Doxycycline (Doxycycline)

Trade Name : Doxycycline

Proficient Rx LP

CAPSULE

Strength 100 mg/1

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

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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 Proficient Rx LP. It is available in strength of 100 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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No data

Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline capsules USP, 75 mg, and 100 mg contain doxycycline monohydrate equivalent to 75 mg, and 100 mg of doxycycline for oral administration. The chemical designation of the light yellow to pale yellow powder is 2-Naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-,[4-(4a,4au221d,5u221d,5au221d,6u221d,12au221d,)]-, monohydrate.n
Structural formula:
CHNOu2022 HOu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 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.n
Inert ingredients: colloidal silicon dioxide; magnesium stearate; microcrystalline cellulose; sodium starch glycolate; and a hard gelatin capsule which contains iron oxide black, iron oxide red, iron oxide yellow, titanium dioxide, gelatin, sodium lauryl sulfate for the 75 mg strength and iron oxide black, iron oxide red, iron oxide yellow, titanium dioxide, FD & C Red # 3, D&C Yellow # 10, gelatin, sodium lauryl sulfate for the 100 mg strength. The capsules are printed with edible ink containing shellac, titanium dioxide, black iron oxide, brown iron oxide and potassium hydroxide for 75 mg and 100 mg strengths.

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:
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 1-5%/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.

No data

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:u00a0u00a0u00a0 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.u00a0u00a0u00a0 Respiratory tract infections caused by . u00a0u00a0u00a0 Lymphogranuloma venereum caused by .u00a0u00a0u00a0 Psittacosis (ornithosis) caused by .u00a0u00a0u00a0 Trachoma caused by , although the infectious agent is not always eliminated as judged by immunofluorescence.u00a0u00a0u00a0 Inclusion conjunctivitis caused by .u00a0u00a0u00a0 Uncomplicated urethral, endocervical or rectal infections in adults caused byu00a0C.u00a0u00a0u00a0 Nongonococcal urethritis caused by .u00a0u00a0u00a0 Relapsing fever due to .
Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms:u00a0u00a0u00a0 Chancroid caused by .u00a0u00a0u00a0 Plague due to .u00a0u00a0u00a0 Tularemia due to .u00a0u00a0u00a0 Cholera caused by . u00a0u00a0u00a0 Campylobacter fetus infections caused by .u00a0u00a0u00a0 Brucellosis due to (in conjunction with streptomycin).u00a0u00a0u00a0 Bartonellosis due to .u00a0u00a0u00a0 Granuloma inguinale caused byu00a0.
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:u00a0u00a0u00a0 n n n n n n n u00a0u00a0u00a0 Respiratory tract infections caused by .u00a0u00a0u00a0 Respiratory tract and urinary tract infections caused by .
Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:u00a0u00a0u00a0 Upper respiratory infections caused by .u00a0u00a0u00a0 Anthrax due to , including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized .
When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:u00a0u00a0u00a0 Uncomplicated gonorrhea caused by .u00a0u00a0u00a0 Syphilis caused by .u00a0u00a0u00a0 Yaws caused by subspecies .u00a0u00a0u00a0 Listeriosis due to .u00a0u00a0u00a0 Vincentu2019s infection caused by .u00a0u00a0u00a0 Actinomycosis caused by .u00a0u00a0u00a0 Infections caused by .
In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.
In severe acne, doxycycline may be useful adjunctive therapy.u00a0

This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

The use of drugs of the tetracycline class, including doxycycline, 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 of 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 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.
Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including doxycycline capsules. 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 capsules 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 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 doxycyclineu2019s 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 G&W Laboratories, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or .

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 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 and ).
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 per kg of body weight divided into two doses on the first day of treatment, followed by a maintenance dose of 2.2 mg per 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):
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):

Doxycycline Capsules, USP 100 mg have a brown opaque cap and a yellow opaque body. The capsules are imprinted u201cG&W 0555u201d with white ink on the cap and u201c100 mgu201d with brown ink on the body, filled with yellow to beige powder. Each capsule contains doxycycline monohydrate equivalent to 100 mg doxycycline.
Doxycycline Capsules, USP 100 mg is available in:
u00a0u00a0u00a0u00a0u00a0 n
Bottles of 14 capsules ........................................................ NDC 71205-135-14u00a0u00a0
u00a0u00a0u00a0u00a0u00a0 n u00a0u00a0u00a0u00a0u00a0 n
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.
PROTECT FROM LIGHT.

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.

Rx only
Manufactured by:
8-DOXYGWSV2Rev. 04/2017
Repackaged By;

NDC 71205-135-20, 100 mg Capsulesu00a0u00a0n

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Doxycycline (Doxycycline)

Trade Name : Doxycycline

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Doxycycline (Doxycycline)

Trade Name : Doxycycline

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