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Morgidox
Overview
What is Morgidox?
Doxycycline Hyclate Capsules, USP, are an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline monohydrate is
with a molecular formula of CHNO∙HO and a molecular weight of 462.46. The chemical designation for doxycycline 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 monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (CHNO∙HCl)∙CHO∙HO and the molecular weight is 1025.89. Doxycycline is a light yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly 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 (anhydrous). Inactive ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate.
The 50 mg and 100 mg capsule shells contain: gelatin, diacetylated monoglycerides, sucrose fatty acid esters, glacial acetic acid, sodium lauryl sulfate, colloidal silicon dioxide, FD&C Blue #1 and titanium dioxide. The printing ink may contain: Shellac Glaze, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol, SDA 3A Alcohol, FD&C Blue #2, FD&C Red #40, FD&C Blue #1, D&C Yellow #10.
What does Morgidox look like?
What are the available doses of Morgidox?
Sorry No records found.
What should I talk to my health care provider before I take Morgidox?
Sorry No records found
How should I use Morgidox?
To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules, USP and other antibacterial drugs, Doxycycline Hyclate 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.
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: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day.
In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.
For children above eight years of age: The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections, up to 2 mg/lb of body weight may be used. For children over 100 lb 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 year's 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 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight, by mouth, twice a day for 60 days. Children weighing 100 lb or more should receive the adult dose.
What interacts with Morgidox?
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
What are the warnings of Morgidox?
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. 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.
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.
Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including doxycycline hyclate 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 hyclate 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 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.
What are the precautions of Morgidox?
General
As with other antibacterial drugs, use of doxycycline hyclate capsules may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, doxycycline hyclate capsules should be discontinued and appropriate therapy instituted.
Incision and drainage or other surgical procedures should be performed in conjunction with antibacterial therapy, when indicated.
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.
Prescribing doxycycline hyclate capsules 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.
Information for Patients
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WARNINGS
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ADVERSE REACTIONS
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Drug Interactions
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Drug Interactions
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Patients taking doxycycline for malaria prophylaxis should be advised:
All patients taking doxycycline should be advised:
Patients should be counseled that antibacterial drugs, including doxycycline hyclate capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When doxycycline hyclate capsules are 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 capsules 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.
Laboratory Tests
In venereal disease, when co-existent syphilis is suspected, dark field examinations should be done before treatment is started and the blood serology repeated monthly for at least 4 months.
In long-term therapy, periodic laboratory evaluation of organ systems, including hematopoietic, renal, and hepatic studies, should be performed.
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 tetracyclines in conjunction with penicillin.
Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.
Absorption of tetracyclines is impaired by bismuth subsalicylate.
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.
Drug/Laboratory Test Interactions
False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.
Carcinogenesis, Mutagenesis, Impairment of Fertility
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 antibacterial drugs, 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 antibacterial drugs (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.
Pregnancy
Teratogenic Effects
Nonteratogenic Effects
See
Labor and Delivery
The effect of tetracyclines on labor and delivery is unknown.
Nursing Mothers
Tetracyclines are excreted in human milk; however, the extent of absorption of tetracyclines, including doxycycline, by the breastfed infant is not known. Short-term use by lactating women is not necessarily contraindicated; however, the effects of prolonged exposure to doxycycline in breast milk are unknown. Because of the potential for serious adverse reactions in nursing infants from doxycycline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother (See ).
Pediatric Use
See and .
What are the side effects of Morgidox?
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, and inflammatory lesions (with monilial overgrowth) in the anogenital region. Hepatotoxicity has been reported rarely. These reactions have been caused by both the oral and parenteral administration of tetracyclines. 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, 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 rash with eosinophilia and systemic symptoms (DRESS).
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 SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What should I look out for while using Morgidox?
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. 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
C. difficile.
C. difficile
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.
Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including doxycycline hyclate 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 hyclate 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 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.
What might happen if I take too much Morgidox?
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.
How should I store and handle Morgidox?
