagliptin and 1000 mg of Metformin.

Precautions

This medication contains Sitagliptin and Metformin and is used for the treatment of diabetes. Firstly, Sitagliptin can rarely cause serious allergic reactions such as anaphylaxis, angioedema, and skin rash. If any of these symptoms occur, immediate discontinuation of the medication and consultation with a physician is necessary. Additionally, Sitagliptin may induce acute pancreatitis, so careful observation for symptoms of pancreatitis, such as abdominal pain, nausea, and vomiting, is required. If suspected, the medication should be discontinued. Metformin can cause lactic acidosis, a rare but very serious side effect. Lactic acidosis can begin with nonspecific symptoms such as muscle pain, difficulty breathing, weakness, and abdominal pain; therefore, both patients and caregivers should be well informed about these symptoms and report them to a physician immediately if they occur. This medication should not be given to patients with moderate to severe renal impairment, acute heart failure, severe infections, dehydration, liver dysfunction, or to women during pregnancy or lactation. Moreover, the use of this medication should be temporarily suspended for a period before and after surgery, and should be restarted only after renal function has been confirmed to be normal. This medication presents a risk of hypoglycemia; therefore, caution is advised in cases of irregular meal timing, excessive physical activity, and concomitant use with other hypoglycemic agents, and immediate appropriate action should be undertaken if hypoglycemic symptoms arise. Furthermore, this medication contains Red 40 dye, which can induce allergic reactions; hence, patients with hypersensitivity to this ingredient should use it cautiously. Regular monitoring of kidney function and blood tests is essential for safety, and vitamin B12 levels may decrease and may require supplementation if necessary. Finally, alcohol consumption should be avoided while taking this medication, and if any unusual symptoms or suspected side effects arise during administration, consultation with a healthcare professional should be sought immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, chest tightness, difficulty breathing, Stevens-Johnson syndrome and other exfoliative skin illnesses, severe rash with fever, blisters, skin peeling, pain in oral/mucosal or ocular areas, pancreatitis, acute renal failure, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, seizures, confusion, visual disturbances, paralysis, marked decrease in urine output,

Mild side effects

  • Diarrhea
  • upper respiratory infection
  • headache
  • nausea
  • vomiting
  • abdominal pain
  • nasopharyngitis
  • muscle pain
  • limb pain
  • back pain
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  • interstitial lung disease
  • pruritus
  • thrombocytopenia
  • rhabdomyolysis
  • severe and disabling arthralgia

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to air and moisture and must be stored in a tightly sealed container. It is best to keep it at room temperature between 1 and 30 degrees Celsius. This will help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Pale blue, double convex, oval-shaped extended-release film-coated tablets

Package unit

Bottle - 100 tablets/bottle, Bottle - 30 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.