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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Sitavig® (acyclovir) 50 mg buccal tablet is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults.
Sitavig® (acyclovir) 50 mg buccal tablet should not be used in patients with known hypersensitivity to acyclovir, milk protein concentrate, or any other component of the product. Sitavig has not been studied in immunocompromised patients. No interaction studies have been performed. Sitavig’s safety and efficacy have not been established in pediatric patients. There are no available data on Sitavig use in pregnant women. However, published observational studies over decades of use of acyclovir have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. It is not known if Sitavig is excreted in breast milk; however, systemic exposure following buccal administration of acyclovir is minimal. Before administration, discuss if the patient is lactating or planning to breastfeed. The possibility of viral resistance to acyclovir should be considered in patients who fail to respond or experience recurrent viral shedding during therapy. In a controlled clinical trial, the most common side effects (greater than or equal to 1%) for Sitavig were: headache (3%), dizziness (1%), lethargy (1%), gingival (gum) pain (1%), aphthous stomatitis (canker sores) (1%), application site pain (1%), application site irritation (1%), erythema (redness) (1%), and rash (1%). In the same trial, these side effects ranged from 0% to 3% for placebo.