Finished product reference
Acarbose
Tablet · Oral · 50 mg
- List code
- 2016
- Pharmacologic class
- alpha-Glucosidase Inhibitor
What it is and how it works
Mechanism class: alpha Glucosidase Inhibitors
Indications
INDICATIONS AND USAGE Acarbose tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Dosage and administration (summary)
DOSAGE AND ADMINISTRATION There is no fixed dosage regimen for the management of diabetes mellitus with acarbose tablets or any other pharmacologic agent. Dosage of acarbose tablets must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended dose of 100 mg t.i.d. Acarbose tablets should be taken three times daily at the start (with the first bite) of each main meal.
Contraindications
CONTRAINDICATIONS Acarbose tablets are contraindicated in patients with known hypersensitivity to the drug. Acarbose tablets are contraindicated in patients with diabetic ketoacidosis or cirrhosis. Acarbose tablets are also contraindicated in patients with inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction.
Pregnancy
Pregnancy Teratogenic Effects: Pregnancy Category B. The safety of acarbose tablets in pregnant women has not been established. Reproduction studies have been performed in rats at doses up to 480 mg/kg (corresponding to 9 times the exposure in humans, based on drug blood levels) and have revealed no evidence of impaired fertility or harm to the fet…
Storage and supply
HOW SUPPLIED Acarbose Tablets, USP are supplied as follows: For 50 mg: White to yellow-tinged, round, biconvex tablets, debossed with "HP" and "148" on one side and plain on other side. NDC: 71335-9725-1: 30 Tablets in a BOTTLE NDC: 71335-9725-2: 90 Tablets in a BOTTLE NDC: 71335-9725-3: 100 Tablets in a BOTTLE Store at 20o to 25oC (68oto 77oF) .
Source: Acarbose (Acarbose) — US FDA prescribing information, 2026-07-16, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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