Gluvas Uses

• Gluvas indications
• Uses of Gluvas in details
• Gluvas description
• Gluvas dosage
• Gluvas interactions
• Gluvas side effects
• Gluvas contraindications

What is Gluvas?

Gluvas 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 Gluvas 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 Gluvas 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.

Gluvas is available only with your doctor's prescription.

Gluvas indications

NIKP-Gluvas 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-Gluvas 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 Gluvas?

Use Gluvas as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Gluvas by mouth with breakfast or the first main meal of the day unless your doctor tells you otherwise.
• Gluvas works best if it is taken at the same time each day.
• Continue to take Gluvas even if you feel well. Do not miss any doses.
• If you miss a dose of Gluvas, 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 Gluvas.

Uses of Gluvas in details

Gluvas is used to lower the blood sugar levels in type 2 diabetes mellitus when diet, physical exercise and weight reduction alone are not adequate.

Gluvas description

Each tablet contains the following colourants: Gluvas 1 mg: Ferric oxide (red); Gluvas 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.

Gluvas dosage

Always take NIKP-Gluvas 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 Gluvas + metformin or of Gluvas + insulin may be initiated. In such case, the physician will determine the proper doses of Gluvas, 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-Gluvas 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-Gluvas until the physician tells the patient to stop.

Administration: Take NIKP-Gluvas by mouth, just before or with the 1st main meal of the day (usually breakfast). If the patient does not take breakfast, take NIKP-Gluvas as prescribed by the physician. It is important not to leave out any meal when the patient is on NIKP-Gluvas.

Swallow the tablet whole with at least ½ glass of water. Do not crush or chew the tablets.

Gluvas interactions

See also:
What other drugs will affect Gluvas?

Drug-Drug Interactions: Increased blood glucose lowering effect of Gluvas can occur when NIKP-Gluvas 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 Gluvas can occur when NIKP-Gluvas 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 Gluvas can occur when NIKP-Gluvas 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-Gluvas tablet 3 mg.

Drug-Food Interactions: Both acute and chronic alcohol intake may increase or decrease the blood glucose lowering action of Gluvas 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.

Gluvas side effects

See also:
What are the possible side effects of Gluvas?

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 Gluvas in the controlled clinical trials. In these trials, approximately 1,700 patients were treated with Gluvas 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 Gluvas-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 Gluvas-treated Patients and at a Greater Incidence than with Placebo*

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 Gluvas 1 mg, 4 mg, 8 mg or placebo. Patients randomized to Gluvas 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 Gluvas 1 mg, 17% for Gluvas 4 mg, 16% for Gluvas 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 Gluvas or placebo daily. The dose of Gluvas was titrated to a target fasting plasma glucose of 90–150 mg/dL. Final daily doses of Gluvas were 1, 2, 3, 4, 6 or 8 mg. The overall incidence of possible hypoglycemia (as defined above for the 14-week trial) for Gluvas vs. placebo was 19.7% vs. 3.2%. All of these events were selftreated.

Weight Gain

Gluvas, 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 Gluvas-treated patients. These may resolve despite continued treatment with Gluvas. 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 Gluvas, 1.9% of Gluvas-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 Gluvas. 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

Gluvas contraindications

See also:
What is the most important information I should know about Gluvas?

Gluvas 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. Gluvas must not be used in patients hypersensitive to Gluvas, other sulfonylureas, other sulfonamides, or any of the excipients (risk of hypersensitivity reactions).

No experience has been gained concerning the use of Gluvas 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, Gluvas 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 Gluvas with the breastmilk may harm the child. Therefore, Gluvas must not be taken by breastfeeding women. Either a changeover to insulin or a complete discontinuation of breastfeeding is necessary.

Active ingredient matches for Gluvas:

Glimepiride in Indonesia.

References

1. 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).
2. PubChem. "glimepiride". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "glimepiride". http://www.drugbank.ca/drugs/DB00222 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology