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Medication: Klinomycin

Klinomycin uses

  1. DESCRIPTION
  2. CLINICAL PHARMACOLOGY
  3. INDICATIONS AND USAGE
  4. CONTRAINDICATIONS
  5. WARNINGS
  6. PRECAUTIONS
  7. ADVERSE REACTIONS
  8. OVERDOSAGE
  9. DOSAGE AND ADMINISTRATION
  10. HOW SUPPLIED
  11. ANIMAL PHARMACOLOGY AND TOXICOLOGY
  12. REFERENCES
  13. PATIENT INFORMATION

DESCRIPTION

Klinomycin hydrochloride is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is:

C23H27N3O7•HCl                      M.W. 493.95

Each Klinomycin hydrochloride capsule, for oral administration, contains the equivalent of 50 mg, 75 mg, or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: magnesium stearate and starch (corn).

The 50 mg, 75 mg, and 100 mg capsule shells contain: D&C Red No. 28, D&C Yellow No. 10, gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide.

The 100 mg capsule shell also contains black iron oxide.

Structural formula of Klinomycin Hydrochloride

CLINICAL PHARMACOLOGY

Following a single dose of two 100 mg capsules of Klinomycin HCl administered to 18 normal fasting adult volunteers, maximum serum concentrations were attained in 1 to 4 hours and ranged from 2.1 to 5.1 mcg/mL (average 3.5 mcg/mL). The serum half-life in the normal volunteers ranged from 11.1 to 22.1 hours (average 15.5 hours).

When Klinomycin hydrochloride capsules were given concomitantly with a high-fat meal, which included dairy products, the extent of absorption of Klinomycin hydrochloride capsules was unchanged compared to dosing under fasting conditions. The mean Tmax was delayed by one hour when administered with food, compared to dosing under fasting conditions. Klinomycin hydrochloride capsules may be administered with or without food.

In previous studies with other Klinomycin dosage forms, the Klinomycin serum half-life ranged from 11 to 16 hours in 7 patients with hepatic dysfunction, and from 18 to 69 hours in 5 patients with renal dysfunction. The urinary and fecal recovery of Klinomycin when administered to 12 normal volunteers was one-half to one-third that of other tetracyclines.

Microbiology

The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including minocycline, have a similar antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative organisms. Cross-resistance of these organisms to tetracycline is common.

Klinomycin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

AEROBIC GRAM-POSITIVE MICROORGANISMS

Because many strains of the following gram-positive microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are especially recommended. Tetracycline antibiotics should not be used for streptococcal diseases unless the organism has been demonstrated to be susceptible. Tetracyclines are not the drug of choice in the treatment of any type of staphylococcal infection.

Bacillus anthracis 1

Listeria monocytogenes 1

Staphylococcus aureus

Streptococcus pneumoniae

AEROBIC GRAM-NEGATIVE MICROORGANISMS

Bartonella bacilliformis

Brucella species

Calymmatobacterium granulomatis

Campylobacter fetus

Francisella tularensis

Haemophilus ducreyi

Vibrio cholerae

Yersinia pestis

Because many strains of the following groups of gram-negative microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility tests are especially recommended.

Acinetobacter species

Enterobacter aerogenes

Escherichia coli

Haemophilus influenzae

Klebsiella species

Neisseria gonorrhoeae 1

Neisseria meningitidis 1

Shigella species

“OTHER” MICROORGANISMS

Actinomyces species1

Borrelia recurrentis

Chlamydia psittaci

Chlamydia trachomatis

Clostridium species1

Entamoeba species

Fusobacterium nucleatum subspecies fusiforme 1

Mycobacterium marinum

Mycoplasma pneumoniae

Propionibacterium acnes

Rickettsiae

Treponema pallidum subspecies pallidum 1

Treponema pallidum subspecies pertenue

Ureaplasma urealyticum

1When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of infections caused by the cited microorganisms.

Susceptibility Tests

Susceptibility testing should be performed with tetracycline since it predicts susceptibility to minocycline. However, certain organisms (e.g., some staphylococci, and Acinetobacter species) may be more susceptible to Klinomycin and doxycycline than to tetracycline.

