Achromycin V

Name: Achromycin V

Why is this medication prescribed?

Tetracycline is used to treat infections caused by bacteria including pneumonia and other respiratory tract infections; ; certain infections of skin, eye, lymphatic, intestinal, genital and urinary systems; and certain other infections that are spread by ticks, lice, mites, and infected animals. It is also used along with other medications to treat acne. Tetracycline is also used to treat plague and tuleramia (serious infections that may be spread on purpose as part of a bioterror attack). It can also be used in patients who cannot be treated with penicillin to treat certain types of food poisoning, and anthrax (a serious infection that may be spread on purpose as part of a bioterror attack). Tetracycline is in a class of medications called tetracycline antibiotics. It works by preventing the growth and spread of bacteria.

Antibiotics such as tetracycline will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light and excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to tetracycline.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking tetracycline.

Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish the tetracycline, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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 lights 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.

Animal pharmacology and animal toxicology

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

Minocycline, tetracycline PO4, methacycline, doxycycline, tetracycline base, oxytetracycline HCl and tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accomplished by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet.

Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline), in chickens (chlortetracycline) and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.

Rx only

Manufactured for:

Heritage Pharmaceuticals Inc.

Eatontown, NJ 07724

1-866-901-DRUG (3784)

MF # 0397-01

Issued: 04/14

How supplied

Achromycin V (Tetracycline HCl Capsules, USP) are available as:

250 mg: Light Blue Opaque Cap/Yellow Opaque Body, Cap and Body Imprinted HP 17 in Black Ink.

Available in bottles of:

100 - NDC 23155-487-01
1000- NDC 23155-487-10

500 mg: Light Blue Opaque Cap/Yellow Opaque Body, Cap and Body Imprinted HP 18 in Black Ink.

Available in bottles of:

100 - NDC 23155-488-01
500 - NDC 23155-488-05

Dispense 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 1-800FDA-1088.

Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724. Revised: Apr 2014

Side effects

Gastrointestinal: anorexia, nausea, epigastric distress, vomiting, diarrhea, glossitis, black hairy tongue, dysphagia, enterocolitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region.

Rare instances of 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 DOSAGE AND ADMINISTRATION).

Teeth: permanent discoloration of teeth may be caused during tooth development. Enamel hypoplasia has also been reported (see WARNINGS).

Skin: maculopapular and erythrematous rashes. Exfoliative dermatitis has been reported but is uncommon. Onycholysis and discoloration of the nails have been reported rarely. Photosensitivity is discussed in WARNINGS.

Renal Toxicity: rise in BUN has been reported and is apparently dose related.

Liver: hepatotoxicity and liver failure have been observed in patients receiving large doses of tetracycline and in tetracycline-treated patients with renal impairment.

Hypersensitivity Reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus, and serum sickness-like reactions, as fever, rash, and arthralgia.

Blood: hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia and eosinophilia have been reported.

Other: bulging fontanels in infants and intracranial pressure in adults (see PRECAUTIONS - General).

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.

Overdose

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Achromycin V (Tetracycline HCl Capsules, USP) is not dialyzable.

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. 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.

Animal Pharmacology And Animal Toxicology

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

Minocycline, tetracycline PO4, methacycline, doxycycline, tetracycline base, oxytetracycline HCl and tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accomplished by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet.

Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline), in chickens (chlortetracycline) and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.

Pregnancy & Lactation

Pregnancy category: D (systemic), C (periodontal fiber)

Lactation: Enters breast milk; some manufacturers say do not nurse; however, AAP considers nursing compatible due to calcium chelation of drug and prevention of its absorption (long-term safety of prolonged exposure unknown)

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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