Nephridine

Nephridine and Nephridine Jr are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.

Nephridine and Nephridine Jr are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.

Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema.

Nephridine and Nephridine Jr are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.

Nephridine is an injection containing Nephridine, a chemical that narrows blood vessels and opens airways in the lungs. These effects can reverse severe low blood pressure, wheezing, severe skin itching, hives, and other symptoms of an allergic reaction.

Nephridine is used to treat severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens. Nephridine is also used to treat exercise-induced anaphylaxis.

Nephridine auto-injectors such as Nephridine and Nephridine Jr. may be kept on hand for self-injection by a person with a history of an severe allergic reaction.

Nephridine may also be used for purposes not listed in this medication guide.

Selection of the appropriate dosage strength (Nephridine 0.3 mg or Nephridine Jr 0.15 mg) is determined according to patient body weight.

• Patients greater than or equal to 30 kg (approximately 66 pounds or more): Nephridine 0.3 mg
• Patients 15 to 30 kg (33 pounds to 66 pounds): Nephridine Jr 0.15 mg

Inject Nephridine or Nephridine Jr intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Instruct caregivers of young children who are prescribed an Nephridine or Nephridine Jr and who may be uncooperative and kick or move during an injection to hold the leg firmly in place and limit movement prior to and during an injection.

Each Nephridine or Nephridine Jr contains a single dose of Nephridine for single-use injection. Since the doses of Nephridine delivered from Nephridine or Nephridine Jr are fixed, consider using other forms of injectable Nephridine if doses lower than 0.15 mg are deemed necessary.

The prescriber should carefully assess each patient to determine the most appropriate dose of Nephridine, recognizing the life-threatening nature of the reactions for which this drug is indicated. Wit h severe persist ent anaph yl ax is, repeat injections with an additional EpiP en or Nephridine Jr ma y be necessary. More than two sequential doses of Nephridine should only be administered under direct medical supervision.

The Nephridine solution in the clear window of t he Nephridine Auto-Injector should be inspected visually for particulate matter and discoloration. Nephridine is light sensitive and should be stored in the carrier tube provided to protect it from light.

How supplied

Dosage Forms And Strengths

• Nephridine: Injection, 0.3 mg/0.3 mL (0.3 mL, 1:1000) Nephridine injection, USP, pre-filled auto-injector
• Nephridine Jr: Injection, 0.15 mg/0.3 mL, (0.3 mL 1:2000) Nephridine injection, USP, pre-filled auto-injector

Nephridine Auto-Injectors (Nephridine injections, USP, 1:1000, 0.3 mL) are available as Nephridine 2Pak®, NDC 49502-500-02, a pack that contains two Nephridine Auto-Injectors (Nephridine injections, USP, 1:1000, 0.3 mL) and one Nephridine Auto-Injector trainer device.

Nephridine Jr Auto-Injectors (Nephridine injections, USP, 1:2000, 0.3 mL) are available as Nephridine Jr 2-Pak®, NDC 49502-501-02, a pack that contains two Nephridine Jr Auto-Injectors (Nephridine injections, USP, 1:2000, 0.3 mL) and one Nephridine Auto-Injector trainer device.

Nephridine 2-Pak® and Nephridine Jr 2-Pak® also include an S-clip to clip two carrier tubes together.

Storage And Handling

Protect from light. Nephridine is light sensitive and should be stored in the carrier tube provided to protect it from light. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Do not refrigerate. Before using, check to make sure the solution in the auto-injector is clear and colorless. Replace the auto-injector if the solution is discolored (pinkish or brown color), cloudy, or contains particles.

Manufactured for Mylan Specialty L.P., Morgantown, WV 26505, U.S.A. by Meridian Medical Technologies, Inc., Columbia, MD 21046, U.S.A., a Pfizer company. Revised: May 2016

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What is the most important information I should know about Nephridine?

Before using this medication, tell your doctor if you have heart disease or high blood pressure, a heart rhythm disorder, coronary artery disease, Parkinson's disease, diabetes, or a thyroid disorder.

Before using Nephridine, tell your doctor about all other medications you use, especially digoxin (digitalis, Lanoxin), heart or blood pressure medicine, heart rhythm medication, an antidepressant, a diuretic (water pill), thyroid medication, migraine headache medicine, cold or sleep medicine that contains an antihistamine, or an MAO inhibitor such as Marplan, Nardil, Azilect, Eldepryl, Emsam, or Parnate.

