Generic Name: sitagliptin and simvastatin (Oral route)
sit-a-GLIP-tin FOS-fate, sim-va-STAT-in
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antihyperlipidemic
Pharmacologic Class: Sitagliptin
Uses For Juvisync
Sitagliptin and simvastatin combination is used together with a proper diet and exercise to treat type 2 diabetes. It is also used together with a proper diet to treat high cholesterol and triglyceride (fats) levels in the blood. This medicine may help prevent medical problems caused by clogged blood vessels such as heart attacks and strokes.
Sitagliptin helps to control blood sugar levels by increasing substances in the body that make the pancreas release more insulin. It also signals the liver to stop producing sugar (glucose) when there is too much sugar in the blood.
Simvastatin belongs to the group of medicines called HMG-CoA reductase inhibitors or "statins." It works to reduce the amount of cholesterol in the blood by blocking an enzyme that is needed to make cholesterol.
This medicine is available only with your doctor's prescription.
Before Using Juvisync
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of sitagliptin and simvastatin combination in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sitagliptin and simvastatin combination in the elderly. However, elderly patients are more likely to have age-related kidney or muscle problems, which may require caution and an adjustment in the dose for patients receiving sitagliptin and simvastatin combination.
Pregnancy
|
Pregnancy Category |
Explanation |
|---|
| All Trimesters |
X |
Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit. |
Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Amprenavir
- Atazanavir
- Boceprevir
- Clarithromycin
- Cyclosporine
- Danazol
- Darunavir
- Erythromycin
- Fosamprenavir
- Gemfibrozil
- Indinavir
- Itraconazole
- Ketoconazole
- Lopinavir
- Mibefradil
- Nefazodone
- Nelfinavir
- Posaconazole
- Ritonavir
- Saquinavir
- Telaprevir
- Telithromycin
- Tipranavir
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acenocoumarol
- Amiodarone
- Amlodipine
- Azithromycin
- Bezafibrate
- Ciprofibrate
- Ciprofloxacin
- Clofibrate
- Colchicine
- Conivaptan
- Dalfopristin
- Daptomycin
- Delavirdine
- Diltiazem
- Everolimus
- Fenofibrate
- Fluconazole
- Fusidic Acid
- Niacin
- Quinupristin
- Ranolazine
- Risperidone
- Tadalafil
- Verapamil
- Voriconazole
- Warfarin
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Alitretinoin
- Bosentan
- Carbamazepine
- Dasatinib
- Digoxin
- Dronedarone
- Efavirenz
- Fosphenytoin
- Imatinib
- Levothyroxine
- Oat Bran
- Oxcarbazepine
- Pectin
- Phenytoin
- Rifampin
- St John's Wort
- Ticagrelor
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol use, excessive or history of or
- Chinese ancestry or
- Hypotension (low blood pressure) or
- Hypothyroidism (an underactive thyroid), uncontrolled or
- Infection, serious or
- Kidney disease or
- Liver disease, history of or
- Major surgery or
- Seizures, uncontrolled—Use with caution. May cause side effects to become worse.
- Diabetic ketoacidosis (high ketones and acid in the blood) or
- Kidney disease, severe or
- Liver disease, active or
- Type 1 diabetes—Should not be used in patients with these conditions.
- Muscle pain or tenderness, history of or
- Muscle weakness, history of—Use with caution. May make these conditions worse.
Proper Use of Juvisync
Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
Your doctor will give you instructions about diet, exercise, testing your blood sugar, and adjusting your dose when you are sick. Carefully follow your doctor's instructions.
Swallow the tablet whole. Do not break, crush, or chew it.
If you are taking diltiazem (Cardizem®) or verapamil (Calan®, Isoptin®, Verelan®) together with this medicine, your dose of Juvisync™ should not be higher than 100 milligrams (mg) of sitagliptin and 10 mg of simvastatin per day, unless otherwise directed by your doctor. Do not use more than 100 mg of sitagliptin and 20 mg of simvastatin per day together with amiodarone (Cordarone®), amlodipine (Norvasc®), or ranolazine (Ranexa®). When used together with higher doses of Juvisync™, these medicines may increase your risk of muscle injury and could result in kidney problems.
Avoid large amounts of grapefruit juice (more than 1 quart each day) while you are taking this medicine. Grapefruit juice may increase your risk of muscle injury and could result in kidney problems.
Do not drink large amounts of alcohol with this medicine. This could cause unwanted effects on the liver.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For type 2 diabetes and high cholesterol:
- Adults—At first, 100 milligrams (mg) of sitagliptin and 40 mg of simvastatin combination once a day in the evening. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using Juvisync
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
Do not use this medicine if you are also taking any of the following medicines: cyclosporine (Gengraf®, Neoral®, Sandimmune®), danazol (Danocrine®), gemfibrozil (Lopid®), nefazodone (Serzone®), certain antibiotics (such as clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, telithromycin, Biaxin®, Ery-Tab®, Ketek®, Nizoral®, Noxafil®, or Sporanox®), or medicines to treat HIV/AIDS (such as atazanavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, Agenerase®, Crixivan®, Invirase®, Kaletra®, Lexiva®, Norvir®, Prezista®, Reyataz®, or Viracept®). Using these medicines together with sitagliptin and simvastatin combination may increase your risk of muscle injury and could result in kidney problems.
