What is Reglidib?
Reglidib is used to treat high blood sugar levels caused by type 2 diabetes. It may be used alone, or in combination with insulin or another oral medicine such as metformin. In type 2 diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly. Using Reglidib will help lower blood sugar when it is too high and help restore the way you use food to make energy.. Some people can control type 2 diabetes with diet alone or diet and exercise. Following a specially planned diet and exercising will always be important when you have diabetes, even when you are taking medicines. To work properly, the amount of Reglidib you take must be balanced against the amount and type of food you eat and the amount of exercise you do. If you change your diet, your exercise, or both, you will want to test your blood sugar to find out if it is too low. Your doctor will teach you what to do if this happens.
Reglidib is available only with your doctor's prescription.
Reglidib indications
NIKP-Reglidib tablet 3 mg is used as monotherapy as adjunct to diet and exercise for the management of type II diabetes mellitus (non-insulin-dependent diabetes mellitus) in patients whose blood glucose levels cannot be controlled adequately by diet and exercise alone.
NIKP-Reglidib tablet 3 mg also may be used in combination with one or more other oral anti-diabetic agents containing metformin or insulin as adjunct to diet and exercise for the management of type II diabetes mellitus (non-insulin diabetes mellitus) patients whose blood glucose levels cannot be controlled adequately by diet, exercise and oral antidiabetic agent monotherapy.
How should I use Reglidib?
Use Reglidib as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Reglidib by mouth with breakfast or the first main meal of the day unless your doctor tells you otherwise.
- Reglidib works best if it is taken at the same time each day.
- Continue to take Reglidib even if you feel well. Do not miss any doses.
- If you miss a dose of Reglidib, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Reglidib.
Uses of Reglidib in details
Reglidib is used to lower the blood sugar levels in type 2 diabetes mellitus when diet, physical exercise and weight reduction alone are not adequate.
Reglidib description
Each tablet contains the following colourants: Reglidib 1 mg: Ferric oxide (red); Reglidib 2 mg: Ferric oxide (yellow) and lake of indigo carmine.
It also contains the following excipients: Lactose, microcrystalline cellulose, sodium starch glycollate, povidone, crospovidone, purified talc, magnesium stearate and anhydrous colloidal silica.
Reglidib dosage
Always take NIKP-Reglidib exactly as the physician has prescribed.
The dose depends on the patient's needs, condition and results of blood and urine sugar tests and is determined by the physician. The patient should not take more tablets than what the physician has prescribed.
Usual Starting Dose: 1 mg once daily. If necessary, the physician may increase the dose after each 1-2 weeks of treatment. Max Dose: 6 mg/day.
A combination therapy of Reglidib + metformin or of Reglidib + insulin may be initiated. In such case, the physician will determine the proper doses of Reglidib, metformin or insulin individually.
Inform the physician if the patient's weight or lifestyle changes or in a stressful situation, this may require change in NIKP-Reglidib doses.
If the patient feels the effect of the medicine is too weak or too strong, do not change the dose, consult the physician.
Missed Dose: If the patient forgot to take a dose, do not take a double dose to make up for forgotten doses.
If treatment is interrupted or stopped, the patient should be aware that the desired blood sugar-lowering effect will not be achieved or that the disease will deteriorate again. Keep taking NIKP-Reglidib until the physician tells the patient to stop.
Administration: Take NIKP-Reglidib by mouth, just before or with the 1st main meal of the day (usually breakfast). If the patient does not take breakfast, take NIKP-Reglidib as prescribed by the physician. It is important not to leave out any meal when the patient is on NIKP-Reglidib.
Swallow the tablet whole with at least ½ glass of water. Do not crush or chew the tablets.
Reglidib interactions
See also:
What other drugs will affect Reglidib?
