DIAPRI [Nifuroxazide] 200 mg Capsules
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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
Hard gelatin capsules.
Composition
per 1 capsule:
active
substance: nifuroxazide 200 mg;
excipients: corn starch, sucrose,
magnesium stearate.
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 (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
Treatment of acute
diarrhea of bacterial origin in the absence of signs of invasion (for example,
deterioration of the general condition, fever, toxic infection, etc.) in
addition to rehydration therapy.
Treatment with Diapri
does not eliminate the need to follow a diet and the need for rehydration.
The dose and method of
rehydration (orally or intravenously) is determined depending on the severity
of diarrhea, age, patient's condition, and the presence of concomitant
diseases.
• hypersensitivity to the active
substance, nitrofuran derivatives or to any of the excipients;
• pregnancy;
• children under 15 years of age.
Method of administration
and dosage
The drug
is taken orally. The capsule should be swallowed whole with a small amount of
water, regardless of food intake at regular intervals.
Adults: 1 capsule
4 times a day, every 6 hours.
Children over
15 years of age: 1 capsule 3 or 4 times a
day every 6-8 hours.
The
duration of taking the drug should not exceed 3 days. If after this the
symptoms of the disease do not disappear, you should consult a doctor.
During
the treatment of diarrhea, constant oral or intravenous replenishment of fluid
deficiency in the body is mandatory, depending on the general condition of the
patient.
Special instructions and precautions
Before using the drug, consult a doctor.
When treating diarrhea, rehydration therapy must
be administered simultaneously with Diapri therapy.
In case of bacterial diarrhea, accompanied by a
deterioration in the general condition, an increase in body temperature,
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.
Drinking alcohol during treatment is prohibited.
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, with drugs that depress the central
nervous system is not recommended.
During treatment,
concomitant use of oral agents should be avoided due to the strong adsorption
properties of the drug.
Consumption of
alcoholic beverages during treatment with nifuroxazide may cause disulfiram-like
reactions.
There is no information on cases of overdose with
nifuroxazide.
In case of overdose, it is recommended to induce
vomiting and consult a doctor. It is necessary to monitor the patient's
condition, treatment is symptomatic.
Storage conditions
Store
in a dry place at a temperature not exceeding 30°C. Keep out of reach of
children.
Shelf life
4
years. Do not use after the expiration date stated on the package.
Vacation conditions
Without prescription.
Release form
14 capsules in an aluminum foil blister. 1 blister together with instructions for use in a cardboard box.