Chinese patients who are taking large amounts of niacin (greater than or equal to 1 gram or 1000 milligrams per day) together with this medicine may have an increased risk for muscle injury. Talk to your doctor if you are Chinese or have Chinese ancestry and take large amounts of niacin (Niacor®, Niaspan®). You may need a different dose of this medicine.
Stop using this medicine and call your doctor right away if you have unexplained muscle pain, tenderness, or weakness along with a fever and unusual tiredness. These could be symptoms of a serious muscle problem called myopathy. Myopathy is more common when high doses of simvastatin are used, but some people get myopathy with lower doses. Myopathy is also more common in women, elderly patients, or patients with renal disease or an underactive thyroid gland (hypothyroidism).
Stop using this medicine and check with your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.
Stop using this medicine and check with your doctor right away if you have dark-colored urine, a general feeling of tiredness or weakness, a headache, light-colored stools, loss of appetite, stomach pain, upper right stomach pain, vomiting, weight loss, or yellow eyes or skin. These could be symptoms of liver damage.
Stop using this medicine and check with your doctor right away if you have bloating; chills; constipation; dark urine; a fast heartbeat; fever; indigestion; loss of appetite; nausea; sudden pains in the stomach, side, or abdomen, possibly radiating to the back; vomiting; or yellow eyes or skin while you are using this medicine. These may be symptoms of a rare condition called pancreatitis (swelling and inflammation of the pancreas).
This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and tell your doctor right away if you have chest pain; itching; a rash; swelling of the face, tongue, and throat; or trouble with breathing or swallowing after using this medicine.
This medicine may cause hypoglycemia (low blood sugar). Low blood sugar can also occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, cannot eat because of nausea or vomiting, take certain medicines, or take sitagliptin with another type of diabetes medicine (eg, insulin, glimepiride, metformin, or pioglitazone). The symptoms of low blood sugar must be treated before they cause you to pass out (unconsciousness). People feel different symptoms with low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly.
The symptoms of low blood sugar include anxiety; behavior changes similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty with thinking; drowsiness; excessive hunger; a fast heartbeat; headaches that continue; nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.
If symptoms of low blood sugar occur, check your blood sugar level. If you have low blood sugar, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drinks, or sugar dissolved in water. Glucagon is a medicine that is used in emergency situations when severe symptoms, such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. The members of your family should also know how to use glucagon.
There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes with a list of all your medicines.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Juvisync Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common- Anxiety
- blurred vision
- chills
- cold sweats
- confusion
- cool, pale skin
- depression
- dizziness
- fainting
- fast or irregular heartbeat
- headache
- increased hunger
- nausea
- nightmares
- seizures
- shakiness
- slurred speech
- unusual tiredness or weakness
Less common- Bladder pain
- bloody or cloudy urine
- difficult, burning, or painful urination
- dry mouth
- flushed, dry skin
- frequent urge to urinate
- fruit-like breath odor
- increased thirst
- increased urination
- loss of consciousness
- lower back or side pain
- stomachache
- sweating
- swelling
- troubled breathing
- unexplained weight loss
- vomiting
Rare- Bloating
- constipation
- dark-colored urine
- fever
- indigestion
- loss of appetite
- muscle cramps or spasms
- muscle pain, tenderness, wasting, or weakness
- pains in the stomach, side, or abdomen, possibly radiating to the back
- yellow eyes or skin
Incidence not known- Agitation
- black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain
- decreased urine output
- diarrhea
- difficulty with moving
- difficulty with swallowing
- feeling of warmth
- hives
- increased sensitivity of the skin to sunlight
- irritability
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lethargy
- pinpoint red spots on the skin
- rapid weight gain
- red, irritated eyes
- red skin lesions, often with a purple center
- redness of the face, neck, arms, and occasionally, upper chest
- red, sore, or itching skin
- seizures
- severe sunburn
- skin rash
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sores, welts, or blisters on the skin
- swollen glands
- swollen joints
- tightness in the chest
- unsteadiness or awkwardness
- unusual bleeding or bruising
- weakness in the arms, hands, legs, or feet
- wheezing
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common- Body aches or pain
- cough that produces mucus
- ear congestion
- loss of voice
- runny or stuffy nose
- sneezing
Less common- Burning feeling in the chest or stomach
- dizziness or lightheadedness
- feeling of constant movement of self or surroundings
- pain or tenderness around the eyes and cheekbones
- sensation of spinning
- skin rash that is encrusted, scaly, and oozing
- sleeplessness
- tenderness in the stomach area
- trouble with sleeping
Incidence not known- Acid or sour stomach
- being forgetful
- belching
- decreased interest in sexual intercourse
- excess air or gas in the stomach or intestines
- full feeling
- hair loss
- heartburn
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
- passing gas
- problems with memory
- stomach discomfort, upset, or pain
- thinning of the hair
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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