Approval Date: 09/01/2007
Revision Date: 01/10/2010
Revision Date: 01/12/2015
Revision Date: 07/18/2016
Revision Date.
Benfotiol Hydrochloride Tablets Instructions
Please read the instruction manual carefully and use under the guidance of your physician
Not recommended for patients with glaucoma, urinary retention, or prostate enlargement.
[Drug Name].
Generic Name: Benadryl Hydrochloride Tablets
English Name: Trihexyphenidyl Hydrochloride Tablets
Hanyu Pinyin: Yansuan Benhaisuo Pian
[Ingredient
The main ingredient of this product is Benhaisuo Hydrochloride.
Chemical name: (±)-α-cyclohexyl-α-phenyl-1-piperidinepropanol hydrochloride.
Chemical structure formula.
Molecular Formula: C20H31NO-HCl
Molecular weight: 337.93
[Properties
This product is a white tablet with an indentation in the middle of one side.
[Indications
For Parkinson’s disease, Parkinson’s syndrome. It can also be used for drug-induced extrapyramidal disorders.
[Specification
2mg
[Dosage].
Orally. For Parkinson’s disease and Parkinson’s syndrome, start with 1~2mg a day, then every3to55increase2mgday by day until the best efficacy without side effects, usually not more than10mg in3to4times and must be taken for a long time. Extreme doses of 20 mg a day. Drug-induced extrapyramidal disorders, first day2 to 4mg in2 to3doses, gradually increasing to5to10mg.
Older patients should reduce the dosage as appropriate. .
[Adverse Reactions
Dry mouth and blurred vision are common. Tachycardia, nausea, vomiting, urinary retention, and constipation are occasionally seen. Long-term application may result in drowsiness, depression, memory loss, hallucinations, and cloudy consciousness.
30-50% of patients will have mild side effects, such as dry mouth, blurred vision, dizziness, mild nausea or nervousness. However, such reactions from the administration of benzhexol hydrochloride are much milder than those from the belladonna alkaloids and are usually less severe than the unremitting symptoms of Parkinson’s syndrome. As treatment continues, these reactions will gradually decrease or even disappear. Until such reactions disappear spontaneously, they can be controlled by adjusting the dosage form, drug dose, and interval between doses.
Purulent mumps due to excessive oral dryness, rash, colonic dilatation, paralytic intestinal obstruction, and certain psychiatric symptoms such as delusions and hallucinations, as well as a case of suspected paranoia, all of which may have occurred as a result of benzhexol hydrochloride administration, have been reported in a few cases. in the treatment of any atropine-like drug.
Patients with atherosclerosis or a history of other drug-specific conditions may experience reactions such as confusion, anxiety, behavioral disorders, or nausea and vomiting. Patients may improve tolerability with low starting doses and slowly increasing doses until an effective therapeutic dose is reached. If a severe reaction occurs, dosing should be stopped for a few days and then restarted at a lower dose. Psychosis may be a persistent euphoria due to drug abuse (leading to overdose).
Potential side effects associated with any atropine-like drug use include constipation, drowsiness, delayed or retained urination, tachycardia, pupillary dilation, increased intraocular pressure, weakness, vomiting, and headache.
Cases of angle-closure glaucoma have been reported with long-term use of benzedrine hydrochloride.
[Contraindication
It is contraindicated in cases of hypersensitivity to any of the ingredients of this product.
Not recommended for patients with glaucoma, urinary retention, or prostatic hypertrophy.
[Caution].
Forbidden to take when the drug properties change.
Keep this medication out of the reach of children.
Patients treated with Benzedrine hydrochloride should be evaluated with an anterior chamber examination and monitored closely for intraocular pressure on a regular basis.
Although benfotiol hydrochloride is not contraindicated in patients with cardiac, hepatic, or renal disease or hypertension, the above patients should be closely monitored when given this product.
