Januvia 50 mg film-coated tablets Sitagliptin - United Kingdom[英国药品]

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Januvia 50 mg film-coated tablets Sitagliptin

2013-12-08 11:11:53 来源: 作者: 【大中小】浏览:348次评论:0条

For doctors

What is it and how is it used?

Januvia is a member of a class of medicines you take by mouth called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in patients with type 2 diabetes mellitus. Type 2 diabetes is also called non-insulin-dependent diabetes mellitus, or NIDDM.

Januvia helps to improve the levels of insulin after a meal and decreases the amount of sugar made by the body. It is unlikely to cause low blood sugar because it does not work when your blood sugar is low. However, when Januvia is used in combination with a sulphonylurea medicine or with insulin, low blood sugar (hypoglycaemia) can occur.

Your doctor has prescribed Januvia to help lower your blood sugar, which is too high because of your type 2 diabetes. Januvia can be used alone or in combination with certain other medicines (insulin, metformin, sulphonylureas, or glitazones) that lower blood sugar, which you may already be taking for your diabetes together with a food and exercise plan.

What is type 2 diabetes?Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation.

What do you have to consider before using it?

Do not take Januvia

Take special care with Januvia
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Januvia. Pancreatitis can be a serious, potentially life-threatening medical condition. Stop taking Januvia and call your doctor if you experience severe and persistent stomach pain, with or without vomiting, because you could have pancreatitis.

Tell your doctor if you have or have had:

If you are taking a sulphonylurea or insulin with Januvia you may experience low blood sugar. Your doctor may reduce the dose of your sulphonylurea or insulin medicine.

Taking other medicines
Januvia may be taken with most medicines. Tell your doctor or pharmacist about all the medicines you take or have recently taken. This includes prescription and non-prescription medicines, and herbal supplements.

Taking Januvia with food and drink
You can take Januvia with or without food and drink.

Pregnancy and breast-feeding
Women who are pregnant or plan to become pregnant should consult their doctor before taking Januvia. You should not use Januvia during pregnancy.

It is not known if Januvia passes into breast milk. You should not use Januvia if you are breast-feeding or plan to breast-feed.

Driving and using machines
Januvia has no known influence on the ability to drive and use machines. However, when driving or operating machinery, it should be taken into account that dizziness and drowsiness have been reported.

Taking Januvia in combination with medicines called sulphonylureas or with insulin can cause hypoglycaemia, which may affect your ability to drive and use machines or work without safe foothold.

How is it used?

Always take Januvia exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is:

Your doctor may prescribe Januvia alone or with certain other medicines that lower blood sugar.

Continue to take Januvia as long as your doctor prescribes it so you can continue to help control your blood sugar.

Diet and exercise can help your body use its blood sugar better. It is important to stay on the diet, exercise and weight loss program recommended by your doctor while taking Januvia.

If you take more Januvia than you should
If you take more than the prescribed dosage of Januvia, contact your doctor immediately.

If you forget to take Januvia
If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose of Januvia.

What are possible side effects?

Like all medicines, Januvia may cause side effects, although not everybody gets them.

Very common side effects (more than 1 per 10 patients)
Common side effects (less than 1 per 10 but more than 1 per 100 patients)
Uncommon side effects (less than 1 per 100 but more than 1 per 1,000 patients)

Some patients have experienced the following side effects after adding sitagliptin to metformin: Common: nausea
Uncommon: weight loss, loss of appetite, abdominal pain, diarrhoea, low blood sugar, drowsiness.

Some patients have experienced stomach discomfort when starting the combination of sitagliptin and metformin together.

Some patients have experienced the following side effects while taking Januvia in combination with a sulphonylurea:
Common: low blood sugar

Some patients have experienced the following side effects while taking Januvia in combination with a sulphonylurea and metformin:
Very common: low blood sugar
Common: constipation

Some patients have experienced the following side effects while taking Januvia and pioglitazone: Common: low blood sugar and flatulence. In addition, some patients have reported foot swelling while taking Januvia and pioglitazone. These side effects may be seen with sitagliptin and any glitazone (e.g., rosiglitazone).

Some patients have experienced the following side effects while taking Januvia in combination with rosiglitazone and metformin:
Common: headache, cough, diarrhoea, vomiting, low blood sugar, fungal skin infection, upper respiratory infection, swelling of the hands or legs.

Some patients have experienced the following side effects while taking Januvia in combination with insulin (with or without metformin):
Common: headache, low blood sugar and flu
Uncommon: dry mouth, constipation

Some patients have experienced the following side effects while taking Januvia alone: Common: low blood sugar, headache
Uncommon: dizziness, constipation

In addition, some patients have reported the following side effects while taking Januvia:

Common: upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain.

During post-approval use of Januvia by itself and/or with other diabetes medicines additional side effects have also been reported (frequency not known): allergic reactions, which may be serious, including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have an allergic reaction, stop taking Januvia and call your doctor right away. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes. Other side effects that have been reported include: inflammation of the pancreas; kidney problems (sometimes requiring dialysis); vomiting.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Januvia after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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For doctors

What is it?

Januvia is a medicine that contains the active substance sitagliptin. It is available as round tablets (pink: 25 mg; beige: 50 and 100 mg).

What is it used for?

Januvia is used in patients with type 2 diabetes to improve the control of blood glucose (sugar) levels. It is used in addition to diet and exercise in the following ways:

How is it used?

Januvia is taken at a dose of 100 mg once a day, with or without food. If Januvia is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).

How does it work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Januvia, sitagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. It works by blocking the breakdown of ‘incretin’ hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By increasing levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Sitagliptin does not work when the blood glucose is low. Sitagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Together, these processes reduce blood glucose levels and help to control type 2 diabetes.

How has it been studied?

Januvia was studied in nine studies involving almost 6,000 patients with type 2 diabetes whose blood glucose levels were not adequately controlled:

What benefits has it shown during the studies?

Januvia was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines. In patients taking Januvia on its own, HbA1c levels fell from around 8.0% at the start of the studies by 0.48% after 18 weeks and 0.61% after 24 weeks. In contrast, they rose by 0.12% and 0.18%, respectively, in the patients taking placebo. Adding Januvia to metformin reduced HbA1c levels by 0.67% after 24 weeks, compared with a fall of 0.02% in the patients adding placebo. When added to pioglitazone, Januvia reduced HbA1c levels by 0.85% after 24 weeks, compared with a fall of 0.15% in the patients adding placebo.
In the studies comparing Januvia with other medicines, the effectiveness of adding Januvia to metformin was similar to that of adding glipizide. When taken on their own, Januvia and metformin produced similar reductions in HbA1c levels, but the effectiveness of Januvia seemed to be slightly lower than that of metformin.
In the additional studies, adding Januvia to glimepiride (with or without metformin) led to a reduction in HbA1c levels of 0.45% after 24 weeks, compared with an increase of 0.28% in the patients adding placebo. HbA1c levels were reduced by 1.03% after 18 weeks in patients adding Januvia to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo. Finally, they were reduced by 0.59% in patients adding Januvia to insulin (with or without metformin), compared with a fall of 0.03% in those adding placebo.

What is the risk associated?

The most common side effects with Januvia (generally seen in more than 5% of patients) include upper respiratory tract infections (colds) and nasopharyngitis (inflammation of the nose and throat). For the full list of all side effects reported with Januvia, see the Package Leaflet.
Januvia should not be used in people who may be hypersensitive (allergic) to sitagliptin or any of the other ingredients.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Januvia’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Januvia to Merck Sharp & Dohme Ltd. on 21 March 2007. The marketing authorisation is valid for five years, after which it can be renewed.

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