Medication info
Samsita 50 mg (Sitagliptin Hydrochloride Hydrate)

Samsita 50 mg (Sitagliptin Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tablet
Manufacturer / importer
삼성제약(주)
Appearance
Pale yellow pink round biconvex film-coated tablet
Packaging
30 tablets - 10 tablets/PTP [x3]
Approval status
Active

MFDS item code 202004040 · Approved 2020.05.29 · Insurance code 642308480

Summary

Main use
Improvement of blood glucose control in type 2 diabetes
Who takes it
Adults
Adult dose
The usual dose of this medication is 100 mg administered once daily, either as monotherapy or in combination therapy, with a maximum daily dose of 100 mg. Dose adjustments are necessary for patients with renal impairment. For mild to moderate renal impairment (glomerular filtration rate 30-45 mL/min/1.73 m2), the dose is 50 mg once daily. For severe renal impairment (glomerular filtration rate 15-30 mL/min/1.73 m2) or end-stage renal disease (glomerular filtration rate < 15 mL/min/1.73 m2), the recommended dose is 25 mg once daily.

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

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

This medication is used in conjunction with diet and exercise to help control blood sugar levels in patients with type 2 diabetes. It can be administered alone to patients who have not previously received diabetes medication. However, if achieving blood sugar control is difficult with monotherapy, it may be combined with metformin. Additionally, it can be used together with any of the following medications when adequate blood sugar control cannot be achieved with monotherapy: sulfonylureas, metformin, thiazolidinediones, or insulin. This medication may also be used in cases where blood sugar control cannot be effectively managed with multiple drug regimens.

How to take

Adult dose

The usual dose of this medication is 100 mg administered once daily, either as monotherapy or in combination therapy, with a maximum daily dose of 100 mg. Dose adjustments are necessary for patients with renal impairment. For mild to moderate renal impairment (glomerular filtration rate 30-45 mL/min/1.73 m2), the dose is 50 mg once daily. For severe renal impairment (glomerular filtration rate 15-30 mL/min/1.73 m2) or end-stage renal disease (glomerular filtration rate < 15 mL/min/1.73 m2), the recommended dose is 25 mg once daily.

Precautions

This medication can very rarely cause serious allergic reactions; therefore, if symptoms such as rash, difficulty breathing, or swelling of the face or neck occur after taking the medication, discontinue use immediately and consult a doctor. It may also cause a serious inflammation of the pancreas called pancreatitis; thus, if abdominal pain, nausea, vomiting, or sudden weight loss occurs during use, inform medical personnel immediately. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and it should be avoided in those with allergies to the drug or its components. Patients with impaired kidney function may experience delayed excretion of this medication, necessitating dose adjustments or careful use as directed by a physician. During treatment with this medication, side effects such as cold-like symptoms, headache, indigestion, diarrhea, and nausea may occur, and hypoglycemic symptoms might also be experienced; hence, it is important to regularly monitor blood sugar levels. Particularly, when taken with insulin or sulfonylureas, the risk of hypoglycemia may be increased, warranting dosage adjustments of these medications. This medication can cause severe joint pain or skin blistering conditions; thus, any such symptoms should be reported to a physician immediately. Pregnant or nursing women are advised against taking this medication, and its safety and efficacy have not been established in children or adolescents under 18 years of age. Elderly patients should be evaluated for renal function before starting this medication and regularly assessed thereafter due to potential renal impairment. In case of overdose, standard emergency treatment should be initiated, and hemodialysis may be employed to remove the medication if necessary. This medication has minimal interactions with other diabetes treatments or certain medications but caution is required when taking specific drugs; consultation with a doctor or pharmacist is recommended.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions (anaphylaxis, angioedema, urticaria, rash, cutaneous vasculitis, Stevens-Johnson syndrome, exfoliative skin diseases), acute pancreatitis (fatal/non-fatal hemorrhagic or necrotizing pancreatitis), acute renal failure (occasionally requiring dialysis), severe and disabling joint pain, bullous pemphigoid, pneumonia, diabetes complications, metabolic acidosis, falls, cardiac arrest, rhabdomyolysis

Mild side effects

  • Upper respiratory infection
  • nasopharyngitis
  • headache
  • constipation
  • vomiting
  • muscle pain
  • limb pain
  • back pain
  • pruritus
  • thrombocytopenia
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  • diarrhea
  • nausea
  • indigestion
  • dizziness
  • elevated blood triglycerides
  • gastritis
  • weight loss
  • hypertension
  • hypernatremia
  • erectile dysfunction

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

Storage

Store this medication in a tightly closed container to prevent air ingress, and keep it at room temperature between 1 to 30 degrees Celsius. This will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

Pale yellow pink round biconvex film-coated tablet

Package unit

30 tablets - 10 tablets/PTP [x3]

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.