Atropine Sulfate
Hf Acquisition Co Llc, Dba Healthfirst
Human Prescription Drug
NDC 51662-1311Atropine Sulfate is a human prescription drug labeled by 'Hf Acquisition Co Llc, Dba Healthfirst'. National Drug Code (NDC) number for Atropine Sulfate is 51662-1311. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Atropine Sulfate drug includes Atropine Sulfate - .4 mg/mL . The currest status of Atropine Sulfate drug is Active.
Drug Information:
| Drug NDC: | 51662-1311 |
| 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 - .4 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAMUSCULAR
INTRAVENOUS
SUBCUTANEOUS
|
| 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: | 06 Oct, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 28 Dec, 2025 |
| 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: | 1190776
|
| 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 |
|---|
| 51662-1311-1 | 20 mL in 1 VIAL, MULTI-DOSE (51662-1311-1) | 06 Oct, 2018 | N/A | No |
| 51662-1311-3 | 25 POUCH in 1 CASE (51662-1311-3) / 1 mL in 1 POUCH (51662-1311-2) | 04 Sep, 2020 | 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 sodium chloride benzyl alcohol water sulfuric acid
Indications and Usage:
Indications & usage atropine sulfate is given parenterally as a preanesthetic medication to decrease salivation and bronchial secretions. it is useful in pylorospasm and other spastic conditions of the gastrointestinal tract. for ureteral and biliary colic, atropine sulfate given with morphine may be indicated. atropine sulfate is indicated for relaxation of the upper gastrointestinal tract and colon during hypotonic radiography. atropine is used as an antidote for pilocarpine, physostigmine, isoflurophate, choline esters, certain species of aminata and in poisoning by the organic phosphate cholinesterase inhibitors found in certain insecticides and by chemical warfare ânerve gasesâ. large doses relieve the muscarine-like symptoms and some of the central nervous system manifestations.
Warnings:
Warnings atropine is a highly potent drug and due care is essential to avoid overdosage, especially with intravenous administration. pediatric populations are more susceptible than adults to the toxic effects of anticholinergic agents. atropine i.v. 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. atropine is not removed by dialysis. this drug is effective in very low dosage and overdose may cause permanent damage or death, especially in children. this product contains benzyl alcohol which has been associated with a fatal gasping syndrome in infants and neonates.
Dosage and Administration:
Dosage & administration the usual dose of atropine sulfate is 0.4 to 0.6 mg. suggested dosages for pediatric patients are as follows: 7 - 16 lbs. â 0.1 mg 40 - 65 lbs. â 0.3 mg 17 - 24 lbs. â 0.15 mg 65 - 90 lbs. â 0.4 mg 24 - 40 lbs. â 0.2 mg over 90 lbs. â 0.4 to 0.6 mg table of dosage equivalents these doses may be exceeded in certain cases. for hypotonic radiography of the gastrointestinal tract, the usual adult dose is 1 mg intramuscularly. adults suspected of contact with organic phosporous insecticides of the parathion type should be given atropine sulfate 0.8 mg intramuscularly. if an atropine effect is not apparent within 30 minutes or if definite symptoms of the poisoning occur (nausea, vomiting, diarrhea, pupillary constriction, pulmonary edema, fasciculations of eyelids and tongue, jerky ocular movements and excessive sweating, salivation and bronchial secretion), atropine sulfate 2 mg should be given intramuscularly at hourly intervals until s
Read more...igns of atropinization are observed. up to 2 or 3 times of this dose (4 to 6 mg) may be required in severe cases. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. dosage
Contraindications:
Contraindications conditions at which inhibition of postganglionic cholinergic nerves are undesirable, such as glaucoma and tachycardia. also contraindicated in asthma, because the parenteral dose which might relieve asthma would have an excessive drying effect upon mucous plugs in the bronchi. prostatic hypertrophy, while not a contraindication, requires special attention to signs of urinary retention.
