Medication info
Positam Extended-Release Tablet 10/100/1000 mg (Dapagliflozin, Sitagliptin, Metformin)

Positam Extended-Release Tablet 10/100/1000 mg (Dapagliflozin, Sitagliptin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride›1000mg / 1 tabletSitagliptin Phosphate Hydrate›128.5mg / 1 tabletDapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
Pink oval extended-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202401772 · Approved 2024.07.23 · Insurance code 671707420

Summary

Main use
Improvement of blood glucose control in type 2 diabetes
Who takes it
Adults
Adult dose
For antidiabetic therapy, the recommended dosage of this medication is 10 mg of dapagliflozin and 100 mg of sitagliptin, with extended-release metformin hydrochloride not exceeding 2000 mg, determined based on the patient’s current treatment regimen, efficacy, and tolerance. This medication should be taken once daily in the evening and with food, and if dosage adjustment of metformin hydrochloride is needed, it should be done gradually. Patients taking this medication 10/1

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

View approved original text

This medication is used to help control blood glucose levels in patients with type 2 diabetes. In particular, it assists in conjunction with dietary and exercise therapies when taking dapagliflozin, sitagliptin, and metformin together. This helps effectively manage blood glucose levels. This medication contributes to the prevention of complications by improving blood glucose control.

How to take

Adult dose

For antidiabetic therapy, the recommended dosage of this medication is 10 mg of dapagliflozin and 100 mg of sitagliptin, with extended-release metformin hydrochloride not exceeding 2000 mg, determined based on the patient’s current treatment regimen, efficacy, and tolerance. This medication should be taken once daily in the evening and with food, and if dosage adjustment of metformin hydrochloride is needed, it should be done gradually. Patients taking this medication 10/1

Precautions

This medication may rarely cause serious allergic reactions due to the sitagliptin component. Therefore, if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck occur within three months after administration, it should be discontinued immediately and consult a doctor. The medication can cause severe inflammation of the pancreas known as acute pancreatitis. If symptoms such as abdominal pain, vomiting, or nausea occur, you must seek medical attention immediately. The metformin component in this medication can rarely cause lactic acidosis, which could be life-threatening; if severe fatigue, muscle pain, breathing difficulties, abdominal pain, or hypothermia occur, treatment should be stopped immediately and medical care should be sought. This medication should not be administered to patients with moderate to severe renal function impairment or acute kidney disease, and patients with decreased kidney function should have regular kidney function tests before and during administration. Patients with conditions affecting kidney function, such as dehydration, severe infections, heart failure, myocardial infarction, or sepsis should avoid using this medication or use it cautiously. This medication must be discontinued for a certain period before and after examinations using radiologic iodine contrast agents, and should only be resumed after confirming that kidney function is normal. This medication should not be used by patients with type 1 diabetes or a history of diabetic ketoacidosis. The administration of this medication must be temporarily suspended for 48 hours before surgery and until kidney function is restored to normal post-surgery, after which it can be resumed. In patients with reduced fluid volume or at risk of hypotension, blood pressure reduction and worsening kidney function can occur; hence, fluid status and blood pressure should be monitored periodically. This medication may increase the risk of genital and urinary tract infections, so treatment should be sought immediately if symptoms of infection occur. Rarely, this medication may cause severe skin disorders, joint pain, or blistering skin conditions. Consult a doctor if skin rashes or severe joint pain occur. During the use of this medication, be vigilant for symptoms of hypoglycemia, especially when used in combination with other hypoglycemic agents, as this may increase the risk of low blood sugar. Alcohol consumption may increase the risk of lactic acidosis; therefore, excessive alcohol should be avoided while taking this medication. Long-term use of this medication may result in vitamin B12 deficiency, so it is advisable to monitor vitamin B12 levels with regular blood tests. Pregnant women or those with placental function issues should not use this medication, and must consult a doctor if planning to become pregnant or if already pregnant.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), anaphylaxis, angioedema, Stevens-Johnson syndrome, cutaneous vasculitis, severe hypersensitivity reactions, severe allergic reactions, fatal/non-fatal hemorrhagic or necrotizing pancreatitis, acute pancreatitis, worsening renal function, acute renal failure, lactic acidosis, ketoacidosis, diabetic ketoacidosis, urosepticemia, severe urinary tract infections, pyelonephritis, perineal necrosis (Fournier's gangrene), and severe and disabling arthralgia.

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • dry mouth
  • dizziness
  • constipation
  • oral dryness
  • back pain
  • dysuria
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  • polyuria
  • nocturia
  • increased serum creatinine
  • dyslipidemia
  • weight loss
  • hypoglycemia
  • indigestion
  • nausea
  • diarrhea
  • vomiting
  • headache
  • itching
  • sweating
  • weakness
  • chest pain
  • fatigue
  • pain
  • swelling
  • foreign body sensation
  • facial pain
  • facial swelling
  • insomnia
  • palpitations
  • taste disturbance
  • drowsiness

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

Storage

Store this medication in a tightly closed container to prevent exposure to air or moisture. It is crucial to maintain storage temperatures between 1 degree and 30 degrees Celsius. This way, the efficacy of the medication can be safely preserved.

Appearance and packaging

Appearance

Pink oval extended-release film-coated tablet

Package unit

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.