Finished product reference
Chloramphenicol
Solution, Drops · Ophthalmic · 0.5 % · 5 mL
- List code
- 52445
WARNING Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia and granulocytopenia) are known to occur after the administration of chloramphenicol. In addition, there have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia. Blood dyscrasias have occurred after both short-term and prolonged therapy with this drug.
Contraindications
CONTRAINDICATIONS: Chloramphenicol is contraindicated in individuals with a history of previous hypersensitivity and/or toxic reaction to it. It must not be used in the treatment of trivial infections or where it is not indicated, as in colds, influenza, infections of the throat; or as a prophylactic agent to prevent bacterial infections.
Pregnancy
Pregnancy Pregnancy Category C – Animal reproduction studies have not been conducted with chloramphenicol. There are no adequate and well-controlled studies to establish safety of this drug in pregnancy. It is not known whether chloramphenicol can cause fetal harm when administered to a pregnant woman.
Storage and supply
HOW SUPPLIED: Chloramphenicol Sodium Succinate for Injection, USP is freeze-dried in the vial. When reconstituted as directed, each vial contains a sterile solution equivalent to 100 mg of chloramphenicol per mL (1 g/10 mL). Product No. NDC No. 1115 63323-011-15 Available in packages of 10 vials. Preservative Free.
Source: Chloramphenicol Sodium Succinate (Chloramphenicol Sodium Succinate) — US FDA prescribing information, 2024-10-10, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
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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