Permisol Max5%+10%

Permisol Max is indicated for the topical treatment of scabies caused by infestation with Sarcoptes scabiei.

• Established use: Eradication of scabies mites and their eggs on the skin. The permethrin component is a pyrethroid scabicide that kills mites, while the crotamiton component provides additional antipruritic (anti-itch) action to relieve the intense itching associated with scabies infestation.
• Adjunct benefit: Because post-scabetic itching commonly persists for several weeks after mites are eliminated, the antipruritic component of Permisol Max is used as an adjunct to reduce discomfort during this recovery period, not as a substitute for completing the full scabicidal treatment course.

Permisol Max is not indicated for the treatment of head lice, body lice, or pubic lice; single-agent, lower-strength permethrin products are used for those indications.

Each unit of Permethrin + Crotamiton topical preparation contains permethrin and crotamiton as combined active ingredients in a cream or lotion base, formulated for external (topical) application to the skin.

Permisol Max is a fixed-dose topical combination product used in the management of scabies. It combines two complementary actions in a single external preparation:

• Permethrin, a synthetic pyrethroid insecticide/scabicide that acts directly on the nervous system of the scabies mite, causing paralysis and death of the parasite.
• Crotamiton, an agent with scabicidal and antipruritic properties that helps relieve the itching that accompanies scabies infestation.

Permisol Max is applied externally to the skin under medical or pharmacist guidance and is not intended for internal use.

Permisol Max belongs to the therapeutic class of topical scabicides and antipruritic agents (ectoparasiticides for external use).

Permethrin + Crotamiton combines two agents with complementary mechanisms of action against scabies:

• Permethrin acts on the sodium channels of the nerve cell membranes of the mite, delaying repolarization and causing disruption of the neuronal membrane. This leads to paralysis and death of the Sarcoptes scabiei mite and its eggs. Permethrin has very low mammalian toxicity because it is metabolized rapidly by skin esterases and has poor systemic absorption through intact human skin.
• Crotamiton has a scabicidal effect against Sarcoptes scabiei through a mechanism that is not fully elucidated, and separately exerts a local antipruritic effect that reduces the sensation of itching in the skin, likely through a direct action on cutaneous sensory nerve endings.

Together, the two components of Permethrin + Crotamiton allow for mite eradication along with symptomatic relief of itching during treatment and the recovery period.

For external (topical) use only. Permisol Max should be applied to clean, dry skin and washed off after the physician-recommended contact period. Avoid contact with eyes, mouth, nose, and other mucous membranes. Wash hands after application unless hands are part of the treated area.

Because Permisol Max is applied topically and systemic absorption is normally minimal through intact skin, clinically significant drug-drug interactions are uncommon.

• Concurrent use of other topical products (e.g. other insecticidal or irritant preparations) on the same skin area is not recommended, as it may increase skin irritation or systemic absorption without added benefit.
• Systemic absorption of both components can be increased when applied to broken, inflamed, or extensively weeping skin, or in infants and young children with a higher skin surface-area-to-body-weight ratio; this is a theoretical caution rather than an established drug interaction, and such use should be medically supervised.

Inform your physician or pharmacist of all other topical or systemic medicines you are using before starting Permisol Max.

Most side effects of Permisol Max are local skin reactions at the site of application. These may include:

• Mild burning, stinging, or tingling sensation on application
• Skin redness (erythema) or irritation
• Itching, which can be difficult to distinguish from the natural post-scabies itch that persists during healing (see Precautions and Warnings)
• Dryness or mild rash
• Rare allergic contact dermatitis

Systemic side effects are rare given minimal absorption through intact skin, but should be reported to a physician if they occur, especially in infants or if applied to broken skin.

Use of Permisol Max during pregnancy or breastfeeding should only occur if clearly needed and after consulting a physician, weighing potential benefit against potential risk.

