Nivalin, 0.1% ampoule, 1ml, 10pcs

Composition

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1 ml of the solution contains:

Active ingredient:

galantamine hydrobromide 1 mg

excipients:

sodium chloride;

water for injection

Pharmacological action

Pharmaceutical Group:

cholinesterase inhibitor.

Pharmaceutical action:

Nivalin is a reversible acetylcholinesterase inhibitor. Facilitates the conduction of nerve impulses in the area of neuromuscular synapses, enhances the excitation processes in the reflex zones of the spinal cord and brain, penetrates well through the BBB.

Increases the tone and stimulates the contraction of smooth and skeletal muscles, the secretion of digestive and sweat glands, restores neuromuscular conduction blocked by curare-like non-depolarizing muscle relaxants. Causes miosis, spasm of accommodation, reduces intraocular pressure in angle-closure glaucoma.

Pharmacokinetics:  

Suction

After oral use, it is rapidly and completely absorbed into the gastrointestinal tract. Absolute bioavailability is high – up to 90%. The therapeutic concentration is reached 30 minutes after taking the drug. Cmax after taking the drug at a dose of 10 mg is reached by 2 hours and is 1.2 mg / ml.

Distribution After repeated use, the galantamine Css is set. To a small extent, it binds to blood proteins. Easily passes through the BBB.

Metabolism to a small extent (about 10%) is metabolized in the liver by demethylation.

Excretion1 / 2-5 hours Is excreted (unchanged and in the form of metabolites) mainly in the urine (up to 74%). Renal clearance is approximately 100 ml / min

. Pharmacokinetics in special clinical cases

In patients with Alzheimer’s disease, the concentration of galantamine in the blood plasma may increase. With moderate to severe liver and kidney function disorders, the concentration of galantamine in the blood plasma increases.

Indications

In neurology: traumatic injuries of the nervous system; cerebral palsy; spinal cord diseases (myelitis, poliomyelitis, poliomyelitis form of tick-borne encephalitis); mononeuritis; polyneuritis;polyneuropathy;polyradiculoneuritis; Guillain-Barre syndrome; idiopathic paresis of the facial nerve;myopathy;night urinary incontinence.

In anesthesiology and surgery: as an antagonist of non-depolarizing muscle relaxants and for the treatment of postoperative intestinal and bladder atony.

In physiotherapy: in the form of iontophoresis in diseases of the peripheral nervous system.

In toxicology: intoxication with anticholinergic drugs, morphine and its analogues.

In radiology: to improve the quality of functional diagnostics of the digestive system, including the gallbladder.

Contraindications

-bronchial asthma;— bradycardia— – AV block; – angina pectoris;— chronic heart failure in the stage of decompensation;- epilepsy— – hyperkinesis;- mechanical intestinal obstruction;- mechanical disorders of the urinary tract patency;- severe liver failure;— severe renal failure— – children under 1 year of age;— pregnancy— – lactation period;- hypersensitivity to the components of the drug. With caution, the drug is prescribed for renal failure, urination disorders, recently undergone surgery on the prostate gland, during surgical interventions with the use of general anesthesia. To improve the quality of X-ray examinations, the drug is not used in children.

Side effects

From the digestive system:  often – nausea, vomiting, cramping abdominal pain, diarrhea, increased salivation, anorexia; rarely-intestinal colic.

From the central nervous system:  often – fatigue, dizziness, headache, drowsiness; rarely-insomnia, visual disturbances (spasm of accommodation).

Other services:  increased sweating; rarely-rhinitis, bradycardia, urinary tract infection, bronchospasm, renal colic.

Interaction

Nivalin, when used simultaneously, reduces the depressing effect of morphine and its analogues on the respiratory center. When Nivalin is co-administered with m-holinoblockers (atropine), ganglioblockers (hexamethonium, azamethonium bromide, pachycarpine), non-depolarizing muscle relaxants (tubocurarin), quinine and novocainamide, the effect is mutually reduced.

Aminoglycoside antibiotics (gentamicin, amikacin) may reduce the therapeutic effect of Nivalin. When used simultaneously, it enhances the effect of depolarizing muscle relaxants.

When used concomitantly, cimetidine may increase the bioavailability of galantamine.

CYP2D6 and CYP3D4 are enzymes involved in galantamine metabolism. Quinidine, paroxetine, and fluoxetine are inhibitors of the CYP2D6 isoenzyme, while ketoconazole, zidovudine, and erythromycin are inhibitors of the CYP3D4 isoenzyme, so they can affect the metabolism of galantamine, which can lead to an increase in its concentration in blood serum.

How to take, course of use and dosage

The drug is administered subcutaneously, in / m, in/V. The dose and duration of the course of therapy are set individually, depending on the severity of the symptoms of the disease and the individual response of the patient. At the beginning of treatment, the drug is prescribed at a minimum dose, then it is gradually increased. For adults, the maximum single dose for subcutaneous use is 10 mg, the maximum daily dose is 20 mg.

The duration of treatment depends on the characteristics and severity of the disease and averages 40-60 days. The course of therapy can be repeated 2-3 times at intervals of 1-2 months.

The drug is administered 1 time/day. When using Nivalin in high doses, the daily dose can be divided into 2-3 injections. For adults, as an antagonist of non-depolarizing muscle relaxants, Nivalin is administered intravenously at a daily dose of 10-20 mg.

During X-ray examinations, the drug is administered to adults in / m at a dose of 1-5 mg.

In diseases of the peripheral nervous system and for the treatment of nighttime urinary incontinence in children, the drug is administered in the form of iontophoresis in a dose of 1-2 ml of 0.25% solution.

Overdose

Symptoms:  nausea, vomiting, spasms, diarrhea, decreased blood pressure, bradycardia, bronchospasm; in severe cases-convulsions, coma.

Treatment:  conduct symptomatic therapy, monitoring the function of the respiratory and cardiovascular systems. As an antidote – intravenous use of atropine at a dose of 0.5-1 mg iv; the dose can be re-administered depending on the clinical picture.

Special instructions

During the treatment period, it is necessary to refrain from driving or working with complex mechanisms, as the drug can cause visual impairment, dizziness and drowsiness.

Form of production

Solution for injection

Storage conditions

The drug should be stored in a dry place protected from light at a temperature not exceeding 25°C.

Shelf life

5 years

Active ingredient

Galantamine

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Description

Children as prescribed by a doctor, Adults as prescribed by a doctor, Children over 1 year of age

Indications

Neuritis, Sciatica, Alzheimer ‘s Disease