ANTIVENIN
Latrodectus mactans · KIT · Merck Sharp & Dohme LLC
ANTIVENIN is a kit containing latrodectus mactans. Manufactured by Merck Sharp & Dohme LLC.
Key Facts
- Brand Name
- ANTIVENIN
- Generic Name
- Latrodectus mactans
- NDC Code (Product)
0006-5424- Manufacturer
- Merck Sharp & Dohme LLC
- Dosage Form
- KIT
- Marketing Status
- Application #
- BLA101062
- Marketing Start
- 12/01/2014
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE North American Coral Snake Antivenin (Equine) is indicated only for the treatment of envenomation caused by bites of North American coral snakes - Micrurus (including the eastern and Texas varieties). North American Coral Snake Antivenin (Equine) is a horse-derived antivenin indicated for the treatment of envenomation caused by North American coral snakes - Micrurus . ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For intravenous use only. For intravenous use only. • In adults and adolescents, the dose may vary from 3 to 5 vials, depending on the response to treatment. ( 2.1 ) • In small children, the dose may be decreased, depending on the response to treatment. ( 2.1 ) • Contents of each reconstituted vial can neutralize approximately 250 mouse (Lethal Dose) LD 50 or approximately 2 mg of M. fulvius venom. ( 2.1 ) • Infuse the first 1 or 2 mL over a 3- to 5-minute period, observing for allergic reaction. If tolerated, administer the rest of the dose at the rate that is comfortable for the patient based on body weight and general condition. Do not exceed 4 mL per minute for children. ( 2.2 ) 2.1 Dose • Contents of each reconstituted vial can neutralize approximately 250 mouse (Lethal Dose) LD 50 or approximately 2 mg of Micrurus fulvius fulvius ( M. f. fulvius) venom. • In adults and adolescents, the dose may vary from 3 to 5 vials, depending on the response to treatment. • In small children, the dose may be decreased, depending on the response to treatment. 2.2 Preparation and Administration Preparation • Pry off the small metal disc in the cap over the diaphrag…
Contraindications
4 CONTRAINDICATIONS • Do not administer North American Coral Snake Antivenin (Equine) prophylactically to asymptomatic patients. 1 • Do not administer North American Coral Snake Antivenin (Equine) to patients with a known history of hypersensitivity to horse serum unless the benefits outweigh the risks and appropriate management for anaphylactic reactions is readily available. • Do not administer North American Coral Snake Antivenin (Equine) prophylactically to asymptomatic patients. ( 4 ) • Do not use in patients with a known history of hypersensitivity to horse serum unless the benefits outweigh the risks and appropriate management for anaphylactic reactions is readily available. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions observed after treatment with North American Coral Snake Antivenin (Equine) were anaphylaxis and serum sickness, vomiting, and abdominal pain. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Adverse reactions may include anaphylaxis and serum sickness, vomiting, and abdominal pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is ANTIVENIN used for?
ANTIVENIN contains Latrodectus mactans. It is a kit taken as directed. Consult your doctor for specific uses.
Is ANTIVENIN a controlled substance?
ANTIVENIN is not classified as a controlled substance by the DEA.
What is the generic name for ANTIVENIN?
The generic name for ANTIVENIN is Latrodectus mactans. There are 1 other brand versions of Latrodectus mactans.
What is the NDC code for ANTIVENIN ?
The NDC (National Drug Code) for ANTIVENIN is 0006-5424, listed by Merck Sharp & Dohme LLC.