Generic drug: atropine

Brand name: Atropen

What is Atropen (atropine), and how does it work?

Atropen (atropine) is a prescription medicine used to treat the symptoms of Anesthesia Premedication, Sinus Bradycardia (ACLS), Bronchospasm, and Organophosphate or Carbamate Poisoning. Atropen may be used alone or with other medications.

Atropen belongs to a class of drugs called Anesthetic Premedication Agents; Cholinergic, Toxicity Antidotes.

What are the side effects of Atropen?

Atropen may cause serious side effects including:

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Atropen include:

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Atropen. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 (atropine) .

A STERILE SOLUTION FOR INTRAMUSCULAR USE ONLY

What is the dosage for Atropen?

Important Administration Information

  • It is recommended that three Atropen autoinjectors be available for use in each patient at risk for organophosphorus or carbamate poisoning; one (1) for mild symptoms plus two (2) more for severe symptoms. Different dose strengths of Atropen are available depending on the patient's weight.
  • Atropen should be used by persons who have had adequate training in the recognition and treatment of nerve agent or insecticide intoxication, but may be administered by a caregiver or self-administration if a trained provider is not available.
  • Only administer Atropen to patients experiencing symptoms of organophosphorus or carbamate poisoning in a situation where exposure is known or suspected. Atropen is a single-dose autoinjector 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.
  • Atropen should be administered as soon as symptoms of organophosphorus or carbamate poisoning appear.
  • In severe poisonings, it may also be desirable to concurrently administer an anticonvulsant (preferably a benzodiazepine) if seizure is suspected in the unconscious individual since the classic tonic-clonic jerking may not be apparent due to the effects of the poison.
  • A cholinesterase reactivator such as pralidoxime may serve as an important adjunct to atropine therapy.
  • Close supervision of all treated patients is indicated for at least 48 to 72 hours.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dosage Information

Different dose strengths of Atropen are available depending on the patient's age and weight (see Table 1).

Table 1: Recommended Dose Strength per Atropen Injection

Age and Body Weight Strength of each Atropen Injection
Adults and pediatric patients weighing over 41 kg (90 pounds) (generally over 10 years of age) Atropen 2 mg (green label)
Pediatric patients weighing 18 kg to 41 kg (40 pounds to 90 pounds) (generally 4 to 10 years of age) Atropen 1 mg (red label)
Pediatric patients weighing 7 kg to 18 kg (15 pounds to 40 pounds) (generally 6 months to 4 years of age) Atropen 0.5 mg (blue label)
Pediatric patients weighing less than 7 kg (15 pounds) (generally less than 6 months of age) Atropen 0.25 mg (yellow label)

Dosage For Mild Symptoms

First Dose

  • If the patient experiences two or more mild symptoms of nerve agent or insecticide exposure listed in Table 2, administer one (1) Atropen injection intramuscularly into the mid-lateral (outer) thigh.

Additional Doses

  • If, at any time after receiving the first Atropen injection, the patient has any of the severe symptoms listed in Table 2, administer two (2) additional Atropen injections in rapid succession. If possible, a person other than the patient should administer the second and third Atropen injections.
  • Wait 10 to 15 minutes for Atropen to take effect. If after 10 to 15 minutes, the patient does not develop any of the severe symptoms listed in Table 2, no additional Atropen injections are recommended.
Dosage For Severe Symptoms
  • If the patient is either unconscious or has any of the severe symptoms listed in Table 2, immediately administer three (3) Atropen injections intramuscularly into the patient's mid-lateral thigh in rapid succession.

Table 2: Common Symptoms of Organophosphorus or Carbamate Poisoning

Mild Symptoms Severe Symptoms
  • Blurred vision, miosis
  • Excessive, unexplained teary eyes*
  • Excessive, unexplained runny nose*
  • Increased salivation such as sudden unexplained excessive drooling*
  • Chest tightness or difficulty breathing
  • Tremors throughout the body or muscular twitching
  • Nausea and/or vomiting
  • Unexplained wheezing, coughing or increased airway secretions
  • Acute onset of stomach cramps
  • Tachycardia or bradycardia
  • Strange or confused behavior
  • Severe difficulty breathing or copious secretions from lungs/airway
  • Severe muscular twitching and general weakness* *
  • Involuntary urination and defecation*
  • Convulsions
  • Unconsciousness
* These symptoms are sometimes observed in healthy infants and young children. In this age group, these symptoms are less reliable than other symptoms listed. Symptoms must be considered collectively when nerve agent or pesticide exposure is known or suspected.
** Infants may become drowsy or unconscious, with muscle floppiness rather than muscle twitching, soon after exposure to nerve agents or insecticides.

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What drugs interact with Atropen?

Pralidoxime

When atropine and pralidoxime are used together, the signs of atropinization (flushing, mydriasis, tachycardia, dryness of the mouth and nose) may occur earlier than might be expected when atropine is used alone because pralidoxime may potentiate the effect of atropine. 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.

Barbiturates

Barbiturates are potentiated by the anticholinesterases; therefore, barbiturates should be used cautiously in the treatment of convulsions resulting from exposure to atropine.

Is Atropen safe to use while pregnant or breastfeeding?

  • It is not known whether atropine can cause fetal harm when administered to a pregnant woman or if these agents can affect reproductive capacity.
  • Atropine should be administered to a pregnant woman only if clearly needed.
  • Atropine is found in human milk in trace amounts.
  • Caution should be exercised when atropine is administered to a nursing woman.

Summary

Atropen (atropine) is a prescription medicine used to treat the symptoms of Anesthesia Premedication, Sinus Bradycardia (ACLS), Bronchospasm, and Organophosphate or Carbamate Poisoning. Atropen may be used alone or with other medications. Serious side effects of Atropen include restlessness, tremor, fatigue, coordination difficulties, confusion, hallucinations, depression, loss of muscle control on one side, sensation loss on one side of the face, nausea, difficulty speaking, vomiting, and cardiac arrest.

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Medically Reviewed on 3/30/2021
References
All sections courtesy of the U.S. Food and Drug Administration