Products Description

 

Product name

Diarrimide

Composition

 

Each tablet contains :

Loperamide ............ 2 mg

 

 

 Indications

 

Description:

Diarrimide (Loperamide ) is an oral drug indicated for the control and relief of acute, nonspecific diarrhea as well as chronic diarrhea associated with inflammatory bowel disease. This agent is also used for reducing the volume of discharge from ileostomies.

 Mechanism of Action :

Diarrimide (Loperamide) interferes with peristalsis by a direct action on the circular and longitudinal muscles of the intestinal wall to slow motility. Diarrimide (Loperamide) also may directly inhibit fluid and electrolyte secretion and/or increase water absorption. By increasing the transit time of the intestinal contents, Diarrimide (Loperamide ) reduces fecal volume, increases the bulk density and the viscosity of the feces, and decreases the loss of electrolytes and fluids from the body. Although Diarrimide (Loperamide) is chemically related to opioids, it does not exhibit analgesic or opiate-like effects, even at high doses.  and it does not appear to produce physical dependence.

Pharmacokinetics:

Diarrimide (Loperamide ) is 40% absorbed from the GI tract following oral administration. Peak plasma concentrations occur within 2.5 hours after administration of oral solution and within 4.5 hours after administration of the capsule. The distribution characteristics of the drug have not been described. It is unknown if Diarrimide (Loperamide) crosses the placenta or is excreted into breast milk. Diarrimide (Loperamide) is 97% plasma protein-bound. Diarrimide (Loperamide) undergoes hepatic metabolism and has a half-life of 10.8 hours and a duration of action of up to 24 hours. Approximately 30% of a dose is eliminated via the feces as unchanged drug, with less than 2% excreted in the urine.

 Indications:

Acute, nonspecific diarrhea as well as chronic diarrhea associated with inflammatory bowel disease.

 

 

Dosage & Administration

 

Dosage & administration:

Administration

* Diarrimide  is administered orally with clear fluids.

 - For the treatment of diarrhea:

For the treatment of acute nonspecific diarrhea including AIDS-associated diarrhea with no identifiable infectious cause:

Oral dosage:

- Adults and adolescents: 4 mg by oral initially, followed by 2 mg by oral after each unformed stool. The maximum dosage is 16 mg/day.

- Children 9 to 11 years (>30 kg): 2 mg by oral three times per day on the first day.

- Children 6 to 8 years (20-30 kg): 2 mg by oral twice daily on the first day.

- Children 2 to 5 years (13-20 kg): 1 mg by oral three times per day on the first day.

NOTE: The maintenance dose in children is 0.1 mg/kg by oral only after an unformed stool. Total daily maintenance doses should not exceed those recommended for the first day.

 - For the treatment of chronic diarrhea:

Oral dosage:

- Adults and adolescents: 4 mg by oral initially, followed by 2 mg after each subsequent unformed stool until symptoms are controlled. Dosages should then be reduced accordingly for maintenance therapy, (typically 4-8 mg/day by oral for adults, given as a single dose or in divided doses).

NOTE: If symptoms do not improve following 10 days of treatment with maximum daily doses of Diarrimide, i.e., 16 mg/day, then improvement is not likely to occur with further Diarrimide  therapy.

 - For self medication (over-the-counter) of acute nonspecific diarrhea:

Oral dosage:

- Adults and adolescents: 4 mg by oral initially, followed by 2 mg by oral after each unformed stool; dosage should not exceed 8 mg/day for 2 days unless directed by a physician.

- Children 9-11 years (27.3-43.2 kg): 2 mg by oral after the first unformed stool, followed by 1 mg by oral after each subsequent unformed stool, not to exceed 6 mg/day for 2 days.

- Children 6-8 years (21.8-26.8 kg): 2 mg by oral after the first unformed stool, followed by 1 mg by oral after each subsequent unformed stool, not to exceed 4 mg/day for 2 days.

NOTE: This drug should not be used for self medication in children under 2 years of age unless directed by the physician. Diarrimide  therapy should be discontinued if improvement is not apparent after 48 hours.

- Patients with renal impairment:

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

 Contraindications :

- Diarrimide (Loperamide) and other drugs that inhibit intestinal motility or prolong

transit time can induce toxic mega colon in patients with acute ulcerative colitis. Patients with ulcerative colitis should be monitored closely and Diarrimide  therapy discontinued if signs of toxicity (e.g., abdominal distension) occur.

- Diarrimide  is relatively contraindicated in cases of diarrhea caused by poisoning or infection with enterotoxin-producing bacteria (bacterial gastroenteritis) because expulsion of the toxic intestinal contents may be a necessary protective mechanism. Diarrimide  is contraindicated in cases of diarrhea caused by pseudomembranous colitis.

- Patients with hepatic disease should be monitored closely for CNS toxicity while receiving Diarrimide. Because Diarrimide (Loperamide ) undergoes extensive first-pass metabolism, a decrease in hepatic function could result in elevated plasma concentrations of the drug.

- Diarrimide  is contraindicated in cases of acute dysentery (hemafecia and elevated temperature >38.3 degrees C).

- Diarrimide  is not recommended for use in children under 2 years of age due to variable responses in this age group. Children under 2 years of age may be more susceptible to the opioid effects of Diarrimide.

- Diarrimide  should be given with caution to breast-feeding women. It is not known whether Diarrimide  is excreted into breast milk.

 Drug interaction :

* bethanechol              * cholestyramine         * cisapride

* erythromycin            * metoclopramide

- Cholestyramine reportedly inhibited the effect of Diarrimide (Loperamide) in  patients, which appeared to be the result of binding in the GI tract. A causal relationship has not been established; however, Diarrimide (Loperamide) should be administered at least 2 hours apart from cholestyramine until the significance of this interaction is known.

- Pharmacodynamic interactions between Diarrimide (Loperamide) and drugs that enhance peristalsis are theoretically possible. It is wise to avoid use Diarrimide (Loperamide) in patients who require bethanechol, cisapride, metoclopramide, and also erythromycin.

 

Side effects:

- abdominal pain          - constipation               - dizziness

- drowsiness                - fatigue                       - nausea/vomiting

- xerostomia

 Instructions to the patients:

* Diarrimide (Loperamide) helps to control and relieve the symptoms of diarrhea including traveler's diarrhea and the diarrhea associated with inflammatory bowel diseases.

* Take Diarrimide  tablets or capsules by mouth.  Swallow the tablets or capsules with a drink of water. Take your doses at regular intervals.

* Special precautions for use in children: This medicine is not for children under 2 years old. Young children may have a very variable response to this medicine and are more susceptible to the effects of dehydration.

* Elderly patients may have a more variable response to the effects of Diarrimide, and are more susceptible to the effects of dehydration.

 What side effects may I notice from taking Diarrimide?

Serious side effects with Diarrimide (loperamide) are rare, they include :

* bloated, swollen feeling        * blurred vision            * loss of appetite

* skin rash                   * stomach pain

Call your doctor as soon as you can if you get any of these side effects.

 Minor side effects with Diarrimide include:

* drowsiness or dizziness        * dry mouth                 * constipation

* nausea, vomiting      * tiredness

Let your doctor know about these side effects if they do not go away or if they annoy you.

Your mouth may get dry. Sucking hard candy or chewing sugarless gum and drinking plenty of water can help. Drinking plenty of water can also help prevent dehydration that can occur with diarrhea.

 Pregnency & lactation :

Generally it is not recommended in pregnancy & lactation.

 

 

Presentation

 

Diarrimide pack of 2 blister X 10 tablets .

 

 

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