Doxycycline Hyclate (Doxycycline Hyclate)

Trade Name : Doxycycline Hyclate

Bryant Ranch Prepack

CAPSULE

Strength 100 mg/1

DOXYCYCLINE HYCLATE Tetracycline-class Drug [EPC],Tetracyclines [CS]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Doxycycline Hyclate (Doxycycline Hyclate) which is also known as Doxycycline Hyclate and Manufactured by Bryant Ranch Prepack. It is available in strength of 100 mg/1 per ml. Read more

Doxycycline Hyclate (Doxycycline Hyclate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
  • Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration.
  • The structural formula of doxycycline hyclate is
  • with a molecular formula of (CHNOu2022HCl)u2022CHOu2022HO and a molecular weight of 1025.89. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water.
  • Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form.
  • Each capsule, for oral administration, contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline. In addition, the capsules contain the inactive ingredients anhydrous lactose, colloidal silicon dioxide, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and stearic acid. The 50 mg capsule shell is composed of D&C Yellow #10, FD&C Blue #1, gelatin, and titanium dioxide. The 100 mg capsule shell is composed of FD&C Blue #1, gelatin, and titanium dioxide. The capsule imprinting ink contains butyl alcohol, denatured alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, propylene glycol, and shellac.
  • Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide.
  • 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. Doxycycline is virtually completely absorbed after oral administration.
  • Following a 200 mg dose, normal adult volunteers averaged peak serum levels of 2.6 mcg/mL of doxycycline at 2 hours, decreasing to 1.45 mcg/mL at 24 hours. Excretion of doxycycline by the kidney is about 40%/72 hours in individuals with normal function (creatinine clearance about 75 mL/min.). This percentage excretion may fall as low as 1% to 5%/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 not alter serum half-life.
  • Results of animal studies indicate that tetracyclines cross the placenta and are found in fetal tissues.
  • Mechanism of Action
  • Resistance
  • Antimicrobial Activityn- in vitron- Array
  • Gram-Negative Bacterian- Acinetobactern- Bartonella bacilliformisn- Brucellan- Klebsiellan- Klebsiella granulomatisn- Campylobacter fetusn- Enterobacter aerogenesn- Escherichia colin- Francisella tularensisn- Haemophilus ducreyin- Haemophilus influenzaen- Neisseria gonorrhoeaen- Shigellan- Vibrio choleraen- Yersinia pestis
  • Gram-Positive Bacterian- Bacillus anthracisn- Listeria monocytogenesn- Streptococcus pneumoniae
  • Anaerobic Bacterian- Clostridium n- Array
  • Other Bacteria n- Nocardiaen- Actinomycesn- Borrelia recurrentis Chlamydophila psittaci Chlamydia trachomatis Mycoplasma pneumoniae n n- Arrayn- Treponema pallidumn- pertenuen- Ureaplasma urealyticum
  • Arrayn- Parasitesn- Balantidium coli Entamoeba n- Array
  • *Doxycycline has been found to be active against the asexual erythrocytic forms of n- Plasmodium falciparumn- , but not against the gametocytes of n- P. falciparumn- . 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.
  • Array
  • To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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.
  • Treatment
  • Doxycycline is indicated for the treatment of the following infections:
  • Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms:
  • Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.
  • Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug:
  • Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:
  • When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:
  • In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.
  • In severe acne, doxycycline may be useful adjunctive therapy.
  • Prophylaxis
  • Doxycycline is indicated for the prophylaxis of malaria due to in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See section and subsection of the section.)
  • This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
  • 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 it 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 difficilen- C. difficile
  • C. difficilen- C. difficile
  • If CDAD is suspected or confirmed, ongoing use of antibacterial drugs not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of , 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 .) 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.
  • All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued.
  • Results of animal studies indicate that tetracyclines 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. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
  • The antianabolic 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.
  • 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.
  • No data
