Aphthasol Warnings, Precautions, Pregnancy, Nursing, Abuse - Amlexanox

Aphthasol Warnings, Precautions, Pregnancy, Nursing, Abuse - Amlexanox

WARNINGS

No Information Provided.

General :  Wash hands immediately after applying amlexanox oral paste, 5%, directly to ulcers with the finger tips. In the event that a rash or contact mucositis occurs, discontinue use.

Information for Patients:

1. Apply the paste as soon as possible after noticing the symptoms of an aphthous ulcer. Continue to use the paste four times daily, preferably following oral hygiene after breakfast, lunch, dinner, and at bedtime.
2. Dry the ulcer(s) by gently patting it with a soft, clean cloth.
3. Wash your hands before applying the Aphthasol.
4. Moisten the tip of your index finger.
5. Squeeze a dab of paste approximately 1/4 inch (0.5 cm) onto a finger tip.
6. Gently dab the Aphthasol on to the ulcer. Repeat the process if you have more than one ulcer.
7. Wash your hands when you are done applying Aphthasol.
8. Wash eyes promptly if they should come in contact with the paste.
9. Use the paste until the ulcer heals. If significant healing or pain relief has not occurred in 10 days, consult your dentist or physician.
10. Keep out of the reach of children.

Carcinogenesis, Mutagenesis, Impairment of Fertility :  Amlexanox was not carcinogenic when administered orally to rats for two years and to mice for 18 months. In vitro (Ames) and in vivo (mouse micronucleus) mutagenicity tests of amlexanox were negative. Amlexanox at doses up to two hundred times the projected human daily dose, on a mg/m ² basis, did not significantly affect fertility or general reproductive performance in rats.

Pregnancy Category B :  Teratology studies were performed with rats and rabbits at doses up to two hundred and six hundred times, respectively, the projected human daily dose, on a mg/m ² basis. No adverse fetal effects were observed. At doses up to two hundred times the projected human daily dose, on a mg/m ² basis, amlexanox did not have significant effect on peri- and postnatal development of rat fetuses. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers :  Amlexanox was found in the milk of lactating rats; therefore, caution should be exercised when administering amlexanox oral paste, 5%, to a nursing woman.

Pediatric Use :  Safety and effectiveness of amlexanox oral paste, 5%, in pediatric patients have not been established.

Geriatric Use :  Clinical studies of Aphthasol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.