AVANDIA 2MG- rosiglitazone maleate tablet, film coated AVANDIA 4MG- rosiglitazone maleate tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

ROSIGLITAZONE MALEATE (UNII: KX2339DP44) (ROSIGLITAZONE - UNII:05V02F2KDG)

Commercializzato da:

GlaxoSmithKline LLC

INN (Nome Internazionale):

ROSIGLITAZONE MALEATE

Composizione:

ROSIGLITAZONE 2 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

AVANDIA is a thiazolidinedione antidiabetic agent indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Risk Summary Limited data with AVANDIA in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations) . In animal reproduction studies, no adverse developmental effects were observed when rosiglitazone was administered to pregnant rats and rabbits during organogenesis at exposures up to 4 times the maximum recommended human dose (MRHD) of 8 mg daily (see Data). The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20% to 25% in women with a HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the

Dettagli prodotto:

Each pentagonal film-coated TILTAB tablet contains rosiglitazone as the maleate as follows: 2 mg: pink, debossed with GSK on one side and 2 on the other; bottles of 60: NDC 0173-0861-18 4 mg: orange, debossed with GSK on one side and 4 on the other; bottles of 30: NDC 0173-0863-13. Store at 25°C (77°F); excursions 15° to 30°C (59° to 86°F). Dispense in a tight, light-resistant container.

Stato dell'autorizzazione:

New Drug Application

Foglio illustrativo

AVANDIA 4MG- ROSIGLITAZONE MALEATE TABLET, FILM COATED
GlaxoSmithKline LLC
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MEDICATION GUIDE
AVANDIA (ah-VAN-dee-a)
(rosiglitazone maleate tablets), for oral use
What is the most important information I should know about AVANDIA?
AVANDIA may cause serious side effects, including:
New or worse heart failure
•
The risk of heart failure may be higher in people who take AVANDIA
with insulin. Most people
who take insulin should not also take AVANDIA.
•
AVANDIA can cause your body to keep extra fluid (fluid retention),
which leads to swelling
(edema) and weight gain. Extra body fluid can make some heart problems
worse or lead to heart
failure. Heart failure means your heart does not pump blood well
enough.
•
If you have severe heart failure, you cannot start AVANDIA.
•
If you have heart failure with symptoms (such as shortness of breath
or swelling), even if these
symptoms are not severe, AVANDIA may not be right for you.
Call your doctor right away if you have any of the following:
•
swelling or fluid retention, especially in the ankles or legs
•
shortness of breath or trouble breathing, especially when you lie down
•
an unusually fast increase in weight
•
unusual tiredness
AVANDIA can have other serious side effects. Be sure to read the
section below “What are possible side
effects of AVANDIA?”
What is AVANDIA?
AVANDIA is a prescription medicine used with diet and exercise to
treat adults with type 2 (“adult-
onset” or “non-insulin dependent”) diabetes mellitus (“high
blood sugar”).
AVANDIA helps to control high blood sugar. AVANDIA may be used alone
or with other diabetes
medicines. AVANDIA can help your body respond better to insulin made
in your body. AVANDIA does
not cause your body to make more insulin.
AVANDIA is not for people with type 1 diabetes mellitus or to treat a
condition called diabetic
ketoacidosis.
It is not known if AVANDIA is safe and effective in children younger
than 18 years old.
Who should not take AVANDIA?
Many people with heart failure should not sta

Scheda tecnica

AVANDIA 2MG- ROSIGLITAZONE MALEATE TABLET, FILM COATED
AVANDIA 4MG- ROSIGLITAZONE MALEATE TABLET, FILM COATED
GLAXOSMITHKLINE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AVANDIA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AVANDIA.
AVANDIA (ROSIGLITAZONE MALEATE TABLETS), FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
WARNING: CONGESTIVE HEART FAILURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
INDICATIONS AND USAGE
AVANDIA is a thiazolidinedione antidiabetic agent indicated as an
adjunct to diet and exercise to improve
glycemic control in adults with type 2 diabetes mellitus. (1)
Important Limitations of Use:
•
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Pentagonal, film-coated tablets in the following strengths: 2 mg and 4
mg (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
THIAZOLIDINEDIONES, INCLUDING ROSIGLITAZONE, CAUSE OR EXACERBATE
CONGESTIVE HEART
FAILURE IN SOME PATIENTS (5.1). AFTER INITIATION OF AVANDIA, AND AFTER
DOSE
INCREASES, OBSERVE PATIENTS CAREFULLY FOR SIGNS AND SYMPTOMS OF HEART
FAILURE
(INCLUDING EXCESSIVE, RAPID WEIGHT GAIN; DYSPNEA; AND/OR EDEMA). IF
THESE SIGNS
AND SYMPTOMS DEVELOP, THE HEART FAILURE SHOULD BE MANAGED ACCORDING TO
CURRENT
STANDARDS OF CARE. FURTHERMORE, DISCONTINUATION OR DOSE REDUCTION OF
AVANDIA
MUST BE CONSIDERED.
AVANDIA IS NOT RECOMMENDED IN PATIENTS WITH SYMPTOMATIC HEART FAILURE.
INITIATION
OF AVANDIA IN PATIENTS WITH ESTABLISHED NYHA CLASS III OR IV HEART
FAILURE IS
CONTRAINDICATED. (4, 5.1)
AVANDIA should not be used in patients with type 1 diabetes mellitus
or for the treatment of diabetic
ketoacidosis. (1)
Coadministration of AVANDIA and insulin is not recommended. (1, 5.1,
5.2)
Start at 4 mg daily in single or divided doses; do not exceed 8 mg
daily. (2)
Dose increases should be accompanied by careful monitoring for adverse
events related to fluid
retention. (2)
Do not initiate AVANDIA if the patient e