Naropin injection 10mg ml 10ml ampoule N5
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Active ingredients
Ropivacaine
Composition
1 ml of ropivacaine hydrochloride (in the form of monohydrate) 10 mg. Excipients: paraffin (paraffin white soft), beeswax white, propylene glycol monostearate.
Pharmacological effect
Local anesthetic long-acting amide type. Reversibly blocks voltage-dependent sodium channels and, thus, prevents the generation of impulses in the terminations of sensory nerves and conduction of impulses along the nerve fibers. The duration of action depends on the route of administration and the dose of the drug.
Indications
Anesthesia for surgical interventions: - epidural blockade for surgical interventions, including cesarean section. - blockade of large nerves and nerve plexuses. - blockade of individual nerves and local infiltration anesthesia. Relief of acute pain syndrome: - long-term epidural infusion or intermittent bolus administration, for example, to eliminate postoperative pain or anesthesia of childbirth. - blockade of individual nerves and local infiltration anesthesia.
Contraindications
- hypersensitivity to local anesthetics amide type.
Use during pregnancy and lactation
Naropin can be used during pregnancy only if justified by the clinical situation. However, in obstetrics, the use of the drug for anesthesia or analgesia is well founded. Ropivacaine in a small amount can penetrate into breast milk, which should be considered when you need to use the drug during lactation (breastfeeding).
Dosage and administration
Before anesthesia, it is necessary to assess the general and physical condition of the patient to select the optimal dose of the drug. For adults, the doses recommended for the most common blockades are given in the table. In general, anesthesia for surgical interventions (for example, for epidural administration) requires higher doses of the drug and more concentrated solutions. for pain relief (for example, epidural administration for the relief of acute pain) it is recommended to use lower doses and concentrations of the drug.Anesthesia for surgical interventions Concentration of the drug (mg / ml) Solution volume (ml) Dose (mg) Onset of action (min) Duration of action (h) Epidural anesthesia at the lumbar level: surgical intervention 7.5 15-25 113-188 10-20 3- 5 10 15-20 150-200 10-20 4-6 cesarean section 7.5 15-20 113-150 10-20 3-5 Epidural anesthesia at the chest level: for example, postoperative anesthetic blockade 7.5 5-15 38-113 10-20 - Blockade of large nerve plexuses: for example, blockade of the brachial plexus 7.5 10-40 75-300 10-25 6-10 Conducting and infiltration anesthesia: 7.5 1-30 7.5-225 1-15 2-6 Relief of acute pain syndrome Drug concentration (mg / ml) Solution volume (ml) Dose (mg) Onset of action (min) Duration of action (h) Epidural introduction at the lumbar level: bolus administration 2.0 10-20 20-40 10-15 0.5- 1.5 repeated administration (for example, for anesthesia of childbirth), the minimum interval is 30 minutes 2.0 10-15 20-30 - - prolonged infusion for anesthesia of childbirth 2.0 6-10 ml / h 12-20 mg / h - - prolonged infusion for postoperative pain relief 2.0 6-14 ml / h 12-28 mg / h - - Epidural administration at the chest level: prolonged infusion (for example, for operating anesthesia) 2.0 6-14 ml / h 12-28 mg / h - - Conductive blockade and infiltration: 2.0 1-100 2-200 1-5 2-6 The doses indicated in the table are considered sufficient to perform a reliable blockade in adults however, the tabular data are approximate (since there is individual variability of the speed of development of the block and its duration). Prior to the administration and during the administration of the drug (which should be carried out slowly or by increasing the successively administered doses at a rate of 25-50 mg / min), an aspiration test should be carefully carried out to prevent the solution from entering the vessel. Accidental intravascular injection is recognized by an increase in heart rate, and random intrathecal administration by signs of spinal blockade. If symptoms of intoxication appear, discontinue the drug immediately. With epidural blockade during surgery, a single dose of ropivacaine up to 250 mg is usually well tolerated. When conducting a prolonged blockade by prolonged infusion or repeated bolus administration, consideration should be given to the possibility of creating toxic anesthetic concentrations in the blood and local nerve damage. It has been established that a total dose of 800 mg of ropivacaine, obtained within 24 hours, as well as a long-term epidural infusion at a rate of 28 mg / h for 72 hours is well tolerated by adults.For the relief of postoperative pain, the following scheme is recommended: if an epidural catheter has not been installed during surgery, after its installation an epidural blockade is performed by Naropin (7.5 mg / ml). Analgesia is supported by Naropin infusion (2 mg / ml). Infusion at a rate of 6-14 ml / h (12-28 mg / h) provides adequate analgesia with a minor and non-progressive motor blockade. This technique can significantly reduce the need for opioid analgesics. Clinical studies have shown that with postoperative analgesia, Naropin's epidural infusion (2 mg / ml) without fentanyl or mixed with it (1-4 μg / ml) can be carried out continuously for 72 hours. In the latter case, the occurrence of with stimulation of opioid receptors. The use of Naropin at a concentration of more than 7.5 mg / ml at caesarean section has not been documented.
Side effects
Allergic reactions: skin reactions, anaphylactic shock. Most of the side effects that occur during anesthesia are not associated with the effect of the anesthetic used, but with the technique of regional anesthesia. Most often (> 1%) the following adverse effects were noted, which were regarded as having clinical significance regardless of whether a causal link was established with the use of anesthetic. Since the cardiovascular system: arterial hypertension, arterial hypotension, bradycardia, tachycardia. On the part of the digestive system: nausea, vomiting. From the side of the central nervous system and peripheral nervous system: headache, dizziness, paresthesia. Neuropathy and dysfunction of the spinal cord (anterior spinal artery syndrome, arachnoiditis) are usually associated with the technique of regional anesthesia, and not with the effect of the drug. Other: fever, chills, urinary retention. The side effect profile when using Naropin is similar to that of other local amide-type anesthetics. With proper use of the drug side effects are very rare.
special instructions
Allergic reactions: skin reactions, anaphylactic shock.Most of the side effects that occur during anesthesia are not associated with the effect of the anesthetic used, but with the technique of regional anesthesia. Most often (> 1%) the following adverse effects were noted, which were regarded as having clinical significance regardless of whether a causal link was established with the use of anesthetic. Since the cardiovascular system: arterial hypertension, arterial hypotension, bradycardia, tachycardia. On the part of the digestive system: nausea, vomiting. From the side of the central nervous system and peripheral nervous system: headache, dizziness, paresthesia. Neuropathy and dysfunction of the spinal cord (anterior spinal artery syndrome, arachnoiditis) are usually associated with the technique of regional anesthesia, and not with the effect of the drug. Other: fever, chills, urinary retention. The side effect profile when using Naropin is similar to that of other local amide-type anesthetics. With proper use of the drug side effects are very rare.