Registered Kenya · PPB

EVA Q

LACTITOL MONOHYDRATE + BENZOIC ACID

H2020/CTD7635/1355ER 10GM + 0.0225 GM GENERIC/BIOSIMILARS alimentary tract and metabolism INN generic

What it does

Benzoic is used to treat various skin conditions and is often found in topical preparations.

Commonly used for: skin infections, fungal infections, eczema, dermatitis

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2020/CTD7635/1355ER
Registration date
2020-04-17 00:00:00
Expiry date
-
Status
Registered
Active ingredient
LACTITOL MONOHYDRATE + BENZOIC ACID
Dosage form
10GM + 0.0225 GM
Strength
-
Pack size
100ML, 120 ML, 200ML
Therapeutic class
GENERIC/BIOSIMILARS
ATC class (WHO)
A06AD - Osmotically acting laxatives
RxNorm RxCUI
28395
Manufacturer / MAH
Zawadi Healthcare
Country of origin
FOREIGN
Manufacturer location
Shop 2, Next To Gen. Shop, Near Deliverance Church, Off Depot Road, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 19:50:08 · updated 2026-08-03 02:59:13

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About benzoic

Benzoic is used to treat various skin conditions and is often found in topical preparations.

What it treats

  • skin infections
  • fungal infections
  • eczema
  • dermatitis

How it works

Benzoic helps to kill bacteria and fungi and reduces irritation in the skin.

Who it's for

This treatment is suitable for people with certain skin issues.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About lactitol

Lactitol is a type of sugar that helps to relieve constipation by softening stools.

What it treats

  • constipation
  • chronic constipation

How it works

Lactitol works by drawing water into the bowel, which makes the stool softer and easier to pass.

Who it's for

Lactitol is suitable for adults and children who need help with constipation.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: benzoic

Benzoic acid is a simple aromatic carboxylic acid with the chemical formula C7H6O2. It is commonly used as a food preservative due to its antimicrobial properties and is found in various food products. In the pharmaceutical field, benzoic acid can be utilized in topical preparations for its antifungal and antibacterial effects. It is also used in the synthesis of other chemicals and as a solvent.

Indications

  • Topical treatment of fungal infections
  • Preservative in food and pharmaceutical products
  • Treatment of hyperammonemia (as part of a combination therapy)

Dosage

Children: Refer to specific product guidelines and clinical protocols for pediatric dosing information.

Adults: Refer to specific product guidelines and clinical protocols for dosing information.

Mechanism of action

Benzoic acid exerts its antimicrobial effects primarily by disrupting the integrity of microbial cell membranes, leading to cell lysis. It can also inhibit certain metabolic pathways in bacteria, such as the conversion of pyruvate to acetyl-CoA, thereby limiting energy production in these organisms.

Pharmacodynamics

Benzoic acid demonstrates a concentration-dependent antibacterial and antifungal activity. The efficacy of benzoic acid is influenced by the pH of the environment; it is more effective in acidic conditions. The compound acts on a broad spectrum of microorganisms, including some bacteria and fungi, making it a useful preservative and therapeutic agent.

Pharmacokinetics

Benzoic acid is absorbed through the gastrointestinal tract when ingested and can be metabolized in the liver. It is primarily excreted in the urine as hippuric acid after conjugation with glycine. The half-life of benzoic acid varies but is generally around 1 to 2 hours. Its distribution in the body is rapid, with a volume of distribution that suggests extensive tissue binding.

Adverse effects

  • Allergic reactions
  • Skin irritation
  • Nausea
  • Vomiting
  • Headache

Precautions

  • Use with caution in individuals with known hypersensitivity to benzoates
  • Monitor for signs of hypersensitivity reactions

Pregnancy

The safety of benzoic acid during pregnancy has not been established. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Benzoic acid is excreted in breast milk. Caution is advised when administered to nursing mothers.

Storage

Store in a cool, dry place, away from direct sunlight and moisture. Keep out of reach of children.

Formulations

  • Topical creams
  • Ointments
  • Solutions

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: lactitol

BNF-referenced

Lactitol is an osmotic laxative primarily used to treat constipation and to manage hepatic encephalopathy. It works by drawing water into the intestines, thereby softening stools and promoting bowel movements. As a sugar alcohol, it is poorly absorbed in the gastrointestinal tract, enhancing its laxative effect. Lactitol is considered as an alternative to lactulose, particularly in hepatic encephalopathy due to its similar effects on colonic metabolism and pH.

Indications

  • Constipation
  • Management of hepatic encephalopathy

Dosage

Children: Refer to the BNF for Children for appropriate paediatric dosing information.

Adults: Refer to the BNF for specific dosing guidelines.

