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  • Name: Isoniazid Tablets
  • Add time: 2015-05-15
  • Views : 54

[Drug Name]
Generic Name:异烟肼片
English name:Isoniazid Tablets
Pinyin:Yiyanjing Pian
Ingredient
Chemical Name: 4-pyridine-carboxylic acid hydrazide
Chemical Structure:
[Character]
White or white film category.
Indications
(1) isoniazid and other anti-TB drugs for treatment of various types of tuberculosis, including tuberculous meningitis and other mycobacterial infections.
(2) isoniazid alone applicable to all types of TB prevention: ① newly diagnosed TB patients family members or close contacts; ② test tuberculin purified protein derivative (PPD) strongly positive chest X-ray examination at the same time in line with non-progressive tuberculosis, sputum negative, in the past had not received regular anti-TB treatment; ③ patients undergoing immunosuppressive drugs or long-term hormone therapy, certain blood diseases or reticuloendothelial system diseases (such as leukemia, Hodgkin ' disease), diabetes, uremia, silicosis or gastrectomy and other patients, the PPD test was positive reaction; patients test positive ④35 years old tuberculin purified protein derivative; ⑤ known or suspected as HIV infection, its tuberculin purified protein derivative test-positive people, or patients with active tuberculosis in close contact.
[Specification]
100mg
Dosage
Oral Prevention: Adult day 0.3g, Dayton clothing; children daily weight 10mg / kg, day total does not exceed 0.3g, Dayton clothing. Treatment: Adult and other anti-TB drugs, according to body weight daily oral 5mg / kg, the highest 0.3g; or daily 15mg / kg, maximum 900mg, 2 or 3 times a week. Children under weight daily 10 ~ 20mg / kg, per day of not more than 0.3g, Dayton clothing. Some children with severe tuberculosis (eg tuberculous meningitis), daily weight of up to 30mg / kg (maximum daily dose 500mg), but pay attention to the occurrence of liver dysfunction neuritis and peripheral.
Adverse reactions
The incidence of many who have unsteady gait or numbness tingling, burning or finger pain (peripheral neuropathy); dark urine, yellowing of the eyes or skin (liver toxicity, liver toxicity in patients over 35 years old increased incidence) ; poor appetite, unusual fatigue or weakness, nausea or vomiting (liver toxicity of prodromal symptoms). The incidence of very few who have blurred vision or vision loss, associated or not with eye pain (optic neuritis); fever, rash, cytopenia and male breast development. This product may cause neurotoxicity caused even twitch.
Taboo
Abnormal liver function, mentally ill and disabled patients with epilepsy.
[Precautions]
(1) cross-allergic reactions, p-ethyl amine isonicotinoyl, pyrazinamide, nicotinic acid or other chemical structure of drug allergies may be allergic to the chemicals.
(2) interfere with the diagnosis: urine determination of copper sulfate method showed a false positive reaction, but does not affect the results of the enzymatic assay. Isoniazid can serum bilirubin, alanine aminotransferase aspartate aminotransferase increased measured values.
(3) mental illness, epilepsy, severe renal dysfunction should be used with caution.
(4) If in the course of optic neuritis symptoms, eye examination should be carried out immediately, and regularly reviewed.
(5) isoniazid poisoning when large doses of vitamin B6 can be used against.
[Pregnant women and lactating women drug]
(1) It can cross the placenta, leading to fetal blood concentrations higher than the maternal plasma concentration. Animal experiments confirmed that isoniazid can cause stillbirth, but not yet confirmed in humans, the application must be fully weighed against pregnant women. When combined with other drugs isoniazid fetal effects has not been elucidated. In addition, the newborn medication should be closely observed adverse reactions.
(2) isoniazid in breast milk concentrations of up to 12mg / L, and plasma concentrations similar; although in humans has not been proven there is a problem, the application should still be fully weigh the nursing period. Such as medication are advised to stop breastfeeding.
Pediatric Use
Dosage and use strictly in accordance with the child.
[Geriatric medicine]
Patients over 50 years the FDA to cause higher incidence of hepatitis.
Drug interactions
(1) taking isoniazid daily drinking can lead to liver toxicity induced by the product, and accelerate isoniazid metabolism, and therefore need to adjust the dose of isoniazid and closely observe the signs of liver toxicity. Patients should be advised to avoid alcoholic beverages while taking this medicine.
(2) antacids containing aluminum can delay and reduce the absorption of isoniazid after oral administration, plasma concentration reduced, it should be taken to avoid both, or prior to oral antacids for at least 1 hour before taking isoniazid.
