Generic Ivermectin ( Ivermectin )

Buy Generic Ivermectin (Ivermectin) without prescription in Canada

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Ivermectin is a semisynthetic anthelmintic agent belonging to the avermectin class. It is indicated for the treatment of certain parasitic worm infections, specifically intestinal strongyloidiasis and onchocerciasis (river blindness), and, in a topical cream formulation, for the inflammatory lesions of rosacea. It works by binding selectively and with high affinity to glutamate‑gated chloride ion channels in invertebrate nerve and muscle cells, leading to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the cell, resulting in paralysis and death of the parasite. Its anti‑inflammatory properties in rosacea are not fully understood but are thought to involve both anti‑parasitic effects on Demodex mites and direct anti‑inflammatory mechanisms.

Usual adult dose: For strongyloidiasis, the recommended dosage is a single oral dose of approximately 200 mcg of ivermectin per kg of body weight. For onchocerciasis, the recommended dosage is a single oral dose of approximately 150 mcg per kg of body weight, which may be repeated every 3 to 12 months until the adult worms die off. As a practical guide, these dosages are administered according to weight‑based dosing schedules using the 3 mg tablet: 15 to 24 kg receives 3 mg; 25 to 35 kg receives 6 mg; 36 to 50 kg receives 9 mg; 51 to 65 kg receives 12 mg; and 66 to 79 kg receives 15 mg. The 6 mg and 12 mg strengths are used to simplify administration. The tablets should be taken on an empty stomach with water. For rosacea, a pea‑sized amount of ivermectin 1% cream is applied to the face once daily at bedtime, avoiding the eyes and lips.

Dosage form: Oral tablets: 3 mg, 6 mg, and 12 mg. Topical cream: 1% (10 mg/g) in a 30 g or 60 g tube.

Onset of action: Following a single oral dose, microfilariae concentrations in the skin begin to decline within 2 to 3 days. The clinical effect on rosacea lesions is typically seen after 4 weeks of nightly application, with further improvement over several months.

Duration of action: Ivermectin has a plasma half‑life of approximately 18 hours. Its antiparasitic activity persists for days to weeks due to its high lipid solubility and prolonged tissue distribution. A single annual or semi‑annual dose is sufficient for the mass control of onchocerciasis.

Alcohol recommendation: Alcohol consumption should be limited during treatment. While no direct disulfiram‑like reaction occurs, alcohol can worsen side effects such as dizziness and drowsiness, and may increase the risk of liver function abnormalities.

Most common side effects: In patients treated for onchocerciasis, a Mazzotti reaction—characterized by fever, pruritus, rash, myalgia, and lymphadenopathy—is common due to the death of microfilariae. For strongyloidiasis, common side effects include nausea, vomiting, diarrhoea, dizziness, and fatigue. The most common side effects of the topical cream are a skin‑burning sensation and skin irritation. Rare but serious adverse effects include Stevens‑Johnson syndrome, toxic epidermal necrolysis, severe hypotension, and neurological events. Health Canada has warned against using veterinary formulations in humans, which can be fatal.

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General Information about Ivermectin

• INN (International Nonproprietary Name): Ivermectin
• Brand names available in Canada: Stromectol® (Merck Canada Inc.) for oral tablets; Rosiver™ (Galderma Canada Inc.) for topical 1% cream. Generic versions of the oral tablet, such as PMS‑Ivermectin, are also available.
• ATC code: P02CF01
• Dosage forms and strengths: Oral tablets: 3 mg, 6 mg, and 12 mg. Topical cream: 1% (10 mg/g) in a 30 g or 60 g tube.
• Manufacturers in Canada: Merck Canada Inc. (oral tablets), Galderma Canada Inc. (topical cream), and various generic manufacturers for oral tablets.
• Registration status in Canada: Approved by Health Canada. The oral tablet (Stromectol, DIN 02480557) was approved in 2018. The topical cream (Rosiver, DIN 02440342) was approved in 2015.
• OTC / Rx classification: Prescription only (Rx). It is classified as a Schedule I drug and requires a valid prescription from a licensed Canadian healthcare professional. Veterinary formulations are not for human use.

