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Avandaryl 4mg/4mg 14 tabs, Rosiglitazona & Glimepirida

THIS IS A BRAND MEDICATION

THERAPEUTIC INDICATIONS: AVANDARYL ® is indicated as an adjunct to diet and exercise to treat type 2 diabetes mellitus (diabetes mellitus insulin-dependent).

AVANDARYL ® is indicated as initial therapy to improve glycemic control in patients with type 2 diabetes mellitus who are not adequately controlled by diet or exercise alone.

AVANDARYL ® is also indicated for glycemic control in patients with type 2 diabetes mellitus who are not adequately controlled by a thiazolidinedione or a sulfonylurea alone or for those who are already treated with a combination of a thiazolidinedione and a sulfonylurea.

CONTRAINDICATIONS: AVANDARYL ® is contraindicated in patients with a history of hypersensitivity to rosiglitazone, glimepiride, other sulfonylureas or sulfonamides, or any other ingredients of the preparation.

CAUTIONS:

Diabetes mellitus type 1: AVANDARYL ® is effective only in the presence of insulin, which should not be used in the treatment of type 1 diabetes mellitus.

Premenopausal anovulatory women: Due to the ability of rosiglitazone to improve insulin sensitivity, treatment with AVANDARYL ® in anovulatory premenopausal women with insulin resistance (eg, patients with polycystic ovarian syndrome) may result in restoration ovulation. These patients may be at risk of pregnancy (see Restrictions on use during pregnancy and lactation, precautions in relation to terms of carcinogenicity, mutagenicity, teratogenicity and fertility).

DOSAGE AND ADMINISTRATION: Oral.

AVANDARYL ® therapy should be individualized in each patient.

AVANDARYL ® should be taken once a day, along with food.

Populations:

Adults:

AVANDARYL ® as initial therapy: The usual starting dose of Avandaryl ® is 4 mg / 1 mg administered once a day.

AVANDARYL ® as second-line therapy: The usual starting dose of Avandaryl ® is 4 mg / l mg or 4 mg / 2 mg, administered once a day.

- When switching a patient from pre-treatment with oral antidiabetic agents with AVANDARYL ® therapy, you should take into account the potency and duration of action of previously administered anti-diabetic agent. It should also consider the control / patient's current glycemic status and risk of hypoglycemia (see WARNINGS).

- When changing the patient a combination therapy with rosiglitazone plus glimepiride, administered in separate tablets, the usual starting dose of Avandaryl ® should be based on the doses of rosiglitazone and glimepiride already being taken.

You can increase the daily dose of Avandaryl ® to maintain the patient's glycemic control. The dose of Avandaryl ® can be adjusted by stepwise titration of 4 mg / day, rosiglitazone component and up to 2 mg / day for the glimepiride component. The adjustment range of doses should be individualized according to each patient's response. It is possible that the full effect resulting from the adjustment of doses is not evident during the first six to eight weeks for the rosiglitazone component, or during the first week or two for the glimepiride component.The dose should be titrated to a maximum recommended total daily dose of 8 mg of rosiglitazone /
8 mg of glimepiride. Should be subjected to careful upward titration component rosiglitazone 8 mg / day, after making appropriate clinical evaluation to assess patient risk of adverse effects related to fluid retention (see WARNINGS and ADVERSE REACTIONS) .

It is possible to decrease the requirements of glimepiride during treatment. In case of hypoglycemia, consider the need to reduce the dose of glimepiride or suspend the therapy itself.

When AVANDARYL ® is coadministered with certain drugs, may be necessary to adjust the dose of rosiglitazone or glimepiride component (see PRECAUTIONS, Drug Interactions and other support, Pharmacokinetics and pharmacodynamics in humans).

AVANDARYL ® in patients with heart failure of mild to moderate: In patients with heart failure of mild to moderate (class I or II NYHA), start the dose of the rosiglitazone component 4 mg / day.

Should be subjected to careful upward titration component rosiglitazone 8 mg / day, after making appropriate clinical evaluation to assess patient risk of adverse effects related to fluid retention (see PRECAUTIONS, ADVERSE REACTIONS, Clinical Studies).

• Children: No data are available to support the use of Avandaryl ® in children under 18 years of age. It is therefore not recommended for use in this age group.

• Elderly: The initial and maintenance dose of Avandaryl ® should be conservative in elderly patients because of the potential decline of renal function in this population. Before making any adjustment in the dosage of glimepiride component, one must take into account the patient's renal function (see PRECAUTIONS, Pharmacokinetics and pharmacodynamics in humans special patient populations).

• Renal impairment: Renal impairment of mild or moderate (creatinine clearance 30 to 80 ml / min).

- In patients who have not previously received any treatment with a sulfonylurea, the recommended starting dose of glimepiride component is 1 mg. If you require any degree, the dose of glimepiride component should be handled carefully and based on the glycemic control of individuals.

- Patients who switch to a therapy with rosiglitazone, glimepiride, after having been treated with other sulfonylureas, may be at increased risk of developing hypoglycemia. Are recommended adequate supervision (see Precautions).

In patients with severe renal impairment (creatinine clearance below 30 ml / min), Avandaryl ® should be used with caution at a recommended dose of 1 mg glimepiride for the component (see PRECAUTIONS, Pharmacokinetics and pharmacodynamics in humans-Stocks Special patient).

There are no data on the use of glimepiride renal dialysis (see PRECAUTIONS, Manifestations and management of overdose or accidental intake, Pharmacokinetics and pharmacodynamics in humans, special patient populations).

• Hepatic impairment: In patients with mild hepatic impairment (Child class-Pugh scores less than or equal to 6), it is necessary to adjust the dosage of rosiglitazone. Due to a difference in the pharmacokinetic profile is not recommended the use of rosiglitazone in patients with moderate hepatic impairment to severe (Class BC Child-Pugh scores greater than 6).

There are no adequate data to support the use of glimepiride in patients with liver failure.

Therefore, we do not recommend the use of Avandaryl ® in patients with impaired liver function (see PRECAUTIONS, Pharmacokinetics and pharmacodynamics in humans-patient populations
Name of medicine: Avandaryl
Comparable patent medicine: Avandaryl
Active ingredient: Rosiglitazone / Glimepiride
Presentation: Tablets
Concentration: 4mg/4mg
Extended-release tablets: No
Lab: GlaxoSmithKline Mexico, SA de CV
Box with 14 tab
Made in: U. S.