RiteMED Loperamide

RiteMED Loperamide

loperamide

Manufacturer:

RiteMED

Distributor:

United Lab
Full Prescribing Info
Contents
Loperamide hydrochloride.
Description
Each capsule contains: Loperamide Hydrochloride 2 mg.
Action
This medicine contains Loperamide, an anti-diarrheal agent which slows intestinal movement and reduces fluid and salt loss in the intestines, resulting in improved stool consistency.
Indications/Uses
This medicine is used for the following conditions: Control and symptomatic relief of: acute nonspecific diarrhea, chronic diarrhea associated with inflammatory bowel disease.
Reduction of number and volume of discharge in patients with ileostomies and colostomies.
In addition to using Loperamide for diarrhea, it is important to replace fluid and salt loss with the use of oral rehydration solutions (ORS) and/or by drinking plenty of fluids.
Dosage/Direction for Use
For Symptomatic relief of Acute Diarrhea: Adult Dose: Take 2 capsules initially followed by 1 capsule after each loose bowel movement.
Or, as directed by a doctor.
Maximum dose is 16 mg (8 capsules) per day.
Discontinue if there is no improvement after 2 days.
For Symptomatic relief of Chronic Diarrhea: Adult Dose: Take 2 capsules initially followed by 1 capsule after each loose bowel movement.
Then reduce loperamide dose to meet individual requirements. When the optimal daily dosage has been established, administer this amount as a single dose or in divided doses.
Or, as directed by a doctor.
Average daily maintenance dose: Take 2 to 4 capsules/day. A dosage of five capsules (10 mg) is rarely exceeded.
If no clinical improvement is observed after treatment with 8 capsules/day (16 mg/day) for at least 10 days, symptoms are unlikely to be controlled by further Loperamide administration.
Missed dose: If a patient misses a dose, just take the next dose if still needed for diarrhea.
Do not double the dose.
Overdosage
Loperamide overdose may result in constipation, central nervous system (CNS) depression (e.g., drowsiness, and dizziness), paralytic ileus (temporary absence of intestinal movement), and urinary retention (decreased urination).
In adults, reported overdosage within 24 hours resulted in nausea after 40 mg (20 capsules) and vomiting after 60 mg (30 capsules).
What to do when taken more than the recommended dose: If the patient has taken more than the recommended dosage (i.e., more than 8 capsules per day), consult a doctor or a Poison Control Center right away.
Contraindications
If patient is allergic to loperamide or any ingredient in the product.
If patient is a child under 12 years old.
If patient is pregnant or breastfeeding.
If patient is constipated and also in whom constipation should be avoided (e.g., Diarrhea resulting from infections).
If the abdomen is swelling or has abdominal pain.
If patient has acute dysentery which is characterized by blood in stools and high fever.
If patient has acute pseudomembranous colitis (diarrhea associated with antibiotics), active ulcerative colitis, meningitis or a history of liver disease.
Special Precautions
Do not take more than the recommended dose.
Consult a doctor: If any undesirable effect occurs or acute diarrhea persists for more than two days, if symptoms worsen, if abdominal swelling or bulging develops, or if fever develops.
If the patient has AIDS and any signs of abdominal swelling or bulging. There have been isolated reports of toxic megacolon (rapid widening of the colon accompanied by infection or inflammation) in AIDS patients treated with Loperamide.
A serious condition may develop if too much fluid has been lost by the body due to diarrhea.
Consult a doctor if any of the following conditions develop: Decreased urination, dizziness and lightheadedness, dryness of mouth, increased thirst, wrinkled skin.
Use In Pregnancy & Lactation
Contraindicated if patient is pregnant or breastfeeding.
Adverse Reactions
Loperamide is generally well tolerated; however, dry mouth, abdominal pain, distention or discomfort, nausea, vomiting, fatigue, flatulence, dyspepsia, constipation, epigastric pain, paralytic ileus (temporary absence of intestinal movement) and toxic megacolon (rapid widening of the colon accompanied by infection or inflammation) may occur. Loperamide may rarely cause drowsiness and dizziness.
Allergic reactions including unexplained wheezing, shortness of breath, passing out, swelling of the face and throat have occurred very rarely.
Undesirable effects involving the skin include pruritus (itch), rash, urticaria (hives) and extremely rare cases of angioedema (rapid swelling beneath the skin) and bullous (large skin blister) eruption including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis (severe allergic reactions characterized by separation or exfoliation of tissue) have been rarely reported.
Drug Interactions
Medicines that slow down the action of the stomach and intestines (e.g., some medicines for depression and cold and allergy medications) as these may increase the constipating effect of Loperamide.
Medicines that cause drowsiness since Loperamide may also cause drowsiness.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
A07DA03 - loperamide ; Belongs to the class of antipropulsives. Used in the treatment of diarrhea.
Presentation/Packing
Cap 2 mg (yellowish-white powder in #3 hard gelatin capsule with a mint green cap and mint green body) x 100's.
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