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AtroPen Auto-Injector

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Overview

What is AtroPen Auto-Injector?

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 4.0–5.0.

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 –ol (±) -tropate. Its empirical formula is CHNO and its structural formula is:



What does AtroPen Auto-Injector look like?



What are the available doses of AtroPen Auto-Injector?

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What should I talk to my health care provider before I take AtroPen Auto-Injector?

Sorry No records found

How should I use AtroPen Auto-Injector?

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. Pralidoxime chloride may serve as an important adjunct to atropine therapy.

The ATROPEN

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.

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. Pralidoxime chloride may serve as an important adjunct to atropine therapy.

The ATROPEN

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.


What interacts with AtroPen Auto-Injector?

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



What are the warnings of AtroPen Auto-Injector?



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.


What are the precautions of AtroPen Auto-Injector?







Laboratory Tests:



Information for Patients:

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Carcinogenesis, Mutagenesis, Impairment of Fertility:



Pregnancy: Teratogenic Effects - Pregnancy Category C:



Nursing Mothers:



Pediatric Use:

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Geriatric Use:


What are the side effects of AtroPen Auto-Injector?

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 37.8°C or 100°F (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:



Cardiovascular:



Eye:



Gastrointestinal:



General:



Immunologic:



Special Investigations:



Metabolic:



Central Nervous System:



Psychiatric:



Genitourinary:



Pulmonary:



Dermatologic:


What should I look out for while using AtroPen Auto-Injector?

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.


What might happen if I take too much AtroPen Auto-Injector?


How should I store and handle AtroPen Auto-Injector?

