Achromycin V

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Tetracycline may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• itching of the rectum or vagina
• swollen tongue
• black or hairy tongue
• sore or irritated throat

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• headache
• blurred vision, seeing double, or loss of vision
• skin rash
• hives
• swelling of the face, throat, tongue, lips, and eyes
• difficulty breathing or swallowing
• joint stiffness or swelling
• unusual bleeding or bruising
• chest pain
• a return of fever, sore throat, chills, or other signs of infection
• watery or bloody stools , stomach cramps, or fever during treatment or for up to two or more months after stopping treatment

Tetracycline may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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. Tetracycline is active against a wide 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. While in vitro studies have demonstrated the susceptibility of most strains of the following microorganisms, clinical efficacy for infections other than those included in the INDICATIONS AND USAGE section has not been documented.

Gram-negative Bacteria

Neisseria gonorrhea

Haemophilus ducreyi

Haemophilus influenzae

Yersinia pestis (formerly Pasteurella pestis)

Francisella tularensis (formerly Pasterurella tularensis)

Vibrio cholera (formerly Vibrio comma)

Bartonella bacilliformis

Brucella species

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

Escherichia coli

Klebsiella species

Enterobacter aerogenes

Shigella species

Acinetobacter species (formerly Mima species and Herellea species)

Bacteroides species

Gram-positive Bacteria

Because many strains of the following groups of gram-positive microorganisms have been shown to be resistant to tetracycline, culture and susceptibility testing are recommended. Up to 44 percent of strains of Streptococcus pyogenes and 74 percent of Streptococcusfaecalis have been found to be resistant to tetracycline drugs. Therefore, tetracyclines should not be used for streptococcal disease unless the organisms have been demonstrated to be susceptible.

Streptococcus pyogenes

Streptococcus pneumoniae

Enterococcus group (Streptococcus faecalis and Streptococcus faecium)

Alpha-hemolytic Streptococci (viridans group)

Other Microorganisms

Chlamydia psittaci

Chlamydia trachomatis

Ureaplasma urealyticum

Borrelia recurrentis

Treponema pallidum

Treponema pertenue

Clostridia species

Fusobacterium fusiforme

Actinomyces species

Bacillus anthraxis

Propionibacterium acnes

Entamoeba species

Balantidium coli

Susceptibility Testing

A tetracycline disk may be used to determine microbial susceptibility to drugs in the tetracycline class. If the Kirby-Bauer method of disk susceptibility testing is used, a 30 mcg tetracycline disk should give a zone of at least 19 mm when tested against a tetracycline susceptible bacterial strain. Microorganisms may be considered susceptible if the MIC (minimum inhibitory concentration) is not more than 4 mcg/mL and intermediate if the MIC is 4 to 12.5 mcg/mL.

General

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

All infections due to Group A beta-hemolytic streptococci should be treated for at least ten days.

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

Prescribing Achromycin V (Tetracycline HCl Capsules, USP) 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

Patients should be counseled that antibacterial drugs including Achromycin V (Tetracycline HCl Capsules, USP) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Achromycin V (Tetracycline HCl Capsules, USP) is 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 Achromycin V (Tetracycline HCl Capsules, USP) or other antibacterial drugs in the future.

Laboratory Tests

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

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

Drug Interactions

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving Achromycin V (Tetracycline HCl Capsules, USP) in conjunction with penicillin or other bactericidal antibiotics.

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 Achromycin V (Tetracycline HCl Capsules, USP) 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 Achromycin V (Tetracycline HCl Capsules, USP) may render oral contraceptives less effective.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies are currently being conducted to determine whether Achromycin V (Tetracycline HCl Capsules, USP) has carcinogenic potential. Some related antibiotics (oxytetracycline, minocycline) have shown evidence of oncogenic activity in rats.

In two in vitro mammalian cell assay systems (L 51784y mouse lymphoma and Chinese hamster lung cells), there was evidence of mutagenicity at tetracycline hydrochloride concentrations of 60 and 10 mcg/mL, respectively.

