DESCRIPTION

FLEXOST is indicated for the treatment and prevention of osteoarthritis. Its composition is formulated from natural products Glucosamine sulfate 220mg, chondroitin 220mg.

WARNINGS

In most human studies, glucosamine sulfate has been well tolerated for 30 to 160 days.

Side effects may include upset stomach, drowsiness, insomnia, headache, skin reactions, sun sensitivity, and nail toughening. There are rare reports of abdominal pain, loss of appetite, vomiting, nausea, flatulence (gas), constipation, heartburn, and diarrhea. Based on several human cases, temporary increases in blood pressure and heart rate, as well as palpitations, may occur with glucosamine/chondroitin products. Based on animal research, glucosamine theoretically may increase the risk for eye cataract formation.

PRECAUTIONS

Allergies

Since glucosamine can be made from the shells of shrimp, crab, and other shellfish, people with shellfish allergy or iodine hypersensitivity may have an allergic reaction to glucosamine products. However, some research suggests that there is not enough shrimp allergen in glucosamine supplements to trigger reactions in patients who are allergic to shrimp. Nevertheless, caution is warranted. A serious hypersensitivity reaction including throat swelling has been reported with glucosamine sulfate. There are reported cases suggesting a link between glucosamine/chondroitin products and asthma exacerbations.

MISUSE POTENTIAL

No potential for misuse has been experienced in pre marketing clinical studies or during post marketing events.

USE IN SPECIAL POPULATIONS

Pregnancy

No adequate and well controlled studies with FLEXOST have been conducted in pregnant women.  Because animal reproductive studies are not always predicative of human response FLEXOST during pregnancy is not recommended. 

Nursing Mothers

It is not known if FLEXOST is secretes in human milk.  Therefore, FLEXOST should not be taken by nursing women. 

Pediatric Use

FLEXOST has not been studied in pediatric patients below the age of 16 years. There is not enough scientific evidence to recommend the use of glucosamine in children.

Geriatric Use

Clinical studies of FLEXOST included significant number of patients aged 65 years and older which determined the resonance was similar to younger patients.