Janumet 50 mg/1000 mg

Sitagliptin (Janumet 50 mg/1000 mg) PHOSPHATE + Metformin (Janumet 50 mg/1000 mg) HCl (Janumet 50 mg/1000 mg) are indicated as initial therapy in patients with type 2 diabetes mellitus to improve glycemic control when diet and exercise do not provide adequate glycemic control.

Sitagliptin (Janumet 50 mg/1000 mg) PHOSPHATE + Metformin (Janumet 50 mg/1000 mg) HCl (Janumet 50 mg/1000 mg) are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus inadequately controlled on Metformin (Janumet 50 mg/1000 mg) or Sitagliptin (Janumet 50 mg/1000 mg) alone or in patients already being treated with the combination of Sitagliptin (Janumet 50 mg/1000 mg) and Metformin (Janumet 50 mg/1000 mg).

Sitagliptin (Janumet 50 mg/1000 mg) PHOSPHATE + Metformin (Janumet 50 mg/1000 mg) HCl (Janumet 50 mg/1000 mg) are indicated as part of triple combination therapy with a sulfonylurea as an adjunct to diet and exercise in patients with type 2 diabetes mellitus inadequately controlled with any two of the three agents: Metformin (Janumet 50 mg/1000 mg), Sitagliptin (Janumet 50 mg/1000 mg), or a sulfonylurea.

Sitagliptin (Janumet 50 mg/1000 mg) PHOSPHATE + Metformin (Janumet 50 mg/1000 mg) HCl (Janumet 50 mg/1000 mg) are indicated as part of triple combination therapy with a PPARγ agonist (i.e., thiazolidinediones) as an adjunct to diet and exercise in patients with type 2 diabetes mellitus inadequately controlled with any two of the three agents: Metformin (Janumet 50 mg/1000 mg), Sitagliptin (Janumet 50 mg/1000 mg), or a PPARγ agonist.

Sitagliptin (Janumet 50 mg/1000 mg) PHOSPHATE + Metformin (Janumet 50 mg/1000 mg) HCl (Janumet 50 mg/1000 mg) are indicated in patients with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control in combination with insulin.

Janumet 50 mg/1000 mg are oral diabetes medicines that help control blood sugar levels.

Metformin (Janumet 50 mg/1000 mg) works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Sitagliptin (Janumet 50 mg/1000 mg) works by regulating the levels of insulin your body produces after eating.

Janumet 50 mg/1000 mg is a combination medicine used to treat type 2 diabetes. This medication is not for treating type 1 diabetes.

Janumet 50 mg/1000 mg may also be used for purposes not listed in this medication guide.

Recommended Dosing

The dose of Janumet 50 mg/1000 mg 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 (Janumet 50 mg/1000 mg) and 2000 mg Metformin (Janumet 50 mg/1000 mg). Initial combination therapy or maintenance of combination therapy should be individualized and left to the discretion of the healthcare provider.

• In patients not currently treated with Metformin (Janumet 50 mg/1000 mg), the recommended total daily starting dose of Janumet 50 mg/1000 mg is 100 mg Sitagliptin (Janumet 50 mg/1000 mg) and 1000 mg Metformin (Janumet 50 mg/1000 mg) hydrochloride (HCl) extended-release. Patients with inadequate glycemic control on this dose of Metformin (Janumet 50 mg/1000 mg) can be titrated gradually, to reduce gastrointestinal side effects associated with Metformin (Janumet 50 mg/1000 mg), up to the maximum recommended daily dose.
• In patients already treated with Metformin (Janumet 50 mg/1000 mg), the recommended total daily starting dose of Janumet 50 mg/1000 mg is 100 mg Sitagliptin (Janumet 50 mg/1000 mg) and the previously prescribed dose of Metformin (Janumet 50 mg/1000 mg).
• For patients taking Metformin (Janumet 50 mg/1000 mg) immediate-release 850 mg twice daily or 1000 mg twice daily, the recommended starting dose of Janumet 50 mg/1000 mg is two 50 mg Sitagliptin (Janumet 50 mg/1000 mg)/1000 mg Metformin (Janumet 50 mg/1000 mg) hydrochloride extended-release tablets taken together once daily.
• Maintain the same total daily dose of Sitagliptin (Janumet 50 mg/1000 mg) and Metformin (Janumet 50 mg/1000 mg) when changing between Janumet 50 mg/1000 mg (Sitagliptin (Janumet 50 mg/1000 mg) and Metformin (Janumet 50 mg/1000 mg) HCl immediate-release) and Janumet 50 mg/1000 mg. Patients with inadequate glycemic control on this dose of Metformin (Janumet 50 mg/1000 mg) can be titrated gradually, to reduce gastrointestinal side effects associated with Metformin (Janumet 50 mg/1000 mg), up to the maximum recommended daily dose.