Achromycin V (Tetracycline HCl Capsules, USP) had no effect on fertility when administered in the diet to male and female rats at a daily intake of 25 times the human dose.

Pregnancy

Teratogenic Effects

Pregnancy Category D

(see WARNINGS)

Nonteratogenic Effects

(see WARNINGS)

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 WARNINGS).

Pediatric Use

See WARNINGS and DOSAGE AND ADMINISTRATION.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Achromycin V (Tetracycline HCl Capsules, USP) and other antibacterial drugs, Achromycin V (Tetracycline HCl Capsules, USP) 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.

Achromycin V (Tetracycline HCl Capsules, USP) 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: Achromycin V (Tetracycline HCl Capsules, USP) 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 of 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 Brucellaspecies (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, Shigellasp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp.
• In severe acne, adjunctive therapy with Achromycin V (Tetracycline HCl Capsules, USP) 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.

>10%

Discoloration of teeth and enamel hypoplasia (young children)

1-10%

Diarrhea

Nausea

Photosensitivity

<1%

Anorexia

Abdominal cramps

Antibiotic-associated pseudomembranous colitis

Bulging fontanels in infants

Diabetes insipidus syndrome

Esophagitis

Exfoliative dermatitis

Incr ICP

Pericarditis

Pseudotumor cerebri

Pancreatitis

Pruritus

Pigmentation of nails

Vomiting

Applies to tetracycline: capsule, capsule delayed release, capsule extended release, powder for suspension, suspension, syrup, tablet, tablet delayed release, tablet extended release

Other dosage forms:

• implant, powder for suspension

Along with its needed effects, tetracycline (the active ingredient contained in Achromycin V) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking tetracycline:

• Increased sensitivity of skin to sunlight (rare with minocycline)

• Abdominal pain
• bulging fontanel (soft spot on head) of infants
• headache
• loss of appetite
• nausea and vomiting
• visual changes
• yellowing skin

• Greatly increased frequency of urination or amount of urine
• increased thirst
• unusual tiredness or weakness

• Pigmentation (darker color or discoloration) of skin and mucous membranes

Some side effects of tetracycline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Cramps or burning of the stomach
• diarrhea

• Itching of the rectal or genital (sex organ) areas
• sore mouth or tongue

• Dizziness, light-headedness, or unsteadiness

In some patients tetracyclines may cause the tongue to become darkened or discolored. This effect is only temporary and will go away when you Stop taking tetracycline.

Applies to tetracycline: compounding powder, oral capsule, oral suspension, oral tablet

Gastrointestinal

Gastrointestinal side effects have included anogenital lesions with monilial overgrowth, anorexia, black hairy tongue, dysphagia, enamel hypoplasia, enterocolitis, epigastric distress, diarrhea, glossitis, nausea, permanent tooth discoloration, and vomiting. Rarely, esophageal ulceration has been reported with oral tablets and capsules.[Ref]

There have been several cases of esophageal ulcers associated with oral tetracycline therapy. In each case, the patient had taken the medication just before bedtime with only small amounts of liquid and reported severe retrosternal pain and painful swallowing shortly thereafter. The ulcers resolved spontaneously after discontinuation of tetracycline therapy. To minimize esophageal irritation, patients should be advised to avoid taking tetracycline just before retiring and to take the medication with plenty of water.

Oral ulcers have also occurred in a patient who gargled with a tetracycline solution made by emptying the contents of a 250 mg capsule into water.[Ref]

Renal

Renal side effects generally occurred in patients with preexisting renal disease and have been the result of accumulation of tetracycline (the active ingredient contained in Achromycin V) Increases in BUN commonly occur because of tetracycline's anti-anabolic effect but do not necessarily indicate renal dysfunction.