Drug-Drug Interactions: Increased blood glucose lowering effect of Reglidib can occur when NIKP-Reglidib tablet 3 mg is taken with:
Oral antidiabetics, injectible antidiabetics (eg, GLP-1 agonists, insulin), ACE inhibitors, allpurinol, androgens (male sex hormones: eg, anabolic steroids), fenfluramine, antibiotics (eg, chloramphenicol and tetracyclines), anticoagulant (eg, coumarin derivatives), anti-depressants (eg, fluoxetine, fluvoxamine), guanethidine, cyclophosphamide, ifosfamide, trofosfamide, azole antifungals (eg, fluconazole, miconazole), β-blockers (eg, propranolol), disopyramide, clarithromycin, CYP450 2C9 inhibitors, fenyramidol, fibrates, histamine H2-antagonists, MAOIs, NSAIDs (eg, azapropazone, oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, salicylates), pentoxifylline, quinolones, sulfonamides, tritoqualine, uricosuric (eg, probenecid, sulfinpyrazone) and herbs with hypoglycemic properties.
Decreased blood glucose lowering effect of Reglidib can occur when NIKP-Reglidib tablet 3 mg is taken with: Rifampicin, phenytoin, nicotinic acid, diazoxide, barbiturate, corticosteroids, CYP2C9 inducers, diuretics (eg, acetazolamide and thiazide diuretic), epinephrine (eg, adrenaline), glucagon, oestrogens, progestogens, thyroid, isoniazid, laxatives (after protracted use), phenothiazines and sympathomimetics.
Either increased or decreased blood glucose lowering effect of Reglidib can occur when NIKP-Reglidib tablet 3 mg is taken with: Clonidine, reserpine and H2-receptor antagonists.
The effect of coumarin derivatives may be potentiated or weakened when coumarin derivatives are taken with NIKP-Reglidib tablet 3 mg.
Drug-Food Interactions: Both acute and chronic alcohol intake may increase or decrease the blood glucose lowering action of Reglidib unpredictably.
Others: The signs of adrenergic counter-regulation to hypoglycemia may be reduced or absent due to the influences of sympatholytics eg, β-blockers, clonidine, guanethidine and reserpine. β-blockers decrease glucose tolerance which may lead to deterioration of metabolic control in patients with diabetes mellitus Additionally, β-blockers may increase the tendency to hypoglycemia due to impaired counter-regulation.
Reglidib side effects
See also:
What are the possible side effects of Reglidib?
The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling:
- Hypoglycemia
- Hemolytic anemia
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Approximately 2,800 patients with type 2 diabetes have been treated with Reglidib in the controlled clinical trials. In these trials, approximately 1,700 patients were treated with Reglidib for at least 1 year.
Table 1 summarizes adverse events, other than hypoglycemia, that were reported in 11 pooled placebocontrolled trials, whether or not considered to be possibly or probably related to study medication. Treatment duration ranged from 13 weeks to 12 months. Terms that are reported represent those that occurred at an incidence of ≥5% among Reglidib-treated patients and more commonly than in patients who received placebo.
Table 1. Eleven Pooled Placebo-Controlled Trials ranging from 13 weeks to 12 months : Adverse Events (Excluding Hypoglycemia) Occurring in ≥5% of Reglidib-treated Patients and at a Greater Incidence than with Placebo*
| Reglidib N=745 % | Placebo N=294 % | |
| Headache | 8.2 | 7.8 |
| Accidental InjuryInsufficient information to determine whether any of the accidental injury events were associated with hypoglycemia |
Hypoglycemia
In a randomized, double-blind, placebo-controlled monotherapy trial of 14 weeks duration, patients already on sulfonylurea therapy underwent a 3-week washout period then were randomized to Reglidib 1 mg, 4 mg, 8 mg or placebo. Patients randomized to Reglidib 4 mg or 8 mg underwent forced-titration from an initial dose of 1 mg to these final doses, as tolerated. The overall incidence of possible hypoglycemia (defined by the presence of at least one symptom that the investigator believed might be related to hypoglycemia; a concurrent glucose measurement was not required) was 4% for Reglidib 1 mg, 17% for Reglidib 4 mg, 16% for Reglidib 8 mg and 0% for placebo. All of these events were self-treated.
