Butorfanol

Butorfanol – drug of group of opioid non-narcotic analgesics for stopping of pain syndromes of various etiology.

Form of release and structure

Colourless, transparent or poorly opalescent solution of 2 mg/ml for intramuscular or intravenous administration. Is issued in:

• Ampoules, of 1 ml, transparent or dark glass (in blister strip packagings on 5 pieces, in a pack of cardboard 1, 2, 4, 10 or 20 packagings, packs are supplied with an ampoule knife);
• The syringe tubes, of 1 ml (in a pack the cardboard 1, 2 or 5 syringe tubes).

Active ingredient – a butorfanola tartrate.

Auxiliary components: Trilonum of B, sodium citrate, citric acid, sodium chloride, water for injections.

Indications to use

Butorfanol is shown:

• At pains which reasons malignant new growths are;
• At the expressed pain syndromes of various origin (including at operative measures, and also the preoperative and postoperative periods);
• At childbirth (if the fruit has no symptoms of pre-natal pathology).

Contraindications

Contraindications to Butorfanol's use are:

• The increased intracranial pressure;
• Respiratory depression;
• Craniocereberal injuries;
• Oppression of TsNS;
• Alcoholic psychosis and acute alcoholic states;
• Spasms;
• Renal and liver failure;
• Bronchial asthma;
• Arterial hypertension;
• Heart failure;
• Disturbance of a rhythm of cordial reductions;
• Acute myocardial infarction;
• Acute surgical diseases of abdominal organs (before establishment of the diagnosis);
• Medicinal dependence to morfinopodobny drugs (Promedolum, Morphine, Fentanyl).
• Hypersensitivity to drug components;
• Pregnancy and the period of a lactation (except removal of a pain syndrome at childbirth and preparation for them);
• Age up to 18 years.

Drug is not appointed against the background of treatment MAO inhibitors, and also within 2 weeks after their cancellation.

To apply with care at advanced age (after 65 years).

Route of administration and dosage

The drug is administered intravenously or intramusculary. The dose of drug is defined by individually attending physician.

Depending on age and a condition of the patient the drug is administered in the following dosages:

• For removal of a pain syndrome – 1 mg intravenously or 2 mg intramusculary, every 3-4 hour as necessary;
• For premedication – 2 mg intramusculary in 1-1,5 hours prior to operation or the same dose intravenously just before the beginning of operation;
• When carrying out the general anesthesia – 2 mg intravenously, before administration of thiopental of sodium, then add 0,5-1 mg for maintenance of necessary depth of an anesthesia. The full dose of Butorfanol demanded for carrying out the general anesthesia can vary from 4 to 12,5 mg;
• During childbirth – 1-2 mg of drug intramusculary or intravenously, to women in labor on duration of gestation not less than 37 weeks, only at absence at a fruit of symptoms of pre-natal pathology. More often than 1 time at 4 o'clock it is not necessary to administer the drug, the last injection has to be made not less, than in 4 hours prior to delivery.

Elderly people (65 years are more senior) are recommended to reduce a dose twice, and to increase an interval between introductions till 6 o'clock.

Side effects

Most often Butorfanol's use can cause dizziness, drowsiness, nausea and vomiting. Other side effects from bodies and systems are seldom possible:

• Bodies of digestive tract: seldom - a lock, anorexia, dryness of a mucous membrane of an oral cavity, pain in epigastriums;
• Cardiovascular system and blood (hemostasis, hemopoiesis): seldom - heartbeat, a vazodilatation; extremely seldom - a syncope, decrease or increase in arterial pressure, thorax pain, tachycardia;
• Nervous system and sense bodys: seldom - euphoria, confusion of consciousness, concern, nervousness, sleeplessness, drowsiness, paresthesia, a headache, an adynamy, a tremor, a ring in ears, eye pain, an illegibility of visual perception, a lethargy; extremely seldom - agitation, hostility, unusual dreams, a dysphoria, hallucinations, вертиго, a depression, a withdrawal;
• Allergic reactions: extremely seldom – urticaria, rash;
• Other: seldom – an itch, the increased perspiration, feeling of heat; extremely seldom – shallow breathing, urination reduction.

Also in the course of post-marketing observations were noted: spasms, an apnoea, nonsense, tranzitorny difficulty of the movement and the speech (connected with excessive influence of drug), medicinal dependence.

Side effects which the overdose by Butorfanol can cause: hypothermia, arterial hypotension, cardiovascular insufficiency, hypoventilation, struporous or coma. At overdose it is required to support adequate lung ventilation, a system hemodynamics and body temperature. At respiratory depression introduction of the specific opioid antagonist Nalokson – 0,4-2 mg intravenously is possible. It is necessary to provide the patient with continuous observation, if necessary to carry out artificial ventilation of the lungs.

Special instructions

Before therapy by Butorfanol it is necessary to hold a complex of the events directed to full removal from an organism of narcotic substances at patients with drug addiction in the anamnesis.

In the course of preparation for childbirth it is possible to appoint drug only on condition of careful medical control.

During treatment it is not necessary to be engaged in potentially dangerous types of works requiring special attention and high speed of psychomotor reactions.

Throughout all course of treatment it is not necessary to use ethanol.

It is not recommended to use drug as anesthetic at short operative measures as the long postanesthetic depression of breath is possible.

It is not necessary to combine administration of drug with reception of other opioid analgetics as the probability of weakening of an analgesia and provoking of a withdrawal at patients with opioid dependence is high.

Against the background of use of hypnotic drugs and means for the general anesthesia, in order to avoid excessive suppression of activity of a respiratory center and strengthening of oppression of TsNS, drug is accepted in the reduced doses and under careful medical observation.

It is necessary to consider that Butorfanol:

• Pharmaceutical it is incompatible with barbiturates, diazepam;
• Loses efficiency at simultaneous use with the local vasoconstrictors entered intranazalno;
• Strengthens effect of drugs, the oppressing TsNS (anxiolytics, barbiturates, antipsychotic means, ethanol, blockers histamine H1 receptors).

Analogs

Butorfanol's analogs are: Stadol, Vero-Butorfanol.

Terms and storage conditions

To store in the unavailable to children, protected from light place, at a temperature of 5-30 °C. Not to freeze.

Solution period of validity – 2 years.