Atropine (Atropen Auto-Injector)

Trade Name : ATROPEN Auto-Injector

Meridian Medical Technologies, Inc.

INJECTION

Strength 2 mg/.7mL

ATROPINE Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]

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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 Atropine (Atropen Auto-Injector) which is also known as ATROPEN Auto-Injector and Manufactured by Meridian Medical Technologies, Inc.. It is available in strength of 2 mg/.7mL per ml. Read more

Atropine (Atropen Auto-Injector) 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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Rx Only
FOR USE IN NERVE AGENT AND INSECTICIDE POISONING ONLY
CAUTION! PRIMARY PROTECTION AGAINST EXPOSURE TO CHEMICAL NERVE AGENTS AND INSECTICIDE POISONING IS THE WEARING OF PROTECTIVE GARMENTS INCLUDING MASKS DESIGNED SPECIFICALLY FOR THIS USE.
INDIVIDUALS SHOULD NOT RELY SOLELY UPON ANTIDOTES SUCH AS ATROPINE AND PRALIDOXIME TO PROVIDE COMPLETE PROTECTION FROM CHEMICAL NERVE AGENTS AND INSECTICIDE POISONING.
SEEK IMMEDIATE MEDICAL ATTENTION AFTER INJECTION WITH ATROPEN.
A STERILE SOLUTION FOR INTRAMUSCULAR USE ONLY

Each prefilled auto-injector provides a dose of the antidote atropine in a self-contained unit, specially designed for self or caregiver administration. Four strengths of ATROPEN are available; they are ATROPEN 0.25 mg, ATROPEN 0.5 mg, ATROPEN 1 mg, and ATROPEN 2 mg.
When activated the ATROPEN 0.25 mg dispenses 0.21 mg atropine base (equivalent to 0.25 mg atropine sulfate). The ATROPEN 0.25 mg delivers 0.3 mL of sterile pyrogen-free solution containing citrate buffer, sodium chloride and Water for Injection. The pH range is 4.0-5.0.
When activated, the ATROPEN 0.5 mg dispenses 0.42 mg atropine base (equivalent to 0.5 mg atropine sulfate), the ATROPEN 1 mg dispenses 0.84 mg atropine base (equivalent to 1 mg atropine sulfate), and the ATROPEN 2 mg dispenses 1.67 mg atropine base (equivalent to 2 mg atropine sulfate). Each 0.5 mg, 1 mg and 2 mg ATROPEN delivers atropine in 0.7 mL of sterile pyrogen-free solution containing glycerin, phenol, citrate buffer and Water for Injection. The pH range is 4.0u20135.0.
After the ATROPEN Auto-Injector has been activated, the empty container should be disposed of properly (see ). It cannot be refilled, nor can the protruding needle be retracted.
Atropine, an anticholinergic agent (muscarinic antagonist), occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is highly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine, whose activity is due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1 H,5 H-Tropan-3 u2013ol (u00b1) -tropate. Its empirical formula is CHNO and its structural formula is:

No data

The ATROPEN Auto-Injector is indicated for the treatment of poisoning by susceptible organophosphorous nerve agents having cholinesterase activity as well as organophosphorous or carbamate insecticides. n n Pralidoxime chloride may serve as an important adjunct to atropine therapy.
The ATROPENn- is intended as an initial treatment of the muscarinic symptoms of insecticide or nerve agent poisonings (generally breathing difficulties due to increased secretions); definitive medical care should be sought immediately.n- Array

In the face of life-threatening poisoning by organophosphorous nerve agents and insecticides, there are no absolute contraindications for the use of atropine (see ).

