Epinephrine (Symjepi)

Trade Name : SYMJEPI

Adamis Pharmaceuticals Corporation

INJECTION

Strength 0.3 mg/.3mL

EPINEPHRINE Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Epinephrine (Symjepi) which is also known as SYMJEPI and Manufactured by Adamis Pharmaceuticals Corporation. It is available in strength of 0.3 mg/.3mL per ml. Read more

Epinephrine (Symjepi) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

SYMJEPIu00a0is 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.
SYMJEPIu00a0is 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.
SYMJEPIu00a0is intended for immediate administration as emergency supportive therapy only and is not a substitute for immediate medical care.
SYMJEPI contains epinephrine, a non-selective alpha and beta-adrenergic receptor agonist, indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis.

This product delivers 0.3 mg epinephrine injection (0.3 mL) and is intended for patients who weigh 30 kg or more (approximately 66 pounds or more).
Inject SYMJEPI intramuscularly or subcutaneously into the anterolateral aspect of the thigh with the needle facing downwards. It can be injected through clothing if necessary. Instruct caregivers of young children who are prescribed SYMJEPI 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 [].
Eachu00a0SYMJEPI contains a single dose of epinephrine for single-use injection. Since the doses of Epinephrine delivered fromu00a0SYMJEPI are fixed, consider using other forms of injectable epinephrine if doses lower than 0.3 mg are deemed necessary.
The prescriber should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is indicated. With severe persistent anaphylaxis, repeat injections with an additionalu00a0SYMJEPI may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision [].
SYMJEPIu00a0prescribers should ensure that the patient or caregiver is instructed and understands the indications and use of this product. A health care provider should review the patient instructions for SYMJEPI, in detail, with the patient or caregiver. Patients and/or any other person who might be in a position to administer an epinephrine injection should be advised of the proper site for injection and given appropriate instructions about imbedding the needle before transferring the thumb to the syringe plunger [].
The epinephrine solution in the syringe should be inspected visually for particulate matter and discoloration. Epinephrine is light sensitive and should be stored in the outer case provided to protect it from light [].
Patients greater than or equal to 30 kg (66 lbs): Injectu00a0SYMJEPI intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Each pre-filled syringe is for a single injection.

Injection: Single-dose pre-filled syringe for manual injection, containing 0.3 mg/0.3 mL epinephrine sterile solution for injection, USP
Injection: single-dose, pre-filled syringe for manual injection containing 0.3 mg/0.3 mL epinephrine sterile solution for injection, USP

None.
None.

No data

In conjunction with use, seek immediate medical or hospital care. ()
Do not inject intravenously, into buttock, or into digits, hands or feet. ()
To minimize the risk of injection-related injury, instruct caregivers to hold the child's leg firmly in place and limit movement prior to and during injection when administering to young children. ()
Rare cases of serious skin and soft tissue infections have been reported following epinephrine injection. Advise patients to seek medical care if they develop signs or symptoms of infection at the epinephrine injection site. ()
The presence of a sulfite in this product should not deter use. ()
Administer with caution in patients with heart disease; may aggravate angina pectoris or produce ventricular arrhythmias. ()

Due to the lack of randomized, controlled clinical trials of epinephrine for the treatment of anaphylaxis, the true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports and studies are listed below. Common adverse reactions to systemically administered epinephrine 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 epinephrine, 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 [].
Rare cases of stress cardiomyopathy have been reported in patients treated with epinephrine.
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.
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 at the injection site following epinephrine injection in the thigh [].
To report SUSPECTED ADVERSE REACTIONS, contact Adamis Pharmaceuticals Corporation at 1-858-997-2400 or FDA at 1-800-FDA-1088 or .

Adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties. ()

Patients who receive epinephrine while concomitantly taking cardiac glycosides, diuretics, or anti-arrhythmics should be observed carefully for the development of cardiac arrhythmias [].
The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.
The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta-adrenergic blocking drugs, such as propranolol.
The vasoconstricting and hypertensive effects of epinephrine are antagonized by alpha-adrenergic blocking drugs, such as phentolamine.
Ergot alkaloids may also reverse the pressor effects of epinephrine.

Cardiac glycosides or diuretics: observe for development of cardiac arrhythmias. ()
Tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines: potentiate effects of epinephrine. ()
Beta-adrenergic blocking drugs: antagonize cardiostimulating and bronchodilating effects of epinephrine. ()
Alpha-adrenergic blocking drugs: antagonize vasoconstricting and hypertensive effects of epinephrine. ()
Ergot alkaloids: may reverse the pressor effects of epinephrine. ()

Elderly patients may be at greater risk of developing adverse reactions. (, )

Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation. Treatment consists of rapidly acting vasodilators or alpha-adrenergic blocking drugs and/or respiratory support.
Epinephrine overdosage can also cause transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions may appear within one minute after injection and may be followed by multifocal ventricular tachycardia (prefibrillation rhythm). Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Treatment of arrhythmias consists of administration of a beta-adrenergic blocking drug such as propranolol.
Overdosage sometimes results in extreme pallor and coldness of the skin, metabolic acidosis, and kidney failure. Suitable corrective measures must be taken in such situations.

Each SYMJEPI pre-filled, syringe delivers a single dose of 0.3 mg of epinephrine from epinephrine injection, USP (0.3mg/0.3 mL).
Each SYMJEPI (epinephrine injection, USP) syringe contains 0.8 mL of sterile aqueous solution of epinephrine for intramuscular or subcutaneous administration. The syringe is overfilled for stability purposes; more than half of the solution remains in the syringe after use and CANNOT BE REUSED.
Each 0.3 mL contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0.
Epinephrine is a sympathomimetic catecholamine (a non-selective alpha and beta-adrenergic receptor agonist) designated chemically as (-)-3,4-Dihydroxy-u03b1-[(methylamino)methyl]benzyl alcohol and has the following structure:
The molecular weight of epinephrine is 183.20.
Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from formation of melanin. Replace SYMJEPI if the solution appears discolored (pinkish or brown color), cloudy, or contains particles.

No data

Long-term studies to evaluate the carcinogenic potential of epinephrine have not been conducted.
Epinephrine and other catecholamines have been shown to have mutagenic potential . Epinephrine was positive in the bacterial reverse mutation assay, positive in the mouse lymphoma assay, and negative in the micronucleus assay. Epinephrine is an oxidative mutagen based on the WP2 Mutoxitest bacterial reverse mutation assay. This should not prevent the use of epinephrine under the conditions noted under n
The potential for epinephrine to impair reproductive performance has not been evaluated, but epinephrine has been shown to decrease implantation in female rabbits dosed subcutaneously with 1.2 mg/kg/day (40-fold the highest human intramuscular or subcutaneous daily dose) during gestation days 3 to 9.

