Uses
INDICATIONS AND USAGE
Ivermectin is indicated for the treatment of the following infections:
CONTRAINDICATIONS
Ivermectin Tablets are contraindicated in patients who are hypersensitive to any component of this product.
Ivermectin Tablets USP, 3mg (IVERMECTIN)
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2024-07-17
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 21:08:14
Key Label Information#
Warnings
CONTRAINDICATIONS
Ivermectin Tablets are contraindicated in patients who are hypersensitive to any component of this product.
WARNINGS
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 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.
Directions And Dosage
OVERDOSAGE
Significant lethality was observed in mice and rats after single oral doses of 25 to 50 mg/kg and 40 to 50 mg/kg, respectively. No significant lethality was observed in dogs after single oral doses of up to 10 mg/kg. At these doses, the treatment-related signs that were observed in these animals include ataxia, bradypnea, tremors, ptosis, decreased activity, emesis, and mydriasis. In accidental intoxication with, or significant exposure to, unknown quantities of veterinary formulations of ivermectin in humans, either by ingestion, inhalation, injection, or exposure to body surfaces, the following adverse effects have been reported most frequently: rash, edema, headache, dizziness, asthenia, nausea, vomiting, and diarrhea. Other adverse effects that have been reported include: seizure, ataxia, dyspnea, abdominal pain, paresthesia, urticaria, and contact dermatitis. In case of accidental poisoning, supportive therapy, if indicated, should include parenteral fluids and electrolytes, respiratory support (oxygen and mechanical ventilation if necessary) and pressor agents if clinically significant hypotension is present. Induction of emesis and/or gastric lavage as soon as possible, followed by purgatives and other routine anti-poison measures, may be indicated if needed to prevent absorption of ingested material.
DOSAGE AND ADMINISTRATION
Other Label Information
PRINCIPAL DISPLAY PANEL
Label Images#
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| IVERMECTIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7fd951fe-040a-0b64-2bea-eefc6aa4fc54 | Product name | 2 | 20250515 |
| 5b0ed980-56ce-7dd0-fb86-ff54be67c2e6 | Product name | 2 | 20200925 |
| eed31638-1288-4eb6-a55c-5fc014dca98d | Product name | 3 | 20200728 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-2242-3 | Ivermectin | 2 in 1 CARTON | TABLET | 2 | 3 | |
| 68071-2242-3 | Ivermectin | 10 in 1 BLISTER PACK | TABLET | 10 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-2242 | IVERMECTIN TABLET [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240719_ad6539f2-94de-1bc5-e053-2a95a90a4cf2.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42799-806-01 | EA - Each | 42799-806 | 9babec5c-e0c3-4e2f-88ab-373e81e98cde | 1 | 2014-12-01 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68071-2242 | 68071-2242-3 |
| 42799-806 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| IVERMECTIN | 8883YP2R6D | ACTIB |
Complete SPL Sections#
DESCRIPTION
Ivermectin is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis . Ivermectin is a mixture containing at least 90% 5- O -demethyl-22,23-dihydroavermectin A 1a and less than 10% 5- O- demethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A 1a , generally referred to as 22,23-dihydroavermectin B 1a and B 1b , or H 2 B 1a and H 2 B 1b , respectively. The respective empirical formulas are C 48 H 74 O 14 and C 47 H 72 O 14 , with molecular weights of 875.10 and 861.07, respectively. The structural formulas are: Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. Ivermectin tablets are available as 3-mg tablets containing the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.
CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE
Ivermectin is indicated for the treatment of the following infections:
CONTRAINDICATIONS
Ivermectin Tablets are contraindicated in patients who are hypersensitive to any component of this product.
WARNINGS
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 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.
PRECAUTIONS
ADVERSE REACTIONS
OVERDOSAGE
Significant lethality was observed in mice and rats after single oral doses of 25 to 50 mg/kg and 40 to 50 mg/kg, respectively. No significant lethality was observed in dogs after single oral doses of up to 10 mg/kg. At these doses, the treatment-related signs that were observed in these animals include ataxia, bradypnea, tremors, ptosis, decreased activity, emesis, and mydriasis. In accidental intoxication with, or significant exposure to, unknown quantities of veterinary formulations of ivermectin in humans, either by ingestion, inhalation, injection, or exposure to body surfaces, the following adverse effects have been reported most frequently: rash, edema, headache, dizziness, asthenia, nausea, vomiting, and diarrhea. Other adverse effects that have been reported include: seizure, ataxia, dyspnea, abdominal pain, paresthesia, urticaria, and contact dermatitis. In case of accidental poisoning, supportive therapy, if indicated, should include parenteral fluids and electrolytes, respiratory support (oxygen and mechanical ventilation if necessary) and pressor agents if clinically significant hypotension is present. Induction of emesis and/or gastric lavage as soon as possible, followed by purgatives and other routine anti-poison measures, may be indicated if needed to prevent absorption of ingested material.
DOSAGE AND ADMINISTRATION
HOW SUPPLIED
Ivermectin tablets USP, 3 mg are white, round, flat, bevel-edged tablets debossed with 806 on one side and plain on the other side. They are supplied as follows: NDC 68071-2242-3 UNIT DOSE PACKAGE OF 20
SPL UNCLASSIFIED SECTION
Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054 Rev. 01/14