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SUMYCIN

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Overview

What is SUMYCIN?

Tetracycline is a yellow, crystalline powder. Tetracycline is soluble in water, slightly soluble in ethanol (96%), practically insoluble in acetone. It dissolves in solutions of alkali hydroxides and carbonates. Solutions in water become turbid on standing, owing to the precipitation of tetracycline. The  chemical  name  for  tetracycline  hydrochloride  is  4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a­octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows:

Each tablet, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride.

Inactive Ingredients:

In addition to these, the 250 mg tablet film coating includes triacetin and 500 mg tablet film coating includes polyethylene glycol.



What does SUMYCIN look like?



What are the available doses of SUMYCIN?

Sorry No records found.

What should I talk to my health care provider before I take SUMYCIN?

Sorry No records found

How should I use SUMYCIN?

To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride tablets should be used only to treat 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.

Tetracycline hydrochloride tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:

Adults: Usual daily dose, 1 gram as 500 mg twice a day or 250 mg four times a day. Higher doses such as 500 mg four times a day may be required for severe infections or for those infections which do not respond to the smaller doses.

For pediatric patients above eight years of age: Usual daily dose, 10 mg/lb to 20 mg/lb (25 mg/kg to 50 mg/kg) body weight divided in four equal doses.

Administration of adequate amounts of fluid with the tablet formulation of tetracycline is recommended to wash down the drug and reduce the risk of esophageal irritation and ulceration (see ).

Absorption of tetracycline is impaired by antacids containing aluminum, calcium or magnesium and preparations containing iron, zinc or sodium bicarbonate. Food and some dairy products also interfere with absorption.

When used in streptococcal infections, therapy should be continued for 10 days.

For treatment of brucellosis, 500 mg tetracycline hydrochloride tablets four times a day for three weeks accompanied by streptomycin, 1 gram intramuscularly twice daily the first week and once daily the second week.

For the treatment of syphilis in patients allergic to penicillin, the following dosage of tetracycline hydrochloride tablets is recommended: early syphilis (less than one year’s duration), 500 mg four times a day for 15 days. Syphilis of more than one year’s duration (except neurosyphilis), 500 mg four times a day for 30 days.

For treatment of gonorrhea, the recommended dose is 500 mg by mouth four times a day for seven days.

Uncomplicated urethral, endocervical or rectal infections in adults caused by : 500 mg, by mouth, four times a day for at least seven days.

In cases of moderate to severe acne which, in the judgement of the clinician, require long-term treatment, the recommended initial dosage is 1 gram daily in divided doses. When improvement is noted, reduce dosage gradually to maintenance levels ranging from 125 mg to 500 mg daily. In some patients it may be possible to maintain adequate remission of lesions with alternate day or intermittent therapy. Tetracycline hydrochloride tablets therapy of acne should augment the other standard measures known to be of value. Duration of long-term treatment which can safely be recommended has not been established (see and ).


What interacts with SUMYCIN?

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



What are the warnings of SUMYCIN?

Use of corticosteroids may cause the breakdown of body protein and increase plasma ammonia levels.

 

The use of drugs of the tetracycline-class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drugs but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracycline drugs should not be used in this age group, except for anthrax, unless other drugs are not likely to be effective or are contraindicated.

 

If CDAD is suspected or confirmed, ongoing use of antibacterial drugs not directed against need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of and institute surgical evaluation clinically indicated.

Photosensitivity

 

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Advise patients apt to be exposed to direct sunlight or ultraviolet lights that this reaction can occur with tetracycline drugs. Discontinue treatment at the first evidence of skin erythema.

Intracranial Hypertension

 

Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including Achromycin V. Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH. Concomitant use of isotretinoin and tetracycline should be avoided because isotretinoin, a systemic retinoid, is also known to cause pseudotumor cerebri.

Although IH typically resolve after discontinuation of treatment, the possibility for permanent visual loss exists. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Since  intracranial  pressure  can  remain  elevated  for  weeks  after  drug  cessation  patients  should  be monitored until they stabilize.

