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.

Please check my assignment below and make corrections or add something if needed also I did not know what to write for Adverse reactions

Drug Name: Lowerstatin

Drug classification: Lipid-lowering agent.

Clinical pharmacology A dose of 20 mg per day, of Lowerstatin, lowers cholesterol level by 17% to 21% and low-density lipoprotein (LDL) cholesterol by 23% to 26%. Lowerstatin raises high-density lipoprotein cholesterol by 4% to 10%. The 2-year studies indicate that Lowerstatin is safe and well tolerated.

Indication for use:

To reduce the risk of Myocardial Infarction, stroke, angina, or revascularization procedures in patients with multiple risk factors for Coronary Artery Disease but who don’t yet have the disease. To reduce the risk of Myocardial Infarction or stoke in patients with type 2 diabetes and multiple risk factors for Coronary Artery Disease but who don’t yet have the disease. Reduce or control the risk of heart diseases and fat deposition in the blood vessels. Adjunct to diet to reduce low-density lipoprotein (LDL), total cholesterol, and triglyceride levels and to increase HDL levels in patients with primary hypercholesterolemia

Contraindications –

Do not use in patients with other medical conditions such as kidney problems or allergies. Do not use if you are pregnant or breastfeeding. Not for children under 14 years of age

Precautions:

Do not drink alcohol while taking Lowerstatin Do not take Lowerstatin if you are currently taking MAOI inhibitors

Adverse reactions

Side effects: Headache, Asthenia, Insomnia, Peripheral Edema, Pharyngitis, Rhinitis, Sinusitis, Nasopharyngitis, Abdominal Pain, Constipation, Diarrhea, Dyspepsia, Nausea, Urinary Track Infection, Arthritis, Arthralgia, Myalgia, Extremity Pain, Bronchitis, Rash Other: Allergic reactions, Flulike Syndrome, Infection

Interactions:

DRUGS; Amiodarone, Antacids, Cholestyramine, Cholestipol, Cyclosporine, Diltiazem, Fibric Acid Derivatives, Macrolides, Nefazodone, Niacin, Protease Inhibitors, Hormonal Contraceptives. HERBS; eucalyptus, kava, red yeast rice.

FOOD; grapefruit juice.

General information: It should not be taken without prescribed by physician Never reduce or overload the dose without physician’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. Dosage and Administration 20 mg once per day for Adults 10 mg once per day for children 14 and up

Storage: Store at room temperature. Do not store above 75°"

Answer 1

Adverse Reactions:

Lowerstain produces an adverse effect on a person with chronic liver disease and pregnant women. Sometimes it produces muscle pain, inflammation, and weakness. It also develops adverse reactions when taking along with over-the-counter medication, herbal supplements, and vitamins.

Mechanism of Action:

Lowerstatin acts by blocking the liver enzyme which is responsible for blood cholesterol level. It stabilizes the build-up of plaques in the arteries by lowering the LDL and triglyceride level and increases HDL level. Thus the patient has minimal risk of heart attacks.