Soholin Injection

Soholin®

Composition:
Each ml contains:
Citicoline sodium Equivalent to Citicoline 125 mg

Indications:
Acute stage:
Unconsciousness following cerebral trauma, traffic accident and brain operation.
Chronic stage:
Neural and psychiatric disorders (hemiplegia, dyskinesia, motorpalsy, aphasia, amnesia, disorientation and headache) following apoplexy and cerebral operation

Dosage and administration:
Acute stage:
250 - 500 mg, 1 to 2 times daily by intravenous drip or intravenous injection
Chronic stage:
100-300 mg 1-2 times daily by IV or IM injection
Dosage may be increased according to condition

Pharmacology:
Effect on disturbance of consciousness and hemiplegia after cerebral apoplexy: Citicoline improves EEG in patients with disturbance of consciousness. It also improves EEG in rats with anoxic or hypoxic brains and dogs with hypothalamic infarct.
Citicoline inhibits elevation of the thresholds for electrocorticographic arousal reaction and muscular discharge evoked by stimulation of the cerebral cortex and stimulates the ascending reticular activating system and pyramidal system to elevate both the level of consciousness and motor function (in rabbits).
In such experimental disease models as stroke-prone rats under experimentally cerebral ischemia, rats under cerebral ischemia-reperfusion, ischemic rats under hypoxia and, monkeys with experimental cerebral infarction, citicoline inhibits development of acute apoplectic stroke and neurological symptoms (disturbance of consciousness and motor disturbances), resulting in a decrease of the death rate.
In patients with cerebral circulatory disturbance, citicoline increases cerebral blood flow and decreases cerebral vascular resistance, thus improves cerebral circulation.
In particular, citicoline increases brain stem blood flow (in dogs). In patients with cerebrovascular disturbance, citicoline improves central motor function by increasing the decreased electromyographic maximum work of the paretic muscle and retarding the appearance of fatigue phenomenon under and exercise load.
Citicoline displays an improving action on cerebral function and disturbed metabolism by promoting glucose uptake of the brain (in rats under cerebral ischemia reperfusion and cerebral perfusion in cats) and inhibiting lactic acid accumulation in the brain (cerebral pel-fusion in cats), by improving depressed respiratory function of the cerebral mitochondria in rabbits with experimental cerebral infarction, by accelerating biosynthesis of acetylcholine from decreased levels of glucose due to ischemia and improving dopamine turnover (in rats), and by inhibiting radicalization of fatty acid in brain under ischemia (in rats). In cerebral ischemic rats, citicoline is incorporated into the nerve-cell membranous fraction and accelerates lecithin biosynthesis to improve lecithin metabolism.

Warning and precautions:

• General: For patients with acute, serious and progressive disturbance of consciousness accompanying head injury and brain - surgery, citicoline should be administered in conjuction with hemostatics and intracranial pressure relieving drug or treatment, eg. hypothermy.
• For patients with disturbance of consciousness in acute stage of cerebral infarction, start of citicoline is recommended within 2 weeks after apoplectic stroke.
• Cautions for usage
  Care should be made to avoid injection at sites a long the course of nerves. In case of intense pain or backflow of blood upon insertion of the injection needle, the needle should be withdrawn immediately and injected at a different site. In case of IV administration, inject as slowly as possible.

Side effects:

• Shock: since shock symptoms may rarely occur, close observation should be made. If such symptoms as dropped blood pressure, chest distressed feeling and dyspnea occur, citicoline should be immediately discontinued. Appropriate measures should be taken.
• Hypersensitivity: infrequently, such as hypersensitivity symptoms as rash, may occur. Discontinue administration of citicoline in such a case.
• Psychoneurologic system: infrequently occur or become intensified.
• Digestive: infrequently, abnormal hepatic function may be noted.
• Ophthalmic: rarely transient diplopia may develop.
• Others: infrequently, feeling of warmth may occur and rarely, transient blood pressure changes or malaise may occur.

Contra indications:
Patients with a history of hypersensitivity to any of the ingredients of this drug

Package:
Box of 5 ampoules @ 2 ml
No. Reg. DKL 0624221943A1

STORE BELOW 25°C, PROTECT FROM LIGHT

ON MEDICAL PRESCRIPTION ONLY

Manufactured by:
PT ETHICA
Jakarta - Indonesia

For:
PT SOHO Industri Pharmasi
Jakarta - Indonesia

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