Medication info
Januprep Tablet 10/100 mg

Januprep Tablet 10/100 mg

Prescription medicationTablet
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletSitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
(주)다산제약
Appearance
Beige oval film-coated tablet
Packaging
30 tablets/PTP [(10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 202300259 · Approved 2023.01.16 · Insurance code 678601990

Summary

Main use
Improvement in blood sugar control
Who uses it
Adults
Adult dosage
For patients receiving sitagliptin 100 mg and dapagliflozin 10 mg, the dosage is one tablet administered once daily regardless of meals. The tablet should be swallowed whole.

Ingredients

Manufacturer
(주)다산제약

Efficacy & effects

Improvement in blood sugar control

View approved original text

This medication is used to assist in the control of blood sugar levels in patients with type 2 diabetes who require a combination of sitagliptin and dapagliflozin. When taken alongside dietary and exercise therapy, it helps effectively improve blood sugar levels. Therefore, this medication plays an important role in the management of blood sugar in patients with type 2 diabetes.

Dosage and Administration

Adult dosage

For patients receiving sitagliptin 100 mg and dapagliflozin 10 mg, the dosage is one tablet administered once daily regardless of meals. The tablet should be swallowed whole.

Precautions

This medication may cause serious allergic reactions within the first 3 months of administration; if symptoms such as skin rash or difficulty breathing occur, discontinue use immediately and consult your physician. While taking this medication, there is a risk of developing pancreatitis, a serious inflammation of the pancreas; if symptoms such as abdominal pain, vomiting, or fever occur, inform healthcare professionals immediately. This medication should not be used in patients with allergies to specific components, type 1 diabetes, diabetic ketoacidosis, or those undergoing dialysis. Particular caution is necessary in patients with impaired kidney function, reduced fluid volume, and the elderly; dosage adjustments and regular monitoring of kidney function should be conducted according to physician's guidance. During treatment, genital infections or urinary tract infections may occur, and active treatment should be sought upon the appearance of signs of infection. This medication may induce hypoglycemia; caution is required when taken with insulin or other hypoglycemic agents, and dosage adjustments may be necessary if hypoglycemic symptoms arise. Symptoms of hypotension or dehydration due to reduced fluid volume may occur; especially in the elderly or those on diuretics, blood pressure and fluid status should be monitored periodically. This medication is not recommended for women who are pregnant or breastfeeding; if pregnancy is confirmed, discontinue use immediately. Safety and efficacy have not been established in children and adolescents under 18 years of age; therefore, use is not advised. In case of overdose, there is no specific antidote; appropriate treatment should be administered according to symptoms, and monitoring in a hospital may be necessary. Care is required when driving or operating machinery, particularly if hypoglycemic symptoms are present; such activities should be avoided.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, anaphylaxis, angioedema, Stevens-Johnson syndrome, severe hypersensitivity reactions, severe rash with high fever, blistering, skin sloughing, mucosal pain in mouth/eyes, acute pancreatitis, fatal/non-fatal hemorrhagic or necrotizing pancreatitis, respiratory issues, shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanied respiratory distress, skin rash

Mild side effects

  • Headache
  • upper respiratory tract infection
  • nasopharyngitis
  • diarrhea
  • nausea
  • constipation
  • muscle pain
  • limb pain
  • back pain
  • pruritus
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  • thrombocytopenia
  • weight loss
  • increased serum triglycerides
  • hypoglycemia (including mild cases)
  • urinary tract infection
  • vulvar pruritus
  • itching
  • chest pain (mild cases)
  • weakness
  • fatigue
  • hunger
  • vaginal discharge
  • hair loss
  • dermatitis
  • dry skin
  • allergic dermatitis
  • contact dermatitis
  • diabetic foot ulcer
  • abnormal sweating

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Beige oval film-coated tablet

Package unit

30 tablets/PTP [(10 tablets/PTP x 3)]

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.