Atropen (atropine)

Atropen may cause serious side effects including:

• 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

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

The most common side effects of Atropen include:

• pain at the injection site,
• dry mouth,
• blurred vision,
• sensitivity to light,
• confusion,
• headache,
• dizziness,
• rapid or irregular heart rate,
• flushing,
• urinary problems,
• constipation,
• bloating,
• nausea,
• vomiting,
• loss of sex drive,
• impotence,
• heat intolerance, and
• skin rash

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

A STERILE SOLUTION FOR INTRAMUSCULAR USE ONLY

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

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

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.

• 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.