Mechanism of Action and Pharmacology

Ivermectin is a member of the avermectin class of anthelmintic agents. Its primary mechanism of action involves binding with high affinity and selectivity to glutamate‑gated chloride ion channels, which are present in invertebrate nerve and muscle cells but are absent in mammals. This binding causes an increase in the permeability of the cell membrane to chloride ions, leading to hyperpolarization of the nerve or muscle cell, paralysis, and eventual death of the parasite. Ivermectin also interacts with other ligand‑gated chloride channels, such as those gated by gamma‑aminobutyric acid (GABA). In the treatment of rosacea, the exact mechanism is not fully understood. However, ivermectin’s efficacy is attributed to a combination of its anti‑parasitic activity against Demodex mites, which are believed to contribute to the inflammatory lesions of rosacea, and its direct anti‑inflammatory properties. After oral administration, the bioavailability of ivermectin is increased when taken with a high‑fat meal. It is extensively metabolized in the liver by the CYP3A4 enzyme and is primarily excreted in the feces. Following topical application of the 1% cream, systemic absorption is minimal, with plasma concentrations just above the lower limit of quantitation.

Indications

• Intestinal Strongyloidiasis: For the treatment of intestinal infection caused by the nematode parasite Strongyloides stercoralis. The recommended dose is a single oral dose of approximately 200 mcg/kg.
• Onchocerciasis (River Blindness): For the treatment of onchocerciasis caused by the nematode parasite Onchocerca volvulus. The recommended dose is a single oral dose of approximately 150 mcg/kg. Periodic re‑treatment every 3 to 12 months is typically required.
• Rosacea (Topical): For the topical treatment of inflammatory lesions (papules and pustules) of rosacea in adults 18 years of age or older. Ivermectin is not indicated for the treatment of the facial redness (erythema) associated with rosacea.
• Health Canada advises that ivermectin has not been authorized for the prevention or treatment of COVID‑19 and warns against using veterinary formulations in humans, which can cause serious health problems.

Important Warnings and Precautions

At‑risk groups

• Pregnancy: Ivermectin should be used during pregnancy only if the potential benefit clearly outweighs the potential risk. It has been shown to be teratogenic in some animal studies. Pregnant women are generally excluded from mass drug administration campaigns using ivermectin.
• Breastfeeding: Ivermectin is excreted in human breast milk in low concentrations. Treatment of mothers who intend to breastfeed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn. One review recommends use in lactating women only after the infant is 7 days old.
• Paediatrics (< 15 kg): The safety and efficacy of oral ivermectin in children weighing less than 15 kg have not been established.
• Elderly: No specific dose adjustment is required based on age alone, but elderly patients may be more sensitive to the neurological side effects and should be monitored.
• Hepatic impairment: Ivermectin is metabolized in the liver and should be used with caution in patients with impaired hepatic function or abnormal liver tests.
• Renal impairment: The pharmacokinetics of ivermectin have not been studied in patients with renal impairment; it should be used with caution in this population.
• Immunocompromised Patients (HIV): In immunocompromised patients, the treatment of strongyloidiasis may be refractory, requiring repeated treatment (e.g., every 2 weeks) and suppressive therapy (e.g., once a month).
• Mazzotti Reaction: Patients treated for onchocerciasis may experience a Mazzotti reaction, a systemic inflammatory response caused by the death of microfilariae. Symptoms include fever, pruritus, rash, myalgia, arthralgia, and lymphadenopathy. This reaction is usually mild and self‑limiting but may require supportive care.
• Severe Cutaneous Adverse Reactions (SCARs): Life‑threatening or fatal skin reactions, including Stevens‑Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with ivermectin treatment.
• Veterinary Formulations Warning: Health Canada has issued multiple advisories warning Canadians not to use veterinary formulations of ivermectin for the prevention or treatment of COVID‑19. Ingesting veterinary ivermectin, especially at high doses, can be dangerous for humans and may cause serious health problems such as vomiting, diarrhea, low blood pressure, allergic reactions, dizziness, seizures, coma, and even death.
• Allergy: Do not take Ivermectin if you have a known hypersensitivity to ivermectin or any component of the formulation.

Driving and alcohol

Ivermectin can cause dizziness, somnolence, and fatigue. Patients should be cautious when driving, operating heavy machinery, or engaging in activities that require mental alertness until they know how the medication affects them. Alcohol consumption should be limited, as it may worsen the side effects of dizziness and drowsiness and may have an additive effect on liver function.

