What is Friladar?
Friladar 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 Friladar 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 Friladar 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.
Friladar is available only with your doctor's prescription.
Friladar indications
NIKP-Friladar 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-Friladar 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 Friladar?
Use Friladar as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Friladar by mouth with breakfast or the first main meal of the day unless your doctor tells you otherwise.
- Friladar works best if it is taken at the same time each day.
- Continue to take Friladar even if you feel well. Do not miss any doses.
- If you miss a dose of Friladar, 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 Friladar.
Uses of Friladar in details
Friladar is used to lower the blood sugar levels in type 2 diabetes mellitus when diet, physical exercise and weight reduction alone are not adequate.
Friladar description
Each tablet contains the following colourants: Friladar 1 mg: Ferric oxide (red); Friladar 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.
Friladar dosage
Always take NIKP-Friladar 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 Friladar + metformin or of Friladar + insulin may be initiated. In such case, the physician will determine the proper doses of Friladar, 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-Friladar 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-Friladar until the physician tells the patient to stop.
Administration: Take NIKP-Friladar by mouth, just before or with the 1st main meal of the day (usually breakfast). If the patient does not take breakfast, take NIKP-Friladar as prescribed by the physician. It is important not to leave out any meal when the patient is on NIKP-Friladar.
Swallow the tablet whole with at least ½ glass of water. Do not crush or chew the tablets.
Friladar interactions
See also:
What other drugs will affect Friladar?
Drug-Drug Interactions: Increased blood glucose lowering effect of Friladar can occur when NIKP-Friladar 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 Friladar can occur when NIKP-Friladar 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 Friladar can occur when NIKP-Friladar 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-Friladar tablet 3 mg.
Drug-Food Interactions: Both acute and chronic alcohol intake may increase or decrease the blood glucose lowering action of Friladar 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.
Friladar side effects
See also:
What are the possible side effects of Friladar?
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 Friladar in the controlled clinical trials. In these trials, approximately 1,700 patients were treated with Friladar 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 Friladar-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 Friladar-treated Patients and at a Greater Incidence than with Placebo*
| Friladar 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 Friladar 1 mg, 4 mg, 8 mg or placebo. Patients randomized to Friladar 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 Friladar 1 mg, 17% for Friladar 4 mg, 16% for Friladar 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 Friladar or placebo daily. The dose of Friladar was titrated to a target fasting plasma glucose of 90–150 mg/dL. Final daily doses of Friladar were 1, 2, 3, 4, 6 or 8 mg. The overall incidence of possible hypoglycemia (as defined above for the 14-week trial) for Friladar vs. placebo was 19.7% vs. 3.2%. All of these events were selftreated.
Weight Gain
Friladar, 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 Friladar-treated patients. These may resolve despite continued treatment with Friladar. 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 Friladar, 1.9% of Friladar-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 Friladar. 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
Friladar contraindications
See also:
What is the most important information I should know about Friladar?
Friladar 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. Friladar must not be used in patients hypersensitive to Friladar, other sulfonylureas, other sulfonamides, or any of the excipients (risk of hypersensitivity reactions).
No experience has been gained concerning the use of Friladar 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, Friladar 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 Friladar with the breastmilk may harm the child. Therefore, Friladar must not be taken by breastfeeding women. Either a changeover to insulin or a complete discontinuation of breastfeeding is necessary.
Active ingredient matches for Friladar:
Glimepiride in Indonesia.
