OXYTETRACYCLINE HCL
Each capsule contains
Oxytetracycline hydrochloride
equivalent to .................. 250 mg. oxytetracycline
Terramycinยฎ (oxytetracycline HCl) is a widely used antibiotic with clinically proved activity against gram-positive and gram-negative bacteria, rickettsiae, spirochetes, large viruses, and certain protozoa. Terramycin is well tolerated and well absorbed after oral administration. It diffuses readily through the placenta and is present in the fetal circulation. It diffuses into the pleural fluid, and under some circumstances, into the cerebrospinal fluid. Oxytetracycline HCl appears to be concentrated in the hepatic system and is excreted in the bile. It is excreted in the urine and in the feces, in high concentrations, in a biologically active form.
INDICATIONS
TERRAMYCIN is indicated in the therapy of a number of genitourinary infections caused by susceptible organisms. These infections include the following: pyelonephritis, pyelitis, ureteritis, cystitis, prostatitis, and urethritis.
CONTRAINDICATIONS
This drug is contraindicated in individuals who have shown hypersensitivity to any of its components.
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 doses are indicated and if therapy is prolonged, tetracycline serum level determinations may be advisable.
Oxytetracycline HCl, which is one of the ingredients of TERRAMYCIN, may form a stable calcium complex in any bone-forming tissue with no serious harmful effects reported thus far in humans. However, use of oxytetracycline during tooth development (last trimester of pregnancy, neonatal period and early childhood) may cause discoloration of the teeth (yellow-grey-brownish). This effect occurs mostly during long term use of the drug but it also has been observed in usual short treatment courses.
Certain hypersensitive individuals may develop a photodynamic reaction precipitated by exposure to direct sunlight during the use of this drug. This reaction is usually of the photoallergic type which may also be produced by other tetracycline derivatives. Individuals with a history of photosensitivity reactions should be instructed to avoid exposure to direct sunlight while under treatment with this or other tetracycline drugs, and treatment should be discontinued at first evidence of skin discomfort.
NOTE: Reactions of a photoallergic nature are exceedingly rare with Terramycin (oxytetracycline HCl). Phototoxic reactions are not believed to occur with Terramycin.
PRECAUTIONS
As with all antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate specific therapy should be instituted. This drug should be used with caution in persons having histories of significant allergies and/or asthma.
ADVERSE REACTIONS
Glossitis, stomatitis, proctitis, nausea, diarrhea, vaginitis, and dermatitis, as well as reactions of an allergic nature, may occur during oxytetracycline HCl therapy, but are rare. If adverse reactions, individual idiosyncrasy, or allergy occur, discontinue medication. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving capsule forms of drugs in the tetracycline class. Most of these patients took medications immediately before going to bed. (See Dosage and Administration .)
With oxytetracycline therapy bulging fontanels in infants and benign intracranial hypertension in adults have been reported in individuals receiving full therapeutic dosages. These conditions disappeared rapidly when the drug was discontinued.
As with most of the ANTIBIOTIC therapy, the following reactions may occur: nausea, vomiting, diarrhea, hepatitis, pancreatitis, blood dyscrasias, neuropathy, drug fever, skin rash, infection of the conjunctiva and sclera, petechiae, purpura. The dosage should be decreased or the drug withdrawn, depending upon the severity of the reaction.
DOSAGE AND ADMINISTRATION
TERRAMYCIN is recommended in adults only. A dose of 1 capsule four times daily is suggested. In refractory cases 2 capsules four times a day may be used.
Therapy should be continued for a minimum of seven days or until bacteriologic cure in acute urinary tract infections.
Administration of adequate amounts of fluid along with capsule forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (See Adverse Reactions .)
To aid absorption of the drug, it should be given at least one hour before or two hours after eating. Aluminum hydroxide gel given with antibiotics has been shown to decrease their absorption and is contraindicated.
SUPPLY