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

allegis pharmaceuticals, llc - spinosad (unii: xpa88eap6v) (spinosad - unii:xpa88eap6v) - spinosad 9 mg in 1 ml - spinosad topical suspension is indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older. adjunctive measures for head lice infestations spinosad topical suspension should be used in the context of an overall lice management program: - wash in hot water or dry-clean all recently worn clothing, hats, used bedding and towels. - wash personal care items such as combs, brushes and hair clips in hot water. - a fine-tooth comb or special nit comb may be used to remove dead lice and nits. spinosad topical suspension is indicated for the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older. adjunctive measures for scabies infestations - wash in hot water or dry-clean any bedding, clothing and towels used by anyone having scabies. none. risk summary spinosad, the active ingredient in spinosad topical suspension, is not absorbed systemically following topical application, and maternal use is not expected to resu

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

elanco us inc, - spinosad (unii: xpa88eap6v) (spinosad - unii:xpa88eap6v), milbemycin oxime (unii: 0502pun0gt) (milbemycin oxime - unii:0502pun0gt) - spinosad 140 mg - trifexis is indicated for the prevention of heartworm disease (dirofilaria immitis ). trifexis kills fleas and is indicated for the prevention and treatment of flea infestations (ctenocephalides felis ), and the treatment and control of adult hookworm (ancylostoma caninum ), adult roundworm (toxocara canis and toxascaris leonina ) and adult whipworm (trichuris vulpis ) infections in dogs and puppies 8 weeks of age or older and 5 pounds of body weight or greater. there are no known contraindications to the use of trifexis.

