Zinplava

Generic name: bezlotoxumab [ BEZ-loe-TOX-ue-mab ]
Drug class: Immune globulins

Medically reviewed by Drugs.com. Last updated on Jul 22, 2021.

What is Zinplava?

Zinplava is a monoclonal antibody. Monoclonal antibodies are made to target only certain cells in the body. Bezlotoxumab works by binding to a specific toxin produced by the Clostridium difficile bacteria, to help neutralize the toxin''s effects.

Zinplava is used together with antibiotic medicine in adults with Clostridium difficile (C. difficile), an infection, that can cause life-threatening diarrhea. Bezlotoxumab may help keep this infection from coming back after treatment.

Zinplava is not an antibiotic and will not treat the infection itself.

Warnings

Before you receive Zinplava, tell your doctor about all your medical conditions or allergies, and all the medicines you are using. Also make sure your doctor knows if you are pregnant or breast-feeding.

Before taking this medicine

To make sure Zinplava is safe for you, tell your doctor if you have:

• congestive heart failure.

It is not known whether Zinplava will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether bezlotoxumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

This medicine is not approved for use by anyone younger than 18 years old.

How is Zinplava given?

Zinplava is injected into a vein through an IV. A healthcare provider will give you this injection.

This medicine must be given slowly, and the IV infusion can take about 60 minutes to complete.

Zinplava has no antibacterial effects and will not treat the underlying infection. You must use antibiotic medication to treat C. difficile infection.

Use your antibiotic medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses of your antibiotic may also increase your risk of further infection that is resistant to antibiotics.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Dosing information

Usual Adult Dose for Clostridial Infection:

10 mg/kg IV over 60 minutes as a single dose

Use: To reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence

What happens if I miss a dose?

Since Zinplava is used as a single dose, it does not have a daily dosing schedule.

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after receiving Zinplava?

Follow your doctor''s instructions about any restrictions on food, beverages, or activity.

Zinplava side effects

Get emergency medical help if you have signs of an allergic reaction to Zinplava: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• worsening symptoms of C. difficile infection, such as severe stomach pain or watery diarrhea;

• swelling in your hands, ankles, or feet;

• rapid weight gain; or

• shortness of breath (even with mild exertion).

Common Zinplava side effects may include:

• nausea;

• fever; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Zinplava?

Other drugs may interact with bezlotoxumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Zinplava only for the indication prescribed.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Copyright 1996-2023 Cerner Multum, Inc. Version: 1.02.

Package insert / product label
Generic name: multivitamin
Dosage form: tablet
Drug class: Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Jan 1, 2023.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

DESCRIPTION:

Full Prescribing Information:

Each Serving Size of 2 caplets contain:

Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake).

INDICATIONS:

Zintrexyl-C TM is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for the treatment of the condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.

CONTRAINDICATIONS:

This product is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

WARNING:

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.

Precaution Section

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

There is a potential danger in administering folic acid to patients with undiagnosed anemia, since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia.

The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

For use on the order of a healthcare practitioner.
Call your doctor about side effects. To report side effects, call PureTek Corporation at
1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions:

Zintrexyl-C TM is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, or Clopidogrel).

Adverse Reactions:

Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.

Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Zintrexyl-C TM after meals may control occasional gastrointestinal disturbances. Zintrexyl-C TM is best absorbed when taken at
bedtime.

Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usually recommended levels, has been associated with gastrointestinal intolerance in some patients.

OVERDOSE:

Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness, and coma. The estimated overdose of orally ingested iron is 300 mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Zintrexyl-C TM should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of reach of children.

Treatment:

For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

DOSAGE AND ADMINISTRATION:

Adults (persons over 12 years of age) Two (2) Zintrexyl-C TM caplet daily, between meals, or as directed by a physician. Do not administer to children under the age of 12.

HOW SUPPLIED:

Zintrexyl-C TM are yellow with slightly brown speckled, coated caplets. Bottles contain 60 caplets – NDC 59088-180-58. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP]. Protect from light and moisture and avoid excessive heat.

STORAGE:

Do not use it if the bottle seal is broken.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP].
Protect from light and moisture and avoid excessive heat.
To report a serious adverse event or to obtain product information, contact
1-877-921-7873.

Chronocap

Zintrexyl-C TM

Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
Questions? Call toll-free:
1-877-921-7873

Frequently asked questions

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