Store between 2°C and 25°C (36°F and 77°F). Retain in the original package to protect from light. Freezing does not adversely affect the product.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 25°C (77°F); excursions permitted to 15–30°C (59–86°F)[see USP Controlled Room Temperature]Keep from freezing. Protect from light.Manufactured by:MERIDIAN MEDICAL TECHNOLOGIES™, INC.COLUMBIA, MD 21046A subsidiary of King Pharmaceuticals, Inc. 1-877-248-72750001306 Rev.11/05Self Aid and Caregiver Aid Directions for Use.FOLLOW THESE INSTRUCTIONS ONLY WHEN READY TO ADMINISTER ATROPINEDIRECTIONS FOR THE USE OF 0.25 mg ATROPEN Rev. 11/05ATROPEN is a registered trademark ofMeridian Medical Technologies™, Inc.Columbia, MD 21046A subsidiary of King Pharmaceuticals, Inc.1-877-248-7275The 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 25°C (77°F); excursions permitted to 15–30°C (59–86°F)[see USP Controlled Room Temperature]Keep from freezing. Protect from light.Manufactured by:MERIDIAN MEDICAL TECHNOLOGIES™, INC.COLUMBIA, MD 21046A subsidiary of King Pharmaceuticals, Inc. 1-877-248-72750001306 Rev.11/05Self Aid and Caregiver Aid Directions for Use.FOLLOW THESE INSTRUCTIONS ONLY WHEN READY TO ADMINISTER ATROPINEDIRECTIONS FOR THE USE OF 0.25 mg ATROPEN Rev. 11/05ATROPEN is a registered trademark ofMeridian Medical Technologies™, Inc.Columbia, MD 21046A subsidiary of King Pharmaceuticals, Inc.1-877-248-7275The 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 25°C (77°F); excursions permitted to 15–30°C (59–86°F)[see USP Controlled Room Temperature]Keep from freezing. Protect from light.Manufactured by:MERIDIAN MEDICAL TECHNOLOGIES™, INC.COLUMBIA, MD 21046A subsidiary of King Pharmaceuticals, Inc. 1-877-248-72750001306 Rev.11/05Self Aid and Caregiver Aid Directions for Use.FOLLOW THESE INSTRUCTIONS ONLY WHEN READY TO ADMINISTER ATROPINEDIRECTIONS FOR THE USE OF 0.25 mg ATROPEN Rev. 11/05ATROPEN is a registered trademark ofMeridian Medical Technologies™, Inc.Columbia, MD 21046A subsidiary of King Pharmaceuticals, Inc.1-877-248-7275The 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 25°C (77°F); excursions permitted to 15–30°C (59–86°F)[see USP Controlled Room Temperature]Keep from freezing. Protect from light.Manufactured by:MERIDIAN MEDICAL TECHNOLOGIES™, INC.COLUMBIA, MD 21046A subsidiary of King Pharmaceuticals, Inc. 1-877-248-72750001306 Rev.11/05Self Aid and Caregiver Aid Directions for Use.FOLLOW THESE INSTRUCTIONS ONLY WHEN READY TO ADMINISTER ATROPINEDIRECTIONS FOR THE USE OF 0.25 mg ATROPEN Rev. 11/05ATROPEN is a registered trademark ofMeridian Medical Technologies™, Inc.Columbia, MD 21046A subsidiary of King Pharmaceuticals, Inc.1-877-248-7275The 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 25°C (77°F); excursions permitted to 15–30°C (59–86°F)[see USP Controlled Room Temperature]Keep from freezing. Protect from light.Manufactured by:MERIDIAN MEDICAL TECHNOLOGIES™, INC.COLUMBIA, MD 21046A subsidiary of King Pharmaceuticals, Inc. 1-877-248-72750001306 Rev.11/05Self Aid and Caregiver Aid Directions for Use.FOLLOW THESE INSTRUCTIONS ONLY WHEN READY TO ADMINISTER ATROPINEDIRECTIONS FOR THE USE OF 0.25 mg ATROPEN Rev. 11/05ATROPEN is a registered trademark ofMeridian Medical Technologies™, Inc.Columbia, MD 21046A subsidiary of King Pharmaceuticals, Inc.1-877-248-7275The 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 25°C (77°F); excursions permitted to 15–30°C (59–86°F)[see USP Controlled Room Temperature]Keep from freezing. Protect from light.Manufactured by:MERIDIAN MEDICAL TECHNOLOGIES™, INC.COLUMBIA, MD 21046A subsidiary of King Pharmaceuticals, Inc. 1-877-248-72750001306 Rev.11/05Self Aid and Caregiver Aid Directions for Use.FOLLOW THESE INSTRUCTIONS ONLY WHEN READY TO ADMINISTER ATROPINEDIRECTIONS FOR THE USE OF 0.25 mg ATROPEN Rev. 11/05ATROPEN is a registered trademark ofMeridian Medical Technologies™, Inc.Columbia, MD 21046A subsidiary of King Pharmaceuticals, Inc.1-877-248-7275The 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 25°C (77°F); excursions permitted to 15–30°C (59–86°F)[see USP Controlled Room Temperature]Keep from freezing. Protect from light.Manufactured by:MERIDIAN MEDICAL TECHNOLOGIES™, INC.COLUMBIA, MD 21046A subsidiary of King Pharmaceuticals, Inc. 1-877-248-72750001306 Rev.11/05Self Aid and Caregiver Aid Directions for Use.FOLLOW THESE INSTRUCTIONS ONLY WHEN READY TO ADMINISTER ATROPINEDIRECTIONS FOR THE USE OF 0.25 mg ATROPEN Rev. 11/05ATROPEN is a registered trademark ofMeridian Medical Technologies™, Inc.Columbia, MD 21046A subsidiary of King Pharmaceuticals, Inc.1-877-248-7275The 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 25°C (77°F); excursions permitted to 15–30°C (59–86°F)[see USP Controlled Room Temperature]Keep from freezing. Protect from light.Manufactured by:MERIDIAN MEDICAL TECHNOLOGIES™, INC.COLUMBIA, MD 21046A subsidiary of King Pharmaceuticals, Inc. 1-877-248-72750001306 Rev.11/05Self Aid and Caregiver Aid Directions for Use.FOLLOW THESE INSTRUCTIONS ONLY WHEN READY TO ADMINISTER ATROPINEDIRECTIONS FOR THE USE OF 0.25 mg ATROPEN Rev. 11/05ATROPEN is a registered trademark ofMeridian Medical Technologies™, Inc.Columbia, MD 21046A subsidiary of King Pharmaceuticals, Inc.1-877-248-7275The 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 25°C (77°F); excursions permitted to 15–30°C (59–86°F)[see USP Controlled Room Temperature]Keep from freezing. Protect from light.Manufactured by:MERIDIAN MEDICAL TECHNOLOGIES™, INC.COLUMBIA, MD 21046A subsidiary of King Pharmaceuticals, Inc. 1-877-248-72750001306 Rev.11/05Self Aid and Caregiver Aid Directions for Use.FOLLOW THESE INSTRUCTIONS ONLY WHEN READY TO ADMINISTER ATROPINEDIRECTIONS FOR THE USE OF 0.25 mg ATROPEN Rev. 11/05ATROPEN is a registered trademark ofMeridian Medical Technologies™, Inc.Columbia, MD 21046A subsidiary of King Pharmaceuticals, Inc.1-877-248-7275The 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 25°C (77°F); excursions permitted to 15–30°C (59–86°F)[see USP Controlled Room Temperature]Keep from freezing. Protect from light.Manufactured by:MERIDIAN MEDICAL TECHNOLOGIES™, INC.COLUMBIA, MD 21046A subsidiary of King Pharmaceuticals, Inc. 1-877-248-72750001306 Rev.11/05Self Aid and Caregiver Aid Directions for Use.FOLLOW THESE INSTRUCTIONS ONLY WHEN READY TO ADMINISTER ATROPINEDIRECTIONS FOR THE USE OF 0.25 mg ATROPEN Rev. 11/05ATROPEN is a registered trademark ofMeridian Medical Technologies™, Inc.Columbia, MD 21046A subsidiary of King Pharmaceuticals, Inc.1-877-248-7275The 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 25°C (77°F); excursions permitted to 15–30°C (59–86°F)[see USP Controlled Room Temperature]Keep from freezing. Protect from light.Manufactured by:MERIDIAN MEDICAL TECHNOLOGIES™, INC.COLUMBIA, MD 21046A subsidiary of King Pharmaceuticals, Inc. 1-877-248-72750001306 Rev.11/05Self Aid and Caregiver Aid Directions for Use.FOLLOW THESE INSTRUCTIONS ONLY WHEN READY TO ADMINISTER ATROPINEDIRECTIONS FOR THE USE OF 0.25 mg ATROPEN Rev. 11/05ATROPEN is a registered trademark ofMeridian Medical Technologies™, Inc.Columbia, MD 21046A subsidiary of King Pharmaceuticals, Inc.1-877-248-7275The 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 25°C (77°F); excursions permitted to 15–30°C (59–86°F)[see USP Controlled Room Temperature]Keep from freezing. Protect from light.Manufactured by:MERIDIAN MEDICAL TECHNOLOGIES™, INC.COLUMBIA, MD 21046A subsidiary of King Pharmaceuticals, Inc. 1-877-248-72750001306 Rev.11/05Self Aid and Caregiver Aid Directions for Use.FOLLOW THESE INSTRUCTIONS ONLY WHEN READY TO ADMINISTER ATROPINEDIRECTIONS FOR THE USE OF 0.25 mg ATROPEN Rev. 11/05ATROPEN is a registered trademark ofMeridian Medical Technologies™, Inc.Columbia, MD 21046A subsidiary of King Pharmaceuticals, Inc.1-877-248-7275


