Janumet 50/1000mg Tab 15

JANUMET 50/1000MG TAB

JANUMET 50/1000MG is a prescription oral medication used to manage blood sugar levels in adults with type 2 diabetes mellitus. It is typically used as an adjunct to diet and exercise.

• Name:
  • Brand Name: JANUMET
  • Common Name: Sitagliptin and Metformin HCl
• Composition:
  • Active Ingredients: Each tablet contains 50 mg of sitagliptin (as sitagliptin phosphate monohydrate) and 1000 mg of metformin hydrochloride.
• Uses:
  • JANUMET is indicated to improve glycemic control in adults with type 2 diabetes mellitus. It is not used for type 1 diabetes or diabetic ketoacidosis.
• Dosage and Administration:
  • Administer orally twice daily with meals.
  • Dosage should be individualized based on the patient's current regimen, effectiveness, and tolerability.
  • The maximum recommended daily dose is 100 mg of sitagliptin and 2000 mg of metformin hydrochloride.
  • Tablets should not be split or divided.
  • For patients already taking 850 mg metformin twice daily, the recommended starting dose of JANUMET is 50 mg sitagliptin/1000 mg metformin hydrochloride twice daily.
  • Gradual dose escalation is recommended for patients not currently treated with metformin to reduce gastrointestinal side effects.
• Side Effects:
  • Common: Stuffy or runny nose, sore throat, headache, upper respiratory infection, weakness, gas, upset stomach, indigestion, diarrhea, nausea, vomiting, and a low level of vitamin B12.
  • Serious:
    • Lactic Acidosis (Boxed Warning): A rare but serious metabolic complication, potentially fatal, characterized by symptoms like muscle pain, abdominal pain, weakness, trouble breathing, dizziness, and feeling cold.
    • Pancreatitis: Severe pain in the upper stomach radiating to the back, with or without vomiting.
    • Severe joint pain.
    • Bullous pemphigoid: A rare skin reaction with blistering and peeling.
    • Heart failure: Symptoms include shortness of breath, swelling, and rapid weight gain.
    • Kidney problems, including acute renal failure.
    • Hypoglycemia (low blood sugar), particularly when used with insulin or sulfonylureas.
    • Serious allergic reactions: Hives, swelling of the face or throat, and difficulty breathing.
• Precautions:
  • Assess renal function prior to initiation and periodically thereafter. JANUMET is contraindicated in severe renal impairment (eGFR <30 mL/min/1.73 m2).
  • Avoid excessive alcohol intake due to increased risk of lactic acidosis.
  • Temporarily discontinue JANUMET for radiologic studies involving intravascular iodinated contrast materials.
  • Caution is advised in patients with a history of pancreatitis.
• Storage:
  • Store at room temperature, between 68°F to 77°F (20°C to 25°C), with excursions permitted to 59°F to 86°F (15°C to 30°C).
  • Keep tablets in a tightly sealed container and protect from moisture and heat.

What is JANUMET 50/1000MG TAB used for?

JANUMET 50/1000MG TAB is a prescription medication used alongside diet and exercise to improve blood sugar control in adults with Type 2 diabetes mellitus. It is not used to treat Type 1 diabetes.

How does JANUMET 50/1000MG TAB work?

JANUMET combines two active ingredients: sitagliptin and metformin. Sitagliptin, a DPP-4 inhibitor, works by increasing the levels of insulin your body produces after eating and decreasing the amount of glucagon (a hormone that raises blood sugar). Metformin, a biguanide, reduces the amount of glucose (sugar) your liver produces, decreases the amount of sugar absorbed from your food, and helps your body use its own insulin more effectively.

What is the usual dosage for JANUMET 50/1000MG TAB?

JANUMET 50/1000MG TAB is typically taken twice daily with meals. The specific dosage is individualized by your doctor based on your current regimen, effectiveness, and tolerability. For patients already taking metformin, the recommended starting dose of JANUMET is often 50 mg sitagliptin and 1000 mg metformin HCl twice daily if they were previously on 850 mg metformin twice daily. The maximum recommended daily dose is 100 mg of sitagliptin and 2000 mg of metformin hydrochloride. It is important to swallow the tablets whole and not to crush, chew, or break them.

What are the possible side effects of JANUMET 50/1000MG TAB?

Common side effects can include a stuffy or runny nose, sore throat, headache, upper respiratory infection, stomach upset, indigestion, gas, diarrhea, nausea, and vomiting.

Serious but rare side effects include:

• Lactic Acidosis: A dangerous buildup of lactic acid in the blood, which requires immediate medical attention. Symptoms can include unusual muscle pain, trouble breathing, stomach pain, nausea with vomiting, feeling cold, dizziness, lightheadedness, and feeling very weak or tired.
• Pancreatitis: Inflammation of the pancreas, characterized by severe and persistent stomach pain that may spread to your back, with or without vomiting.
• Severe Allergic Reactions: Symptoms such as rash, hives, blisters, peeling skin, swelling of the face or throat, or difficulty breathing.
• Heart Failure: Symptoms like increasing shortness of breath, unusual tiredness, rapid weight gain, and swelling in your legs or feet.
• Severe Joint Pain.
• Low Vitamin B12 Levels: Metformin can decrease vitamin B12 absorption, potentially leading to a deficiency.

Is JANUMET 50/1000MG TAB safe during pregnancy or breastfeeding?

Pregnancy: JANUMET is generally not recommended for use during pregnancy. While published data with metformin has not reported a clear association with major birth defects, limited data for the combination product are insufficient to fully assess risk. Poorly controlled diabetes during pregnancy can pose risks to both the mother and the fetus. Breastfeeding: It is not recommended to take JANUMET while breastfeeding or if you plan to breastfeed. Metformin is known to be excreted into human milk in small amounts, but it is unknown if sitagliptin is. An alternative medication may be preferred due to the lack of information on sitagliptin's use during breastfeeding, especially for newborns or premature infants.

Can JANUMET 50/1000MG TAB be taken with other medications?

Yes, but caution is advised as JANUMET can interact with other medications. If JANUMET is taken with other diabetes medications known to cause low blood sugar (e.g., sulfonylureas or insulin), the risk of hypoglycemia (low blood sugar) increases, and the dosage of these other medications may need to be adjusted. Certain drugs, including some anti-seizure medications, anti-viral medications for HIV/AIDS, specific antipsychotic medications, carbonic anhydrase inhibitors (e.g., topiramate), cimetidine, and some diuretics, can interact with JANUMET and potentially increase the risk of lactic acidosis or affect blood sugar control. Always inform your doctor or pharmacist about all prescription and over-the-counter medications, vitamins, and herbal supplements you are currently taking.

What precautions should be taken while taking JANUMET 50/1000MG TAB?

Avoid excessive alcohol consumption while taking JANUMET, as it can increase the risk of lactic acidosis. Inform your doctor about any history of kidney problems, liver problems, heart failure, or pancreatitis, as these conditions may affect the suitability or dosage of JANUMET. Your kidney function will be assessed before and periodically during treatment. You may need to temporarily stop taking JANUMET before certain surgeries or imaging procedures that involve the injection of iodine contrast dye. Take JANUMET with meals to help reduce gastrointestinal side effects. Continue to follow your prescribed diet and exercise program while on this medication.

What happens if a dose of JANUMET 50/1000MG TAB is missed?

If you miss a dose of JANUMET, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should JANUMET 50/1000MG TAB be stored?

Store JANUMET at room temperature, typically between 68°F to 77°F (20°C to 25°C), away from moisture and heat. Keep all medications out of the sight and reach of children.