CAUTION! PRIMARY PROTECTION AGAINST EXPOSURE TO CHEMICAL NERVE AGENTS AND INSECTICIDE POISONING IS THE WEARING OF PROTECTIVE GARMENTS INCLUDING MASKS DESIGNED SPECIFICALLY FOR THIS USE.
INDIVIDUALS SHOULD NOT RELY SOLELY UPON ANTIDOTES SUCH AS ATROPINE AND PRALIDOXIME TO PROVIDE COMPLETE PROTECTION FROM CHEMICAL NERVE AGENTS AND INSECTICIDE POISONING.
Patients who have had previous anaphylactic reactions to atropine who have mild symptoms of organophosphorous or nerve agent poisoning should not be treated without adequate medical supervision.
While ATROPEN can be administered to all individuals with a life-threatening exposure to organophosphorous nerve agents and insecticides, it should be administered with extreme caution to individuals with the following disorders when the symptoms of nerve agent poisoning are less severe: individuals who are hypersensitive to any component of the product, disorders of heart rhythm such as atrial flutter, severe narrow angle glaucoma, pyloric stenosis, prostatic hypertrophy, significant renal insufficiency, or a recent myocardial infarction.
More than one dose of atropine (ATROPEN Auto-Injector) may be necessary initially, especially when exposure is massive or symptoms are severe. High doses of atropine may be required for many hours following high-dose exposure to maintain atropinization. (See )
Children and the elderly may be more susceptible to the pharmacologic effects of atropine.
Severe difficulty in breathing requires artificial respiration in addition to the use of atropine since atropine is not dependable in reversing the weakness or paralysis of the respiratory muscles.

No data

Mild to moderate pain may be experienced at the site of injection.
The major and most common side effects of atropine can be attributed to its antimuscarinic action. These include dryness of the mouth, blurred vision, photophobia, confusion, headache, dizziness, tachycardia, palpitations, flushing, urinary hesitance or retention, constipation, abdominal distention, nausea, vomiting, loss of libido and impotency. Anhidrosis may produce heat intolerance and impairment of temperature regulation especially in a hot environment. Larger or toxic doses may produce such central effects as restlessness, tremor, fatigue, locomotor difficulties, delirium, followed by hallucinations, depression and ultimately, medullary paralysis and death. Large doses can also lead to circulatory collapse. In such cases, blood pressure declines and death due to respiratory failure may ensue following paralysis and coma. Hypersensitivity reactions will occasionally occur with atropine; these are usually seen as skin rashes, on occasion progressing to exfoliation. Adverse events seen in pediatrics are similar to those that occur in adult patients although central nervous system complaints are often seen earlier and at lower doses.
When atropine and pralidoxime are used together, the signs of atropinization may occur earlier than might be expected than when atropine is used alone. This is especially true if the total dose of atropine has been large and the administration of pralidoxime has been delayed. Excitement and manic behavior immediately following recovery of consciousness have been reported in several cases. However, similar behavior has occurred in cases of organophosphate poisoning that were not treated with pralidoxime.
Amitai et el (JAMA 1990) evaluated the safety of ATROPEN 0.5 mg, 1 mg and 2 mg in a case series of 240 children who received ATROPEN inappropriately (i.e., no nerve agent exposure) during the 1990 Gulf War Period. Overall, severity of atropinization followed a nonlinear correlation with dose. Estimated doses up to 0.045 mg/kg produced no signs of atropinization. Estimated doses between 0.045 mg/kg to 0.175 mg/kg and even greater than 0.175 mg/kg were associated with mild and severe effects respectively. Actual dosage received by children may have been considerably lower than estimated since incomplete injection in many cases was suspected. Regardless, adverse events reported were generally mild and self-limited. Few children required hospitalization. Adverse reactions reported were dilated pupils (43%), tachycardia (39%), dry membranes (35%), flushed skin (20%), temperature 37.8u00b0C or 100u00b0F (4%) and neurologic abnormalities (5%). There was also local pain and swelling. In 91 children with ECGs, no abnormalities were noted other than sinus tachycardia; 22 children had severe tachycardia of 160-190 bpm. Neurologic abnormalities consisted of irritability, agitation, confusion, lethargy, and ataxia.
The following adverse reactions were reported in published literature for atropine in both adults and children:

Atropine possesses no known potential for dependence.

