Drugs Details

Drugs Info of Declomycin
Drugs Details
  • Drugs Type  : Multum
  • Date : 14th Jan 2015 04:22 am
  • Brand Name : Declomycin
  • Generic Name :  demeclocycline (Pronunciation: DEM e kloe SYE kleen)
Descriptions

Demeclocycline hydrochloride is an antibiotic isolated from a mutant strain of Streptomyces aureofaciens. Chemically it is 7-Chloro-4-(dimethylamino)1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-1,11-dioxo-2naphthacenecarboxamide monohydrochloride. Its structural formula is:

 

Demeclocycline hydrochloride Structural Formula Illustration

Demeclocycline hydrochloride tablets, USP, for oral administration, contain 150 mg or 300 mg of demeclocycline hydrochloride and the following inactive ingredients: alginic acid, corn starch, D&C Red #7, D&C Yellow #10 Aluminium Lake, ethylcellulose, hypromellose, light mineral oil, magnesium stearate, mineral oil, sodium lauryl sulfate, sorbitol and titanium dioxide.

What are the possible side effects of demeclocycline (Declomycin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using demeclocycline and call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • pale skin, dark colored urine, jaundice (yellowing of the skin or eyes);
  • confusion, mood changes, weakness, increased thirst or...

Read All Potential Side Effects and See Pictures of Declomycin »

What are the precautions when taking demeclocycline hcl (Declomycin)?

See also Side Effects section.

Before taking demeclocycline, tell your doctor or pharmacist if you are allergic to it; or to other tetracycline medication (e.g., doxycycline, minocycline, tetracycline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, problems swallowing, esophagus problems (e.g., esophageal ulcers, hiatal hernia, acid reflux disease-GERD), lupus, a certain hormone imbalance called "water diabetes" (diabetes insipidus).

This drug may make you dizzy. Do not drive, use machinery, or do any...

Read All Potential Precautions of Declomycin »


This monograph has been modified to include the generic and brand name in many instances.

Indications

Demeclocycline hydrochloride, USP is indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below:

Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by rickettsiae;

Respiratory tract infections caused by Mycoplasma pneumoniae

Lymphogranuloma venereum due to Chlamydia trachomatis

Psittacosis (Ornithosis) due to Chlamydia psittaci

Trachoma due to Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence

Inclusion conjunctivitis caused by Chlamydia trachomatis

Nongonococcal urethritis in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis

Relapsing fever due to Borrelia recurrentis

Chancroid caused by Haemophilus ducreyi

Plague due to Yersinia pestis

Tularemia due to Francisella tularensis

Cholera caused by Vibrio cholerae

Campylobacter fetus infections cause by Campylobacter fetus

Brucellosis due to Brucella species (in conjunction with streptomycin);

Bartonellosis due to Bartonella bacilliformis

Granuloma inguinale caused by Calymmatobacterium granulomatis

Demeclocycline hydrochloride, USP is indicated for treatment of infections by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:

Escherichia coli

Enterobacter aerogenes

Shigella species

Acinetobacter species

Respiratory tract infections caused by Haemophilus influenzae

Respiratory tract and urinary tract infections caused by Klebsiella species

Demeclocycline hydrochloride, USP 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 Streptococcus pneumoniae

Skin and skin structure infections caused by Staphylococcus aureus. (Note: Tetracyclines, including demeclocycline, are not the drugs of choice in the treatment of any type of staphylococcal infection).

When penicillin is contraindicated, tetracyclines, including demeclocycline hydrochloride, are alternative drugs in the treatment of the following infections:

Uncomplicated urethritis in men due to Neisseria gonorrhoeae, and for the treatment of other uncomplicated gonococcal infections

Infections in women caused by Neisseria gonorrhoeae

Syphilis caused by Treponema pallidum subspecies pallidum

Yaws caused by Treponema pallidum subspecies pertenue

Listeriosis due to Listeria monocytogenes

Anthrax due to Bacillus anthracis

Vincent's infection caused by Fusobacterium fusiforme

Actinomycosis caused by Actinomyces israelii

Clostridial diseases caused by Clostridium species

In acute intestinal amebiasis, demeclocycline hydrochloride may be a useful adjunct to amebicides.