Dilution techniques:

Quantitative methods are used to determine antimicrobial minimal inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on a dilution method (Ref1, Ref3 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of tetracycline powder. The MIC values should be interpreted according to the following criteria:

For testing aerobic gram-negative microorganisms (Enterobacteriaceae), Acinetobacter species and Staphylococcus aureus:

 MIC (mcg/mL)  Interpretation
 ≤4.0  Susceptible (S)
 8.0  Intermediate (I)
 ≥16.0  Resistant (R)

For testing Haemophilus influenzae 2 and Streptococcus pneumoniae 3:

 MIC (mcg/mL)  Interpretation
 ≤2.0  Susceptible (S)
 4.0  Intermediate (I)
 ≥8.0  Resistant (R)

2These interpretative standards are applicable only to broth microdilution susceptibility testing with Haemophilus influenzae using Haemophilus Test Medium. Ref1

3These interpretative standards are applicable only to broth microdilution susceptibility testing using cation-adjusted Muller-Hinton broth with 2 to 5% lysed horse blood.1

For testing Neisseria gonorrhoeae 4:

 MIC (mcg/mL)  Interpretation
 ≤0.25  Susceptible (S)
 0.5 to 1.0  Intermediate (I)
 ≥2.0  Resistant (R)

4These interpretative standards are applicable only to agar dilution susceptibility testing using GC agar base and 1% defined growth supplements. Ref1

A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. 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 is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard tetracycline powder should provide the following MIC values:

 Microorganism  MIC Range (mcg/mL)
 Escherichia coli ATCC 25922 0.5 to 2.0
 Enterococcus faecalis ATCC 29212  8.0 to 32.0
 Staphylococcus aureus ATCC 29213  0.25 to 1.0
 Haemophilus influenzae ATCC 49247  4.0 to 32.0
 Streptococcus pneumoniae ATCC 49619  0.12 to 0.5
 Neisseria gonorrhoeae ATCC 49226  0.25 to 1.0

Diffusion techniques:

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure (Ref2, Ref3) requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 30 mcg tetracycline (class disk) or 30 mcg Klinomycin to test the susceptibility of microorganisms to minocycline.

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 30-mcg tetracycline or Klinomycin disk should be interpreted according to the following criteria:

For testing aerobic gram-negative microorganisms (Enterobac-teriaceae), Acinetobacter species and Staphylococcus aureus:

 Zone Diameter (mm)  Interpretation
 ≥19  Susceptible (S)
 15 to 18  Intermediate (I)
 ≤14  Resistant (R)

For testing Haemophilus influenzae 5:

 Zone Diameter (mm)  Interpretation
 ≥29  Susceptible (S)
 26 to 28  Intermediate (I)
 ≤25  Resistant (R)

5These zone diameter standards are applicable only to susceptibility testing with Haemophilus influenzae using Haemophilus Test Medium and a 30-mcg tetracycline disk. Ref2

For testing Neisseria gonorrhoeae 6:

 Zone Diameter (mm)  Interpretation
 ≥38  Susceptible (S)
 31-37  Intermediate (I)
 ≤30  Resistant (R)

6These interpretative standards are applicable only to disk diffusion testing using GC agar and 1% growth supplements, and a 30-mcg tetracycline disk. Ref2

For testing Streptococcus pneumoniae 7:

 Zone Diameter (mm)  Interpretation
 ≥23  Susceptible (S)
 19 to 22  Intermediate (I)
 ≤18  Resistant (R)

7These interpretative standards are applicable only to disk diffusion testing using Muller-Hinton agar adjusted with 5% sheep blood and a 30-mcg tetracycline disk. Ref2

For testing Vibrio cholerae 8:

 Zone Diameter (mm)  Interpretation
 ≥19  Susceptible (S)
 15 to 18  Intermediate (I)
 ≤14  Resistant (R)

8These interpretative standards are applicable only to disk diffusion testing performed with a 30-mcg tetracycline disk. Ref2

Interpretation should be as stated above for results using dilution techniques. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for tetracycline.