Skeletal Development

 

All tetracyclines form a stable calcium complex in any bone forming tissue. A decrease in fibula growth rate has been observed in premature 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. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus. Tetracycline drugs should not be used during pregnancy unless absolutely necessary.

Antianabolic Action

 

The antianabolic 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 renal function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia and acidosis.

Laboratory Monitoring for Long-Term Therapy

 

In long-term therapy, perform periodic laboratory evaluation of organ systems, including hematopoietic, renal and hepatic studies. 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.


What are the precautions of SUMYCIN?

General

As with other antibacterials, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue antibacterial and institute appropriate therapy.

Treat all infections due to Group A beta-hemolytic streptococci for at least ten days.

Perform incision and drainage or other surgical procedures in conjunction with antibacterial therapy, when indicated.

Prescribing  tetracycline  in  the  absence  of  proven  or  strongly  suspected  bacterial  infection  or  a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Information for Patients

Counsel patients that antibacterial drugs including tetracycline should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When tetracycline is prescribed to treat a bacterial infection, tell patients 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 tetracycline or other antibacterial drugs in the future.

Laboratory Tests

In sexually transmitted infections, when coexistent syphilis is suspected, perform dark field examinations before treatment is started and the blood serology repeated monthly for at least four months.

Drug Interactions

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline in conjunction with penicillin or other bactericidal antibacterials.

Because the tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

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

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

Concurrent use of tetracycline may render oral contraceptives less effective.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies are currently being conducted to determine whether tetracycline hydrochloride has carcinogenic potential.  Some related antibacterials (oxytetracycline, minocycline) have shown evidence of oncogenic activity in rats.

In two mammalian cell assay systems (L 51784y mouse lymphoma and Chinese hamster lung cells), there was evidence of mutagenicity with tetracycline hydrochloride.

Tetracycline hydrochloride had no effect on fertility when administered in the diet to male and female rats at a daily intake of approximately 400 mg/kg/day, roughly 8 times the highest recommended human dose based on body surface area.

Pregnancy

Teratogenic Effects

Pregnancy Category D

(see )

Nonteratogenic Effects

(see )

Pregnant women with renal disease may be more prone to develop tetracycline-associated liver failure.

Labor and Delivery

The effect of tetracyclines on labor and delivery is unknown.

Nursing Mothers

Because of potential for serious adverse reaction in nursing infants from tetracyclines, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother (see ).

Pediatric Use

See and


What are the side effects of SUMYCIN?

Gastrointestinal:

Candida

Esophagitis and esophageal ulceration have been reported in patients receiving particularly the capsule and also the tablet forms of tetracyclines.

Most of the patients were reported to have taken medication immediately before going to bed (see ).

Teeth:

WARNINGS

Skin:

WARNINGS

Renal Toxicity:

Liver:

Hypersensitivity Reactions:

Blood:

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.


What should I look out for while using SUMYCIN?

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

T

ooth Development

 

The use of drugs of the tetracycline-class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drugs but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracycline drugs should not be used in this age group, except for anthrax, unless other drugs are not likely to be effective or are contraindicated.

A

ssociated Diarrhea

 

C

l

ostridium difficile

C. difficile

C. difficile

C. difficile

If CDAD is suspected or confirmed, ongoing use of antibacterial drugs not directed against need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of and institute surgical evaluation clinically indicated.

Photosensitivity

 

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Advise patients apt to be exposed to direct sunlight or ultraviolet lights that this reaction can occur with tetracycline drugs. Discontinue treatment at the first evidence of skin erythema.

Intracranial Hypertension

 

Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including Achromycin V. Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH. Concomitant use of isotretinoin and tetracycline should be avoided because isotretinoin, a systemic retinoid, is also known to cause pseudotumor cerebri.

Although IH typically resolve after discontinuation of treatment, the possibility for permanent visual loss exists. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Since  intracranial  pressure  can  remain  elevated  for  weeks  after  drug  cessation  patients  should  be monitored until they stabilize.

Skeletal Development

 

All tetracyclines form a stable calcium complex in any bone forming tissue. A decrease in fibula growth rate has been observed in premature 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. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus. Tetracycline drugs should not be used during pregnancy unless absolutely necessary.

