About diabetic gastroparesis
About diabetic gastroparesis
Gastroparesis, also known as delayed gastric emptying, is a condition in which the stomach empties slower than normal or food stops moving through the digestive tract.
Gastroparesis occurs in approximately 4% of the general population and in up to 12% of patients with diabetes.4,5 The disorder occurs as a result of a disruption in the normal digestive process. With gastroparesis, muscular contractions in the esophagus, stomach, and small intestine may be too slow or out of rhythm, resulting in food emptying slowly from the stomach or stopping in the digestive tract. When food stays in the stomach for too long, it can cause many uncomfortable symptoms and eventually may lead to more serious complications.
Metozolv ODT* is a prescription medicine used in adults for 4 to 12 weeks to relieve symptoms of diabetic gastroparesis. If you have diabetic gastroparesis, talk with your healthcare professional about Metozolv ODT.
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Diabetic gastroparesis symptoms
People who do not receive treatment for gastroparesis can experience a variety of uncomfortable symptoms. Without treatment, gastroparesis can cause complications with diabetic medicine, making it difficult for people with diabetes to control blood glucose levels. Diabetic gastroparesis symptoms may include
- Nausea
- Vomiting—Many people with diabetic gastroparesis vomit repeatedly several hours after eating
- Bloating immediately after a meal—These feelings of fullness may develop even after eating small amounts of food
- Weight loss and dehydration—Feeling full after eating small amounts of food may make it difficult to consume healthy amounts of food and water. This can lead to weight loss and dehydration
- Early satiety—Feeling full soon after you start eating or after eating a small amount of food
- Decreased appetite
- Heartburn
- Abdominal pain
If you have diabetes and are experiencing any of these symptoms, talk to your healthcare professional. He or she can perform tests to determine if you have diabetic gastroparesis and prescribe the right medicine for you.
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Diabetic gastroparesis risk factors
Many diabetic gastroparesis risk factors stem from problems related to controlling the level of glucose (sugar) in the blood. For people with diabetes, gastroparesis causes may include
- High glucagon levels—Glucagon is a hormone that increases the amount of glucose in the blood
- Vagus nerve neuropathy—Complications in the vagus nerve can disrupt muscle contraction in the digestive system
- Reduced number and density of interstitial cells of Cajal—Interstitial cells of Cajal act as pacemakers to time muscle contractions in the digestive system
- Stress—A corticotrophin-releasing hormone that the body releases in response to stress can also reduce digestion speed
- Taking certain medications—Some medicines may delay the speed at which the stomach empties
- Duration of diabetes—People with diabetic gastroparesis often have had diabetes for at least 10 years
There is no guaranteed plan for acute and recurrent diabetic gastroparesis prevention, but controlling blood sugar levels and regularly visiting your healthcare professional can help. If prevention efforts fail, ask your healthcare professional about Metozolv ODT, a treatment option for acute and recurrent diabetic gastroparesis.
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Important Safety Information About METOZOLV® ODT
WARNING: TARDIVE DYSKINESIA
See full prescribing information for complete boxed warning.
Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose.
Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.
Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.
Call your doctor right away if you experience symptoms you cannot stop or control such as lip smacking, chewing, or puckering of your lips; frowning or scowling; sticking out of your tongue; blinking and moving your eyes; or shaking of your arms and legs.
It is not possible for your doctor to know if you will get TD if you take METOZOLV ODT. Factors that increase your risk for TD include increased age, especially for females; a diagnosis of diabetes; and extended use and increased dosage of METOZOLV ODT. You should not take METOZOLV ODT for more than 12 weeks.
METOZOLV ODT can cause other serious side effects including uncontrolled muscle spasms; depression, thoughts about suicide, and suicide; a rare but potentially fatal disorder known as neuroleptic malignant syndrome (NMS), the symptoms of which include high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased swelling; parkinsonism, the symptoms of which include slight body shaking, body stiffness, and trouble moving or keeping your balance; high blood pressure; and too much body water. If you experience any of these symptoms, call your doctor and get medical help right away.
The most common side effects of METOZOLV ODT include headache, nausea, vomiting, tiredness, and sleepiness. Tell your doctor about any side effects that bother you or do not go away.
You may still have side effects after stopping METOZOLV ODT, and you may have symptoms from stopping METOZOLV ODT (withdrawal symptoms), such as headaches and feeling dizzy or nervous.
Do not drink alcohol while taking METOZOLV ODT, as it may worsen some side effects. Do not drive, work with machines, or do dangerous tasks until you know how METOZOLV ODT affects you.
Do not take METOZOLV ODT if you have stomach or intestinal problems, such as bleeding, blockage, or a tear in your stomach or bowel wall; have an adrenal tumor (pheochromocytoma); are allergic to metoclopramide or any of the ingredients in METOZOLV ODT; take medications that can cause uncontrolled movements, such as medicines for mental illness; or have seizures.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
Patient Medication Guide and full Prescribing Information for METOZOLV ODT, including BOXED WARNING.
References: 1. METOZOLV ODT [package insert]. Morrisville, NC: Salix Pharmaceuticals, Inc; 2009.
2. Overview. US Food and Drug Administration. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=REGLAN. Accessed May 6, 2009.
3. Overview. US Food and Drug Administration. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=METOCLOPRAMIDE%20HYDROCHLORIDE. Accessed May 6, 2009.
4. Abell TL, Bernstein RK, Cutts T, et al. Treatment of gastroparesis: a multidisciplinary clinical review. Neurogastroenterol Motil. 2006;18:263-283. 5. Haans JJL, Masclee AAM. Review article: the diagnosis and management of gastroparesis. Aliment Pharmacol Ther. 2007;26(suppl 2):37-46.