|adverseReactions=application site erythema and ocular erythema
|adverseReactions=application site erythema and ocular erythema
Line 60:
Line 60:
<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|contraindications=* None
<!--Warnings-->
<!--Warnings-->
|warnings=* Description
|warnings=* Benzyl Alcohol Toxicity
Spinosad Topical Suspension contains benzyl alcohol and is not recommended for use in neonates and infants below the age of 6 months. Systemic exposure to benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants
====Precautions====
* Description
<!--Adverse Reactions-->
<!--Adverse Reactions-->
<!--Clinical Trials Experience-->
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
Spinosad Topical Suspension was studied in two randomized, active-controlled trials (N=552) in subjects with head lice; the results are presented in Table 1.
=====Neurologic=====
[[File:Spinosad adv.png|none|400px]]
Other less common reactions (less than 1% but more than 0.1%) were application site dryness, application site exfoliation, alopecia, and dry skin.
Systemic safety was not assessed in pediatric subjects under 4 years of age as laboratory parameters were not monitored in these controlled studies.
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
Line 194:
Line 133:
<!--Drug Interactions-->
<!--Drug Interactions-->
|drugInteractions=* Drug
|drugInteractions=
:* Description
<!--Use in Specific Populations-->
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|FDAPregCat=B
|useInPregnancyFDA=* There are no adequate and well-controlled studies with Spinosad Topical Suspension in pregnant women. Studies in humans did not assess for the absorption of benzyl alcohol contained in Spinosad Topical Suspension. Reproduction studies conducted in rats and rabbits were negative for teratogenic effects. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
No comparisons of animal exposure with human exposure are provided in this labeling due to the low systemic exposure noted in the clinical pharmacokinetic study [see CLINICAL PHARMACOLOGY (12.3)] which did not allow for the determination of human AUC values that could be used for this calculation.
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 teratogenic 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 teratogenic 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.
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInNursing=Spinosad, the active ingredient in Spinosad Topical Suspension is not systemically absorbed; and therefore, will not be present in human milk. However, Spinosad Topical Suspension contains benzyl alcohol, which may be systemically absorbed through the skin, and the amount of benzyl alcohol excreted in human milk with use of Spinosad Topical Suspension is unknown. Caution should be exercised when Spinosad Topical Suspension is administered to a lactating woman. A lactating woman may choose to pump and discard breast milk for 8 hours (5 half-lives of benzyl alcohol) after use to avoid infant ingestion of benzyl alcohol.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInPed=The safety and effectiveness of Spinosad Topical Suspension have been established in pediatric patients 4 years of age and older with active head lice infestation [see CLINICAL STUDIES (14)].
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
Safety in pediatric patients below the age of 4 years has not been established. 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 which 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. 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, may be more likely to develop toxicity
|useInGeri=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.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
Line 214:
Line 165:
<!--Administration and Monitoring-->
<!--Administration and Monitoring-->
|administration=* Oral
|administration=* topical
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
* Description
<!--IV Compatibility-->
<!--IV Compatibility-->
Line 225:
Line 174:
<!--Overdosage-->
<!--Overdosage-->
|overdose====Acute Overdose===
|overdose=If oral ingestion occurs, seek medical advice immediately.
====Signs and Symptoms====
* Description
====Management====
* Description
===Chronic Overdose===
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Spinosad is a Dermatological Agent that is FDA approved for the treatment of head lice. Common adverse reactions include application site erythema and ocular erythema.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
Spinosad Topical Suspension is indicated for the topical treatment of head lice infestation in patients four (4) years of age and older.
1.2 Adjunctive Measures
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.
Dosage
For topical use only. Spinosad Topical Suspension is not for oral, ophthalmic, or intravaginal use.
Shake bottle well. Apply sufficient Spinosad Topical Suspension to cover dry scalp, then apply to dry hair. Depending on hair length, apply up to 120 mL (one bottle) to adequately cover scalp and hair. Leave on for 10 minutes, then thoroughly rinse off Spinosad Topical Suspension with warm water. If live lice are seen 7 days after the first treatment, a second treatment should be applied. Avoid contact with eyes.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Spinosad in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Spinosad in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Indications
Spinosad Topical Suspension is indicated for the topical treatment of head lice infestation in patients four (4) years of age and older.
