DIAPRI [Nifuroxazide] 220 mg/5 ml Suspension
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instructions
for the medical use of the medicinal product
DIAPRI
Tradename
Diapri, Диапри
International non-proprietary name
or generic name
Nifuroxazide, нифуроксазид
Dosage form
Suspension for oral administration.
Composition per 5 ml of suspension
active
substance: nifuroxazide 220 mg;
excipients: carbomer 934, sodium
hydroxide, anhydrous citric acid, sucrose, ethanol, polysorbate 80, banana
flavor, purified water.
Pharmacotherapeutic group
Antidiarrheal, anti-inflammatory,
antimicrobial agents for the treatment of intestinal infections.
АТХ Code: А07АХ03
Pharmacological properties
Pharmacodynamics
Nifuroxazide is
an intestinal antiseptic, a derivative of 5-nitrofuran, has a local
antibacterial effect against gram-positive (Staphylococcus family) and
gram-negative bacteria (Enterobacteriaceae family: Escherichia,
Citrobacter, Enterobacter, Klebsiella, Salmonella, Shigella, Proteus, Yersinia)
bacteria.
Not active against bacteria of the Pseudomonas
species and strains of subgroup A of the Proteus inconstans species,
Providentia alcalifaciens.
Does not destroy saprophytic
bacterial flora of the digestive tract (does not cause dysbacteriosis). Does
not cause the emergence of drug-resistant strains. The effectiveness of the
drug is not determined by the pH environment in the intestinal lumen and does
not depend on the sensitivity of bacteria to antibiotics. Nifuroxazide inhibits
the activity of dehydrogenases and disrupts protein synthesis in microbial
cells. Reduces the production of toxins by microorganisms.
Pharmacokinetics
Absorption of nifuroxazide after oral administration
is extremely low, provided there are no changes in the intestinal mucosa.
Excreted through the intestine: 20% unchanged, the rest - chemically modified.
Indications for
use
Acute bacterial diarrhea that occurs without
deterioration of the general condition, increased body temperature, or
intoxication.
• hypersensitivity
to the active substance, nitrofuran derivatives or to any of the excipients;
•
pregnancy;
•
children under 2 years of age.
Method of administration
and dosage
Take orally regardless
of food intake.
Dosage
Children from 2 years
old: 5 ml of suspension 3 times a day.
Adults: 5 ml of
suspension 4 times a day.
Before use, shake the
bottle thoroughly until a homogeneous suspension is obtained. A measuring
syringe is used for dosing.
The duration of the
course of treatment is 5-7 days, but not more than 7 days.
If there is no
improvement during the first 3 days of treatment, you should consult a doctor.
Special instructions and precautions
Before using the drug,
consult a doctor.
When treating
diarrhea, rehydration therapy must be carried out simultaneously with Diapri
therapy, it is necessary to consume large amounts of drinks containing salt and
sugar. In case of severe and prolonged diarrhea, severe vomiting or anorexia,
intravenous rehydration is necessary depending on the age and condition of the
patient.
In case of bacterial
diarrhea, occurring with deterioration of the general condition, fever,
symptoms of intoxication or infection, you should consult a doctor to decide on
the use of systemic antibacterial drugs. If symptoms of hypersensitivity
(shortness of breath, rash, itching) appear, you should stop taking the drug.
You should take into
account the recommendations for the dietary regimen: avoid eating fresh
vegetables and fruits, spicy foods, frozen foods and cold drinks. Decisions on
the use of dairy products should be made depending on the specific case.
During therapy with
the drug, alcohol consumption is prohibited.
This drug contains
sucrose. Its use is not recommended for patients with sucrose intolerance.
Influence on the ability to drive
vehicles and mechanisms
The drug does not affect the ability
to drive a car or operate other mechanisms.
Use during pregnancy and
breastfeeding
It is not recommended to use the drug
during pregnancy.
During breastfeeding, it should be used
with caution and in a short course.
Side effect
Diapri is usually well
tolerated and has virtually no side effects.
From the digestive system: in cases of individual
hypersensitivity to nifuroxazide, abdominal pain, nausea, and exacerbation of
diarrhea may occur. In the event of such symptoms of minor intensity, there is
no need for special therapy or discontinuation of nifuroxazide. If the above
symptoms develop with significant intensity, the drug should be discontinued.
In the future, the patient should not take nitrofuran derivatives.
From the skin and
subcutaneous tissue:
allergic reactions may develop (skin rash, urticaria, Quincke's edema,
anaphylactic reactions).
If any of the side effects
listed in the instructions worsen, or you notice any other side effects not
listed in the instructions, tell your doctor.
Interaction with
other medicinal products
Concomitant use with
drugs that cause disulfiram-like reactions or with drugs that depress the
central nervous system is not recommended.
During treatment,
concomitant use of oral medications should be avoided due to the strong
adsorption properties of the drug.
Overdose symptoms are
unknown. In case of overdose, gastric lavage and symptomatic treatment are
recommended.
Storage conditions
Store
at a temperature not exceeding 30°C. Keep out of reach of children.
3 years.
After
opening the bottle, the shelf life of the suspension is 30 days.
Do not use
after the expiration date.
Vacation conditions
Without prescription.
Release form
60 ml of the preparation in PET bottles with a screw
cap.
1 bottle and a measuring syringe together with instructions for use in a cardboard box.