Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ceva animal health pty ltd - prilocaine hydrochloride - unknown - prilocaine hydrochloride caine active 0.0 - active constituent

Canada - English - Health Canada

novocol pharmaceutical of canada inc - prilocaine hydrochloride; epinephrine - solution - 40mg; 0.005mg - prilocaine hydrochloride 40mg; epinephrine 0.005mg - local anesthetics

Australia - English - Department of Health (Therapeutic Goods Administration)

dentsply sirona pty ltd - prilocaine, quantity: 42.5 mg; lidocaine, quantity: 42.5 mg - gel - excipient ingredients: poloxamer; hydrochloric acid; purified water - for use in adults for localised anaesthesia in periodontal pockets for probing, scaling and/or root planing.

United States - English - NLM (National Library of Medicine)

a-s medication solutions - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987), prilocaine (unii: 046o35d44r) (prilocaine - unii:046o35d44r) - lidocaine 25 mg in 1 g - lidocaine and prilocaine cream usp, 2.5%/2.5% (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: • normal intact skin for local analgesia. • genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. lidocaine and prilocaine cream is not recommended in any clinical situation in which penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see warnings). lidocaine and prilocaine cream is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.

United States - English - NLM (National Library of Medicine)

dentsply pharmaceutical - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987), prilocaine (unii: 046o35d44r) (prilocaine - unii:046o35d44r) - lidocaine 25 mg in 1 g - oraqix is an amide local anesthetic indicated for adults who require localized anesthesia in periodontal pockets during scaling and/or root planing. oraqix is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to any other component of the product. pregnancy category b .reproduction studies have been performed in rats with lidocaine, prilocaine and a 1:1 (weight:weight) mixture of the two compounds. there was no evidence of harm to the fetus at subcutaneous doses of up to 30 mg/kg lidocaine (estimated exposure was approximately equivalent to the expected lidocaine exposure at the maximum recommended human dose of oraqix (lidocaine and prilocaine periodontal gel) 2.5% / 2.5% on a mg/m2 basis). following intramuscular prilocaine doses of up to 300 mg/kg (estimated exposure was approximately 11 times the expected prilocaine exposure at the maximum recommended human dose of oraqix gel on a mg/m2 basis), there was no evidence of impaired fertility or harm to the fetus. similarly, subcutaneous administration of a lidocaine and prilocaine mixture of 40 mg/kg of each compound (estimated exposures were approximately 1.5 times the expected lidocaine and prilocaine exposures at the maximum recommended human dose of oraqix gel on a mg/m2 basis) produced no teratogenic, embryotoxic, or fetotoxic effects. reproductive toxicology studies of lidocaine were also conducted in rabbits. there was no evidence of harm to the fetus at a dose of 5 mg/kg, s.c. (60 mg/m2 ). treatment of rabbits with 15 mg/kg (180 mg/m2 ) produced evidence of maternal toxicity and evidence of delayed fetal development, including a non-significant decrease in fetal weight (7%) and an increase in minor skeletal anomalies (skull and sternebral defects, reduced ossification of the phalanges). the effects of lidocaine and prilocaine on post-natal development was examined in rats treated for 8 months with 10 or 30 mg/kg, s.c. lidocaine or prilocaine (60 mg/m2 and 180 mg/m2 on a body surface area basis, respectively up to 1.4-fold the maximum recommended exposure for a single procedure). this time period encompassed 3 mating periods. there was no evidence of altered post-natal development in any offspring; however, both doses of either drug reduced the average number of pups per litter surviving until weaning of offspring from the first 2 mating periods. in a separate study, the effect of prilocaine on pre- and postnatal development was examined in rats treated with up to 60 mg/kg, s.c. (up to 2.8 times the maximum recommended human dose of prilocaine in oraqix gel on a mg/m2 basis) from day 6 of gestation to weaning. there was no evidence of altered post-natal development, viability, or reproductive capacity in any offspring. all the above calculations of exposure are assuming 100% bioavailability of lidocaine and prilocaine after oraqix administration. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, oraqix should be used during pregnancy only if the benefits outweigh the risks. reproduction studies on the oraqix drug product, including the inactive ingredients, have not been conducted. lidocaine and, possibly, prilocaine are excreted in breast milk. caution should be exercised when oraqix is administered to nursing women. safety and effectiveness in pediatric patients have not been established. very young children are more susceptible to methemoglobinemia. there have been reports of clinically significant methemoglobinemia in infants and children following excessive applications of lidocaine 2.5% topical cream [see warnings and precautions (5.1)] . of the total number of subjects in clinical studies of oraqix, 7% were aged 65 and over, while 1% were aged 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 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.

United States - English - NLM (National Library of Medicine)

asclemed usa, inc. - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987), prilocaine (unii: 046o35d44r) (prilocaine - unii:046o35d44r) - lidocaine 25 mg in 1 g - lidocaine and prilocaine cream usp, 2.5%/2.5% (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: • normal intact skin for local analgesia. • genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. lidocaine and prilocaine cream is not recommended in any clinical situation in which penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see warnings). lidocaine and prilocaine cream is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.

United States - English - NLM (National Library of Medicine)

accelis pharma - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987), prilocaine (unii: 046o35d44r) (prilocaine - unii:046o35d44r) - lidocaine 25 mg in 1 g - lidocaine 2.5% and prilocaine 2.5% cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on:       normal intact skin for local analgesia.       genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. lidocaine 2.5% and prilocaine 2.5% cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see warnings). lidocaine 2.5% and prilocaine 2.5% cream (lidocaine 2.5% and prilocaine 2.5%) is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.

United States - English - NLM (National Library of Medicine)

accelis pharma - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987), prilocaine (unii: 046o35d44r) (prilocaine - unii:046o35d44r) - lidocaine 25 mg in 1 g - lidocaine 2.5% and prilocaine 2.5% cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on:       normal intact skin for local analgesia.       genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. lidocaine 2.5% and prilocaine 2.5% cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see warnings). lidocaine 2.5% and prilocaine 2.5% cream (lidocaine 2.5% and prilocaine 2.5%) is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.

United States - English - NLM (National Library of Medicine)

asclemed usa, inc. - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987), prilocaine (unii: 046o35d44r) (prilocaine - unii:046o35d44r) - lidocaine 25 mg in 1 g - lidocaine and prilocaine cream usp, 2.5%/2.5% (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: • normal intact skin for local analgesia. • genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. lidocaine and prilocaine cream is not recommended in any clinical situation in which penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see warnings). lidocaine and prilocaine cream is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.

United States - English - NLM (National Library of Medicine)

skya health, llc - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987), prilocaine (unii: 046o35d44r) (prilocaine - unii:046o35d44r) - lidocaine and prilocaine cream, 2.5%/2.5% is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.