Registered Malawi · PMRA

FOETAFINE COMBINATION PRODOCT CAPSULE

IRON, VITAMINS AND DOCUSATE SODIUM

PMPB/PL461/5 CAPSULE alimentary tract and metabolism INN generic

What it does

Docusate is a stool softener that helps relieve constipation by making bowel movements easier.

Commonly used for: constipation, hard stools

Read more in plain English ↓

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

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
PMPB/PL461/5
Registration date
16/02/2016
Expiry date
30/06/2019
Status
Registered
Active ingredient
IRON, VITAMINS AND DOCUSATE SODIUM
Dosage form
CAPSULE
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
A06AA - Softeners, emollients
RxNorm RxCUI
82003
Manufacturer / MAH
-
Applicant / LTR
-
Country of origin
-

Source: Pharmacy and Medicines Regulatory Authority · fetched 2026-04-21 17:37:43 · updated 2026-09-29 04:33:06

Disclaimer: This information is sourced from Pharmacy and Medicines Regulatory Authority (Malawi). Always consult a qualified healthcare professional before using any medication.

About docusate

Docusate is a stool softener that helps relieve constipation by making bowel movements easier.

What it treats

  • constipation
  • hard stools

How it works

It works by increasing the amount of water and fats in the stool, which helps soften it.

Who it's for

It is suitable for adults and children who need help with bowel movements.

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

About vitamins

Vitamins are essential nutrients that help support various bodily functions and maintain overall health.

What it treats

  • vitamin deficiency
  • general health support
  • boosting immune system
  • improving energy levels

How it works

Vitamins support different processes in the body, such as energy production, immune function, and the maintenance of healthy skin and bones.

Who it's for

Vitamins are for anyone who wants to improve their health or address specific vitamin deficiencies.

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

Clinical monograph: Docusatesodium

BNF-referenced

Docusate sodium is a surfactant laxative primarily used to alleviate constipation by promoting the softening of stool. It functions by reducing the surface tension of the stool, allowing water and lipids to penetrate and soften the stool mass. It is commonly indicated for the treatment of constipation and for use in bowel cleansing prior to medical procedures.

Indications

  • Constipation
  • Softening of impacted feces
  • Bowel cleansing prior to medical procedures

Dosage

Children: For children aged 2-11 years: 12.5 to 25 mg 3 times a day, adjusted according to response. For children aged 12-17 years: 120 mg for 1 dose.

Adults: For oral use: 50 to 500 mg daily in divided doses, adjusted according to response. For rectal use: 120 mg as a single dose.

Mechanism of action

Docusate sodium acts as a stool softener by increasing the wetting efficiency of the intestinal fluid, facilitating the mixing of aqueous and fatty substances, which leads to a reduction in stool hardness. It also promotes the secretion of intestinal fluids, which aids in the overall ease of bowel movements.

Pharmacodynamics

Docusate sodium works by altering the surface tension of the stool, making it easier for water to mix with the stool, thus softening it. Its effects are generally observed within 1 to 3 days of oral administration, while rectal administration can lead to a quicker response, typically within 20 minutes.

Pharmacokinetics

Docusate sodium is absorbed in the gastrointestinal tract, with a peak plasma concentration occurring approximately 1 to 2 hours after administration. The elimination half-life is not well-characterized, but the drug is excreted mainly in the urine. The onset of action varies depending on the route of administration; oral doses typically take 1-3 days to have an effect, whereas rectal doses have a faster onset.

Contra-indications

  • Inflammatory bowel disease (except under medical supervision)
  • Intestinal obstruction
  • Hypersensitivity to soya
  • History of hypersensitivity to arachis oil or peanuts

Adverse effects

  • Anal irritation
  • Contact dermatitis
  • Granuloma pneumonia
  • Lipoid pneumonia
  • Rectal discharge

Interactions

  • Avoid concurrent use with liquid paraffin
  • Excessive use of stimulant laxatives may cause diarrhea and related effects such as hypokalemia

Precautions

  • Prolonged use should be avoided
  • Administered at night for optimal effect
  • Rectal preparations not indicated if hemorrhoids or anal fissure are present

Pregnancy

Manufacturer advises caution; consult a healthcare professional before use during pregnancy.

