BRAND NAME: SB-METSITA

GENERIC NAME WITH SPECIFICATION: Metformin Hydrochloride BP & Sitagliptin Phosphate Monohydrate USP

STRENGTH: 500/50 mg & 1000/50 mg

COMPOSITION

SB-Metsita 500/50 Tablet: Each film coated Tablet contains Metformin Hydrochloride BP 500 mg & Sitagliptin Phosphate

Monohydrate USP equivalent to Sitagliptin 50 mg.

SB-Metsita 1000/50 Tablet: Each film coated Tablet contains Metformin Hydrochloride BP 1000 mg & Sitagliptin Phosphate

Monohydrate USP equivalent to Sitagliptin 50 mg.

INDICATION AND USAGE

SB-Metsita is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when

treatment with both Sitagliptin and Metformin Hydrochloride is appropriate.

DOSAGE AND ADMINISTRATION

Dose of this combination should be individualized on the basis of the patient’s current regimen, effectiveness, and tolerability while

not exceeding the maximum recommended daily dose of 100 mg Sitagliptin and 2000 mg Metformin Hydrochloride. Sitagliptin

/Metformin Hydrochloride combination should generally be given twice daily with meals, with gradual dose escalation, to reduce

the gastrointestinal (Gl) side effects due to Metformin Hydrochloride.

The recommended starting dose in patients not currently treated with Metformin Hydrochloride is 500 mg Sitagliptin 50 mg

Metformin Hydrochloride twice daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated

with Metformin Hydrochloride.

The starting dose in patients already treated with Metformin Hydrochloride should provide sitagliptin dosed as 50 mg twice daily

(100 mg total daily dose) and the dose of Metformin Hydrochloride already being taken. For patients taking Metformin Hydrochlo¬

ride 850 mg twice daily, the recommended starting dose of this combination is 50 mg Sitagliptin/1000 mg Metformin Hydrochloride

twice daily.

Patients treated with an insulin secretagogue or insulin

Co-administration of the combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the

insulin secretagogue or insulin to reduce the risk of hypoglycemia.

CONTRAINDICATIONS

Combination (Metformin Hydrochloride/ Sitagliptin) is contraindicated in patients with:

• Renal disease or renal dysfunction, e.g., as suggested by serum creatinine levels 1.5 mg/dL [males],1.4 mg/dL

(females)

• Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
• History of a serious hypersensitivity reaction to the combination or Sitagliptin, such as anaphylaxis or angioedema.

ADVERSE EFFECTS

The most common (>5%) adverse reactions due to initiation of Metformin Hydrochloride therapy are diarrhea, nausea/vomiting,

flatulence, abdominal discomfort, indigestion, asthenia, and headache.

PREGNANCY & LACTATION

Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women with the combination of Metformin

Hydrochloride/Sitagliptin or its individual components; therefore, the safety of the combination in pregnant women is not known.

The combination of Sitagliptin & Metformin Hydrochloride should be used during pregnancy only if clearly needed.

NURSING MOTHERS

It is not known whether Sitagliptin is excreted in human milk. Because many drugs are excreted in human milk, caution should

be exercised when this combination is administered to a nursing woman.

AVAILABLE PACKAGING:

SB-Metsita 500/50 Tablet: Each box contains 20 Film coated Tablets in Alu-Alu blister pack.

SB-Metsita 1000/50 Tablet: Each box contains 20 Film coated Tablets in Alu-Alu blister pack.

PRICE :

SB-METSITA 500/50 mg MRP 400 TK.

SB-METSITA 1000/50 mg MRP 440 TK.