Peiona solution for infusions 20 mg/ml. 1ml. ampoules №10

Description

Peiona storage
active substance: Caffeine citrate;
1 ml of the drug contains 20 mg of caffeine citrate (equivalent to 10 mg of caffeine);
excipients: citric acid, monohydrate; sodium citrate; water for injections.

Dosage form
Solution for infusion and oral administration.

Pharmacological properties
Caffeine is structurally related to methylxanthines theophylline and theobromine. Most of its effects are associated with antagonism of adenosine receptor subtypes A1 and A2A, as demonstrated by receptor binding assays and observed at concentrations approximately equal to therapeutic concentrations in these indications.
The main effect of caffeine is to stimulate the central nervous system. It is the basis of caffeine in apnea in premature infants and has several mechanisms, including:

• stimulation of respiratory centers;
• increase in minute volume of lungs ventilation;
• lowering the threshold of carbon dioxide in the blood;
• increasing the response to the content of carbon dioxide in the blood;
• increase the tone of skeletal muscles;
• reduction of diaphragmatic fatigue;
• increased metabolic rate;
• increased oxygen consumption.

Indication
Treatment of primary apnea in premature infants.

Contraindication
Hypersensitivity to the active substance or to any of the excipients.

Children
The drug Peiona is used in premature infants.

Use during pregnancy or breastfeeding
In animal studies, high-dose caffeine has been shown to be embryotoxic and teratogenic. Such effects are not associated with short-term administration in the group of premature infants.
Caffeine is excreted in breast milk and rapidly enters the bloodstream through the placenta.
Mothers who are breastfeeding newborns receiving caffeine therapy with citrate should avoid caffeinated foods, beverages, and medications.
In neonates whose mothers consumed large amounts of caffeine before delivery, the baseline plasma caffeine concentration should be determined prior to treatment with caffeine citrate.

Method of application and dosage
The start of Peiona therapy is allowed under the supervision of a physician with experience in resuscitation in newborns. The drug is prescribed only in the neonatal intensive care unit with the appropriate equipment for observation and monitoring.
Dosage
The recommended dose for first-time infants is 20 mg of caffeine citrate per 1 kg of body weight by slow intravenous infusion over 30 minutes using a syringe infusion machine or other adjustable infusion device. After 24 hours, maintenance doses of 5 mg per 1 kg of body weight by slow intravenous infusion for 10 minutes every 24 hours are allowed. Alternatively, oral maintenance doses of 5 mg per 1 kg body weight every 24 hours using devices such as a nasogastric tube are allowed.
Method of administration
Caffeine citrate can be administered by intravenous infusion or orally. The drug should not be administered by intramuscular, subcutaneous, intrathecal or intraperitoneal injection.
When intravenous caffeine is administered, citrate is administered by controlled intravenous infusion using a syringe infusion machine or other device for controlled infusions. Caffeine citrate can be administered without dilution or diluted with sterile infusion solutions such as glucose solution 50 mg / ml (5%), sodium chloride 9 mg / ml (0.9%) or calcium gluconate 100 mg / ml (10%), immediately after removal from the ampoule.

Overdose
According to published data, after overdose, the level of caffeine in plasma ranged from 50 mg / l to 350 mg / l.
Symptoms
In the literature, reports of symptoms of caffeine overdose in premature infants include hypoglycemia, hypokalemia, small limb tremor, agitation, hypertension, opisthotonus, tonic-clonic seizures, epileptic seizures, tachypnea, tachycardia, hemorrhoids, , syndrome of increased neuro-reflex excitability, elevated blood urea and leukocytosis, uncontrolled mobility of the jaw and lips. One case of caffeine overdose was reported to be complicated by intraventricular hemorrhage and prolonged neurological complications. There have been no reports of deaths from caffeine overdose in preterm infants.
Actions in case of overdose
In case of caffeine overdose, mainly symptomatic and maintenance therapy is performed. Potassium and glucose levels should be monitored and measures taken to correct hypokalaemia and hyperglycaemia. Studies have shown that plasma caffeine levels decrease after a replacement blood transfusion. Seizures may be administered by intravenous anticonvulsants (diazepam or barbiturates such as sodium pentobarbital or phenobarbital).

Side effects:

• Infections and invasions: sepsis;
• Disorders of the immune system: hypersensitivity reactions;
• Metabolism and nutrition disorders: hypoglycemia, hyperglycemia, delayed weight gain, food intolerance;
• Nervous system disorders: irritability, syndrome of increased neuro-reflex excitability, agitation, brain damage, convulsions;
• Hearing and balance disorders: deafness;
• Cardiovascular disorders: tachycardia, also associated with increased ejection of blood from the left ventricle and increased systolic volume of the heart;
• Digestive system disorders: belching, increased gastric aspirate, necrotic enterocolitis;
• General disorders and administration site conditions: phlebitis at the infusion site, inflammation at the infusion site;
• Research results: increased urination, increased levels of sodium and calcium in the urine, decreased hemoglobin, decreased thyroxine.

Expiration date
3 years.
After opening the ampoule – use the drug immediately.

Storage conditions
Store Peiona at a temperature not exceeding 25 ° C in the original package.
Keep out of reach of children.