Kalipsol - Instructions For Use, Reviews, Price, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Calypsol

Calipsol: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Drug interactions
11. Analogs
12. Terms and conditions of storage
13. Terms of dispensing from pharmacies
14. Reviews
15. Price in pharmacies

Latin name: Calypsol

ATX code: N01AX03

Active ingredient: ketamine (ketamine)

Manufacturer: Gedeon Richter (Hungary)

Description and photo updated: 2018-23-11

Kalipsol is a drug for non-inhalation anesthesia.

Release form and composition

The release form of Kalipsol is a solution for injection (10 ml in dark glass vials, 5 vials in a cardboard box).

Composition for 1 ml of solution:

active ingredient: ketamine hydrochloride - 57.67 mg (in terms of ketamine - 50 mg);
auxiliary ingredients: sodium chloride, benzethonium chloride, water for injection.

Pharmacological properties

Pharmacodynamics

The active component of Calypsol is ketamine, which causes the so-called. dissociative anesthesia, which is a functional dissociation between the thalamo-neocortical and limbic systems. Its analgesic effect is already manifested at a subdissociative dose and is longer in time than anesthesia. Sedative and hypnotic effects are less pronounced. In the area of peripheral nerves and spinal cord, the substance exhibits a local anesthetic effect.

As a result of the use of ketamine, muscle tone does not change or may increase, and therefore the protective reflexes, as a rule, are not affected. The threshold of convulsive readiness does not decrease. Spontaneous breathing can cause an increase in intracranial pressure; therefore, guided breathing is recommended.

The ability of ketamine to induce sympathicotonia can lead to an increase in blood pressure (BP) and heart rate (HR), an increase in coronary blood flow increases myocardial oxygen demand. Ketamine has a direct antiarrhythmic effect on the heart and has a negative inotropic effect. The total peripheral vascular resistance (OPSR) remains unchanged.

The consequence of the use of ketamine is significant hyperventilation, while the parameters of blood gases do not change significantly. Calypsol has a relaxing effect on the muscles of the bronchi.

Ketamine does not affect metabolism, kidneys, liver, endocrine glands, gastrointestinal tract (GIT) and blood clotting.

Pharmacokinetics

absorption: ketamine is a fat-soluble compound; after intravenous (i / v) administration, its maximum concentration (C _max) in blood plasma is determined after 1 min, after intramuscular (i / m) administration - after 5–30 (on average 20) minutes; bioavailability with i / m administration - 93%;
distribution and metabolism: the substance binds to plasma proteins by about 47%; The α-phase, clinically manifested by an anesthetic effect, lasts 45 minutes. In tissues with a good blood supply (for example, in the brain), ketamine is distributed quickly. Its concentration in tissues corresponds to an open two-phase model. The termination of the anesthetic effect occurs as a result of the redistribution of the active substance from the central nervous system (CNS) to peripheral tissues with a weaker blood supply and its biotransformation in the liver with the formation of active metabolites, one of which has a hypnotic effect;
excretion: the substance is excreted by the kidneys, mainly (up to 90%) in the form of metabolites; the half-life (T _1/2) in the α-phase for ketamine is 10-15 minutes, in the β-phase - about 2.5 hours.

Indications for use

According to the instructions, Calipsol is recommended to be used for induction and basic anesthesia during the following short-term surgical interventions, painful diagnostic and instrumental manipulations (in combination with other drugs for anesthesia and local anesthetics or as monotherapy):

painful procedures (including changing dressings in patients with burns);
endoscopy;
neurodiagnostic examination (including pneumoencephalography, ventriculography, myelography);
painful manipulations in ophthalmology;
surgical interventions in the oral cavity or neck;
painful procedures on the ENT organs;
gynecological extraperitoneal surgery (including colpopexy);
operations in obstetrics, introduction to anesthesia during caesarean section;
painful manipulations in traumatology and orthopedics;
anesthesia in patients with arterial hypotension in a state of shock (due to the peculiarities of the effect of ketamine on cardiac activity and blood circulation);
anesthesia in patients for whom intramuscular administration of the drug is preferable (for example, in children).

Contraindications

severe / poorly controlled arterial hypertension with BP> 180/100 mm Hg. Art.;
diseases / conditions that can be complicated due to arterial hypertension (including congestive heart failure, severe cardiovascular pathologies, traumatic brain injury, intracranial hemorrhage, brain tumors, stroke);
anamnestic data on mental illness (schizophrenia, acute psychosis), convulsions;
eclampsia or preeclampsia;
hyperthyroidism (untreated or insufficiently treated);
hypersensitivity to the components of the drug.

Instructions for the use of Kalipsol: method and dosage

Recommended dosage of Kalipsol depending on the route of administration:

IV injection: the initial dose is 0.7–2 mg / kg body weight, the surgical stage of anesthesia lasts from 5 to 10 minutes, the effect after administration begins in about 30 seconds. For patients in serious condition (including in a state of shock) and elderly patients, it is recommended to administer a dose of 0.5 mg / kg of body weight;
i / m introduction: the initial dose is 4–8 mg / kg of body weight, the surgical stage of anesthesia lasts from 12 to 25 minutes, the effect after administration begins in a few minutes;
IV drip injection: 1 bottle (500 mg) of ketamine is diluted with 500 ml of saline or 5% dextrose / glucose solution. The initial dose is 80–100 drops per minute, the maintenance dose is 20–60 drops per minute (2–6 mg / kg / h).

If it is necessary to maintain general anesthesia, Kalipsol is injected intramuscularly or intravenously in an amount of from half to the whole initial dose.

Nystagmus and the patient's motor response to irritation indicate insufficient anesthesia; in this case, it may need to be administered in a repeated dose. However, involuntary limb movements can occur regardless of the depth of anesthesia.