In severe acne, demeclocycline hydrochloride may be a useful adjunctive therapy.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of demeclocycline hydrochloride tablets and other antibacterial drugs, demeclocycline hydrochloride tablets 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.

Dosage Administration

Therapy should be continued for at least 24 to 48 hours after symptoms and fever have subsided.

Concomitant therapy: Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and by iron-containing preparations. Foods and some dairy products also interfere with absorption. Oral forms of tetracycline should be given at least 1 hour before or 2 hours after meals.

In patients with renal impairment: (See WARNINGS.) Tetracyclines should be used cautiously in patients with impaired renal function. Total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses.

In patients with liver impairment: Tetracyclines should be used cautiously in patients with impaired liver function. Total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses. Administration of adequate amounts of fluid with the oral formulations of tetracyclines is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS.)

Adults

Usual daily dose – Four divided doses of 150 mg each or two divided doses of 300 mg each.

For pediatric patients above eight years of age: Usual daily dose, 7 to 13 mg per kg body weight per day, depending upon the severity of the disease, divided into two to four doses not to exceed adult dosage of 600 mg per day.

Gonorrhea patients sensitive to penicillin may be treated with demeclocycline administered as an initial oral dose of 600 mg followed by 300 mg every 12 hours for four days to a total of 3 grams.

 

How Supplied

Demeclocycline hydrochloride tablets USP, 150 mg, are round, convex, red, film coated tablets, engraved with D11 on one side, and are supplied as follows:

Bottles of 100 NDC 64720-334-10

Demeclocycline hydrochloride tablets USP, 300 mg, are round, convex, red, film coated tablets, engraved with D12 on one side, and are supplied as follows:

Bottles of 48 NDC 64720-335-48

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Manufactured by: Patheon Puerto Rico, Inc. Manati, Puerto Rico 00674, USA. Distributed by: CorePharma, LLC Middlesex, NJ 08846. Rev. August, 2012.


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

The following reactions have been reported in patients receiving tetracyclines:

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. (See DOSAGE AND ADMINISTRATION.)

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. (See WARNINGS.)

Renal toxicity: Acute renal failure. Rise in BUN has been reported and is apparently dose related. Nephrogenic diabetes insipidus. (See WARNINGS.)

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 (see PRECAUTIONSGeneral). 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 has been reported rarely in adults.

Read the Declomycin (demeclocycline hcl) Side Effects Center for a complete guide to possible side effects

Interactions

Because tetracyclines have 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.

Read the Declomycin Drug Interactions Center for a complete guide to possible interactions

Learn More »


This monograph has been modified to include the generic and brand name in many instances.

Warnings

DEMECLOCYCLINE HYDROCHLORIDE, LIKE OTHER TETRACYCLINE-CLASS ANTIBIOTICS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. 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 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 DURING TOOTH DEVELOPMENT UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.

All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants 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 has also been noted in animals treated early in pregnancy. The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulation of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated and, if therapy is prolonged, serum level determinations of the drug may be advisable.

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Phototoxic reactions can occur in individuals taking demeclocycline, and are characterized by severe burns or exposed surfaces resulting from direct exposure of patients to sunlight during therapy with moderate or large doses of demeclocycline. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur and treatment should be discontinued at the first evidence of erythema of the skin.

Administration of demeclocycline hydrochloride has resulted in appearance of the diabetes insipidus syndrome (polyuria, polydipsia and weakness) in some patients on long-term therapy. The syndrome has been shown to be nephrogenic, dose-dependent and reversible on discontinuance of therapy. Patients, who are experiencing central nervous system symptoms associated with demeclocycline therapy, should be cautioned about driving vehicles or using hazardous machinery while on demeclocycline therapy.

Clostridium difficile associated with diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including demeclocycline hydrochloride and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to discontinue. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Precautions

General

Pseudotumor cerebri (benign intracranial hypertension) in adults has been associated with the use of tetracyclines. The usual clinical manifestations are headache and blurred vision. Bulging fontanels have been associated with the use of tetracyclines in infants. While both of these conditions and related symptoms usually resolve soon after discontinuation of the tetracycline, the possibility for permanent sequelae exists.

As with other antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy should be instituted. Incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy, when indicated. Prescribing demeclocycline hydrochloride tablets in the absence of a 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.

