Doxy 100

Doxycycline


Fresenius Kabi Usa, Llc
Human Prescription Drug
NDC 63323-130
Doxy 100 also known as Doxycycline is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Doxy 100 is 63323-130. This drug is available in dosage form of Injection, Powder, Lyophilized, For Solution. The names of the active, medicinal ingredients in Doxy 100 drug includes Doxycycline Hyclate - 100 mg/10mL . The currest status of Doxy 100 drug is Active.

Drug Information:

Drug NDC: 63323-130
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: Doxy 100
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: Doxycycline
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Fresenius Kabi Usa, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Injection, Powder, Lyophilized, For 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:DOXYCYCLINE HYCLATE - 100 mg/10mL
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: 17 Oct, 2000
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 01 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.
Application Number: ANDA062475
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:Fresenius Kabi USA, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:310027
544840
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.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0363323130022
UPC stands for Universal Product Code.
UNII:19XTS3T51U
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:Tetracycline-class Drug [EPC]
Tetracyclines [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
63323-130-1110 VIAL in 1 TRAY (63323-130-11) / 10 mL in 1 VIAL (63323-130-02)17 Oct, 2000N/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:

Doxy 100 doxycycline ascorbic acid mannitol doxycycline hyclate doxycycline anhydrous

Drug Interactions:

Drug interactions because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline in conjunction with penicillin. barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline. the concurrent use of tetracycline and penthrane ® (methoxyflurane) has been reported to result in fatal renal toxicity. concurrent use of tetracycline may render oral contraceptives less effective.

Indications and Usage:

Indications and usage: to reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline for injection, usp and other antibacterial drugs, doxycycline for injection, usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. doxycycline for injection, usp is indicated in infections caused by the following microorganisms: rickettsiae (rocky mountain spotted fever, typhus fever, and the typhus group, q fever, rickettsial pox and tick fevers). mycoplasma pneumoniae (pplo, eaton agent). agents of psittacosis and ornithosis. agents of lymphogranuloma venereum and granuloma inguinale. the spirochetal agent of relapsing fever (borre
lia recurrentis) . the following gram-negative microorganisms: haemophilus ducreyi (chancroid). yersinia pestis (formerly pasteurella pestis ) and francisella tularensis (formerly pasteurella tularensis ). bartonella bacilliformis . bacteroides species. vibrio cholerae (formerly vibrio comma ) and campylobacter fetus (formerly vibrio fetus ). brucella species (in conjunction with streptomycin). because many strains of the following groups of microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended. doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: escherichia coli . enterobacter aerogenes (formerly aerobacter aerogenes ). shigella species. acinetobacter species (formerly mima species and herellea species). haemophilus influenzae (respiratory infections). klebsiella species (respiratory and urinary infections). doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: streptococcus species: up to 44 percent of strains of streptococcus pyogenes and 74 percent of enterococcus faecalis (formerly streptococcus faecalis ) have been found to be resistant to tetracycline drugs. therefore, tetracyclines should not be used for streptococcal disease unless the organism has been demonstrated to be sensitive. for upper respiratory infections due to group a beta-hemolytic streptococci, penicillin is the usual drug of choice, including prophylaxis of rheumatic fever. streptococcus pneumoniae (formerly diplococcus pneumoniae ). staphylococcus aureus , respiratory, skin and soft tissue infections. tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections. anthrax due to bacillus anthracis , including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis . when penicillin is contraindicated, doxycycline is an alternative drug in the treatment of infections due to: neisseria gonorrhoeae and n. meningitidis . treponema pallidum and treponema pertenue (syphilis and yaws). listeria monocytogenes . clostridium species. fusobacterium fusiforme (vincent's infection). actinomyces species. in acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. doxycycline is indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence.

