Flanax/Flanax Forte Special Precautions

Flanax/Flanax Forte should not be given to patients with active peptic ulcer. In other patients with a history of GI disease, it should be given under close supervision.
Flanax/Flanax Forte decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined.
Elevations of one or more liver function tests have been reported with drugs of this class.
Flanax contains approximately 25 mg (about 1 mEq) of sodium. Flanax Forte contains approximately 50 mg (about 2 mEq) of sodium. This should be considered in patients whose overall intake of sodium must be markedly restricted.
Patients with Impaired Renal Function: As naproxen and its metabolites are eliminated to a large extent (95%) by urinary excretion via glomerular filtration, Flanax/Flanax Forte should be used with great caution in patients with significantly impaired renal function and the monitoring of serum creatinine and/or creatinine clearance is advised in these patients.
Flanax/Flanax Forte should not be used chronically in patients having baseline creatinine clearance >20 mL/min. Certain patients, especially those where renal blood flow is compromised eg, in extracellular volume depletion, cirrhosis of the liver, sodium restriction, congestive heart failure and preexisting renal disease, should have renal function assessed before and during Flanax/Flanax Forte therapy. Some elderly patients in whom impaired renal function may be expected could also fall within this category. A reduction in daily dosage should be considered to avoid the possibility of excessive accumulation of naproxen metabolites in these patients.
Patients with Impaired Liver Function: Chronic alcoholic liver disease and probably also other forms of cirrhosis reduce the total plasma concentration of naproxen, but the plasma concentration of unbound naproxen is increased. The implication of this finding for Flanax/Flanax Forte dosing is unknown, but it is prudent to use the lowest effective dose.
Use in pregnancy & lactation: As with other drugs of this type, Flanax/Flanax Forte produces a delay in parturition in animals and also affects the human fetal cardiovascular system (closure of the ductus arteriosus). Therefore, it should not be used during pregnancy unless clearly needed. The use of Flanax/Flanax Forte in pregnancy requires cautious balancing of possible benefits against potential risks to the mother and fetus, especially in the first and third trimesters.
Naproxen has been found in the milk of lactating mothers. The use of Flanax/Flanax Forte should therefore be avoided in patients who are breastfeeding.
Use in children: As safety and efficacy studies are not yet complete, Flanax/Flanax Forte is not recommended for use in children <16 years.
Use in the elderly: Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. The implication of this finding for Flanax/Flanax Forte dosing is unknown. As with other drugs used in the elderly, it is prudent to use the lowest effective dose.
For the effect of reduced elimination in the elderly, see Patients with Impaired Renal Function.