Laboratory Tests

In venereal diseases when coexistent syphilis is suspected, darkfield examination 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, should be performed. All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with demeclocycline hydrochloride should have a follow-up serologic test for syphilis after 3 months.

Carcinogenesis, Mutagenesis, Impairment of Fertility

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 (tetracyclines hydrochloride and oxytetracycline). (See WARNINGS and Animal Pharmacology And Animal Toxicology.)

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.

Pregnancy

Teratogenic effects

Pregnancy Category D

(See WARNINGS.) Result 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.

Nonteratogenic effects

(See WARNINGS.)

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 (See WARNINGS.)

Pediatric Use

Not for use in patients younger than eight years of age. See WARNINGS, PRECAUTIONS (General subsection) and DOSAGE AND ADMINISTRATION


This monograph has been modified to include the generic and brand name in many instances.

OverDose

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Tetracyclines are not removed in significant quantities by hemodialysis or peritoneal dialysis.

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.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

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 μg/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.

Microbiology

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.

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

Cross-resistance between antibiotics of the tetracycline family occurs.

Demeclocycline has been shown to be active against most isolates of the following bacteria, in vitro and/or in clinical infections as described in the INDICATIONS AND USAGE section.

Gram-positive bacteria

Bacillus anthracis
Listeria monocytogenes

Staphylococcus aureus

Streptococcus pneumoniae

Gram-negative bacteria

Bartonella bacilliformis
Brucella
species
Calymmatobacterium granulomatis

Campylobacter fetus

Francisella tularensis

Haemophilus ducreyi

Haemophilus influenzae

Neisseria gonorrhoeae

Vibrio cholerae

Yersinia pestis

Because isolates of the following groups of gram-negative bacteria have been shown to be resistant to tetracyclines, culture and susceptibility testing are especially recommended:

Acinetobacter species
Enterobacter aerogenes

Escherichia coli

Klebsiella
species
Shigella
species

Other microorganisms

Actinomyces israelii
Borrelia recurrentis

Chlamydia psittaci

Chlamydia trachomatis

Clostridium
species
Entamoeba
species
Fusobacterium fusiforme

Mycoplasma pneumoniae

Propionibacterium acnes

Rickettsiae

Treponema pallidum
subspecies pallidum
Treponema pallidum
subspecies pertenue
Ureaplasma urealyticum

Susceptibility Test Methods

When available, the clinical microbiology laboratory should provide the results of in vitro susceptibility test results for antimicrobial drug products used in resident hospitals to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antibacterial drug product for treatment.

Dilution Techniques

Quantitaive methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized test method (broth and/or agar)1,2,3. The MIC values should be interpreted according to the criteria in Table 1.

Diffusion techniques

Quantitative methods that require measurement of zone diameters can also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size provides an estimate of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized test method.2,4 This procedure uses paper disks impregnated with 30 mcg tetracycline to test the susceptibility of microorganisms to tetracycline. The disc diffusion interpretive criteria are provided in Table 1.

Table 1: Susceptibility Test Interpretive Criteria for Tetracycline

Pathogen Minimum Inhibitory Concentration (mcg/mL) Disk Diffusion (zone diameters in mm)
S I R S I R
Enterobacteriaceae, Acinetobacter spp. ≤ 4 8 > 16 ≥ 15 12 -14 < 11
Haemophilus influenzae < 2 4 > 8 > 29 26-28 < 25
Neisseria gonorrhoeae < 0.25 0.5-1 > 2 > 38 31-37 < 30
Staphylococcus aureus ≤ 4 8 ≥ 16 ≥ 19 15-18 ≤ 14
S. pneumoniae (non-meningitis isolates) ≤ 1 2 ≥ 4 ≥ 28 25-27 ≤ 24
Bacillus anthracis < 1 -- -- -- -- --
Franciscella tularensis < 4 -- -- -- -- --

A report of Susceptible indicates that the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations at the infection site necessary to inhibit growth of the pathogen. A report of Intermediate indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug product is physiologically concentrated or in situations where a high dosage of the drug product can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of Resistant indicates that the antimicrobial is not likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations usually achievable at the infection site; other therapy should be selected.

