Jentadueto
Jentadueto
Metformin Hydrochloride, Linagliptin
Select product strength & quantity:
Select product strength & quantity:
Select product strength & quantity:

Jentadueto® (Metformin Hydrochloride, Linagliptin)

What is Jentadueto®?

Jentadueto is the brand name of a combination medication that includes linagliptin and metformin hydrochloride

Jentadueto is a prescription medication in tablet form (both immediate release and slow-release XR forms) that is used to lower blood sugar in individuals with Type-2 diabetes. It is most effective when used with a healthy diet and exercise. Jentadueto is a combination medicine containing two different diabetes medications – linagliptin and metformin.

The slow-release tablet is made with an extended-release core of metformin covered with immediate-release linagliptin. Besides the active ingredients, each tablet contains polyethylene oxide, hypromellose, and magnesium stearate in the core. The coating includes but is not limited to hydroxypropyl cellulose, hypromellose, talc, titanium dioxide, arginine, polyethylene glycol, and colorants.

Indications

Jentadueto contains linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor and metformin hydrochloride (HCl), a biguanide indicated as an adjunct to diet and exercise to improve blood glucose control in adults with Type-2 diabetes mellitus.

How Does it Work?

The two ingredients in Jentadueto work together to lower blood glucose levels.

  1. Linagliptin inhibits dipeptidyl peptidase-4 (DPP-4), thereby slowing the inactivation and breakdown of GLP-1, a hormone that removes glucose from the gut. Therefore, it works by increasing the amount of this natural substance that lowers blood glucose levels when they’re high.
  2. Metformin hydrochloride works by decreasing the amount of glucose the body produces and absorbs by lowering glucose production in the liver. It also increases the body’s sensitivity to insulin.

Note that this medication does not directly increase insulin production. It lowers blood glucose in three ways – firstly, by increasing hormones that stimulate the pancreas to produce more insulin; secondly, by increasing the hormones that stimulate the liver to produce less glucose; thirdly, by aiding the body to utilize insulin more efficiently. Overall, the medication helps Type-2 diabetics to manage their glucose levels and decrease their A1C levels.

Dosage

Adults: The starting dose will be individualized based on your current regimen. Here are the recommended starting doses:

Linaglipton/metformin immediate-release tablet: Jentadueto

  • 5mg/500mg
  • 5mg/850mg
  • 5mg/1000mg

The initial dose for patients not already taking metformin is 2.5mg/500mg twice a day.

The initial dose for patients already on metformin is based on the metformin dose. For instance, if they’re on 1000mg twice a day, then start with 2.5mg/1000mg Jentadueto twice a day. The dose should not exceed 2.5mg/1000mg twice a day.

Linaglipton/metformin slow-release tablet: Jentadueto XR

Doses should be individualized based on effectiveness and tolerability. The recommended daily dose should not exceed 5mg/2000mg.

The initial dose for patients not already taking metformin is 5mg/1000mg once a day.

The medication is usually given twice a day with meals and the dose is increased gradually up to a maximum of 2.5mg linagliptin/1000mg metformin HCL twice a day. This slow start minimizes any gastrointestinal effects (caused by metformin). It should be taken at the same time each day.

Before starting the treatment, the doctor will assess your kidney function by doing an eGFR test (estimated glomerular filtration rate). If the result is too low, this medication cannot be used. eGFR will be done regularly while on the treatment.

Jentadueto comes in the following strengths:

  • 2.5 mg /1000 mg are yellow, oval, coated tablets with one side having the Boehringer Ingelheim logo in black ink and “D2” on the top line and “1000M” on the bottom line.
  • 5 mg/1000 mg are white, oval, coated tablets with one side printed having the Boehringer Ingelheim logo in black ink and “D5” on the top line and “1000M” on the bottom line.

The medication is supplied in bottles of 30 or 90 tablets.

You may also be taking other diabetes medication. In this case, your doctor will adjust the dose of Jentadueto to fit in with that as low blood glucose levels can happen more often in this case.

Children: It is unknown whether Jentadueto is safe for children under the age of 18 years so it is usually not given to them.

How JENTADUOTO® is administered

The tablets are taken by mouth with a meal. They should be swallowed whole and not be crushed or chewed.

Storage

Jentaduoto should be stored between 68 and 77?F (20 and 25?C).

The tablets must be kept in their original packaging with the lid tightly closed to keep the tablets dry.

Jentadueto tablets must be kept out of children’s reach.

Side Effects

Allergic reactions to this medication have been reported. If experienced, discontinue the medication and go to the emergency room immediately. Symptoms of an allergy include swelling of the face, tongue, or throat, difficulty breathing, and hives.