Janumet 50 mg/1000 mg should be administered with food to reduce the gastrointestinal side effects associated with the Metformin (Janumet 50 mg/1000 mg) component. Janumet 50 mg/1000 mg should be given once daily with a meal preferably in the evening. Janumet 50 mg/1000 mg should be swallowed whole. The tablets must not be split, crushed, or chewed before swallowing. There have been reports of incompletely dissolved Janumet 50 mg/1000 mg tablets being eliminated in the feces. It is not known whether this material seen in feces contains active drug. If a patient reports repeatedly seeing tablets in feces, the healthcare provider should assess adequacy of glycemic control.

The 100 mg Sitagliptin (Janumet 50 mg/1000 mg)/1000 mg Metformin (Janumet 50 mg/1000 mg) hydrochloride extended-release tablet should be taken as a single tablet once daily. Patients using two Janumet 50 mg/1000 mg tablets (such as two 50 mg Sitagliptin (Janumet 50 mg/1000 mg)/500 mg Metformin (Janumet 50 mg/1000 mg) hydrochloride extended-release tablets or two 50 mg Sitagliptin (Janumet 50 mg/1000 mg)/1000 mg Metformin (Janumet 50 mg/1000 mg) hydrochloride extended-release tablets) should take the two tablets together once daily.

Patients treated with an insulin secretagogue or insulin

Coadministration of Janumet 50 mg/1000 mg 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.

No studies have been performed specifically examining the safety and efficacy of Janumet 50 mg/1000 mg in patients previously treated with other oral antihyperglycemic agents and switched to Janumet 50 mg/1000 mg. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.

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What is the most important information I should know about Janumet 50 mg/1000 mg?

Known hypersensitivity to Sitagliptin (Janumet 50 mg/1000 mg) phosphate, Metformin (Janumet 50 mg/1000 mg) HCl or any other component of Janumet 50 mg/1000 mg.

Renal disease or renal dysfunction, eg, 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 eg, cardiovascular collapse (shock), acute myocardial infarction, and septicemia.

Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.

Janumet 50 mg/1000 mg should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because the use of such products may result in acute alteration of renal function.

Use in lactation: No studies in lactating animals have been conducted with the combined components of Janumet 50 mg/1000 mg. In studies performed with the individual components, both Sitagliptin (Janumet 50 mg/1000 mg) and Metformin (Janumet 50 mg/1000 mg) are secreted in the milk of lactating rats. It is not known whether Sitagliptin (Janumet 50 mg/1000 mg) is excreted in human milk. Therefore, Janumet 50 mg/1000 mg should not be used by a woman who is nursing.

Use Janumet 50 mg/1000 mg as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Janumet 50 mg/1000 mg comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Janumet 50 mg/1000 mg refilled.
• Take Janumet 50 mg/1000 mg by mouth with your evening meal, unless your doctor tells you otherwise.
• Swallow Janumet 50 mg/1000 mg whole. Do not break, crush, split, or chew before swallowing. If you have difficulty swallowing tablets whole, talk with your doctor.
• Taking Janumet 50 mg/1000 mg at the same times each day will help you remember to take it.
• Take Janumet 50 mg/1000 mg on a regular schedule to get the most benefit from it.
• Continue to take Janumet 50 mg/1000 mg even if you feel well. Do not miss any doses.
• If you miss a dose of Janumet 50 mg/1000 mg, take it with food as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Janumet 50 mg/1000 mg.

