NEW TEROCIN (capsaicin/methyl salicylate/menthol)

There are 0 contraindications.

There are 1 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Burns

There are 0 moderate contraindications.

There are 14 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Anaphylaxis Burns Dyspnea Facial edema Hypersensitivity drug reaction Hypertension Periorbital edema Pharyngeal edema Severe burns Skin ulcer Superficial skin ulcer Syncope Throat constriction Urticaria

There are 16 less severe adverse reactions.

More Frequent	Less Frequent
Blistering skin Contact dermatitis Stinging of skin	Acute pain at drug application site Dry skin Erythema Pruritus of skin Skin irritation Stinging of skin

Rare/Very Rare
Cough Dysgeusia Headache disorder Ocular pain Pruritus of skin Reduced sensation of skin Stinging of skin

Maternal use of capsaicin 8% patches is not expected to result in fetal exposure; systemic absorption of the drug following topical administration is negligible. In animal reproductive studies, no evidence of malformations were observedwhen capsaicin was administered daily by the topical route to pregnant rats and rabbitsduring the period of organogenesis at doses of up to 11- and 37-times, respectively, themaximum recommended human dose (MRHD) at 716 mg capsaicin perday (4 topical systems containing 179 mg/topical systems). In a peri- and postnataldevelopment study, no adverse effects were observed when capsaicin was administereddaily by the topical route to rats during implantation to weaning at doses of up to 11-times the MRHD.

Breastfeeding is not expected to result in fetal exposure of capsaicin; systemic absorption from topical application of capsaicin 8% patch is negligible. There are no data on the effects of capsaicin on human milk production. To minimize potential direct exposure of capsaicin to the breastfed infant, avoid applying the patches directly to the nipple andareola. Consider the developmental and health benefits of breastfeeding along withthe mother's clinical need for capsaicin and any potential adverse effects on thebreastfed infant from the drug or from the underlying maternal condition.

In controlled clinical trials of capsaicin 8% patch in patients with postherpeticneuralgia, 75% of patients were 65 years of age and older and 43% of patients were 75 yearsof age and older. The safety and effectiveness were similar in geriatric patients and youngerpatients.