Mechanism of action

Lactitol exerts its pharmacologic effect by creating a hyperosmotic environment within the small intestine. This osmotic effect draws water into the intestinal lumen, loosening stools and facilitating bowel movements. It is metabolized by colonic bacteria, producing volatile fatty acids, and can lower colonic pH, similar to lactulose.

Pharmacodynamics

Lactitol facilitates bowel movements by increasing water content in the gastrointestinal tract. Its osmotic action is effective in treating constipation and may influence the colonic environment, which is beneficial in managing conditions like hepatic encephalopathy. Lactitol may also reduce the absorption of other oral medications, necessitating staggered administration.

Pharmacokinetics

Lactitol is minimally absorbed in the gastrointestinal tract, allowing it to act directly within the intestines. Its effects can be seen within 24 to 48 hours of administration. It does not significantly alter the systemic absorption of other medications, but it is advised to time their administration accordingly to avoid interaction.

Adverse effects

  • Abdominal cramps
  • Diarrhea
  • Flatulence
  • Nausea
  • Vomiting

Interactions

  • May reduce absorption of concomitant medications

Precautions

  • Use with caution in patients with diabetes mellitus
  • Monitor for electrolyte imbalances in patients with prolonged use

Pregnancy

Lactitol should only be used during pregnancy if clearly needed and after assessing the risks and benefits.

Breast-feeding

Lactitol is considered safe during breastfeeding, but consult a healthcare professional for individual cases.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of the reach of children.

Formulations

  • Oral solution
  • Granules for oral solution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: lactitol

PubChem CID 157355

Molecular formula: C12H24O11

Mechanism of action

Lactitol is an osmotic laxative - it exerts its pharmacologic effect by creating a hyperosmotic environment within the small intestine. The osmotic effect generated by lactitol draws water into the small intestine, which loosens stools and ultimately facilitates bowel movements. Lactitol, an unabsorbed sugar with defined laxative threshold and superior taste properties has been suggested as an alternative to lactulose in the treatment of hepatic encephalopathy. In the present study /investigators/ compared the colonic metabolism of the two sugars using an in vitro fecal incubation system. Both sugars were readily metabolized by fecal bacteria producing volatile fatty acids and the metabolism was inhibited by neomycin. The effect of lactitol and lactulose on terminal ileal and colonic pH was monitored in six normal subjects using a radiotelemetry technique. Both sugars significantly lowered right colonic pH (basal -6.51 +/- 0.48 vs lactitol -5.63 +/- 0.50; lactulose -5.18 +/- 0.82, p less than 0.05). The pH of rest of the colon and terminal ileum was unaffected. Neomycin given concurrently with lactulose abolished acidification of right colon. As lactitol and lactulose have similar effects within the colon, lactitol would appear to have a role in the treatment of hepatic encephalopathy. As neomycin antagonizes the effect of lactulose in the colon, its concurrent use may be less effective in the treatment of hepatic encephalopathy. ... Reports from authoritative bodies and reviews indicates that the decrease in pH in plaque as a consequence of metabolic acid production by saccharolytic bacteria when exposed to fermentable carbohydrates (i.e. sugars and starches) may promote demineralization and prevent remineralization of the hydroxyapatite crystals. Tooth hydroxyapatite crystals are very resistant to dissolution at neutral pH, but their solubility drastically increases as pH drops. Typically, the critical pH for dental enamel is around 5.5. ... Demineralization of tooth tissues can also occur as a result of consumption of dietary acids in foods or beverages, and that frequent consumption can lead to dental erosion. Xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose and polydextrose are slowly metabolized by bacteria in the mouth. The rate and amount of acid production from these food constituents is significantly less than that from sucrose. ... Xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose and polydextrose do not promote dental caries because they do not lower plaque pH to the level associated with enamel demineralization. ... A cause and effect relationship has been established between the consumption of sugar-containing foods/drinks at an exposure frequency of four times daily or more and an increased tooth demineralization, and that the consumption of foods/drinks containing xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose, instead of sugar in sugar-containing foods/drinks, may maintain tooth mineralization by decreasing tooth demineralization compared with sugar-containing foods, provided that such foods/drinks do not lead to dental erosion. The food constituents xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose resulted in reduced post-prandial blood glucose (or insulinemic) responses compared with sugars on a weight by weight basis owing to their reduced/delayed digestion/absorption and/or to a decrease in the amount of available carbohydrates, and that the consumption of foods/drinks in which xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose replaced sugars induced lower post-prandial glycemic and insulinemic responses than sugar-containing foods/drinks. ... A cause and effect relationship has

Pharmacodynamics

Lactitol helps to facilitate bowel movements by drawing water into the gastrointestinal tract. The oral administration of lactitol may reduce the absorption of concomitant medications - other oral medications should be administered at least 2 hours before or 2 hours after lactitol.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

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The same active ingredient registered across other registries we cover - including different brands.