Sitagliptin (Janumet 50 mg/1000 mg)/Metformin (Janumet 50 mg/1000 mg) is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

This product contains 2 medications: Sitagliptin (Janumet 50 mg/1000 mg) and Metformin (Janumet 50 mg/1000 mg). Sitagliptin (Janumet 50 mg/1000 mg) works by increasing levels of natural substances called incretins. Incretins help to control blood sugar by increasing insulin release, especially after a meal. They also decrease the amount of sugar your liver makes. Metformin (Janumet 50 mg/1000 mg) works by helping to restore your body's proper response to the insulin you naturally produce. It also decreases the amount of sugar that your liver makes and that your stomach/intestines absorb.

How to use Janumet 50 mg/1000 mg

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using Sitagliptin (Janumet 50 mg/1000 mg)/Metformin (Janumet 50 mg/1000 mg) and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily with a meal, preferably in the evening. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing. Drink plenty of fluids while taking this medication unless otherwise directed by your doctor.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To reduce your risk of side effects (such as upset stomach), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Carefully follow the medication treatment plan, meal plan, and exercise program your doctor has recommended.

Tell your doctor if your condition does not improve or if it worsens (your blood sugar levels are too high or too low).

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What other drugs will affect Janumet 50 mg/1000 mg?

Carbonic Anhydrase Inhibitors

Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently decrease serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs may induce metabolic acidosis. Use these drugs with caution in patients treated with Janumet 50 mg/1000 mg, as the risk of lactic acidosis may increase.

Cationic Drugs

Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin) that are eliminated by renal tubular secretion theoretically have the potential for interaction with Metformin (Janumet 50 mg/1000 mg) by competing for common renal tubular transport systems. Although such interactions remain theoretical (except for cimetidine), careful patient monitoring and dose adjustment of Janumet 50 mg/1000 mg and/or the interfering drug is recommended in patients who are taking cationic medications that are excreted via the proximal renal tubular secretory system.

The Use of Metformin (Janumet 50 mg/1000 mg) with Other Drugs

Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving Janumet 50 mg/1000 mg the patient should be closely observed to maintain adequate glycemic control.

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What are the possible side effects of Janumet 50 mg/1000 mg?

Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Sitagliptin (Janumet 50 mg/1000 mg) and Metformin (Janumet 50 mg/1000 mg) Co-Administration in Patients with Type 2 Diabetes Inadequately Controlled on Diet and Exercise: Table 6 summarizes the most common (≥5% of patients) adverse reactions reported (regardless of investigator assessment of causality) in a 24-week placebo-controlled factorial study in which Sitagliptin (Janumet 50 mg/1000 mg) and Metformin (Janumet 50 mg/1000 mg) were co-administered to patients with type 2 diabetes inadequately controlled on diet and exercise.

Sitagliptin (Janumet 50 mg/1000 mg) Add-On Therapy in Patients with Type 2 Diabetes Inadequately Controlled on Metformin (Janumet 50 mg/1000 mg) Alone: In a 24-week placebo-controlled trial of Sitagliptin (Janumet 50 mg/1000 mg) 100 mg administered once daily added to a twice daily Metformin (Janumet 50 mg/1000 mg) regimen, there were no adverse reactions reported regardless of investigator assessment of causality in ≥5% of patients and more commonly than in patients given placebo. Discontinuation of therapy due to clinical adverse reactions was similar to the placebo treatment group (Sitagliptin (Janumet 50 mg/1000 mg) and Metformin (Janumet 50 mg/1000 mg), 1.9%; placebo and Metformin (Janumet 50 mg/1000 mg), 2.5%).

Gastrointestinal Adverse Reactions: The incidences of pre-selected gastrointestinal adverse experiences in patients treated with Sitagliptin (Janumet 50 mg/1000 mg) and Metformin (Janumet 50 mg/1000 mg) were similar to those reported for patients treated with Metformin (Janumet 50 mg/1000 mg) alone.

