Acarbose (Page 3 of 3)

ADVERSE REACTIONS

Digestive Tract

Gastrointestinal symptoms are the most common reactions to acarbose. In U.S. placebo-controlled trials, the incidences of abdominal pain, diarrhea, and flatulence were 19%, 31% and 74% respectively in 1255 patients treated with acarbose 50 to 300 mg t.i.d., whereas the corresponding incidences were 9%, 12% and 29% in 999 placebo-treated patients.

In a one-year safety study, during which patients kept diaries of gastrointestinal symptoms, abdominal pain and diarrhea tended to return to pretreatment levels over time, and the frequency and intensity of flatulence tended to abate with time. The increased gastrointestinal tract symptoms in patients treated with acarbose are a manifestation of the mechanism of action of acarbose and are related to the presence of undigested carbohydrate in the lower GI tract.

If the prescribed diet is not observed, the intestinal side effects may be intensified. If strongly distressing symptoms develop in spite of adherence to the diabetic diet prescribed, the doctor must be consulted and the dose temporarily or permanently reduced.

Elevated Serum Transaminase Levels

See PRECAUTIONS.

Other Abnormal Laboratory Findings

Small reductions in hematocrit occurred more often in acarbose-treated patients than in placebo-treated patients but were not associated with reductions in hemoglobin. Low serum calcium and low plasma vitamin B 6 levels were associated with acarbose therapy but are thought to be either spurious or of no clinical significance.

Postmarketing Adverse Event Reports

Additional adverse events reported from worldwide postmarketing experience include fulminant hepatitis with fatal outcome, hypersensitive skin reactions (for example rash, erythema, exanthema and urticaria), edema, ileus/subileus, jaundice and/or hepatitis and associated liver damage, thrombocytopenia, and pneumatosis cystoides intestinalis (see PRECAUTIONS).

Pneumatosis Cystoides Intestinalis

There have been rare postmarketing reports of pneumatosis cystoides intestinalis associated with the use of alpha-glucosidase inhibitors, including acarbose. Pneumatosis cystoides intestinalis may present with symptoms of diarrhea, mucus discharge, rectal bleeding, and constipation. Complications may include pneumoperitoneum, volvulus, intestinal obstruction, intussusception, intestinal hemorrhage, and intestinal perforation. If pneumatosis cystoides intestinalis is suspected, discontinue acarbose and perform the appropriate diagnostic imaging.

OVERDOSAGE

Unlike sulfonylureas or insulin, an overdose of acarbose will not result in hypoglycemia. An overdose may result in transient increases in flatulence, diarrhea, and abdominal discomfort which shortly subside. In cases of overdosage the patient should not be given drinks or meals containing carbohydrates (polysaccharides, oligosaccharides and disaccharides) for the next 4 to 6 hours.

DOSAGE AND ADMINISTRATION

There is no fixed dosage regimen for the management of diabetes mellitus with acarbose or any other pharmacologic agent. Dosage of acarbose 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 should be taken three times daily at the start (with the first bite) of each main meal.

Acarbose should be started at a low dose, with gradual dose escalation as described below, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. If the prescribed diet is not observed, the intestinal side effects may be intensified. If strongly distressing symptoms develop in spite of adherence to the diabetic diet prescribed, the doctor must be consulted and the dose temporarily or permanently reduced.

During treatment initiation and dose titration (see below), one-hour postprandial plasma glucose may be used to determine the therapeutic response to acarbose and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both postprandial plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of acarbose, either as monotherapy or in combination with sulfonylureas, insulin or metformin.

Initial Dosage

The recommended starting dosage of acarbose is 25 mg given orally three times daily at the start (with the first bite) of each main meal. However, some patients may benefit from more gradual dose titration to minimize gastrointestinal side effects. This may be achieved by initiating treatment at 25 mg once per day and subsequently increasing the frequency of administration to achieve 25 mg t.i.d.

Maintenance Dosage

Once a 25 mg t.i.d. dosage regimen is reached, dosage of acarbose should be adjusted at 4 to 8 week intervals based on one-hour postprandial glucose or glycosylated hemoglobin levels, and on tolerance. The dosage can be increased from 25 mg t.i.d. to 50 mg t.i.d. Some patients may benefit from further increasing the dosage to 100 mg t.i.d. The maintenance dose ranges from 50 mg t.i.d. to 100 mg t.i.d. However, since patients with low body weight may be at increased risk for elevated serum transaminases, only patients with body weight > 60 kg should be considered for dose titration above 50 mg t.i.d. (see PRECAUTIONS). If no further reduction in postprandial glucose or glycosylated hemoglobin levels is observed with titration to 100 mg t.i.d., consideration should be given to lowering the dose. Once an effective and tolerated dosage is established, it should be maintained.

Maximum Dosage

The maximum recommended dose for patients ≤ 60 kg is 50 mg t.i.d. The maximum recommended dose for patients > 60 kg is 100 mg t.i.d.

Patients Receiving Sulfonylureas or Insulin

Sulfonylurea agents or insulin may cause hypoglycemia. Acarbose given in combination with a sulfonylurea or insulin will cause a further lowering of blood glucose and may increase the potential for hypoglycemia. If hypoglycemia occurs, appropriate adjustments in the dosage of these agents should be made.

HOW SUPPLIED

Acarbose Tablets, USP

25 mg tablets are supplied as round, white to off-white, biconvex tablets, debossed with product identification “54” over “311” on one side and plain on the other side.

NDC 72789-131-60:Bottle of 60 Tablets

NDC 72789-131-90: Bottle of 90 Tablets

50 mg tablets are supplied as round, white to off-white, biconvex tablets, debossed with product identification “54” over “737” on one side and plain on the other side.

NDC 72789-132-60: Bottle of 60 Tablets

NDC 72789-132-90: Bottle of 90 Tablets

100 mg tablets are supplied as round, white to off-white, biconvex tablets, debossed with product identification “54” over “251” on one side and plain on the other side.

NDC 72789-133-60: Bottle of 60 Tablets

NDC 72789-133-90: Bottle of 90 Tablets

Storage

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. For bottles, keep container tightly closed.

Package/Label Principal Display Panel

72789131 Label
(click image for full-size original)

Package/Label Principal Display Panel

72789132
(click image for full-size original)

Package/Label Principal Display Panel

72789133 Label
(click image for full-size original)
ACARBOSE
acarbose tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-131(NDC:0054-0140)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACARBOSE (ACARBOSE) ACARBOSE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 54;311
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72789-131-60 60 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:72789-131-90 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078470 05/07/2008
ACARBOSE
acarbose tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-132(NDC:0054-0141)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACARBOSE (ACARBOSE) ACARBOSE 50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 54;737
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72789-132-60 60 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:72789-132-90 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078470 05/07/2008
ACARBOSE
acarbose tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-133(NDC:0054-0142)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACARBOSE (ACARBOSE) ACARBOSE 100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color white Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 54;251
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72789-133-60 60 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:72789-133-90 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078470 05/07/2008
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (72789-131), repack (72789-132), repack (72789-133)

Revised: 09/2022 PD-Rx Pharmaceuticals, Inc.

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