Medicinal Products

ARESTAL 1 mg

Generic drug of the therapeutic class: Gastro-Entero-Hepatology
Active ingredients: Loperamide
laboratory: Janssen Cilag

Compressed
Box of 20
All forms

Indication

Symptomatic treatment of acute diarrhea in adults.

The treatment does not dispense dietary measures and rehydration if it is necessary.

The importance of rehydration by oral or intravenous rehydration solution should be adapted according to the intensity of the diarrhea, the age and the particularities of the patient.

Dosage ARESTAL 1 mg Tablet Box of 20

Oral way.

Reserved for adults.

The initial dosage is 2 tablets.

After each unmolded stool, an additional tablet will be administered, not to exceed 8 tablets per 24 hours.

Elderly

No dosage adjustment is necessary.

Renal failure

No dosage adjustment is necessary.

Hepatic insufficiency

Although there are no pharmacokinetic data in patients with hepatic impairment, loperamide should be used with caution in these patients because of the reduced first-pass effect (see Warnings and Precautions section). ).

Against indications

· Hypersensitivity to loperamide or any of the ingredients.

· In case of acute attacks of ulcerative colitis.

· In case of haemorrhagic diarrhea and / or severe fever.

· In patients with bacterial enterocolitis due to an invasive bacterium such as Salmonella, Shigella or Campylobacter .

Arestal side effects

Data from clinical trials

The use of loperamide oxide was evaluated in 1776 patients with acute diarrhea.

The most common side effects reported with the use of this drug in clinical studies are constipation (1.8%) and headache (2%).

Post marketing experience

Loperamide oxide is the prodrug of loperamide. Loperamide oxide is converted into loperamide by the intestinal flora. Thus, the adverse effects considered significant for loperamide hydrochloride are included in this section because it is theoretically expected that the two active ingredients have the same tolerance profile even in the absence of reported notifications for loperamide oxide.

Adverse effects are classified by organ system and frequency using the following convention:

Very common:> 1/10

Frequent:> 1/100, <1/10

Uncommon:> 1/1000, <1/100

Rare:> 1/10000, <1/1000

Very rare: <1/10000

No frequency is indicated when this could not be estimated on the basis of available data.

Skin and subcutaneous tissue disorders:

Rash, hives, pruritus.

Immune system disorders:

Allergic reactions and in some cases, severe hypersensitivity reactions including angioedema, anaphylactic shock and anaphylactoid reactions.

Gastrointestinal disorders:

Frequent: nausea, constipation, abdominal cramps.

Abdominal pain, ileus, abdominal distension, vomiting, megacolon including colectatic syndrome, flatulence, dyspepsia, dry mouth.

Renal and urinary disorders:

Urinary retention

Central nervous system disorders:

Very rare: drowsiness, dizziness, loss of consciousness and decreased level of consciousness.

General disorders and administration site defects:

Asthenia

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