Atropine Sulfate Monohydrate
Generic Name: atropine sulfate monohydrate
Brand Names:
Atropine Sulfate
11 DESCRIPTION Atropine Sulfate Injection, USP is a sterile, nonpyrogenic, isotonic, clear colorless solution of atropine sulfate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by subcutaneous, intramuscular or intravenous injection. Each mL contains atropine sulfate, 0.4 mg; benzyl alcohol, 9 mg; sodium chloride 9 mg. May contain sulfuric acid for pH adjustment. pH 3.5 (3.0 to 3.8).
Overview
11 DESCRIPTION Atropine Sulfate Injection, USP is a sterile, nonpyrogenic, isotonic, clear colorless solution of atropine sulfate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by subcutaneous, intramuscular or intravenous injection. Each mL contains atropine sulfate, 0.4 mg; benzyl alcohol, 9 mg; sodium chloride 9 mg. May contain sulfuric acid for pH adjustment. pH 3.5 (3.0 to 3.8).
Uses
1 INDICATIONS AND USAGE Atropine is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia Atropine is a muscarinic antagonist indicated for temporary blockade of severe or life threatening muscarinic effects. (1)
Dosage
2 DOSAGE AND ADMINISTRATION Dosage is individualized by use, refer to the full prescribing information for recommended adult and pediatric dosages (2.2, 2.3). Patients with Ischemic Heart Disease: Do not exceed 0.04 mg/kg. (2.4, 5.2) 2.1 General Administration Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless solution is clear and seal is intact. After initial use, discard unused portion within 24 hours. Intravenous administration is usually preferred, but subcutaneous, intramuscular, endotracheal, and intraosseous administration are possible.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in labeling: • Hypersensitivity (5.1) • Worsening of Ischemic Heart Disease (5.2) • Acute Glaucoma (5.3) • Pyloric Obstruction (5.4) • Complete Urinary Retention (5.5) • Viscid Plugs (5.6) The following adverse reactions have been identified during post-approval use of atropine sulfate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Most of the side effects of atropine are directly related to its antimuscarinic action. Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur. Anhidrosis can produce heat intolerance.
Interactions
7 DRUG INTERACTIONS Mexiletine : Decreases rate of mexiletine absorption. (7.1) 7.1 Mexiletine Atropine Sulfate Injection decreased the rate of mexiletine absorption without altering the relative oral bioavailability; this delay in mexiletine absorption was reversed by the combination of atropine and intravenous metoclopramide during pretreatment for anesthesia.
Warnings
5 WARNINGS AND PRECAUTIONS Hypersensitivity (5.1) Worsening of Ischemic Heart Disease (5.2) Acute Glaucoma (5.3) Pyloric obstruction (5.4) Complete urinary retention (5.5) Viscid plugs (5.6) 5.1 Hypersensitivity Atropine may cause anaphylaxis. 5.2 Worsening of Ischemic Heart Disease In patients with ischemic heart disease, the total dose should be restricted to 2 to 3 mg (maximum 0.03 to 0.04 mg/kg) to avoid atropine-induced tachycardia, increased myocardial oxygen demand and the potential for worsening cardiac ischemia or increasing infarction size. 5.3 Acute Glaucoma Atropine may precipitate acute glaucoma. 5.4 Pyloric Obstruction Atropine may convert partial organic pyloric stenosis into complete obstruction. 4 CONTRAINDICATIONS None. None. (4)
Pregnancy
8.1 Pregnancy Risk Summary Limited available data with Atropine Sulfate Injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes ( see Data ). There are risks to the mother and fetus associated with untreated severe or life-threatening muscarinic events ( see Clinical Considerations ). Animal reproduction studies have not been conducted with Atropine Sulfate Injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Atropine Sulfate Injection, USP is a non-pyrogenic, isotonic, clear colorless solution and is supplied as follows: Presentation Single Vial 10 Vial Pack NDC# 70069-481-01 70069-481-10 Description 8 mg per 20 mL (0.4 mg per mL) Multiple-dose vial 20 mL multiple-dose vial, packaged in a carton containing 10 vials.
Frequently Asked Questions
What is Atropine Sulfate Monohydrate used for?▼
1 INDICATIONS AND USAGE Atropine is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia Atropine is a muscarinic antagonist indicated for temporary blockade of severe or life threatening muscarinic effects. (1)
What are the side effects of Atropine Sulfate Monohydrate?▼
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in labeling: • Hypersensitivity (5.1) • Worsening of Ischemic Heart Disease (5.2) • Acute Glaucoma (5.3) • Pyloric Obstruction (5.4) • Complete Urinary Retention (5.5) • Viscid Plugs (5.6) The following adverse reactions have been identified during post-approval use of atropine sulfate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Most of the side effects of atropine are directly related to its antimuscarinic action. Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur. Anhidrosis can produce heat intolerance.
Can I take Atropine Sulfate Monohydrate during pregnancy?▼
8.1 Pregnancy Risk Summary Limited available data with Atropine Sulfate Injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes ( see Data ). There are risks to the mother and fetus associated with untreated severe or life-threatening muscarinic events ( see Clinical Considerations ). Animal reproduction studies have not been conducted with Atropine Sulfate Injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
What are the important warnings for Atropine Sulfate Monohydrate?▼
5 WARNINGS AND PRECAUTIONS Hypersensitivity (5.1) Worsening of Ischemic Heart Disease (5.2) Acute Glaucoma (5.3) Pyloric obstruction (5.4) Complete urinary retention (5.5) Viscid plugs (5.6) 5.1 Hypersensitivity Atropine may cause anaphylaxis. 5.2 Worsening of Ischemic Heart Disease In patients with ischemic heart disease, the total dose should be restricted to 2 to 3 mg (maximum 0.03 to 0.04 mg/kg) to avoid atropine-induced tachycardia, increased myocardial oxygen demand and the potential for worsening cardiac ischemia or increasing infarction size. 5.3 Acute Glaucoma Atropine may precipitate acute glaucoma. 5.4 Pyloric Obstruction Atropine may convert partial organic pyloric stenosis into complete obstruction. 4 CONTRAINDICATIONS None. None. (4)
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.