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  • Name: Ethambutol Hydrochloride Tablets
  • Add time: 2015-05-15
  • Views : 131

[Drug Name]
Generic Name:盐酸乙胺丁醇片
English name:Ethambutol Hydrochloride Tablets
Pinyin:Yansuan Yi’andingchun Pian

Ingredient
Chemical Name: [2R, 2 [S- (R *, R *)] - R] - (+) 2,2 '- (1,2- ethanediyl two imino) - bis-1-butanol two hydrochloride
Chemical Structure:
 
Formula: C10H24N2O2 • 2HCl
Molecular Weight: 277.23
[Character]
White tablets.
Indications
Apply to tuberculosis and other anti-TB caused by Mycobacterium tuberculosis drug combination therapy. It can be used for tuberculous meningitis and SARS
Mycobacterium tuberculosis infection.
[Specification]
0.25g
Dosage
1. The amount of adult common with other anti-TB drugs, TB treatment early, according to the weight 15mg / kg, once daily Dayton clothing; or oral administration of 25 ~ 30mg / kg, the highest 2.5g, 3 times a week; or 50mg / kg, up to 2.5g, 2 times a week. Tuberculosis retreatment, according to the weight 25mg / kg, once daily Dayton clothing, for 60 days, followed by weight 15mg / kg, once daily Dayton clothing. Atypical mycobacterial infections, daily 15 ~ 25mg / kg, a Dayton clothing.
2. The amount used in children under 13 years old should not be using; the same amount of children and adults over 13 years old.
Adverse reactions
1. The incidence of the higher number of blurred vision, eye pain, color blindness or vision loss, reduced vision (optic neuritis-prone body weight daily dose 25mg / kg or more). Changes in vision can be unilateral or bilateral.
2. The person less incidence of chills, joint pain (especially the big toe, condylar knee), the joint surface of the skin lesions fever taut feeling (acute gout, hyperuricemia).
3. The incidence of those rare rash, fever, joint pain and other allergic reactions; or numbness, tingling, burning pain or weakness of hand-foot (peripheral neuropathy).
Taboo
Not to proceed with the experiment and no reliable references.
[Precautions]
1. interfere with the diagnosis: taking the product can make the blood uric acid concentration increased measured values.
2. The following should be careful: gout, optic neuritis, kidney dysfunction.
3. During treatment should be checked:
(1) eye, vision, vision, red-green discrimination, etc., before treatment, treatment of daily checks, especially courses
Long, daily doses greater than 15mg / kg of the patient;
(2) serum uric acid, due to the onset of serum uric acid concentration increased, causing gout. Therefore, in the course of treatment should be measured regularly.
4. The gastrointestinal tract irritation, ethambutol can with clothes and food. Daily dose divided doses may not reach the effective blood concentration, therefore a daily dose of this product should be a Dayton clothing.
5. Bacteria can develop resistance quickly 5. ethambutol alone, so you must combination with other anti-TB drugs. This product is used in patients who have received anti-TB drugs, should be at least one or more drugs in combination.
6. In view there is no practical method measured plasma concentration, dose should be calculated according to the weight of the patient. Patients with liver or kidney dysfunction, the product may increase the plasma concentration, half-life. Renal dysfunction in patients with the application required reductions.
[Pregnant women and lactating women drug]
1. ethambutol can cross the placenta, fetal blood concentration of about Mother plasma concentration of 30%. The goods in mice high doses can cause cleft palate, brain and spine malformations exposed; rats high doses of this product may cause mild cervical abnormalities; in rabbits high doses of this product may cause Cyclopia, short limbs, cleft lip and cleft palate and other deformities. Although not confirmed in humans, pregnant women still fully weigh the application. This product in combination with other drugs on the fetus are unknown.
2. ethambutol may be distributed to the milk, similar to the concentration and plasma concentration, although not confirmed in humans have problems lactating women must weigh.
Pediatric Use
Children under the age of 13 is still a lack of clinical data. Because young children is not easy to monitor vision changes, so this product is not recommended for children under 13 years of age.
[Geriatric medicine]
The elderly often accompanied by physiological renal dysfunction, renal function should therefore adjust the dosage.
Drug interactions
1. isonicotinoyl amine and acetic combined increase adverse reactions.
2. with the use of aluminum hydroxide reduces absorption of the product.
3. neurotoxic drugs in combination with this product can increase neurotoxicity, such as optic neuritis or peripheral neuritis.
Overdosage
Not to proceed with the experiment and no reliable references.
 Pharmacology and Toxicology
This product is a synthetic antibacterial anti-TB drugs. Its mechanism of action has not been fully elucidated. It can penetrate the body interfering RNA synthesis mycobacteria, thereby inhibiting the propagation of bacteria, this product only to the growth and reproduction of mycobacteria effective. So far not found the goods with other anti-TB drugs have cross-resistance.
Pharmacokinetics
After gastrointestinal absorption after oral 75% to 80%. Widely distributed in body tissues and fluids (except cerebrospinal fluid). Within the red blood cell concentration and plasma concentration equal to or for the 2-fold, and sustainable 24 hours; the higher the kidneys, lungs, saliva and the urine drug concentration within; but pleural effusion and ascites, the concentration is lower. This product can not penetrate normal meninges, but tuberculous meningitis in cerebrospinal fluid of patients may have trace. Its volume of distribution of 1.6L / kg. Protein binding rate of about 20% to 30%. Oral administration of 2 to 4 hours up to the peak plasma concentration, half-life (Т1 / 2) of 3 to 4 hours, renal dysfunction may be extended to eight hours. Mainly by the liver, about 15% of the dose is metabolized to inactive metabolites. By glomerular filtration and tubular secretion discharge; after administration about 80% within 24 hours of discharge, at least 50% of the prototype excretion, approximately 15% to inactive metabolites. Excreted unchanged in the feces of about 20%. Milk in concentrations approximately equivalent to maternal blood concentration. A considerable amount of ethambutol can be cleared from the body by hemodialysis and peritoneal dialysis.
[Storage]
Shading, sealed and stored.
[Packaging]
Plastic bottles, 100 / bottle.
[Validity]
24 months
[Executive standard]
"Chinese Pharmacopoeia" 2010 edition Third Supplement
Approval Number
Zhunzi H21022349
Manufacturer
Company Name: Shenyang Hongqi Pharmaceutical Co., Ltd.
Production Address: Shenyang Hunnan New District envelope 6th Street
Postal Code: 110179
Phone Number: (024) 2,378,626,023,786,261
Fax: (024) 23786263

 

The above is for reference
If you have questions can contact the manufacturer