Prothionamide instructions for use, contraindications, side effects, warnings. Prothionamide - instructions from the application.
Side effects of protionamide appear from the side duct-intestinal tract, liver, skin, endocrine and nervous system.
From the side of the shlunkovo-intestinal tract: loss of appetite, tedium, vomit, dryness, and a metal tingle in the mouth. If you give the drug, the appearances, as a rule, will disappear quickly.
Often, the hour of rejoicing is indicated by the presence of transaminases in the blood. Rarely, manifestations of impaired liver function with signs of hepatitis and zhovtyanitsy are observed. Hepatotoxicity of the drug can occur in cases of obvious damage to the liver function, such as liver failure due to alcoholism or after surgical intervention. qi side effects especially indicated in combination therapy with isoniazid, rifampicin and prazinamide.
Shkirnі reactions are noted rarely, in other ways, pellagro-like reactions are described, apparently up to a combination of skin manifestations and damage to the side of the central nervous system.
Some people are afraid of destruction from the side of the endocrine system. A series of developments of hypoglycemia (decrease in blood glucose less than 50 mg%) in patients with diabetes mellitus, development of gynecomastia (decrease thoracic ulcers in people). Rarely, menstrual cycle disorder and impotence, as well as hypothyroidism (decreased function of the thyroid gland), are observed.
Prothionamide can be used elsewhere damage to the peripheral and central nervous system. In combination with isoniazid, polyneuropathy has been described. Taking protionamide can cause confusion, headaches. Impaired concentration of respect, disorder of the psyche (rarely - neuritis of the optic nerve, tachycardia). Overnight use of other anti-tuberculosis drugs that affect the CNS, such as isoniazid or cycloserine, can lead to exacerbation of CNS side effects. The same effect can be caused by an overnight intake of alcohol. In a few cases, allergic reactions and damage to the side of the cystic brain are described.
Anti-tuberculosis zasіb of the II row, for the chemical structure, close to etionamide.
Drug: PROTHIONAMIDE
Active speech to the drug:
protionamide
ATX coding: J04AD01
CFG: anti-tuberculosis drug
Registration number: P №010795
Date of registration: 26.08.05
Vlasnik of the register. credit: PROMED EXPORTS Pvt. Ltd. (India)
Protionamide release form, drug packaging and warehouse.
Tablets, covered with a shell of yellow color, round, biconvex. Pigulki, covered with shell 1 tab. protionamide 250 mg
Additional speech: povidone, starch, silica dioxide (anhydrous), talc cleansers, magnesium stearate, croscarmellose sodium.
Warehouse of the hull: hypromellose, titanium dioxide, purifying talc, diethyl phthalate, quinolin zhovtii.
10 pieces. - blisters (5) - packs of cardboard.
10 pieces. - blisters (10) - packs of cardboard.
10 pieces. - blisters (200) - packs of cardboard.
1000 pcs. - Polyethylene bags (1) - Plastic cans.
DESCRIPTION OF ACTIVE SPEECH.
All information provided is presented only for familiarization with the drug;
Pharmacological action Protionamide
Anti-tuberculosis zasіb of the II row, for the chemical structure, close to etionamide. Die bacteriostatically. Between protionamide and etionamide there is a clear cross-resistance.
Pharmacokinetics.
If I take internal protionamide, it is good to get wet from the PCT. Cmax in blood plasma is reached after 2 years. Widely distributed in tissues and tissues of the body, including the spinal cord. Metabolized by 2 metabolites - active sulfoxide and inactive. Seen from the section, less than 1% in apparently unchangeable speech.
Indication before zastosuvannya:
Tuberculosis (with resistance to therapy and intolerance to drugs in the first row).
Dosing and administration of the drug.
For internal intake in mature adults, administer at a cob dose of 250 mg 3 times per doba, then - 500 mg 2 times per doba. For children, the dose should be 10-20 mg/kg.
anti-tuberculosis drug
Release form, warehouse and packaging
Coated tablets yellow color, round, biconvex.
| 1 tab. | |
| protionamide | 250 mg |
Additional speeches: povidone, starch, silica dioxide (anhydrous), talc cleansers, magnesium stearate, croscarmellose sodium.
