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BETOPTIC STERILE OPHTHALMIC SOLUTION 0.5%

Product Information

Registration Status: Active

SIN04716P

BETOPTIC STERILE OPHTHALMIC SOLUTION 0.5% is approved to be sold in Singapore with effective from 1990-06-13. It is marketed by NOVARTIS (SINGAPORE) PTE LTD, with the registration number of SIN04716P.

This product contains Betaxolol 0.5% w/v in the form of SOLUTION. It is approved for OPHTHALMIC use.

This product is manufactured by ALCON-COUVREUR NV in BELGIUM.

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 cardioselective beta-1-adrenergic antagonist with no partial agonist activity.

Indication

For the management of hypertension.

Mechanism of Action

Betaxolol selectively blocks catecholamine stimulation of beta(1)-adrenergic receptors in the heart and vascular smooth muscle. This results in a reduction of heart rate, cardiac output, systolic and diastolic blood pressure, and possibly reflex orthostatic hypotension. Betaxolol can also competitively block beta(2)-adrenergic responses in the bronchial and vascular smooth muscles, causing bronchospasm.

Pharmacokinetics

Absorption
Absorption of an oral dose is complete. There is a small and consistent first-pass effect resulting in an absolute bioavailability of 89% ± 5% that is unaffected by the concomitant ingestion of food or alcohol.
Distribution
Metabolism
Primarily hepatic. Approximately 15% of the dose administered is excreted as unchanged drug, the remainder being metabolites whose contribution to the clinical effect is negligible.
Elimination

Toxicity

Oral LD50s are 350 to 400 mg betaxolol/kg in mice and 860 to 980 mg/kg in rats. Predicted symptoms of overdose include bradycardia, congestive heart failure, hypotension, bronchospasm, and hypoglycemia.

Active Ingredient/Synonyms

1-(4-(2-(Cyclopropylmethoxy)ethyl)phenoxy)-3-((1-methylethyl)amino)-2-propanol | 1-(Isopropylamino)-3-[P-(cyclopropylmethoxyethyl)phenoxy]-2-propanol | Betaxololum | Betaxolol |


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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