No data

[see FDA-Approved Patient Labeling ( and )]
A healthcare provider should review the patient instructions and operation of SYMJEPI, in detail, with the patient or caregiver.
Epinephrine is essential for the treatment of anaphylaxis. Patients who are at risk of or have a history of severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens, as well as idiopathic and exercise-induced anaphylaxis, should be carefully instructed about the circumstances under which epinephrine should be used.
Administration and Training
Instruct patients and/or caregivers in the appropriate use of SYMJEPI. SYMJEPI should be injected into the middle of the outer thigh (through clothing, if necessary). Each syringe is for a single-use injection. Advise patients to seek immediate medical care in conjunction with administration of SYMJEPI.
Young children may be uncooperative and kick or move during and injection. Instruct caregivers of young children who are prescribed SYMJEPI to hold the leg firmly in place and limit movement prior to and during an injection [n ].
Complete patient information, including dosage, directions for proper administration and precautions can be found inside each SYMJEPI carton. A printed label on the surface of the SYMJEPI case shows instructions for use.
Adverse Reactions
Epinephrine may produce symptoms and signs that include an increase in heart rate, the sensation of a more forceful heartbeat, palpitations, sweating, nausea and vomiting, difficulty breathing, pallor, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These signs and symptoms usually subside rapidly, especially with rest, quiet and recumbency. Patients with hypertension or hyperthyroidism may develop more severe or persistent effects, and patients with coronary artery disease could experience angina. Patients with diabetes may develop increased blood glucose levels following epinephrine administration. Patients with Parkinsonu2019s disease may notice a temporary worsening of symptoms. [].
Accidental Injection
Advise patients to seek immediate medical care in the case of accidental injection. Since epinephrine is a strong vasoconstrictor when injected into the digits, hands, or feet, treatment should be directed at vasodilatation if there is such an accidental injection to these areas [].
Serious Infections at the Injection Site
Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site [].
Storage and Handling
Instruct patients to inspect the epinephrine solution visually periodically. SYMJEPI should be replaced if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Epinephrine is light sensitive and should be stored in the outer case provided to protect it from light. Instruct patients that SYMJEPI must be used or properly disposed once the protective cap covering the needle is removed []. Instruct patients to give a used SYMJEPI syringe to their healthcare provider or emergency room personnel for proper disposal, and to return expired or discolored SYMJEPI to their healthcare provider or pharmacy for proper disposal.
Complete patient information, including dosage, directions for proper administration and precautions can be found inside each SYMJEPI case.
Manufactured for Adamis Pharmaceuticals Corporation. San Diego, CA

SYMJEPIu2122 (sim-JEP-ee) (epinephrine)injection for intramuscular or subcutaneous useFor allergic emergencies (anaphylaxis)
Read this Patient Information leaflet carefully before using SYMJEPI and each time you get a refill. There may be new information. You, your parent, caregiver, or others who may be in a position to administer SYMJEPI should know how to use it before you have an allergic emergency. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about SYMJEPI?
1. SYMJEPI contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life threatening, can happen within minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or unknown causes. Symptoms of anaphylaxis may include:
2. n Talk to your healthcare provider if you need additional prefilled syringes to keep at work, school, or other locations. Tell your family members, caregivers, and others where you keep your SYMJEPI and how to use it before you need it. You may be unable to speak in an allergic emergency.
3.n
What is SYMJEPI?
Before using SYMJEPI, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take
Especially tell your healthcare provider if you take certain asthma medicines.
SYMJEPIu00a0and other medicines may affect each other, causing side effects. SYMJEPI may affect the way other medicines work, and other medicines may affect how SYMJEPI works.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
Use your SYMJEPI for treatment of anaphylaxis as prescribed by your healthcare provider, regardless of your medical conditions or the medicines you take.
How should I use SYMJEPI?
What are the possible side effects of SYMJEPI?
SYMJEPI may cause serious side effects.
If you accidentally inject SYMJEPI into any other part of your body, go to the nearest emergency room right away. Tell the healthcare provider where on your body you received the accidental injection.
Common side effects of SYMJEPI include:
These side effects may go away with rest. n
These are not all the possible side effects of SYMJEPI. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store SYMJEPI?
Keep SYMJEPI and all medicines out of the reach of children.
General information about the safe and effective use of SYMJEPI.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use SYMJEPI for a condition for which it was not prescribed. Do not give your SYMJEPI to other people.
This Patient Information leaflet summarizes the most important information about SYMJEPI. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about SYMJEPI that is written for health professionals.
What are the ingredients in SYMJEPI?
Active Ingredients: n- Inactive Ingredients:
Manufactured for Adamis Pharmaceuticals Corporation. San Diego, CASYMJEPI is a registered trademark of Adamis Pharmaceuticals Corporation.For more information and instructions on the use of SYMJEPI, go to www.symjepi.com or call 1-858-997-2400.
Important Information
This Patient Information has been approved by the U.S. Food and Drug Administration Issued: 06/2017.