Store DALIRESP tablets at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature]. Doxycycline Hyclate Capsules, USP equivalent to 50 mg doxycycline: No. 2 Blue/White Opaque Hard Gelatin Capsule Printed "West-ward 3141" in Black Ink.Morgidox 1×50 mg Kit (NDC 43538-621-30). Kit contains:Morgidox 1×50 mg (NDC 43538-620-30).Doxycycline Hyclate Capsules, USP equivalent to 100 mg doxycycline: No. 0 Blue/Blue Opaque Hard Gelatin Capsule Printed "West-ward 3142" in Black Ink.Morgidox 1×100 mg Kit (NDC 43538-601-30). Kit contains:Morgidox 1×100 mg (NDC 43538-600-30).Morgidox 2×100 mg Kit (NDC 43538-611-60). Kit contains:Morgidox 2×100 mg (NDC 43538-610-60).Doxycycline Hyclate Capsules, USP equivalent to 50 mg doxycycline: No. 2 Blue/White Opaque Hard Gelatin Capsule Printed "West-ward 3141" in Black Ink.Morgidox 1×50 mg Kit (NDC 43538-621-30). Kit contains:Morgidox 1×50 mg (NDC 43538-620-30).Doxycycline Hyclate Capsules, USP equivalent to 100 mg doxycycline: No. 0 Blue/Blue Opaque Hard Gelatin Capsule Printed "West-ward 3142" in Black Ink.Morgidox 1×100 mg Kit (NDC 43538-601-30). Kit contains:Morgidox 1×100 mg (NDC 43538-600-30).Morgidox 2×100 mg Kit (NDC 43538-611-60). Kit contains:Morgidox 2×100 mg (NDC 43538-610-60).Doxycycline Hyclate Capsules, USP equivalent to 50 mg doxycycline: No. 2 Blue/White Opaque Hard Gelatin Capsule Printed "West-ward 3141" in Black Ink.Morgidox 1×50 mg Kit (NDC 43538-621-30). Kit contains:Morgidox 1×50 mg (NDC 43538-620-30).Doxycycline Hyclate Capsules, USP equivalent to 100 mg doxycycline: No. 0 Blue/Blue Opaque Hard Gelatin Capsule Printed "West-ward 3142" in Black Ink.Morgidox 1×100 mg Kit (NDC 43538-601-30). Kit contains:Morgidox 1×100 mg (NDC 43538-600-30).Morgidox 2×100 mg Kit (NDC 43538-611-60). Kit contains:Morgidox 2×100 mg (NDC 43538-610-60).Doxycycline Hyclate Capsules, USP equivalent to 50 mg doxycycline: No. 2 Blue/White Opaque Hard Gelatin Capsule Printed "West-ward 3141" in Black Ink.Morgidox 1×50 mg Kit (NDC 43538-621-30). Kit contains:Morgidox 1×50 mg (NDC 43538-620-30).Doxycycline Hyclate Capsules, USP equivalent to 100 mg doxycycline: No. 0 Blue/Blue Opaque Hard Gelatin Capsule Printed "West-ward 3142" in Black Ink.Morgidox 1×100 mg Kit (NDC 43538-601-30). Kit contains:Morgidox 1×100 mg (NDC 43538-600-30).Morgidox 2×100 mg Kit (NDC 43538-611-60). Kit contains:Morgidox 2×100 mg (NDC 43538-610-60).Doxycycline Hyclate Capsules, USP equivalent to 50 mg doxycycline: No. 2 Blue/White Opaque Hard Gelatin Capsule Printed "West-ward 3141" in Black Ink.Morgidox 1×50 mg Kit (NDC 43538-621-30). Kit contains:Morgidox 1×50 mg (NDC 43538-620-30).Doxycycline Hyclate Capsules, USP equivalent to 100 mg doxycycline: No. 0 Blue/Blue Opaque Hard Gelatin Capsule Printed "West-ward 3142" in Black Ink.Morgidox 1×100 mg Kit (NDC 43538-601-30). Kit contains:Morgidox 1×100 mg (NDC 43538-600-30).Morgidox 2×100 mg Kit (NDC 43538-611-60). Kit contains:Morgidox 2×100 mg (NDC 43538-610-60).Doxycycline Hyclate Capsules, USP equivalent to 50 mg doxycycline: No. 2 Blue/White Opaque Hard Gelatin Capsule Printed "West-ward 3141" in Black Ink.Morgidox 1×50 mg Kit (NDC 43538-621-30). Kit contains:Morgidox 1×50 mg (NDC 43538-620-30).Doxycycline Hyclate Capsules, USP equivalent to 100 mg doxycycline: No. 0 Blue/Blue Opaque Hard Gelatin Capsule Printed "West-ward 3142" in Black Ink.Morgidox 1×100 mg Kit (NDC 43538-601-30). Kit contains:Morgidox 1×100 mg (NDC 43538-600-30).Morgidox 2×100 mg Kit (NDC 43538-611-60). Kit contains:Morgidox 2×100 mg (NDC 43538-610-60).Doxycycline Hyclate Capsules, USP equivalent to 50 mg doxycycline: No. 2 Blue/White Opaque Hard Gelatin Capsule Printed "West-ward 3141" in Black Ink.Morgidox 1×50 mg Kit (NDC 43538-621-30). Kit contains:Morgidox 1×50 mg (NDC 43538-620-30).Doxycycline Hyclate Capsules, USP