Miglitol
Generic: MIGLITOL
Basic Information
Manufacturer
Proficient Rx LP
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
f16ecb50-e54e-43e1-8789-eaf5bc94f332
Indications & Usage
INDICATIONS AND USAGE Miglitol tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Adverse Reactions
ADVERSE REACTIONS Gastrointestinal Gastrointestinal symptoms are the most common reactions to miglitol tablets.
In U.S.
placebo-controlled trials, the incidences of abdominal pain, diarrhea, and flatulence were 11.7%, 28.7%, and 41.5% respectively in 962 patients treated with miglitol tablets, 25 mg to 100 mg 3 times daily, whereas the corresponding incidences were 4.7%, 10.0%, and 12.0% in 603 placebo-treated patients.
The incidence of diarrhea and abdominal pain tended to diminish with continued treatment.
Dermatologic Skin rash was reported in 4.3% of patients treated with miglitol tablets compared to 2.4% of placebo-treated patients.
Rashes were generally transient and most were assessed as unrelated to miglitol tablets by physician investigators.
Abnormal Laboratory Findings Low serum iron occurred more often in patients treated with miglitol tablets (9.2%) than in placebo-treated patients (4.2%) but did not persist in the majority of cases and was not associated with reductions in hemoglobin or changes in other hematologic indices.
Postmarketing Experience The following adverse reactions have been reported during post-approval use of miglitol tablets.
Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal Disorders: ileus (including paralytic ileus), subileus, gastrointestinal pain, nausea, abdominal distention.
• Pneumatosis Cystoides Intestinalis There have been rare postmarketing reports of pneumatosis cystoides intestinalis associated with the use of alpha-glucosidase inhibitors, including miglitol tablets.
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 miglitol tablets and perform the appropriate diagnostic imaging.
In U.S.
placebo-controlled trials, the incidences of abdominal pain, diarrhea, and flatulence were 11.7%, 28.7%, and 41.5% respectively in 962 patients treated with miglitol tablets, 25 mg to 100 mg 3 times daily, whereas the corresponding incidences were 4.7%, 10.0%, and 12.0% in 603 placebo-treated patients.
The incidence of diarrhea and abdominal pain tended to diminish with continued treatment.
Dermatologic Skin rash was reported in 4.3% of patients treated with miglitol tablets compared to 2.4% of placebo-treated patients.
Rashes were generally transient and most were assessed as unrelated to miglitol tablets by physician investigators.
Abnormal Laboratory Findings Low serum iron occurred more often in patients treated with miglitol tablets (9.2%) than in placebo-treated patients (4.2%) but did not persist in the majority of cases and was not associated with reductions in hemoglobin or changes in other hematologic indices.
Postmarketing Experience The following adverse reactions have been reported during post-approval use of miglitol tablets.
Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal Disorders: ileus (including paralytic ileus), subileus, gastrointestinal pain, nausea, abdominal distention.
• Pneumatosis Cystoides Intestinalis There have been rare postmarketing reports of pneumatosis cystoides intestinalis associated with the use of alpha-glucosidase inhibitors, including miglitol tablets.
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 miglitol tablets and perform the appropriate diagnostic imaging.