Sitagliptin (Janumet 50 mg/1000 mg) in Combination with Metformin (Janumet 50 mg/1000 mg) and Glimepiride: In a 24-week placebo-controlled study of Sitagliptin (Janumet 50 mg/1000 mg) 100 mg as add-on therapy in patients with type 2 diabetes inadequately controlled on Metformin (Janumet 50 mg/1000 mg) and glimepiride (Sitagliptin (Janumet 50 mg/1000 mg), n=116; placebo, n=113), the adverse reactions reported regardless of investigator assessment of causality in ≥5% of patients treated with Sitagliptin (Janumet 50 mg/1000 mg) and more commonly than in patients treated with placebo were: Hypoglycemia and headache (6.9%, 2.7%).

Sitagliptin (Janumet 50 mg/1000 mg) in Combination with Metformin (Janumet 50 mg/1000 mg) and Insulin: In a 24-week placebo-controlled study of Sitagliptin (Janumet 50 mg/1000 mg) 100 mg as add-on therapy in patients with type 2 diabetes inadequately controlled on Metformin (Janumet 50 mg/1000 mg) and insulin (Sitagliptin (Janumet 50 mg/1000 mg), N=229; placebo, N=233), the only adverse reaction reported regardless of investigator assessment of causality in ≥5% of patients treated with Sitagliptin (Janumet 50 mg/1000 mg) and more commonly than in patients treated with placebo was hypoglycemia (Table 8).

Hypoglycemia: In all (N=5) studies, adverse reactions of hypoglycemia were based on all reports of symptomatic hypoglycemia; a concurrent glucose measurement was not required although most (77%) reports of hypoglycemia were accompanied by a blood glucose measurement ≤70 mg/dL. When the combination of Sitagliptin (Janumet 50 mg/1000 mg) and Metformin (Janumet 50 mg/1000 mg) was co-administered with a sulfonylurea or with insulin, the percentage of patients reporting at least 1 adverse reaction of hypoglycemia was higher than that observed with placebo and Metformin (Janumet 50 mg/1000 mg) co-administered with a sulfonylurea or with insulin (Table 8).

The overall incidence of reported adverse reactions of hypoglycemia in patients with type 2 diabetes inadequately controlled on diet and exercise was 0.6% in patients given placebo, 0.6% in patients given Sitagliptin (Janumet 50 mg/1000 mg) alone, 0.8% in patients given Metformin (Janumet 50 mg/1000 mg) alone, and 1.6% in patients given Sitagliptin (Janumet 50 mg/1000 mg) in combination with Metformin (Janumet 50 mg/1000 mg). In patients with type 2 diabetes inadequately controlled on Metformin (Janumet 50 mg/1000 mg) alone, the overall incidence of adverse reactions of hypoglycemia was 1.3% in patients given add-on Sitagliptin (Janumet 50 mg/1000 mg) and 2.1% in patients given add-on placebo.

With the combination of Sitagliptin (Janumet 50 mg/1000 mg) and Metformin (Janumet 50 mg/1000 mg), no clinically meaningful changes in vital signs or in ECG (including in QTc interval) were observed.

The most common adverse experience in Sitagliptin (Janumet 50 mg/1000 mg) monotherapy reported regardless of investigator assessment of causality in ≥5% of patients and more commonly than in patients given placebo was nasopharyngitis.

The most common (>5%) established adverse reactions due to initiation of Metformin (Janumet 50 mg/1000 mg) therapy are diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia and headache.

Laboratory Tests: Sitagliptin (Janumet 50 mg/1000 mg): The incidence of laboratory adverse reactions was similar in patients treated with Sitagliptin (Janumet 50 mg/1000 mg) and Metformin (Janumet 50 mg/1000 mg) (7.6%) compared to patients treated with placebo and Metformin (Janumet 50 mg/1000 mg) (8.7%). In most but not all studies, a small increase in white blood cell count (approximately 200 cells/microliter difference in WBC vs placebo, mean baseline WBC approximately 6600 cells/microliter) was observed due to a small increase in neutrophils. This change in laboratory parameters is not considered to be clinically relevant.

