Tetracycline HCL Capsules 250MG 500MG BP / USP Antibiotics Medicines

TETRACYCLINE 250 MG Capsules

COMPOSITION:

Each capsule contains 250 mg tetracycline hydrochloride with 70 mg sodium hexametaphosphate.

PHARMACOLOGICAL ACTION:
Tetracycline hydrochloride is a broad spectrum antibiotic produced by fermentation from a species of Streptomyces.
Sodium hexametaphosphate enhances the absorption of tetracycline from the gastro-intestinal tract. Tetracycline is excreted primarily by the kidneys.
Laboratory and clinical studies have shown that tetracycline is effective against Diplococcus pneumoniae, Neisseria gonorrhoea, Neisseria meningitidis, certain clostridia, Haemophilus influenza, Shigella, Klebsiella pneumoniae, and Enterobacter aerogenes.

INDICATIONS:

Infections of the respiratory tract, such as pneumonia, chronic bronchitis, sinusitis, laryngitis, pharyngitis and otitis media.
Infections of the gastrointestinal tract, such as bacterial gastro-enteritis (Gram negative coliform bacteria, Shigella, Bacteroides).
Infections of the genitourinary tract, such as gonorrhoea, lymphogranuloma inguinale and cystitis, urethritis and renal infections caused by tetracycline sensitive organisms.
Systemic infections, such as mixed infections, peritonitis, typhus infections (epidemic, endemic and scrub typhus) and other rickettsial infections (Mediterranean-boutonneuse fever, South African tick-bite fever, rickettsial pox, Q-fever).

CONTRA-INDICATIONS:

Renal Impairment:
This medicine is contra-indicated in individuals who have shown serious hypersensitivity to tetracycline.

WARNINGS:

Tetracycline may form a stable calcium complex in any bone- forming tissue with no serious harmful effects reported thus far in humans. However, use of tetracycline during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-grey-brownish). This effect occurs mostly during long-term therapy, but it has been observed following short treatment courses. Enamel hypoplasia has been observed in a few children. Tetracycline therefore, should not be used in this age group unless other drugs are not likely to be effective or are contra-indicated.
Use with care in patients with liver function impairment.
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.
Do not use concomitantly with hepatotoxic medicines

DOSAGE AND DIRECTIONS FOR USE:

Adults: The usual dose is 1 g per day in 4 divided doses of 250 mg each.

Children:The maximum dose for children should not exceed 50 mg/kg bodymass/day. Therapy for most infections should be continued for 24 - 48 hours after the patient has become asymptomatic or afebrile.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Anorexia, nausea, vomiting, diarrhoea, stomatitis, glossitis, dysphagia, enterocolitis, and pruritus ani may occur.
Maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Onycholysis and discoloration of the nails have been noted rarely.
Hypersensitivity reactions to tetracycline including urticaria angioneurotic oedema, anaphylaxis, anaphylactoid purpura, pericarditis and exacerbations of systemic lupus erythematosus have been reported.

STORAGE INSTRUCTIONS:

Store in a cool dry place.
Temperature should not exceed 25°C
Keep out of reach of children.