Treatment of non-insulin-dependent diabetes, in addition to the diet, as monotherapy and in combination with other antidiabetic therapies

The recommended starting dose is 1 tablet 50 mg 3 times daily (use ACARBOSE ARROW 50 mg tablet).
Depending on the effect on glycemic parameters, the dose may be increased to 100 mg 3 times a day.
In rare cases, the dose may be increased to 200 mg, 3 times a day.
The acarbose tablets should be swallowed with a little water at the beginning of the meals or crunched with the first bites.

No information in the marketing authorization.

Pharmacotherapeutic group: ALPHA INHIBITORS - GLUCOSIDASE

ATC code: A10BF01.

Acarbose is a pseudotetrasaccharide, of microbial origin. At the brush border of the intestine, acarbose acts by competitive inhibition of alpha-glucosidases. It thus reduces the degradation of carbohydrates (dioligo- and polysaccharides) and of absorbable monosaccharides. Acarbose therefore decreases, postprandial hyperglycemia, without causing hyperinsulinemia or weight modification.

A multicenter, randomized, double-blind, placebo-controlled study evaluated the effects of acarbose on 1429 subjects at risk for developing type 2 diabetes. After a follow-up of an average duration of 3 , 3 years, 32% of patients in the acarbose group developed diabetes, versus 42% in the placebo group (statistically significant difference), but three months after discontinuation of treatment; Diabetes was similar in both treatment groups.

The clinical benefit of long-term results is not known.


Not applicable.

· Hypersensitivity to acarbose or to any of the constituents

· In the absence of data in children, this medicinal product should not be administered to children under the age of 15.

Gastrointestinal: because of its possible effects, undesirable digestive, acarbose should not be prescribed in case of

O Chronic diseases associating digestion and absorption disorders

O chronic inflammatory bowel disease

O major intestinal hernia

O history of sub-occlusive syndromes

• Severe renal impairment: In the absence of data in patients with severe renal impairment, acarbose should not be used in patients with clearance, creatinine
What to do

The re-equilibration of diabetes makes it possible to standardize the course of pregnancy in this category of patients.

It is imperative to appeal to insulin, irrespective of the type of diabetes, I or II, gestational or permanent.

In the latter case it is advisable to stop treatment with acarbose and to take over from insulin as soon as pregnancy is contemplated or in case of discovery pregnancy Exposed to this drug: in this case, this does not constitute the systematic argument for advising a termination of pregnancy but leads to an attitude of caution and a prenatal-oriented surveillance.

Neonatal blood glucose monitoring is recommended.

Breastfeeding

This medication is contraindicated in case of breast-feeding.
Gastrointestinal disorders

Gastrointestinal symptoms, flatulence, meteorism, dyspepsia, diarrhea, nausea and abdominal pain

These symptoms depend on the dosage and diet. These effects decrease, usually during treatment. They decrease, also when the prescribed hypoglucidal diet is respected. If the symptoms persist, the dosage should be temporarily or permanently reduced.


Hepatic reactions: Transient increase in liver enzymes, jaundice (see section 4.4) Warning and precautions for use
Undesirable effects from pharmacovigilance reports (unknown frequency)

Gastrointestinal disorders: occlusions, subocclusions, intestinal cystic pneumatosis (see Warnings and precautions for use.)

· Hepato-biliary disorders: hepatitis, potentially serious

· Skin and subcutaneous tissue disorders, skin reactions (rash, erythema, exanthema, urticaria)

Treatment of non-insulin-dependent diabetes, in addition to the diet, as monotherapy and in combination with other antidiabetic therapies