Quality Control

Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individuals performing the test.1,2,3,4 Standard tetracycline powder should provide the following range of MIC values noted in Table 2. For the diffusion technique using the 30 mcg tetracycline disk, the criteria in Table 2 should be achieved.

Table 2: Acceptable Quality Control Ranges for Tetracycline

QC Strain Minimum Inhibitory Concentrations (mcg/mL) Disk Diffusion (zone diameters in mm)
Escherichia coli ATCC* 25922 0.5 to 2 18 -25
Staphylococcus aureus ATCC 29213 0.12 to 1 ----
Staphylococcus aureus ATCC 25923 ---- 24-30
Haemophilus influenzae ATCC 49247 4 to 32 14 -22
Neisseria gonorrhoeae ATCC 49226 0.25 - 1 30 - 42
Streptococcus pneumoniae ATCC 49619 0.06 - 0.5 27 - 31
*ATCC = American Type Culture Collection

Animal Pharmacology And Animal Toxicology

Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO4 and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO4, and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline.

Minocycline, tetracycline PO4, 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.

REFERENCES

1. Clinical and Laboratory Standards Institute (CLSI.) Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically. Approved Standard – 9th Edition. CLSI document M7-A9, 950 West Valley Rd. Suite 2500,.Wayne, PA 19087, 2012.

2. CLSI. Performance Standards for Antimicrobial Susceptibility Testing. 22nd Informational Supplement. CLSI document M100-S22. Wayne, PA, 2012.

3. CLSI. Methods or Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria: Approved Guideline - 2nd Edition. CLSI document M45-A2. CLSI, Wayne, PA, 2011.

4. CLSI. Performance Standards for Antimicrobial Disk Susceptibility Tests. Approved Standard – 11th Edition. CLSI document M2-A11. Wayne, PA, 2012.


This monograph has been modified to include the generic and brand name in many instances.

Patient 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. (See DRUG INTERACTIONS.) Patients should be informed that demeclocycline hydrochloride tablets should be taken at least 1 hour before meals or 2 hours after meals (See DOSAGE AND ADMINISTRATION.) 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 (See WARNINGS.)

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 (1) decrease the effectiveness of the immediate treatment and (2) 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 cause 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.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

DEMECLOCYCLINE - ORAL

 

(dem-eh-klo-SYE-kleen)

 

COMMON BRAND NAME(S): Declomycin

 

USES: Demeclocycline is used to treat a wide variety of bacterial infections, including those that cause acne. This medication is known as a tetracycline antibiotic. It works by stopping the growth of bacteria.

This antibiotic treats only bacterial infections. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

 

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for treating a certain hormone imbalance (Syndrome of Inappropriate Antidiuretic Hormone-SIADH) which causes your body to retain water and your urine to be more concentrated than it should be. Demeclocycline works by increasing the amount of water in your urine to more normal levels.

 

HOW TO USE: Take this medication by mouth, usually 2 to 4 times a day or as directed by your doctor. Demeclocycline works best when taken on an empty stomach at least 1 hour before or 2 hours after a meal. Take each dose with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for 10 minutes after taking this drug. For this reason, do not take it right before bedtime.

If stomach upset occurs, ask your doctor if you can take this medication with food.

Take this medication 2 to 3 hours before or after taking any medications containing magnesium, aluminum, or calcium. Some examples include quinapril, certain forms of didanosine (chewable/dispersible buffered tablets or pediatric oral solution), vitamins/minerals, and antacids. Dairy products (e.g., milk, yogurt), calcium-enriched juice, sucralfate, bismuth subsalicylate, iron, and zinc are also included. These products bind with demeclocycline, preventing its full absorption.

The dosage is based on your medical condition and response to treatment. When treating children over 8 years of age, the dosage is also based on weight. For the treatment of infection, children should not take more than 600 milligrams of this medication per day.

This medication works best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals.

If you are taking this medication to treat an infection, continue to take it until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Inform your doctor if your condition persists or worsens. If you are using this medication to treat SIADH, you should notice an increase in the amount of urine within 5 days.

