INN monograph
Norfloxacin /Tinidazole
Fluoroquinolone antibiotic · POM
Verified · Updated 01 Aug 2026 · Source: Local active-ingredient clinical extract; RxNorm (NLM RxNav); PubChem; Component monographs (multi-source pipeline)
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- Hypersensitivity to quinolones.
- History of quinolone-related tendon disorder.
- Avoid in myasthenia gravis (exacerbation).
- Generally avoid in children/adolescents except specific labelled indications.
- Caution pregnancy/lactation — prefer alternatives when possible.
Precautions
- FDA/EMA boxed risks: tendinopathy/rupture, peripheral neuropathy, CNS effects, aortic aneurysm risk in susceptible patients, QT prolongation (esp. moxifloxacin), dysglycaemia, psychiatric effects.
- Avoid in patients with significant risk factors unless benefits outweigh risks.
- Photosensitivity.
- Separate from polyvalent cations (antacids, Fe, Ca, dairy, sucralfate) by several hours.
Point of care
Dosing
Adult
Dosing is indication-, age-, weight- and organ-function-specific for this INN. Do not use class averages for high-risk patients. Confirm the exact regimen in the current SmPC and Kenya Standard Treatment Guidelines. Typical professional workflow: (1) confirm indication, (2) check renal/hepatic function, (3) screen interactions/allergies, (4) select dose/route/duration, (5) define monitoring.
Paediatric
Paediatric dosing is weight- and age-based; use a paediatric formulary / SmPC. Do not extrapolate adult tablets without calculation.
Renal
Many agents need CrCl-based adjustment (e.g. ciprofloxacin, levofloxacin).
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
Hepatotoxicity uncommon but reported; moxifloxacin has more hepatic clearance.
Safety
Drug interactions
- Reduced absorption when taken with milk and yoghurt.
- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Norfloxacin, Tinidazole.
- Confirm combination SmPC for exact dosing.
Safety
Adverse effects
- GI upset, headache, dizziness, insomnia.
- Serious: tendon rupture, neuropathy, seizures, QT prolongation/TdP, severe hypersensitivity, C. difficile, aortic events (rare), dysglycaemia.
Use
Indications
- Diarrhoea and dysentery of amoebic, bacterial or mixed origins Clinical selection for Norfloxacin /Tinidazole should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
- Class context: Fluoroquinolone antibiotic.
- Confirm site-specific dose, duration and monitoring before prescribing.
Pharmacology
Mode of action
See under norfloxacin and tinidazole respectively.
Full mechanism text
See under norfloxacin and tinidazole respectively. Fluoroquinolones inhibit bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, blocking DNA replication and transcription. Bactericidal concentration-dependent killing with a post-antibiotic effect.
ADME
Pharmacokinetics & PD
| Onset | 1–2 hours oral |
|---|---|
| Duration | 12–24 hours (agent-dependent) |
| Route | ORAL / IV |
| Distribution | including prostate and bone (agent-dependent). Renal and/or hepatic clearance varies by agent — adjust dose in organ impairment as labelled. |
Full PK/PD text
Excellent oral bioavailability for most agents (near-IV for ciprofloxacin/levofloxacin in many settings). Wide tissue distribution including prostate and bone (agent-dependent). Renal and/or hepatic clearance varies by agent — adjust dose in organ impairment as labelled.
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| Combicor | ARKRAY HEALTH CARE PVT LTD | Standard Commercial Pack | — |
| Nortiz | Innocia Life Sciences PVT. Ltd | Standard Commercial Pack | — |
Special populations
Pregnancy & lactation
Pregnancy
[From component Tinidazole] 8.1 Pregnancy Risk Summary Available published data from a case-control study and case report with Tinidazole Tablets use in pregnant women are insufficient to identify a risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks associated with untreated lower genital tract infections during pregnancy (see Clinical Considerations) . In animal reproduction studies, oral administration of tinidazole to pregnant mice and rats during organogenesis at 6 and 3 times, respectively, the maximum recommended human dose (based on body surface area comparison) showed a slight increase in fetal mortality in rats at the highest dose, with no other adverse fetal effects noted in either species (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Embryo-fetal developmental toxicity studies in pregnant mice administered oral tinidazole on gestation days (GD) 7 to 12 indicated no embryo-fetal toxicity or malformations at the highest dose level of 2,500 mg/kg (approximately 6.3-fold the highest human therapeutic dose based upon body surface area conversions). In a study with pregnant rats administered oral tinidazole on GD 9 to 14, a slightly higher incidence of fetal mortality was observed at a maternal dose of 500 mg/kg (2.5-fold the highest human therapeutic dose based upon body surface area conversions). No biologically relevant neonatal developmental effects were observed in surviving rat neonates following maternal doses as high as 600 mg/kg (3-fold the highest human therapeutic dose based upon body surface area conversions).
Lactation
[From component Tinidazole] 8.3 Females and Males of Reproductive Potential Infertility Infertility Males Based on findings in rodents, Tinidazole may impair fertility in males of reproductive potential. It is not known whether effects on fertility are reversible [see Nonclinical Toxicology (13.1) ].
Diet
Food & alcohol
- Food
- Food
Trust
Sources & disclaimer
Source: Local active-ingredient clinical extract; RxNorm (NLM RxNav); PubChem; Component monographs (multi-source pipeline)
Last reviewed: 01 Aug 2026
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.