As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 30-mcg tetracycline or Klinomycin disk should provide the following zone diameters in these laboratory test quality control strains:

 Microorganism  Zone Diameter Range (mm)
   Tetracycline  Minocycline
 Escherichia coli ATCC 25922  18 to 25  19 to 25
 Staphylococcus aureus ATCC 29213  24 to 30  25 to 30
 Haemophilus influenzae ATCC 49247  14 to 22  –
 Neisseria gonorrhoeae ATCC 49226  30 to 42  –
 Streptococcus pneumoniae ATCC 49619  27 to 31  –

INDICATIONS AND USAGE

Klinomycin hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms:


  • 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 caused by Chlamydia trachomatis.


  • Psittacosis (Ornithosis) due to Chlamydia psittaci.


  • Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.


  • Inclusion conjunctivitis caused by Chlamydia trachomatis.


  • Nongonococcal urethritis, endocervical, or rectal infections 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 caused by Campylobacter fetus.


  • Brucellosis due to Brucella species (in conjunction with streptomycin).


  • Bartonellosis due to Bartonella bacilliformis.


  • Granuloma inguinale caused by Calymmatobacterium granulomatis.


Klinomycin is indicated for the treatment of infections caused 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.


Klinomycin hydrochloride capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:


  • Upper respiratory tract infections caused by Streptococcus pneumoniae.


  • Skin and skin structure infections caused by Staphylococcus aureus. (Note: Klinomycin is not the drug of choice in the treatment of any type of staphylococcal infection.)


When penicillin is contraindicated, Klinomycin is an alternative drug in the treatment of the following infections:


  • Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other 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.


  • Infections caused by Clostridium species.


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

In severe acne, Klinomycin may be useful adjunctive therapy.

Oral Klinomycin is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of Klinomycin in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of Klinomycin be reserved for situations in which the risk of meningococcal meningitis is high.

Oral Klinomycin is not indicated for the treatment of meningococcal infection.

Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral Klinomycin hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum.

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

CONTRAINDICATIONS

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

WARNINGS

Klinomycin, 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 drug 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 the 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 been noted in animals treated early in pregnancy.

Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) including fatal cases have been reported with Klinomycin use. If this syndrome is recognized, the drug should be discontinued immediately.

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. Under such conditions, monitoring of creatinine and BUN is recommended, and the total daily dosage should not exceed 200 mg in 24 hours. (See DOSAGE AND ADMINISTRATION .) If renal impairment exists, even usual oral or parenteral doses may lead to systemic accumulation of the drug and possible liver toxicity.

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. This has been reported with minocycline.

Central nervous system side effects including light-headedness, dizziness, or vertigo have been reported with Klinomycin therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on Klinomycin therapy. These symptoms may disappear during therapy and usually disappear rapidly when the drug is discontinued.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including minocycline, 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 be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

PRECAUTIONS

General

As with other antibiotic preparations, use of this drug may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy instituted.

Pseudotumor cerebri 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 after discontinuation of the tetracycline, the possibility for permanent sequelae exists.

Hepatotoxicity has been reported with minocycline; therefore, Klinomycin should be used with caution in patients with hepatic dysfunction and in conjunction with other hepatotoxic drugs.

Incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy when indicated.

Prescribing Klinomycin hydrochloride capsules 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.

Information for Patients

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.

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. This reaction has been reported with use of minocycline.

Patients who experience central nervous system symptoms should be cautioned about driving vehicles or using hazardous machinery while on Klinomycin therapy. (See WARNINGS .)

Concurrent use of tetracycline with oral contraceptives may render oral contraceptives less effective. (See Drug Interactions .)

Patients should be counseled that antibacterial drugs including Klinomycin hydrochloride capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Klinomycin hydrochloride 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 Klinomycin hydrochloride capsules or other antibacterial drugs in the future.

Unused supplies of tetracycline antibiotics should be discarded by the expiration date.