Consumer Overview Side Effect

SIDE EFFECTS: Diarrhea, loss of appetite, nausea, vomiting, headache, dizziness, lightheadedness, or rectal discomfort may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: sunburn-like skin reaction (sun sensitivity), darkening of the skin and other areas of the body (e.g., lips, inside of the mouth), difficult/painful swallowing, unusual increase in the amount of urine (except for the expected increase in urination if you are treating SIADH), unusual decrease in the amount of urine or no urine, unusual thirst, weakness, unusual tiredness, brown/gray tooth discoloration.

Tell your doctor immediately if any of these rare but very serious side effects occur: hearing changes (e.g., ringing in the ears, decreased hearing), easy bruising/bleeding, new signs of infection (e.g., persistent sore throat, fever, chills), stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine.

Tetracycline drugs such as demeclocycline may rarely cause a serious increase in pressure inside the skull (intracranial hypertension-IH). The risk of this side effect is greater for women of childbearing age who are overweight or who have had IH in the past. If IH develops, it usually goes away after demeclocycline is stopped; however, there is a chance of permanent vision loss or blindness. Get medical help right away if you have: persistent/severe headache, vision changes (such as blurred/double vision, decreased vision, sudden blindness), persistent nausea/vomiting.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction, including: rash, skin sores/blisters, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, new or worsening swelling/pain in the joints, chest pain, fast/irregular heartbeat.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Declomycin (demeclocycline hcl) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: See also Side Effects section.

Before taking demeclocycline, tell your doctor or pharmacist if you are allergic to it; or to other tetracycline medication (e.g., doxycycline, minocycline, tetracycline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, problems swallowing, esophagus problems (e.g., esophageal ulcers, hiatal hernia, acid reflux disease-GERD), lupus, a certain hormone imbalance called "water diabetes" (diabetes insipidus).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist that you are using demeclocycline.

This medication should not be used in children younger than 8 years of age because it may cause permanent tooth discoloration and other problems. Tooth discoloration has also occurred in older children and young adults. Consult your doctor for more information.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control.

This medication passes into breast milk in very small amounts. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: See also How to Use section.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: retinoid medications taken by mouth (such as acitretin, isotretinoin), strontium ranelate.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting demeclocycline.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: digoxin, kaolin pectin, live bacterial vaccines, penicillins, warfarin.

Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic.

This product can affect the results of certain lab tests (e.g., some urine tests for sugar), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case.

With prolonged use or if this medication is used to treat SIADH, laboratory and/or medical tests (e.g., complete blood count, kidney and liver function tests, mineral levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) in a tightly closed container away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Taking outdated demeclocycline can result in serious illness. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Declomycin

Generic Name: demeclocycline (Pronunciation: DEM e kloe SYE kleen)

  • What is demeclocycline (Declomycin)?
  • What are the possible side effects of demeclocycline (Declomycin)?
  • What is the most important information I should know about demeclocycline (Declomycin)?
  • What should I discuss with my healthcare provider before taking demeclocycline (Declomycin)?
  • How should I take demeclocycline (Declomycin)?
  • What happens if I miss a dose (Declomycin)?
  • What happens if I overdose (Declomycin)?
  • What should I avoid while taking demeclocycline (Declomycin)?
  • What other drugs will affect demeclocycline (Declomycin)?
  • Where can I get more information?

What is demeclocycline (Declomycin)?

Demeclocycline is a tetracycline antibiotic. It fights bacteria in the body.

Demeclocycline is used to treat many different bacterial infections, such as urinary tract infections, acne, gonorrhea, chlamydia, and others.

Demeclocycline may also be used for purposes not listed in this medication guide.

Declomycin 150 mg

round, red, imprinted with LL, D 11

What are the possible side effects of demeclocycline (Declomycin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using demeclocycline and call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • pale skin, dark colored urine, jaundice (yellowing of the skin or eyes);
  • confusion, mood changes, weakness, increased thirst or urination;
  • swelling, weight gain, urinating less than usual or not at all;
  • chest pain, wheezing, dry cough, rapid breathing, feeling short of breath;
  • severe tingling, numbness, pain, muscle weakness;
  • headache, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes;
  • sore throat and headache with a severe blistering, peeling, and red skin rash; or
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate.

Less serious side effects may include:

  • sores or swelling in your rectal or genital area;
  • mild nausea, vomiting, diarrhea, loss of appetite;
  • white patches or sores inside your mouth or on your lips;
  • swollen tongue, trouble swallowing; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Declomycin (demeclocycline hcl) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about demeclocycline (Declomycin)?