Warnings:

Warnings: the use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). this adverse reaction is more common during long-term use of the drugs but has been observed following repeated short-term courses. enamel hypoplasia has also been reported. use doxycycline in pediatric patients 8 years of age or less only when the potential benefits are expected to outweigh the risks in severe or life-threatening conditions (e.g., anthrax, rocky mountain spotted fever), particularly when there are no alternative therapies. clostridium difficile associated diarrhea (cdad) has been reported with use of nearly all antibacterial agents, including doxycycline for injection, usp, and may range in severity from mild diarrhea to fatal colitis. treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of c. difficile. c. diffici
le produces toxins a and b which contribute to the development of cdad. hypertoxin producing strains of c. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. cdad must be considered in all patients who present with diarrhea following antibiotic use. careful medical history is necessary since cdad has been reported to occur over two months after the administration of antibacterial agents. if cdad is suspected or confirmed, ongoing antibiotic use not directed against c. difficile may need to be discontinued. appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of c. difficile, and surgical evaluation should be instituted as clinically indicated. severe skin reactions, such as exfoliative dermatitis, erythema multiforme, stevens-johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (dress) have been reported in patients receiving doxycycline (see adverse reactions ). if severe skin reactions occur, doxycycline should be discontinued immediately and appropriate therapy should be instituted. intracranial hypertension (ih, pseudotumor cerebri) has been associated with the use of tetracyclines including doxycycline. clinical manifestations of ih include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. women of childbearing age who are overweight or have a history of ih are at greater risk for developing tetracycline associated ih. concomitant use of isotretinoin and doxycycline should be avoided because isotretinoin is also known to cause pseudotumor cerebri. although ih typically resolves after discontinuation of treatment, the possibility for permanent visual loss exists. if visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. since intracranial pressure can remain elevated for weeks after drug cessation patients should be monitored until they stabilize. photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. patients apt to be exposed to direct sunlight or ultraviolet light, should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema. the anti-anabolic action of the tetracyclines may cause an increase in bun. studies to date indicate that this does not occur with the use of doxycycline in patients with impaired renal function.

General Precautions:

General as with other antibacterial drugs, use of doxycycline may result in overgrowth of nonsusceptible organisms, including fungi. if superinfection occurs, doxycycline should be discontinued and appropriate therapy instituted. incision and drainage or other surgical procedures should be performed in conjunction with antibacterial therapy, when indicated. prescribing doxycycline in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. all infections due to group a beta-hemolytic streptococci should be treated for at least 10 days.

Dosage and Administration:

Dosage and administration: note: rapid administration is to be avoided. parenteral therapy is indicated only when oral therapy is not indicated. oral therapy should be instituted as soon as possible. if intravenous therapy is given over prolonged periods of time, thrombophlebitis may result. the usual dosage and frequency of administration of doxycycline for injection (100 to 200 mg/day) differs from that of the other tetracyclines (1 to 2 g/day). exceeding the recommended dosage may result in an increased incidence of side effects. studies to date have indicated that doxycycline hyclate at the usual recommended doses does not lead to excessive accumulation of the antibiotic in patients with renal impairment. adults the usual dosage of doxycycline for injection is 200 mg on the first day of treatment administered in one or two infusions. subsequent daily dosage is 100 to 200 mg depending upon the severity of infection, with 200 mg administered in one or two infusions. in the treatment
of primary and secondary syphilis, the recommended dosage is 300 mg daily for at least 10 days. in the treatment of inhalational anthrax (post-exposure) the recommended dose is 100 mg of doxycycline, twice a day. parenteral therapy is only indicated when oral therapy is not indicated and should not be continued over a prolonged period of time. oral therapy should be instituted as soon as possible. therapy must continue for a total of 60 days. pediatric patients for all pediatric patients weighing less than 45 kg with severe or life-threatening infections (e.g., anthrax, rocky mountain spotted fever), the recommended dosage is 2.2 mg/kg of body weight administered every 12 hours. children weighing 45 kg or more should receive the adult dose (see warnings and precautions ). for pediatric patients with less severe disease (greater than 8 years of age and weighing less than 45 kg), the recommended dosage schedule is 4.4 mg/kg of body weight divided into two doses on the first day of treatment, followed by a maintenance dose of 2.2 mg/kg of body weight (given as a single daily dose or divided into twice daily doses). for pediatric patients weighing over 45 kg, the usual adult dose should be used. in the treatment of inhalational anthrax (post-exposure) the recommended dose is 2.2 mg/kg of body weight, twice a day in children weighing less than 45 kg. parenteral therapy is only indicated when oral therapy is not indicated and should not be continued over a prolonged period of time. oral therapy should be instituted as soon as possible. therapy must continue for a total of 60 days. general the duration of infusion may vary with the dose (100 to 200 mg/day), but is usually one to four hours. a recommended minimum infusion time for 100 mg of a 0.5 mg/ml solution is one hour. therapy should be continued for at least 24 to 48 hours after symptoms and fever have subsided. the therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage. intravenous solutions should not be injected intramuscularly or subcutaneously. caution should be taken to avoid the inadvertent introduction of the intravenous solution into the adjacent soft tissue.

