Universal reference book for medicines
Product name: NALBUFIN (NALBUPHIN)

Active substance: nalbuphine

Type: Opioid receptor antagonist.
Analgesic
Manufacturer: INTERNATIONAL PHARMACEUTICAL SERVISES (USA) manufactured by MOSHIMFARM PREPARATES them.
N.А. Semashko OJSC (Russia)
Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

PHARMACHOLOGIC EFFECT
Opioid analgesic, opioid receptor antagonist agonist.
Activates the endogenous antinociceptive system mainly through opioid? -receptors and thus disrupts the interneuronal transmission of pain impulses at various levels of the central nervous system, and also changes the emotional color of the pain, affecting the higher parts of the brain.
Has a comparable morphine analgesic effect, has a sedative effect, stimulates the vomiting center, causes miosis, inhibits conditioned reflexes.
To a lesser degree than the agonists of opioid? -receptors (morphine, promedol, fentanyl) depresses the respiratory center. Has no significant effect on hemodynamics and on the motility of the gastrointestinal tract.
The analgesic effect develops rapidly: with iv introduction, after a few minutes;
with a / m - after 10-15 minutes. The maximum effect is achieved in 1-2 hours, the duration of action is 3-6 hours.
PHARMACOKINETICS
Metabolised in the liver.

T 1/2 is 2.5-3 hours. Unchanged nalbuphine is excreted mainly with urine (about 70%), in the form of metabolites - mainly with bile.

INDICATIONS
Severe pain syndrome of various genesis (including in the postoperative period, with myocardial infarction, with gynecological interventions, with malignant neoplasms);
premedication before inhalation anesthesia, as a component of IV / anesthesia.
DOSING MODE
Individual.
Enter in / in, / m and s / k. For adults, the single dose varies from 100 μg / kg to 1 mg / kg. For children, the initial single dose is 300 μg / kg. The frequency of administration depends on the indications and the clinical situation. Duration of application - no more than 3 days.
SIDE EFFECT
From the side of the central nervous system and peripheral nervous system: often - drowsiness, retardation;
Possible - dizziness, imbalance, headache; rarely - nervousness, depression, confusion, dysphoria; in some cases - difficulty speech, blurred vision.
From the digestive system: nausea, vomiting, dry mouth.

From the side of the cardiovascular system: in some cases - arterial hypertension or hypotension, bradycardia, tachycardia.

Allergic reactions: in some cases - hives.

Other: sweating is possible.

CONTRAINDICATIONS
Hypersensitivity to nalbuphine.

PREGNANCY AND LACTATION
Use during pregnancy is possible only on strict indications.

Use with caution in preterm delivery and the alleged immaturity of the fetus (because nalbuphine penetrates the placental barrier and can cause respiratory depression in the newborn).

Use with caution during lactation (breastfeeding).

Nalbuphine is excreted in mother's milk in very small, clinically insignificant amounts (less than 1% of the administered dose).

APPLICATION FOR FUNCTIONS OF THE LIVER
In case of renal insufficiency, nalbuphine should be carefully dosed and provided for the possibility of rapid cessation of administration.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
In case of hepatic failure, nalbuphine should be thoroughly dosed and provided for the possibility of rapid discontinuation of administration.

APPLICATION IN ELDERLY PATIENTS
With caution should be used in the elderly.

SPECIAL INSTRUCTIONS
With caution should be used for violations of respiratory function (including with obstructive pulmonary disease, emphysema), because
Nalbuphine may cause a reduction in the minute volume of respiration by approximately 20-25% (when administered at a dose of 20 mg per 70 kg of body weight), with uremia, in the elderly, with severe depletion.
With caution and under constant supervision, nalbuphine should be used for trauma to the skull (due to the possible development of respiratory depression), increased intracranial pressure and pressure of CSF in the spinal canal.

In renal and hepatic insufficiency, nalbuphine should be thoroughly dosed and provided for the possibility of rapid cessation of administration.

Nalbuphine should not be combined with other opioid analgesics because of the risk of weakening analgesia and the possibility of provoking a withdrawal syndrome in patients with opioid dependence.

Under careful supervision and in reduced doses, nalbuphine should be used against the background of anesthetic agents, hypnotics, anxiolytics, antidepressants and antipsychotics (antipsychotics) in order to avoid excessive CNS suppression and inhibition of respiratory center activity.

Impact on the ability to drive vehicles and manage mechanisms

They are used with caution in outpatient settings in patients engaging in potentially hazardous activities requiring increased attention and high speed of psychomotor reactions.

DRUG INTERACTION
With simultaneous use with anesthetics, hypnotics, sedatives, anxiolytics (tranquilizers), antipsychotic drugs (antipsychotics), antidepressants, antihistamines with sedative effect, ethanol, the depressing effect on the central nervous system increases.

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