Shell warehouse: hydromelose, titanium dioxide, purification talc, diethyl phthalate, quinolin yellow.
10 pieces. - blisters (5) - packs of cardboard.
10 pieces. - blisters (10) - packs of cardboard.
10 pieces. - blisters (200) - packs of cardboard.
1000 pcs. - Polyethylene bags (1) - Plastic cans.
Pharmacological activity
Anti-tuberculosis zasіb ІІ row. It is bacteriostatic, blocking the synthesis of mycolic acids, which is the most important structural component of the clitin wall of mycobacterium tuberculosis. May the power of the antagonist of nicotinic acid. AT high concentrations disrupting the synthesis of microbial cell protein and bactericidal action. Effective against mycobacterium tuberculosis, resistant to drugs of the 1st line. The stagnation in other cases of anti-tuberculosis diseases reduces the development of resistance to tuberculosis.
Pharmacokinetics
Prothionamide is readily absorbed from the intestinal tract, creating Cmax in blood plasma 2-3 years after ingestion. Penetrates in health and pathological changes in tissue (tuberculosis middle and cavities in the leg, serous and purulent pleural effusion, spinal cord in meningitis). In the body, it is often converted to sulfoxide, which leads to tuberculostatic activity. Frequently excreted at a constant sight (up to 15-20% of the dose taken) through the stool and faeces.
Indication
Prothionamide zastosovuetsya on the treatment of all forms of tuberculosis, zocrema. with resistance to other anti-tuberculosis drugs (I row) or intolerance to them.
Contraindication
- Virazkov's ailment of the slug and twelve-fingered intestines;
- host gastritis;
- Erosive-virazic colitis;
- chronic alcoholism;
- vaginess;
- lactation period;
- Individual sensitivity to the components of the preparation.
W thrift- bloody diabetes, severe liver failure.
Dosing
Accept internally after you go.
Doroslim prescribe 0.25 g 3 times per doba; with good tolerance - 0.5 g 2 times per doba.
At ailments older than 60 years and with body weight less than 50 kg the additional dose is not guilty of overdosing 0.75 g (often prescribe 0.25 g 2 times per dose).
Children prescribe 10-20 mg/kg body weight/day.
Pobichna diya
Side effects of protionamide are manifested from the side of the intestinal tract, liver, skin, endocrine and nervous system.
3 side herbal systems: loss of appetite, tedium, vomiting, dryness and hypersalivation, metal licking in the mouth. If you give the drug, the appearances, as a rule, will disappear quickly. Often, there is an increase in transaminase levels at the hour of the lure. Rarely, manifestations of impaired liver function with signs of hepatitis and zhovtyanitsy are observed. Hepatotoxicity of the drug can occur in cases of obvious damage to the liver function, such as liver failure due to alcoholism or after surgical intervention. These side effects are especially pronounced in combination therapy with isoniazid, rifampicin, and pirazinamide.
From the side of the skinny curves: are noted rarely, in other ways, pellagro-like reactions are described, apparently up to a combination of skin manifestations and damage to the side of the central nervous system.
From the side of the endocrine system: In a row with the development of hypoglycemia (decrease in blood glucose less than 50 mg%) in patients with diabetes mellitus, the development of gynecomastia (reduction of chest ulcers in people) has been described. Rarely, menstrual cycle disorder and impotence, as well as hypothyroidism (decreased function of the thyroid gland), are observed.
From the side of the CNS: in combination with isoniazid, polyneuropathy has been described. Taking protionamide can cause confusion, headache, weakness, impaired concentration of respect, mental disorder. Rarely - neuritis of the zotor nerve, tachycardia. Overnight use of other anti-tuberculosis drugs that affect the CNS, such as isoniazid or cycloserine, can lead to exacerbation of CNS side effects. The same effect can be caused by an overnight intake of alcohol. In a few cases, allergic reactions and damage to the side of the cystic brain are described.
Medical interaction
When combined therapy for tuberculosis, the additive hepatotoxic effect of the other drugs was taken into account. It is especially recommended to combine prothionamide with isoniazid, rifampicin and pirazinamide.
An additive effect on the CNS is seen with the total intake of isoniazid and cycloserine.
