Medication info
Fosiglip M Tablet 10/100 Milligrams

Fosiglip M Tablet 10/100 Milligrams

Prescription medicationTablet
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›113.4mg / 1 tabletDapagliflozin citric acid›14.7mg / 1 tablet
Manufacturer / importer
(주)마더스제약
Appearance
Yellow oblong film-coated tablet
Packaging
28 tablets/box [(7 tablets/PTP x 4)], 30 tablets/box [(10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 202200488 · Approved 2022.01.28 · Insurance code 622805060

Summary

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

Ingredients

Manufacturer
(주)마더스제약

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used in conjunction with dietary and exercise regimens to assist in the blood sugar control of patients with type 2 diabetes who are using sitagliptin and dapagliflozin together. It helps effectively manage blood sugar and supports diabetes treatment.

Dosage and Administration

Adult dosage

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

Precautions

This medication contains sitagliptin and dapagliflozin and is used in the treatment of diabetes. Firstly, sitagliptin may cause serious allergic reactions in some patients, so if symptoms such as rash, difficulty breathing, or swelling of the face or neck occur within the first 3 months after administration, treatment should be stopped immediately and a physician should be consulted. Additionally, acute pancreatitis, which is a serious side effect involving inflammation of the pancreas, has been reported, so if symptoms such as abdominal pain or vomiting occur, immediately discontinue the medication and notify healthcare personnel. Dapagliflozin should be used with caution in patients with impaired kidney function or reduced fluid volume. This medication may cause dehydration or hypotension due to its action of expelling glucose through urine, so elderly patients or those taking diuretics should regularly monitor blood pressure and kidney function. Furthermore, although rare, genital infections or urinary tract infections may occur, so immediate treatment should be sought if symptoms of infection appear. This medication should not be used in patients with type 1 diabetes, diabetic ketoacidosis, or in patients with lactose intolerance; it is also advisable not to use it in patients undergoing dialysis. Pregnant or breastfeeding women are advised not to use this medication, and if pregnancy is confirmed, treatment should be stopped immediately. During treatment with this medication, symptoms of hypoglycemia may occur, so when used with other hypoglycemic agents such as insulin or sulfonylureas, dosage adjustment may be necessary to reduce the risk of hypoglycemia. In cases of overdose, since there is no specific antidote, appropriate treatment should be administered according to symptoms, and blood dialysis may be considered if necessary. Finally, this medication has not been established for safety and efficacy in children under 18 years of age, so it should not be used in this population. In elderly patients, it is important to periodically evaluate kidney function when administering this medication. Patients taking this medication should be aware of the potential risk of hypoglycemia when driving or operating machinery and exercise caution.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, paleness, severe allergic reaction, severe rash with high fever, blisters, pain in mouth/eye mucous membranes, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanied by respiratory abnormalities, respiratory issues, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden onset

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infection, fungal infection, hypoglycemia, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, elevated hematocrit, decreased initial renal creatinine clearance, dyslipidemia, elevated initial serum creatinine, elevated blood urea nitrogen, weight loss, upper respiratory infection, nasopharyngitis, headache, diarrhea, nausea, dyspepsia, vomiting, chest pain, fatigue,

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 exposure to air or moisture. It is best to store it at room temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow oblong film-coated tablet

Package unit

28 tablets/box [(7 tablets/PTP x 4)], 30 tablets/box [(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.