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

parapro llc - spinosad (unii: xpa88eap6v) (spinosad - unii:xpa88eap6v) - spinosad topical suspension is indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older. adjunctive measures for head lice infestations spinosad topical suspension should be used in the context of an overall lice management program: - wash in hot water or dry-clean all recently worn clothing, hats, used bedding and towels. - wash personal care items such as combs, brushes and hair clips in hot water. - a fine-tooth comb or special nit comb may be used to remove dead lice and nits. spinosad topical suspension is indicated for the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older. adjunctive measures for scabies infestations - wash in hot water or dry-clean any bedding, clothing and towels used by anyone having scabies. none. risk summary spinosad, the active ingredient in spinosad topical suspension, is not absorbed systemically following topical application, and maternal use is not expected to result in fetal exposure to the drug. spinosad topical suspension contains benzyl alcohol. topical benzyl alcohol is unlikely to be absorbed through the skin in clinically relevant amounts; therefore, maternal use is not expected to result in fetal exposure to the drug [see clinical pharmacology (12.3) ]. in animal reproduction studies, no adverse embryofetal effects were seen at oral doses of spinosad up to 200 mg/kg/day in pregnant rats or 50 mg/kg/day in pregnant rabbits administered during the period of organogenesis (see data ). the available data do not allow the calculation of relevant comparisons between the systemic exposure of spinosad in animal studies to the systemic exposure that would be expected in humans after topical use of spinosad topical suspension. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk for birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data systemic embryofetal development studies were conducted in rats and rabbits. oral doses of 10, 50 and 200 mg/kg/day spinosad were administered during the period of organogenesis (gestational days 6 – 15) to pregnant female rats. no adverse embryofetal effects were noted at any dose. maternal toxicity occurred at 200 mg/kg/day. oral doses of 2.5, 10, and 50 mg/kg/day spinosad were administered during the period of organogenesis (gestational days 7 – 19) to pregnant female rabbits. no adverse embryofetal effects were noted at any dose. maternal toxicity occurred at 50 mg/kg/day. a two-generation dietary reproduction study was conducted in rats. oral doses of 3, 10, and 100 mg/kg/day spinosad were administered to male and female rats from 10-12 weeks prior to mating and throughout mating, parturition, and lactation. no reproductive/developmental toxicity was noted at doses up to 10 mg/kg/day. in the presence of maternal toxicity, increased dystocia in parturition, decreased gestation survival, decreased litter size, decreased pup body weight, and decreased neonatal survival occurred at a dose of 100 mg/kg/day. risk summary spinosad, the active ingredient in spinosad topical suspension, is not systemically absorbed by the mother following topical application. therefore, breastfeeding is not expected to result in the exposure of the child to spinosad [see clinical pharmacology (12.3)] . advise breastfeeding women to remove spinosad topical suspension from the breast with soap and water before breastfeeding to avoid direct infant exposure to spinosad topical suspension. spinosad topical suspension contains benzyl alcohol. topical benzyl alcohol is unlikely to be absorbed through the skin of breastfeeding women in clinically relevant amounts; therefore, breastfeeding is not expected to result in exposure of the infant to spinosad topical suspension [see clinical pharmacology (12.3) ]. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for spinosad topical suspension and any potential adverse effects on the breastfed child from spinosad topical suspension, or from the underlying maternal condition. head lice infestation the safety and effectiveness of spinosad topical suspension for the topical treatment of head lice infestation have been established in pediatric patients 6 months of age and older [see clinical pharmacology (12.3) and clinical studies (14)] . spinosad topical suspension is not recommended in pediatric patients below the age of 6 months because of the potential for increased systemic absorption due to a high ratio of skin surface area to body mass and the potential for an immature skin barrier. spinosad topical suspension contains benzyl alcohol. intravenous administration of benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants. the "gasping syndrome" (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birthweight infants when administered intravenously. additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. the minimum amount of benzyl alcohol at which toxicity may occur is not known. premature and low-birthweight infants, as well as patients receiving high dosages of benzyl alcohol, may be more likely to develop toxicity [see warning and precautions (5.1)] . scabies infestation the safety and effectiveness of spinosad topical suspension for the topical treatment of scabies infestation have been established in pediatric patients 4 years of age and older. use of spinosad topical suspension in this age group is supported by trial 1 and trial 2 which included 165 pediatric subjects ages 4 to 17 years old with scabies infestation. the safety and efficacy were generally consistent between pediatric and adult patients. [see clinical pharmacology (12.3) and clinical studies (14)] . the safety and effectiveness of spinosad topical suspension have not been established in pediatric patients less than 4 years of age with scabies infestation. clinical studies of spinosad topical suspension 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. before you use spinosad topical suspension, it is important that you read this instructions for use. be sure that you read, understand, and follow this instructions for use so that you use spinosad topical suspension the right way. ask your healthcare provider or pharmacist if you have questions about the right way to use spinosad topical suspension. important information: - your hair and scalp must be dry before applying spinosad topical suspension. - for very thick, medium length hair or long hair, an entire bottle (120ml) of spinosad topical suspension may be needed to cover the scalp and hair. less spinosad topical suspension may be needed for shorter, thinner hair. how to apply spinosad topical suspension to your scalp and hair: step 1 - shake spinosad topical suspension bottle well right before use. step 2 - cover your face and eyes with a towel and keep your eyes closed tightly. - apply spinosad topical suspension directly to dry hair and scalp. - completely cover the scalp and hair closest to the scalp first, and then apply outwards towards the ends of the hair. - it is important to apply enough spinosad topical suspension to cover your entire scalp and hair so that all lice and eggs are exposed to spinosad topical suspension. step 3 - allow spinosad topical suspension to stay on your scalp and hair for 10 minutes. use a timer or clock and start timing after you have completely covered your hair and scalp with spinosad topical suspension. - continue to keep eyes covered to prevent dripping into your eyes. - after 10 minutes, completely rinse spinosad topical suspension from your hair and scalp with warm water. - you may use a fine-tooth comb to remove treated lice and nits from the hair and scalp, but combing is not required. - wash your hands after applying spinosad topical suspension. - it is okay to shampoo your hair any time after the treatment. if you see live lice on your scalp or hair one week (7 days), after your first treatment, repeat the steps above. how do i stop the spread of lice? to help prevent the spread of lice from one person to another, here are some steps you can take: - avoid direct head-to-head contact with anyone known to have live, crawling lice. - do not share combs, brushes, hats, scarves, bandannas, ribbons, barrettes, hair bands, towels, helmets, or other hair-related personal items with anyone else, whether they have lice or not. - avoid sleepovers and slumber parties during lice outbreaks. lice can live in bedding, pillows, and carpets that have recently been used by someone with lice. - after finishing treatment with lice medicine, check everyone in your family for lice after one week. be sure to talk to your healthcare provider about treatments for those who have lice. - machine-wash or dry-clean any bedding, towels and clothing used by anyone having lice. machine-wash at high temperatures (150°f) and tumble in a hot dryer for 20 minutes. - wash personal items such as combs, brushes, and hair clips in hot water. distributed by: parapro llc, brownsburg, in 46112 this patient information and instructions for use have been approved by the u.s. food and drug administration. revised: 01/2024 before you use spinosad topical suspension, it is important that you read this instructions for use. be sure that you read, understand, and follow this instructions for use so that you use spinosad topical suspension the right way. ask your healthcare provider or pharmacist if you have questions about the right way to use spinosad topical suspension. how to apply spinosad topical suspension to your body: step 1 - shake the spinosad topical suspension bottle well right before use. step 2 - apply spinosad topical suspension to the skin. (see figure a) - apply enough spinosad topical suspension to completely cover your body from your neck to the soles of your feet. (see figure b). make sure you apply to folds of skin, between fingers and toes, and under finger and toe nails . (see figure c) - if you are balding, you should also apply spinosad topical suspension to the scalp, hairline, temples and forehead. - you may need help applying spinosad topical suspension to ensure full coverage. - if you do not completely cover your body with spinosad topical suspension, some scabies mites may escape treatment. - wash your hands after applying spinosad topical suspension to someone else. step 3 - allow spinosad topical suspension to soak into the skin and dry for 10 minutes. use a timer or clock and start timing after you have completely covered your body with spinosad topical suspension. (see figure d) - after 10 minutes, you can get dressed. (see figure e) - wait at least 6 hours before showering or bathing. (see figure f) how do i stop the spread of scabies? to help prevent the spread of scabies from one person to another, here are some steps you can take: - get household members checked by their healthcare provider. - avoid direct body-to-body contact with anyone known to have scabies, including sexual partners. - do not share clothing, towels, bedding or linens with anyone else. the scabies mite can live in bedding, pillows, and carpets that have recently been used by someone with scabies. - machine-wash or dry clean any bedding, clothing and towels that you have used anytime during the three days before treatment by washing in hot water and drying in a hot dryer, or by sealing in a plastic bag for at least 72 hours. machine-wash at high temperatures (150°f) and tumble in a hot dryer for 20 minutes. distributed by: parapro llc, brownsburg, in 46112 spn-pi-003 this patient information and instructions for use have been approved by the u.s. food and drug administration. issued: 01/2024

