Dipyridamole


Hf Acquisition Co Llc, Dba Healthfirst
Human Prescription Drug
NDC 51662-1447
Dipyridamole is a human prescription drug labeled by 'Hf Acquisition Co Llc, Dba Healthfirst'. National Drug Code (NDC) number for Dipyridamole is 51662-1447. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Dipyridamole drug includes Dipyridamole - 5 mg/mL . The currest status of Dipyridamole drug is Active.

Drug Information:

Drug NDC: 51662-1447
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: Dipyridamole
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: Dipyridamole
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:DIPYRIDAMOLE - 5 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details: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: ANDA
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: 10 Jan, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 20 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.
Application Number: ANDA074521
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
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:309953
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.
NUI:N0000008832
N0000175578
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:64ALC7F90C
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:Platelet Aggregation Inhibitor [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:Decreased Platelet Aggregation [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:Decreased Platelet Aggregation [PE]
Platelet Aggregation Inhibitor [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
51662-1447-110 mL in 1 VIAL (51662-1447-1)10 Jan, 2020N/ANo
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:

Dipyridamole dipyridamole dipyridamole dipyridamole tartaric acid hydrochloric acid polyethylene glycol 600 water

Indications and Usage:

Indications & usage dipyridamole injection is indicated as an alternative to exercise in thallium myocardial perfusion imaging for the evaluation of coronary artery disease in patients who cannot exercise adequately. in a study of about 1100 patients who underwent coronary arteriography and dipyridamole injection assisted thallium imaging, the results of both tests were interpreted blindly and the sensitivity and specificity of the dipyridamole thallium study in predicting the angiographic outcome were calculated. the sensitivity of the dipyridamole test (true positive dipyridamole divided by the total number of patients with positive angiography) was about 85%. the specificity (true negative divided by the number of patients with negative angiograms) was about 50%. in a subset of patients who had exercise thallium imaging as well as dipyridamole thallium imaging, sensitivity and specificity of the two tests were almost identical.

Warnings:

Warnings serious adverse reactions associated with the administration of intravenous dipyridamole injection have included cardiac death, fatal and non-fatal myocardial infarction, ventricular fibrillation, symptomatic ventricular tachycardia, stroke, transient cerebral ischemia, seizures, anaphylactoid reaction and bronchospasm. there have been reported cases of asystole, sinus node arrest, sinus node depression and conduction block. patients with abnormalities of cardiac impulse formation/conduction or severe coronary artery disease may be at increased risk for these events. in a study of 3911 patients given intravenous dipyridamole as an adjunct to thallium myocardial perfusion imaging, two types of serious adverse events were reported: 1) four cases of myocardial infarction (0.1%), two fatal (0.05%) and two non-fatal (0.05%) and 2) six cases of severe bronchospasm (0.2%). although the incidence of these serious adverse events was small (0.3%, 10 of 3911), the potential clinical info
rmation to be gained through use of intravenous dipyridamole thallium imaging (see indications and usage noting the rate of false positive and false negative results) must be weighed against the risk to the patient. patients with a history of unstable angina may be at a greater risk for severe myocardial ischemia. patients with a history of asthma may be at a greater risk for bronchospasm during dipyridamole injection use. when thallium myocardial perfusion imaging is performed with intravenous dipyridamole, parenteral aminophylline should be readily available for relieving adverse events such as bronchospasm or chest pain. vital signs should be monitored during, and for 10-15 minutes following, the intravenous infusion of dipyridamole and an electrocardiographic tracing should be obtained using at least one chest lead. should severe chest pain or bronchospasm occur, parenteral aminophylline may be administered by slow intravenous injection (50-100 mg over 30-60 seconds) in doses ranging from 50 to 250 mg. in the case of severe hypotension, the patient should be placed in a supine position with the head tilted down if necessary, before administration of parenteral aminophylline. if 250 mg of aminophylline does not relieve chest pain symptoms within a few minutes, sublingual nitroglycerin may be administered. if chest pain continues despite use of aminophylline and nitroglycerin, the possibility of myocardial infarction should be considered. if the clinical condition of a patient with an adverse event permits a one-minute delay in the administration of parenteral aminophylline, thallium-201 may be injected and allowed to circulate for one minute before the injection of aminophylline. this will allow initial thallium perfusion imaging to be performed before reversal of the pharmacologic effects of dipyridamole on the coronary circulation.

