General hospitals clear Norvasc for pediatric use

SNU, Severance, and KU Guro Hospital Drug Committees pass the drug in lower dose

Last year Norvasc defended its top seller title in CCB monotherapy market

More general hospitals are reportedly listing Norvasc on their drug codes for pediatric treatment.

 

Pharmaceutical industry on Jan.

 

28 said respective Drug Committees in Seoul National University Hospital, Severance Hospital and Korea University Guro Hospital cleared Norvasc (Amlodipine) 2.5 mg for prescription from the release in last year to now.

 

The 2.5 mg dose of high blood pressure medicine Norvasc is newly approved dose of the drug and the only calcium channel blocker (CCB) in Korea approved by Ministry of Food and Drug Safety (MFDS) for treating pediatric high blood pressure patients aged six to 17.

 

The pediatric indication allows administrating minimum 2.5 mg or maximum 5 mg of the drug once daily.

 

From 2013 to 2017, the number of child and adolescent patients treated in a hospital for high blood pressure has been increased from 4,500 to 6,497, respectively.

 

A clinical study confirmed the drug’s effect in 268 high blood pressure patients ages six to 17, randomized to be administered 2.5 mg or 5 mg of the drug once daily for first four weeks of treatment.

 

The study outcome found, the 2.5 mg and 5 mg arms demonstrated significantly lower systolic blood pressure than the placebo group.

 

In particular, the study reported 5 mmHg systolic on the 5 mg dose and 3.3 mmHg systolic on the 2.5 mg dose.

 

Pfizer Upjohn Korea has diversified the original amlodipine item’s dose and formulation into Norvasc, Norvasc T, and in lower doses to keep the high market share of the off-patent drug.

 

According to UBIST, Norvasc in last year has generated 58.9 billion won from outpatient prescription and defended its title of top single antihypertensive drug.

 

The drug is the first prescribed drug to have made 100 billion won in 2001.

 

Other pharmaceutical companies in Korea have released products with the same active ingredient, and S-amlodipine drugs that maintain the equivalent effect with lowered dose are also available in the market.