Odnochasne vzhivannya alcohol lead to depression of the central nervous system.
In severe cases, when taking protionamide, it is necessary to change the dose of insulin or oral antidiabetic drugs.
especially vkazіvki
Sliding intolerance of chronic congestion of prothionamide and alcohol through the inability to become addicted to CNS depression (causing increased toxic effects of alcohol).
When combined with protionamide with isoniazid and cycloserine, special attention is paid to the possibility of mental damage.
Oskilki drug constantly zastosovuetsya in combination with other anti-tuberculosis drugs, the need for regular monitoring of serum transaminases, gamma-glutamate transferase and puffer phosphatase.
In patients with diabetes mellitus, it is necessary to control the level of glucose in the blood at least once a month.
Skin and especially mucus reactions can be the first signs of pellagro-like side effects. Tse slid razzinuvaty as the reason for the need to administer the drug.
Vagity and lactation
It is contraindicated before congestion with pregnancy and during lactation.
Zastosuvannya in a child's life Wash that term of saving
The term of appurtenance - 4 years. The drug should be taken at a temperature of 30°C in a protected area of light and inaccessible to children.
International name
Protionamide (Protionamide)Group affiliation
Anti-tuberculosis zasibDescription of fluent speech (INN)
ProtionamidePharmaceutical form
Coated tabletsPharmacological activity
Anti-tuberculosis drug of the 2nd line, according to the chemical structure, close to etionamide.
Blocking the synthesis of mycolic acids, which is the most important structural component of the clitin wall of mycobacterium tuberculosis, may have the power of the nicotinic acid antagonist. At high concentrations, it disrupts the synthesis of microbial cell protein. May be bacteriostatic, mainly on mycobacterium tuberculosis, which multiply (including atypical), on post- and internally rotting microorganism.
Secondary stability develops quickly. Between protionamide and etionamide there is a clear cross-resistance.
Indication
Tuberculosis (legene and post-legal forms, resistant to treatment with anti-tuberculosis LDs of the 1st row or with poor tolerance): infiltrative, virazkovy and exudative processes.Contraindication
Hypersensitivity, hostritis gastritis, Viraz's disease of the mucosa and duodenum, Viraz's colitis, cirrhosis of the liver, vaginess, lactation period, child's age. With care. Blood diabetes, severe liver failure.Pobichna diya
On the side of the herbal system: nausea, vomit, diarrhea, hypersalivation, "metal" mucus in the mouth, impaired liver function.
The “Antibiotics catalogue” section has a complete database of drug prescriptions. Please leave your thoughts on the effectiveness of the drug Protionamide, the instructions for which are given below. Your comments may be brown to other brownies.
Virobniki Rusan Pharma Ltd.
Dyuchi speeches
- Lomefloxacin
- pyridoxine
- Pirazinamide
- Ethambutol
- Not specified. Div. instruction
- Not specified. Div. instruction
Pharmacological activities
- Anti-tuberculosis
- Other synthetic antibacterial agents
Indication for zastosuvannya.
Multi-resistant tuberculosis with a deadly resistance to MBT (isoniazid - up to 10, rifampicin - up to 40, ethambutol - up to 2 mcg / ml), acutely progressing tuberculosis.
Tuberculosis due to concomitant inflammatory diseases causing non-specific pathogenic flora sensitive to lomefloxacin
Form of release of the drug Protionamide
coated tablets 250 mg; packaging contour oseredkov 10 cardboard pack 5;
Pigulki, covered with shell 250 mg; a package (bag) of polyethylene 100, a jar (jar) of polyethylene 1;
Pigulki, covered with shell 250 mg; a package (bag) of polyethylene 1000, a jar (jar) of polyethylene 1;
Pigulki, covered with shell 250 mg; a package (bag) of polyethylene 500, a jar (jar) of polyethylene 1;
Pigulki, covered with shell 250 mg; a package (bag) of polyethylene 3000, a jar (jar) of polyethylene 1;
Pigulki, covered with shell 250 mg; a package (bag) of polyethylene 50, a jar (jar) of polyethylene 1;
Pharmacodynamics
Blocking the synthesis of mycolic acids, which is the most important structural component of the clitin wall of mycobacterium tuberculosis; May the power of the antagonist of nicotinic acid. At high concentrations, it disrupts the synthesis of microbial cell protein.
