TEGRETOL 200 TABLET 200mg

Contents

Carbamazepine

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.

Active Ingredient / Synonyms

5-Carbamoyl-5H-dibenz(b,f)azepine | 5-Carbamoyl-5H-dibenz[b,F]azepine | 5-Carbamoyl-5H-dibenzo(b,F)azepine | 5-Carbamyl-5H-dibenzo(b,F)azepine | 5H-Dibenz(b,F)azepine-5-carboxamide | Carbamazepen | Carbamazepin | Carbamazepina | Carbamazépine | Carbamazepinum | CBZ | Carbamazepine |

Description

An anticonvulsant used to control grand mal and psychomotor or focal seizures. Its mode of action is not fully understood, but some of its actions resemble those of phenytoin; although there is little chemical resemblance between the two compounds, their three-dimensional structure is similar. [PubChem]

Indication

For the treatment of epilepsy and pain associated with true trigeminal neuralgia.

Mechanism of Action

Carbamazepine inhibits sustained repetitive firing by blocking use-dependent sodium channels. Pain relief is believed to be associated with blockade of synaptic transmission in the trigeminal nucleus and seizure control with reduction of post-tetanic potentiation of synaptic transmission in the spinal cord. Carbamazepine also possesses anticholinergic, central antidiuretic, antiarrhythmic, muscle relaxant, antidepressant (possibly through blockade of norepinephrine release), sedative, and neuromuscular-blocking properties.

Pharmacodynamics

Carbamazepine, an anticonvulsant structurally similar to tricyclic antidepressants, is used to treat partial seizures, tonic-clonic seizures, pain of neurologic origin such as trigeminal neuralgia, and psychiatric disorders including manic-depressive illness and aggression due to dementia. The response to carbamazepine is variable and may be due to its variable transport, especially across the blood-brain-barrier. The transporter that may confer drug resistance is RALBP1.

Pharmacokinetics

Absorption:

In clinical studies, carbamazepine suspension, conventional tablets, and extended-release tablets delivered equivalent amounts of drug to the systemic circulation. However, it has been observed that the suspension is somewhat faster absorbed. Furthermore, the extended-release tablet is slightly slower than the conventional tablet. The bioavailability of the extended-release tablet is 89%, compared to the suspension. Plasma levels of carbamazepine are variable. The time to peak concentration for the different formulations are as follows: Suspension = 1.5 hours; Conventional tablets = 4-5 hours; Extended-release tablets = 3-12 hours.

Distribution:

Not Available

Metabolism:

Hepatic. CYP3A4 is the primary isoform responsible for the formation of carbamazepine-10,11-epoxide. This metabolite is active and shown to be equipotent to carbamazepine as an anticonvulsant. Carbamazepine is more rapidly metabolized to the aforementioned metabolite in younger patients than in adults. It also undergoes glucuronidation via UGT2B7, however this finding has been disputed.

Elimination:

72% of the dose is in the urine while 28% is in the feces. Hydroxylated and conjugated metabolites are largely what was recovered in the urine. 3% of the dose is recovered as unchanged carbamazepine.

Half-life

Initial half-life values range from 25-65 hours, decreasing to 12-17 hours on repeated doses.

Clearance

Not Available

Toxicity

Mild ingestions cause vomiting, drowsiness, ataxia, slurred speech, nystagmus, dystonic reactions, and hallucinations. Severe intoxications may produce coma, seizures, respiratory depression, and hypotension

References

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

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Approval Information

TEGRETOL 200 TABLET 200mg was registered with Health Science Authority of Singapore by NOVARTIS (SINGAPORE) PTE LTD. It is marketed with the registration number of SIN00352P with effective from 1988-04-26.

This product contains 200mg of Carbamazepine in the form of TABLET.

The medicine was manufactured by NOVARTIS FARMA S P A Mipharm S.p.A (primary & secondary packaging) in ITALY

It is a Presciption Only Medicine which can only be obtained from a doctor or a dentist, or from a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Anatomical Therapeutic Chemical (ATC) Classification

ATC Code: N03AF01

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