  • Due to oral doxycycline's virtually complete absorption, side effects of the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines:
  • Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, 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 .) Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of the drugs in the tetracycline class. Most of these patients took medications immediately before going to bed. (See .)
  • Skin: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, skin hyperpigmentation, maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above. (See .)
  • Renal toxicity: Rise in BUN has been reported and is apparently dose related. (See .)
  • Immune: Hypersensitivity reactions including urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, exacerbation of systemic lupus erythematosus, and drug reaction with eosinophilia and systemic symptoms (DRESS), and Jarisch-Herxheimer reaction has been reported in the setting of spirochete infections treated with doxycycline.
  • Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.
  • Other: Bulging fontanels in infants and intracranial hypertension in adults. (See .)
  • When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid gland. No abnormalities of thyroid function studies are known to occur.
  • To report n- Arrayn- SUSPECTED ADVERSE REACTIONS, contact Alvogen, Inc. at 1-866-770-3024 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdosage.
  • The usual dosage and frequency of administration of doxycycline differs from that of the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of side effects.
  • Adults:
  • Pediatric Patients:n- Arrayn- Array
  • 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.
  • The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage.
  • When used in streptococcal infections, therapy should be continued for 10 days.
  • Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (See .)
  • If gastric irritation occurs, it is recommended that doxycycline be given with food or milk. The absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk.
  • Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of doxycycline in patients with renal impairment.
  • Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. The dose may be administered with food, including milk or carbonated beverage, as required.
  • Uncomplicated urethral, endocervical, or rectal infection in adults caused by 100 mg, by mouth twice a day for 7 days.
  • Nongonococcal urethritis (NGU) caused by or : 100 mg by mouth, twice a day for 7 days.
  • Syphilis - early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 2 weeks.
  • Syphilis of more than one yearu2019s duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 4 weeks.
  • Acute epididymo-orchitis caused by : 100 mg, by mouth, twice a day for at least 10 days.
  • Acute epididymo-orchitis caused by : 100 mg, by mouth, twice a day for at least 10 days.
  • For prophylaxis of malaria: For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1 to 2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.
  • Inhalational anthrax (post-exposure):
  • ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days. CHILDREN: weighing less than 45 kg; 2.2 mg/kg of body weight by mouth, twice a day for 60 days. Children weighing 45 kg or more should receive the adult dose.
  • Product: 71335-1316
  • NDC: 71335-1316-0 6 CAPSULE in a BOTTLE
  • NDC: 71335-1316-1 10 CAPSULE in a BOTTLE
  • NDC: 71335-1316-2 20 CAPSULE in a BOTTLE
  • NDC: 71335-1316-3 30 CAPSULE in a BOTTLE
  • NDC: 71335-1316-4 40 CAPSULE in a BOTTLE
  • NDC: 71335-1316-5 60 CAPSULE in a BOTTLE
  • NDC: 71335-1316-6 28 CAPSULE in a BOTTLE
  • NDC: 71335-1316-7 14 CAPSULE in a BOTTLE
  • NDC: 71335-1316-8 90 CAPSULE in a BOTTLE
  • NDC: 71335-1316-9 365 CAPSULE in a BOTTLE
  • Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO, and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO, and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline.
  • Minocycline, tetracycline PO, methacycline, doxycycline, tetracycline base, oxytetracycline HCl, and tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet.
  • Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline); in chickens (chlortetracycline); and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.
  • 1. Friedman JM and Polifka JE. Baltimore, MD: The Johns Hopkins University Press, 2000: 149-195.
  • 2. Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. 1997; 89: 524-528.
  • 3. Horne HW Jr and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a prospective study. 1980; 25: 315-317.
  • 4. Hale T. 9 edition. Amarillo, TX: Pharmasoft Publishing, 2000: 225-226.
  • For more information, please call Alvogen, Inc. at 1-866-770-3024.
  • Brands listed are the trademarks of their respective owners.
  • Manufactured By:Chartwell Pharmaceuticals, LLC Congers, NY 10920 USA
  • Distributed By:Alvogen, Inc.Pine Brook, NJ 07058 USA
  • PI489-02 Rev. 12/2018
  • No data

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