Atropine Sulfate
Hf Acquisition Co Llc, Dba Healthfirst
Human Prescription Drug
NDC 51662-1378Atropine Sulfate is a human prescription drug labeled by 'Hf Acquisition Co Llc, Dba Healthfirst'. National Drug Code (NDC) number for Atropine Sulfate is 51662-1378. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Atropine Sulfate drug includes Atropine Sulfate - .1 mg/mL . The currest status of Atropine Sulfate drug is Active.
Drug Information:
| Drug NDC: | 51662-1378 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Atropine Sulfate |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Atropine Sulfate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hf Acquisition Co Llc, Dba Healthfirst |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ATROPINE SULFATE - .1 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | PARENTERAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 15 Oct, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | HF Acquisition Co LLC, DBA HealthFirst
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1190546
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UNII: | 03J5ZE7KA5
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Anticholinergic [EPC]
Cholinergic Antagonists [MoA]
Cholinergic Muscarinic Antagonist [EPC]
Cholinergic Muscarinic Antagonists [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 51662-1378-1 | 1 SYRINGE in 1 BOX (51662-1378-1) / 10 mL in 1 SYRINGE | 15 Oct, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Atropine sulfate atropine sulfate atropine sulfate atropine
Indications and Usage:
Indications & usage atropine sulfate injection, usp, may be given parenterally as a pre-anesthetic medication in surgical patients to reduce salivation and bronchial secretions. it may also be used to suppress vagal activity associated with the use of halogenated hydrocarbons during inhalation anesthesia and reflex excitation arising from mechanical stimulation during surgery. the antispasmodic action of atropine is useful in pylorospasm and other spastic conditions of the gastrointestinal tract. for ureteral and biliary colic, atropine concomitantly with morphine may be indicated. atropine relaxes the upper gi tract and colon during hypotonic radiography. in poisoning by the organic phosphate cholinesterase inhibitors found in certain insecticides and by chemical warfare nerve gases, large doses of atropine relieve the muscarine-like symptoms and some of the central nervous system manifestations. it is also used as an antidote for mushroom poisoning due to muscarine in certain species
Read more... such as amanita muscaria.
Warnings:
Warnings heat prostration can occur with anticholinergic drug use (fever and heat stroke due to decreased sweating) in the presence of a high environmental temperature. diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. treatment of diarrhea with these drugs is inappropriate and possibly harmful. usage in the elderly: elderly patients may react with excitement, agitation, drowsiness and other untoward manifestations to even small doses of anticholinergic drugs. usage in gastric ulcer may produce a delay in gastric emptying time and may complicate such therapy (antral stasis).
Dosage and Administration:
Dosage & administration usual adult dosage: antimuscarinic: intramuscular, intravenous, or subcutaneous, 400 to 600 μg (0.4 to 0.6 mg) every four to six hours. arrhythmias: intravenous, 400 μg (0.4 mg) to 1 mg every one to two hours as needed, up to a maximum of 2 mg. gastrointestinal radiography: intramuscular, 1 mg. preanesthesia (antisialagogue): intramuscular, 200 to 600 μg (0.2 to 0.6 mg) one-half to one hour before surgery. cholinergic adjunct (curariform block): intravenous, 600 μg (0.6 mg) to 1.2 mg administered a few minutes before or concurrently with 500 μg (0.5 mg) to 2 mg of neostigmine methylsulfate, using separate syringes. antidote (to cholinesterase inhibitors): intravenous, 2 to 4 mg initially, then 2 mg repeated every five to ten minutes until muscarinic symptoms disappear or signs of atropine toxicity appear. antidote (to muscarine in mushroom poisoning): intramuscular or intravenous, 1 to 2 mg every hour until respiratory effects subside. antidote (t
Read more...o organophosphate pesticides): intramuscular or intravenous 1 to 2 mg, repeated in twenty to thirty minutes as soon as cyanosis has cleared. continue dosage until definite improvement occurs and is maintained, sometimes for two days or more. usual pediatric dosage antimuscarinic: subcutaneous, 10 μg (0.01 mg) per kg of body weight, not to exceed 400 μg (0.4 mg), or 300 μg (0.3 mg) per square meter of body surface, every four to six hours. arrhythmias: intravenous, 10 to 30 μg (0.01 to 0.03 mg) per kg of body weight. preanesthesia (antisialagogue): or preanesthesia (antiarrhythmic): subcutaneousâ children weighing up to 3 kg: 100 μg (0.1 mg). children weighing 7 to 9 kg: 200 μg (0.2 mg). children weighing 12 to 16 kg: 300 μg (0.3 mg). children weighing 20 to 27 kg: 400 μg (0.4 mg). children weighing 32 kg: 500 μg (0.5 mg). children weighing 41 kg; 600 μg (0.6 mg). antidote (to cholinesterase inhibitors): intravenous or intramuscular, 1 mg initially, then 0.5 to 1 mg every five to ten minutes until muscarinic symptoms disappear or signs of atropine toxicity appear. note: parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Contraindications:
Contraindications atropine sulfate is contraindicated in patients with a history of hypersensitivity to this drug. ocular: narrow-angle glaucoma; adhesions (synechiae) between the iris and lens of the eye. cardiovascular: tachycardia; unstable cardiovascular status in acute hemorrhage. gi: obstructive disease (e.g., achalasia, pyloroduodenal stenosis, or pyloric obstruction, cardiospasm, etc.); paralytic ileus; intestinal atony of the elderly or debilitated patient; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; hepatic disease. gu: obstructive uropathy (e.g., bladder neck obstruction due to prostatic hypertrophy); renal disease. musculoskeletal: myasthenia gravis.
