Indications in Prescribing Information - Product Label

It states what diseases or conditions a medicine should be used for, by which patients, and under what situations.

An indication will specify:
• The recognized disease or condition for which the medicine’s use is approved, or the important manifestation of a disease or condition, such as:
i. Hypertension.
ii. Edema in patients with congestive heart failure.

• Whether the medicine is approved to treat, prevent, or diagnose the disease or condition, or to relieve the symptoms associated with a disease or syndrome, such as:
i.Penicillin is indicated for the treatment of pneumonia due to susceptible pneumococci.
ii.Chlorpheniramine is indicated for the symptomatic relief of nasal congestion in patients with vasomotor rhinitis.

• Whether the medicine may be used by itself (often referred to as “monotherapy”), should be used as the primary therapy (ie, without first trying another medicine) versus secondary/tertiary therapy (ie, used only if another medicine has been found not to be sufficiently effective or to have unacceptable side effects), or in conjunction with another mode of therapy (such as surgery, diet, etc—often referred to as “adjunctive therapy”) or in combination with another medicine.

• Whether the medicine is only approved for certain subgroups of patients with the disease or
symptom, such as:
i. Patients with mild disease.
ii. Patients in certain age groups.
iii.
• Whether use of the medicine should be reserved for certain situations, such as:
i.Cases where other therapy has not been effective (often referred to as “refractory” to other therapy).
ii.Patients who are not able to tolerate the adverse effects they experience with another therapy or medicine.

You will get more information about the Prescribing Information including Highlights of Prescribing Information and Full Prescribing Information in my next post.