Anti-Diarrheal Tablet

(in each caplet)
Loperamide HCl 2 mg

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Quality Plus

Anti-Diarrheal

Loperamide HCl Tablets USP, 2 mg

96 Caplets**

**Each caplet (capsule shaped tablet) Contains 2 mg of Loperamide Hydrochloride

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788

Applies to loperamide: compounding powder, oral capsule, oral liquid, oral suspension, oral tablet, oral tablet chewable

Gastrointestinal

Necrotizing enterocolitis with perforation was reported in two women following short courses (24 hours and 3 days) of loperamide for the treatment of acute diarrhea with fever. Resected bowel in both cases revealed extensive mucosal hemorrhage and necrosis.

Toxic megacolon has been reported in association with the use of loperamide to treat symptoms of ulcerative colitis and pseudomembranous colitis due to antibiotic therapy. In one patient treated for ulcerative colitis, abdominal symptoms seemed to improve in the days before requiring emergency laparotomy.

Loperamide has also been implicated in a case of appendicitis. A 35-year-old male self-treated traveler's diarrhea with loperamide at greater than the recommended daily dose for seven days. Three days later, an appendalith was noted during an emergency appendectomy. The authors speculated that fecal stasis induced by loperamide increases the risk of fecalith and appendalith formation, the latter being associated with the pathogenesis of appendicitis.

Gastrointestinal side effects reported during loperamide therapy are often likely due to the underlying illness and include nausea, vomiting, dyspepsia, abdominal cramps, and anorexia.

Cases of paralytic ileus associated with abdominal distention have been reported rarely. Many of these reports had occurred in a setting with acute dysentery, overdose, and children less than 2-years-old.[Ref]

Gastrointestinal side effects have included nausea, vomiting, dyspepsia, abdominal cramps, anorexia, abdominal pain, abdominal distention, dry mouth, abdominal discomfort, and constipation. Gastrointestinal side effects have rarely included ileus, toxic megacolon and necrotizing enterocolitis, with or without perforation.[Ref]

Nervous system

Severe central nervous system depression may occur with overdose.[Ref]

Nervous system side effects have rarely included drowsiness, tiredness, dizziness and severe central nervous system depression.[Ref]

Other

While structurally related to meperidine and diphenoxylate, abuse potential is very low with loperamide. At therapeutic doses, it does not produce euphoria.

In opioid addicted monkeys, loperamide in high doses did prevent withdrawal symptoms.

A 26-year-old male with a history of opioid and alcohol abuse, began taking loperamide for the treatment of acute diarrhea. Despite denying euphoric effects from the drug, he gradually increased his intake to 320 mg per day. Attempts to stop the drug resulted in acute withdrawal (chest pain, shortness of breath, chills, diaphoresis, abdominal discomfort, nausea, and vomiting). Methadone relieved the symptoms. A slow methadone taper in an inpatient setting was successful in treating the physical dependence.[Ref]

Other side effects have rarely included physical dependence.[Ref]

Hypersensitivity

Hypersensitivity side effects have included skin rash. Anaphylactic shock and anaphylactoid reactions have been reported rarely.[Ref]

Dermatologic

Dermatologic side effects have included rash, pruritus, urticaria, and angioedema. Bullous eruptions including erythema multiforme, Stevens-Johnson syndrome, and Toxic Epidermal Necrolysis (TEN) have been reported rarely.[Ref]

Genitourinary

Genitourinary side effects have included urinary retention.[Ref]

Some side effects of loperamide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Data not available

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Constipation (may be a sign that you are using too much loperamide).
• Rarely may cause dizziness or drowsiness which may affect your ability to drive or operate machinery. Avoid alcohol.
• Bloating, loss of appetite, stomach pain, and skin rash are also rare side effects of loperamide.
• May not be suitable for people with a bowel obstruction, abdominal pain without diarrhea, blood or mucus in their diarrhea, or phenylketonuria (some loperamide tablets contain aspartame or phenylalanine).
• May interact with some medications used to treat HIV.
• Not to be used in children aged less than six years except on a doctor's advice. Children may be more sensitive to the effects of loperamide.
• Not to be used in pregnancy or breastfeeding except on a doctor's advice.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

• Loperamide effectively treats diarrhea by slowing down the movement of the bowel. In some people it may cause drowsiness.

• May be taken with or without food.
• Drink extra fluids (electrolyte solutions offer a good alternative to water and contain electrolytes that are typically lost during diarrhea).
• Do not drive or operate machinery if loperamide makes you drowsy or dizzy. Avoid alcohol.
• See your doctor if your diarrhea does not get better within 48 hours.
• Stop taking loperamide and seek immediate medical attention if a rash, itching, facial swelling, difficulty breathing, bloating, blood in your stools, or severe dizziness develop.

Loperamide has been assigned to pregnancy category C by the FDA. Animal studies failed to reveal evidence of teratogenicity or fetal harm. There are no controlled data in human pregnancy. Loperamide should only be given during pregnancy if the potential benefits outweighs the risks.

LactMed Record Number

424

Last Revision Date

20130907

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.