Medication info
JanuaTine Duo Sustained-release Tablet 50/500 mg

JanuaTine Duo Sustained-release Tablet 50/500 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.69mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
(주)팜젠사이언스
Appearance
Light blue, biconvex, oval sustained-release film-coated tablet
Packaging
Bottle - 100 tablets/bottle, Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 202300611 · Approved 2023.02.17 · Insurance code 670105440

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication should be taken once a day with the evening meal and must be swallowed whole without splitting, crushing, or chewing. - This medication, sustained-release 100/1000 mg, is taken once daily, one tablet per dose. - The 50/500 mg or 50/1000 mg sustained-release formulation is taken once daily, two tablets per dose. 1. For patients not previously treated with metformin: The initial dosage is sitagliptin 100 mg and metformin 1000 mg.

Ingredients

Manufacturer
(주)팜젠사이언스

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used as an adjunct to diet and exercise to improve blood sugar control in patients with type 2 diabetes. Sitagliptin and metformin work together to efficiently help regulate blood sugar. This helps maintain blood sugar levels within a healthy range, supporting patients in achieving more stable blood glucose management. Therefore, this medication is used to improve blood sugar control in patients with type 2 diabetes.

How to take

Adult dose

This medication should be taken once a day with the evening meal and must be swallowed whole without splitting, crushing, or chewing. - This medication, sustained-release 100/1000 mg, is taken once daily, one tablet per dose. - The 50/500 mg or 50/1000 mg sustained-release formulation is taken once daily, two tablets per dose. 1. For patients not previously treated with metformin: The initial dosage is sitagliptin 100 mg and metformin 1000 mg.

Precautions

This medication contains two components, sitagliptin and metformin, and is used in diabetes treatment. Sitagliptin can rarely cause severe allergic reactions, so if symptoms such as skin rash, angioedema, or anaphylaxis occur, medication should be discontinued immediately. Additionally, acute pancreatitis, which is inflammation of the pancreas, can occur, so if symptoms such as abdominal pain, nausea, or vomiting appear, consult a healthcare professional promptly. Metformin can cause a rare complication called lactic acidosis, which is a serious condition resulting from excessive lactic acid accumulation in the body. Symptoms of lactic acidosis include muscle pain, weakness, difficulty breathing, and abdominal pain, so if any of these symptoms occur, the patient should stop the medication immediately and inform a healthcare professional. This medication should not be used in patients with moderate to severe renal impairment, acute heart failure, severe infections or dehydration, or in women who are pregnant or breastfeeding. Furthermore, the medication should be discontinued for a certain period before and after surgery and restarted only after renal function has returned to normal. During the use of this medication, there is a risk of hypoglycemia, especially when used in conjunction with insulin or sulfonylureas; hence, blood sugar levels should be monitored frequently, and attention should be paid to signs of hypoglycemia. Irregular meals, intense exercise, or combination with certain medications may also increase the risk of hypoglycemia or lactic acidosis, so caution is advised. If allergic to one of the ingredients, Red 40, caution should be exercised during administration. Long-term use requires regular blood tests to check kidney function and vitamin B12 levels; if vitamin B12 deficiency is suspected, appropriate supplementation is needed. Excessive alcohol consumption can increase the risk of lactic acidosis; thus, it is advisable to avoid drinking during medication use. During the use of this medication, if there is sudden difficulty in breathing, severe muscle pain, altered consciousness, skin rash, blisters, etc., consult a physician immediately. Finally, this medication is not recommended for children under 18 years of age as its safety and efficacy have not been established.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, Stevens-Johnson syndrome, severe rash, skin peeling, pain in oral/eye mucosa, acute pancreatitis, acute kidney failure, severe joint pain accompanied by disability, bullous pemphigoid, liver abnormalities due to elevated liver enzymes (risk of jaundice), hypoglycemia (including severe), lactic acidosis, acute or chronic metabolic acidosis, ketoacidosis, severe edema, swelling associated with hypertension, severe

Mild side effects

  • Diarrhea
  • upper respiratory infection
  • headache
  • nasopharyngitis
  • nausea
  • vomiting
  • abdominal pain
  • muscle pain
  • limb pain
  • back pain
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  • pruritus
  • thrombocytopenia
  • rhabdomyolysis

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture. It is recommended to keep it at room temperature between 1°C and 30°C. Proper storage helps maintain the medication's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Light blue, biconvex, oval sustained-release film-coated tablet

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.

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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.