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

parapro llc - spinosad (unii: xpa88eap6v) (spinosad - unii:xpa88eap6v) - spinosad 9 mg in 1 ml - natrobatm is indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older. adjunctive measures for head lice infestations natroba should be used in the context of an overall lice management program: - wash in hot water or dry-clean all recently worn clothing, hats, used bedding and towels. - wash personal care items such as combs, brushes and hair clips in hot water. - a fine-tooth comb or special nit comb may be used to remove dead lice and nits. natroba is indicated for the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older. adjunctive measures for scabies infestations - wash in hot water or dry-clean any bedding, clothing and towels used by anyone having scabies. none. risk summary spinosad, the active ingredient in natroba, is not absorbed systemically following topical application, and maternal use is not expected to result in fetal exposure to the drug. natroba contains benzyl alcohol. topical ben

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

elanco animal health co - spinosad (unii: xpa88eap6v) (spinosad - unii:xpa88eap6v) - spinosad 140 mg

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

elanco animal health co - spinosad (unii: xpa88eap6v) (spinosad - unii:xpa88eap6v) - spinosad 90 mg

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

vicar operating inc - spinosad (unii: xpa88eap6v) (spinosad - unii:xpa88eap6v), milbemycin oxime (unii: 0502pun0gt) (milbemycin oxime - unii:0502pun0gt) - spinosad 140 mg - comboguard is indicated for the prevention of heartworm disease (dirofilaria immitis ). comboguard kills fleas and is indicated for the prevention and treatment of flea infestations (ctenocephalides felis ), and the treatment and control of adult hookworm (ancylostoma caninum ), adult roundworm (toxocara canis and toxascaris leonina ) and adult whipworm (trichuris vulpis ) infections in dogs and puppies 8 weeks of age or older and 5 pounds of body weight or greater. there are no known contraindications to the use of comboguard.

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

vicar operating inc - spinosad (unii: xpa88eap6v) (spinosad - unii:xpa88eap6v) - spinosad 90 mg - acuguard kills fleas and is indicated for the prevention and treatment of flea infestations (ctenocephalides felis ), for one month, on cats and kittens 14 weeks of age and older and two pounds of body weight or greater. there are no known contraindications for the use of acuguard. acuguard kills fleas and is indicated for the prevention and treatment of flea infestations (ctenocephalides felis ) for one month, on dogs and puppies 14 weeks of age and older and 3.3 pounds of body weight or greater. there are no known contraindications for the use of acuguard.

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

elanco australasia pty ltd - spinosad manufacturing concentrate; milbemycin oxime - oral tablet - spinosad manufacturing concentrate ungrouped active 140.0 mg/tb; milbemycin oxime antibiotic active 2.3 mg/tb - v15c + v15f vet small ani - dog | bitch | castrate | puppy - flea | flea allergic dermatitis | heartworm - prevention of | hookworm | roundworm | whipworm - trichuris spp. | ancylostoma braziliense | ancylostoma caninum | ctenocephalides spp. | ground fleas | to prevent heartworm | toxocara mystax | toxocara spp. | uncinaria stenocephala

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

elanco australasia pty ltd - spinosad manufacturing concentrate; milbemycin oxime - oral tablet - spinosad manufacturing concentrate ungrouped active 270.0 mg/tb; milbemycin oxime antibiotic active 4.5 mg/tb - v15c + v15f vet small ani - dog | bitch | castrate | puppy - flea | flea allergic dermatitis | heartworm - prevention of | hookworm | roundworm | whipworm - trichuris spp. | ancylostoma braziliense | ancylostoma caninum | ctenocephalides spp. | ground fleas | to prevent heartworm | toxocara mystax | toxocara spp. | uncinaria stenocephala