No data

CAUTION! PRIMARY PROTECTION AGAINST EXPOSURE TO CHEMICAL NERVE AGENT AND INSECTICIDE POISONING IS THE WEARING OF PROTECTIVE GARMENTS INCLUDING MASKS, DESIGNED SPECIFICALLY FOR THIS USE.
INDIVIDUALS SHOULD NOT RELY SOLELY UPON THE AVAILABILITY OF ANTIDOTES SUCH AS ATROPINE AND PRALIDOXIME TO PROVIDE COMPLETE PROTECTION FROM CHEMICAL NERVE AGENT AND INSECTICIDE POISONING.
Immediate evacuation from the contaminated environment is essential. Decontamination of the poisoned individual should occur as soon as possible.
The ATROPEN Auto-Injector is indicated for the treatment of poisoning by susceptible organophosphorous nerve agents having cholinesterase activity as well as organophosphorous or carbamate insecticides. n n Pralidoxime chloride may serve as an important adjunct to atropine therapy.
The ATROPENn- is intended as an initial treatment of the muscarinic symptoms of insecticide or nerve agent poisonings (generally breathing difficulties due to increased secretions); definitive medical care should be sought immediately.
It is recommended that ATROPEN Auto-Injectors be available for use in each person at risk for nerve agent or organophosphate insecticide poisoning; one (1) for mild symptoms plus two (2) more for severe symptoms as described below. No more than three (3) ATROPEN injections should be used unless the patient is under the supervision of a trained medical provider. Different dose strengths of the ATROPEN are available depending on the recipient's age and weight.

The ATROPEN is supplied in four strengths. The ATROPEN 0.25 mg (NDC 11704-107-01), provides Atropine Injection (atropine, 0.21 mg/0.3 mL), ATROPEN 0.5 mg (NDC 11704-104-01) provides Atropine Injection (atropine, 0.42 mg/0.7 mL), ATROPEN 1 mg (NDC 11704-105-01) provides Atropine Injection (atropine, 0.84 mg/0.7 mL), and ATROPEN 2 mg (NDC 11704-106-01) provides Atropine Injection (atropine, 1.67 mg/0.7 mL) in sterile solution for intramuscular injection. The ATROPEN is a self-contained unit designed for self or caregiver administration.
Store at 25u00b0C (77u00b0F); excursions permitted to 15u201330u00b0C (59u201386u00b0F)
[see USP Controlled Room Temperature]
Keep from freezing. Protect from light.
Manufactured by:MERIDIAN MEDICAL TECHNOLOGIESu2122, INC.COLUMBIA, MD 21046A subsidiary of King Pharmaceuticals, Inc. 1-877-248-7275
0001306 Rev.11/05
Self Aid and Caregiver Aid Directions for Use.
FOLLOW THESE INSTRUCTIONS n- ONLYn- WHEN READY TO ADMINISTER ATROPINE
DIRECTIONS FOR THE USE OF 0.25 mg ATROPENn
Rev. 11/05ATROPEN is a registered trademark ofMeridian Medical Technologiesu2122, Inc.Columbia, MD 21046A subsidiary of King Pharmaceuticals, Inc.1-877-248-7275

NDC 11704-107-01n
MERIDIAN MEDICAL TECHNOLOGIESn- Array
ATROPENn- Array
AUTO-INJECTOR
Rx Only
in 0.3 mL sterile solution for intramuscular use onlyn
For use in NERVE AGENT and INSECTICIDE POISONINGn

NDC 11704-104-01n
MERIDIAN MEDICAL TECHNOLOGIESn- Array
ATROPENn- Array
AUTO-INJECTOR
Rx Only
for use in NERVE AGENT and INSECTICIDE POISONINGn

NDC 11704-105-01n
MERIDIAN MEDICAL TECHNOLOGIESn- Array
ATROPENn- Array
AUTO-INJECTOR
Rx Only
for use in NERVE AGENT and INSECTICIDE POISONINGn

NDC 11704-106-01n
MERIDIAN MEDICAL TECHNOLOGIESn- Array
ATROPENn- Array
AUTO-INJECTOR
Rx Only
for use in NERVE AGENT and INSECTICIDE POISONINGn

NDC 11704-101-01n
MERIDIAN MEDICAL TECHNOLOGIESn
Columbia, MD 21046, U.S.A/ A subsidiary of King Pharmaceuticalsu00ae, Inc.n
Store at 25C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F).n
[See USP Controlled Room Temperature]. Keep from freezing.n
NSN 6505-00-926-9083n
ATROPENu00ae AUTO-INJECTORn
(atropine injection 2mg)n
For use in NERVE AGENT and INSECTICIDE POISONINGn
1 REMOVE YELLOW SAFETY
2 PLACE GREEN END ONnn- OUTERnn- THIGH AND PUSH HARD TILL INJECTOR FUNCTIONS
Rx Onlyn
NDC 11704-101-01n
0001294n

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Atropine (Atropen Auto-Injector)

Trade Name : ATROPEN Auto-Injector

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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Atropine (Atropen Auto-Injector)

Trade Name : ATROPEN Auto-Injector

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

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