Repair bacteriostatic disease. Active, especially in the sour medium, prominently Mycobacterium tuberculosis, which sporadically and commensurately reproduce, rotting postures - and internally. In high concentrations, there are Mycobacterium leprae and atypical mycobacteria.
Substance of phagocytosis in the cavity of specific inflammation. In the process of treatment, the resistance of microorganism is blamed for a short time, and there is an overlap of resistance to etionamide.
Galmuє development of resistance to other anti-tuberculosis diseases.
To be tolerated more quickly, lower etionamide.
Pharmacokinetics
Swidko vmoktuєtsya іz shlunkovo-intestinal tract, Cmax in the blood reach in 2-3 years after receiving internally. Easily penetrates health and pathological changes in tissues (tuberculosis follicles, including encapsulation, cavities in legenia, serous and purulent pleural effusion, cerebrospinal root in meningitis), penetrates through the placental barrier.
Metabolized in the liver, often converted to sulfoxide, which leads to tuberculostatic activity. T1/2 becomes 2-3 years. It is important to be excreted by nirks, up to 15-20% is excreted in the unchanging mind.
Vykoristannya to the drug Protionamide pіd hour vagіtnostі
Contraindicated for vagity; Protionamide crosses the placenta. For an hour of jubilation, follow baby shower(data about penetration into breast milk ni).
Contraindication to congestion
Hypersensitivity, hostile gastritis, Viraz's disease of the duodenum and twelfth intestine, Viraz's colitis, cirrhosis of the liver and other diseases of the liver in the acute phase, chronic alcoholism, nirkov's deficiency, child's age (it is not recommended to recognize children under 14).
Pobichna diya
On the side of the nervous system and organs are sensitive: confusion, headache, impaired concentration of respect, paresthesia, hallucinations, arousal, anxiety, drowsiness or sleeplessness, depression, weakness.
From the side of the organs of the mucosal-intestinal tract: dyspeptic manifestations (metal mucus in the mouth, rotten smell, nausea, vomiting), anorexia, dryness in the mouth or hypersalivation, diarrhea, flatulence, abdominal pain, hepatotoxic reactions up to the development of hepatitis.
Others: tachycardia, disruption of the menstrual cycle, changes in body mass, episodes of hypoglycemia in patients with diabetes mellitus, and other allergic reactions.
Method of stosuvannya that dose
Into the middle, after all.
Doroslim - 250 mg 3 times a day; with good tolerance - 0.5 g 2 times per doba. In patients over 60 years of age, with a body weight of less than 50 kg, the additional dose should not be increased to 0.75 g (often 0.25 g is prescribed 2 times per dose). For children, 10–20 mg/kg/day is administered from rosemary.
Overdose
Chi is not described.
Interaction with other drugs
Strengthens the toxic effect of alcohol. In case of vicarious disease, synergism is manifested in the same time with other anti-tuberculosis diseases. With one-hour administration of isoniazid, rifampicin, and pirazinamide, the risk of hepatotoxicity is increased, with cycloserine, sudomitis is more frequent. For an hour of rejoicing in patients with diabetes mellitus, adjust the dose of insulin or oral hypoglycemic diseases. To change the rizik rosette side effects, take vitamin B6 at a dose of 150–300 mg/day.
Caution against prescription of Protionamide
Before the jubilation, it is necessary to study the SHKT and the functions of the liver. During the first hour of treatment, it is necessary to control the level of activity of hepatic transaminases, gamma-glutamate transferase and puffer phosphatase, patients with diabetes mellitus - regularly administer the level of glycemia.
For an hour of likuvannya, the next thing is to get used to alcohol. To protect the waters of transport facilities and people, the activity of which will require increased concentration of respect.
Wash away the savings
List B.: In the dry, protected view of the light of the world at room temperature.
The term of appurtenance
ATH-classification:
J Antimicrobial preparations for systemic congestion
J04 Drugs active against mycobacteria
J04A Anti-tuberculosis drugs
J04AD Disposal of thiocarbamide
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