• Pregnancy: Permethrin has low systemic absorption through intact skin and is generally regarded, among topical scabicidal options, as one with a relatively more favorable safety profile in pregnancy when treatment is medically necessary; however, data specific to the combination with crotamiton are more limited, so Permisol Max should be used in pregnancy only under a physician's direction.
• Lactation: It is not established whether the components of Permisol Max pass into breast milk in clinically significant amounts. As a precaution, avoid application to the breast/nipple area, and use only under medical supervision while breastfeeding.

The following precautions apply when using Permisol Max:

• External use only: Permisol Max is not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes, mouth, and other mucous membranes; if accidental contact occurs, rinse thoroughly with water.
• Treat close contacts simultaneously: All household members and close physical/sexual contacts should be treated at the same time, per standard scabies management practice, even if they are not currently symptomatic, to prevent re-infestation and interrupt transmission.
• Persistent itching after treatment: Itching may continue for several weeks after successful treatment due to an ongoing allergic-type skin reaction to dead mites and eggs. This is expected and does not necessarily mean the treatment has failed; patients should avoid repeated or excessive re-application based on itching alone and should consult a physician before retreating.
• Avoid overuse: Do not apply more frequently or for a longer contact time than recommended, as this increases the risk of skin irritation and systemic absorption without added benefit.
• Broken or inflamed skin: Use with caution and under medical guidance if the skin is broken, weeping, or extensively inflamed, since absorption may be increased.
• Cross-sensitivity: Use with caution in individuals with known sensitivity to chrysanthemums or ragweed (see Contraindications).

Accidental ingestion or extensive/prolonged skin exposure to Permisol Max may lead to symptoms such as nausea, vomiting, headache, dizziness, excessive skin irritation, or in rare cases more significant systemic effects.

If accidental ingestion occurs, or if excessive skin absorption is suspected (e.g. after application to large areas of broken skin or overuse in an infant), seek immediate medical attention or contact a poison control center/emergency services. Do not attempt to manage a suspected overdose at home without professional medical guidance.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Pediatric patients: Permisol Max may be used in children under close medical supervision; in infants, application area and duration should be determined by a physician, and application to the scalp/face may be required with strict avoidance of the eyes and mouth. Safety and efficacy of the crotamiton component specifically have not been well established in very young infants, so pediatric use should always be physician-directed.

Elderly patients: No specific dose adjustment is generally required, but elderly patients, particularly those who are immunocompromised or institutionalized, may have more extensive or atypical infestation (e.g. crusted scabies) and may need closer medical supervision and follow-up.

Renal/hepatic impairment: No well-established dose adjustment is required for topical use of Permisol Max, given minimal systemic absorption through intact skin; however, caution is advised if used on extensive areas of broken skin in such patients.

Permisol Max is typically used as a single application left on the skin for the physician-recommended contact time (commonly 8-14 hours), with a possible second application after about one week if live mites persist, as advised by a physician. Treatment duration should not be extended beyond what is recommended without medical advice.

Topical scabicide and antipruritic combination (pyrethroid ectoparasiticide plus antipruritic agent).

Permethrin + Crotamiton combines permethrin, which disrupts sodium channel function in the nerve membranes of the scabies mite leading to paralysis and death of the parasite, with crotamiton, which has scabicidal activity together with a local antipruritic effect that reduces the sensation of itching in affected skin.

Permisol Max may be used in pediatric patients, including infants, but only under the direction and supervision of a physician. In infants and young children, scabies infestation can involve the scalp, face, neck, palms, and soles, so the treated area may need to extend beyond what is used in adults, while carefully avoiding the eyes, mouth, and mucous membranes.

Because infants have a higher skin surface-area-to-body-weight ratio, they are at greater risk of increased systemic absorption; therefore, application should be limited to the physician-recommended area, amount, and duration in this age group. Safety and efficacy of the crotamiton component have not been well established in very young infants, and it should be used in this population only when a physician determines the benefit outweighs the risk.