Demeclocycline hydrochloride
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]
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Overview
Demeclocycline hydrochloride is a tetracycline that is FDA approved for the {{{indicationType}}} of {{{indication}}}. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Demeclocycline hydrochloride FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Demeclocycline hydrochloride in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Demeclocycline hydrochloride in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Demeclocycline hydrochloride FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Demeclocycline hydrochloride in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Demeclocycline hydrochloride in pediatric patients.
Contraindications
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any of the components of the product formulation.
Warnings
There is limited information regarding Demeclocycline hydrochloride Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
Gastrointestinal
- Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, pancreatitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region, increases in liver enzymes, and hepatic toxicity has been reported rarely.
- Rarely, hepatitis and liver failure have been reported. These reactions have been caused by both the oral and parenteral administration of tetracyclines.
- Instances of esophageal ulcerations have been reported in patients receiving oral tetracyclines. Most of the patients were reported to have taken the medication immediately before lying down.
Skin
- Maculopapular and erythematous rashes, erythema multiforme. Exfoliative dermatitis has been reported but is uncommon. Fixed drug eruptions and Stevens-Johnson syndrome have been reported rarely. Lesions occurring on the glans penis have caused balanitis. Pigmentation of the skin and mucous membranes has also been reported. Photosensitivity is discussed above.
Renal toxicity
- Acute renal failure. Rise in BUN has been reported and is apparently dose related. Nephrogenic diabetes insipidus.
Hypersensitivity reactions
- Urticaria, angioneurotic edema, polyarthralgia, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus, lupus-like syndrome, pulmonary infiltrates with eosinophilia.
Hematologic
- Hemolytic anemia, thrombocytopenia, neutropenia and eosinophilia have been reported.
CNS
- Pseudotumor cerebri (benign intracranial hypertension) in adults and bulging fontanels in infants. Dizziness, headache, tinnitus, and visual disturbances have been reported.
- Myasthenic syndrome has been reported rarely.
Other
- When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands. No abnormalities of thyroid function studies are known to occur. Very rare cases of abnormal thyroid function have been reported.
- Tooth discoloration has occurred in pediatric patients less than 8 years of age (see WARNINGS), and also has been reported rarely in adults.
Postmarketing Experience
There is limited information regarding Demeclocycline hydrochloride Postmarketing Experience in the drug label.
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 penicillins, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.
- Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective.
- The concurrent use of tetracyclines and methoxyflurane has been reported to result in fatal renal toxicity.
´* Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium, and by iron-containing preparations.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): D
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 been noted in animals treated early in pregnancy.
Pregnancy Category (AUS): D
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Demeclocycline hydrochloride in women who are pregnant.
Labor and Delivery
The effect of tetracyclines on labor and delivery is unknown.
Nursing Mothers
Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from the tetracyclines, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Not for use in patients younger than eight years of age.
Geriatic Use
There is no FDA guidance on the use of Demeclocycline hydrochloride in geriatric settings.
Gender
There is no FDA guidance on the use of Demeclocycline hydrochloride with respect to specific gender populations.
Race
There is no FDA guidance on the use of Demeclocycline hydrochloride with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Demeclocycline hydrochloride in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Demeclocycline hydrochloride in patients with hepatic impairment.
Females of Reproductive Potential and Males
Demeclocycline hydrochloride had no effect on fertility when administered in the diet to male and female rats at a daily intake of 45 times the human dose.
Immunocompromised Patients
There is no FDA guidance one the use of Demeclocycline hydrochloride in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Demeclocycline hydrochloride Administration in the drug label.
Monitoring
There is limited information regarding Demeclocycline hydrochloride Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Demeclocycline hydrochloride and IV administrations.
Overdosage
In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Tetracyclines are not removed in significant quantities by hemodialysis or peritoneal dialysis.
Pharmacology
There is limited information regarding Demeclocycline hydrochloride Pharmacology in the drug label.
Mechanism of Action
The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including demeclocycline, have a similar antimicrobial spectrum of activity against a wide range of gram-negative and gram-positive organisms.
Structure
There is limited information regarding Demeclocycline hydrochloride Structure in the drug label.
Pharmacodynamics
There is limited information regarding Demeclocycline hydrochloride Pharmacodynamics in the drug label.
