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Uzara® (Tablets, Solution, Syrup) Instructions for Use

ATC Code

A07X (Other antidiarrheal drugs)

Clinical-Pharmacological Group

Antidiarrheal phytopharmaceutical

Pharmacotherapeutic Group

Antidiarrheal agent of plant origin

Pharmacological Action

An antidiarrheal agent of plant origin. The mechanism of the antiperistaltic action of Uzara is based on the stimulation of the sympathetic nervous system, resulting in a weakening of intestinal motility.

In addition to inhibiting the motility of the digestive tract, Uzara® has an antispasmodic, antisecretory, astringent, and enveloping effect.

Indications

Nonspecific acute and chronic diarrhea

  • Diarrhea associated with allergic reactions;
  • Diarrhea caused by psychoemotional factors;
  • Diarrhea caused by disorders of metabolism and nutrient absorption;
  • “traveler’s diarrhea” due to changes in diet and habitual food intake.

As an auxiliary agent for diarrhea of infectious origin.

ICD codes

ICD-10 code Indication
A09 Other and unspecified gastroenteritis and colitis of infectious origin
K59.1 Functional diarrhea
ICD-11 code Indication
1A40.Z Infectious gastroenteritis or colitis, unspecified
DD91.2 Functional diarrhea
DD93.Y Other specified functional gastrointestinal disorders in infants, toddlers and school-age children
DD9Z Functional gastrointestinal disorders, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

Orally, regardless of meals.

Adults and children over 12 years old initial dose on the first day – 5 tablets (200 mg) as a single dose, on subsequent days – 1 tablet (40 mg) 3-6 times a day until stool normalizes. Tablets should be taken with a small amount of liquid.

Syrup

Orally, regardless of meals.

Adults initial dose on the first day – 25 ml of syrup as a single dose, on subsequent days – 5 ml 3-6 times/day until stool normalizes.

School-age children (from 7 to 16 years old) initial dose on the first day 5-7 ml of syrup, on subsequent days 3-4 ml 3-6 times/day.

Preschool children (from 2 to 6 years old) 1-2 ml of syrup 3-6 times/day.

Children from 1 to 2 years old 0.5 ml of syrup 3 times/day.

Adverse Reactions

Allergic reactions.

Contraindications

  • Treatment with cardiac glycosides;
  • Pregnancy;
  • Lactation period;
  • Children under 1 year of age;
  • Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Experimental studies have not revealed any teratogenic or mutagenic properties of Uzara. To date, no developmental defects have been reported with the use of the drug.

Since clinical experience with the drug in pregnant and lactating women is very limited, the use of Uzara during pregnancy and lactation is not indicated.

Special Precautions

If the duration of diarrhea exceeds 2 days, is accompanied by high body temperature, or if there are blood impurities in the stool, it is necessary to consult a doctor immediately.

Use in pediatrics

In children, the drug should be used under medical supervision to avoid overdose.

In children under 6 years of age, oral rehydration agents must be used as the main therapy. The course of treatment should not exceed 7 days.

Drug Interactions

With simultaneous use with calcium preparations, saluretics, or during long-term therapy with cortisol preparations, cardiac arrhythmias may occur.

Storage Conditions

Store at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 5 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Stada Arzneimittel, AG (Germany)

Dosage Form

Bottle Rx Icon Uzara® Oral solution 40 mg/1 ml: bottle 30 ml or 100 ml

Dosage Form, Packaging, and Composition

Oral solution transparent, from light brown to brown in color, slight opalescence is allowed.

1 ml
Uzara root dry extract (4-6:1) (calculated as uzarin) 40 mg

Excipients : ethanol 96%, disodium edetate dihydrate, purified water up to 1 ml.

30 ml – dark glass bottles with a dropper (1) in a set with a measuring cap – cardboard boxes.
100 ml – dark glass bottles with a dropper (1) in a set with a measuring cap – cardboard boxes.

Marketing Authorization Holder

Stada Arzneimittel, AG (Germany)

Manufactured By

Rottendorf Pharma, GmbH (Germany)

Dosage Form

Bottle Rx Icon Uzara® Film-coated tablets, 40 mg: 20 or 50 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, round, biconvex; the tablet core is from light brown to brown in color with white specks.

1 tablet
Uzara root dry extract (4-6:1) (calculated as uzarin) 40 mg

Excipients : wheat starch, lactose monohydrate, carob bean starch, talc, colloidal anhydrous silicon dioxide, magnesium stearate.

Tablet coating composition: calcium carbonate, glucose syrup (dry substance), magnesium oxide, corn starch (Snowflake 06598), castor oil, sucrose, shellac, talc, titanium dioxide E171, glycol mountain wax.

10 pcs. – blister packs (2) – cardboard boxes.
10 pcs. – blister packs (5) – cardboard boxes.

Marketing Authorization Holder

Stada Arzneimittel, AG (Germany)

Dosage Form

Bottle Rx Icon Uzara® Syrup 7.56 mg/1 ml: bottle 100 ml in set with measuring cap

Dosage Form, Packaging, and Composition

Syrup transparent to opalescent, from yellowish to brownish in color, with a characteristic odor.

1 ml
Uzara root dry extract (4.5-6.2:1) 7.56 mg

Excipients : propylene glycol, macrogolglycerol hydroxystearate, cola flavor, dextrose (glucose) monohydrate, liquid dextrose (glucose), purified water.

100 ml – dark glass bottles (1) in a set with a measuring cap – cardboard boxes.

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