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JANUMET (METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE) TABLETS: PRESCRIBING INFORMATION

DESCRIPTION

Janumet description


INDICATIONS AND USAGE

Janumet (Sitagliptin Phosphate, Metformin Hydrochloride) 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 is appropriate.

Important Limitations of Use

Janumet (Sitagliptin Phosphate, Metformin HCl) should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

This medication has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Janumet.


DOSAGE AND ADMINISTRATION

Janumet dosage and administration


DOSAGE FORMS AND STRENGTHS

  • 50 mg / 500 mg tablets are light pink, capsule-shaped, film-coated tablets with "575" debossed on one side.
  • 50 mg / 1000 mg tablets are red, capsule-shaped, film-coated tablets with "577" debossed on one side.


    CONTRAINDICATIONS

    Janumet (Sitagliptin, Metformin) 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) or abnormal creatinine clearance which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia.
  • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
  • History of a serious hypersensitivity reaction to Janumet or sitagliptin (one of the components of this medication), such as anaphylaxis or angioedema.
  • Janumet (Sitagliptin Phosphate, Metformin Hydrochloride) should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.


    WARNINGS

    Janumet warnings


    WARNINGS FOR LACTIC ACIDOSIS

    Janumet warnings for lactic acidosis


    PRECAUTIONS

    Janumet precautions


    DRUG-DRUG INTERACTIONS

    Janumet drug-drug interactions


    USE IN PREGNANCY

    Janumet use in pregnancy


    USE IN SPECIFIC POPULATIONS

    Janumet use in specific populations


    ADVERSE REACTIONS

    Janumet adverse reactions


    ADVERSE REACTIONS: CLINICAL TRIALS EXPERIENCE

    Janumet adverse reactions: clinical trials experience


    OVERDOSAGE

    Janumet overdosage


    CLINICAL PHARMACOLOGY

    MECHANISM OF ACTION

    Janumet mechanism of action


    PHARMACODYNAMICS

    Janumet pharmacodynamics


    PHARMACOKINETICS

    Janumet pharmacokinetics


    PHARMACOKINETICS IN SPECIAL POPULATIONS

    Janumet pharmacokinetics in special populations


    DRUG INTERACTIONS

    Janumet drug interactions


    NONCLINICAL TOXICOLOGY

    Janumet nonclinical toxicology


    CLINICAL STUDIES

    Janumet clinical studies


    HOW SUPPLIED / STORAGE AND HANDLING

    Tablets Janumet, 50 mg / 500 mg, are light pink, capsule-shaped, film-coated tablets with "575" debossed on one side. They are supplied as follows: unit-of-use bottles of 60, 180; unit dose blister packages of 50; bulk bottles of 1000.

    Tablets Janumet, 50 mg / 1000 mg, are red, capsule-shaped, film-coated tablets with "577" debossed on one side. They are supplied as follows: unit-of-use bottles of 60, 180; unit dose blister packages of 50; bulk bottles of 1000.

    Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F).

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