Doxycycline Hyclate Information
Doxycycline hyclate (Doxycycline hyclate) Indications And Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline hyclate (Doxycycline hyclate) delayed-release tablets, USP and other antibacterial drugs, Doxycycline hyclate (Doxycycline hyclate) delayed-release tablets, 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 a tetracycline-class antimicrobial indicated in the following conditions or diseases:
Doxycycline hyclate (Doxycycline hyclate) Dosage Forms And Strengths
Doxycycline hyclate (Doxycycline hyclate) delayed-release tablets USP, 75 mg are off-white oval scored tablets containing yellow pellets and debossed with "F" bisected with "91" on one side and plain on the other side. Each tablet contains specially coated pellets of Doxycycline hyclate (Doxycycline hyclate) equivalent to 75 mg of doxycycline.
Doxycycline hyclate (Doxycycline hyclate) delayed-release tablets USP, 100 mg are off-white oval scored tablets containing yellow pellets and debossed with "F" bisected with "92" on one side and plain on the other side. Each tablet contains specially coated pellets of Doxycycline hyclate (Doxycycline hyclate) equivalent to 100 mg of doxycycline.
Doxycycline hyclate (Doxycycline hyclate) Contraindications
The drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
Doxycycline hyclate (Doxycycline hyclate) Warnings And Precautions
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 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 embryotoxicity also 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.
Doxycycline offers substantial but not complete suppression of the asexual blood stages of strains.
Doxycycline does not suppress sexual blood stage gametocytes. Subjects completing this prophylactic regimen may still transmit the infection to mosquitoes outside endemic areas.
Doxycycline hyclate (Doxycycline hyclate) Adverse Reactions
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:
Maculopapular and erythematous rashes, Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme have been reported. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above [].
Doxycycline hyclate (Doxycycline hyclate) Use In Specific Populations
Clinical studies of Doxycycline hyclate (Doxycycline hyclate) delayed-release tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Doxycycline hyclate (Doxycycline hyclate) delayed-release tablets, 75 mg contain 4.8 mg (0.209 mEq) of sodium.
Doxycycline hyclate (Doxycycline hyclate) delayed-release tablets, 100 mg contain 6.4 mg (0.278 mEq) of sodium.
Doxycycline hyclate (Doxycycline hyclate) . Overdosage
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.
Doxycycline hyclate (Doxycycline hyclate) . Description
Doxycycline hyclate (Doxycycline hyclate) delayed-release tablets USP, for oral administration, contain specially coated pellets of Doxycycline hyclate (Doxycycline hyclate) , a broad-spectrum antibiotic synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration.
The structural formula for Doxycycline hyclate (Doxycycline hyclate) is:
with a molecular formula of CHNO, HCl, ½ CHO, ½ HO and a molecular weight of 512.9. The chemical designation for Doxycycline hyclate (Doxycycline hyclate) is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonapthtacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate (Doxycycline hyclate) is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. 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. Inert ingredients in the tablet formulation are: lactose monohydrate; microcrystalline cellulose; hypromellose phthalate; sodium lauryl sulfate; sodium chloride; talc; hypromellose 2910; triethyl citrate; corn starch; crospovidone; magnesium stearate.
USP Dissolution Test pending.
Doxycycline hyclate (Doxycycline hyclate) Clinical Pharmacology
Doxycycline is virtually completely absorbed after oral administration. Following administration of a single 200 mg dose to adult volunteers, average peak serum doxycycline levels were 2.6 mcg/mL at 2 hours, decreasing to 1.45 mcg/mL at 24 hours. The mean Cmax and AUC 0-∞ of doxycycline are 24% and 13% lower, respectively, following single dose administration of Doxycycline hyclate (Doxycycline hyclate) delayed-release tablets, 100 mg with a high fat meal (including milk) compared to fasted conditions. The mean Cmax of doxycycline is 19% lower and the AUC 0-∞ is unchanged following single dose administration of Doxycycline hyclate (Doxycycline hyclate) delayed-release tablets, 150 mg with a high fat meal (including milk) compared to fasted conditions. The clinical significance of these decreases is unknown.