| Unit description / dosage (Manufacturer) | Price, USD |
| Friladar 2 mg x 3 x 10's | |
| Friladar 3 mg x 3 x 10's | |
List of Friladar substitutes (brand and generic names): | |
| Flodilan 4 (Vietnam) | |
| Flodilan 4 2 Blister x 14 Tablet | |
| G Tase G | |
| G Tase G 15+2 Vencare Formulations Tablet (Vencare Formulations Pvt Ltd) | $ 0.04 |
| G Tase G 1+15 Tablet (Vencare Formulations Pvt Ltd) | $ 0.03 |
| G Tase G 15+1 Unisearch Tablet (Vencare Formulations Pvt Ltd) | $ 0.04 |
| G Tase G 15+2 Unichem Labs Tablet (Vencare Formulations Pvt Ltd) | $ 0.04 |
| G Tase G 15+1 Vencare Formulations Tablet (Vencare Formulations Pvt Ltd) | $ 0.03 |
| G TASE G 15 MG/1 MG TABLET 1 strip / 10 tablets each (Vencare Formulations Pvt Ltd) | $ 0.39 |
| G TASE G 15 MG/2 MG TABLET 1 strip / 10 tablets each (Vencare Formulations Pvt Ltd) | $ 0.49 |
| G Tase G 15 mg/1 mg Tablet (Vencare Formulations Pvt Ltd) | $ 0.04 |
| G Tase G 15 mg/2 mg Tablet (Vencare Formulations Pvt Ltd) | $ 0.05 |
| G-Helix (Pakistan) | |
| G-Pride (Oman) | |
| G-Pride 1mg (Oman) | |
| G-Pride 2mg (Oman) | |
| G-Pride 3mg (Oman) | |
| G-Pride 4mg (Oman) | |
| G-Tab (India) | |
| G-Tab 1mg TAB / 10 (Nostrum) | $ 0.29 |
| G-Tab 2mg TAB / 10 (Nostrum) | $ 0.39 |
| G-TAB tab 1 mg x 10's (Nostrum) | $ 0.41 |
| G-TAB tab 2 mg x 10's (Nostrum) | $ 0.51 |
| G-Tab Forte (India) | |
| G-Tab Forte Glimepiride 2 mg, metformin/ SR 500 mg. TAB / 10 (Nostrum) | $ 0.81 |
| G-TAB FORTE tab 10's (Nostrum) | $ 0.81 |
| G-Tab M (India) | |
| G-Tab M Glimepiride 1 mg, metformin/ SR 500 mg. TAB / 10 (Nostrum) | $ 0.59 |
| G-TAB M tab 10's (Nostrum) | $ 0.59 |
| G1 | |
| G1 1 mg Tablet (Oscar Remedies Pvt. Ltd.) | $ 0.03 |
| G2 MF | |
| G2 MF 2+500 Tablet (Welbe Life Sciences) | $ 0.05 |
| Gadz (India) | |
| Gadz 1mg TAB / 10 (Xeena (Aamorb Pharmaceuticals Pvt Ltd)) | $ 0.18 |
| Gadz 2mg TAB / 10 (Xeena (Aamorb Pharmaceuticals Pvt Ltd)) | $ 0.32 |
| 1 mg x 10's (Xeena (Aamorb Pharmaceuticals Pvt Ltd)) | $ 0.18 |
| 2 mg x 10's (Xeena (Aamorb Pharmaceuticals Pvt Ltd)) | $ 0.32 |
| Gadz 1 mg Tablet (Xeena (Aamorb Pharmaceuticals Pvt Ltd)) | $ 0.02 |
| Gadz 2 mg Tablet (Xeena (Aamorb Pharmaceuticals Pvt Ltd)) | $ 0.03 |
| GADZ 1MG TABLET 1 strip / 10 tablets each (Xeena (Aamorb Pharmaceuticals Pvt Ltd)) | $ 0.18 |
| GADZ 2MG TABLET 1 strip / 10 tablets each (Xeena (Aamorb Pharmaceuticals Pvt Ltd)) | $ 0.32 |
| GADZ tab 1 mg x 10's (Xeena (Aamorb Pharmaceuticals Pvt Ltd)) | $ 0.30 |
| GADZ tab 2 mg x 10's (Xeena (Aamorb Pharmaceuticals Pvt Ltd)) | $ 0.46 |
| Gadz 1mg Tablet (Xeena (Aamorb Pharmaceuticals Pvt Ltd)) | $ 0.02 |
| Gadz 2mg Tablet (Xeena (Aamorb Pharmaceuticals Pvt Ltd)) | $ 0.03 |
| GALA G | |
| GALA G 1 MG TABLET 1 strip / 10 tablets each (Kinesis Pharmaceuticals Pvt Ltd) | $ 0.31 |
| GALA G 2 MG TABLET 1 strip / 10 tablets each (Kinesis Pharmaceuticals Pvt Ltd) | $ 0.55 |
| GALA G 3 MG TABLET 1 strip / 10 tablets each (Kinesis Pharmaceuticals Pvt Ltd) | $ 0.56 |
| GALA G 4 MG TABLET 1 strip / 10 tablets each (Kinesis Pharmaceuticals Pvt Ltd) | $ 0.67 |
See 3474 substitutes for Friladar | |
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 Friladar 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 Friladar. 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
