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Phenobimine hydrochloride tablets

Product description

Approval date: 29 January 2007

 

 

Modified date: 01 October 2010

 

 

October 1st, 2012

 

 

November 30, 2015

 

 

Instructions for phenobimine hydrochloride tablets

 

 

Please read the instructions carefully and use them under the guidance of your physician.

 

 

[name of drug]

 

 

General name: phenobimine hydrochloride tablets

 

 

Phenoxybenzamine suitable Tablets

 

 

Yansuan Fenbianming Pian

 

 

The main ingredient of this product is phenobenzamine hydrochloride. Its chemical name is: N-(1- methyl -2- phenoxyethyl)-N-(2- chlorethyl) phenymethylamine hydrochloride.

 

 

Molecular formula: C18H22ClNO·HCl

 

 

Molecular weight: 340.29

 

 

[properties] this product is white sheet or film coating sheet, showing white after removing coating.

 

 

[indications]

 

 

1. Treatment and preoperative preparation of pheochromocytoma.

 

 

2. Peripheral vascular spastic disease.

 

 

3. Urinary retention caused by prostatic hyperplasia.

 

 

[specification] 10mg

 

 

[usage and dosage]

 

Dosage should be adjusted according to clinical response and urine catecholamines and their metabolites. Begin with 10mg(1 tablet) once a day, 2 times a day, and increase by 10mg(1 tablet) every other day until expected clinical efficacy or mild adverse reactions of alpha receptor blockade occur. Maintain at 20 ~ 40mg(2 ~ 4 tablets) twice daily.

 

[adverse reactions] common postural hypotension, nasal obstruction, dry mouth, pupil constriction, reflex rapid heartbeat and gastrointestinal stimulation. Rarely blurred consciousness, burnout, headache, impotence, lethargy, occasionally cause angina pectoris and myocardial infarction.

 

【 taboo 】

 

1. Low blood pressure.

 

2. Angina pectoris and myocardial infarction.

 

3. Allergic to this product.

 

[precautions]

 

1. Animal experiments show that long-term oral administration can cause gastrointestinal cancer.

 

2. When using this product, it is necessary to pay attention to the drop of blood pressure, which may aggravate cerebral ischemia.

 

3. Compensatory heart failure can cause reflex rapid heartbeat, resulting in decompensation of cardiac function.

 

4. Coronary heart disease patients can cause angina pectoris due to reflex accelerated heartbeat.

 

5. Renal dysfunction may lead to further impairment of renal function due to hypotension and renal ischemia.

 

6. Symptoms of upper respiratory tract infection may be aggravated by nasal obstruction.

 

7. Blood pressure should be measured regularly during medication.

 

8. When starting treatment of pheochromocytoma, it is recommended to determine the dosage of urinary catecholamine and its metabolites regularly.

 

9. Beta blockers can be added to reflex heart rate acceleration; Take with food or milk to reduce gastrointestinal irritation.

 

10. Epinephrine should not be used in excess of phenobenzyme, otherwise it will further aggravate hypotension, which is called the reverse effect of epinephrine.

 

[drugs for pregnant and lactating women]

 

The effect of this product on pregnancy has not been fully studied, only when it is very necessary for pregnant women to use this product. It is not known whether this product is secreted through milk, but for the sake of caution, lactation women should choose to stop or stop breastfeeding.

 

【 medicines for children 】

 

Oral, starting at 0.2mg per kg of body weight, twice daily; Or 6 ~ 10mg per square meter, once a day. Increment every 4 days until curative effect is obtained. The maintenance dose was 0.4 ~ 1.4mg per kg of body weight or 12 ~ 36mg per square meter of body surface area, and was taken orally 3 ~ 4 times a day.

 

[geriatric medication] is not clear. However, the elderly are sensitive to its antihypertensive effect, prone to low temperature, poor renal function, the use of this product should be careful.

 

[drug interactions]

 

1. When combined with sympathetic amines, the boost effect is weakened or disappeared.

 

2. Combined with guanidine, it is prone to postural hypotension.

 

3. When used in combination with diazine, it antagonizes the action of the latter in inhibiting insulin release.

 

4. This product can block the hyperthermia caused by levo-noradrenaline and the hypothermia caused by reserpine.

 

[drug overdose]

 

In case of postural hypotension, dizziness, fatigue, tachycardia, vomiting, drowsiness or shock, the drug should be stopped immediately and anti-shock treatment should be given at the same time. In light cases, the patient was placed in the low head and high foot decustrine position to restore oxygen supply to the brain. Severe hypotension requires intravenous administration of norepinephrine heavy tartrate to antagonize the alpha receptor block of phenobimine hydrochloride.

 

【 pharmacology and toxicology 】

 

Phenobimine hydrochloride tablets are long-acting alpha - receptor blockers (alpha 1, alpha 2). It ACTS on the post-holiday alpha adrenalin receptor to prevent or reverse the action of endogenous or exogenous catecholamine, so as to dilate peripheral blood vessels and increase blood flow. Blood pressure decreases slightly in the recumbent position and significantly in the upright position. A drop in blood pressure can reflexively cause an increase in heart rate.

 

In vitro Ames test for carcinogenic, mutagenic and reproductive toxic mouse lymphoma showed that phenobenzamine hydrochloride had mutagenic activity. There was no mutagenic activity in the micronucleus test. Peritoneal sarcoma can be induced by continuous intraperitoneal injection of phenbenzamine hydrochloride in rats or mice. Long-term oral administration of drugs in rats can cause gastrointestinal malignancies, most of which are non-glandular malignancies of the stomach. In the chronic oral experiment, the incidence of ulcerative or erosive gastritis in rats is high, which is related to the effect of drugs. No effect of phenobimine hydrochloride on reproduction was observed.

 

[pharmacokinetics]

 

After oral administration, about 30% phenobimine hydrochloride was absorbed in gastrointestinal tract, with half life (t1/2) of about 24 hours, lasting for 3 to 4 days. This product metabolizes in the liver, most drugs are discharged from the kidney and bile within 24 hours, and a few remain in the body for several days.

 

[storage] shading, sealed (10 ~ 30℃) storage.

 

[packaging] aluminum and plastic packaging, 24 pieces per box; Each box contains 48 tablets. Packed in aluminum foil, 20 pieces per box.

 

[validity period] 24 months

 

[executive standard] the second edition of Chinese pharmacopoeia in 2015

 

[approval document no.] Chinese medicine approval number H44021427

 

[production enterprise]

 

Company name: guangdong peidi pharmaceutical co., LTD

 

Production address: 66 peidi avenue, yueshan town, kaiping city, guangdong province

 

Zip: 529331

 

Telephone number :(0750)2789348 400-8899-328 (national service number)

 

Fax number :(0750)2789348

 

Web site: http://www.pdpharm.com

 
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