Dosage Instructions

• Intestinal Strongyloidiasis (Adults and Pediatrics > 15 kg): The recommended dosage is a single oral dose of approximately 200 mcg per kg of body weight. The dose is administered as a single oral dose on an empty stomach with a full glass of water. A repeat stool examination should be performed 3 to 4 weeks post‑treatment to confirm eradication. In immunocompromised patients, repeated courses may be necessary.
• Onchocerciasis (Adults and Pediatrics > 15 kg): The recommended dosage is a single oral dose of approximately 150 mcg per kg of body weight. The recommended treatment interval is every 12 months. Patients with heavy ocular infection may require retreatment every 6 months.
• Weight‑Based Dosing Guide for Oral Tablets (for doses equivalent to the recommended 150‑200 mcg/kg range):
  • 15 to 24 kg: 3 mg (one 3 mg tablet)
  • 25 to 35 kg: 6 mg (one 6 mg tablet or two 3 mg tablets)
  • 36 to 50 kg: 9 mg (three 3 mg tablets or combination of 3 mg and 6 mg)
  • 51 to 65 kg: 12 mg (one 12 mg tablet or four 3 mg tablets)
  • 66 to 79 kg: 15 mg (combination of 3 mg and 12 mg tablets)
  • ≥ 80 kg: The dose should be calculated at 200 mcg/kg.
• Rosacea (Topical Cream): Apply a pea‑sized amount of the 1% cream to each of the five areas of the face (forehead, chin, nose, and each cheek) once daily at bedtime. The cream should be applied to clean, dry skin. Avoid contact with eyes and lips. If no improvement is seen after 3 months, treatment should be re‑evaluated.
• Missed dose: For oral therapy, if a dose is missed, take it as soon as remembered with a full glass of water on an empty stomach. If it is close to the time of the next scheduled dose, skip the missed dose and resume the regular schedule. Do not double the dose. For the topical cream, skip the missed dose and apply the next dose at the regular time.

Side Effects and Contraindications

• Most common side effects (oral, Strongyloidiasis): Nausea, vomiting, diarrhoea, dizziness, fatigue, and pruritus. These are generally mild and transient.
• Most common side effects (oral, Onchocerciasis – Mazzotti Reaction): Fever, pruritus, rash, myalgia, arthralgia, lymphadenopathy, and facial oedema. This inflammatory reaction is due to the death of the microfilariae and is usually self‑limiting.
• Most common side effects (topical cream): Skin burning sensation and skin irritation (incidence ≤ 1%).
• Serious adverse reactions: Life‑threatening or fatal skin reactions including Stevens‑Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Neurological events including seizure, ataxia, and worsening of bronchial asthma have been reported.
• Post‑marketing reports: Increased INR when co‑administered with warfarin, elevated liver enzymes, and severe hypotension.
• Contraindications: Hypersensitivity to ivermectin or any excipient in the formulation. Pregnancy and breastfeeding are relative contraindications, and use should only be considered if the benefit outweighs the potential risk.

Drug Interactions

• Warfarin: Post‑marketing reports of increased INR (International Normalized Ratio) have been rarely reported when ivermectin was co‑administered with warfarin. Close monitoring of INR is recommended.
• Strong CYP3A4 Inhibitors (e.g., ketoconazole, posaconazole): These antifungals may increase the plasma concentration of ivermectin by inhibiting its metabolism. Caution is advised.
• CNS Depressants: Alcohol, benzodiazepines, opioids, and other central nervous system depressants may have additive effects, increasing the risk of dizziness and sedation.