Laboratory Tests

In venereal disease when coexistent syphilis is suspected, a dark-field examination should be done before treatment is started and the blood serology repeated monthly for at least four months.

Periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic 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 tetracycline-class drugs in conjunction with penicillin.

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium, and iron-containing preparations.

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective.

Administration of isotretinoin should be avoided shortly before, during, and shortly after Klinomycin therapy. Each drug alone has been associated with pseudotumor cerebri.

Increased risk of ergotism when ergot alkaloids or their derivatives are given with tetracyclines.

Drug/Laboratory Test Interactions

False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Dietary administration of Klinomycin in long-term tumorigenicity studies in rats resulted in evidence of thyroid tumor production. Klinomycin has also been found to produce thyroid hyperplasia in rats and dogs. In addition, there has been evidence of oncogenic activity in rats in studies with a related antibiotic, oxytetracycline. Likewise, although mutagenicity studies of Klinomycin 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). Segment I (fertility and general reproduction) studies have provided evidence that Klinomycin impairs fertility in male rats.

Pregnancy

Teratogenic Effects

Pregnancy Category D.

All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. There are no adequate and well-controlled studies on the use of Klinomycin in pregnant women. Minocycline, like other tetracycline-class antibiotics, crosses the placenta and may cause fetal harm when administered to a pregnant woman. Rare spontaneous reports of congenital anomalies including limb reduction have been reported in post-marketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established. If Klinomycin 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.

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.

Pediatric Use

Klinomycin is not recommended for the use in children below 8 years of age unless the expected benefits of therapy outweigh the risks. (See WARNINGS .)

Geriatric Use

Clinical studies of oral Klinomycin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. (See WARNINGS , DOSAGE AND ADMINISTRATION .)

ADVERSE REACTIONS

Due to oral minocycline’s virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines.

Body as a whole: Fever, and discoloration of secretions.

Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, dyspepsia, stomatitis, glossitis, dysphagia, enamel hypoplasia, enterocolitis, pseudomembranous colitis, pancreatitis, inflammatory lesions (with monilial overgrowth) in the oral and anogenital regions. Instances of esophagitis and esophageal ulcerations have been reported in patients taking the tetracycline-class antibiotics in capsule and tablet form. Most of these patients took the medication immediately before going to bed. (See DOSAGE AND ADMINISTRATION .)

Genitourinary: Vulvovaginitis.

Hepatic toxicity: Hyperbilirubinemia, hepatic cholestasis, increases in liver enzymes, fatal hepatic failure, and jaundice. Hepatitis, including autoimmune hepatitis, and liver failure have been reported. (See PRECAUTIONS .)

Skin: Alopecia, erythema nodosum, hyperpigmentation of nails, pruritus, toxic epidermal necrolysis and vasculitis. Maculopapular and erythematous rashes. Exfoliative dermatitis has been reported. Fixed drug eruptions have been reported. Lesions occurring on the glans penis have caused balanitis. Erythema multiforme and Stevens-Johnson syndrome have been reported. Photosensitivity is discussed above. (See WARNINGS .) Pigmentation of the skin and mucous membranes has been reported.

Respiratory: Cough, dyspnea, bronchospasm, exacerbation of asthma, and pneumonitis.

Renal toxicity: Interstitial nephritis. Elevations in BUN have been reported and are apparently dose related. (See WARNINGS .) Reversible acute renal failure has been reported.

Musculoskeletal: Arthralgia, arthritis, bone discoloration, myalgia, joint stiffness, and joint swelling.

Hypersensitivity reactions: Urticaria, angioneurotic edema, polyarthralgia, anaphylaxis/anaphylactoid reaction (including shock and fatalities), anaphylactoid purpura, myocarditis, pericarditis, exacerbation of systemic lupus erythematosus and pulmonary infiltrates with eosinophilia have been reported. A transient lupus-like syndrome and serum sickness-like reactions also have been reported.

Blood: Agranulocytosis, hemolytic anemia, thrombocytopenia, leukopenia, neutropenia, pancytopenia, and eosinophilia have been reported.