Antianabolic Action

 

The antianabolic 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 renal function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia and acidosis.

Laboratory Monitoring for Long-Term Therapy

 

In long-term therapy, perform periodic laboratory evaluation of organ systems, including hematopoietic, renal and hepatic studies. 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.


What might happen if I take too much SUMYCIN?

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Tetracycline is not dialyzable.


How should I store and handle SUMYCIN?

Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from moisture.Tetracycline Hydrochloride Tablets, USP are available as:250 mg: Light pink, ovaloid, coated tablet debossed with “732” on one side and plain on the other side. Available in bottles of:Bottles of 100            NDC 49884-732-01Bottles of 1,000         NDC 49884-732-10500 mg: Pink, ovaloid, coated tablet debossed with “733” on one side and plain on the other side. Available in bottles of:Bottles of 100           NDC 49884-733-01Bottles of 500           NDC 49884-733-05Dispense in a tight, light-resistant containers as defined in the USP. Use child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Tetracycline Hydrochloride Tablets, USP are available as:250 mg: Light pink, ovaloid, coated tablet debossed with “732” on one side and plain on the other side. Available in bottles of:Bottles of 100            NDC 49884-732-01Bottles of 1,000         NDC 49884-732-10500 mg: Pink, ovaloid, coated tablet debossed with “733” on one side and plain on the other side. Available in bottles of:Bottles of 100           NDC 49884-733-01Bottles of 500           NDC 49884-733-05Dispense in a tight, light-resistant containers as defined in the USP. Use child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Tetracycline Hydrochloride Tablets, USP are available as:250 mg: Light pink, ovaloid, coated tablet debossed with “732” on one side and plain on the other side. Available in bottles of:Bottles of 100            NDC 49884-732-01Bottles of 1,000         NDC 49884-732-10500 mg: Pink, ovaloid, coated tablet debossed with “733” on one side and plain on the other side. Available in bottles of:Bottles of 100           NDC 49884-733-01Bottles of 500           NDC 49884-733-05Dispense in a tight, light-resistant containers as defined in the USP. Use child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Tetracycline Hydrochloride Tablets, USP are available as:250 mg: Light pink, ovaloid, coated tablet debossed with “732” on one side and plain on the other side. Available in bottles of:Bottles of 100            NDC 49884-732-01Bottles of 1,000         NDC 49884-732-10500 mg: Pink, ovaloid, coated tablet debossed with “733” on one side and plain on the other side. Available in bottles of:Bottles of 100           NDC 49884-733-01Bottles of 500           NDC 49884-733-05Dispense in a tight, light-resistant containers as defined in the USP. Use child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Tetracycline Hydrochloride Tablets, USP are available as:250 mg: Light pink, ovaloid, coated tablet debossed with “732” on one side and plain on the other side. Available in bottles of:Bottles of 100            NDC 49884-732-01Bottles of 1,000         NDC 49884-732-10500 mg: Pink, ovaloid, coated tablet debossed with “733” on one side and plain on the other side. Available in bottles of:Bottles of 100           NDC 49884-733-01Bottles of 500           NDC 49884-733-05Dispense in a tight, light-resistant containers as defined in the USP. Use child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Tetracycline Hydrochloride Tablets, USP are available as:250 mg: Light pink, ovaloid, coated tablet debossed with “732” on one side and plain on the other side. Available in bottles of:Bottles of 100            NDC 49884-732-01Bottles of 1,000         NDC 49884-732-10500 mg: Pink, ovaloid, coated tablet debossed with “733” on one side and plain on the other side. Available in bottles