Contraindications:

Contraindications: this drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Adverse Reactions:

Adverse reactions: gastrointestinal anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis and inflammatory lesions (with monilial overgrowth) in the anogenital region, and pancreatitis. hepatotoxicity has been reported rarely. these reactions have been caused by both the oral and parenteral administration of tetracyclines. superficial discoloration of the adult permanent dentition, reversible upon drug discontinuation and professional dental cleaning has been reported. permanent tooth discoloration and enamel hypoplasia may occur with drugs of the tetracycline class when used during tooth development (see warnings ). skin maculopapular and erythematous rashes. exfoliative dermatitis has been reported but is uncommon. photosensitivity is discussed above (see warnings ). renal toxicity rise in bun has been reported and is apparently dose related (see warnings ). immune hypersensitivity reactions including urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purp
ura, pericarditis and exacerbation of systemic lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (dress). other bulging fontanels in infants and intracranial hypertension in adults (see warnings ). blood hemolytic anemia, thrombocytopenia, neutropenia and eosinophilia have been reported. when given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands. no abnormalities of thyroid function studies are known to occur.

Drug Interactions:

Drug interactions because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline in conjunction with penicillin. barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline. the concurrent use of tetracycline and penthrane ® (methoxyflurane) has been reported to result in fatal renal toxicity. concurrent use of tetracycline may render oral contraceptives less effective.

Use in Pregnancy:

Usage in pregnancy (see warnings about use during tooth development.) doxycycline for injection has not been studied in pregnant patients. it should not be used in pregnant women unless, in the judgment of the physician, it is essential for the welfare of the patient. results of animal studies indicate that tetracycline cross the placenta, are found in fetal tissues and can have toxic effects on the developing fetus (often related to retardation of skeletal development). evidence of embryotoxicity has also been noted in animals treated early in pregnancy.

Description:

Description: doxycycline for injection, usp is a sterile, lyophilized powder prepared from a solution of doxycycline hyclate, ascorbic acid and mannitol in water for injection. doxycycline hyclate is a broad spectrum antibiotic derived from oxytetracycline. it is meant for intravenous use only after reconstitution. doxycycline hyclate is a yellowish crystalline powder which is chemically designated 4-(dimethylamino)-1,4,4a,5,5a,6,11, 12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-de monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. it has the following structural formula: (c 22 h 24 n 2 o 8 • hcl) 2 • c 2 h 6 o • h 2 o m.w. 1025.89 doxycycline hyclate is soluble in water and chars at 201°c without melting. the base doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. it is highly stable in normal human serum. each 100 mg vial contains: doxycycline hyclate equivalent to 100 mg doxycycline; ascorbic acid 480 mg; mannitol 300 mg. ph of the reconstituted solution (10 mg/ml) is between 1.8 and 3.3. structural formula

Clinical Pharmacology:

Clinical pharmacology: tetracyclines are readily absorbed and are bound to plasma proteins in varying degree. they are concentrated by the liver in the bile, and excreted in the urine and feces at high concentrations and in a biologically active form. following a single 100 mg dose administered in a concentration of 0.4 mg/ml in a one-hour infusion, normal adult volunteers averaged a peak of 2.5 mcg/ml, while 200 mg of a concentration of 0.4 mg/ml administered over two hours averaged a peak of 3.6 mcg/ml. excretion of doxycycline by the kidney is about 40 percent/72 hours in individuals with normal function (creatinine clearance about 75 ml/min). this percentage of excretion may fall as low as 1 to 5 percent/72 hours in individuals with severe renal insufficiency (creatinine clearance below 10 ml/min). studies have shown no significant difference in serum half-life of doxycycline (range 18 to 22 hours) in individuals with normal and severely impaired renal function. hemodialysis does n
ot alter this serum half-life of doxycycline. population pharmacokinetic analysis of sparse concentration-time data of doxycycline following standard of care intravenous and oral dosing in 44 pediatric patients (2-18 years of age) showed that allometrically -scaled clearance (cl) of doxycycline in pediatric patients ≥2 to ≤8 years of age (median [range] 3.58 [2.27-10.82] l/h/70 kg, n=11) did not differ significantly from pediatric patients ˃8 to 18 years of age (3.27 [1.11-8.12] l/h/70 kg, n=33). for pediatric patients weighing ≤45 kg, body weight normalized doxycycline cl in those ≥2 to ≤8 years of age (median [range] 0.071 [0.041-0.202] l/kg/h, n=10) did not differ significantly from those ˃8 to 18 years of age (0.081 [0.035-0.126] l/kg/h, n=8) in pediatric patients weighing ˃45 kg, no clinically significant differences in body weight normalized doxycycline cl were observed between those ≥2 to ≤8 years of age (0.050 l/kg/h, n=1) and those ˃8 to 18 years of age (0.044 [0.014-0.121] l/kg/h, n=25). no clinically significant difference in cl between oral and iv dosing was observed in the small cohort of pediatric patients who received the oral (n=19) or iv (n=21) formulation alone. microbiology mechanism of action doxycycline inhibits bacterial protein synthesis by binding to the 30s ribosomal subunit. doxycycline has bacteriostatic activity against a broad range of gram-positive and gram-negative bacteria. resistance cross resistance with other tetracyclines is common. antimicrobial activity doxycycline has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections (see indications and usage ). gram-negative bacteria acinetobacter species bartonella bacilliformis brucella species enterobacter aerogenes escherichia coli francisella tularensis haemophilus ducreyi haemophilus influenzae klebsiella granulomatis klebsiella species neisseria gonorrhoeae shigella species vibrio cholerae campylobacter fetus yersinia pestis gram-positive bacteria bacillus anthracis listeria monocytogenes streptococcus pneumoniae anaerobic bacteria clostridium species fusobacterium fusiforme propionibacterium acnes other bacteria nocardiae and other aerobic actinomyces species borrelia recurrentis chlamydophila psittaci chlamydia trachomatis mycoplasma pneumoniae rickettsiae treponema pallidum treponema pallidum subspecies pertenue ureaplasma urealyticum parasites balantidium coli entamoeba species plasmodium falciparum * *doxycycline has been found to be active against the asexual erythrocytic forms of plasmodium falciparum but not against the gametocytes of p. falciparum. the precise mechanism of action of the drug is not known. susceptibility testing for specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by fda for this drug, please see: https://www.fda.gov/stic.

Mechanism of Action:

Mechanism of action doxycycline inhibits bacterial protein synthesis by binding to the 30s ribosomal subunit. doxycycline has bacteriostatic activity against a broad range of gram-positive and gram-negative bacteria.

How Supplied:

How supplied: doxycycline for injection, usp, sterile powder, supplied as follows: product code unit of sale strength each 1311 ndc 63323-130-11 unit of 10 doxycycline hyclate equivalent to 100 mg doxycycline per vial ndc 63323-130-02 20 ml single dose vial store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. protect from light. retain in carton until time of use. the brand names mentioned in this document are the trademarks of their respective owners. lake zurich, il 60047 www.fresenius-kabi.com/us 45824l revised: february 2020 fresenius kabi logo

Information for Patients:

Information for patients patients taking doxycycline should be advised: to avoid excessive sunlight or artificial ultraviolet light while receiving doxycycline and to discontinue therapy if phototoxicity (e.g., skin eruption, etc.) occurs. sunscreen or sunblock should be considered. (see warnings .) that the use of doxycycline might increase the incidence of vaginal candidiasis. patients should be counseled that antibacterial drugs, including doxycycline should only be used to treat bacterial infections. they do not treat viral infections (e.g., the common cold). when doxycycline is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable
by doxycycline or other antibacterial drugs in the future. diarrhea is a common problem caused by antibacterial drugs, which usually ends when the antibacterials are discontinued. sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. if this occurs, patients should contact their physician as soon as possible.

Package Label Principal Display Panel:

Principal display panel – doxy 100™ 100 mg per vial tray panel ndc 63323-130-11 1311 doxy 100 tm doxycycline for injection, usp equivalent to 100 mg per vial doxycycline for intravenous infusion only. must be further diluted after reconstitution. preservative free. 10 x single dose vials rx only principal display panel – doxy 100™ 100 mg per vial tray panel

Principal display panel – doxy 100™ 100 mg per vial label ndc 63323-130-02 1311 doxy 100 tm doxycycline for injection, usp equivalent to 100 mg per vial doxycycline for intravenous infusion only. must be further diluted after reconstitution. preservative free. rx only principal display panel – doxy 100™ 100 mg per vial label


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