Medication info
Fosibia Tablet 10/100 Milligrams

Fosibia Tablet 10/100 Milligrams

Prescription medicationTablet
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletSitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
(주)바이넥스
Appearance
Bright yellow rectangular film-coated tablets
Packaging
28 tablets/box [7 tablets/Alu-Alu x 4], 30 tablets/box [10 tablets/Alu-Alu x 3]
Approval status
Active

MFDS item code 202200051 · Approved 2022.01.04 · Insurance code 643105740

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication can be administered to patients receiving 100 mg of sitagliptin and 10 mg of dapagliflozin, 1 tablet once daily regardless of meals. The tablet should be swallowed whole.

Ingredients

Manufacturer
(주)바이넥스

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. It is particularly suitable for patients using a combination of sitagliptin and dapagliflozin, and it helps in effective blood sugar management. Taking this medication can help maintain blood sugar levels more consistently. It aids in overall blood sugar control and plays an important role in diabetes management.

Dosage and Administration

Adult dosage

This medication can be administered to patients receiving 100 mg of sitagliptin and 10 mg of dapagliflozin, 1 tablet once daily regardless of meals. The tablet should be swallowed whole.

Precautions

This medication contains the ingredients sitagliptin and dapagliflozin, which are used for the treatment of type 2 diabetes. Sitagliptin may rarely cause serious allergic reactions or skin disorders; therefore, if you experience symptoms such as rash, difficulty breathing, or swelling of the face or neck after taking the medication, discontinue use immediately and consult a doctor. Additionally, serious side effects such as acute pancreatitis, which is inflammation of the pancreas, have been reported; hence, if you experience abdominal pain, vomiting, or severe indigestion while taking this medication, you should go to the hospital immediately. Dapagliflozin may lead to reduced body fluids, resulting in lower blood pressure, so elderly patients or those with weakened kidney function should exercise particular caution and undergo regular blood pressure and kidney function tests. Furthermore, dapagliflozin can increase the risk of genital infections and urinary tract infections, so if you experience symptoms such as pain or itching during urination or an increase in discharge, immediate treatment is advised. This medication is not meant for patients with type 1 diabetes, diabetic ketoacidosis, or those undergoing dialysis. Women who are pregnant or breastfeeding should avoid taking this medication, especially during breastfeeding, as it may affect the baby. While taking this medication, there is a risk of hypoglycemia; therefore, if insulin or sulfonylureas are taken concomitantly, blood sugar levels should be monitored frequently, and dosage adjustments may be necessary. If you notice unusual skin symptoms, severe joint pain, or skin disorders with blisters, notify your doctor immediately and seek treatment. For patients with reduced kidney function, dosage adjustments are necessary; thus, regular kidney function tests should be conducted, with particular attention for elderly patients. In case of overdose, there are no specific antidotes, so appropriate treatment based on symptoms should be provided, and blood dialysis may be considered if necessary. Lastly, the safety and efficacy of this medication in children have not been established; therefore, it should not be used in patients under the age of 18. Caution is advised when driving or operating machinery during the use of this medication, as hypoglycemic symptoms may occur; therefore, always exercise caution.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, anaphylaxis, angioedema, Stevens-Johnson syndrome, exfoliative skin disease, acute pancreatitis, fatal/non-fatal hemorrhagic or necrotizing pancreatitis, acute renal failure, worsening of kidney function, severe skin adverse reactions, severe edema or urination abnormalities, perineal necrosis (Fournier's gangrene), severe allergic reactions, severe headache, thunderclap headache, rash

Mild side effects

  • Headache
  • diarrhea
  • vomiting
  • abdominal pain
  • indigestion
  • thirst
  • constipation
  • lumbago
  • weakness
  • fatigue
Show 26 more
  • fever
  • hunger
  • itching
  • hives
  • cold sweat
  • chest pain
  • palpitations
  • insomnia
  • dizziness
  • vaginal discharge
  • myalgia
  • arthralgia
  • increased blood triglycerides
  • elevated blood creatinine
  • weight loss
  • allergic dermatitis
  • skin dryness
  • rash
  • hives
  • cold sweat
  • musculoskeletal pain
  • lumbago
  • dysuria
  • nocturia
  • urinary tract infection
  • external genitalia

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius. Proper storage will ensure the medication's effectiveness.

Appearance and packaging

Appearance

Bright yellow rectangular film-coated tablets

Package unit

28 tablets/box [7 tablets/Alu-Alu x 4], 30 tablets/box [10 tablets/Alu-Alu 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.