LEVOFLOXACIN IN
As listed in the register: LEVOFLOXACIN IN 5% DEXTROSE INJECTION
5 mg · solution
- Prescription only
- Antibiotics, antivirals and antifungals taken into the body
- Active substance
- Levofloxacin
- Made by
- Sterimax Inc
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
This product’s leaflet is published as a scanned document. This section quotes the US prescribing label for the same active substance (levofloxacin). It describes the substance, not this Bulgarian product — its uses and doses can differ.
Levofloxacin is a member of the fluoroquinolone class of antibacterial agents [ see Microbiology (12.4)].
Due to the limited extent of levofloxacin metabolism, the pharmacokinetics of levofloxacin are not expected to be affected by hepatic impairment [see Use in Specific Populations ( 8.7 )].
Levofloxacin undergoes limited metabolism in humans and is primarily excreted as unchanged drug in the urine.
Oral administration of a 500 mg dose of levofloxacinwith food prolongs the time to peak concentration by approximately 1 hour and decreases the peak concentration by approximately 14% following tablet and approximately 25% following oral solution administration.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-05-20
Safety of the active substance
This product’s leaflet is published as a scanned document. This section quotes the US prescribing label for the same active substance (levofloxacin). It describes the substance, not this Bulgarian product — its uses and doses can differ.
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS.
- Levofloxacin tablets are contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [ see Warnings and Precautions (5.3 )].
- Known hypersensitivity to levofloxacin or other quinolones ( 4, 5.7 )
The most common reactions (≥3%) were nausea, headache, diarrhea, insomnia, constipation and dizziness (6.2).
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
BulgariaNo exact match for this strength and form
European UnionNo exact match for this strength and form
SpainNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Sterimax Inc |
|---|---|
| Active substance | Levofloxacin |
| Used in | Antibiotics, antivirals and antifungals taken into the body |
| Strength | 5 mg |
| Form | solution |
| Classification | J01MA12 · Antibiotics, antivirals and antifungals taken into the body |
| Route | intravenous |
| Dispensing (as stated by the register) | PRESCRIPTION |
| Status | Approved |
| Marketed | No — authorised but not currently marketed, according to the register |
| Name in the register | LEVOFLOXACIN IN 5% DEXTROSE INJECTION |
| DIN | 02460122 |
| DPD drug code | 94742 |
Source: Drug Product Database · 2026-09-30 · not reviewed by a clinician
Contains information licensed under the Open Government Licence – Canada. Reuse terms: Open Government Licence – Canada.
Other strengths and forms
3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- solution3 products
5 mg3
5 mg · 3 companies
- Hikma Canada Limited
- Pfizer Canada Ulc
- Sterimax Inc · this page
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.