Glybofen Uses

• Glybofen indications
• Glybofen description
• Glybofen dosage
• Glybofen interactions
• Glybofen side effects
• Glybofen contraindications

Glybofen indications

This anti-diabetic medication is a combination of 2 drugs (glyburide and Metformin (Glybofen)). It is used along with a diet and exercise program to control high blood sugar in patients with type 2 diabetes (non-insulin-dependent diabetes).Glyburide is a sulfonylurea and works by stimulating the release of your body’s natural insulin and by decreasing the amount of sugar that your liver makes. Metformin (Glybofen) is a biguanide and works by decreasing the amount of sugar that your liver makes and that your stomach/intestines absorb.

Glybofen description

Each 500/2.5-mg and 500/5-mg film-coated tablet contains 500 mg Metformin (Glybofen) HCl equivalent to Metformin (Glybofen) 390 mg, and Glibenclamide (Glybofen) 2.5 mg and 5 mg, respectively.

Glybofen dosage

General: As for all hypoglycemic agents, the dosage should be adapted according to the individual metabolic response (glycemia, HbA1c).

Initiation of Treatment: Treatment should be initiated with a dose of the combination product equivalent to previous individual doses of Metformin (Glybofen) and Glibenclamide (Glybofen); the dose being gradually increased depending on results on glycemic parameters.

Dosage Regimen: The dosage regimen depends on the individual posology: Once a Day: Morning at breakfast, 1 tab/day.

Twice a Day: Morning and evening, 2 or 4 tab/day.

Three Times a Day: Morning, noon and evening, for a dosage of 3, 5 or 6 tab/day (500 mg/2.5 mg film-coated tablets) or 3 tab/day (500 mg/5 mg film-coated tablets).

Dose Titration: The dosage should be adjusted every 2 weeks or longer, by increments of 1 tab, depending on glycemia results. A gradual increase in the dosage may aid gastrointestinal tolerance and prevent the onset of hypoglycemia.

Maximum Daily Recommended Dose: 500/2.5-mg film-coated tablets: 6 tab; 500/5-mg film-coated tablets: 3 tab. In exceptional cases, an increase up to 4 tab may be recommended.

Combination with Insulin Therapy: No clinical data are available on the concomitant use of Glybofen with insulin therapy.

Elderly: The dosage of Metformin (Glybofen)/Glibenclamide (Glybofen) should be adjusted depending on renal function parameters [start with 1 tab of Metformin (Glybofen) 500 mg/Glibenclamide (Glybofen) 2.5 mg; regular checks on the renal function are necessary ].

Administration: The tablets should be taken with meals. The dosage regimen should be adjusted according to the individual eating habits. However, any intake must be followed by a meal with a sufficiently high carbohydrate content to prevent the onset of hypoglycemic episodes.

Glybofen interactions

You may be more likely to have hyperglycemia (high blood sugar) if you are taking Metformin (Glybofen) with other drugs that raise blood sugar. Drugs that can raise blood sugar include:

isoniazid;

diuretics (water pills);

steroids (prednisone and others);

phenothiazines (Compazine and others);

thyroid medicine (Synthroid and others);

birth control pills and other hormones;

seizure medicines (Dilantin and others); and

diet pills, or medicines to treat asthma, colds or allergies.

You may be more likely to have hypoglycemia (low blood sugar) if you are taking Metformin (Glybofen) with other drugs that lower blood sugar. Drugs that can lower blood sugar include:

some nonsteroidal anti-inflammatory drugs (NSAIDs);

aspirin or other salicylates (including Pepto-Bismol);

sulfa drugs (Bactrim and others);

a monoamine oxidase inhibitor (MAOI);

beta-blockers (Tenormin and others); or

probenecid (Benemid).

Some medications may interact with Metformin (Glybofen). Tell your doctor if you are using any of the following drugs:

furosemide (Lasix);

nifedipine (Adalat, Procardia);

cimetidine (Tagamet) or ranitidine (Zantac);

amiloride (Midamor) or triamterene (Dyrenium);

digoxin (Lanoxin);

morphine (MS Contin, Kadian, Oramorph);

procainamide (Procan, Pronestyl, Procanbid);

quinidine (Cardioquin, Quinidex, Quinaglute);

trimethoprim (Proloprim, Primsol, Bactrim, Cotrim, Septra); or

vancomycin (Vancocin, Lyphocin).

This list is not complete and there may be other drugs that can interact with Metformin (Glybofen). Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugsprescribed by other doctors. Do not start using a new medication without telling your doctor.

Glybofen side effects

Nausea, stomach upset, diarrhea, or weight gain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If stomach symptoms return later (after you are on the same dose for several days or weeks), tell your doctor immediately. Stomach symptoms that occur after the first days of your treatment may be a sign of lactic acidosis. Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, signs of infection (e.g., persistent sore throat, fever), persistent nausea, severe stomach/abdominal pain, yellowing eyes/skin, dark urine. This medication may cause low blood sugar (hypoglycemia), especially if you take other medications for diabetes, drink large amounts of alcohol, do unusually heavy exercise, or do not consume enough calories from food. Symptoms include cold sweat, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, headache, fainting, tingling of the hands/feet, and hunger. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Glybofen contraindications

Hypersensitivity to Metformin (Glybofen) HCl, Glibenclamide (Glybofen), or other sulfonylureas and sulfonamides, or to any of the excipients of Glybofen.

Type 1 diabetes (insulin-dependent diabetes), ketoacidosis, diabetic pre-coma. Renal failure or renal dysfunction (CrCl <60 mL/min). Acute conditions with the potential to alter renal function eg, dehydration, severe infection, shock or intravascular administration of iodinated contrast materials. Acute or chronic disease which may cause tissue hypoxia eg, cardiac or respiratory failure, recent myocardial infarction, shock. Hepatic insufficiency, acute alcohol intoxication, alcoholism; porphyria; and concurrent miconazole treatment.

Use in lactation: Metformin (Glybofen) is excreted in the milk of lactating rats. In humans, in the absence of data concerning passage of Metformin (Glybofen) and Glibenclamide (Glybofen) into the breast milk, and in view of the risk of neonatal hypoglycemia, Glybofen is contraindicated while breastfeeding.

Active ingredient matches for Glybofen:

Glibenclamide/Metformin in Egypt.

References

1. DailyMed. "GLYBURIDE; METFORMIN 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. "metformin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. PubChem. "Glibenclamide". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology