Product Information
Registration Status: ActiveROPIVACAINE-AFT SOLUTION FOR INJECTION 0.75% W/V is approved to be sold in Singapore with effective from 2017-06-08. It is marketed by APEX PHARMA MARKETING PTE LTD, with the registration number of SIN15262P.
This product contains Ropivacaine 7.5mg/mL in the form of INJECTION, SOLUTION. It is approved for EPIDURAL use.
This product is manufactured by Elpen Pharmaceutical Co. in GREECE.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
Ropivacaine is a local anaesthetic drug belonging to the amino amide group. The name ropivacaine refers to both the racemate and the marketed S-enantiomer. Ropivacaine hydrochloride is commonly marketed by AstraZeneca under the trade name Naropin.
Indication
Used in obstetric anesthesia and regional anesthesia for surgery.
Mechanism of Action
Local anesthetics such as Ropivacaine block the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. Specifically, they block the sodium-channel and decrease chances of depolarization and consequent action potentials. In general, the progression of anesthesia is related to the diameter, myelination and conduction velocity of affected nerve fibers.
Pharmacokinetics
- Absorption
- Bioavailability is 87%–98% following epidural administration.
- Distribution
- Metabolism
- Hepatic
- Elimination
Clearance
* 387 +/- 107 mL/min * unbound plasma clearance=7.2 +/- 1.6 L/min
Toxicity
Systemic exposure to excessive quantities of ropivacaine mainly result in central nervous system (CNS) and cardiovascular effects – CNS effects usually occur at lower blood plasma concentrations and additional cardiovascular effects present at higher concentrations, though cardiovascular collapse may also occur with low concentrations. CNS effects may include CNS excitation (nervousness, tingling around the mouth, tinnitus, tremor, dizziness, blurred vision, seizures) followed by depression (drowsiness, loss of consciousness, respiratory depression and apnea). Cardiovascular effects include hypotension, bradycardia, arrhythmias, and/or cardiac arrest – some of which may be due to hypoxemia secondary to respiratory depression.
Active Ingredient/Synonyms
(S)-(−)-1-propyl-2',6'-pipecoloxylidide | (S)-ropivacaine | L-N-n-propylpipecolic acid-2,6-xylidide | Ropivacaina | Ropivacaine | Ropivacainum | Ropivacaine |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.