Spinoderm Lotion 100ml

For topical use only. Not for oral, ophthalmic, or intravaginal use.

Treatment of Scabies Infestations:

• The bottle should be shaken well before use
• The medication should be thoroughly rubbed into the entire body from the neck down to the soles of the feet
• Patients with balding scalp should also apply the medication to the scalp, hairline, temples, and forehead
• Sufficient time should be allowed for the medication to absorb into the skin and dry for 10 minutes before dressing
• Bathing should be avoided for at least 6 hours after application

Treatment of Head Lice Infestations:

• The bottle should be shaken well before use
• The medicine should be applied thoroughly so that the scalp is completely covered. Then the medication should be applied to dry hair
• After 10 minutes, the hair should be rinsed with warm water
• If live lice are observed 7 days after the first treatment, the treatment should be repeated or as directed by the physician.

Use in Children & Adolescents

Scabies Infestation: The safety and effectiveness of Spinosad Topical Suspension have not been established in pediatric patients less than 4 years of age with scabies infestation.

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. Drug Interactions

Generally has minimal drug interactions due to its low systemic absorption. while using spinosad with other topical medications, such as corticosteroids or retinoids, there could be an increased risk of local skin irritation or hypersensitivity, though this is more of a compounded side effect rather than a true drug interaction. Overall, spinosad 0.9% topical suspension is considered safe with minimal interaction concerns, especially when used as directed.

No information is available.

Most common adverse reactions for:

• Scabies treatment (>1%) are application site irritation and dry skin
• Lice treatment (>1%) are application site erythema and ocular erythema

Pregnancy category B. Breastfeeding is not expected to result in the exposure of the child to Spinosad. Breastfeeding women should remove Spinosad Topical Suspension from the breast with soap and water before breastfeeding.

Spinosad Topical Suspension contains benzyl alcohol and is not approved 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 when administered intravenously.

Topical Antifungal preparations

Keep out of the reach of children. Store in a dry place, below 25°C temperature and protected from light.