Adverse Reactions:
Adverse reactions gi: xerostomia; altered taste perception; nausea; vomiting; dysphagia; heartburn, constipation; bloated feeling; paralytic ileus; gastroesophageal reflux. gu: urinary hesitancy and retention; impotence. ocular: blurred vision; mydriasis; photophobia; cycloplegia; increased intraocular pressure. cardiovascular: palpitations; bradycardia (following low doses of atropine); tachycardia (after higher doses). cns: headache; flushing; nervousness; drowsiness; weakness; dizziness; insomnia; fever. elderly patients may exhibit mental confusion or excitement to even small doses. large doses may produce cns stimulation (restlessness, tremor). dermatologic - hypersensitivity: severe allergic reactions including anaphylaxis, urticaria and other dermal manifestations. other: suppression of lactation; nasal congestion; decreased sweating. complete anhidrosis cannot occur because large doses would be required, producing severe side effects from parasympathetic paralysis.
Overdosage:
Overdosage symptoms: gi: dry mouth; dysphagia; vomiting; nausea; abdominal distention. cns: theoretically, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and paralysis. cns stimulation; delirium; drowsiness; stupor; fever; dizziness; headache; restlessness; seizures; depression; tremor; hallucinations; ataxia; coma; psychotic behavior; other signs of an acute organic psychosis. cardiovascular: circulatory failure; rapid pulse and respiration; tachycardia with weak pulse; hypertension; palpitations. gu: urinary urgency with difficulty in micturition. ocular: blurred vision; photophobia; dilated pupils. miscellaneous: leukocytosis, flushed hot dry skin, rash; respiratory failure. treatment: administer supportive and symptomatic therapy as indicated. physostigmine 1 to 3 mg i.v. has been utilized to reverse anticholinergic effects. however, profound bradycardia, asystole and seizures may occur. the role of physostigmine is not clear; its use should be avoided if other therapeutic agents are successful in reversing cardiac dysrhythmias. neostigmine methylsulfate 0.5 to 2 mg i.v., repeated as needed, may be given. diazepam or short-acting barbiturates may control excitement. hemodialysis is ineffective for atropine poisoning. hyperpyrexia may be treated with physical cooling measures. if photophobia occurs, the patient may be kept in a dark room.
Description:
Description atropine is chemically 1 α h, 5 α h - tropan-3 α-ol (±) -tropate (ester), with the following structural formula: atropine rarely occurs as such in any of the plants and has been prepared by synthesis. it is usually employed in the form of atropine sulfate (the sulfate [2:1] monohydrate salt of atropine), which has much greater solubility in water. atropine sulfate injection, usp, is a sterile aqueous solution of atropine sulfate. each ml contains atropine sulfate, 0.1 mg; sodium chloride, 8.8 mg, for isotonicity; citric acid, 0.63 mg, and sodium citrate, 0.29 mg, as buffers. may contain additional citric acid and/or sodium citrate for ph adjustment (3.0-6.5). the air above the liquid in the container has been displaced by nitrogen gas. structure
Clinical Pharmacology:
Clinical pharmacology atropine inhibits the muscarinic actions of acetylcholine at postganglionic parasympathetic neuroeffector sites including smooth muscle, secretory glands and cns sites. large doses may block nicotinic receptors at the autonomic ganglia and at the neuromuscular junction. specific anticholinergic responses are dose-related. small doses of atropine inhibit salivary and bronchial secretions and sweating; moderate doses dilate the pupil, inhibit accommodation and increase the heart rate (vagolytic effect); larger doses will decrease motility of the gi and urinary tracts; very large doses will inhibit gastric acid secretion.
How Supplied:
How supplied atropine sulfate inj. usp is supplied in the following dosage forms. ndc 51662-1378-1 atropine sulfate inj. usp (0.1 mg/ml) 1 mg per 10 ml luer-jet⢠syr hf acquisition co llc, dba healthfirst mukilteo, wa 98275 also supplied in the following manufacture supplied dosage forms atropine sulfate injection, usp. in unit-use packages containing the luer-jet luer-lock prefilled syringe. ten cartons per package. syringe assembly directions: *caution improper engaging may cause glass breakage and subsequent injury. store at controlled room temperature 15° to 30°c (59° to 86°f). rx only international medication systems, limited so. el monte, ca 91733, u.s.a. an amphastar pharmaceuticals company rev. 2-13 © international medication systems, limited 2013 how supplied 1 how supplied 2
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