Side effects

cardiovascular system: often - tachycardia, arterial hypertension; possibly - arterial hypotension, bradycardia, arrhythmia. The maximum increase in blood pressure is observed a few minutes after intravenous administration of Kalipsol, after 15 minutes blood pressure decreases to its original value; the cardiac stimulating efficacy can be prevented by the previous intravenous administration of diazepam at a dose of 0.2–0.25 mg / kg of body weight;
central and peripheral nervous system: an increase in skeletal muscle tone, often accompanied by tonic / clonic convulsive movements (not an indicator of a decrease in the depth of anesthesia, does not require an additional dose of Calypsol); during awakening, visual hallucinations, vivid dreams, emotional disturbances, psychomotor agitation, delirium, disorientation are possible (less often observed in patients under 15 years of age and after 65 years);
digestive system: nausea, drooling, vomiting, loss of appetite;
respiratory system (due to rapid administration or overdose): often - depression or respiratory arrest; rarely - laryngospasm;
organ of vision: possible - nystagmus, diplopia, moderate increase in intraocular pressure;
allergic and local reactions: rarely at the injection site - pain, rash; in isolated cases - transient erythema / measles-like rash, anaphylaxis;
other reactions: drug tolerance (as a rule, with repeated use of Calypsol for a short period; especially in young children; the desired effect in this case is achieved by a corresponding increase in the dose).

Overdose

Calipsol has a broad therapeutic index.

Overdose symptoms are depression / respiratory arrest.

Artificial ventilation is recommended until spontaneous breathing is fully restored.

special instructions

Calipsol can only be used by an experienced anesthesiologist in a specialized intensive care unit equipped with the necessary means.

Only after assessing the benefit / risk ratio of anesthesia, with special care, an anesthetic should be used in the following cases: within six months after the state of unstable angina pectoris, myocardial infarction; in patients with increased intracranial pressure, glaucoma, or penetrating eye injury; in case of alcohol intoxication.

The intravenous drug is injected slowly (over 1 minute). With the rapid introduction of Kalipsol, respiratory depression and a sharp increase in blood pressure are possible.

With arterial hypertension or heart failure during anesthesia, constant monitoring of heart function is required.

Since the introduction of Calypsol usually does not affect pharyngeal reflexes, mechanical irritation of the pharynx must be avoided. For surgical interventions on the pharynx, trachea or larynx, the combined use of Calypsol with other muscle relaxants, as well as careful breathing control, is necessary.

Operations involving the visceral pathways of pain transmission may require the administration of other pain relievers.

In obstetric interventions, during which complete relaxation of the muscles of the uterus is required, it is not recommended to administer ketamine as monotherapy.

Diagnostic / therapeutic interventions on the organ of vision are usually not performed under local anesthesia.

Upon recovery from anesthesia, acute delirium may begin. This reaction can be prevented by the administration of benzodiazepines or by reducing the effect of tactile, verbal and visual stimuli. This requires monitoring of vital indicators of the state of the body.

After the use of Calypsol in an outpatient clinic, the patient is released only after full recovery of consciousness, always accompanied by an adult.

Influence on the ability to drive vehicles and complex mechanisms

To restore the cognitive and psychophysical functions of the body after the use of Calypsol, the patient needs at least 12 hours. At this time, driving should be avoided, as well as performing other types of work that require increased concentration of attention and speed of psychomotor reactions.

Application during pregnancy and lactation

In experimental studies on animals, no teratogenic effects of ketamine were observed.

The use of Kalipsol for anesthesia during pregnancy is permissible after assessing the ratio of benefits to the mother and risks to the fetus. Ketamine crosses the placental barrier rapidly. In obstetrics, it should be used in low doses. The use of a dose of 2 mg / kg or more may cause respiratory depression in the newborn.

There are no data on the release of ketamine during lactation.

Drug interactions

When used simultaneously with barbiturates and opioid analgesics, ketamine potentiates their muscle relaxant effect, enhances the effectiveness of tubocurarine and ergometrine, but does not affect the effect of pipcuronium, pancuronium and succinylcholine.

The duration of action of ketamine is increased by means for inhalation anesthesia, including fluorinated hydrocarbons (enflurane, fluorotane, isoflurane, methoxyflurane), and barbiturates.

Sleeping pills (especially benzodiazepine derivatives) and antipsychotics (antipsychotics) prolong the effect of ketamine, reducing the likelihood of adverse reactions.

The simultaneous use of Calypsol with euphyllin can reduce the seizure threshold.

Calipsol is pharmacologically compatible with other muscle relaxants and anesthetics.

The use of Kalipsol in patients receiving thyroid hormones can lead to an increase in blood pressure and tachycardia.

Pharmaceutical interactions:

barbiturates: show chemical incompatibility with ketamine, they cannot be injected in the same syringe;
diazepam: should not be mixed with ketamine in the same syringe or infusion solution, they must be administered separately.

Analogs

Analogs of Kalipsol are: Ketalar, Ketamine, Ketazhest, Velonarcon, Ketanest, etc.

Terms and conditions of storage

Store in a dark place at a temperature of 15-30 ° C. Keep out of the reach of children.

The shelf life is 5 years.

Terms of dispensing from pharmacies

The drug is intended for hospital use only.

Reviews about Calypsole

Patients are actively discussing the drug on medical forums, but reviews about Calypsole are far from always positive. It is considered by many to be the cheapest type of anesthetic with severe adverse reactions in the form of hallucinations, confusion, unpleasant and even scary dreams. You should not rely on the objectivity of these reviews, since the selection of anesthesia is a difficult task, the solution of which can only be done by a professional anesthesiologist.

Price for Kalipsol in pharmacies

Since the drug is intended for distribution exclusively in specialized pharmacies for medical institutions, the price of Calypsol is unknown.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!