Alice12 mg

Alice is an antiparasitic (anthelmintic) medicine. Its evidence-supported uses are classified below by strength of evidence.

Established / FDA-approved oral uses

• Strongyloidiasis: Treatment of intestinal infection caused by Strongyloides stercoralis.
• Onchocerciasis (river blindness): Treatment of infection caused by Onchocerca volvulus microfilariae. Alice has no activity against adult worms, so periodic retreatment is usually required, and surgical removal of nodules may be used as adjunct therapy.

Guideline-supported uses (WHO / national scabies and lice programmes)

• Scabies: Oral Alice is used, often together with topical scabicides, for classical and crusted (Norwegian) scabies, particularly in outbreak settings or when topical treatment fails or cannot be used.
• Lymphatic filariasis: Used as part of WHO mass drug administration programmes, typically in combination with albendazole and/or diethylcarbamazine (combination therapy required; not effective as monotherapy for this indication).
• Pediculosis (head lice): A topical lotion formulation of Alice is approved for head lice in patients above a defined minimum age; oral Alice is used off-label for resistant infestations under medical supervision.

Off-label / dermatological use

• A topical cream formulation of Alice is approved for inflammatory lesions of rosacea; this is a distinct, separate indication from the antiparasitic oral use.

Alice should be used strictly for these established and guideline-supported parasitic and dermatological indications. It should not be used for the prevention or treatment of viral illnesses, as this is not an approved or evidence-supported use.

Each oral tablet contains Ivermectin USP as the active ingredient, commonly available in 3 mg, 6 mg and 12 mg strengths. A topical lotion (0.5%) and topical cream (1%) formulation are also available for dermatological use. Tablets contain standard inactive excipients such as microcrystalline cellulose, lactose, starch, magnesium stearate and colloidal silicon dioxide, which vary by manufacturer.

Alice is a semi-synthetic macrocyclic lactone derived from avermectins, produced by fermentation of Streptomyces avermitilis. It is an antiparasitic agent active against a range of nematodes and ectoparasites. Oral Alice is supplied as tablets; topical formulations (cream, lotion) are also marketed for specific dermatological indications.

Alice belongs to the anthelmintic (antiparasitic) drug class, specifically the avermectin group of macrocyclic lactones.

Ivermectin binds selectively and with high affinity to glutamate-gated chloride ion channels found in invertebrate nerve and muscle cells. This binding increases the permeability of the cell membrane to chloride ions, causing hyperpolarization of the nerve or muscle cell, which leads to paralysis and death of the parasite.

Ivermectin may also interact with other ligand-gated chloride channels, such as those gated by gamma-aminobutyric acid (GABA). Because mammals do not have glutamate-gated chloride channels, and because Ivermectin has low affinity for mammalian ligand-gated chloride channels and does not readily cross an intact blood-brain barrier, it is well tolerated in humans at approved doses.

Pharmacokinetics: After oral administration, Ivermectin is well absorbed, with peak plasma concentrations reached about 4 hours after dosing. It is highly protein bound (~93%), extensively metabolized in the liver (largely via CYP3A4), and eliminated almost exclusively in feces, with an elimination half-life of approximately 18 hours.

Take Alice tablets by mouth with water, on an empty stomach (at least one hour before food), unless a physician specifically directs otherwise. Swallow tablets whole; do not chew or crush unless the specific product labeling permits it. Do not take with alcohol. If a topical Alice formulation has been prescribed, apply only to the skin/scalp as directed and avoid contact with eyes and mucous membranes; topical forms are not to be taken by mouth.

Clinically significant interactions

• Warfarin: Post-marketing reports describe increased International Normalized Ratio (INR) when Alice is co-administered with warfarin. Patients on warfarin who receive Alice should have INR monitored more closely.
• CYP3A4 inhibitors/inducers: Since Alice is metabolized substantially by CYP3A4, strong inhibitors (e.g. certain azole antifungals, macrolide antibiotics) may increase Alice plasma levels, while strong inducers may reduce efficacy; caution is advised with concurrent use.
• CNS depressants: Concomitant use with other drugs that enhance GABAergic transmission (e.g. benzodiazepines, sodium valproate) should be used cautiously, as it may theoretically potentiate CNS depressant effects.

Always inform the prescribing physician of all other medicines being taken before starting Alice.

Most patients tolerate Alice well. Reported adverse effects vary somewhat by indication because some reactions reflect the host response to dying parasites (Mazzotti-type reaction) rather than direct drug toxicity.

Common (strongyloidiasis/general use)

• Dizziness
• Pruritus (itching)
• Nausea, diarrhea, abdominal pain
• Headache
• Fatigue/asthenia

Common with onchocerciasis treatment (Mazzotti-type reaction to dying microfilariae)

• Pruritus and worsening skin rash
• Fever
• Lymph node tenderness/swelling
• Joint and muscle pain
• Peripheral edema, tachycardia, postural hypotension (less common)
• Eye symptoms such as limbitis or punctate opacity in patients with ocular onchocerciasis

Rare / serious (post-marketing)

• Seizures
• Hepatitis, elevated liver enzymes
• Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) - rare
• Neurotoxicity (confusion, altered consciousness) - see Precautions and Warnings

Patients should seek medical attention promptly for severe rash, breathing difficulty, yellowing of skin/eyes, or altered mental status.