Dosage and Administration:

Dosage & administration the dose of intravenous dipyridamole injection as an adjunct to thallium myocardial perfusion imaging should be adjusted according to the weight of the patient. the recommended dose is 0.142 mg/kg/min (0.57 mg/kg total) infused over 4 minutes. although the maximum tolerated dose has not been determined, clinical experience suggests that a total dose beyond 60 mg is not needed for any patient. prior to intravenous administration, dipyridamole injection should be diluted in at least a 1:2 ratio with sodium chloride injection 0.45%, sodium chloride injection 0.9% or dextrose injection 5% for a total volume of approximately 20 to 50 ml. infusion of undiluted dipyridamole may cause local irritation. thallium-201 should be injected within 5 minutes following the 4-minute infusion of dipyridamole. do not mix dipyridamole injection with other drugs in the same syringe or infusion container. parenteral drug products should be inspected visually for particulate matter and
discoloration prior to administration, whenever solution and container permit.

Contraindications:

Contraindications hypersensitivity to dipyridamole.

Adverse Reactions:

Adverse reactions adverse reaction information concerning intravenous dipyridamole injection is derived from a study of 3911 patients in which intravenous dipyridamole was used as an adjunct to thallium myocardial perfusion imaging and from spontaneous reports of adverse reactions and the published literature. serious adverse events (cardiac death, fatal and non-fatal myocardial infarction, ventricular fibrillation, asystole, sinus node arrest, symptomatic ventricular tachycardia, stroke, transient cerebral ischemia, seizures, anaphylactoid reaction and bronchospasm) are described above (see warnings ). in a study of 3911 patients, the most frequent adverse reactions were: chest pain/angina pectoris (19.7%), electrocardiographic changes (most commonly st-t changes) (15.9%), headache (12.2%) and dizziness (11.8%). adverse reactions occurring in greater than 1% of the patients in the study are shown in the following table: less common adverse reactions occurring in 1% or less of the pati
ents within the study included: cardiovascular system electrocardiographic abnormalities unspecified (0.8%), arrhythmia unspecified (0.6%), palpitation (0.3%), ventricular tachycardia (0.2%-see warnings ), bradycardia (0.2%), myocardial infarction (0.1%–see warnings ), av block (0.1%), syncope (0.1%), orthostatic hypotension (0.1%), atrial fibrillation (0.1%), supraventricular tachycardia (0.1%), ventricular arrhythmia unspecified (0.03%–see warnings ), heart block unspecified (0.03%), cardiomyopathy (0.03%), edema (0.03%). central and peripheral nervous system hypothesia (0.5%), hypertonia (0.3%), nervousness/anxiety (0.2%), tremor (0.1%), abnormal coordination (0.03%), somnolence (0.03%), dysphonia (0.03%), migraine (0.03%), vertigo (0.03%). gastrointestinal system dyspepsia (1%), dry mouth (0.8%), abdominal pain (0.7%), flatulence (0.6%), vomiting (0.4%), eructation (0.1%), dysphagia (0.03%), tenesmus (0.03%), appetite increase (0.03%). respiratory system pharyngitis (0.3%), bronchospasm (0.2%–see warnings ), hyperventilation (0.1%), rhinitis (0.1%), coughing (0.03%), pleural pain (0.03%). other myalgia (0.9%), back pain (0.6%), injection site reaction unspecified (0.4%), diaphoresis (0.4%), asthenia (0.3%), malaise (0.3%), arthralgia (0.3%), injection site pain (0.1%), rigor (0.1%), earache (0.1%), tinnitus (0.1%), vision abnormalities unspecified (0.1%), dysgeusia (0.1%), thirst (0.03%), depersonalization (0.03%), eye pain (0.03%), renal pain (0.03%), perineal pain (0.03%), breast pain (0.03%), intermittent claudication (0.03%), leg cramping (0.03%). in additional postmarketing experience, there have been rare reports of allergic reaction including urticaria, pruritus, dermatitis and rash. adverse

Overdosage:

Overdosage no cases of overdosage in humans have been reported. it is unlikely that overdosage will occur because of the nature of use (i.e., single intravenous administration in controlled settings). see warnings .

