Caffeine And Sodium Benzoate
American Regent, Inc.
Human Prescription Drug
NDC 0517-2502Caffeine And Sodium Benzoate is a human prescription drug labeled by 'American Regent, Inc.'. National Drug Code (NDC) number for Caffeine And Sodium Benzoate is 0517-2502. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Caffeine And Sodium Benzoate drug includes Caffeine - 125 mg/mL . The currest status of Caffeine And Sodium Benzoate drug is Active.
Drug Information:
| Drug NDC: | 0517-2502 |
| 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: | Caffeine And Sodium Benzoate |
| 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: | Caffeine And Sodium Benzoate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | American Regent, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| 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: | CAFFEINE - 125 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAMUSCULAR
INTRAVENOUS
|
| 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: | 01 Feb, 1993 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 Jan, 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: | American Regent, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0305172502100
|
| UPC stands for Universal Product Code. |
| NUI: | N0000175739
N0000175729
N0000175790
M0023046
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 3G6A5W338E
|
| 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 EPC: | Central Nervous System Stimulant [EPC]
Methylxanthine [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Central Nervous System Stimulation [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class CS: | Xanthines [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Central Nervous System Stimulant [EPC]
Central Nervous System Stimulation [PE]
Methylxanthine [EPC]
Xanthines [CS]
|
| 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 |
|---|
| 0517-2502-10 | 10 VIAL, SINGLE-DOSE in 1 BOX (0517-2502-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-2502-01) | 01 Feb, 1993 | 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:
Caffeine and sodium benzoate caffeine and sodium benzoate caffeine caffeine sodium benzoate hydrochloric acid sodium hydroxide water
Indications and Usage:
Indications and usage caffeine and sodium benzoate injection has been used in conjunction with supportive measure to treat respiratory depression associated with overdosage with cns depressant drugs (e.g., narcotic analgesics, alcohol). however, because of questionable benefit and transient action, most authorities believe caffeine and other analeptics should not be used in these conditions and recommend other supportive therapy.
Dosage and Administration:
Dosage and administration caffeine and sodium benzoate injection may be administered by intramuscular or slow intravenous injection. some clinicians suggest that when used as a mild cns stimulant to overcome fatigue, oral doses of 100-200 mg of anhydrous caffeine are required. one manufacturer recommends that citrated caffeine be administered orally in dosages of 65-325 mg (about 32-162 mg of anhydrous caffeine) 3 times daily. another manufacturer recommends an oral dosage of 250 mg of anhydrous caffeine in an extended-release formulation once daily, but warns that the drug should not be administered less than 6 hours before retiring. analeptic use of caffeine is strongly discouraged by most clinicians. however, the manufacturer of caffeine and sodium benzoate injection recommends intramuscular, or in emergency respiratory failure, intravenous injection of 500 mg of the drug (about 250 mg of anhydrous caffeine) or a maximum single dose of 1 gram (about 500 mg of anhydrous caffeine) for
Read more... the treatment of respiratory depression associated with overdosage of cns depressants, including narcotic analgesics and alcohol, and with electric shock. the usual dose is 0.5 g (7 ½ grains) as frequently as directed by the physician. the maximum safe dose is 0.5 g and the total dose in 24 hours should rarely exceed 2.5 g. parenteral drug products should be inspected visually for particulate matter prior to administration whenever solution and container permit.
Contraindications:
Contraindications none known.
Use in Pregnancy:
Pregnancy teratogenic effects pregnancy category c. animal reproduction studies have not been conducted with caffeine and sodium benzoate injection. it is also not known whether caffeine and sodium benzoate injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. caffeine and sodium benzoate injection should be given to a pregnant woman only if clearly needed.
Overdosage:
Overdosage acute toxicity involving caffeine has been reported rarely. mild delirium, insomnia, diuresis, dehydration, and fever commonly occur with overdosage. more serious symptoms of overdosage include cardiac arrhythmias and clonic-tonic convulsions. in adults, iv doses of 57 mg/kg of body weight and oral doses of 18.50 grams have been fatal. in one 5-year-old patient, death occurred following oral ingestion of approximately 3 grams of caffeine. convulsions may be treated with iv administration of diazepam or a barbiturate such as pentobarbital sodium.