Central nervous system: Convulsions, dizziness, hypesthesia, paresthesia, sedation, and vertigo. Bulging fontanels in infants and benign intracranial hypertension (pseudotumor cerebri) in adults have been reported. (See PRECAUTIONS-General .) Headache has also been reported.

Other: Thyroid cancer has been reported in the post-marketing setting in association with Klinomycin products. When Klinomycin therapy is given over prolonged periods, monitoring for signs of thyroid cancer should be considered. When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid gland. Cases of abnormal thyroid function have been reported.

Tooth discoloration in children less than 8 years of age (see WARNINGS ) and also, in adults has been reported.

Oral cavity discoloration (including tongue, lip, and gum) have been reported.

Tinnitus and decreased hearing have been reported in patients on Klinomycin hydrochloride.

The following syndromes have been reported. In some cases involving these syndromes, death has been reported. As with other serious adverse reactions, if any of these syndromes are recognized, the drug should be discontinued immediately:

Hypersensitivity syndrome consisting of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. Fever and lymphadenopathy may be present.

Lupus-like syndrome consisting of positive antinuclear antibody; arthralgia, arthritis, joint stiffness, or joint swelling; and one or more of the following: fever, myalgia, hepatitis, rash, and vasculitis.

Serum sickness-like syndrome consisting of fever; urticaria or rash; and arthralgia, arthritis, joint stiffness, or joint swelling. Eosinophilia may be present.

OVERDOSAGE

The adverse events more commonly seen in overdose are dizziness, nausea, and vomiting.

No specific antidote for Klinomycin is known.

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

DOSAGE AND ADMINISTRATION

THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF Klinomycin DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.

Klinomycin hydrochloride capsules may be taken with or without food. (See CLINICAL PHARMACOLOGY .)

Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration. The capsules should be swallowed whole.

For Pediatric Patients Above 8 Years of Age

Usual pediatric dose: 4 mg/kg initially followed by 2 mg/kg every 12 hours, not to exceed the usual adult dose.

Adults

The usual dosage of Klinomycin hydrochloride is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg capsules may be given initially followed by one 50 mg capsule 4 times daily.

Uncomplicated gonococcal infections other than urethritis and anorectal infections in men: 200 mg initially, followed by 100 mg every 12 hours for a minimum of 4 days, with post-therapy cultures within 2 to 3 days.

In the treatment of uncomplicated gonococcal urethritis in men, 100 mg every 12 hours for 5 days is recommended.

For the treatment of syphilis, the usual dosage of Klinomycin hydrochloride should be administered over a period of 10 to 15 days. Close follow-up, including laboratory tests, is recommended.

In the treatment of meningococcal carrier state, the recommended dosage is 100 mg every 12 hours for 5 days.

Mycobacterium marinum infections: Although optimal doses have not been established, 100 mg every 12 hours for 6 to 8 weeks have been used successfully in a limited number of cases.

Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis or Ureaplasma urealyticum: 100 mg orally, every 12 hours for at least 7 days.

Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration.

The pharmacokinetics of Klinomycin in patients with renal impairment (CLCR <80 mL/min) have not been fully characterized. Current data are insufficient to determine if a dosage adjustment is warranted. The total daily dosage should not exceed 200 mg in 24 hours. However, due to the anti-anabolic effect of tetracyclines, BUN and creatinine should be monitored. (See WARNINGS .)

HOW SUPPLIED

Klinomycin Hydrochloride Capsules USP, equivalent to 50 mg Klinomycin are opaque yellow capsules imprinted Klinomycin 50 and DAN 5694 supplied in bottles of 60 and 100.

Klinomycin Hydrochloride Capsules USP, equivalent to 75 mg Klinomycin are opaque white and opaque yellow capsules imprinted Klinomycin 75 and WPI supplied in bottles of 100.

Klinomycin Hydrochloride Capsules USP, equivalent to 100 mg Klinomycin are opaque dark gray and opaque yellow capsules imprinted Klinomycin 100 and DAN 5695 supplied in bottles of 50.

