Tetracycline 250 MG Oral Capsule
WARNINGS
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 IN THIS AGE GROUP 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 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, the patient should be apprised of the potential hazard to the fetus.
Tetracycline drugs should not be used during pregnancy unless absolutely necessary.
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.
Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs.
Treatment should be discontinued at the first evidence of skin erythema.
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.
OVERDOSAGE
In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures.
Tetracycline is not dialyzable.
DESCRIPTION
Tetracycline is a yellow, odorless, crystalline powder.
Tetracycline is stable in air but exposure to strong sunlight causes it to darken.
Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions.
Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether.
The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride.
Its structural formula is as follows: C22H24N208HCI M.W.
480.90 MM1
HOW SUPPLIED
Tetracycline Hydrochloride Capsules USP, 500 mg are available as black and yellow capsules, imprinted with company logo and 2407, containing 500 mg of tetracycline hydrochloride, packaged in blisters of 30 capsules.
PHARMACIST: Dispense in a tight, light resistant container as defined in the USP, with a child-resistant closure (as required).
Store at 20to 25(68to 77[See USP Controlled Room Temperature].
INDICATIONS AND USAGE
INDICATIONS & USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride 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.
Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae.
Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible.
Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.) Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus.
(Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.) Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox.
Psittacosis or ornithosis caused by Chlamydia Psittaci.
Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum.
Granuloma inquinale caused by Calymmatobacterium granulomatis.
Relapsing fever caused by Borrelia sp.
Bartonellosis caused by Bartonella bacilliformis.
Chancroid caused by Hemophilus ducreyi.
Tularemia caused by Francisella tularensis.
Plaque caused by Yersinia pestis.
Cholera caused by Vibrio cholerae.
Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside).
Infections due to Campylobacter fetus.
As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica.
Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc.
Other infections caused by susceptible gram-negative organisms such as E.
coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp.
In severe acne, adjunctive therapy with tetracycline may be useful.
When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of the following infections: syphilis and yaws caused by Treponema pallidum and pertenue, respectively, Vincent’s infection caused by Fusobacterium fusiforme, infections caused by Neisseria gonorrhoeae, anthrax caused by Bacillus anthracis, infections due to Listeria monocytogenes, actinomycosis caused by Actinomyces species, infections due to Clostridium species.
INACTIVE INGREDIENTS
INACTIVE INGREDIENT lactose magnesium stearate sodium lauryl sulfate DC yellow no.
10 FDC yellow no.
6 gelatin titanium dioxide benzyl alcohol butylparaben DC red no.
22 edetate calcium disodium methylparaben propylparaben silicon dioxide sodium propionate pharmaceutical glaze synthetic black iron oxide DC yellow no.
10 aluminum lake dimethylpolysiloxane water ethylene glycol monoethyl ether FDC blue no.
1 aluminum lake FDC blue no.
2 aluminum lake FDC red no.
40 aluminum lake lecithin n-butyl alcohol propylene alcohol SDA-3A alcohol
DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION Adults Usual daily dose, 1 gram as 500 mg b.i.d.
or 250 mg q.i.d.
Higher doses such as 500 mg q.i.d.
may be required for severe infections or for those infections which do not respond to the smaller doses.
Children above eight years of age Usual daily dose, 10 to 20 mg/lb (25 to 50 mg/kg) body weight divided in four equal doses.
Therapy should be continued for at least 24 to 48 hours after symptoms and fever have subsided.
For treatment of brucellosis, 500 mg tetracycline q.i.d.
for three weeks should be 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 is recommended: early syphilis (less than one year’s duration)-500 mg q.i.d.
for 15 days.
Syphilis of more than one year’s duration (except neurosyphilis)-500 mg q.i.d.
for 30 days.
For treatment of gonorrhea, the recommended dose is 500 mg by mouth four times a day for 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, dosage should be gradually reduced 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 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 WARNINGS and Carcinogenicity, Mutagenicity, Impairment of Fertility).
Concomitant therapy 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.
In the treatment of streptococcal infections, a therapeutic dose of tetracycline should be administered for at least ten days.
In patients with renal impairment (see WARNINGS): total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses.
Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis: 500 mg, by mouth, four times a day for at least seven days.
Administration of adequate amounts of fluid with the capsule formulation of tetracycline is recommended to wash down the drug and reduce the risk of esophageal irritation and ulceration (see ADVERSE REACTIONS).