Side effects of Jentadueto include but are not limited to the following:

  • Stuffy or runny nose
  • Sore throat
  • Diarrhea
  • A build-up of lactic acid (symptoms include weakness, dizziness, stomach discomfort, and muscle cramps)
  • Inflammation of the pancreas (symptoms include severe stomach pain, nausea and vomiting)
  • Hypoglycemia (low blood sugar). This is more likely if Jentadueto is being taken with sulfonylurea or insulin. Symptoms include headache, sleepiness, dizziness or confusion, sweating, and rapid heartbeat.
  • One of metformin’s side effects, especially in the long term, is vitamin B12 deficiency. Your doctor should do annual blood tests to monitor this.
  • Joint pain can be caused by the DPP-4 inhibitors contained in the medication.
  • Skin reactions such as blisters
  • Heart failure. Symptoms include shortness of breath, difficulty breathing, fluid retention, tiredness

These are not all the possible side effects of Jentadueto. For more information, ask your doctor or pharmacist. Please report serious side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1?800?FDA?1088.

Warnings and Special Precautions

  • This medication is not suitable for those with Type-1 diabetes or anyone with diabetic ketoacidosis.
  • It should be used with care in people who have previously had pancreatitis. There have been cases of acute pancreatitis while using this medication.
  • Jentadueto should be used with caution in patients who have risk factors for heart failure.
  • If using insulin or sulfonylurea as well, your doctor may consider lowering the doses of these medications to reduce the risk of hypoglycemia.
  • Allergic reactions have been reported with this medication so if anaphylaxis or skin conditions occur, Jentadueto should be discontinued immediately.
  • The medication may need to be temporarily discontinued in the following circumstances:
  • If you become dehydrated such as from vomiting, diarrhea or heat stroke
  • If you are scheduled for a surgical procedure.
  • If you are scheduled for a procedure involving the injection of a dye or contrast medium for purposes of an X-ray
  • In cases of extreme stress such as a vehicle accident or other form of injury

Do not reduce or discontinue the medication yourself. Follow your doctor’s instructions.

  • Blood sugar levels must be monitored while on this medication. Home monitoring is usually done as well as blood glucose tests and HbA1C.
  • Kidney function must also be carefully checked before commencement of Jentadueto and while taking it.
  • A healthy diet is part of the treatment for Type-2 diabetes and must be followed.
  • Regular exercise is also important and must be done regularly.
  • Be cautious if breastfeeding and inform your doctor first. We know that metformin is passed into the breastmilk. We do not know if linagliptin is.

Contraindications

Jentadueto is contraindicated in the following cases:

  • Severe kidney dysfunction especially an eGFR of less than 30mL/min/1.73m2
  • Metabolic acidosis or diabetic ketoacidosis
  • Allergies to any of the ingredients

Interactions

  • Carbonic anhydrase inhibitors (type of diuretic) may increase the risk of lactic acidosis. More frequent monitoring is indicated here.
  • Medications that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) might increase metformin build-up.
  • Alcohol can potentiate metformin’s effect. Excessive alcohol intake is strongly discouraged while taking Jentadueto. 

FREQUENTLY ASKED QUESTIONS

Medication safety in pregnancy is categorized by the FDA in five categories – A, B, C, D, X. Jentadueto is category B. This is because there were some studies done on pregnant animals and some of the babies had issues. No reliable studies on this medication have been done on pregnant humans. Premenopausal women should be aware that there is a risk of unintended pregnancy since the medication can cause ovulation.

This medication can be used in the elderly population but renal function must be checked more frequently.

If you miss a dose, take it with a small meal as soon as you remember. Alternatively, you can wait until your next scheduled dose and take it then. If you accidentally take too much, call your doctor or the Poison Control Center at 1-800-222-1222. You can also go to your closest hospital emergency room right away.

If you have Type-2 diabetes, this medication will help you to manage your blood sugar levels and assist you with reaching your target A1C.

  • Any existing health conditions
  • All medications you are currently taking including vitamins and herbal supplements. It is vital to tell your doctor if you are on insulin or rifampin (for tuberculosis).
  • If you have any kidney, liver, or heart problems
  • If you have ever had pancreatitis
  • If you binge drink
  • If you are pregnant, planning a pregnancy, or breastfeeding. It is unknown whether Jentadueto causes harm to the fetus or passes through the breastmilk.

Taking the medication with meals will protect you from gastro-intestinal upsets which can be a side effect of this medicine.

No. It is a readily available medication provided you have a prescription for it.

You should notify your doctor and go to the emergency room. An overdose may cause hypoglycemia.

No, it will not cure your diabetes but it will help to control your blood sugar levels. It is very important to adhere to your recommended diet and to exercise as these will also help to keep your diabetes under control.

Not everyone who takes Jentadueto experiences side effects. The most common are sore throat, blocked or runny nose, and an upset stomach. There are rarer, more serious, side effects such as pancreatitis, low blood sugar, joint pain, and skin reactions.

It varies but most Type-2 diabetics need to get their HbA1C level checked every three months.

No, you still need to stick to a healthy diet rich in unprocessed vegetables, lean protein, and whole-grain carbohydrates.