(3) anticoagulants (such as coumarin or indane diketone derivative) is applied simultaneously with isoniazid, due to inhibition of the enzyme metabolism of anticoagulants, so anticoagulation effects.
(4) and cycloserine may increase when the central nervous system side effects with the service (such as dizziness or drowsiness), the need to adjust the dose, and closely observe the signs of central nervous system toxicity, especially in the need to work with higher sensitivity patients.
(5) increases when rifampin and isoniazid hepatotoxicity risk, and in particular, liver dysfunction or fast acetylation of isoniazid, so in the first three months of treatment should be closely followed up there No signs of liver toxicity occurs.
(6) antagonists isoniazid vitamin B6, and vitamin B6 may increase excretion by the kidneys, which may lead to peripheral neuropathy, increase the vitamin B6 requirement of taking isoniazid.
(7) and adrenocorticotropic hormone (especially prednisolone) is combined to increase isoniazid in liver metabolism and excretion, causing the latter to reduce the plasma concentration and affect the efficacy of the fast acetylation more significant, the dose should be adjusted.
(8) and alfentanil (alfentanil) combination, since the drug isoniazid liver enzyme inhibitor, extended alfentanil effect; with disulfiram (disulfiram) can be combined to enhance its role in the central nervous system, vertigo, incoordination, irritability, insomnia; increase the combined form of inorganic fluorine nephrotoxic metabolite and enflurane.
(9) B isonicotinoyl amine or other anti-TB drugs, adverse reactions may increase both. Increase the liver toxicity of this product in combination with other hepatotoxic drugs, and therefore should be avoided.
(10) not with ketoconazole or miconazole isoniazid combination, because after can reduce blood levels of both.
(11) both inhibit the metabolism in the liver when combined with phenytoin or theophylline, resulting in phenytoin or theophylline blood concentration increased, so has both isoniazid and application or combination, phenytoin or theophylline dose should be adjusted.
(12) of acetaminophen in combination, since isoniazid may induce hepatic cytochrome P450, that the former is formed to increase the amount of toxic metabolites, increase liver toxicity and kidney toxicity.
(13) simultaneously with the application carbamazepine, isoniazid inhibits its metabolism, increased plasma concentrations of carbamazepine, and cause toxic reactions; carbamazepine can induce microsomal metabolism of isoniazid, to form a liver intermediate metabolites increased toxicity.
(14) The product should not be combined with other nerve poisons, so as not to increase neurotoxicity.
Overdosage
Not to proceed with the experiment and no reliable references.
Pharmacology and Toxicology
This product is a synthetic antibacterial agent having a bactericidal action, this product is only for mycobacteria, mainly growth and reproduction of bacteria effectively. Its mechanism of action has not been elucidated, may inhibit sensitive bacteria mycolic acids (mycolic acid) leaving the cell wall synthesis break.
Pharmacokinetics
The goods quickly after oral absorption from the gastrointestinal tract and distributed in the body tissues and fluids, including cerebrospinal fluid, pleural effusion, ascites, skin, muscle, milk and cheese-like tissue. You can cross the placental barrier. Protein binding rate 0 to 10%. Orally 1 to 2 hours up to the peak plasma concentration, but 4 to 6 hours after the plasma concentration of acetylated speed depending on the patient rather than a fast acetylation, T1 / 2 0.5 to 1.6 hours, slow acetylation of 2 to 5 hours, liver and kidney dysfunction may be extended. Metabolism acetylation mainly in the liver from inactive metabolites, some of which have liver toxicity. Acetylation rate determined by heredity. Liver often slow acetylation N- acetyltransferase enzyme deficiency, acetylation of isoniazid may not be part of the combination.
This product is mainly excreted by the kidneys (about 70%), discharge within 24 hours, mostly inactive metabolites. Fast acetylation of 93% to acetylation excreted in the urine, slow acetylation of 63%. Fast acetylation of isoniazid 7% of the urine in free or combined form, and slow acetylation was 37%. This product is easy through the blood brain barrier, it can be discharged from the milk, a small amount from saliva, sputum and feces. A considerable amount of isoniazid may be hemodialysis and peritoneal dialysis.
[Storage]
Shading, sealed and stored in a dry place.
[Packaging]
Plastic bottles, 100 / bottle.
[Validity]
36 months
[Executive standard]
"Chinese Pharmacopoeia" 2010 edition two
Approval Number
Zhunzi H21022350
Manufacturer
Company Name: Shenyang Hongqi Pharmaceutical Co., Ltd.
Production Address: Shenyang Hunnan new network on the 6th Street Postcode: 110179
Phone Number: (024) 2,378,626,023,786,261
Fax: (024) 23786263

 


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