Nefopam (nefopam) ampoules 20 mg/ml. №3

Description

Nefopam composition
active substance: nefopam;
1 ml of solution contains nefopam hydrochloride 20 mg;
Excipients: sodium phosphate dihydrate, anhydrous sodium hydrogen phosphate, water for injections.

Dosage form
Solution for injection.

Pharmacological properties
Nefopam is a non-narcotic analgesic that is structurally different from other analgesics. Experimental studies indicate a central effect, which is to inhibit the reuptake of dopamine, norepinephrine and serotonin at the synapse level. In animals, nefopam showed antinociceptive activity by possibly reducing the release of glutamate at the presynaptic level and activating N-methyl-D-aspartate receptors at the postsynaptic level. Nefopam has shown a positive effect on postoperative tremor in clinical trials. Nefopam has no anti-inflammatory or antipyretic effect, does not suppress respiration and does not affect intestinal motility. Nefopam has a slight anticholinergic effect.

Indication
Postoperative analgesia as part of multimodal analgesia (nefopam also has positive properties to prevent postoperative tremor).
Pain syndrome of various etiology and intensity (trauma, pain after surgery, analgesia, toothache, myalgia, renal and hepatic colic). Premedication before painful medical procedures.

Contraindication
Hypersensitivity to nefopam or to other components of the drug. Convulsions or their history. Risk of urinary retention associated with urethral prostatic disorders. Risk of acute glaucomatous attack. Concomitant use of MAO inhibitors.

Children
Do not apply to children under 15 years.

Use during pregnancy or breastfeeding.
The drug is not used during pregnancy or breastfeeding.

Method of application and dosage
Therapy should be appropriate to the intensity of the pain and the patient’s response. Intramuscular injection. Nefopam should be administered intramuscularly deep. A dose of 20 mg is recommended for one injection. If necessary, the injection is repeated every 6 hours. The maximum daily dose is 120 mg.
Intravenous administration. Nefopam should be administered as a long-term intravenous infusion at a rate of not more than 5 mg / min for at least 15 minutes, the patient should be in a supine position. The single dose per injection is 20 mg. If necessary, the injection is repeated every 4 hours. The maximum daily dose is 120 mg.
Input method.
Nefopam can be administered in the usual solution for infusion (0.9% sodium chloride solution or 5% glucose solution). The optimal ratio for dilution – 1 ampoule of the drug in 50 ml of solution for infusion
The course of treatment – no more than 8-10 days.

Overdose
Symptoms: tachycardia, convulsions, hallucinations, agitation.
Treatment: symptomatic treatment, cardiac and respiratory monitoring in the hospital.

Side effects:

• From the central nervous system: drowsiness, dizziness *, syncope, convulsions *, tremor, blurred vision, insomnia, headache, paresthesia.
• From the psyche: agitation *, irritability *, hallucinations, drug addiction, confusion.
• From the heart: tachycardia *, hypotension, palpitations *.
• From the digestive tract: nausea, vomiting, dry mouth *, abdominal pain, diarrhea.
• From the urinary system: rarely there may be a change in urine color, urinary retention.
• Immune system disorders: Hypersensitivity reactions, including urticaria, Quincke’s edema, anaphylactic shock.
• General disorders: hyperhidrosis, malaise, changes in the injection site.

Expiration date
3 years.

Storage conditions
Store in a dry place at a temperature of 15-25 ° C.
Avoid freezing.
Keep out of reach of children.