INN monograph
Metronidazole/ Diloxanide furoate / Dicyclomine
Nitroimidazole antimicrobial / antiprotozoal · POM
Source-linked · Updated 03 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 nitroimidazoles.
- First trimester use traditionally avoided unless essential (practice evolving — follow current obstetric guidance).
- Disulfiram within 2 weeks.
Precautions
- Avoid alcohol during and for 24–72 h after (disulfiram-like reaction).
- Neurologic toxicity with prolonged/high dose (neuropathy, seizures).
- Metallic taste common.
- Dark urine possible.
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
Metabolites accumulate in renal failure; review dosing in ESRD.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
Hepatic metabolism — reduce dose in severe liver disease.
Safety
Drug interactions
- Diloxanide furoate is active against the cystic form of amoeba.
- Hence the combination is effective in all forms of amoebiasis.
- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Metronidazole, Dicyclomine.
- Confirm combination SmPC for exact dosing.
Safety
Adverse effects
- [From component Metronidazole] GI discomfort, anorexia, metallic taste, dry mouth, headache, skin rash, vertigo, depression, insomnia, drowsiness, urethral discomfort, darkened urine, transient fall in BP, temporary leucopenia, bone marrow depression, transient epileptic seizure, furred tongue.
Use
Indications
- Therapeutic use is agent- and indication-specific within the class (Nitroimidazole antimicrobial / antiprotozoal).
- Use according to culture results, national guidelines (Kenya STG/EML where applicable) and the current product SmPC.
- Amoebiasis.
Pharmacology
Mode of action
Combination product.
Full mechanism text
Combination product. Component mechanism (Metronidazole): Metronidazole, ornidazole and other imidazoles are selective for anaerobic bacteria due to their ability to intracellularly reduce imidazole which covalently binds to DNA, disrupt its helical structure, inhibiting bacterial nucleic acid synthesis
ADME
Pharmacokinetics & PD
| Onset | 1–2 hours |
|---|---|
| Duration | 8–24 hours |
| Route | ORAL / IV / TOPICAL / VAGINAL |
| Distribution | including abscesses and CSF. Hepatic |
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| No brands linked yet. | |||
Special populations
Pregnancy & lactation
Pregnancy
[Metronidazole] [Metronidazole] Widely used in later pregnancy for BV/trichomoniasis in many protocols; avoid unnecessary first-trimester exposure — follow current guidance. [Diloxanide furoate] Use only if potential benefit justifies potential risk; prefer agents with better reproductive data when alternatives exist. [Dicyclomine] 8.1 Pregnancy Pregnancy Category B Adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy. Reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Lactation
[Metronidazole] [Metronidazole] Single-dose regimens often compatible with pumping/timing advice; prolonged high dose — review. [Diloxanide furoate] Assess infant risk vs benefit of maternal therapy; prefer agents with lactation data. [Dicyclomine] 8.3 Nursing Mothers Dicyclomine hydrochloride is contraindicated in women who are breastfeeding. Dicyclomine hydrochloride is excreted in human milk. Because of the potential for serious adverse reactions in breast-fed infants from dicyclomine hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother [see Use in Specific Populations (8.4) ] .
Diet
Food & alcohol
- Food
- Food
Trust
Sources & disclaimer
Source: Local active-ingredient clinical extract; RxNorm (NLM RxNav); PubChem; Component monographs (multi-source pipeline)
Clinical review date not recorded.
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.