LOPEDIUM

Active material: Loperamide
When ATH: A07DA03
CCF: Symptomatic antidiarrheal drug
ICD-10 codes (testimony): A09, K59.1, K91.4
When CSF: 11.07.03.02
Manufacturer: Hexal AG (Germany)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

◊ Capsules hard gelatin, with the housing and a dark gray-green lid; contents of capsules – White homogeneous powder.

Excipients: lactose monohydrate, corn starch, talc, magnesium stearate.

The composition of the housing a hard gelatin capsule: gelatin, gland (III) Black oxide (E172), Titanium dioxide.
Composition cap hard gelatin capsule: gelatin, gland (III) oxide yellow (E172), Blue dye (E131), gland (III) Black oxide (E172), Titanium dioxide (E171).

10 PC. – blisters (1) – packs cardboard.
10 PC. – blisters (2) – packs cardboard.
10 PC. – blisters (3) – packs cardboard.
10 PC. – blisters (5) – packs cardboard.

◊ Pills white or almost white, round, convex on one side and a line on the other, chamfered surface to Risk.

Excipients: lactose monohydrate, calcium hydrogen phosphate dihydrate, corn starch, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate.

10 PC. – blisters (1) – packs cardboard.
10 PC. – blisters (2) – packs cardboard.
10 PC. – blisters (3) – packs cardboard.
10 PC. – blisters (5) – packs cardboard.

Pharmacological action

Symptomatic antidiarrheal drug.

By binding to opioid receptors of the intestinal wall, loperamide reduces the tone and motility of the smooth muscle of the intestine. It slows peristalsis and increases the passage of intestinal contents. Increases tone of the anal sphincter. It helps keep the stool and deceleration urge to defecate.

The action comes fast and lasts for 4-6 no.

Pharmacokinetics

Absorption

Absorption loperamide – 40%. The time to reach C_max is 2.5 no.

Distribution

Plasma protein binding – 97%. Do not cross the BBB.

Metabolism

Almost completely metabolized in the liver by conjugation.

Deduction

Write mainly in the bile and urine. T_1/2 is 9-14 no.

Testimony

- Symptomatic treatment of acute and chronic diarrhea allergic, Emotional, drug and radiation genesis;

- Diarrhea, a change of diet, qualitative composition of food, malabsorption and metabolism;

- As an aid for diarrhea of ​​infectious origin;

- Regulation of stool in patients with iliostoma.

Dosage regimen

The drug is taken orally, Tablets and capsules are swallowed, without chewing, drinking 100 ml of water.

Adults at acute and chronic diarrhea originally prescribed 4 mg, then – by 2 mg after each act of defecation in the case of loose stool. The maximum daily dose – 16 mg.

Children over 6 years appoint 2 mg after each act of defecation in the case of loose stool. The maximum daily dose – 6 mg.

After normalization of a chair or no chair more 12 h treatment should be discontinued.

Side effect

From the digestive system: gastralgia, dry mouth, nausea, vomiting, kišečnaâ how, constipation; rarely – ileus.

CNS: drowsiness or insomnia, dizziness, headache.

Allergic reactions: skin rash.

Contraindications

- Diverticulosis;

- Bowel obstruction;

- Ulcerative colitis in the acute stage;

- Diarrhea with acute pseudomembranous enterocolitis;

- As monotherapy for dysentery and other gastrointestinal infections;

- I trimester of pregnancy;

- Lactation;

- Children up to age 6 years;

- Hypersensitivity to the drug.

FROM caution the drug should be used in patients with hepatic insufficiency.

Cautions

If no effect after 2 days of application Lopedium necessary to clarify the diagnosis and to rule out infection genesis of diarrhea.

If the treatment develops constipation or bloating, the drug should be discontinued.

Patients with impaired hepatic function should be closely monitored signs of CNS toxicity.

In the period of treatment is necessary to fill the loss of fluids and electrolytes.

Each tablet or capsule Lopedium matches 0.01 HE.

Effects on ability to drive vehicles and management mechanisms

In case of drowsiness or dizziness, avoid driving and using machinery.

Overdose

Symptoms: CNS depression (stupor, incoordination, drowsiness, mioz, Muscle hypertonicity, respiratory depression), ileus.

Treatment: Antidote – Naloxone. Since loperamide longer duration, than naloxone, possible re-introduction of the last. Symptomatic therapy (Activated carbon, gastric lavage, IVL). The need for medical surveillance of the patient for at least 48 no.

Drug Interactions

Clinically significant interaction loperamide with other drugs is not installed.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C. Shelf life – 5 years.