Question

If you were a member of the drug development committee at a pharmaceutical sponsor, how would you draft a package insert indication for a new lipid lowering drug that is proven more potent than atorvastatin. The new drug is called lowerstatin.

at least one page. No plagiarism.

Thanks

Answer 1

Package insert indication:

It gives the information about the drug to the users and to the medical professionals.

It must include the details such as uses of medication,indications,Action time,effects if overdosed,storage,Contraindications,general information and ingredients it include,

This provides the basic information about the drug.

For example:(It is a sample information of the drug not absolute information.like this can prepare the drug label. )

Drug name - Lowerstatin

Lowerstatin is the lipid lowering agent.

Uses of medication:

It reduce the bad cholesterol amount in the body and increase the good cholesterol level.

To control the cholesterol level in the blood.

Reduce or control the risk of heart diseases and fat deposition in the blood vessels.

Indications:

Increased cholesterol level in the blood(High LDL , VLDL and triglycerides level)

Heart problems

Atherosclerosis

Action time:

here to define the time taken to act,its peak period.

Effects:

If it is taken more than the actual dose it cause damage to other organs.

It can cause liver and kidney problems.

Storage :

keep in room temperature.

Contraindications:

For children and pregnant women

General information:

It should not be taken without prescribed by physician

Never reduce or overload the dose without physicians's advice.

Never miss the dose.If missed take medicine if exceeds 12 hours from the previous dose.

Contact physician if any unusual symptoms occurred.