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Janumet

2015-01-04 12:32:19 来源: 作者: 【大中小】浏览:1003次评论:0条

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Manufacturer

MSD

Distributor

Zuellig

Contents

Per 50/500 mg tab Sitagliptin phosphate 50 mg, metformin HCl 500 mg. Per 50/1,000 mg tab Sitagliptin phosphate 50 mg, metformin HCl 1,000 mg

Indications

As initial therapy in type 2 DM when diet & exercise do not provide adequate glycemic control. As adjunct to diet & exercise to improve glycemic control in type 2 DM inadequately controlled on metformin or sitagliptin alone, or patients already receiving combination sitagliptin & metformin. May also be used in combination w/ a sulfonylurea, PPARγ agonist (eg thiazolidinedione) or insulin.
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Dosage

Individualized dosage. Initially 50 mg sitagliptin/500 mg metformin HCl bid, may be titrated up to 50 mg sitagliptin/1,000 mg metformin HCl bid. Max daily dose: Sitagliptin 100 mg. Patients inadequately controlled on metformin monotherapy Usual starting dose: Sitagliptin 50 mg bid, plus the dose of metformin already being taken. Patients inadequately controlled on sitagliptin monotherapy Usual starting dose: 50 mg sitagliptin/500 mg metformin HCl bid, may be titrated up to 50 mg sitagliptin/1,000 mg metformin HCl bid. Switching from co-administration of sitagliptin & metformin May be initiated at the dose of sitagliptin & metformin already being taken. Patients inadequately controlled on dual combination therapy w/ any 2 of these agents: sitagliptin, metformin or a sulfonylurea, or a PPARγ agonist, or insulin Usual starting dose: 50 mg sitagliptin bid. Determine dose of metformin based on glycemic control level & current metformin dose.
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Overdosage

View Janumet overdosage for action to be taken in the event of an overdose.

Administration

Should be taken with food

Contraindications

Renal disease or dysfunction, acute or chronic metabolic acidosis including diabetic ketoacidosis w/ or w/o coma. Intravascular administration of iodinated contrast materials (discontinue Janumet temporarily).
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Special Precautions

Not for use in type 1 DM. Monitor renal function & for signs/symptoms of pancreatitis. Hypoglycemia in combination w/ a sulfonylurea or insulin. Risk of lactic acidosis due to metformin content. Hypoxic states, surgery, impaired hepatic function, decreased vit B₁₂ levels. Avoid excessive alcohol intake. Loss of glycemic control. Pregnancy & lactation. Childn <18 yr. Elderly.
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Adverse Drug Reactions

Diarrhea, nausea, dyspepsia, flatulence, vomiting, headache, hypoglycemia, abdominal pain.
View ADR Monitoring Form

Side Effects

View Janumet side effects

Drug Interactions

Metformin: Furosemide, nifedipine, cationic drugs (eg amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin), oral cimetidine. Thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OC, phenytoin, nicotinic acid, sympathomimetics, Ca antagonists, INH.
View more drug interactions with Janumet

Pregnancy Category (US FDA)

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1^st trimester (and there is no evidence of a risk in later trimesters).

Storage

View Janumet storage conditions for details to ensure optimal shelf-life.

Description

View Janumet description for details of the chemical structure and excipients (inactive components).

Mechanism of Action

View Janumet mechanism of action for pharmacodynamics and pharmacokinetics details.

Presentation/Packing

Form

Packing

Photo

Janumet 50/500 mg tablet

Janumet 28's