equivalent to 100 mg doxycycline: No. 0 Blue/Blue Opaque Hard Gelatin Capsule Printed "West-ward 3142" in Black Ink.Morgidox 1×100 mg Kit (NDC 43538-601-30). Kit contains:Morgidox 1×100 mg (NDC 43538-600-30).Morgidox 2×100 mg Kit (NDC 43538-611-60). Kit contains:Morgidox 2×100 mg (NDC 43538-610-60).Doxycycline Hyclate Capsules, USP equivalent to 50 mg doxycycline: No. 2 Blue/White Opaque Hard Gelatin Capsule Printed "West-ward 3141" in Black Ink.Morgidox 1×50 mg Kit (NDC 43538-621-30). Kit contains:Morgidox 1×50 mg (NDC 43538-620-30).Doxycycline Hyclate Capsules, USP equivalent to 100 mg doxycycline: No. 0 Blue/Blue Opaque Hard Gelatin Capsule Printed "West-ward 3142" in Black Ink.Morgidox 1×100 mg Kit (NDC 43538-601-30). Kit contains:Morgidox 1×100 mg (NDC 43538-600-30).Morgidox 2×100 mg Kit (NDC 43538-611-60). Kit contains:Morgidox 2×100 mg (NDC 43538-610-60).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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. Cross resistance with other tetracyclines is common.
Doxycycline has been shown to be active against most isolates of the following microorganisms, both and in clinical infections as described in the section of the package insert for doxycycline hyclate capsules.
Gram-Negative Bacteria
Acinetobacter speciesBartonella bacilliformisBrucella speciesKlebsiella speciesKlebsiella granulomatisCampylobacter fetusEnterobacter aerogenesEscherichia coliFrancisella tularensisHaemophilus ducreyiHaemophilus influenzaeNeisseria gonorrhoeaeShigella speciesVibrio choleraeYersinia pestis
Gram-Positive Bacteria
Bacillus anthracisStreptococcus pneumoniae
Anaerobic Bacteria
Clostridium speciesFusobacterium fusiformePropionibacterium acnes
Other Bacteria
Nocardiae and other aerobic Actinomyces speciesBorrelia recurrentisChlamydophila psittaciChlamydia trachomatisMycoplasma pneumoniaeRickettsiaeTreponema pallidumTreponema pallidum subspecies pertenueUreaplasma urealyticum
Parasites
Balantidium coliEntamoeba speciesPlasmodium falciparum
Non-Clinical Toxicology
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. 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
C. difficile.
C. difficile
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.
Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including doxycycline hyclate 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 hyclate 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 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.
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 tetracyclines in conjunction with penicillin.
Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.
Absorption of tetracyclines is impaired by bismuth subsalicylate.
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.
As with other antibacterial drugs, use of doxycycline hyclate capsules may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, doxycycline hyclate capsules should be discontinued and appropriate therapy instituted.
Incision and drainage or other surgical procedures should be performed in conjunction with antibacterial therapy, when indicated.
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.
Prescribing doxycycline hyclate capsules 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.
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, and inflammatory lesions (with monilial overgrowth) in the anogenital region. Hepatotoxicity has been reported rarely. These reactions have been caused by both the oral and parenteral administration of tetracyclines. 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, 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 rash with eosinophilia and systemic symptoms (DRESS).
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 SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).