Achromycin V

Name: Achromycin V

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

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:

C22H24N208•HCI M.W. 480.90

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

Inactive Ingredients: Lactose, light mineral oil, and magnesium stearate.

The 250 mg and 500 mg capsule shells contain D&C yellow no. 10, FD&C blue no. 1, FD&C yellow no. 6, gelatin, and titanium dioxide.

The imprinting ink for the 250 mg and 500 mg capsules contains D&C yellow #10, FD&C blue no. 1, FD&C blue no. 2, FD&C red no. 40, iron oxide black, pharmaceutical shellac glaze, propylene glycol and n-butyl alcohol.

Adverse Reactions

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.

Overdosage

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

Achromycin V Dosage and 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 Achromycin V (Tetracycline HCl Capsules, USP) 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 Achromycin V (Tetracycline HCl Capsules, USP) 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. Achromycin V (Tetracycline HCl Capsules, USP) 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 Carcinogenesis, Mutagenesis, Impairment of Fertility).

Concomitant Therapy

Absorption of Achromycin V (Tetracycline HCl Capsules, USP) 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 Achromycin V (Tetracycline HCl Capsules, USP) 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 Chlamydiatrachomatis: 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).

Patient Handout

Print without Office InfoPrint with Office Info

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.

Read the entire FDA prescribing information for Achromycin V (tetracycline)

Read More »

Tetracycline Pregnancy Warnings

Tetracycline has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of embryotoxicity and teratogenicity, including toxic effects on skeletal formation. There are no controlled data in human pregnancy, however, congenital defects and maternal hepatotoxicity have been reported. When used during tooth development (second half of pregnancy) tetracyclines may cause permanent yellow-gray-brown discoloration of the teeth and enamel hypoplasia. The use of tetracycline during pregnancy is generally not recommended, especially during the last half of pregnancy.

Tetracycline Levels and Effects while Breastfeeding

Summary of Use during Lactation

A number of reviews have stated that tetracycline is contraindicated during breastfeeding because of possible staining of infants' dental enamel or bone deposition of tetracyclines. However, a close examination of available literature indicates that there is not likely to be harm in short-term use of tetracycline during lactation because milk levels are low and absorption by the infant is inhibited by the calcium in breastmilk. Short-term use of tetracycline is acceptable in nursing mothers. As a theoretical precaution, avoid prolonged or repeat courses during nursing. Monitor the infant for rash and for possible effects on the gastrointestinal flora, such as diarrhea or candidiasis (thrush, diaper rash).

Drug Levels

Maternal Levels. In a study using a microbiologic assay, milk tetracycline levels were in an unspecified number of nursing mothers at 9 am after various dosages of tetracycline during the previous days. Whether they had mastitis and the time postpartum were not stated. Milk levels increased to 2.5 mg/L after a daily dose of 1 gram orally for 3 days. Milk levels increased to 2 mg/L after a daily dose of 1.5 grams orally for 2 days. Milk levels increased to 2.5 mg/L after a daily dose of 2 grams orally for 3 days.[1]

Five women were given oral tetracycline 500 mg 4 times a day for 3 days. Milk levels ranged from 0.43 to 2.58 mg/L (times not specified).[2]

After a single dose of 150 mg of tetracycline orally in 2 women, milk levels of tetracycline averaged 0.7 mg at 2 and 6 hours after the dose and had an average peak of 0.8 mg/L 4 hours after the dose.[3]

Infant Levels. Five women were given oral tetracycline 500 mg 4 times a day for 3 days. Their infants were allowed to nurse and tetracycline was undetectable (<50 mcg/L) in the infants' serum.[2]

Effects in Breastfed Infants

No adverse effects were noted in an unspecified number of breastfed infants whose mothers were taking oral tetracycline 1, 1.5 or 2 grams daily for 3 days. Ages of the infants and extent of breastfeeding were not stated.[1] In one study, 5 infants breastfed during maternal therapy with tetracycline 500 mg 4 times daily with no adverse effects observed.[2]

In an observational study of 251 women, 23.8% of nursing mothers received tetracycline during breastfeeding. No gross adverse effect occurred in any of the breastfed infants.[4]

Although it is often stated that tetracyclines are to be avoided during lactation because of tooth staining, this adverse effect has never been reported after exposure via breastmilk. Milk calcium may inhibit absorption of the small amounts of tetracyclines in milk.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Doxycycline

References

1. Gruner JM. [The excretion of terramycin and tetracycline in human milk]. Geburtshilfe Frauenheilkd. 1955;15:354-60. PMID: 14380696

2. Posner AC, Prigot A, Konicoff NG. Further observations on the use of tetracycline hydrochloride in prophylaxis and treatment of obstetric infections. Antibiot Annu. 1955-1956;594-8. PMID: 13355291

3. Matsuda S. Transfer of antibiotics into maternal milk. Biol Res Pregnancy. 1984;5:57-60. PMID: 6743732

4. Prakash O, Mathur GP et al. Drug exposure in pregnant and lactating mothers in periurban areas. Indian Pediatr. 1990;27:1301-2. PMID: 2093678

Tetracycline Identification

Substance Name

Tetracycline

CAS Registry Number

60-54-8

Drug Class

Antiinfective Agents

Antibacterial Agents

Tetracyclines

(web3)