Drug Interaction:
Interacting drugs- summary
+ Acarbose
Digestive enymes - effect of acarbose reduced. Do not use concomittamtly
Charcoal - effect of acarbose reduced. Do not use concomittantly.
Acarbose may enhance hypoglycemic action of antidiabetics. Dosage titration is required.
Thiazides, frusimide, corticosteroids, phenothiazine, thyroid products, oestrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics and isoniazid may counter antihyperglycemic effect of acarbose.
Monitor patients regularly. Concomittant admin of cholestyramine may enhance the effects of acarbose, particularly the reduction of postprandial insulin levels
Simultanous admin of intestinal adsorbents (charcoal) and digestive enzyme preparations (amylaes, pancreatin) may reduce the effect of acarbose and should be avoided, whenever possible.
Indication:
Adjunct to prescribed diet for management of blood glucose concentrations in non- insulin dependent diabetes melitus NIDDM patients.
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Acarbose Diabetes Bayer Group 29-09-2001
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Acarbose 25mg/50mg + 23-02-2009
Metformin 500mg/500mg FC tablets
For the treatment of patients with type II diabetes mellitus
when diet, excercise and single agent do not result in
adequate glycemic control
Adverse Reaction:
GI-
Flatulance, abdominal pain, distention, nausea, vomiting, dyspepsia,
Anorexia, tenesmus, stool discolouration, gastritis, asthenia, elevation in transaminase.
Lab test abnormalities- small reductions in hemotocrit occurred more often in acarbose treated patients than in pacebo treated patients but were not associted with reductions in hemoglobin.
Low serum calcium and low plasma Vitamin B12 levels were associated with acarbose therapy but were thought to be either spurious or of no clinical significance .
Elevated serum transaminase levels have occured .
Contra-Indications:
Hyprsensitivity to drug. Patients under 18 years.
G I disoders associated with malabsorption, ulcerative colitis & crohns disease
Special precautions:
Ingestion of sucrose and food that contains sucrose can easily lead to considerable intestinal symptoms (flatulence and bloating).
Acarbose has an antihyperglycemic effect, but does not itself induce hypoglycemia. In the event of severe hypoglycemia, IV glucose infusion, may be required.
Monitor hepatic enzyme value regularly.
Monitoring- monitor therapeutic response to acarbose by periodic blood glucose tests.
Measurement of glycosylated hemoglobin is recommended for the monitoring of long term glycemic control.
Hypoglycemia- severe hypoglycemia may require the use of IV glucose infusion or glucagon injection.
Loss of blood glucose control- when diabetic patients are exposed to stress such as fever, trauma, infection or surgery , a temporary loss of control of blood glucose may occur. At such times, temporary insulin therapy may be necessary.
Warnings
Diet /physical activity- ininitiating treatment of NIDDM, emphasize diet as the primary form of treatment.
Proper dietary management alone may be efffective in controlling blood glucose symptoms and symptoms of hyperglycemia.
Renal function impairment- long term clinical trials in diabetic patients with significant renal dysfunction , have not been conducted. Therefore treatment of these patients with acarbose is not recommended.
Pregnancy- safety and efficacy of acarbose in pregnant women has not been established.use during pregnancy only if clearly needed.
Lactation- do not administer to a nursing women.
Children- safety and efficacy have not been established
Dosages/ Overdosage Etc:
Indication:
Adjunct to prescribed diet for management of blood glucose concentrations in non-insulin dependent diabetes melitus NIDDM patients.
Dosage:
Take with 1st bite of each main meal
Initial - 50mg once daily for the first week, 50mg b.i.d for the second week, and 50mg t.i.d for the third week.
Further increase may be done after 4-8 weeks based on blood glucose reading
.Average adult dose is 100mg t.i.d upto a max of 200mg t.i.d.
Overdosage- Symptoms
Unlike sufonylureas or insulin an overdose of acarbose will not result inhypoglycemia.
An overdosage may result in transcient increases in flatulence, diarrhea, and abdominal discomfort, which shortly subside
Treatment
1. An overdosage may result in transcient increases in flatulence, diarrhea, and abdominal discomfort which shortly subside.
Other Information:
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Acarbose Diabetes Bayer Group 29-09-2001
Patient Information:
1. Tell patients to take acarbose oraly three times a day at the start (with the first bite ) of main meals.
2. It is important that patients continue to adhere to dietary instructions, a regular excercise program and regular testing of urine or blood glucose
3.Acarbose itself does not cause hypoglyemia even when administered to patients in the fasted state
4.Sulfonylurea drugs and insulin, however can lower blood sugar, enough to cause symptoms or sometime life threatening hypoglycemia.
5.Because acarbose given in combination with a sulfonylurea or insulin will cause further lowering of blood sugar, it may increase the hypoglycemic potential of these drugs
6.Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use, and no increased incidence of hypoglycemia was observed in patients when acarbose was added to metformin therapy
7. The risk of hypoglycemia its symptoms and treatment and conditions that predispose to its development should be well understood by patients and responsible family members
8. If side effects occur with acarbose they usually develop during the first few weeks of therapy. They are most commonly mild-to-moderate gastrointestinal effects such as flatulance, diarrhea, or abdominal discomfort and generally diminish in frequency and intensity with time.
Pharmacology/ Pharmacokinetics:
Pharmacology:
Acarbose is an alpha glucoside inhibitor obtained from fermentation process of actinoplanes utahensis.It is pseudotetrasaccharide that retards the digestion and absorption of carbohydrates therby reducing postgrandial glucose peaks.
Pharmacokinetics:
The drug is metabolised exclusively in the intestinal lumen and about 35% of the is absorbed as metabolites. The drug is excreted in the feces and the plasma half-life is about 2 hours.
Interaction with Food:
Take with 1st bite of each main meal
Tablets should be swallowed with a little liquid directly before a meal or chewed with the few mouthful of the meal.
Pregnancy and lactation:
Pregnancy
Safety and efficacy of acarbose in pregnant women has not been established.use during pregnancy only if clearly needed.
Lactation
Do not administer to a nursing women.
Children-
Safety and efficacy have not been established
Manufacturer Details