Pregnancy: Alice should be used during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects at high doses, and safety in human pregnancy has not been firmly established. Treatment for endemic parasitic disease is generally deferred until after delivery when possible; a physician should be consulted before use in pregnancy.

Lactation: Alice is excreted into human breast milk in low concentrations. Treatment of breastfeeding mothers should only be undertaken when the risk of delaying treatment to the mother is judged to outweigh the possible risk to the nursing infant. Consult a physician before use while breastfeeding.

Loa loa co-infection - serious encephalopathy risk

In patients from Loa loa-endemic regions of West/Central Africa who are heavily co-infected with Loa loa microfilariae, treatment of onchocerciasis with Alice has rarely been associated with serious, and occasionally fatal, encephalopathy. Patients with significant exposure to Loa loa-endemic areas should be assessed for Loa loa infection before treatment, and monitored closely if treatment proceeds.

Mazzotti-type reactions

Treatment of onchocerciasis provokes an immune/inflammatory response to dying microfilariae (Mazzotti reaction), which can include pruritus, rash, fever, lymphadenopathy and, rarely, orthostatic hypotension. Ophthalmological reactions can occur in patients with ocular involvement; those with severe eye disease should be closely monitored during treatment.

Neurotoxicity

Altered mental status, including somnolence, confusion, stupor and (rarely) coma, has been reported, more often in patients with heavy parasite burdens or Loa loa co-infection, and generally resolves with supportive care and discontinuation.

Not for viral illness

Alice has no established role in preventing or treating viral infections; it should be used only for its approved and guideline-supported antiparasitic/dermatological indications.

Hepatic impairment

Use with caution in patients with significant hepatic impairment, as Alice is extensively hepatically metabolized; dose adjustment data are limited, so specialist advice is recommended.

Overdose of Alice may cause pronounced central nervous system effects, including drowsiness, ataxia, tremor, confusion or, rarely, coma, as well as gastrointestinal symptoms and low blood pressure. There is no specific antidote. If overdose is suspected, seek immediate medical attention or contact a poison control center/emergency services. Management is supportive and symptomatic (e.g. general supportive care, monitoring of vital signs and, if appropriate and performed by medical personnel, measures to reduce further drug absorption); do not attempt unsupervised home treatment for a suspected overdose.

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

Pediatric use

Safety and effectiveness of oral Alice have not been established in children weighing less than 15 kg. In children weighing 15 kg or more, dosing follows the same weight-based schedule as adults. See Pediatric Uses for further detail.

Elderly

No specific dose adjustment is generally required for elderly patients on the basis of age alone, but they should be assessed for hepatic/renal function and concurrent medications (e.g. warfarin) before treatment.

Renal impairment

Formal dose-adjustment studies in renal impairment are limited; Alice is eliminated mainly via the hepatic/fecal route, so significant renal-based accumulation is not expected, but caution and physician supervision are advised in severe renal impairment.

Hepatic impairment

Use with caution; see Precautions and Warnings.

Low body weight / malnutrition

Data in very low body weight patients are limited; conservative, physician-supervised dosing is advised.

Most approved indications for oral Alice (strongyloidiasis, onchocerciasis, scabies) are treated with a single dose or a short one-to-two-dose regimen rather than a prolonged daily course. Onchocerciasis often requires periodic retreatment (commonly around every 12 months) because Alice does not kill adult worms, and follow-up assessment (e.g. stool exams for strongyloidiasis) guides whether a repeat dose is needed. The treating physician determines the exact duration and any retreatment schedule based on indication and clinical response.

Ivermectin is classified as an antiparasitic agent, specifically an anthelmintic of the avermectin (macrocyclic lactone) class.

Ivermectin binds selectively to glutamate-gated chloride channels in parasite nerve and muscle cells, increasing chloride ion influx and causing hyperpolarization that leads to paralysis and death of the parasite. It may also potentiate other chloride channels such as GABA-gated channels. Because these glutamate-gated channels are absent in mammals and Ivermectin does not readily cross an intact blood-brain barrier, it selectively affects the parasite with minimal effect on the human host at approved doses.

C

Oral Alice is not established as safe and effective in children weighing less than 15 kg; safety and efficacy have not been established in this weight group, and use should be avoided unless a physician determines the benefit clearly outweighs the risk. In children weighing 15 kg or more, weight-based single-dose regimens similar to those used in adults are applied for strongyloidiasis, onchocerciasis and scabies, under medical supervision. A topical Alice lotion is approved for head lice only above a specified minimum age (check product-specific labeling); topical cream for rosacea is intended for adult use. Parents/caregivers should consult a pediatrician before use in any child.