Description:
Description caffeine and sodium benzoate injection, usp is a clear, sterile, nonpyrogenic, solution of caffeine alkaloid. each ml contains: caffeine (anhydrous) 125 mg; sodium benzoate (added to increase the solubility of caffeine) 125 mg; water for injection, usp q.s. ph (range 6.5 to 8.5) adjusted with hydrochloric acid and/or sodium hydroxide. for intramuscular or slow intravenous administration only.
Clinical Pharmacology:
Clinical pharmacology caffeine is pharmacologically similar to the other xanthine drugs, such as theobromine and theophylline; however, these three agents differ in the intensity of their actions on various structures. caffeine's cns and skeletal muscle effects are greater than those of the other xanthines. in all other areas, theophylline has greater activity than caffeine, although some studies report that caffeine has greater diuretic effect than theobromine. the increased levels of intracellular cyclic-amp mediate most of caffeine's pharmacologic actions. caffeine competitively inhibits phosphodiesterase, the enzyme that degrades cyclic 3'- 5' adenosine monophosphate. caffeine stimulates all levels of the cns. caffeine's cortical effects are milder and of shorter duration than those of the amphetamines. in slightly larger doses, caffeine stimulates medullary vagal, vasomotor and respiratory centers, promoting bradycardia, vasoconstriction, and increased respiratory rate. caffeine p
Read more...roduces a positive inotropic effect of the myocardium and a positive chronotropic effect at the sinoatrial node, causing transient increases in heart rate, force of contraction, cardiac output and heart work. in doses greater than 250 mg, the centrally mediated vagal effects of caffeine may be masked by increased sinus rates; tachycardia, extrasystoles, or other major ventricular arrhythmias may result. caffeine constricts cerebral vasculature. in contrast, the drug directly dilates peripheral blood vessels, decreasing peripheral vascular resistance. the effect of this decrease in peripheral vascular resistance (and possibly that of vagal cardiac stimulation) on blood pressure is offset by increased cardiac output (and possibly stimulation of the medullary vasomotor area). the overall effect of caffeine on heart rate and blood pressure depends on whether cns or peripheral effects predominate. therapeutic doses of caffeine increase blood pressure only slightly. caffeine stimulates voluntary skeletal muscle, increasing the force of contraction and decreasing muscular fatigue. the drug also stimulates gastric acid secretion from parietal cells. caffeine increases renal blood flow and glomerular filtration rate and decreases proximal tubular reabsorption of sodium and water, resulting in mild diuresis. caffeine stimulates glycogenolysis and lipolysis, but increase in blood glucose and in plasma lipids are insignificant in normal patients. tolerance may develop to the diuretic, cardiovascular, and cns effects of caffeine. pharmacokinetics caffeine is rapidly distributed throughout the body tissues, readily crossing the placenta and blood-brain barrier. approximately 17% of the drug is bound to plasma proteins. caffeine has approximately a half-life (t ½) of 3-4 hours in adults. in adults, the drug is rapidly metabolized in the liver to 1-methyluric acid, 1-methylxanthine and 7-methylxanthine. caffeine and its metabolites are excreted primarily by the kidneys.
Pharmacokinetics:
Pharmacokinetics caffeine is rapidly distributed throughout the body tissues, readily crossing the placenta and blood-brain barrier. approximately 17% of the drug is bound to plasma proteins. caffeine has approximately a half-life (t ½) of 3-4 hours in adults. in adults, the drug is rapidly metabolized in the liver to 1-methyluric acid, 1-methylxanthine and 7-methylxanthine. caffeine and its metabolites are excreted primarily by the kidneys.
How Supplied:
How supplied caffeine and sodium benzoate injection, usp 250 mg/ml ndc 0517-2502-10 2 ml single dose vials packed in boxes of 10. store at 20°-25°c (68°-77°f); excursions permitted to 15°-30"c (59°-86°f) (see usp controlled room temperature). american regent, inc. shirley, ny 11967 in2502 rev. 11/05
Package Label Principal Display Panel:
Package label.principal display panel container label ndc 0517-2502-01 rx only caffeine and sodium benzoate injection, usp 250 mg/ml (125 mg/ml caffeine) for im or slow iv use 2 ml single-dose vial discard unused portion carton labeling ndc 0517-2502-10 rx only caffeine and sodium benzoate injection, usp 250 mg/ml (125 mg/ml caffeine) for intramuscular or slow intravenous use 10 x 2 ml single-dose vials discard unused portion container label carton labeling
Serialization label serialization label