of:Bottles of 100           NDC 49884-733-01Bottles of 500           NDC 49884-733-05Dispense in a tight, light-resistant containers as defined in the USP. Use child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Tetracycline Hydrochloride Tablets, USP are available as:250 mg: Light pink, ovaloid, coated tablet debossed with “732” on one side and plain on the other side. Available in bottles of:Bottles of 100            NDC 49884-732-01Bottles of 1,000         NDC 49884-732-10500 mg: Pink, ovaloid, coated tablet debossed with “733” on one side and plain on the other side. Available in bottles of:Bottles of 100           NDC 49884-733-01Bottles of 500           NDC 49884-733-05Dispense in a tight, light-resistant containers as defined in the USP. Use child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Tetracycline Hydrochloride Tablets, USP are available as:250 mg: Light pink, ovaloid, coated tablet debossed with “732” on one side and plain on the other side. Available in bottles of:Bottles of 100            NDC 49884-732-01Bottles of 1,000         NDC 49884-732-10500 mg: Pink, ovaloid, coated tablet debossed with “733” on one side and plain on the other side. Available in bottles of:Bottles of 100           NDC 49884-733-01Bottles of 500           NDC 49884-733-05Dispense in a tight, light-resistant containers as defined in the USP. Use child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Tetracycline Hydrochloride Tablets, USP are available as:250 mg: Light pink, ovaloid, coated tablet debossed with “732” on one side and plain on the other side. Available in bottles of:Bottles of 100            NDC 49884-732-01Bottles of 1,000         NDC 49884-732-10500 mg: Pink, ovaloid, coated tablet debossed with “733” on one side and plain on the other side. Available in bottles of:Bottles of 100           NDC 49884-733-01Bottles of 500           NDC 49884-733-05Dispense in a tight, light-resistant containers as defined in the USP. Use child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Tetracycline Hydrochloride Tablets, USP are available as:250 mg: Light pink, ovaloid, coated tablet debossed with “732” on one side and plain on the other side. Available in bottles of:Bottles of 100            NDC 49884-732-01Bottles of 1,000         NDC 49884-732-10500 mg: Pink, ovaloid, coated tablet debossed with “733” on one side and plain on the other side. Available in bottles of:Bottles of 100           NDC 49884-733-01Bottles of 500           NDC 49884-733-05Dispense in a tight, light-resistant containers as defined in the USP. Use child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Tetracycline Hydrochloride Tablets, USP are available as:250 mg: Light pink, ovaloid, coated tablet debossed with “732” on one side and plain on the other side. Available in bottles of:Bottles of 100            NDC 49884-732-01Bottles of 1,000         NDC 49884-732-10500 mg: Pink, ovaloid, coated tablet debossed with “733” on one side and plain on the other side. Available in bottles of:Bottles of 100           NDC 49884-733-01Bottles of 500           NDC 49884-733-05Dispense in a tight, light-resistant containers as defined in the USP. Use child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Tetracycline Hydrochloride Tablets, USP are available as:250 mg: Light pink, ovaloid, coated tablet debossed with “732” on one side and plain on the other side. Available in bottles of:Bottles of 100            NDC 49884-732-01Bottles of 1,000         NDC 49884-732-10500 mg: Pink, ovaloid, coated tablet debossed with “733” on one side and plain on the other side. Available in bottles of:Bottles of 100           NDC 49884-733-01Bottles of 500           NDC 49884-733-05Dispense in a tight, light-resistant containers as defined in the USP. Use child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Tetracyclines are readily absorbed and are bound to plasma protein in varying degrees. They are concentrated by the liver in the bile and excreted in the urine and feces at high concentrations in a biologically active form.