Dispense in a tight, light-resistant container with child-resistant closure.

Store at 20° to 25°C (68° to 77°F).

Protect from light, moisture and excessive heat.

ANIMAL PHARMACOLOGY AND TOXICOLOGY

Klinomycin hydrochloride has been observed to cause a dark discoloration of the thyroid in experimental animals (rats, minipigs, dogs and monkeys). In the rat, chronic treatment with Klinomycin hydrochloride has resulted in goiter accompanied by elevated radioactive iodine uptake and evidence of thyroid tumor production. Klinomycin hydrochloride has also been found to produce thyroid hyperplasia in rats and dogs.

REFERENCES


  • Ref1. National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically – Fourth Edition; Approved Standard. NCCLS Document M7-A4, Vol. 17, No. 2, NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA, January 1997.


  • Ref2. National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disks Susceptibility Tests – Sixth Edition; Approved Standard NCCLS Document M2-A6, Vol. 17, No. 1, NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA, January 1997.


  • Ref3. National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Susceptibility Testing – Eighth Edition; Approved Standard NCCLS Document M100-S8, Vol. 18, No. 1, NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA, January 1998.


Manufactured by: 

Watson Pharma Private Ltd.

Verna, Salcette Goa 403 722 INDIA

Distributed by:

Watson Pharma, Inc.

Parsippany, NJ 07054 USA

Revised: July 2014

PATIENT INFORMATION

Klinomycin Hydrochloride Capsules

50, 75 and 100 mg

Read the Patient Information that comes with Klinomycin hydrochloride capsules before you or a family member starts taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment.

What are Klinomycin hydrochloride capsules?

Klinomycin hydrochloride capsules are a tetracycline-class antibiotic medicine. Klinomycin hydrochloride capsules are used to treat certain infections caused by bacteria. These include infections of the skin, respiratory tract, urinary tract, some sexually transmitted diseases, and others. Klinomycin hydrochloride capsules may be used along with other treatments for severe acne.

Sometimes, other germs, called viruses cause infections. The common cold is a virus. Klinomycin hydrochloride, like other antibiotics, does not treat viruses.

Who should not use Klinomycin hydrochloride capsules?

Do not take Klinomycin hydrochloride capsules if you are allergic to Klinomycin or other tetracycline antibiotics.

Ask your doctor or pharmacist for a list of these medications if you are not sure. See the end of this leaflet for a complete list of ingredients in Klinomycin hydrochloride capsules.

Klinomycin hydrochloride capsules are not recommended for pregnant women or children up to 8 years old because:


  • Klinomycin hydrochloride capsules may harm an unborn baby


  • Klinomycin hydrochloride capsules may permanently turn a baby's or child's teeth yellow-gray-brown during tooth development. Tooth development happens in the last half of pregnancy and birth to age 8 year.


What should I tell my doctor before starting Klinomycin hydrochloride capsules?

Tell your doctor about all of your medical conditions, including if you:


  • have liver or kidney problems


  • are pregnant or planning to become pregnant. Klinomycin hydrochloride may

    harm your unborn baby. Stop taking Klinomycin hydrochloride capsules and

    call your doctor if you become pregnant while taking it.


  • are breastfeeding. Klinomycin hydrochloride passes into your milk and may

    harm your baby. You should decide whether to use Klinomycin hydrochloride

    capsules or breastfeed, but not both.


Tell your doctor about all the medicines you are taking including prescription and nonprescription medications, vitamins, and herbal supplements. Klinomycin hydrochloride capsules and other medicines may interact. Especially tell your doctor if you take:


  • birth control pills. Klinomycin hydrochloride capsules may make your birth

    control pills less effective


  • a blood thinner medicine. The dose of your blood thinner may have to be

    lowered.


  • a penicillin antibiotic medicine. Klinomycin hydrochloride capsules and

    penicillins should not be used together.


  • Migraine medicines called ergot alkaloids


  • An acne medicine called isotretinoin (Accutane, Amnesteem, Claravis,

    Sotret)


  • Antacids that contain aluminum, calcium, or magnesium, or iron-containing

    products.


