Schedule H

Oral

• Tablet: 200 mg, 400 mg

• Chewable tablet: 400 mg

• Oral suspension: 200 mg/5 mL

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Soil-Transmitted Helminthiases (Ascariasis, Trichuriasis, Hookworm Infection)

Parameter Adults & Children >2 years Children 1–2 years

Starting dose 400 mg orally 200 mg orally

Titration Not applicable Not applicable

Usual maintenance dose Single dose; repeat after 6 months in endemic areas Single dose; repeat after 6 months in endemic areas

Maximum dose 400 mg/dose 200 mg/dose

Key Clinical Notes:

• Part of National Deworming Day (NDD) programme

• Administer with food to improve absorption

• May be taken without regard to time of day

1. Enterobiasis (Pinworm Infection)

Parameter Adults & Children >2 years

Starting dose 400 mg orally single dose

Titration Not applicable

Usual maintenance dose Repeat 400 mg after 2 weeks (to eliminate reinfection)

Maximum dose 400 mg/dose

Key Clinical Notes:

• Treat all household members simultaneously

• Emphasise hygiene measures to prevent reinfection

1. Neurocysticercosis

Parameter Recommendation

Starting dose 15 mg/kg/day orally in 2 divided doses

Titration Not applicable

Usual maintenance dose 15 mg/kg/day in 2 divided doses for 7–28 days

Maximum dose 800 mg/day

Key Clinical Notes:

• Specialist supervision mandatory

• Concomitant corticosteroids (dexamethasone 0.1 mg/kg/day or equivalent) essential to prevent inflammatory reaction

• Rule out ocular cysticercosis before initiating therapy

• Duration based on lesion number, type, and imaging response

• Administer with fatty meal to enhance absorption

1. Hydatid Disease (Echinococcosis)

Parameter Recommendation

Starting dose 10–15 mg/kg/day orally in 2 divided doses

Titration Not applicable

Usual maintenance dose 10–15 mg/kg/day in 2 divided doses for 28 days per cycle

Maximum dose 800 mg/day

Treatment Regimen:

• 3 cycles of 28 days each

• 14-day drug-free interval between cycles

• Total duration: Approximately 3–6 months

Key Clinical Notes:

• Specialist input mandatory (Surgery/Gastroenterology/Infectious Diseases)

• Used as adjunct to surgery or as primary therapy in inoperable cases

• Monitor LFTs before each cycle

1. Larva Migrans (Cutaneous and Visceral)

Parameter Adults Children

Starting dose 400 mg orally once daily 10 mg/kg orally once daily

Titration Not applicable Not applicable

Usual maintenance dose 400 mg once daily for 5–7 days 10 mg/kg once daily for 5–7 days

Maximum dose 400 mg/day 400 mg/day

Key Clinical Notes:

• Cutaneous larva migrans: 5 days usually sufficient

• Visceral larva migrans: 7 days or longer under specialist guidance

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

Indication Dose Duration Specialist Only Evidence Basis

Trichinellosis (OFF-LABEL) 400 mg twice daily 8–14 days Yes Regional parasitology expert consensus; case series

Giardiasis (OFF-LABEL) 400 mg once daily 5–7 days No Small RCTs; metronidazole/tinidazole remain first-line

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Soil-Transmitted Helminthiases

1–2 years 200 mg single dose Not applicable Single dose; repeat after 6 months 200 mg Part of NDD campaigns

2 years 400 mg single dose Not applicable Single dose; repeat after 6 months 400 mg Chewable tablet preferred for compliance

1. Enterobiasis

2 years 400 mg single dose Not applicable Repeat after 2 weeks 400 mg Treat all household contacts

1. Neurocysticercosis

2 years 15 mg/kg/day in 2 divided doses Not applicable 15 mg/kg/day for 7–28 days 800 mg/day Mandatory corticosteroid cover; ophthalmologic exam required

Safety Monitoring:

• Baseline and weekly LFTs

• CBC at baseline and during therapy

• Neurological assessment

• Ophthalmologic examination before starting

1. Hydatid Disease

6 years 10–15 mg/kg/day in 2 divided doses Not applicable 10–15 mg/kg/day × 28 days per cycle 800 mg/day 3 cycles with 14-day intervals

Safety Monitoring:

• LFTs before each cycle

• CBC monitoring

1. Larva Migrans

All paediatric ages 10 mg/kg once daily Not applicable 10 mg/kg/day for 5–7 days 400 mg/day Cutaneous or visceral forms

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

Indication Dose Duration Specialist Only Evidence Basis

Giardiasis (OFF-LABEL) 10 mg/kg once daily (max 400 mg) 5–7 days Yes Small paediatric studies; metronidazole preferred

Age Restriction Statement:

• Not recommended below 1 year of age except under Paediatric Infectious Disease specialist supervision

Mild to moderate impairment No dose adjustment required

Notes:

• Albendazole is minimally renally excreted

• Active metabolite (albendazole sulfoxide) may accumulate in severe renal impairment — clinical significance unclear

Notes:

• Albendazole undergoes extensive first-pass hepatic metabolism

• Pre-existing liver disease increases risk of drug-induced hepatitis

• Known hypersensitivity to albendazole or any benzimidazole class anthelmintics

• Pregnancy (especially first trimester) — teratogenic in animal studies

• Severe hepatic impairment or active hepatic disease

• Ocular cysticercosis (retinal involvement) — risk of irreversible ocular damage from inflammatory response

• Bone marrow suppression or pre-existing cytopenias (for prolonged therapy)

• Hepatic impairment — increased risk of hepatotoxicity; monitor LFTs

• History of bone marrow suppression — risk of pancytopenia with prolonged use

• Concurrent corticosteroid therapy — may increase risk of haematological toxicity

• Neurocysticercosis with multiple lesions — risk of raised intracranial pressure during treatment

• Patients on enzyme-inducing antiepileptics (carbamazepine, phenytoin) — reduced efficacy

• Biliary obstruction in hydatid disease — may require surgical drainage first

Parameter Recommendation

Risk Category Contraindicated (especially first trimester)

Safety Statement Teratogenic in animal studies; embryotoxic and fetotoxic effects demonstrated

Preferred Alternatives Defer treatment until after delivery if possible; pyrantel pamoate for hookworm (category B)

When May Be Used Second/third trimester only if life-threatening infection and no safer alternative; specialist input mandatory

What to Monitor Fetal growth, structural abnormalities via ultrasound

Additional Notes:

• Excluded from mass deworming programmes during pregnancy

• Pregnancy test recommended before initiating prolonged therapy in women of childbearing age

Parameter Recommendation

Compatible with Breastfeeding Yes — considered compatible

Expected Drug Levels in Milk Low (minimal excretion)

Preferred Alternatives Mebendazole also acceptable

What to Monitor in Infant GI upset, rash (rare)

Notes:

• Single-dose therapy poses negligible risk to breastfed infant

• Prolonged therapy: monitor infant for any adverse effects

Parameter Recommendation

Starting Dose Standard adult dose

Titration Slower titration for prolonged regimens (neurocysticercosis, hydatid disease)

Extra Risks Increased hepatotoxicity risk; higher incidence of cytopenias; reduced hepatic reserve

Monitoring More frequent LFT and CBC monitoring recommended

Interacting Drug Effect Recommendation

Carbamazepine Induces CYP3A4 → reduced albendazole sulfoxide levels → decreased efficacy Avoid combination in CNS parasitic infections; consider alternative antiepileptic

Phenytoin Induces hepatic metabolism → reduced efficacy Avoid in neurocysticercosis if possible; monitor treatment response

Phenobarbital CYP induction → decreased albendazole levels Same as above

Praziquantel Increases albendazole sulfoxide levels by ~50% Beneficial in combined therapy; no dose adjustment needed but monitor for toxicity