Microbiology

Tetracyclines are primarily bacteriostatic and exert their antimicrobial effect by the inhibition of protein synthesis by binding to the 30S ribosomal subunit. Tetracycline is active against a broad range of gram-negative and gram-positive organisms. The drugs in the tetracycline class have closely similar antimicrobial spectra, and cross-resistance among them is common.

Tetracycline has been shown to be active against most isolates of the following bacteria, both and in clinical infections as described in the section of the package insert.

G

ram-

negative

B

acteria

 

Acinetobacter

Bartonella bacilliformis

Brucella

C

ampylobacter fetus

Enterobacter aerogenes

Escherichia coli

Francisella tularensis

Haemophilus ducreyi

Haemophilus influenzae

Klebsiella

K

l

ebsiella granulomatis

N

eisseria gonorrhoeae

Shigella

Vibrio cholerae

Y

e

rsinia pestis

 

G

ram-positive Bacteria

 

Bacillus anthracis

Streptococcus pyogenes

Streptococcus pneumoniae

Staphylococcus aureus

Listeria monocytogenes

 

A

naerobes

 

Bacteroides

C

l

ostridium

Fusobacterium fusiforme

Propionibacterium acnes

 

Ot

her Bacteria

 

Actinomyces

Borrelia recurrentis

C

hlamydophila psittaci

C

hlamydia trachomatis

Rickettsiae

Treponema pallidum

Treponema pallidum

pertenue

 

P

arasites

 

Entamoeba

Balantidium coli

 

Susceptibility Test Methods

 

When available, the clinical microbiology laboratory should provide the results of susceptibility test results for antimicrobial drugs 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 the most effective antimicrobial.

 

D

il

ution Techniques

 

Quantitative 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). The MIC values should be interpreted according to the criteria provided in Table 1.

 

Di

f

f

u

sion 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 standard test method. This procedure uses paper disks impregnated with 30 mcg tetracycline to test the susceptibility of bacteria to tetracycline. The disk diffusion interpretive criteria are provided in Table 1.

 

A

naerobic Techniques

 

For anaerobic bacteria, the susceptibility to tetracycline can be determined by a standardized test method. The MIC values obtained should be interpreted according to the criteria provided in Table 1.

A report of (S) indicates that the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations usually achievable at the site of infection. A report of (I) indicates that the result should be considered equivocal, and, if the bacteria 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 that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of (R) 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.

Q

uality Control

 

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

Non-Clinical Toxicology
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

T

ooth Development

 

The use of drugs of the tetracycline-class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drugs but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracycline drugs should not be used in this age group, except for anthrax, unless other drugs are not likely to be effective or are contraindicated.

A

ssociated Diarrhea

 

C

l

ostridium difficile

C. difficile

C. difficile

C. difficile

If CDAD is suspected or confirmed, ongoing use of antibacterial drugs not directed against need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of and institute surgical evaluation clinically indicated.

Photosensitivity

 

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Advise patients apt to be exposed to direct sunlight or ultraviolet lights that this reaction can occur with tetracycline drugs. Discontinue treatment at the first evidence of skin erythema.

Intracranial Hypertension

 

Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including Achromycin V. Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH. Concomitant use of isotretinoin and tetracycline should be avoided because isotretinoin, a systemic retinoid, is also known to cause pseudotumor cerebri.

Although IH typically resolve after discontinuation of treatment, the possibility for permanent visual loss exists. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Since  intracranial  pressure  can  remain  elevated  for  weeks  after  drug  cessation  patients  should  be monitored until they stabilize.

Skeletal Development

 

All tetracyclines form a stable calcium complex in any bone forming tissue. A decrease in fibula growth rate has been observed in premature 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. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus. Tetracycline drugs should not be used during pregnancy unless absolutely necessary.

Antianabolic Action

 

The antianabolic 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 renal function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia and acidosis.

Laboratory Monitoring for Long-Term Therapy

 

In long-term therapy, perform periodic laboratory evaluation of organ systems, including hematopoietic, renal and hepatic studies. 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.

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline in conjunction with penicillin or other bactericidal antibacterials.

Because the tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

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

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

Concurrent use of tetracycline may render oral contraceptives less effective.

As with other antibacterials, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue antibacterial and institute appropriate therapy.

Treat all infections due to Group A beta-hemolytic streptococci for at least ten days.

Perform incision and drainage or other surgical procedures in conjunction with antibacterial therapy, when indicated.

Prescribing  tetracycline  in  the  absence  of  proven  or  strongly  suspected  bacterial  infection  or  a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Gastrointestinal:

Candida

Esophagitis and esophageal ulceration have been reported in patients receiving particularly the capsule and also the tablet forms of tetracyclines.

Most of the patients were reported to have taken medication immediately before going to bed (see ).

Teeth:

WARNINGS

Skin:

WARNINGS

Renal Toxicity:

Liver:

Hypersensitivity Reactions:

Blood:

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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).