Instructions for Use
SYMJEPI (sim-JEP-ee)u00a0(epinephrine injection, USP) 0.3 mg prefilled syringe
For Allergic Emergencies (anaphylaxis)
Read this Instructions for Use carefully before you use this product.
Before you need to use your SYMJEPI syringe make sure your healthcare provider shows you the right way to use it. Parents, caregivers, and others who may be in a position to administer SYMJEPI should also understand how to use it. If you have questions, ask your healthcare provider.
Get Ready to Use SYMJEPI
SYMJEPI works like a standard prefilled syringe.
SYMJEPI is injected downwards, into the while sitting (as shown), through clothing if necessary.
Ready to Use SYMJEPI
When ready to inject, pull off cap to expose needle.
DO NOT put finger on top of the device.
If you are administering SYMJEPI to a young child, hold the leg firmly in place while administering the injection.
Hold SYMJEPI by finger grips only and slowly insert the needle into the thigh.
After needle is in thigh: Push the plunger all the way down until it and hold for 2 seconds.
Remove the syringe and massage the injection area for 10 seconds.
Get Help
Get emergency medical help now.
Tell healthcare provider that you received an injection of epinephrine.
Use second syringe if necessary
You may need a second SYMJEPI syringe if symptoms continue or recur.
SYMJEPI
The correct dose has been injected if the plunger has been pushed all the way down and the solution window is at least partially blocked.
If you will be administering SYMJEPI to a young child, ask your healthcare provider to show you how to properly hold the leg in place while administering a dose.
After use and Disposal
u200bAfter Use
Safety Guard
Using one hand with fingers behind the needle slide safety guard over needle.
For more information see Patient Information sheet or ask your healthcare provider.
How to Store
Check Your SYMJEPI Periodicallyn- u00a0u2014
Your SYMJEPI Has an Expiration Date
For more information about SYMJEPI prefilled syringe and proper use of the product, call 1-858-997-2400 or visit www.symjepi.com.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
SYMJEPI is a registered trademark of Adamis Pharmaceuticals Corporation.
Manufactured for Adamis Pharmaceuticals, San Diego, CA 92130, USA. Approved: June 2017
SYMJEPI
(epinephrine injection, USP) 0.3 mg pre-filled syringe
Instructions for Use
Pull out and Read before Use
Rx Only

Syringe Label
SYMJn
Epinephrine Injection
0.3 mg
Lot: Exp:
Distributor: Adamis Pharmaceuticals
Replace when discolored or expired
[2] Insert Needle in Thigh
After use Call 911

SYMJn (epinephrine)u200binjection 0.3 mg
Prefilled Syringe
Remove Device From Case
1n- 2n- 3
Pull latch to open
How to Store
Important
Check Solution
If solution is discolored, replace your SYMJEPI.n
RX only
ADAMIS Pharmaceutical Corporation
NDC 38739-200-01
Lot
Exp

NDC #38739-200-02
RX ONLY
SYMJn n
(epinephrine) Injection 0.3 mg
(0.3 mg PRE-FILLED SINGLE DOSE SYRINGE)
FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS)
Protect from light. Store at room temperature.
USP (0.3mg/ 0.3mL)
Contains Two Syringes

NDC #38739-200-12
RX ONLY
Protect from light
SYMJn n
(epinephrine) Injection 0.3 mg
(0.3 mg PRE-FILLED SINGLE DOSE SYRINGE)
For Allergic Emergencies (Anaphylaxis)
USP (0.3mg/ 0.3mL)
PCR-720-07468
6 two-pack units

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Epinephrine (Symjepi)

Trade Name : SYMJEPI

INJECTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Epinephrine (Symjepi)

Trade Name : SYMJEPI

INJECTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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