Interacting Drug Effect Recommendation

Dexamethasone Increases albendazole sulfoxide plasma levels Beneficial in neurocysticercosis; monitor for increased adverse effects

Cimetidine Inhibits first-pass metabolism → increased albendazole levels Monitor for hepatotoxicity; consider alternative H2 blocker

Ritonavir/Ketoconazole CYP3A4 inhibition → increased albendazole levels Monitor LFTs closely

Warfarin Potential increase in INR with prolonged albendazole use Monitor INR during hydatid/neurocysticercosis treatment

Methotrexate Additive bone marrow suppression Avoid concurrent use if possible; monitor CBC closely

Theophylline May increase theophylline levels Monitor theophylline levels

• Abdominal pain, nausea, vomiting

• Headache, dizziness

• Transient elevation of liver enzymes (ALT, AST)

• Alopecia (reversible, with prolonged use)

• Fever

Adverse Effect Action Required

Hepatotoxicity/Hepatitis Discontinue immediately; monitor LFTs; supportive care

Pancytopenia/Agranulocytosis Stop therapy; haematology referral; supportive care

Stevens-Johnson Syndrome (SJS) Immediate discontinuation; hospitalisation

Anaphylaxis Emergency management; discontinue drug

Seizures (in neurocysticercosis — inflammatory response) Ensure adequate corticosteroid cover; antiepileptic therapy

Retinal damage (in ocular cysticercosis) Irreversible; screen before starting therapy

During therapy Weekly LFTs and CBC for prolonged therapy (neurocysticercosis, hydatid disease)

Before each cycle (hydatid disease) LFTs, CBC

Long-term LFTs and CBC at start of each treatment cycle; neuroimaging as indicated

• Zentel® (GlaxoSmithKline)

• Bandy® (Mankind Pharma)

• Albendol® (Intas)

• Wormin® (Cipla)

• Noworm® (Alkem)

• ABZ® (Micro Labs)

FDCs:

• Note: FDCs not first-line for routine deworming

Formulation Private Pharmacy Government Supply

Tablet 400 mg ₹5–15 per tablet Free under NDD

Chewable tablet 400 mg ₹8–20 per tablet Free under NDD

Suspension 10 mL (200 mg/5 mL) ₹15–35 Free under NDD

Notes:

• Included in NLEM India

• Under NPPA price control

• Supplied free in government sector under National Deworming Day programme

1. National Deworming Day (NDD): Standard dose is 400 mg for children >2 years; 200 mg for 1–2 years. Held biannually on February 10 and August 10.

1. Neurocysticercosis: Always co-administer corticosteroids to prevent life-threatening cerebral oedema from dying cysts. Rule out ocular involvement before starting therapy.

1. Pregnancy caution: Never use albendazole in early pregnancy or during mass drug administration (MDA) programmes for pregnant women. Pyrantel pamoate is a safer alternative for hookworm.

1. Absorption tip: Bioavailability increases significantly (up to 5-fold) when taken with a fatty meal — important for systemic infections (neurocysticercosis, hydatid disease).

1. Drug interactions in epilepsy patients: Enzyme-inducing antiepileptics (carbamazepine, phenytoin) significantly reduce albendazole efficacy — consider levetiracetam or valproate as alternatives for seizure control.

1. Hydatid disease cycling: Strict adherence to 28-day treatment cycles with 14-day drug-free intervals is essential for efficacy and safety.

Albendazole; anthelmintic; benzimidazole; deworming; neurocysticercosis; hydatid disease; ascariasis; hookworm; National Deworming Day; NLEM India; pregnancy-contraindicated

RxIndia v1.0 — 06 May 2025

• CDSCO Approved Prescribing Information

• Indian Pharmacopoeia (IP)

• NLEM India 2022

• National Deworming Day Operational Guidelines (MoHFW)

• API Textbook of Medicine (24th Edition)

• AIIMS Neurology Protocol 2023

• IAP Treatment Guidelines 2021

• ICMR Guidelines on Parasitic Infections

• Goodman & Gilman's The Pharmacological Basis of Therapeutics