Ivermectin 3mg Tablets

Manufacturer EDENBRIDGE PHARMACEUTICALS Active Ingredient Ivermectin (Systemic)(eye ver MEK tin) Pronunciation eye ver MEK tin
It is used to treat certain parasite infections.
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Drug Class
Anthelmintic
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Pharmacologic Class
Macrocyclic lactone
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Pregnancy Category
Category C
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FDA Approved
Nov 1996
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ivermectin is an anti-parasitic medication used to treat certain parasitic infections of the intestines, skin, and eyes. It works by paralyzing and killing the parasites.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take the medication on an empty stomach with a full glass of water. It's also important to drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry location, avoiding the bathroom. This will help maintain its effectiveness and safety.

Missing a Dose

Since only one dose of this medication is required, it's essential to take it as scheduled. If you miss your dose, take it as soon as you remember.
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Lifestyle & Tips

  • Take Ivermectin on an empty stomach with water, unless otherwise directed by your doctor. Some sources suggest taking it with food to improve absorption and reduce stomach upset, so follow specific instructions.
  • Do not drive or operate machinery if you experience dizziness or drowsiness.
  • Maintain good hygiene to prevent re-infection (e.g., hand washing, proper sanitation).
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 200 mcg/kg as a single oral dose
Dose Range: 0.2 - 0.2 mg

Condition-Specific Dosing:

Strongyloidiasis (intestinal): 200 mcg/kg as a single oral dose. Follow-up stool examinations are recommended.
Onchocerciasis (river blindness): 150 mcg/kg as a single oral dose every 3, 6, or 12 months, depending on the microfilarial load and clinical response. Retreatment may be necessary.
Scabies (off-label): 200 mcg/kg as a single oral dose, repeated in 7-14 days.
Pediculosis (off-label): 200 mcg/kg as a single oral dose, repeated in 7-9 days.
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Pediatric Dosing

Neonatal: Not established (safety and efficacy not established in pediatric patients weighing less than 15 kg or under 2 years of age).
Infant: Not established (safety and efficacy not established in pediatric patients weighing less than 15 kg or under 2 years of age).
Child: For children weighing â‰Ĩ15 kg: 200 mcg/kg as a single oral dose for strongyloidiasis or 150 mcg/kg for onchocerciasis. Dosing based on weight.
Adolescent: Same as adult dosing (200 mcg/kg for strongyloidiasis, 150 mcg/kg for onchocerciasis).
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended, but use with caution.
Severe: No specific dose adjustment recommended, but use with caution due to potential for increased systemic exposure.
Dialysis: Not well studied; consider monitoring for adverse effects. Ivermectin is highly protein-bound and not significantly removed by dialysis.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: Use with caution; potential for increased systemic exposure due to hepatic metabolism. Monitor for adverse effects.
Severe: Use with caution; potential for increased systemic exposure due to hepatic metabolism. Monitor for adverse effects. Dose reduction may be considered, but specific guidelines are not available.

Pharmacology

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Mechanism of Action

Ivermectin binds selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells. This binding leads to an increase in the permeability of the cell membrane to chloride ions, resulting in hyperpolarization of the nerve or muscle cell, and ultimately paralysis and death of the parasite. Ivermectin does not readily cross the blood-brain barrier in mammals, limiting its effects on mammalian glutamate-gated chloride channels.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 28% (oral, relative to IV)
Tmax: Approximately 4-5 hours
FoodEffect: Increased absorption when taken with food, particularly high-fat meals.

Distribution:

Vd: Approximately 47 L/kg
ProteinBinding: Approximately 93% (primarily to plasma proteins)
CnssPenetration: Limited (does not readily cross the intact blood-brain barrier in mammals, but can cross in conditions of impaired barrier function or at very high doses)

Elimination:

HalfLife: Approximately 12-36 hours (terminal half-life)
Clearance: Not readily available (primarily hepatic metabolism and fecal excretion)
ExcretionRoute: Fecal (nearly exclusively)
Unchanged: Less than 1% (excreted unchanged in urine)
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Pharmacodynamics

OnsetOfAction: Variable, depends on parasite and location (e.g., microfilarial reduction in onchocerciasis can be seen within days, but full effect may take weeks)
PeakEffect: Variable, generally within days to weeks for antiparasitic effects
DurationOfAction: Several months for some parasitic infections (e.g., onchocerciasis, due to slow release from tissues and sustained plasma levels)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Changes in vision, eye pain, or severe eye irritation
Joint pain
Swelling
Fever
Swollen glands
Nervous system problems, which can lead to coma or death. Seek immediate medical attention if you feel:
+ Extremely sleepy
+ Sluggish
+ Confused
+ Disoriented
A rare but potentially life-threatening brain problem can occur in patients with a Loa loa infection, typically acquired in West Africa or Central Africa. If you have traveled to these regions, inform your doctor. Seek immediate medical attention if you experience:
+ Neck pain
+ Back pain
+ Red eyes
+ Eye bleeding
+ Shortness of breath
+ Seizures
+ Difficulty walking or standing
+ Confusion
+ Extreme fatigue or weakness
+ Loss of bladder or bowel control

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

Itching
* Skin irritation

This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting
  • Seizures
  • Confusion or changes in mental status
  • Severe skin rash or blistering
  • Swelling of the face, lips, tongue, or throat (signs of allergic reaction)
  • Difficulty breathing
  • Eye pain or vision changes (especially in onchocerciasis patients)
  • Severe or persistent nausea, vomiting, or diarrhea
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure safe use, carefully review all your medications and health issues with your doctor and pharmacist. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. After completing the treatment, you will need to undergo a stool examination to confirm that the infection has been successfully eliminated. In some cases, your doctor may recommend an additional dose of this medication to ensure the infection is fully treated, so be sure to discuss this with your doctor.

