Alkaloid AD Skopje #Digestive_system #Diarrhea #HEALTH_CARE
Pharmacological properties
Pharmacodynamics. Nifuroxazide is a 5-nitrofuran derivative that acts exclusively in the intestinal lumen and is not absorbed from the gastrointestinal tract. local activity and the lack of penetration into the organs and tissues of the body determines the uniqueness of nifuroxazide in comparison with other nitrofuran derivatives, since there are no systemic effects. the mechanism of action of nifuroxazide is not fully understood. the antimicrobial and antiparasitic properties of nifuroxazide and other nitrofurantoin derivatives are due to the no2-group, which is most effective in the treatment of intestinal infections. the preparation is especially effective against gram-positive bacteria: streptococcus pyogenes, staphylococcus pyogenes and gram-negative bacteria: escherichia coli, salmonella and shigella.
Pharmacokinetics
Suction. After oral administration, the absorption of nifuroxazide in the gastrointestinal tract is extremely low, since more than 99% of the taken preparation remains in the intestine.
Distribution. Nifuroxazide is practically not absorbed from the digestive tract, and ultimately absorption does not exceed 0.005%, since there is no distribution to organs and tissues.
Metabolism. Biotransformation of nifuroxazide occurs in the intestine, only 20% of the administered amount of the preparation is excreted unchanged.
Excretion. Nifuroxazide and its metabolites are excreted completely in the feces. The rate of elimination depends on the amount of the preparation taken and the motility of the gastrointestinal tract.
Usually, elimination of nifuroxazide is slow, and the preparation remains in the digestive tract for a long time.
Indications
Acute diarrhea of infectious etiology.
Application
For oral administration.
Nifuroxazide Alkaloid capsules. Adults and children over the age of 12.
Adults: a single dose of 200 mg (or 2 capsules of 100 mg) 4 times a day.
Children (from 12 years old): 200 mg (or 2 capsules of 100 mg) 3-4 times a day (600-800 mg of nifuroxazide per day). The duration of treatment is no more than 7 days. If necessary, the use of the preparation can be extended depending on the clinical condition of the patient.
Nifuroxazide Alkaloid, suspension. The dose is set by means of a measuring cup. Shake the prepared suspension well before use!
Adults: 200 mg - 5 ml of suspension 4 times a day.
Children over 12 years of age: 5 ml 3-4 times a day (600-800 mg of nifuroxazide per day); children aged 2–12 years: 5 ml 3 times a day (600–800 mg of nifuroxazide per day). The duration of treatment is no more than 7 days.
Children. Children under the age of 12 are advised to use the preparation Nifuroxazide Alkaloid in the form of an oral suspension. Do not administer Nifuroxazide Alkaloid in the form of an oral suspension to children under 2 years of age.
Contraindications
Hypersensitivity to nitrofuran derivatives and / or preparation excipients.
Side effects
In patients with hypersensitivity to nitrofuran derivatives, granulocytopenia may occur; allergic reactions, usually of a skin type (skin rash, itching, urticaria, pustulosis). in isolated cases, as with the use of other nitrofuran derivatives, shortness of breath, severe hypersensitivity reactions, including angioedema and anaphylactic shock, may occur.
In case of severe adverse reactions, the preparation should be canceled and symptomatic therapy should be carried out. Further, the patient should avoid taking nifuroxazide and other nitrofuran derivatives.
On the part of the immune system: possible allergic reactions, including angioedema, urticaria and pruritus, reactions in the form of a skin rash, anaphylactic shock. The occurrence of an allergic reaction requires discontinuation of the preparation.
From the digestive system: individual cases of hypersensitivity to nifuroxazide are manifested by abdominal pain, nausea, vomiting and exacerbation of diarrhea. In the event of the appearance of such symptoms of low intensity, there is no need for special therapy or discontinuation of nifuroxazide, since the symptoms quickly disappear. If the exacerbation is severe, nifuroxazide should be discontinued.
Special instructions
If, during treatment with the preparation, the symptoms of diarrhea persist for more than 48 hours, the treatment should be reviewed and the use of the preparation should be evaluated.
The use of alcohol during therapy with nifuroxazide is prohibited due to the risk of developing a disulfiram-like reaction.
Treatment with nifuroxazide does not exclude dietary regimen and rehydration. If necessary, concomitant rehydration therapy should be used depending on the age and condition of the patient and the intensity of the diarrhea.
Rehydration should be a key element in the management of acute diarrhea in children. Children need to be provided with frequent (every 15 minutes) drinking.
Prevention or treatment of dehydration should be carried out by oral or intravenous solutions. If rehydration is prescribed, it is recommended to use solutions intended for this purpose, in accordance with the instructions for dilution and use. The amount of oral rehydration solutions provided depends on the weight loss. In case of severe diarrhea, intense vomiting and refusal to eat, IV rehydration is required.
If there is no need for such rehydration, it is necessary to compensate for the loss of fluid by drinking a large number of drinks containing salt and sugar (based on an average daily requirement of about 2 liters of water).
Consider dietary guidelines for diarrhea: avoid certain foods such as fresh vegetables and fruits, green vegetables, spicy foods, frozen foods and drinks. Preference should be given to grilled rice and meat. The decision to use dairy products should be made on a case-by-case basis.
If diarrhea is accompanied by clinical manifestations that indicate the progression of the condition (deterioration of the general condition, fever, symptoms of intoxication), nifuroxazide should be prescribed together with antibacterial preparations of systemic action, which are used to treat intestinal infections, since it is not absorbed in the intestine and does not enter the systemic circulation ...
The preparation should not be prescribed as monotherapy for the treatment of intestinal infections complicated by septicemia.
In the event of a hypersensitivity reaction (shortness of breath, swelling of the face, lips, tongue, skin rashes, itching), you should immediately stop taking nifuroxazide.
The preparation in the form of capsules contains FCF sunset yellow dye, which can cause allergic reactions.
The suspension formulation contains sorbitol. If a patient has an established intolerance to some sugars, a doctor should be consulted before using this medication.
Application during pregnancy or lactation. In animal studies, no teratogenic effects have been identified. There is not enough substantiated data to assess the possible teratogenic or fetotoxic effect when using nifuroxazide during pregnancy. Therefore, as a precautionary measure, it is recommended to avoid the use of nifuroxazide during pregnancy (it can be used in women during breastfeeding, subject to short-term treatment).
The ability to influence the reaction rate when driving vehicles or other mechanisms. Does not affect.
Interactions
Nifuroxazide can be used in combination with preparations commonly used to treat diarrhea: rehydration solutions, antibiotics, chemotherapy preparations, antispasmodics, and pain relievers.
The use of nifuroxazide with CNS depressants and preparations that may cause addiction is not recommended.
Concomitant use of other oral medicinal products should be avoided due to the strong adsorption properties of nifuroxazide.
Nifuroxazide is not recommended to be used simultaneously with sorbents, preparations that contain alcohol, agents that can cause antabuse reactions.
During treatment with nifuroxazide, alcohol consumption is strictly prohibited due to the possibility of a disulfiram-like reaction, which is manifested by exacerbation of diarrhea, vomiting, abdominal pain, a feeling of heat in the face and upper body, flushing, tinnitus, difficulty breathing, tachycardia.
Overdose
Overdose symptoms are not described. in case of suspicion of an overdose of nifuroxazide, the patient's condition should be carefully monitored, and supportive and symptomatic treatment should be prescribed.
Storage conditions
In original packaging. capsules - at a temperature not exceeding 30 ° c. suspension - at a temperature not exceeding 25 ° c.
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