When Doxycycline hyclate (Doxycycline hyclate) delayed-release tablets are sprinkled over applesauce and taken with or without water, the extent of doxycycline absorption is unchanged, but the rate of absorption is increased slightly.
Tetracyclines are concentrated in bile by the liver and excreted in the urine and feces at high concentrations and in a biologically active form. Excretion of doxycycline by the kidney is about 40%/72 hours in individuals with a creatinine clearance of about 75 mL/min. This percentage may fall as low as 1 to 5%/72 hours in individuals with a creatinine clearance below 10 mL/min.
Studies have shown no significant difference in the serum half-life of doxycycline (range 18 to 22 hours) in individuals with normal and severely impaired renal function. Hemodialysis does not alter the serum half-life.
The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including doxycycline, have a similar antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative organisms. Cross-resistance between tetracyclines is common.
Because isolates of the following gram-negative, gram-positive, anaerobic and other microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing, when possible, is recommended prior to initiating therapy.
Doxycycline has been found to be active against the asexual erythrocytic forms of but not against the gametocytes of The precise mechanism of action of the drug is not known.
Doxycycline hyclate (Doxycycline hyclate) Nonclinical Toxicology
Long-term studies in animals to evaluate carcinogenic potential of doxycycline have not been conducted. However, there has been evidence of oncogenic activity in rats in studies with the related antibiotics, oxytetracycline (adrenal and pituitary tumors) and minocycline (thyroid tumors). Likewise, although mutagenicity studies of doxycycline have not been conducted, positive results in mammalian cell assays have been reported for related antibiotics (tetracycline, oxytetracycline).
Doxycycline administered orally at dosage levels as high as 250 mg/kg/day had no apparent effect on the fertility of female rats. Effect on male fertility has not been studied.
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.
Results of animal studies indicate that tetracyclines cross the placenta and are found in fetal tissues.
Doxycycline hyclate (Doxycycline hyclate) How Supplied/storage And Handling
Doxycycline hyclate (Doxycycline hyclate) delayed-release tablets USP, 75 mg are off-white oval scored tablets containing yellow pellets and debossed with "F" bisected with "91" on one side and plain on the other side. Each tablet contains specially coated pellets of Doxycycline hyclate (Doxycycline hyclate) equivalent to 75 mg of doxycycline, supplied in:
Bottles of 30...............................................................................NDC 0115-1208-08
Bottles of 60...............................................................................NDC 0115-1208-13
Bottles of 1000...........................................................................NDC 0115-1208-03
Doxycycline hyclate (Doxycycline hyclate) delayed-release tablets USP, 100 mg are off-white oval scored tablets containing yellow pellets and debossed with "F" bisected with "92" on one side and plain on the other side. Each tablet contains specially coated pellets of Doxycycline hyclate (Doxycycline hyclate) equivalent to 100 mg of doxycycline, supplied in:
Bottles of 30................................................................................NDC 0115-1209-08
Bottles of 100..............................................................................NDC 0115-1209-01
Bottles of 1000............................................................................NDC 0115-1209-03
Doxycycline hyclate (Doxycycline hyclate) Patient Counseling Information
Patients taking doxycycline for malaria prophylaxis should be advised:
All patients taking doxycycline should be advised:
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, 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 antibiotic. If this occurs, patients should contact their physician as soon as possible.
Patients should be counseled that antibacterial drugs including Doxycycline hyclate (Doxycycline hyclate) delayed-release tablets should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When Doxycycline hyclate (Doxycycline hyclate) delayed-release tablet 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 hyclate (Doxycycline hyclate) delayed-release tablets or other antibacterial drugs in the future.
Doxycycline hyclate (Doxycycline hyclate)
Doxycycline hyclate (Doxycycline hyclate)
Doxycycline hyclate (Doxycycline hyclate)