In a randomized, double-blind, placebo-controlled monotherapy trial of 22 weeks duration, patients received a starting dose of either 1 mg Reglidib or placebo daily. The dose of Reglidib was titrated to a target fasting plasma glucose of 90–150 mg/dL. Final daily doses of Reglidib were 1, 2, 3, 4, 6 or 8 mg. The overall incidence of possible hypoglycemia (as defined above for the 14-week trial) for Reglidib vs. placebo was 19.7% vs. 3.2%. All of these events were selftreated.
Weight Gain
Reglidib, like all sulfonylureas, can cause weight gain.
Allergic Reactions
In clinical trials, allergic reactions, such as pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, occurred in less than 1% of Reglidib-treated patients. These may resolve despite continued treatment with Reglidib. There are postmarketing reports of more serious allergic reactions (e.g., dyspnea, hypotension, shock).
Laboratory Tests
Elevated Serum Alanine Aminotransferase (ALT)
In 11 pooled placebo-controlled trials of Reglidib, 1.9% of Reglidib-treated patients and 0.8% of placebo-treated patients developed serum ALT greater than 2 times the upper limit of the reference range.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Reglidib. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Serious hypersensitivity reactions, including anaphylaxis, angioedema, and Stevens-Johnson Syndrome
- Hemolytic anemia in patients with and without G6PD deficiency
- Impairment of liver function (e.g. with cholestasis and jaundice), as well as hepatitis, which may progress to liver failure.
- Porphyria cutanea tarda, photosensitivity reactions and allergic vasculitis
- Leukopenia, agranulocytosis, aplastic anemia, and pancytopenia
- Thrombocytopenia (including severe cases with platelet count less than 10,000/μL) and thrombocytopenic purpura
- Hepatic porphyria reactions and disulfiram-like reactions
- Hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIADH), most often in patients who are on other medications or who have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone
- Dysgeusia
- Alopecia
Reglidib contraindications
See also:
What is the most important information I should know about Reglidib?
Reglidib is not suitable for the treatment of insulin-dependent (type I) diabetes mellitus (eg, for the treatment of diabetics with a history of ketoacidosis), of diabetic ketoacidosis, or of diabetic precoma or coma. Reglidib must not be used in patients hypersensitive to Reglidib, other sulfonylureas, other sulfonamides, or any of the excipients (risk of hypersensitivity reactions).
No experience has been gained concerning the use of Reglidib in patients with severe impairment of liver function and in dialysis patients. In patients with severe impairment of renal or hepatic function, a changeover to insulin is indicated, not least to achieve optimal metabolic control.
Use in pregnancy & lactation: To avoid risk of harm to the child, Reglidib must not be taken during pregnancy; a changeover to insulin is necessary. Patients planning a pregnancy must inform their physician and should changeover to insulin. Ingestion of Reglidib with the breastmilk may harm the child. Therefore, Reglidib must not be taken by breastfeeding women. Either a changeover to insulin or a complete discontinuation of breastfeeding is necessary.
Active ingredient matches for Reglidib:
Glimepiride in Egypt.
