Diatabs

Diatabs

loperamide

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Full Prescribing Info
Contents
Loperamide hydrochloride.
Description
Each capsule contains: Loperamide Hydrochloride 2 mg.
Action
This medicine contains loperamide, an antidiarrheal agent which slows intestinal movement and reduced 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 non-specific 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 that fluid and salt loss with the use of oral rehydration solution (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 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 the patient missed a dose, just take the next dose if still needed for diarrhea. Do not double the dose.
Overdosage
Signs and Symptoms of 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).
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 the patient is allergic to loperamide or any ingredient in the product.
If it is for a child under 12 years old.
If the patient is pregnant or breastfeeding.
If the patient is constipated and also in whom constipation should be avoided (e.g., diarrhea resulting from infections).
If the abdomen is swollen or the patient has abdominal pain.
If the patient has acute dysentery which is characterized by blood in stools and high fever.
If the patient has 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.
Stop use and consult the 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.
The patient has Acquired Immune Deficiency Syndrome (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
This medication is contraindicated if the 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, or 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
Concomitant administration with the following may result in increased loperamide plasma levels: Ritonavir (used to treat Human Immunodeficiency Virus), Quinidine (used to treat abnormal heart rhythms), Oral desmopressin (used to treat excessive urination), Itraconazole or ketoconazole (used to treat fungal infections), Gemfibrozil (used to lower cholesterol).
Medicine 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
Antidiarrheals
ATC Classification
A07DA03 - loperamide ; Belongs to the class of antipropulsives. Used in the treatment of diarrhea.
Presentation/Packing
Form
Diatabs cap 2 mg
Packing/Price
100's (P800/pack, P8/cap);4's (P8/cap, P32/blister);500's (P4,000/pack, P8/cap)
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in