Description

Nalbufin (nalbuphine hydrochloride) #10 vials         

Active Substance: Nalbuphine

Each 1 ml of solution contains:
– Nalbuphine hydrochloride 10 mg
– Excipients: Sodium citrate, anhydrous citric acid, sodium chloride, water for injections.

Release Form:
Nalbufin is available in the form of an injectable solution (10 mg/ml).

Pharmacological Properties:
Nalbufin is an opioid analgesic (pain reliever) that affects the higher brain regions, disrupting the transmission of pain impulses between neurons at different levels of the central nervous system. It also has a sedative (calming) effect, causes miosis (constriction of the pupils), inhibits conditioned reflexes, and stimulates the vomiting center.

Indications:
Nalbufin is prescribed for moderate to severe pain syndrome (4-10 points on the VAS – visual analogue scale). It can be used as an adjunct for anesthesia and for pain relief in the pre-/postoperative period, as well as during childbirth.

Contraindications:
– Hypersensitivity (allergies)
– Children under eighteen years of age
– Respiratory depression
– Severe depression of the brain
– Head injury
– Alcoholic intoxication
– Alcoholic psychosis
– Increased intracranial pressure
– Renal/hepatic failure
– Acute surgical pathologies of the abdominal organs (without performing an appropriate preliminary diagnosis), as it may mask their manifestations.

Nalbufine should be prescribed with caution to the elderly and to patients with exhaustion.

Children:
Not recommended for pediatric use.

Use During Pregnancy and Lactation:
Nalbuphine should not be used during pregnancy (except for pain relief during labor) or breastfeeding.

Method of Administration and Dosage:
Nalbufin is administered intravenously and intramuscularly. The dose should be calculated based on pain intensity, the patient’s physical condition, and concomitant medications. Typically, 0.15 to 0.3 mg/kg of the patient’s body weight is administered intravenously or intramuscularly for pain syndrome. A single dose can be administered every 4-6 hours if necessary. The maximum single dose for adults is 0.3 mg/kg of body weight, and the maximum daily dose is 2.4 mg/kg of body weight.

For myocardial infarction, 20 mg of the drug, slowly injected into a vein, is often sufficient, but the dose may need to be increased to 30 mg. If there is no clear improvement in pain, another 20 mg can be administered after 30 minutes.

When using Nalbuphine as an adjunct to anesthesia, higher doses are required than for analgesia.

For premedication: 100-200 μg/kg of body weight. During intravenous anesthesia: for induction, 0.3-1 mg/kg over 10-15 minutes, and for maintenance, 250-500 μg/kg slowly intravenously every 30 minutes.

For analgesia during childbirth, the drug should be used in a dose of 20 mg intramuscularly.

With caution, the drug should be prescribed to elderly patients and those with general exhaustion and insufficient respiratory function. In such cases, treatment should start with the lowest effective doses due to the increased risk of adverse reactions.

Overdose
In the event of an overdose, naloxone should be administered intravenously, as it is the specific antidote. If necessary, medications that elevate blood pressure are employed, and oxygen is supplied to the patient. Detoxification and symptomatic therapy are also administered.

Side Effects
Most commonly, patients experience sedation. Furthermore, the use of this medication may lead to the occurrence of abdominal cramps, drowsiness, nausea, dizziness, headaches, excessive sweating (hyperhidrosis), depression, dysphoria, hot flashes, confusion, dry mouth, visual disturbances, vomiting, bradycardia/tachycardia, neurotic reactions, speech disorders, urticaria, as well as mood fluctuations and changes in blood pressure. Local reactions such as local edema, tenderness, a sensation of warmth or burning, and redness (hyperemia) are also possible.

Storage conditions and periods
Store no more than 2 years at a temperature not exceeding +30 ° С.