1.2 Adjunctive Measures
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.
Dosage
For topical use only. Spinosad Topical Suspension is not for oral, ophthalmic, or intravaginal use.
Shake bottle well. Apply sufficient Spinosad Topical Suspension to cover dry scalp, then apply to dry hair. Depending on hair length, apply up to 120 mL (one bottle) to adequately cover scalp and hair. Leave on for 10 minutes, then thoroughly rinse off Spinosad Topical Suspension with warm water. If live lice are seen 7 days after the first treatment, a second treatment should be applied. Avoid contact with eyes.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Spinosad in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Spinosad in pediatric patients.
Contraindications
None
Warnings
Benzyl Alcohol Toxicity
Spinosad Topical Suspension contains benzyl alcohol and is not recommended for use in neonates and infants below the age of 6 months. Systemic exposure to benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants
Adverse Reactions
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
Spinosad Topical Suspension was studied in two randomized, active-controlled trials (N=552) in subjects with head lice; the results are presented in Table 1.
Other less common reactions (less than 1% but more than 0.1%) were application site dryness, application site exfoliation, alopecia, and dry skin.
Systemic safety was not assessed in pediatric subjects under 4 years of age as laboratory parameters were not monitored in these controlled studies.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Spinosad in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
There is limited information regarding Spinosad Drug Interactions in the drug label.
There are no adequate and well-controlled studies with Spinosad Topical Suspension in pregnant women. Studies in humans did not assess for the absorption of benzyl alcohol contained in Spinosad Topical Suspension. Reproduction studies conducted in rats and rabbits were negative for teratogenic effects. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
No comparisons of animal exposure with human exposure are provided in this labeling due to the low systemic exposure noted in the clinical pharmacokinetic study [see CLINICAL PHARMACOLOGY (12.3)] which did not allow for the determination of human AUC values that could be used for this calculation.
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 teratogenic 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 teratogenic 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.
Pregnancy Category (AUS):
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Spinosad in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Spinosad during labor and delivery.
Nursing Mothers
Spinosad, the active ingredient in Spinosad Topical Suspension is not systemically absorbed; and therefore, will not be present in human milk. However, Spinosad Topical Suspension contains benzyl alcohol, which may be systemically absorbed through the skin, and the amount of benzyl alcohol excreted in human milk with use of Spinosad Topical Suspension is unknown. Caution should be exercised when Spinosad Topical Suspension is administered to a lactating woman. A lactating woman may choose to pump and discard breast milk for 8 hours (5 half-lives of benzyl alcohol) after use to avoid infant ingestion of benzyl alcohol.
Pediatric Use
The safety and effectiveness of Spinosad Topical Suspension have been established in pediatric patients 4 years of age and older with active head lice infestation [see CLINICAL STUDIES (14)].
Safety in pediatric patients below the age of 4 years has not been established. 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 which 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. 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, may be more likely to develop toxicity
Geriatic Use
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.
Gender
There is no FDA guidance on the use of Spinosad with respect to specific gender populations.
Race
There is no FDA guidance on the use of Spinosad with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Spinosad in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Spinosad in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Spinosad in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Spinosad in patients who are immunocompromised.
Administration and Monitoring
Administration
topical
Monitoring
There is limited information regarding Monitoring of Spinosad in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Spinosad in the drug label.
Overdosage
If oral ingestion occurs, seek medical advice immediately.
Pharmacology
There is limited information regarding Spinosad Pharmacology in the drug label.
Mechanism of Action
Structure
File:Spinosad01.pngThis image is provided by the National Library of Medicine.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Spinosad in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Spinosad in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Spinosad in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Spinosad in the drug label.
How Supplied
Storage
There is limited information regarding Spinosad Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Spinosad
|?Pill Name
|?Drug Name
|?Pill Ingred
|?Pill Imprint
|?Pill Dosage
|?Pill Color
|?Pill Shape
|?Pill Size (mm)
|?Pill Scoring
|?NDC
|?Drug Author
|format=template
|template=DrugPageImages
|mainlabel=-
|sort=Pill Name
}}