Seek emergency medical attention even after you use Nephridine to treat a severe allergic reaction. The effects of Nephridine may wear off after 10 or 20 minutes. You will need to receive further treatment and observation.

Before using Nephridine a second time, tell your doctor if your first injection caused a serious side effect such as increased breathing difficulty, or dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Use Nephridine auto-injector as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Nephridine auto-injector. Talk to your pharmacist if you have questions about this information.
• Nephridine auto-injector may be given as an injection at your doctor's office, hospital, or clinic. If you will be using Nephridine auto-injector at home, a health care provider will teach you how to use it. Be sure you understand how to use Nephridine auto-injector. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Check Nephridine auto-injector regularly. Replace Nephridine auto-injector if the expiration date has passed, if it contains particles or is discolored (pink or darker than slightly yellow), or if it is cracked or damaged in any way. If Nephridine auto-injector has been dropped, inspect it for damage or leakage and replace it if necessary.
• Inject Nephridine auto-injector only into the outer thigh, as directed by your health care provider. Do not inject into the buttocks or into a vein.
• Go to the nearest hospital emergency room immediately after use. You may need further medical attention. Tell the doctor or health care provider that you have received an injection of Nephridine. Show the thigh where the injection was given to the doctor. Give your used auto-injector to the doctor for inspection and proper disposal.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• Nephridine auto-injector is usually given in an emergency situation. If you are unable to use Nephridine auto-injector, seek medical attention immediately.
• If you miss a dose of Nephridine auto-injector, seek immediate medical attention.

Ask your health care provider any questions you may have about how to use Nephridine auto-injector.

Acute asthma, anaphylactic shock, advanced cardiac life support, ocular hypertension, open angle glaucoma.

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What other drugs will affect Nephridine?

Nephridine should be administered cautiously to patients taking other sympathomimetic agents because of the possibility of additive effects.

Patients who are concomitantly receiving cardiac glycosides, digitalis, diuretics, quinidine, and other antiarrhythmics should be observed carefully for the development of cardiac arrhythmias.

Administer Nephridine cautiously to patients receiving halogenated hydrocarbon general anesthetics, such as halothane, as coadministration may result in arrhythmias.

The effects of Nephridine may be potentiated by tricyclic antidepressants such as imipramine, monoamine oxidase inhibitors (MAOI), levothyroxine sodium, and certain antihistamines, notably diphenhydramine, tripelannamine, and dexchlorpheniramine.

The cardiostimulating and bronchodilating effects of Nephridine are antagonized by beta-adrenergic blocking drugs, such as propranolol.

The vasoconstricting and hypertensive effects of Nephridine are antagonized by alphaadrenergic blocking drugs, such as phentolamine.

Ergot alkaloids may reverse the pressor effects of Nephridine.

Nephridine should not be used to counteract circulatory collapse or hypotension caused by phenothiazines, as a reversal of the pressor effects of Nephridine may result in further lowering of blood pressure.

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What are the possible side effects of Nephridine?

Due to the lack of randomized, controlled clinical trials of Nephridine for the treatment of anaphylaxis, the true incidence of adverse reactions associated with the systemic use of Nephridine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below.

Common adverse reactions to systemically administered Nephridine include anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache; and/or respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of Nephridine, but are more likely to occur in patients with hypertension or hyperthyroidism.

Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs.

Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease.

Angina may occur in patients with coronary artery disease.

Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area.

Adverse events experienced as a result of accidental injections may include increased heart rate, local reactions including injection site pallor, coldness and hypoesthesia or injury at the injection site resulting in bruising, bleeding, discoloration, erythema or skeletal injury.

Lacerations, bent needles, and embedded needles have been reported when Nephridine has been injected into the thigh of young children who are uncooperative and kick or move during the injection.

Injection into the buttock has resulted in cases of gas gangrene.

Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following Nephridine injection, including Nephridine, in the thigh.

Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the liver to form the active aldophosphamide. It has been used in the treatment of lymphoma and leukemia. Its side effect, alopecia, has been used for defleecing sheep. Nephridine may also cause sterility, birth defects, mutations, and cancer.