Ivermectin

P02C - Antinematodal agents ATC D11AX22 Unknown approved 1996 Oral Topical

JFDA label: soolantra

Mechanism of Action

Modulator of Glutamate-gated chloride channel — Glutamate-gated chloride channel modulator

Target	Action	Gene / class
Glutamate-gated chloride channel efficacy	MODULATOR
Glutamate-gated chloride channel efficacy	MODULATOR	GluClX

Indications

Approved

Helminthiasis — Helminthiasis
Lice Infestations — lice infestation
Onchocerciasis — onchocerciasis
Rosacea — rosacea
Strongyloidiasis — strongyloidiasis

Off-label

Acne Vulgaris
Anosmia
Blepharitis
Dengue
Dermatitis, Atopic
Elephantiasis, Filarial
Influenza, Human
Malaria
Onchocerciasis, Ocular
Pneumonia
Severe Acute Respiratory Syndrome
Severe Dengue
Trichuriasis

Contraindications

Source: openFDA

Ivermectin tablets are contraindicated in patients who are hypersensitive to any component of this product. Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Cardiac disorders (1)

Common And Tachycardia

Vascular disorders (2)

Common Orthostatic Hypotension · Peripheral Edema

Nervous system disorders (3)

Common Dizziness

Uncommon Somnolence · Tremor

Blood and lymphatic system disorders (2)

Common And Hemoglobin Increase · Eosinophilia

Gastrointestinal disorders (6)

Common Diarrhea · Nausea

Uncommon Abdominal Pain · Anorexia · Constipation · Vomiting

Skin and subcutaneous tissue disorders (4)

Very Common Papular And Pustular Or Frank Urticarial Rash

Common Pruritus

Uncommon And Urticaria · Rash

Ear and labyrinth disorders (1)

Uncommon Vertigo

General disorders and administration site conditions (6)

Very Common And Fever

Common Decrease In Leukocyte Count · Facial Edema · Or Ast · Synovitis

Uncommon Fatigue

Dosing

Source: openFDA

Strongyloidiasis The recommended dosage of ivermectin tablets for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg of ivermectin per kg of body weight. See Table 1 for dosage guidelines. Patients should take tablets on an empty stomach with water. (See CLINICAL PHARMACOLOGY, Pharmacokinetics .) In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection. (See CLINICAL PHARMACOLOGY, Clinical Studies .) Table 1: Dosage Guidelines for Ivermectin Tablets for Strongyloidiasis Body Weight (kg) Single Oral Dose Number of 3-mg Tablets 15 to 24 1 tablet 25 to 35 2 tablets 36 to 50 3 tablets 51 to 65 4 tablets 66 to 79 5 tablets ≥80 200 mcg/kg Onchocerciasis The recommended dosage of ivermectin tablets for the treatment of onchocerciasis is a single oral dose designed to provide approximately 150 mcg of ivermectin per kg of body weight. See Table 2 for dosage guidelines. Patients should take tablets on an empty stomach with water. (See CLINICAL PHARMACOLOGY, Pharmacokinetics .) In mass distribution campaigns in international treatment programs, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months. Table 2: Dosage Guidelines for Ivermectin Tablets for Onchocerciasis Body Weight (kg) Single Oral Dose Number of 3-mg Tablets 15 to 25 1 tablet 26 to 44 2 tablets 45 to 64 3 tablets 65 to 84 4 tablets ≥85 150 mcg/kg

Warnings & Precautions

Source: openFDA

Warnings & Precautions

Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory responses to the death of microfilariae. Patients treated with ivermectin tablets for onchocerciasis may experience these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself. (See ADVERSE REACTIONS, Onchocerciasis .) The treatment of severe Mazzotti reactions has not been subjected to controlled clinical trials. Oral hydration, recumbency, intravenous normal saline, and/or parenteral corticosteroids have been used to treat postural hypotension. Antihistamines and/or aspirin have been used for most mild to moderate cases. Neurotoxicity with the use of ivermectin, including alteration of consciousness of variable severity (e.g., somnolence/drowsiness, stupor, and coma), confusion, disorientation and death, has been reported in patients without onchocerciasis or in patients with onchocerciasis in the absence of Loa loa infection. These reactions have generally resolved with supportive care and the discontinuation of ivermectin.

Pregnancy & Lactation

Pregnancy

Lactation

Caution Hale L3

Amounts ingested by the infant are small and would not be expected to cause any adverse

Biology & Pharmacokinetics

Transporters

BCRP (Inhibitor)MDR1 (Inhibitor)MRP (Inhibitor)MRP1 (Inhibitor)MRP2 (Inhibitor)MRP3 (Inhibitor)OATP1B1 (Inhibitor)OATP1B3 (Inhibitor)OATP2B1 (Inhibitor)BCRP (Substrate)MDR1 (Substrate)MRP1 (Substrate)MRP2 (Substrate)

Drug–drug interactions (76, DDInter)

Interacting drug	Severity	Management
Abametapir (topical)	moderate
Amprenavir	moderate
Anisindione	moderate
Apalutamide	moderate
Aprepitant	moderate
Atazanavir	moderate
Boceprevir	moderate
Bosentan	moderate
Brigatinib	moderate
Chloramphenicol	moderate
Clarithromycin	moderate
Cobicistat	moderate
Conivaptan	moderate
Darunavir	moderate
Dasatinib	moderate
Deferasirox	moderate
Delavirdine	moderate
Dicoumarol	moderate
Dronedarone	moderate
Duvelisib	moderate
Echinacea	moderate
Efavirenz	moderate
Enzalutamide	moderate
Erythromycin	moderate
Ethanol	moderate
Etravirine	moderate
Fosamprenavir	moderate
Fosaprepitant	moderate
Fosnetupitant	moderate
Fostamatinib	moderate
Idelalisib	moderate
Indinavir	moderate
Iodide I-123	moderate
Iodide I-131	moderate
Isavuconazonium	moderate
Itraconazole	moderate
Ivacaftor	moderate
Ketoconazole	moderate
Lapatinib	moderate
Larotrectinib	moderate

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Registered Products (2)

Brand	Form / strength	Pack	Agent	Citizen (JOD)
JOSWE Ivermectin	Tablet 3 mg	4 tab	JORDAN SWEDEN MEDICAL&STERILE.CO (JOSWE)/JORDAN / General	4.000
soolantra	Cream 10 mg/1 g	30 GM/1 TUB	IBN CINA DRUG STORE	19.310