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MYOTONE 250mg and 1gm Injection

MYOTONE
Injection 250mg/1gm
Citicoline (as Sodium)

COMPOSITION
Each ampoule (2ml) contains
Citicoline..................250mg
Each ampoule (4ml) contains
Citicoline..................1gm

DESCRIPTION
Clear, colorless solution in amber glass ampoules.

INDICATIONS
Cognative disorder caused by head trauma and cerebral surgery. Concomitant therapy with anticholinergic agents in the following symptoms of Parkinson’s disease:

Adverse effect due to levodopa.
In case that administering of levodopa is not available due to celiotomy or complication In case that use of levodopa is not affective. Acceleration of upper limbs function recovery in patients with cerebral apoplexy hemiplegia-but only in case of relatively weak lower limbs paralysis after practicing rehabilitation  and  drug therapy (cerebral metabolism accelerator, cerebral vasodilator) with in one year following attack.Concomitant therapy with antiproteolytic in the following disease
Acute pancreatitis
* Stage of acute depravation of chronic recurrent pancreatitis.
* Acute pancreatitis after operation
* DOSAGE & ADMINISTRATION
Cognative disorder caused by head trauma and cerebraal surgery:
The usual adult dose is given 100-500 mg once or twice daily by I.M. or I.V. infusion.
Concomitant therapy with antichalinergic agents for Parkinson’s disease:
The usual daily dose is 500 mg given once daily, I.V with anticholinergic agent.
Following 3-4 weeks of highly effective treatment, administration of Myotone should be discontinued and progress should be  observed only under the treatment of antichloinergics.
If symtoms get worse, administration of levodopa should be considered. In case levodope can not be substituted, dose of anticholinergic agents can be increased or 250-500 mg of Myotone can be used once daily at 2-3 intervals of week. The use of Myotone should be discontinued if the two weeks concomitant therapy of 500 mg of Myotone and antichlonergics is not effective.
Hemiplegia after cerebral apoplexy: 250mg or 1000 mg of Myotone is administered. I.V once daily for four weeks.
Pancreatitis; 1000 mg of  Myotone is concomitantly administered with antiproteolytic agents by I.V once daily for two weeks,
* Dosage  schedule can be adjusted depending upon patients age and symptoms.

ADVERSE EFFECTS
Shock: Rarely, shock may occur. Therefore, it should be sufficiently observed, if
compression of chest, dyspnea have been developed , the administration should be
discontinued and/or appropriate therapy instituted. Hypersensitivity:  Since eruption may appear  occasionally,  the administration  should  be discontinued in this case.
Psychoneurologic: Headache, vertigo excitation, and cramp can be developed. If this drug is used in hemiplegia after cerebral apoplexy, sometimes numbness in paretic site may occur or increase.  
Gastrointestioal: Occasionally nausea,rarely anorexia may occur.
Hepatic: Abnormalities in hepatic test may occur.
Others: Sometimes burning sensation, temporay change of blood pressure, malaise may appear.

GENERAL PRECAUTIONS
In case of stupor caused by acute severe/progressive head trauma or cerebrat surgery. It should be given concomitant treatment with depressant and hypothermic agent.

DRUGINTERACTIONS
In combination of levodopa, this drug can increase effects of levodopa.

USE IN PREGNANCY
Since  it has  not been  established whether Myotone may adversely affect therapy of pregnant women, and this drug should not be used in pregnant women  or women of child bearing potential who might become pregnant unless the benefit of treatment is considered to out weight the risk

USE IN PEDIATRIC 
It has not been established whether Myotone may adversely effect children.

USE IN ELDERLY
Use  in  elderly  should  be  cautioned  about  manifestation  of  adverse  effects  and  prescribed cautiously.

CONTRA-INDICATION:
It is contraindicated in Asthmatic patients

CAUTIONS OF APPLICATION
Intramuscular administration should be cautioned in the following.
Intramuscular injection should be administered as a minimum dose, if only necessary, Special care should be taken in treat in neonate, immature infant, and children, Administration of Myotone near pathway of nerve should be avoided.
Injection site should be controlled because severe local pain or extravasation may have developed by Myotone administration.
Intravenous injection should be administrated as possible as slow.

STORAGE
Preserve in sealed containers. Store at room temperature (1-30OC).
Protect from heat, light and moisture.