To minimize the risk of dizziness or fainting, it is crucial to stand up slowly when getting up from a sitting or lying down position. Additionally, exercise caution when climbing up or down stairs.

If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to consult with your doctor. You and your doctor will need to weigh the benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Rash
  • Edema
  • Headache
  • Dizziness
  • Asthenia
  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Seizures
  • Ataxia
  • Dyspnea
  • Paresthesia
  • Tremor
  • Coma

What to Do:

Call 1-800-222-1222 (Poison Control). Supportive care, including parenteral fluids and electrolytes, respiratory support (if necessary), and measures to maintain blood pressure. Emesis and/or gastric lavage may be indicated as soon as possible following oral ingestion.

Drug Interactions

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Major Interactions

  • Warfarin (potential for increased INR/bleeding risk, though evidence is limited and conflicting)
  • CNS depressants (e.g., benzodiazepines, barbiturates, alcohol) - theoretical risk of additive CNS depression, especially if blood-brain barrier is compromised.
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Moderate Interactions

  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice) - may increase ivermectin plasma concentrations.
  • CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's Wort) - may decrease ivermectin plasma concentrations.

Monitoring

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Baseline Monitoring

Weight

Rationale: To calculate appropriate dose (mcg/kg).

Timing: Prior to administration.

Stool examination (for Strongyloidiasis)

Rationale: To confirm diagnosis and assess parasite burden.

Timing: Prior to treatment.

Skin snips or ocular examination (for Onchocerciasis)

Rationale: To confirm diagnosis and assess microfilarial load.

Timing: Prior to treatment.

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Routine Monitoring

Clinical response (e.g., resolution of symptoms, reduction in parasite burden)

Frequency: As clinically indicated, typically weeks to months post-treatment.

Target: Resolution of symptoms, negative stool exams (strongyloidiasis), reduction in microfilarial counts (onchocerciasis).

Action Threshold: Persistent symptoms or positive parasite findings may indicate need for retreatment.

Adverse effects (e.g., dizziness, nausea, headache, Mazzotti reaction)

Frequency: During and after treatment, especially within the first 24-48 hours.

Target: Absence or mild, tolerable side effects.

Action Threshold: Severe or persistent adverse effects warrant medical evaluation.

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Symptom Monitoring

  • Dizziness
  • Nausea
  • Diarrhea
  • Headache
  • Fatigue
  • Abdominal pain
  • Skin rash
  • Pruritus
  • Fever
  • Myalgia
  • Arthralgia
  • Lymphadenopathy (especially in onchocerciasis, indicative of Mazzotti reaction)

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenicity at high doses. Limited human data suggest no increased risk of major birth defects, but data are insufficient to rule out risk.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies; use with caution and only if clearly needed.
Second Trimester: Limited human data, generally considered safer than first trimester but still use with caution.
Third Trimester: Limited human data, generally considered safer than first trimester but still use with caution.
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Lactation

Ivermectin is excreted in human milk in low concentrations. The American Academy of Pediatrics considers it compatible with breastfeeding. However, caution is advised, and the infant should be monitored for potential adverse effects.

Infant Risk: Low risk. Monitor for gastrointestinal upset or drowsiness in the infant.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients weighing less than 15 kg or under 2 years of age. Dosing for children â‰Ĩ15 kg is weight-based. Close monitoring for adverse effects is important.

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Geriatric Use

No specific dose adjustment is generally required based on age alone. However, elderly patients may have reduced hepatic or renal function, or concomitant diseases, which could affect drug clearance. Use with caution and monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • Ivermectin is highly effective against a range of parasitic infections, particularly strongyloidiasis and onchocerciasis.
  • For strongyloidiasis, follow-up stool examinations are crucial to confirm eradication, as a single dose may not always be curative.
  • In onchocerciasis, Ivermectin does not kill adult worms but effectively reduces microfilarial load, preventing disease progression and transmission. Retreatment is often necessary.
  • The Mazzotti reaction (fever, headache, dizziness, rash, pruritus, arthralgia, myalgia, lymphadenopathy, hypotension) can occur in patients with onchocerciasis due to the death of microfilariae; it is usually mild and self-limiting but can be severe.
  • Ivermectin is generally well-tolerated, with most adverse effects being mild and transient.
  • While often taken on an empty stomach, some sources suggest taking it with food to improve absorption and reduce GI upset. Follow specific instructions from the prescribing physician or package insert.
  • Not effective against adult worms of Onchocerca volvulus or against the adult stages of other filarial parasites.
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Alternative Therapies

  • Albendazole (for strongyloidiasis, hookworm, ascariasis, trichuriasis)
  • Mebendazole (for hookworm, ascariasis, trichuriasis, pinworm)
  • Diethylcarbamazine (DEC) (for onchocerciasis, loiasis, lymphatic filariasis - note: DEC is contraindicated in onchocerciasis due to severe Mazzotti reaction)
  • Thiabendazole (for strongyloidiasis, cutaneous larva migrans)
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Cost & Coverage

Average Cost: $20 - $100 per 30 tablets (3mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.