Know the medicines you take, keep a list of them to show your doctor and pharmacist each time you get a new medicine.

How should I take Klinomycin hydrochloride capsules?

  • Take Klinomycin hydrochloride capsules exactly as your doctor tells you to take them. Skipping doses or not taking all your Klinomycin hydrochloride capsules may:
    • Decrease the effectiveness of the treatment
    • Increase the chance that bacteria will develop resistance to Klinomycin hydrochloride capsules

  • Take Klinomycin hydrochloride capsules with a full glass of liquid. Taking Klinomycin hydrochloride capsules with enough liquid may lower your chance of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.


  • Klinomycin hydrochloride capsules may be taken with or without food. If you forget to take Klinomycin hydrochloride capsules, take it as soon as you remember.


  • If you take too much Klinomycin hydrochloride capsules, call your doctor or poison control center right away.


What are the possible side effects of Klinomycin hydrochloride capsules?

Klinomycin hydrochloride capsules may cause serious side effects. Stop Klinomycin hydrochloride capsules and call your doctor if you have:


  • watery diarrhea


  • bloody stools


  • stomach cramps


  • unusual headaches


  • blurred vision


  • fever


  • rash


  • joint pain


  • feeling very tired


Klinomycin hydrochloride capsules may also cause:


  • central nervous system effects. Symptoms include light-headedness, dizziness, and a spinning feeling (vertigo). You should not drive or operate machines if you have these symptoms.


  • sun sensitivity (photosensitivity). You may get a worse sunburn with Klinomycin hydrochloride capsules. Avoid sun exposure and the use of sunlamps or tanning beds. Protect your skin while out in the sunlight. Stop Klinomycin hydrochloride capsules and call your doctor if your skin turns red.


These are not all the side effects with Klinomycin hydrochloride capsules. Ask your doctor or pharmacist for more information.

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

How should I store Klinomycin hydrochloride capsules?


  • Store Klinomycin hydrochloride capsules at room temperature and away from excess heat and moisture.


  • Throw away any Klinomycin hydrochloride capsules that are outdated or no longer needed.


  • Keep Klinomycin hydrochloride capsules and all medicines out of the reach of children.


General advice about Klinomycin hydrochloride capsules

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Klinomycin hydrochloride capsules for a condition for which it was not prescribed. Do not give Klinomycin hydrochloride capsules to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Klinomycin hydrochloride. If you would like more information, talk with your doctor.

Your doctor or pharmacist can give you information about Klinomycin hydrochloride that is written for health care professionals. For more information, you can also call Watson Laboratories, Inc. at 1-800-272-5525

What are the ingredients in Klinomycin hydrochloride capsules?

Active ingredient: Klinomycin hydrochloride, 50 mg, 75 mg and 100 mg.

Inactive ingredients: magnesium stearate and starch (corn).

The 50 mg, 75 mg, and 100 mg capsule shells contain: D&C Red No. 28, D&C Yellow No. 10, gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide. The 100 mg capsule shell also contains black iron oxide.

Manufactured by:

Watson Pharma Private Ltd.

Verna, Salcette Goa 403 722 INDIA

Distributed by:

Watson Pharma, Inc.

Parsippany, NJ 07054 USA

Revised: July 2014

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Klinomycin pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug. The below information contains the active ingredients of Klinomycin.


Klinomycin available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease. The below information contains the forms, composition, doses of Klinomycin.


Klinomycin destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so. The below information contains the destination, category of Klinomycin.


Klinomycin Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code. The below information contains the Indications and usages, anatomical therapeutic chemical and diseases classification codes of Klinomycin.


Klinomycin pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug. The below information contains the information about Pharmaceutical companies and Researchers involved in the development of Klinomycin.


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Frequently asked Questions

Can i drive or operate heavy machine after consuming Klinomycin?

Depending on the reaction of the Klinomycin after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Klinomycin not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Klinomycin addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sDrugs.com conducted a study on Klinomycin, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Klinomycin consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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