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Atropine is commonly classified as an anticholinergic or antiparasympathetic (parasympatholytic) drug. More precisely, however, it is termed an antimuscarinic agent since it antagonizes the muscarine-like actions of acetylcholine and other choline esters.

Atropine inhibits the muscarinic actions of acetylcholine on structures innervated by postganglionic cholinergic nerves, and on smooth muscles, which respond to endogenous acetylcholine but are not so innervated. As with other antimuscarinic agents, the major action of atropine is a competitive or surmountable antagonism, which can be overcome by increasing the concentration of acetylcholine at receptor sites of the effector organ (e.g., by using anticholinesterase agents, which inhibit the enzymatic destruction of acetylcholine). The receptors antagonized by atropine are the peripheral structures that are stimulated or inhibited by muscarine, (i.e., exocrine glands and smooth and cardiac muscle). Responses to postganglionic cholinergic nerve stimulation may also be inhibited by atropine, but this occurs less readily than with responses to injected (exogenous) choline esters.

Non-Clinical Toxicology
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.

Drug Interactions:

The following precaution should be kept in mind in the treatment of anticholinesterase poisoning although it does not bear directly on the use of atropine and pralidoxime. Since barbiturates are potentiated by the anticholinesterases, they should be used cautiously in the treatment of convulsions.

General:

Atropine should be used with caution in individuals with cardiac disease. Conventional systemic doses may precipitate acute glaucoma in susceptible individuals, convert partial pyloric stenosis into complete pyloric obstruction, precipitate urinary retention in individuals with prostatic hypertrophy, or cause inspissation of bronchial secretions and formation of dangerous viscid plugs in individuals with chronic lung disease.

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 37.8°C or 100°F (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:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).