Pharmacokinetics
The absorption of demeclocycline is slower than that of tetracycline. The time to reach the peak concentration is about 4 hours. After a 150 mg oral dose of demeclocycline tablet, the mean concentrations at 1 hour and 3 hours are 0.46 and 1.22 mcg/mL (n = 6), respectively. The serum half-life ranges between 10 and 16 hours. When demeclocycline hydrochloride is given concomitantly with some dairy products, or antacids containing aluminum, calcium, or magnesium, the extent of absorption is reduced by more than 50%. Demeclocycline hydrochloride penetrates well into various body fluids and tissues. The percent of demeclocycline hydrochloride bound to plasma protein is about 40% using a dialysis equilibrium method and 90% using an ultra-filtration method. Demeclocycline hydrochloride, like other tetracyclines, is concentrated in the liver and excreted into the bile where it is found in much higher concentrations than in the blood. The rate of demeclocycline hydrochloride renal clearance (35 mL/min/1.73 m2) is less than half that of tetracycline. Following a single 150 mg dose of demeclocycline hydrochloride in normal volunteers, 44% (n = 8) was excreted in urine and 13% and 46%, respectively, were excreted in feces in two patients within 96 hours as active drug.
Nonclinical Toxicology
Mechanism(s) of Resistance
- Resistance to tetracyclines may be mediated by efflux, alteration in the target site of tetracycline, enzymatic inactivation, and decreased bacterial permeability to the tetracycline or a combination of these mechanisms.
- Cross-resistance between antibiotics of the tetracycline family occurs.
Carcinogenesis and Mutagenesis
- Long-term studies in animals to evaluate carcinogenic potential of demeclocycline hydrochloride 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).
- Although mutagenicity studies of demeclocycline hydrochloride have not been conducted, positive results in in vitro mammalian cell assays (i.e., mouse lymphoma and Chinese hamster lung cells) have been reported for related antibiotics (tetracycline hydrochloride and oxytetracycline).
Clinical Studies
There is limited information regarding Demeclocycline hydrochloride Clinical Studies in the drug label.
How Supplied
Demeclocycline Hydrochloride Tablets 150 mg
- Packaged in bottle of 100 tablets
Demeclocycline Hydrochloride Tablets 300 mg
- Packaged in bottle of 48 tablets
Storage
Store at 20º to 25ºC (68º to 77ºF)
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
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. Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective. Patients should be informed that demeclocycline hydrochloride tablets should be taken at least 1 hour before meals or 2 hours after meals. Unused supplies of tetracycline antibiotics should be discarded by the expiration date. Patients who are experiencing headache, dizziness, light-headedness, vertigo, or blurred vision while on demeclocycline therapy, should be cautioned about driving vehicles or using hazardous machinery while receiving demeclocycline therapy.
Patients should be counseled that antibacterial drugs, including demeclocycline hydrochloride tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When demeclocycline hydrochloride tablets 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:
- decrease the effectiveness of the immediate treatment and
- increase the likelihood that bacteria will develop resistance and will not be treatable by demeclocycline hydrochloride tablets or other antibacterial drugs in the future.
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 the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Precautions with Alcohol
Alcohol-Demeclocycline hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- Declomycin
Look-Alike Drug Names
There is limited information regarding Demeclocycline hydrochloride Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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| Demeclocycline hydrochloride |
|---|
| DEMECLOCYCLINE HYDROCHLORIDE® FDA Package Insert |
| Description |
| Clinical Pharmacology |
| Microbiology |
| Indications and Usage |
| Contraindications |
| Warnings and Precautions |
| Adverse Reactions |
| Drug Interactions |
| Overdosage |
| Dosage and Administration |
| How Supplied |
| Labels and Packages |
For patient information, click here.
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]
Overview
Demeclocycline is a tetracycline antibiotic derived from a strain of Streptomyces aureofaciens.[1]
It is officially indicated for the treatment of various types of bacterial infections.[2] It is used as an antibiotic in the treatment of Lyme disease, acne, and bronchitis.[citation needed] Resistance, though, is gradually becoming more common, and demeclocycline is now rarely used for infections.
Category
US Brand Names
DEMECLOCYCLINE HYDROCHLORIDE®
FDA Package Insert
Description | Clinical Pharmacology | Microbiology | Indications and Usage | Contraindications | Warnings and Precautions | Adverse Reactions | Drug Interactions | Overdosage | Dosage and Administration | How Supplied | Labels and Packages
Mechanism of Action
As with related tetracycline antibiotics, demeclocycline acts by binding to the 30S and 50S ribosomal subunits, which impairs protein synthesis by bacteria. It is bacteriostatic (it impairs bacterial growth, but does not kill bacteria directly).
It is not completely understood why demeclocycline impairs the action of antidiuretic hormone, but is thought to block the binding of the hormone from its receptor.[3]
References
- ↑ Template:DorlandsDict
- ↑ "DailyMed: About DailyMed". Retrieved 2008-12-20.
- ↑ De Troyer A, Demanet JC (1975). "Correction of antidiuresis by demeclocycline". N Engl J Med. 293 (18): 915–8. doi:10.1056/NEJM197510302931809. PMID 170519.