Tetracycline Hydrochloride

Indications

INDICATIONS AND 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 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.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Adults: Usual daily dose, 1 gram as 500 mg twice a day or 250 mg four times a day. Higher doses such as 500 mg four times a day may be required for severe infections or for those infections which do not respond to the smaller doses. For pediatric patients above eight years of age: Usual daily dose, 10 mg/lb to 20 mg/lb (25 mg/kg to 50 mg/kg) body weight divided in four equal doses. 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 ).

Contraindications

CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Warnings and precautions

WARNINGS Tooth Development 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 it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracycline drugs should not be used in this age group, except for anthrax, unless other drugs are not likely to be effective or are contraindicated.

Storage and supply

HOW SUPPLIED Tetracycline Hydrochloride Capsules, USP are available as: 250 mg: Yellow Opaque Cap/Yellow Opaque Body, Cap and Body Imprinted 5225 in Black Ink. NDC 71335-3170-1: 20 CAPSULEs in a BOTTLE NDC 71335-3170-2: 40 CAPSULEs in a BOTTLE NDC 71335-3170-3: 60 CAPSULEs in a BOTTLE NDC 71335-3170-4: 30 CAPSULEs in a BOTTLE NDC 71335-3170-5: 28 C…

Source: Tetracycline Hydrochloride (Tetracycline Hydrochloride) — US FDA prescribing information, 2026-08-11, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.