SPINOSAD suspension

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

SPINOSAD (UNII: XPA88EAP6V) (SPINOSAD - UNII:XPA88EAP6V)

זמין מ:

Allegis Pharmaceuticals, LLC

INN (שם בינלאומי):

spinosad

הרכב:

spinosad 9 mg in 1 mL

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

leaflet_short:

How Supplied Spinosad Topical Suspension, 0.9% w/w; each gram contains 9 mg of spinosad in a slightly opaque (white soft particles may be visible), light orange-colored, viscous liquid, supplied in 4 oz (120 mL) high density polyethylene (HDPE) bottles. NDC 28595-570-04 Storage and Handling Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F).

מצב אישור:

New Drug Application Authorized Generic

מאפייני מוצר

SPINOSAD- SPINOSAD SUSPENSION
ALLEGIS PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SPINOSAD TOPICAL
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR SPINOSAD TOPICAL
SUSPENSION.
SPINOSAD TOPICAL SUSPENSION
INITIAL U.S. APPROVAL: 2011
RECENT MAJOR CHANGES
Indications and Usage ( 1)
04/2021
Dosage and Administration ( 2)
04/2021
Warnings and Precautions ( 5)
04/2021
INDICATIONS AND USAGE
Spinosad Topical Suspension is a pediculicide indicated for the
topical treatment of head lice infestations
in adult and pediatric patients 6 months of age and older. ( 1.1)
Spinosad Topical Suspension is a scabicide indicated for the topical
treatment of scabies infestations in
adult and pediatric patients 4 years of age and older, ( 1.2)
DOSAGE AND ADMINISTRATION
For topical use only. Not for oral, ophthalmic, or intravaginal use. (
2)
Treatment of head lice infestations ( 2.2):
Shake bottle well
Apply a sufficient amount to cover dry scalp, then apply to dry hair
Rinse off with warm water after 10 minutes
Repeat treatment only if live lice are seen 7 days after first
treatment
Treatment of scabies infestations ( 2.3):
Shake bottle well
Apply product to skin by rubbing it in to completely cover the body
from the neck down to the soles
of the feet
Patients with balding scalp should also apply product to the scalp,
hairline, temples, and forehead
Allow to absorb in the skin and dry for 10 minutes before getting
dressed
Leave on the skin for at least 6 hours before showering or bathing
DOSAGE FORMS AND STRENGTHS
Topical suspension: 0.9% w/w ( 3)
CONTRAINDICATIONS
None. ( 4)
WARNINGS AND PRECAUTIONS
Benzyl Alcohol Toxicity: Not recommended in infants below the age of 6
months; potential for increased
systemic absorption. ( 5.1)
ADVERSE REACTIONS
Most common adverse events for lice treatment (>1%) were application
site erythema and ocular
erythema. ( 6.1)
Most common adverse reactions for scabies treatment (>1%) were
appli