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  • Name: Ethambutol Hydrochloride Capsules
  • Add time: 2015-05-15
  • Views : 83

[Drug Name]
Generic Name:盐酸乙胺丁醇胶囊
English name:Ethambutol Hydrochloride Capsules
Pinyin:Yansuan Yi’andingchun Jiaonang 
Ingredient
Chemical Name: [2R, 2 [S- (R *, R *)] - R] - (+) 2,2 '- (1,2- ethanediyl two imino) - bis-1-butanol two hydrochloride
Chemical Structure:
[Character]
$ Capsule contents of the white crystalline powder.
Indications
This is suitable for combination therapy with other anti-TB drugs due to Mycobacterium tuberculosis and extrapulmonary tuberculosis, it can be used for atypical Mycobacterium tuberculosis infection.
[Specification]
0.25g
Dosage
Need to be used in combination with other anti-TB drugs.
1. Initial treatment: Oral, according to the weight 15mg / kg, day 1; or a 25 ~ 30mg / kg, the highest 2.5g, 3 times a week; or according to the weight 50mg / kg, the highest 2.5g 2 times a week.
2. retreatment: Oral, according to the weight 25mg / kg, day 1, 60 consecutive days, followed by weight 15mg / kg, day 1.
3. atypical Mycobacterium tuberculosis infection: according to the weight 15 ~ 25mg / kg, day 1.
Adverse reactions
1. Common optic nerve damage, such as retrobulbar optic neuritis, optic fiber damage center. This product may cause the copper, zinc and other metal elements chelated with those of metals in decline. After retrobulbar neuritis rate of about 0.8%, and the dose, treatment related, long-term medication, a daily dose of more than 25mg / kg is apt to occur, the daily dose of 15mg / kg incidence of 1%, 25mg / kg of 6%, 35mg / kg to 15%. Manifested as blurred vision, eye pain, color blindness or vision loss, reduced vision. He said early detection and timely response to withdrawal may disappear on their own within a few weeks or a few months, permanent loss of visual function rarely occurs.
2. Rare chills, joint pain (especially the big toe, condylar knee) and skin lesions of the articular surface tension flu fever (acute gout, hyperuricemia).
3. Occasional gastrointestinal discomfort, nausea, vomiting, diarrhea, liver damage, peripheral neuritis (usually numbness, tingling, burning pain or hand-foot weakness) and allergic reactions (usually a rash, itching, headache, fever, joint pain) and so on.
Taboo
Those who are allergic to the chemicals known to patients with optic neuritis, alcohol poisoning, and age <13 years of age should be used with caution.
[Precautions]
1. Gout, optic neuritis, diabetic retinopathy, liver and kidney dysfunction in patients with caution. Patients with renal dysfunction should be reduced.
2. Single FDA bacteria can develop resistance quickly, so you must combination with other anti-TB drugs.
3. During treatment should be checked:
(1) eye, vision, vision, red-green discrimination, etc., before treatment, the course checked once a month, especially the long course of treatment, daily doses greater than 15mg / kg of the patient.
(2) Since the product can make the blood uric acid concentration increased, causing gout attacks, so the treatment should be regularly serum uric acid.
4. Interfere with the diagnosis: taking the product can make the blood uric acid concentration increased measured values.
5. In the event of gastrointestinal irritation, it can be used with or without food. Daily dose divided doses may not reach the effective blood concentration, therefore the product should be administered once daily dose.
[Pregnant women and lactating women drug]
1. Due to be used through the placenta, fetal blood concentration of about 30% of maternal plasma concentration, animal experiments have shown the product can cause deformity, although not confirmed in humans, there is a problem, but pregnant women should remain FDA ban, if indeed There are trade-offs to be fully taken when indications.
2. This product can be secreted into milk, the concentration of maternal plasma concentration are similar, so the FDA ban lactating women, if there are indications of the need to take pause breastfeeding.
Pediatric Use
Children under the age of 13 is still a lack of clinical data, as in young children is not easy to monitor changes in vision, so the product should not be used in children under the age of 13; the same amount of children over the age of 13 and adults.
[Geriatric medicine]
Elderly patients with renal dysfunction due to physical, it should adjust the amount of kidney function.
Drug interactions
1. Aluminum, including DDI buffer may reduce the absorption of the product.
2. The goods and verapamil can reduce the absorption of the latter.
3. In combination with neurotoxic drugs can increase the neurotoxicity of this product, such as optic neuritis or peripheral neuritis.
4. Combined to increase hepatitis with jaundice and B isonicotinoyl amine, optic neuritis adverse reactions.
Overdosage
1. Overdose mainly for adverse reactions in the symptoms can be severe, a permanent optic atrophy.
2. Drug overdose treatment
(1) withdrawal.
(2) symptomatic treatment: ① retrobulbar optic neuritis who used vitamin B6, copper and zinc complex vitamins and the like. ② restore vision after optional dexamethasone 5mg, daily intravenous injections or ball; Tolazoline 12.5mg, after daily injections ball; hydrocortisone 200mg, daily intravenous infusion. Also be oral prednisone 20mg, 2 or 3 times a day. While giving vitamins. Recovery can be treated with acupuncture, oral methimazole, nicotinic acid, or placental tissue fluid daily intramuscular injection. Hemodialysis and peritoneal dialysis ③ necessary.
Pharmacology and Toxicology
1. Pharmacological product is a synthetic antibacterial anti-TB drugs. On the growth and reproduction of bacteria with strong activity against stationary phase bacteria almost no effect. To all types of mycobacteria highly antibacterial activity. Mycobacterium tuberculosis between this product with other drugs without cross-resistance phenomenon.
Mechanism of action of this product has not been fully elucidated, may inhibit the metabolism of sensitive bacteria, inhibiting the synthesis of RNA interference Mycobacterium tuberculosis protein metabolism, leading to bacterial death.
2. Toxicology large doses of this product in test mice can cause cleft palate, brain and spine malformations exposed; in the rat experiments can cause mild cervical abnormalities; in the rabbit test may cause one-eyed, short limbs and cleft palate Wait.
Pharmacokinetics
After oral administration through the gastrointestinal absorption of 75% to 80%, the peak time of 2 to 4 hours. In the body tissues are widely distributed, it can be concentrated in the erythrocytes (red blood cell concentrations up blood concentration of 2 to 3 times), kidneys, lungs, saliva and urine, pleural effusion, ascites concentration is very low. CSF plasma concentration of drug concentration of about 20% to 80%, apparent volume of distribution (Vd) is 1.6 ~ 3.9L / kg, protein binding rate of about 10% to 30%. Plasma elimination half-life (T1 / 2β) is from 2.5 to 4 hours, renal dysfunction may be extended to 7 to 15 hours, it should be dose adjustment. About 10% to 20% of the goods in the liver metabolism, the goods by glomerular filtration and tubular secretion discharged after administration about 50% to 90% of the drug within 24 hours of the prototype by renal excretion, approximately 15% No active metabolite, renal clearance (ClR) is 5.93 ~ 8.45ml / min / kg. Excreted unchanged in the feces of about 20%. Drug concentration in milk equivalent to about maternal plasma concentration. Hemodialysis and peritoneal dialysis to clear the goods.
[Storage]
Shading, sealed and stored in a dry place.
[Packaging]
Plastic bottles, 100 / bottle.
[Validity]
24 months
[Executive standard]
"Chinese Pharmacopoeia" 2010 edition Third Supplement
Approval Number
Zhunzi H21021909
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