What are the possible side effects of Repandin?
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; headache; joint or back pain; sinus pain or pressure; symptoms of upper respiratory tract infection (eg, cough, mild sore throat, runny or stuffy nose, sneezing).
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fever, chills, or persistent sore throat; low blood sugar symptoms (eg, anxiety; fainting; fast heartbeat; increased hunger; light-headedness; severe or persistent dizziness, drowsiness, or headache; tremors; unusual sweating; weakness; vision changes); unusual bruising or bleeding.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Side effects of Repandin in details
Hypoglycemia: See PRECAUTIONS and OVERDOSAGE sections.
Repandin has been administered to 2931 individuals during clinical trials. Approximately 1500 of these individuals with type 2 diabetes have been treated for at least 3 months, 1000 for at least 6 months, and 800 for at least 1 year. The majority of these individuals (1228) received Repandin in one of five 1-year, active-controlled trials. The comparator drugs in these 1-year trials were oral sulfonylurea drugs (SU) including glyburide and glipizide. Over one year, 13% of Repandin patients were discontinued due to adverse events, as were 14% of SU patients. The most common adverse events leading to withdrawal were hyperglycemia, hypoglycemia, and related symptoms. Mild or moderate hypoglycemia occurred in 16% of Repandin patients, 20% of glyburide patients, and 19% of glipizide patients.
The table below lists common adverse events for Repandin patients compared to both placebo (in trials 12 to 24 weeks duration) and to glyburide and glipizide in one year trials. The adverse event profile of Repandin was generally comparable to that for sulfonylurea drugs (SU).
| *: Events >2% for the Repandin group in the placebo-controlled studies and ≥ events in the placebo group **: See trial description in CLINICAL PHARMACOLOGY, Clinical Trials | ||||
| EVENT | Repandin N = 352 | PLACEBO N = 108 | Repandin N = 1228 | SU N = 498 |
| Placebo Controlled Studies | Active Controlled Studies | |||
| Metabolic | ||||
| Hypoglycemia | 31** | 7 | 16 | 20 |
| Respiratory | ||||
| URI | 16 | 8 | 10 | 10 |
| Sinusitis | 6 | 2 | 3 | 4 |
| Rhinitis | 3 | 3 | 7 | 8 |
| Bronchitis | 2 | 1 | 6 | 7 |
| Gastrointestinal | ||||
| Nausea | 5 | 5 | 3 | 2 |
| Diarrhea | 5 | 2 | 4 | 6 |
| Constipation | 3 | 2 | 2 | 3 |
| Vomiting | 3 | 3 | 2 | 1 |
| Dyspepsia | 2 | 2 | 4 | 2 |
| Musculoskeletal | ||||
| Arthralgia | 6 | 3 | 3 | 4 |
| Back Pain | 5 | 4 | 6 | 7 |
| Other | ||||
| Headache | 11 | 10 | 9 | 8 |
| Paresthesia | 3 | 3 | 2 | 1 |
| Chest Pain | 3 | 1 | 2 | 1 |
| Urinary Tract Infection | 2 | 1 | 3 | 3 |
| Tooth disorder | 2 | 0 | <1 | <1 |
| Allergy | 2 | 0 | 1 | <1 |
Cardiovascular Events
In one-year trials comparing Repandin to sulfonylurea drugs, the incidence of angina was comparable (1.8%) for both treatments, with an incidence of chest pain of 1.8% for Repandin and 1% for sulfonylureas. The incidence of other selected cardiovascular events (hypertension, abnormal EKG, myocardial infarction, arrhythmias, and palpitations was ≤ 1% and not different between Repandin and the comparator drugs.
The incidence of total serious cardiovascular adverse events, including ischemia, was higher for Repandin (4%) than for sulfonylurea drugs (3%) in controlled comparator clinical trials. In 1-year controlled trials, Repandin treatment was not associated with excess mortality when compared to the rates observed with other oral hypoglycemic agent therapies.
| *: glyburide and glipizide | ||
| Total Exposed | Repandin | SU* |
| 1228 | 498 | |
| Serious CV Events | 4% | 3% |
| Cardiac Ischemic Events | 2% | 2% |
| Deaths due to CV Events | 0.5% | 0.4% |
Seven controlled clinical trials included Repandin combination therapy with NPH-insulin (n=431), insulin formulations alone (n=388) or other combinations (sulfonylurea plus NPH-insulin or Repandin plus metformin) (n=120). There were six serious adverse events of myocardial ischemia in patients treated with Repandin plus NPH-insulin from two studies, and one event in patients using insulin formulations alone from another study.