You should not take this medication if you are allergic to demeclocycline or to similar antibiotics such as doxycycline (Adoxa, Alodox, Avidoxy, Oraxyl, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap).

Do not use demeclocycline if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life.

Demeclocycline can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking demeclocycline.

Demeclocycline passes into breast milk and may affect bone and tooth development in a nursing baby. You should not breast-feed while you are taking demeclocycline.

Do not give demeclocycline to a child younger than 8 years old. Demeclocycline can affect a child's growth or cause permanent yellowing or graying of the teeth.

Avoid exposure to sunlight or tanning beds. Demeclocycline can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Do not take iron supplements, multivitamins, calcium supplements, antacids, or laxatives within 2 hours before or after taking demeclocycline. Also avoid a product that contains bismuth subsalicylate (such as Pepto-Bismol) within 2 hours before or after taking demeclocycline. These medications can make it harder for your body to absorb demeclocycline.

Throw away any unused demeclocycline after the expiration date on the label has passed.

Side Effects Centers
  • Declomycin

Patient Detailed How Take

What should I discuss with my healthcare provider before taking demeclocycline (Declomycin)?

You should not take this medication if you are allergic to demeclocycline or to similar antibiotics such as doxycycline (Adoxa, Alodox, Avidoxy, Oraxyl, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap).

To make sure you can safely take demeclocycline, tell your doctor if you have any of these other conditions:

  • kidney disease;
  • liver disease; or
  • diabetes.

If you are being treated for gonorrhea, your doctor may test you to make sure you do not also have syphilis, another sexually transmitted disease.

FDA pregnancy category D. Do not use demeclocycline if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Demeclocycline can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking demeclocycline.

Demeclocycline passes into breast milk and may affect bone and tooth development in a nursing baby. You should not breast-feed while you are taking demeclocycline.

Do not give demeclocycline to a child younger than 8 years old. Demeclocycline can affect a child's growth or cause permanent yellowing or graying of the teeth.

How should I take demeclocycline (Declomycin)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take demeclocycline on an empty stomach, at least 1 hour before or 2 hours after a meal.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Demeclocycline is usually given for up to 2 days after lab tests show that the infection has cleared. Demeclocycline will not treat a viral infection such as the common cold or flu.

Do not share this medication with another person, even if they have the same symptoms you have.

If you take this medication long-term, your blood will need to be tested often. Your kidney and liver function may also need to be tested. Visit your doctor regularly.

Store at room temperature away from moisture, heat, and light. Throw away any unused demeclocycline after the expiration date on the label has passed.

Side Effects Centers
  • Declomycin

Patient Detailed Avoid Taking

What happens if I miss a dose (Declomycin)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Declomycin)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking demeclocycline (Declomycin)?

Do not take demeclocycline with milk or other dairy products, unless your doctor has told you to. Dairy products can make it harder for your body to absorb the medicine.

Demeclocycline may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid exposure to sunlight or tanning beds. Demeclocycline can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Do not take iron supplements, multivitamins, calcium supplements, antacids, or laxatives within 2 hours before or after taking demeclocycline. Also avoid a product that contains bismuth subsalicylate (such as Pepto-Bismol) within 2 hours before or after taking demeclocycline. These medications can make it harder for your body to absorb demeclocycline.

What other drugs will affect demeclocycline (Declomycin)?

Tell your doctor about all other medicines you use, especially:

  • colestipol (Colestid);
  • methotrexate (Rheumatrex, Trexall);
  • isotretinoin (Accutane);
  • vitamin A or a retinoid such as acitretin (Soriatane) or tretinoin (Renova, Retin-A, Vesanoid);
  • an antacid such as Tums, Rolaids, Milk of Magnesia, Maalox, and others;
  • a blood thinner such as warfarin (Coumadin); or
  • a penicillin antibiotic such as amoxicillin (Amoxil, Trimox, others), penicillin (BeePen-VK, Pen-Vee K, Veetids, others), dicloxacillin (Dynapen), oxacillin (Bactocill), and others.

This list is not complete and other drugs may interact with demeclocycline. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about demeclocycline.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 7.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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