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FDA-Approved Drugs 2010

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FDA-Approved Drugs 2010 Empty FDA-Approved Drugs 2010

مُساهمة من طرف صيدلاني سوداني الأحد يونيو 20, 2010 12:53 am

Drug Name: Zyclara (imiquimod)

Company: Graceway
Approval Status: Approved March 2010
Treatment Area: actinic keratoses

General Information

Zyclara contains the active ingredient imiquimod, which belongs to a class of drugs called immune response modifiers (IRM's). IRM's have shown both antitumor and antiviral activity in vivo. The exact mechanism of action in which imiquimod activates the immune system is not yet known. However, it is known that imiquimod activates immune cells through the toll-like receptor 7, commonly involved in pathogen recognition, on the cell surface.
Zyclara is specifically approved for the topical treatment of clinically typical visible or palpable actinic keratoses of the full face or balding scalp in immunocompetent adults.
Zyclara is supplied as a cream 3.75% designed for topical administration. Zyclara cream should be applied once daily before bedtime to the skin of the affected area (either the face or balding scalp) for two 2-week treatment cycles separated by a 2-week no-treatment period. The cream should be applied as a thin film to the entire treatment area and rubbed in until the cream is no longer visible. Up to 2 packets of Zyclara Cream may be applied to the treatment area at each application. It should be left on the skin for approximately 8 hours, after which time the cream should be removed by washing the area with mild soap and water.
Clinical Results


Side Effects

Adverse events associated with Zyclara Cream may include, but are not limited to, the following:
local skin reactions
erythema
edema weeping/exudate
flaking/scaling/dryness
scabbing/crusting
erosion/ulceration

Mechanism of Action

Zyclara contains the active ingredient imiquimod, which belongs to a class of drugs called immune response modifiers (IRM's). IRM's have shown both antitumor and antiviral activity in vivo. The exact mechanism of action in which imiquimod activates the immune system is not yet known. However, it is known that imiquimod activates immune cells through the toll-like receptor 7, commonly involved in pathogen recognition, on the cell surface.
صيدلاني سوداني
صيدلاني سوداني
Admin

عدد المساهمات : 96
نقاط : 189
تاريخ التسجيل : 05/05/2010

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مُساهمة من طرف صيدلاني سوداني الأحد يونيو 20, 2010 12:59 am

Drug Name: Victoza (liraglutide)

Company: Novo Nordisk
Approval Status: Approved January 2010
Treatment Area: type 2 diabetes mellitus

General Information

Victoza is contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. Liraglutide increases intracellular cyclic AMP (cAMP) leading to insulin release in the presence of elevated glucose concentrations. This insulin secretion subsides as blood glucose concentrations decrease and approach euglycemia. Liraglutide also decreases glucagon secretion in a glucose-dependent manner. The mechanism of blood glucose lowering also involves a delay in gastric emptying.
Victoza is specifically indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Victoza is supplied as solution designed for subcutaneous injection. Victoza can be administered once daily at any time of day, independently of meals, and can be injected subcutaneously in the abdomen, thigh or upper arm. The recommended initial dose is 0.6 mg per day for one week. After one week at 0.6 mg per day, the dose should be increased to 1.2 mg. If the 1.2 mg dose does not result in acceptable glycemic control, the dose can be increased to 1.8 mg


Side Effects

Adverse events associated with the use of Victoza may include, but are not limited to, the following:
Nausea
Vomiting
Diarrhea
Constipation
Headache

Mechanism of Action

Victoza is contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. Liraglutide increases intracellular cyclic AMP (cAMP) leading to insulin release in the presence of elevated glucose concentrations. This insulin secretion subsides as blood glucose concentrations decrease and approach euglycemia. Liraglutide also decreases glucagon secretion in a glucose-dependent manner. The mechanism of blood glucose lowering also involves a delay in gastric emptying.
صيدلاني سوداني
صيدلاني سوداني
Admin

عدد المساهمات : 96
نقاط : 189
تاريخ التسجيل : 05/05/2010

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