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Gastrointestinal System

Loperamid STADA®

 

Pack size:

Box of 5 blisters x 10 capsules.

 

Composition:

Each capsule contains loperamid hydrochloride 2 mg.

 

Shelf-life:

60 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • For the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease.
  • For reducing the volume of discharge from ileostomies, colostomies.
     
  • Administered orally. Patients should receive appropriate fluid and electrolyte replacement as needed.
     
  • Acute diarrhea
    Adults:
    The recommended initial dose is 4 mg followed by 2 mg after each unformed stool. Daily dosage should not exceed 16 mg. Clinical improvement is usually observed within 48 hours.
    Children:
  • Chronic diarrhea 
    Adults:

    The recommended initial dose is 4 mg followed by 2 mg after each unformed stool until diarrhea is controlled, after which the dosage of loperamide should be reduced to meet individual requirements. When the optimal daily dosage has been established, this amount may then be administered as a single dose or in divided doses.
    Children:
    Dose has not been established.

Or as advised by physicians.

 

  • Known hypersensitivity to any ingredient of the drug.
  • Patients with abdominal pain without diarrhoea.
  • Children under 2 years of age.
  • Abdominal distention.
  • First loperamide avoided use in acute dysentery, ulcerative colitis in phase bleed acute, pseudomembranous colitis, bacterial enterocolitis caused as Salmonella, Shigella and Campylobacter.
  • Acute ulcerative colitis, pseudomembranous colitis (may induce toxic megacolon) caused by antibiotic use.

     

Common

  • Headache, dizziness.
  • Constipation, nausea, flatulence.

Uncommon

  • Somnolence.
  • Abdominal pain, abdominal discomfort, dry mouth, abdominal pain upper, vomiting, dyspepsia.
  • Rash.

Rare

  • Hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock), anaphylactoid reaction.
  • Loss of consciousness, stupor, depressed level of consciousness, hypertonia, coordination abnormality.
  • Miosis.
  • Ileus (including paralytic ileus), megacolon (including toxic megacolon), abdominal distension.
  • Bullous eruption (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), angioedema, urticaria, pruritus.
  • Urinary retention.
  • Fatigue.

     

  • Treatment of diarrhoea with loperamide is only symptomatic. Need to find cause (if applicable) and responding appropriate.
  • Fluid and electrolyte depletion often occur in patients who have diarrhea. In such cases, administration of appropriate fluid and electrolytes is very important. The use of loperamide does not preclude the need for appropriate fluid and electrolyte therapy.
  • In some patients with acute ulcerative colitis, and in pseudomembranous colitis associated with broad – spectrum antibiotics, agents which inhibit intestinal motility or delay intestinal transit time have been reported to induce toxic megacolon.
  • Loperamide therapy should be discontinued promptly if abdominal distention, constipation, or ileus occurs.
  • Loperamide should be used with special caution in young children because of the greater variability of response in this age group. Dehydration, particularly in younger children, may further influence the variability of response to loperamide.
  • In acute diarrhea, if clinical improvement is not observed in 48 hours, the administration of loperamide should be discontinued.
  • Should not be used for prolonged periods. Indicated only for the symptomatic treatment of acute episodes of diarrhoea associated with irritable bowel syndrome.
  • Patients with hepatic dysfunction should be monitored closely for signs of CNS toxicity because of the apparent large first pass biotransformation.
  • Patients should be advised to check with their physician if their diarrhea does not improve after a couple of days or if they note blood in their stools or develop a fever.
  • Pregnancy: There are no adequate and controlled studies in pregnant women. Avoid using in pregnancy.
  • Lactation: Loperamide should not be used in breast-feeding women.
  • Effects on ability to drive and use machines: Fatigue, vertigo, or headache may occur in the setting of diarrhoeal syndromes treated with loperamide hydrochloride. Therefore, it is advisable to use caution when driving a car or operating machinery.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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