In some cases, long-term administration of Benfotiol hydrochloride may be required, and given its atropine-like nature, patients should undergo continuous careful long-term observation to avoid allergic and other adverse reactions. Because of its parasympathetic activity, Benzedrine hydrochloride should be contraindicated in patients with glaucoma, obstructive gastrointestinal or genitourinary tract disease, and in elderly male patients who may have prostate enlargement. Older patients, especially those over 60 years of age, often have increased sensitivity to this class of drugs and therefore require strict dose modulation. Parasympathomimetic drugs may trigger early glaucoma, such as Benzedrine hydrochloride.
Late onset dyskinesia may occur in some patients receiving either long-term treatment with antipsychotics or discontinuation of treatment. Anti-Parkinsonian medications do not relieve the symptoms of tardive dyskinesia and in some cases may make it worse. However, patients treated with chronic antipsychotic medications often have both Parkinson’s syndrome and delayed-onset dyskinesia, and these Parkinson’s syndrome symptoms have been relieved with anticholinergic therapy with Benzedrine hydrochloride. [For pregnant and lactating women].
This trial was not performed and no references are available.
[Pediatric Use
This trial was not performed and no references were available.
[Geriatric use
Long-term use in the elderly may lead to glaucoma. Those with arteriosclerosis are prone to confusion, disorientation, anxiety, hallucinations, and psychotic-like symptoms with commonly used anti-Parkinsonian drugs, and should be used with caution.
[Drug Interactions
1. When combined with ethanol or other central nervous system depressants, this product may enhance central depressant effects.
2. When combined with amantadine, anticholinergics, monoamine oxidase inhibitors pagylin and procarbazine, this product may enhance the anticholinergic effect and paralytic intestinal obstruction may occur.
3. Combination of this product with monoamine oxidase inhibitors may lead to hypertension.
4. The efficacy of this product may be diminished when combined with acid-suppressing drugs or adsorbent antidiarrheal agents.
5. When this product is combined with chlorpromazine, the latter is metabolized faster and its blood concentration can be reduced.
6. The combination of this product with cardiac glycosides may prolong the residence time of the latter in the gastrointestinal tract, increase the absorption, and make it easy to be poisoned.
[Drug overdose
Symptoms of poisoning: In overdose, dilated pupils, increased intraocular pressure, palpitations, tachycardia, difficulty urinating, weakness, headache, redness, fever, or abdominal distension are seen. Sometimes accompanied by psychosis, delirium, delusions, hallucinations and other toxic psychiatric symptoms. In severe cases, coma, convulsions, and circulatory collapse may occur.
Treatment: induce vomiting or gastric lavage, take measures to increase excretion, and administer appropriate symptomatic and supportive therapy depending on the condition.
[Pharmacology and Toxicology
This product is a central anticholinergic anti-Parkinson’s drug that works by selectively blocking cholinergic pathways in the striatum with less peripheral effects, thereby facilitating the restoration of dopamine and acetylcholine balance in the brain of patients with Parkinson’s disease and improving their Parkinson’s disease symptoms.
[Pharmacokinetics
After oral administration, it is rapidly and completely absorbed and can cross the blood-brain barrier, with an onset of action in 1 hour and a duration of action of 6-12 hours. It is also a good choice for those who want to take advantage of the benefits of the new product.
[Storage].
Seal and store.
[Package
Packaged in high-density polyethylene bottles of 100 tablets per bottle for oral solid dosage.
[Expiry date
12 months
[Execution Standard
[Approval Number
State Pharmacopoeia H12020224
[Drug Listing Permit Holder
Name: Tianjin Lisheng Pharmaceutical Co.
Registered Address: No. 16, Saeda North Road, Xiqing Economic Development Zone, Tianjin
[Manufacturer
Company Name: Tianjin Lisheng Pharmaceutical Co.
Manufacturing Address: No. 16, Saeda North Road, Xiqing Economic Development Zone, Tianjin
Postal Code: 300385
Tel: 022-27366012
Fax Number: 022-27364239
Website: www.lishengpharma.com
Toll free consultation: 4006490098