Description:

Description dipyridamole is a coronary vasodilator described as 2,6 bis-(diethanolamino)-4,8 dipiperidino-pyrimido-(5,4-d) pyrimidine. the structural formula is: c24h40n8o4 mw 504.63 dipyridamole injection, usp is a sterile, odorless, pale yellow liquid which can be diluted in sodium chloride injection or dextrose injection for intravenous administration. each ml contains 5 mg dipyridamole, usp, 50 mg polyethylene glycol 600 and 2 mg tartaric acid in water for injection, usp. ph 2.2-3.2; hydrochloric acid added for ph adjustment. structure

Clinical Pharmacology:

Clinical pharmacology in a study of 10 patients with angiographically normal or minimally stenosed (less than 25% luminal diameter narrowing) coronary vessels, dipyridamole injection in a dose of 0.56 mg/kg infused over 4 minutes resulted in an average fivefold increase in coronary blood flow velocity compared to resting coronary flow velocity (range 3.8 to 7 times resting velocity). the mean time to peak flow velocity was 6.5 minutes from the start of the 4-minute infusion (range 2.5 to 8.7 minutes). cardiovascular responses to the intravenous administration of dipyridamole injection when given to patients in the supine position include a mild but significant increase in heart rate of approximately 20% and mild but significant decreases in both systolic and diastolic blood pressure of approximately 2-8%, with vital signs returning to baseline values in approximately 30 minutes. mechanism of action dipyridamole is a coronary vasodilator in man. the mechanism of vasodilation has not bee
n fully elucidated, but may result from inhibition of uptake of adenosine, an important mediator of coronary vasodilation. the vasodilatory effects of dipyridamole are abolished by administration of the adenosine receptor antagonist theophylline. how dipyridamole-induced vasodilation leads to abnormalities in thallium distribution and ventricular function is also uncertain but presumably represents a “steal” phenomenon in which relatively intact vessels dilate and sustain enhanced flow, leaving reduced pressure and flow across areas of hemodynamically important coronary vascular constriction. pharmacokinetics and metabolism plasma dipyridamole concentrations decline in a triexponential fashion following intravenous infusion of dipyridamole, with half-lives averaging 3-12 minutes, 33-62 minutes and 11.6-15 hours. two minutes following a 0.568 mg/kg dose of dipyridamole injection administered as a 4-minute infusion, the mean dipyridamole serum concentration is 4.6 ± 1.3 mcg/ml. the average plasma protein binding of dipyridamole is approximately 99%, primarily to α1-glycoprotein. dipyridamole is metabolized in the liver to the glucuronic acid conjugate and excreted with the bile. the average total body clearance is 2.3-3.5 ml/min/kg, with an apparent volume of distribution at steady state of 1-2.5 l/kg and a central apparent volume of 3-5 liters.

How Supplied:

How supplied dipyridamole injection, usp is supplied in the following dosage forms. ndc 51662-1447-1 dipyridamole injection, usp 50mg/10ml (5mg/ml) 10ml vial hf acquisition co llc, dba healthfirst mukilteo, wa 98275 also supplied in the following manufacture supplied dosage forms dipyridamole injection, usp is available in: 10 ml (50 mg/10 ml) single dose vial packaged in 5s (ndc 0641-2569-44) storage protect from light: keep covered in carton until time of use. store between 15°-25°c (59°-77°f). avoid freezing. 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. manufactured by: west-ward pharmaceuticals eatontown, nj 07724 usa revised: may 2011 462-341-02

Package Label Principal Display Panel:

Principal display panel - vial label vial label

Principal display panel-serialized labeling serialized vial labeling


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