Metformin (Janumet 50 mg/1000 mg) HCl: In controlled clinical trials of Metformin (Janumet 50 mg/1000 mg) of 29 weeks duration, a decrease to subnormal levels of previously normal serum vitamin B12 levels, without clinical manifestations, was observed in approximately 7% of patients. Such decrease, possibly due to interference with vitamin B12 absorption from the B12-intrinsic factor complex is however, very rarely associated with anemia and appears to be rapidly reversible with discontinuation of Metformin (Janumet 50 mg/1000 mg) or vitamin B12 supplementation.

Post-Marketing Experience: Additional adverse reactions have been identified during post-approval of Janumet 50 mg/1000 mg or Sitagliptin (Janumet 50 mg/1000 mg), 1 of the components of Janumet 50 mg/1000 mg. These reactions have been reported when Janumet 50 mg/1000 mg or Sitagliptin (Janumet 50 mg/1000 mg) have been used alone and/or in combination with other antihyperglycemic agents. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity reactions, including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis and exfoliative skin conditions, including Stevens-Johnson syndrome, upper respiratory tract infection; hepatic enzyme elevations; acute pancreatitis, including fatal and nonfatal hemorrhagic and necrotizing pancreatitis; worsening renal function, including acute renal failure (sometimes requiring dialysis); constipation; vomiting; headache; arthralgia; myalgia; pain in extremity; back pain.

Each film-coated tablet contains Sitagliptin (Janumet 50 mg/1000 mg) phosphate monohydrate 64.25 mg and Metformin (Janumet 50 mg/1000 mg) HCl equivalent to: Sitagliptin (Janumet 50 mg/1000 mg) 50 mg as free base and Metformin (Janumet 50 mg/1000 mg) HCl 500 mg (Janumet 50 mg/1000 mg 50/500 mg), Metformin (Janumet 50 mg/1000 mg) HCl 850 mg (Janumet 50 mg/1000 mg 50/850 mg) or Metformin (Janumet 50 mg/1000 mg) HCl 1000 mg (Janumet 50 mg/1000 mg 50/1000 mg).

It also contains the following inactive ingredients: Microcrystalline cellulose, polyvinylpyrrolidone, sodium lauryl sulfate and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: Polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide and black iron oxide.

Janumet 50 mg/1000 mg contains 2 oral antihyperglycemic drugs used in the management of type 2 diabetes: Sitagliptin (Janumet 50 mg/1000 mg) phosphate and Metformin (Janumet 50 mg/1000 mg) HCl.

Sitagliptin (Janumet 50 mg/1000 mg) phosphate is an orally-active inhibitor of the dipeptidyl peptidase-4 (DDP-4) enzyme. Sitagliptin (Janumet 50 mg/1000 mg) is present in Janumet 50 mg/1000 mg in the form of Sitagliptin (Janumet 50 mg/1000 mg) phosphate monohydrate. Sitagliptin (Janumet 50 mg/1000 mg) phosphate monohydrate is 7-[(3R)-3-amino-1-oxo-4-(2, 4, 5-trifluorophenyl)butyl]-5, 6, 7, 8-tetrahydro-3-(trifluoromethyl)-1, 2, 4-triazolo[4, 3-a]pyrazine phosphate (1:1) monohydrate with an empirical formula of C₁₆H₁₅F₆N₅O·H₃PO₄·H₂O and a molecular weight of 523.32.

Sitagliptin (Janumet 50 mg/1000 mg) phosphate monohydrate is a white to off-white, crystalline, nonhygroscopic powder. It is soluble in water and N, N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone and acetonitrile; and insoluble in isopropanol and isopropyl acetate.

Metformin (Janumet 50 mg/1000 mg) HCl (N, N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. Metformin (Janumet 50 mg/1000 mg) HCl is a white to off-white crystalline compound with a molecular formula of C₄H₁₁N₅·HCl and a molecular weight of 165.63. Metformin (Janumet 50 mg/1000 mg) HCl is freely soluble in water and is practically insoluble in acetone, ether and chloroform. The pKa of Metformin (Janumet 50 mg/1000 mg) is 12.4. The pH of a 1% aqueous solution of Metformin (Janumet 50 mg/1000 mg) HCl is 6.68.