Doxycycline (Doxycycline)

Trade Name : Doxycycline

Amneal Pharmaceuticals of New York LLC

CAPSULE

Strength 150 mg/1

DOXYCYCLINE 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 (Doxycycline) which is also known as Doxycycline and Manufactured by Amneal Pharmaceuticals of New York LLC. It is available in strength of 150 mg/1 per ml. Read more

Doxycycline (Doxycycline) 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.

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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
  • 150 mgn
  • Rx only
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline capsules and other antibacterial drugs, doxycycline capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
  • Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline capsules USP, 150 mg contain doxycycline monohydrate equivalent to 150 mg of doxycycline for oral administration. The chemical designation of the light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline.
  • Structural formula:
  • CHNO u2219 HO u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 M.W. = 462.45
  • Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form.
  • The inactive ingredients in doxycycline capsules, USP include colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The capsule shells contain gelatin, titanium dioxide, and FD&C Yellow No. 6. Additionally, the capsule imprint ink contains shellac, u00a0ferrosoferric oxide, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, D&C Yellow No. 10 Aluminum Lake, and FD&C Blue No. 1.
  • Tetracyclines are readily absorbed and are bound to plasma proteins in varying degrees. They are concentrated by the liver in the bile and excreted in the urine and feces at high concentrations in a biologically active form. Doxycycline is virtually completely absorbed after oral administration.
  • Following a 200 mg dose of doxycycline monohydrate, 24 normal adult volunteers averaged the following serum concentration values:
  • Average Observed Values
  • 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.
  • Population pharmacokinetic analysis of sparse concentration-time data of doxycycline following standard of care intravenous and oral dosing in 44 pediatric patients (2 to 18 years of age) showed that allometrically u2013scaled clearance (CL) of doxycycline in pediatric patients 2 to 8 years of age (median [range] 3.58 [2.27 to 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 to 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 to 0.202] L/kg/h, N=10) did not differ significantly from those >8 to 18 years of age (0.081 [0.035 to 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 (0.050 L/kg/h, N=1) and those >8 to 18 years of age (0.044 [0.014 to 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.
  • To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline capsules, 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 is indicated for the treatment of the following infections: n
  • Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by . Respiratory tract infections caused by . caused by . Psittacosis (ornithosis) caused by . Trachoma caused by , although the infectious agent is not always eliminated as judged by immunofluorescence. Inclusion conjunctivitis caused by . Uncomplicated urethral, endocervical or rectal infections in adults caused by .Nongonococcal urethritis caused by . Relapsing fever due to .
  • Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms:
  • Chancroid caused by . Plague due to . Tularemia due to . Cholera caused by . Campylobacter fetus infections caused by . Brucellosis due to species (in conjunction with streptomycin). Bartonellosis due to . Granuloma inguinale caused by .
  • 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 microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:
  • Escherichia coli Enterobacter aerogenes Shigella n- Arrayn- Haemophilus influenzaen- Klebsiella
  • Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:
  • Upper respiratory infections caused by . Anthrax due to , including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized . n
  • When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:
  • Uncomplicated gonorrhea caused by . Syphilis caused by . Yaws caused by . Listeriosis due to . Vincentu2019s infection caused by . Actinomycosis caused by . Infections caused by species.
  • In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.
  • 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 has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP, EXCEPT FOR ANTHRAX, INCLUDING INHALATIONAL ANTHRAX (POST-EXPOSURE), UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.
  • Clostridium difficile n- C. difficile
  • C. difficile n- C. difficile
  • If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
  • All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in the fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every six 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 embryo toxicity has been noted in animals treated early in pregnancy. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking these drugs, 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 to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines.
  • Gastrointestinal: n- Array
  • Skin: n- Array
  • Renal Toxicity: n- Array
  • Hypersensitivity Reactions:
  • Blood:
  • Other: n- Array
  • When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid gland. No abnormalities of thyroid function are known to occur.
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or 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 it 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:
  • For pediatric patients above eight years of age:
  • Uncomplicated gonococcal infections in adults (except anorectal infections in men):
  • Acute epididymo-orchitis caused by :
  • Primary and secondary syphilis:
  • Uncomplicated urethral, endocervical, or rectal infection in adults caused by :
  • Nongonococcal urethritis caused by and :
  • Acute epididymo-orchitis caused by :
  • Inhalational anthrax (post-exposure):
  • 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, doxycycline may be given with food. Ingestion of a high fat meal has been shown to delay the time to peak plasma concentrations by an average of one hour and 20 minutes. However, in the same study, food enhanced the average peak concentration by 7.5% and the area under the curve by 5.7%.
  • Doxycycline Capsules USP, have an orange opaque cap printed u201cM1u201d in black ink/orange opaque body. Each capsule contains doxycycline monohydrate equivalent to 150 mg of doxycycline. They are supplied as follows:
  • Bottles of 30: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1327-08
  • Bottles of 60: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1327-13
  • Bottles of 90: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1327-10
  • Bottles of 100: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1327-01
  • Bottles of 1000: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1327-03
  • STORE AT 20u00b0 TO 25u00b0C (68u00b0 TO 77u00b0F) [SEE USP CONTROLLED ROOM TEMPERATURE].
  • DISPENSE IN A TIGHT LIGHT-RESISTANT CONTAINER AS DEFINED IN THE USP
  • NF.
  • 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 hydrochloride and tetracycline hydrochloride 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.
  • No data
  • Manufactured by:n Jhunan, Taiwan
  • Distributed by:n Bridgewater, NJ 08807
  • 1040-07
  • Rev. 01-2020-01
  • No data

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