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OLFEN-75 INJECTION

Product Information

Registration Status: Active

SIN05645P

OLFEN-75 INJECTION is approved to be sold in Singapore with effective from 1991-08-04. It is marketed by APEX PHARMA MARKETING PTE LTD, with the registration number of SIN05645P.

This product contains Diclofenac 75mg/2ml, and Lignocaine 20mg/2ml in the form of INJECTION. It is approved for INTRAMUSCULAR use.

This product is manufactured by Acino Pharma AG in SWITZERLAND, andMERCKLE GMBH in GERMANY.

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.

Product Reference
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Description

A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt. [PubChem]

Indication

For the acute and chronic treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis.

Mechanism of Action

The antiinflammatory effects of diclofenac are believed to be due to inhibition of both leukocyte migration and the enzyme cylooxygenase (COX-1 and COX-2), leading to the peripheral inhibition of prostaglandin synthesis. As prostaglandins sensitize pain receptors, inhibition of their synthesis is responsible for the analgesic effects of diclofenac. Antipyretic effects may be due to action on the hypothalamus, resulting in peripheral dilation, increased cutaneous blood flow, and subsequent heat dissipation.

Pharmacokinetics

Absorption
Completely absorbed from the gastrointestinal tract.
Distribution
* 1.3 L/kg
Metabolism
Hepatic
Elimination

Clearance

* oral cl=622 mL/min [healthy] * renal cl

Toxicity

Symptoms of overdose include loss of consciousness, increased intracranial pressure, and aspiration pneumonitis. LD50=390mg/kg (orally in mice)

Active Ingredient/Synonyms

[2-(2,6-dichloroanilino)phenyl]acetic acid | 2-((2,6-dichlorophenyl)amino)benzeneacetic acid | Diclofenac Acid | Diclofenaco | Diclofenacum | Diclofenac |


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.


Description

A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of procaine but its duration of action is shorter than that of bupivacaine or prilocaine. [PubChem]

Indication

For production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks.

Mechanism of Action

Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses thereby effecting local anesthetic action. Lidocaine alters signal conduction in neurons by blocking the fast voltage gated sodium (Na+) channels in the neuronal cell membrane that are responsible for signal propagation. With sufficient blockage the membrane of the postsynaptic neuron will not depolarize and will thus fail to transmit an action potential. This creates the anaesthetic effect by not merely preventing pain signals from propagating to the brain but by aborting their birth in the first place.

Pharmacokinetics

Absorption
Information derived from diverse formulations, concentrations and usages reveals that lidocaine is completely absorbed following parenteral administration, its rate of absorption depending, for example, upon various factors such as the site of administration and the presence or absence of a vasoconstrictor agent.
Distribution
* 0.7 to 2.7 L/kg [healthy volunteers]
Metabolism
Primarily hepatic.
Elimination

Clearance

* 0.64 +/- 0.18 L/min

Toxicity

The oral LD 50 of lidocaine HCl in non-fasted female rats is 459 (346-773) mg/kg (as the salt) and 214 (159-324) mg/kg (as the salt) in fasted female rats. Symptoms of overdose include convulsions, hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest.

Active Ingredient/Synonyms

2-(Diethylamino)-2',6'-acetoxylidide | 2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide | alpha-diethylamino-2,6-dimethylacetanilide | Lignocaine | α-diethylamino-2,6-dimethylacetanilide | Lidocaine |


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.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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