Finished product reference

Streptomycin

Injection, Powder, for Solution · Parenteral · 1 g

List code
1173
Salt form
Sulfate
Boxed warning

WARNING THE RISK OF SEVERE NEUROTOXIC REACTIONS IS SHARPLY INCREASED IN PATIENTS WITH IMPAIRED RENAL FUNCTION OR PRE-RENAL AZOTEMIA. THESE INCLUDE DISTURBANCES OF VESTIBULAR AND COCHLEAR FUNCTION, OPTIC NERVE DYSFUNCTION, PERIPHERAL NEURITIS, ARACHNOIDITIS, AND ENCEPHALOPATHY MAY ALSO OCCUR.

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Indications

INDICATIONS AND USAGE Streptomycin is indicated for the treatment of individuals with moderate to severe infections caused by susceptibile strains of microorganisms in the specific conditions listed below: 1. Mycobacterium tuberculosis: The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and the Center for Disease Control recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH or rifampin resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. In the past when the national rate of primary drug resistance to isoniazid was known to be less than 4% and was either stable or declining, therapy with two and three drug regimens was considered adequate. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Intramuscular Route Only Adults: The preferred site is the upper outer quadrant of the buttock (i.e., gluteus maximus) or the mid-lateral thigh. Children: It is recommended that intramuscular injections be given preferably in the mid-lateral muscles of the thigh. In infants and small children the periphery of the upper outer quadrant of the gluteal region should be used only when necessary, such as in burn patients, in order to minimize the possibility of damage to the sciatic nerve. The deltoid area should be used only if well developed, such as in certain adults and older children, and then only with caution to avoid radial nerve injury.

Contraindications

CONTRAINDICATIONS A history of clinically significant hypersensitivity to streptomycin is a contraindication to its use. Clinically significant hypersensitivity to other aminoglycosides may contraindicate the use of streptomycin because of the known cross-sensitivity of patients to drugs in this class.

Warnings and precautions

WARNINGS Ototoxicity Both vestibular and auditory dysfunction can follow the administration of streptomycin. The degree of impairment is directly proportional to the dose and duration of streptomycin administration, to the age of the patient, to the level of renal function and to the amount of underlying existing auditory dysfunction. The ototoxic effects of the aminoglycosides, including streptomycin, are potentiated by the co-administration of ethacrynic acid, mannitol, furosemide and possibly other diuretics.

Pregnancy

Pregnancy See WARNINGS section.

Storage and supply

HOW SUPPLIED Streptomycin for Injection, USP is available in vials (NDC 39822-0706-1) containing 1 gram. Boxes of ten vials use NDC 39822-0706-2. Store dry powder at 20° to 25°C (68° to 77°F) . PROTECT FROM LIGHT Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814 Revised: October 2025 STRP-PI-MV-00 Made in India. Rx Only

Source: Streptomycin (Streptomycin) — US FDA prescribing information, 2026-01-21, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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