Somazina 500 mg 4 ml/ 5 amp.

Trade Name:

SOMAZINA 500 mg solution for injection

5 ampoules of 4 ml solution for I/V or I/M injection

Composition:

Each 4 ml ampoule contains:

Citicoline 500 mg (as sodium salt)

Inactive ingredients:

Water for injection and hydrochloric acid or sodium hydroxide for pH adjustment.

Properties:

Pharmacotherapeutic group: Other psychostimulants and nootropics.

Citicoline stimulates the biosynthesis of structural phospholipids of the neuronal membrane as it is demonstrated in the magnetic resonance spectroscopy studies. Citicoline, through this action, improves the function of the membrane mechanisms, such as the functioning of the ionic exchange pumps and receptors inserted in the latter, the modulation of which is indispensable in neurotransmission.

Citicoline due to its membrane stabilising activity has properties which favour brain oedema reabsorption.

Experimental studies have shown that Citicoline inhibits the activation of some 

phospholipases (A1, A2, C and D), reducing the formation of free radicals, avoiding the destruction of membranous systems and preserving antioxidant defence systems as glutathione.

Citicoline preserves the neuronal energetic reserve, inhibits apoptosis and stimulates acetylcholine synthesis.

It has been experimentally shown that Citicoline also exerts a prophylactic neuroprotective effect in focal brain ischemic models.

Clinical trials have shown that Citicoline significantly increases the functional evolution of patients with acute ischemic cerebrovascular accident, coinciding with a lower growth of the brain ischemic injury in neuroimaging tests.

In patients with craniocerebral traumatisms, citicoline speeds up their recuperation and reduces the duration and intensity of the post-concussional syndrome.

Citicoline improves the level of attention and consciousness and acts favourably over amnesia and cognitive and neurological disorders associated with brain ischemia.

Indications:

• Stroke, Acute phase and its neurological sequelae.
• Traumatic Brain injury and its neurological sequelae.
• Cognitive and behavioural impairment secondary to chronic vascular and degenerative cerebral disorders.

Dosage and administration:

Adults:

The recommended dose is from 500 to 2,000 mg/ day depending on the severity of the symptoms to be treated.

It can be administered by intramuscular, slow intravenous route( from 3 to 5 minutes depending on the administered dose) or in intravenous drop perfusion ( drippin speed: 40-60 drops per minute ).

Elderly:

SOMAZINA does not need any specific dose adjustment for this age group.

Children: The experience in children is limited; therefore it may only be administered when the expected  therapeutic benefit is higher than any possible risk.

Side effects:

Very rare:

Psychiatric disorders: hallucinations

Nervous system disorders: cephalea, vertigo;

Vascular disorders: arterial hypertension, arterial hypotension;

Respiratory, thoracic and mediastinal disorders: dyspnoea;

Gastrointestinal disorders: nausea, vomiting, occasional diarrhoea;

Skin and subcutaneous tissue disorders: blush, hives, exanthems, purple;

General disorders and administration site conditions: shiver, oedema.

Contraindications:

-allergy to Citicoline or any excipient

-hypertonia of the parasympathetic

Warnings and precautions:

• When administered by intravenous route, the administration must be slow (from 3 to 5 minutes depending on the administered dose).
• When administered by intravenous drop perfusion, the dripping speed must be 40-60 drops per minute.
• In case of persistent intracranial haemorrhage, do not exceed the dose of 1000 mg daily by very slow intravenous administration (30 drops per minute).
• It must not be administered in conjunction with medications containing Meclofenoxate.
• SOMAZINA should not be used during pregnancy unless clearly necessary. That is, only when the expected therapeutic benefit is higher than any possible risk.
• SOMAZINA has no influence on the ability to drive and use machines.

Storage:

Store at a temperature not exceeding 30°C

Package:

Carton box holds a plastic container with 5 ampoules each 4 ml solution