Fanconi's syndrome is characterized by renal glycosuria, phosphaturia, aminoaciduria, and acidosis with or without proteinuria and rickets. It is associated with the ingestion of outdated or degraded tetracycline. Additionally, previous formulations of tetracycline contained citric acid which may contribute to metabolic acidosis; however, current formulations of the drug do not. Patients generally require hospitalization with intravenous medication to correct the accompanying metabolic abnormalities. Most cases resolve over time after discontinuation of tetracycline without permanent sequelae. Patients should be instructed to discard any unused portions of tetracycline at the end of therapy and to never use tetracycline remaining from a previous prescription.[Ref]

Renal side effects have included increased BUN and Fanconi's syndrome. In patients with preexisting renal impairment, tetracycline may cause azotemia, hyperphosphatemia, and acidosis. Patients with dehydration are particularly vulnerable.[Ref]

Dermatologic

Dermatologic side effects have included exfoliative dermatitis, maculopapular and erythematous rashes, nail discoloration, onycholysis, and photosensitivity.[Ref]

Musculoskeletal

Musculoskeletal side effects have included adult tooth discoloration, enamel hypoplasia, and a decrease in linear skeletal growth rate. Tetracycline (the active ingredient contained in Achromycin V) should not be administered to pregnant women or children less than 12 years of age.[Ref]

Tetracycline deposits into calcium-rich developing osseous tissue thereby causing the discoloration of permanent teeth, decreased rate of enamel growth, and a decrease in linear skeletal growth rate.[Ref]

Nervous system

There have been several cases of benign intracranial hypertension (pseudotumor cerebri) associated with tetracycline (the active ingredient contained in Achromycin V) therapy. In most cases, the patient was female and was prescribed tetracycline to treat acne. Symptoms commonly occurring in these cases consisted of severe headaches, nausea, and blurred vision. Physical examination revealed papilledema in all cases, and several had significantly increased pressure on lumbar puncture. All patients recovered over time after discontinuation of tetracycline therapy. The mechanism for development of increased intracranial pressure is unknown.[Ref]

Nervous system side effects have included benign intracranial hypertension (pseudotumor cerebri) in adults and bulging fontanels in infants.[Ref]

Hematologic

Hematologic side effects have included hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia, and eosinophilia.[Ref]

At least two cases of tetracycline-induced hemolytic anemia have been reported. In both cases, the anemia resolved over time after discontinuation of the medication and reoccurred 1 to 2 years later following another course of tetracycline therapy. The mechanism for development of hemolytic anemia is unknown.[Ref]

Hypersensitivity

Hypersensitivity side effects have included urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, exacerbation of systemic lupus erythematosus, hypersensitivity myocarditis, and serum sickness-like reactions (fever, rash, arthralgia).[Ref]

Hepatic

Hepatic side effects have included increased liver enzyme levels, hepatotoxicity, liver failure, and bile duct paucity with prolonged cholestasis. These may be dose-related.[Ref]

Other

Other side effects have included superinfection due to overgrowth of resistant organisms. The long-term use of tetracyclines has been associated with microscopic brown-black discoloration of the thyroid gland; however, abnormal thyroid function has not been reported.[Ref]

Metabolic

Metabolic side effects have included azotemia, hyperphosphatemia, and metabolic acidosis. Increases in serum BUN levels may occur as a result of the anti-anabolic action of tetracycline (the active ingredient contained in Achromycin V) and not necessarily indicate renal disease.[Ref]

These metabolic side effects have occurred more commonly in the presence of preexisting renal disease, and occur as a result of the accumulation of tetracycline.[Ref]

Some side effects of Achromycin V may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Tetracycline is excreted into human milk in small amounts. Theoretical risks of dental staining and inhibition of bone growth exist, although are unlikely. In one study, tetracycline levels were undetectable in nursing infants. Tetracycline is considered compatible with breast-feeding by the American Academy of Pediatrics. However, the manufacturer recommends that because of the risk of serious potential adverse reactions in nursing infants, a decision should be made whether to continue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother.

LactMed Record Number

252

Last Revision Date

20150310

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