Schedule H

Oral, Topical (cutaneous)

Formulation Strengths Available

Tablets 3 mg, 6 mg, 12 mg

Lotion (topical) 0.5% w/v

Cream (topical) 1% w/w

Oral suspension NOT AVAILABLE in India

Injectable forms NOT AVAILABLE for human use in India

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

✦ Strongyloidiasis (Intestinal)

Parameter Details

Starting dose 200 mcg/kg body weight orally as a single dose

Titration Not applicable for uncomplicated cases

Usual maintenance Single dose treatment; repeat every 2 weeks in immunocompromised patients until stool examination negative

Maximum dose 200 mcg/kg per dose

Clinical Notes:

• Administer on empty stomach with plain water

• Repeat dosing essential in hyperinfection syndrome or disseminated strongyloidiasis

• Immunocompromised patients require specialist supervision

✦ Onchocerciasis / Lymphatic Filariasis (Wuchereria bancrofti)

Parameter Details

Starting dose 150–200 mcg/kg orally as a single dose

Titration Not applicable

Usual maintenance Repeat every 6–12 months as per MoHFW Mass Drug Administration protocols

Maximum dose 200 mcg/kg per dose

Clinical Notes:

• Commonly administered alongside albendazole ± DEC under national filariasis elimination programmes

• Annual dosing for 5 consecutive years recommended in endemic areas

✦ Scabies (Classic/Uncomplicated)

Oral Route:

Parameter Details

Starting dose 200 mcg/kg orally as a single dose

Titration Not applicable

Usual maintenance Repeat identical dose after 7–14 days

Maximum dose 200 mcg/kg per dose

Topical Route:

Parameter Details

Starting dose 1% cream/lotion applied to entire body below neck

Titration Not applicable

Usual maintenance Repeat after 7 days if required

Maximum dose Single application covering affected areas

Clinical Notes:

• Oral therapy preferred for widespread infestation, crusted scabies, or treatment-refractory cases

• Treat all household contacts simultaneously

• Wash and dry clothing/bedding at high temperature

✦ Pediculosis Capitis (Head Lice)

Topical Route (First-line):

Parameter Details

Starting dose 0.5% lotion applied to dry scalp and hair

Titration Not applicable

Usual maintenance Leave for 10 minutes, rinse; repeat after 7 days if needed

Maximum dose Not applicable

Oral Route (Reserved for resistant cases):

Parameter Details

Starting dose 200 mcg/kg orally

Titration Not applicable

Usual maintenance Single dose; may repeat after 7–10 days

Maximum dose 200 mcg/kg per dose

Clinical Notes:

• Oral route not first-line; reserve for permethrin-resistant cases

• Topical ivermectin has slower efficacy compared to permethrin

Secondary Indications — Adults (Off-label, if any)

Indication Dose Duration Notes

Crusted (Norwegian) Scabies 200 mcg/kg orally on days 1, 2, 8, 9, 15 (severe cases: additional doses days 22, 29) Multiple doses over weeks based on crust burden OFF-LABEL — Specialist only; combine with topical keratolytics and permethrin; based on dermatology specialist practice

Rosacea (Papulopustular) 1% cream applied once daily 12–16 weeks OFF-LABEL — Dermatologist prescription; evidence from international RCTs

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

✦ Strongyloidiasis, Scabies, Filariasis

Eligibility: ≥15 kg body weight (not recommended below this threshold)

Oral Dose: 200 mcg/kg as single dose; repeat after 7–14 days based on indication

Weight-based Dosing Chart:

Body Weight (kg) Calculated Dose Practical Tablet Regimen

15–24 ~3 mg 1 tablet of 3 mg

25–35 ~6 mg 1 tablet of 6 mg

36–50 ~9 mg 1 tablet of 3 mg + 1 tablet of 6 mg

51–65 ~12 mg 1 tablet of 12 mg

65 Weight-based calculation Combine tablets to approximate 200 mcg/kg

Clinical Notes:

• Administer on empty stomach

• Scabies: repeat dose after 7–14 days

• Persistent helminthic infection: repeat dose after 14 days

• Specialist consultation essential for immunocompromised children or extrapulmonary disease

Secondary Indications — Paediatric Doses (Off-label, if any)

Indication Eligibility Notes

Off-label use below 15 kg Children <15 kg or <5 years NOT RECOMMENDED routinely; use only under paediatric infectious disease or dermatology specialist supervision

Topical formulations in infants Below 6 months Safety NOT established; avoid

Mild to Moderate Impairment No dose adjustment required

• Known hypersensitivity to ivermectin or any macrocyclic lactone compound

• Children weighing <15 kg (oral formulation)

• Severe hepatic impairment (unless specialist-supervised)

• Active ocular involvement in onchocerciasis (risk of severe inflammatory reaction causing visual damage)