List of Reglidib substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Redu-St (Mexico) | |
| Relide (Indonesia) | |
| Relide 2 mg x 3 x 10's (Fahrenheit) | $ 12.28 |
| Relide 4 mg x 3 x 10's (Fahrenheit) | $ 18.23 |
| RIOGLIM | |
| RIOGLIM 2 MG TABLET 1 strip / 30 tablets each (Ranbaxy Laboratories Ltd) | $ 1.80 |
| RiteMED Glimepiride (Philippines) | |
| RiteMED Glimepiride tab 2 mg 100's (RiteMED) | |
| RiteMED Glimepiride tab 3 mg 100's (RiteMED) | |
| Roname (Spain) | |
| Ronyglim | |
| Ronyglim 1mg Tablet (Ronyd Healthcare Pvt Ltd) | $ 0.04 |
| Ronyglim 2mg Tablet (Ronyd Healthcare Pvt Ltd) | $ 0.07 |
| Rui Ping (China) | |
| Saccharofar (Greece) | |
| Sandoz Glimepiride (Canada, South Africa) | |
| Sandoz Glimepiride tablet 2 mg (Sandoz Canada Incorporated (Canada)) | |
| Sandoz Glimepiride tablet 3 mg (Sandoz Canada Incorporated (Canada)) | |
| Sandoz Glimepiride tablet 4 mg (Sandoz Canada Incorporated (Canada)) | |
| Sandoz Glimepiride tablet 1 mg (Sandoz Canada Incorporated (Canada)) | |
| Sanofi Pasteur Glimepiride (Philippines) | |
| Sanprid (Turkey) | |
| SAVIPiride 2 (Vietnam) | |
| SAVIPiride 2 2 mg x 3 Blister x 10 Tablet | |
| SECRETAG (India) | |
| SECRETAG Capsule/ Tablet / 1mg / 10 units (Bal Pharma Limited) | $ 0.27 |
| SECRETAG Capsule/ Tablet / 2mg / 10 units (Bal Pharma Limited) | $ 0.52 |
| Secretag 1mg TAB / 10 (Bal Pharma Limited) | $ 0.23 |
| Secretag 2mg TAB / 10 (Bal Pharma Limited) | $ 0.45 |
| 1 mg x 10's (Bal Pharma Limited) | $ 0.23 |
| 2 mg x 10's (Bal Pharma Limited) | $ 0.45 |
| Secretag 2 mg Tablet (Bal Pharma Limited) | $ 0.05 |
| Secretag 1 mg Tablet (Bal Pharma Limited) | $ 0.03 |
| SECRETAG 1MG TABLET 1 strip / 10 tablets each (Bal Pharma Limited) | $ 0.36 |
| SECRETAG 2MG TABLET 1 strip / 10 tablets each (Bal Pharma Limited) | $ 0.72 |
| SECRETAG tab 1 mg x 10's (Bal Pharma Limited) | $ 0.23 |
| SECRETAG tab 2 mg x 10's (Bal Pharma Limited) | $ 0.45 |
| Secretag 1mg TAB / 10 (Bal Pharma Limited) | $ 0.23 |
| Secretag 2mg TAB / 10 (Bal Pharma Limited) | $ 0.45 |
| Secretag 1mg Tablet (Bal Pharma Limited) | $ 0.04 |
| Secretag 2mg Tablet (Bal Pharma Limited) | $ 0.07 |
| Secrin (Bangladesh) | |
| SEMI AMARYL | |
| SEMI AMARYL 0.5 MG TABLET 1 strip / 30 tablets each (Sanofi India Ltd) | $ 1.29 |
| Semi-Amaryl | |
| Semi-Amaryl 0.5mg Tablet (Sanofi India Ltd) | $ 0.04 |
| Sensedia (Lebanon) | |
| Shampa | |
| Shampa 1 mg Tablet (Shamsri Pharma Pvt. Ltd) | $ 0.04 |
| Shampa 2 mg Tablet (Shamsri Pharma Pvt. Ltd) | $ 0.07 |
| Shampa MF | |
| Shampa MF 1+500 Tablet (Shamsri Pharma Pvt. Ltd) | $ 0.05 |
| Shampa MF 2+500 Tablet (Shamsri Pharma Pvt. Ltd) | $ 0.07 |
See 3475 substitutes for Reglidib | |
References
- DailyMed. "GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE: 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).
- PubChem. "glimepiride". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "glimepiride". http://www.drugbank.ca/drugs/DB00222 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Reglidib 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 Reglidib. 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 useful
No survey data has been collected yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
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Information checked by Dr. Sachin Kumar, MD Pharmacology