Infrequent Adverse Events (<1% of Patients)
Less common adverse clinical or laboratory events observed in clinical trials included elevated liver enzymes, thrombocytopenia, leukopenia, and anaphylactoid reactions.
Although no causal relationship with Repandin has been established, postmarketing experience includes reports of the following rare adverse events: alopecia, hemolytic anemia, pancreatitis, Stevens-Johnson syndrome, and severe hepatic dysfunction including jaundice and hepatitis.
Combination Therapy with Thiazolidinediones
During 24-week treatment clinical trials of Repandin-rosiglitazone or Repandin-pioglitazone combination therapy (a total of 250 patients in combination therapy), hypoglycemia (blood glucose < 50 mg/dL) occurred in 7% of combination therapy patients in comparison to 7% for Repandin monotherapy, and 2% for thiazolidinedione monotherapy.
Peripheral edema was reported in 12 out of 250 Repandin-thiazolidinedione combination therapy patients and 3 out of 124 thiazolidinedione monotherapy patients, with no cases reported in these trials for Repandin monotherapy. When corrected for dropout rates of the treatment groups, the percentage of patients having events of peripheral edema per 24 weeks of treatment were 5% for Repandin-thiazolidinedione combination therapy, and 4% for thiazolidinedione monotherapy. There were reports in 2 of 250 patients (0.8%) treated with Repandin-thiazolidinedione therapy of episodes of edema with congestive heart failure. Both patients had a prior history of coronary artery disease and recovered after treatment with diuretic agents. No comparable cases in the monotherapy treatment groups were reported.
Mean change in weight from baseline was +4.9 kg for Repandin-thiazolidinedione therapy. There were no patients on Repandin-thiazolidinedione combination therapy who had elevations of liver transaminases (defined as 3 times the upper limit of normal levels).
What is the most important information I should know about Repandin?
- Dizziness may occur while you are taking Repandin. This effect may be worse if you take it with alcohol or certain medicines. Use Repandin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink large amounts of alcohol while you use Repandin. Talk to your doctor or health care provider before you drink alcohol while you use Repandin.
- Follow the diet and exercise program given to you by your health care provider.
- Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher than they should be and you take Repandin exactly as prescribed, tell your doctor.
- Repandin may lower your blood sugar levels. Low blood sugar may be more likely to occur if you skip a meal, exercise heavily, or drink alcohol. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you hungrier. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
- It may be harder to control your blood sugar during times of stress such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.
- Tell your doctor or dentist that you take Repandin before you receive any medical or dental care, emergency care, or surgery.
- Lab tests, including fasting blood sugar and hemoglobin A levels, may be performed while you take Repandin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Repandin with caution in the ELDERLY; they may be more sensitive to its effects. Low blood sugar levels may also be more difficult to recognize in elderly patients.
- Repandin should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Repandin while you are pregnant. It is not known if Repandin is found in breast milk. Do not breast-feed while you are taking Repandin.
Repandin contraindications
Known hypersensitivity to Repandin or any of the excipients of Repandin.
Type 1 diabetes (insulin-dependent diabetes mellitus, C-peptide negative diabetes); diabetic ketoacidosis with or without coma; pregnancy or lactation; children <12 years; severe renal or hepatic function disorders.
Concomitant therapy with medicinal products which are CYP3A4 inhibitors or inducers.
References
- DailyMed. "REPAGLINIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DTP/NCI. "Repaglinide: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "2-ethoxy-4-({[(1S)-3-methyl-1-[2-(piperidin-1-yl)phenyl]butyl]carbamoyl}methyl)benzoic acid: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Repandin are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Repandin. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
No survey data has been collected yetConsumer reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
