Medication info
Janus Tablet 100 mg (Sitagliptin Phosphate Hydrate)

Janus Tablet 100 mg (Sitagliptin Phosphate Hydrate)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
(주)화이트생명과학
Appearance
Beige round biconvex film-coated tablets
Packaging
30 tablets/bottle, 90 tablets/bottle
Approval status
Active

MFDS item code 202100007 · Approved 2021.01.04 · Insurance code 625202150

Summary

Main use
Improvement in blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication is administered as 100 mg once daily for either monotherapy or combination therapy, with a maximum daily dosage of 100 mg. It can be taken regardless of meals. For patients with renal impairment, 1. In patients with mild renal impairment (eGFR ≥ 60 and < 90), dosage adjustment is not necessary. 2. In patients with moderate renal impairment (eGFR ≥ 45 and < 60), dosage adjustment is not necessary. 3. In patients with moderate renal impairment

Ingredients

Manufacturer
(주)화이트생명과학

Efficacy & effects

Improvement in blood sugar control in type 2 diabetes

  • Difficulty in blood sugar control in patients with type 2 diabetes
View approved original text

This medication is used alongside diet and exercise to help control blood sugar levels in patients with type 2 diabetes. It can be administered as monotherapy initially, and in cases where blood sugar control is difficult with monotherapy due to previous non-use of diabetes medications, it is combined with metformin. It may also be used in conjunction if blood sugar is inadequately controlled with monotherapy of sulfonylurea, metformin, thiazolidinedione, or insulin. Furthermore, if blood sugar control remains insufficient after several combination therapies, this medication can be additionally used. This medication is employed at various stages of treatment to improve blood sugar control.

Dosage and Administration

Adult dosage

This medication is administered as 100 mg once daily for either monotherapy or combination therapy, with a maximum daily dosage of 100 mg. It can be taken regardless of meals. For patients with renal impairment, 1. In patients with mild renal impairment (eGFR ≥ 60 and < 90), dosage adjustment is not necessary. 2. In patients with moderate renal impairment (eGFR ≥ 45 and < 60), dosage adjustment is not necessary. 3. In patients with moderate renal impairment

Precautions

This medication may cause severe hypersensitivity reactions after administration; therefore, if any allergic symptoms or skin abnormalities occur, use should be discontinued immediately, and a physician should be consulted. Additionally, this medication may induce severe pancreatic conditions such as pancreatitis, so if symptoms like abdominal pain, vomiting, or appetite loss arise, it should be discontinued immediately and medical personnel should be notified. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and it should not be administered in cases of allergy to this medication or its components. Patients with impaired renal function should have their dosage adjusted; regular renal function tests should be obtained, and administration should be conducted under medical supervision. This medication can increase the risk of hypoglycemia when used with other glucose-lowering medications, especially insulin or sulfonylureas, so attention should be paid to symptoms of hypoglycemia, with dosage adjustments made as needed. Side effects such as headache, upper respiratory infections, nasopharyngitis, diarrhea, etc., may occur during treatment; if these symptoms are severe or persistent, consult a physician. In cases of severe arthralgia or skin blistering, medication should be stopped immediately, and specialized medical attention should be sought. Pregnant or breastfeeding women are advised not to use this medication, and safety in children and adolescents under 18 years has not been established. Elderly patients may have a risk of reduced renal function, necessitating dosage adjustments and regular renal function tests. In cases of overdose, general treatment along with ECG monitoring is necessary as some may be removed by hemodialysis, so this should be considered if needed. This medication has a relatively low interaction with other drugs; however, caution is necessary when taking specific medications, hence all medications should be disclosed to medical personnel. Finally, while this medication does not majorly affect cardiovascular safety, immediate consultation with medical personnel is necessary if any abnormal symptoms occur during use.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), anaphylaxis, rash, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash, blistering, skin peeling, oral/ocular mucosal pain, severe skin reactions, sudden and very severe headache, thunderclap headache, seizure, altered consciousness, vision changes, paralysis, severe neurological symptoms, significantly decreased urine output, generalized severe swelling and increased blood pressure

Mild side effects

  • Hypoglycemia
  • upper respiratory infections
  • nasopharyngitis
  • headache
  • diarrhea
  • nausea
  • constipation
  • myalgia
  • limb pain
  • back pain
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  • pruritus
  • thrombocytopenia
  • dyspepsia
  • dizziness
  • increased blood triglycerides
  • increased low-density lipoprotein levels
  • hyperglycemia
  • weight loss
  • hypertension
  • hypernatremia
  • erectile dysfunction

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering. It is recommended to maintain the storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Beige round biconvex film-coated tablets

Package unit

30 tablets/bottle, 90 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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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.