Adverse Reactions:
Adverse reactions individual tolerance varies greatly, but these systemic doses are likely to produce the following effects: a scarlatiniform rash may occur. atropine may produce fever, particularly in children, through inhibition of heat loss by evaporation. although large doses of atropine may cause an alarming condition, recovery is usual. adverse event tabel
Overdosage:
Overdosage toxic doses from atropine are not uncommon, especially in children. symptoms the principle manifestations of poisoning with atropine are delirium, tachycardia and fever. treatment in the treatment of atropine poisoning, respiratory assistance and symptomatic support are indicated. physostigmine salicylate, 1 to 5 ml of a dilution containing 1 mg per 5 ml of saline, should be administered intravenously. administer the smaller dose in children and administer in not less than 2 minutes. monitor with ecg. medication can be repeated every 5 minutes for a total dose of 2 mg in children and every 30 minutes for a total dose of 6 mg in adults. the fatal dose of atropine in children may be as low as 10 mg. in an adult, recovery after 1,000 mg of atropine sulfate has been reported. death is usually due to paralysis of the medullary centers. the fatality rate is less than 1%. if the patient survives 24 hours, they will probably recover.
Description:
Description atropine sulfate injection, usp is a sterile solution of atropine sulfate in water for injection. each ml contains atropine sulfate 0.4 mg; sodium chloride 9 mg; benzyl alcohol 9 mg; water for injection qs; ph may be adjusted with sulfuric acid if necessary. ph 3.0-6.5. atropine sulfate injection, usp may be given intramuscularly, intravenously or subcutaneously. atropine is a white crystalline alkaloid which may be extracted from belladonna root or may be produced synthetically. it is used as atropine sulfate because this compound has much greater solubility. atropine sulfate is an anticholinergic drug. the empirical formula of atropine sulfate is (c17h23no3)2â¢h2so4â¢h2o. the structural formula is: structure
Clinical Pharmacology:
Clinical pharmacology the most important therapeutic action of atropine is the inhibition of smooth muscle and glands innervated by postganglionic cholinergic nerves. it also has central nervous system activity, which may be stimulating or depressing depending upon the dose. following the administration of usual clinical doses, atropine produces stimulation of the medulla and higher cerebral centers. this effect is manifested by mild central vagal excitation and moderate respiratory stimulation. atropine sulfate also acts peripherally as a competitive antagonist of the muscarinic actions of acetylcholine. it does not prevent the release of acetylcholine but antagonizes the effect of acetylcholine on the effector cells. these actions include vasodilation, drying of the mouth, an increase in the pulse rate, inhibition of contractions of the gastrointestinal tract, ureter, and bladder, and reduction of salivary, bronchial, gastric and sweat gland secretions. following clinical and larger
Read more...doses, atropine sulfate causes dilation of the pupils and paralysis of accommodation and, in narrow-angle glaucoma, can increase intraocular pressure.
How Supplied:
How supplied atropine sulfate injection, usp is supplied in the following dosage forms: ndc 51662-1311-1 atropine sulfate injection, usp 8mg/20ml (0.4mg/ml) 20ml vial ndc 51662-1311-2 - 1 pouch of atropine sulfate injection, usp 8mg/20ml (0.4mg/ml) 20ml vial ndc 51662-1311-3 - case of 25 pouches of atropine sulfate injection, usp 8mg/20ml (0.4mg/ml) 20ml vial hf acquisition co llc, dba healthfirst mukilteo, wa 98275 also supplied in the following manufacture supplied dosage forms atropine sulfate injection, usp is available in the following: 0.4 mg/ml 20 ml multiple dose vial packaged in 10s (ndc 0641-6006-10) use only if solution is clear and seal intact. store at 20°-25°c (68°-77°f), excursions permitted to 15°-30°c (59°-86°f) [see usp controlled room temperature]. to report suspected adverse reactions, contact west-ward pharmaceutical corp. at 1-877-845-0689, or the fda at 1-800-fda-1088 or www.fda.gov/medwatch. for product inquiry call 1-877-845-0689. manufa
Read more...ctured by: west-ward pharmaceuticals eatontown, nj 07724 usa revised june 2011 462-416-01 logo
Package Label Principal Display Panel:
Principal display panel, vial ndc 0641-6006-01 atropine sulfate injection, usp 8 mg/20 ml (0.4 mg/ml) 20 ml multiple dose vial ndc 0641-6006-01 vial
Principal display panel, ndc 51662-1311-1 serialized vial serialized vial
Principal display label - ndc 51662-1311-2 serialized pouch label serialized pouch label
Principal display label - ndc 51662-1311-3 serialized case label case
Principal display label - ndc 51662-1311-3 serialized rfid label serialized rfid