Practical Advice

• Administration: Take the oral tablet on an empty stomach with a full glass of water. Avoid a high‑fat meal immediately before dosing, as this increases the bioavailability and may increase the risk of adverse effects. The topical cream is for external use only and should be applied at bedtime.
• Monitoring: For patients treated for onchocerciasis, a skin snip biopsy or slit‑lamp examination of the eye may be used to assess the microfilarial load before and after treatment. For strongyloidiasis, a stool examination should be repeated 3 to 4 weeks post‑treatment. No routine laboratory monitoring is required for the topical cream.
• Storage: Store oral tablets at room temperature (15‑30 °C), protected from light and moisture. Store the topical cream at room temperature, away from heat and open flame. Do not freeze. Keep all medications out of the reach and sight of children.
• Lifestyle: In patients with rosacea, avoid triggers such as excessive sun exposure, spicy foods, and alcohol, which can exacerbate facial flushing. Use a gentle, non‑comedogenic moisturizer and sunscreen daily. For patients with onchocerciasis, supportive measures such as antihistamines and analgesics may be used to manage symptoms of the Mazzotti reaction.
• Missed dose: For the topical cream, if a dose is missed, skip the missed dose and apply the next dose at the usual time. For the oral tablet, if a dose is missed, take it as soon as possible; if it is close to the next dose, resume the normal schedule.
• When to seek medical review: Seek immediate medical attention for signs of a severe allergic reaction (swelling of the face, tongue, or throat, difficulty breathing), a severe skin reaction (widespread rash, blistering, or peeling skin), or neurological symptoms (seizure, confusion, severe dizziness).
• Disposal: Return unused or expired medication to a pharmacy for safe disposal. Do not flush down the toilet or discard in household waste.

Alternative Medications

• Albendazole (Albenza®): An alternative oral anthelmintic used for the treatment of strongyloidiasis. It is often used when ivermectin is not available or is contraindicated. The recommended dose is 400 mg twice daily for 3 days.
• Diethylcarbamazine (DEC, Hetrazan®): An older anthelmintic agent used for the treatment of onchocerciasis. However, it is no longer a first‑line therapy due to its higher toxicity and the availability of ivermectin.
• Metronidazole 0.75% cream or gel (Metrogel®): A topical antibiotic and anti‑inflammatory agent used for the treatment of rosacea. It is a common first‑line alternative to ivermectin cream. In clinical trials, ivermectin 1% was shown to be statistically significantly more effective than metronidazole 0.75% cream in reducing inflammatory lesion counts.
• Azelaic acid 15% gel (Finacea®): Another topical treatment for rosacea that reduces inflammation and promotes skin renewal. It may cause a temporary stinging sensation, which is typically mild.
• Oral doxycycline 40 mg modified‑release (Apprilon®, Oracea®): A tetracycline antibiotic with anti‑inflammatory properties used for the treatment of moderate to severe rosacea. It is often combined with a topical agent for optimal results.

Clinical Efficacy

The efficacy of oral ivermectin for the treatment of strongyloidiasis and onchocerciasis is well‑established, forming the cornerstone of global mass drug administration campaigns for the elimination of lymphatic filariasis and onchocerciasis. A single oral dose of ivermectin (200 mcg/kg) results in a cure rate of over 90% for intestinal strongyloidiasis. For onchocerciasis, annual treatment with ivermectin (150 mcg/kg) suppresses microfilarial loads in the skin and eye, preventing the progression to blindness. The efficacy of topical ivermectin 1% cream for the treatment of inflammatory lesions of rosacea was established in two pivotal, randomized, double‑blind, vehicle‑controlled trials (Studies 18170 and 18171). In these studies, ivermectin 1% applied once daily was associated with a statistically significantly greater reduction in inflammatory lesion counts and a significantly higher success rate compared with the vehicle cream. In a comparative trial of 962 patients (Study 40173), ivermectin 1% cream demonstrated a significantly greater percentage reduction in inflammatory lesion counts ( ~ 83.0% vs. ~ 73.7%) and a higher success rate (84.9% vs. 75.4%) compared with metronidazole 0.75% cream applied twice daily.

Important:

Ivermectin is a prescription medication that should be used only under the supervision of a qualified healthcare professional. It is essential to use only the human formulation of ivermectin as prescribed by your doctor. Do not use veterinary formulations of ivermectin intended for animals, as they are highly concentrated and can cause severe, life‑threatening toxicity in humans, including seizures, coma, and death. Health Canada has specifically warned against the use of veterinary ivermectin for the prevention or treatment of COVID‑19, as it has not been authorized for this purpose and is dangerous. Serious skin reactions, including Stevens‑Johnson syndrome and toxic epidermal necrolysis, have been reported. Seek immediate medical attention if you develop a severe rash, blisters, or peeling skin. If you experience a seizure, severe dizziness, or signs of a serious allergic reaction, stop taking the medication and seek emergency medical attention. This information is not a substitute for professional medical advice, diagnosis, or treatment.

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