Freescab 0.9% w/w

INDICATIONS

Scabies Infestations: Spinosad Topical Suspension is a scabicide Indicated for the topical treatment of scabies infestations in adult and paediatric patients 4 years of age and older.Head Lice Infestations: Spinosad Topical Suspension is a pediculicide indicated for the topical treatment of head lice infestations in adult and paediatric patients 6 months of age and older.

PHARMACOLOGY

Spinosad causes neuronal excitation in insects. After periods of hyperexcitation, lice and mites become paralyzed and die.
Pharmacokinetics: When applied topically, spinosad shows minimal absorption into the bloodstream. After topical application, detectable plasma levels of spinosad are either very low or absent. In clinical studies, plasma spinosad concentrations were below the level of quantification in most subjects following a single topical application to the scalp for lice treatment. The absorption in children follows a similar pattern, with minimal systemic exposure. Spinosad remains localized to the treated area, specifically targeting lice and scabies on the surface of the skin and scalp. Due to its minimal absorption, significant distribution into systemic circulation is not observed. Because spinosad is minimally absorbed, metabolism within the body is very limited. If any trace amounts are absorbed, spinosad is likely metabolized by the liver's CYP450 enzyme system. Spinosad is predominantly excreted as unchanged drug through the skin or external means (e.g., through washing off). Minimal amounts, if any, are excreted via urine or feces due to low systemic absorption. Due to its negligible systemic absorption, spinosad's systemic half-life is not well-defined in humans. It primarily remains active on the surface of the skin until washed off.

DOSAGE & ADMINISTRATION

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 & AdolescentsScabies 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

INTERACTION

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.

SIDE EFFECTS

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 & LACTATION

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.

PRECAUTIONS & WARNINGS

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.

THERAPEUTIC CLASS

Topical Antifungal preparations

STORAGE CONDITIONS

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