• Elderly or debilitated patients: heightened CNS sensitivity

• Patients with blood-brain barrier compromise (e.g., meningitis, encephalitis): risk of neurotoxicity

• Immunocompromised patients: may require repeated dosing and specialist oversight

• Concomitant use with CNS-active drugs: potential additive effects

• Neurological disorders: use with close monitoring

Parameter Details

Safety Category Not recommended (limited human data; animal studies suggest risk)

Preferred Alternatives Topical permethrin 5% for scabies/lice

When May Be Used Severe infestations where benefit clearly outweighs risk; specialist decision with informed consent

Monitoring Fetal surveillance if used; document clinical justification

Parameter Details

Compatibility Compatible with breastfeeding

Drug Levels in Milk Low; minimal excretion

WHO Guidance Considered safe after 1 week postpartum

Topical Use Very low systemic absorption; considered safe

Infant Monitoring Observe for adequate feeding, unusual sedation (rare)

Parameter Recommendation

Starting Dose Standard weight-based dosing (200 mcg/kg)

Titration Avoid unnecessary repeat doses

Special Risks Falls, confusion, neurotoxicity (especially if impaired blood-brain barrier or polypharmacy)

Monitoring CNS effects; consider extended interval between repeat doses in frail patients

Interacting Drug Mechanism/Effect Recommendation

Warfarin Potentiation of anticoagulant effect; raised INR Monitor INR closely; adjust warfarin dose as needed

GABA agonists (benzodiazepines, barbiturates) Additive CNS depression Avoid combination in elderly or debilitated patients

Cyclosporine Increased ivermectin plasma levels Use with caution; monitor for toxicity

Interacting Drug Mechanism/Effect Recommendation

Rifampicin CYP3A4 induction; reduced ivermectin efficacy Monitor for treatment failure; consider alternative or timing adjustment

Ketoconazole, Macrolides CYP3A4 inhibition; increased ivermectin levels Monitor if prolonged or repeated ivermectin dosing

Phenytoin, Carbamazepine Variable CYP-mediated interactions Clinical monitoring advised

• Nausea

• Dizziness

• Diarrhoea, abdominal discomfort

• Pruritus (often due to immune response against dying parasites; Mazzotti-like reaction)

• Transient rash

• Mild headache

• Local irritation (topical formulations)

Adverse Effect Clinical Notes

Encephalopathy Reported with high Loa loa microfilarial burden (not endemic in India)

Toxic Epidermal Necrolysis / Stevens-Johnson Syndrome Rare; discontinue immediately and seek specialist care

Severe hypotension Rare; monitor in elderly

Seizures Rare; typically in patients with blood-brain barrier dysfunction

Hepatotoxicity Monitor LFTs in prolonged or repeated courses

Phase Parameters

Baseline Body weight (essential for dosing); LFTs if repeated dosing anticipated

After Initiation Monitor for rash, neurological symptoms, hypersensitivity within 48 hours

Long-term Not applicable for single-dose treatments

Scabies Re-treatment Clinical assessment at 2 weeks to evaluate response

Brand Name Manufacturer

Ivecop Menarini

Ivrea Ajanta Pharma

Hernivac Mankind Pharma

Iverfast Lupin

Soolantra (1% cream) Galderma

Multiple generics Various Indian manufacturers

0.5% lotion (100 ml) ₹100–200

Note: Included in government MDA programmes (free supply in endemic areas)

• Always calculate dose by body weight — never use age-based dosing for ivermectin

• Scabies management requires environmental decontamination — wash clothes and bedding in hot water; treat all close contacts simultaneously

• Avoid in children <15 kg except under paediatric infectious disease or dermatology specialist care

• Topical ivermectin works slower than permethrin for head lice; reserve for resistant cases

• Evaluate for re-infestation sources — household contacts, close physical contacts, and living conditions

• In national filariasis programmes, ivermectin is given with DEC + albendazole as annual single-dose MDA

• Single-dose efficacy is the norm for most parasitic indications; repeat dosing only when specifically indicated

ivermectin; antiparasitic; scabies; filariasis; strongyloidiasis; macrocyclic lactone; paediatric use >15 kg; weight-based dosing; dermatology; NLEM India; MDA programme

RxIndia v1.1 — 27-01-2026

• CDSCO approved product inserts

• Indian Pharmacopoeia

• NLEM (National List of Essential Medicines) India

• ICMR Guidelines on Lymphatic Filariasis Elimination

• AIIMS Antiparasitic Treatment Protocols

• WHO PCT Manual and WHO Guidelines on Neglected Tropical Diseases

• MoHFW Mass Drug Administration Guidelines

• IAP Textbook of Pediatrics (Scabies and Helminthic Infections chapter)

• Standard Dermatology Texts — Indian practice for scabies and pediculosis