Breast-feeding

Manufacturer advises caution; present in small amounts in milk following oral administration.

Storage

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

Formulations

  • Docusate sodium 2.5 mg per 1 ml oral solution
  • Docusate sodium 10 mg per 1 ml oral solution
  • Docusate sodium 12.5 mg/5 ml oral solution
  • Docusate sodium 100 mg capsules
  • Docusate sodium 120 mg enema
BNF 85 (British National Formulary) p.82 BNF 85 (British National Formulary) p.1337 BNF for Children 2019-2020 p.68 BNF for Children 2019-2020 p.740 PubChem / pathway

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: docusate

BNF-referenced

Docusate is a stool softener and laxative primarily used to treat constipation by facilitating the incorporation of water and fats into the stool, resulting in a softer fecal mass. It is often indicated for patients who may be at risk of straining during defecation, such as those recovering from surgery or childbirth.

Indications

  • Constipation
  • Prevention of straining during bowel movements
  • Management of conditions such as hemorrhoids or anal fissures

Dosage

Children: Refer to the BNF for Children for appropriate dosing in children.

Adults: The usual oral dosage is 50 to 500 mg daily in divided doses, or 100 to 250 mg taken once daily. Rectal administration can involve 283 to 566 mg as a single dose.

Mechanism of action

Docusate exerts its effects primarily through its surfactant properties in the intestines. It allows for the incorporation of fat and water into the feces, which softens the stool. Studies have shown that docusate increases the secretion of water, sodium, chloride, and potassium while decreasing the absorption of glucose and bicarbonate. This mechanism may involve an increase in intracellular cyclic AMP, either directly by docusate or through E series prostaglandins.

Pharmacodynamics

As an anionic detergent and laxative, docusate promotes stool softening by reducing surface tension. Its onset of action varies, with oral administration taking 6 to 72 hours and rectal administration acting within 2 to 15 minutes. The effects are localized in the jejunum, aiding in the passage of feces.

Pharmacokinetics

Docusate is absorbed in the gastrointestinal tract, but its specific absorption and elimination characteristics are not well-documented. It is primarily metabolized in the intestines, and the active metabolites facilitate the stool softening effect. The pharmacokinetic profile indicates that its action can vary based on the route of administration and individual patient factors.

Adverse effects

  • Abdominal cramping
  • Diarrhea
  • Nausea
  • Throat irritation

Precautions

  • Use with caution in patients with intestinal obstruction or abdominal pain of unknown origin
  • Not recommended for long-term use

Pregnancy

Docusate is generally considered safe to use during pregnancy, but it is advisable to consult a healthcare provider before use.

Breast-feeding

Docusate is excreted in breast milk; however, it is considered safe to use while breastfeeding.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Oral capsules
  • Oral liquid
  • Rectal suppositories

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: vitamins

Vitamins are organic compounds that are essential for normal growth and metabolism in the body. They play a critical role in various biochemical processes, including energy production, immune function, and the synthesis of hormones and neurotransmitters. Vitamins are classified into two main categories: water-soluble and fat-soluble. Water-soluble vitamins include the B-complex vitamins and vitamin C, while fat-soluble vitamins include vitamins A, D, E, and K.

Indications

  • Vitamin deficiency
  • Nutritional supplementation
  • Prevention of certain diseases
  • Supporting metabolic functions

Dosage

Children: Refer to specific guidelines for individual vitamins or consult a healthcare professional for personalized dosing recommendations.

Adults: Refer to specific guidelines for individual vitamins or consult a healthcare professional for personalized dosing recommendations.

Mechanism of action

Vitamins function primarily as coenzymes or precursors for enzyme cofactors in various metabolic pathways. For instance, B vitamins are involved in energy metabolism by assisting in the conversion of carbohydrates, fats, and proteins into energy. Vitamin C acts as an antioxidant, protecting cells from damage, and is also crucial for collagen synthesis. Fat-soluble vitamins like A are involved in vision and immune function, while vitamin D regulates calcium and phosphate metabolism.

Pharmacodynamics

Vitamins exert their effects by participating in biochemical reactions and influencing metabolic pathways. For example, vitamin A is vital for vision and immune response, while vitamin D is important for maintaining bone health through its role in calcium absorption. The effects of vitamins can vary significantly depending on their solubility, with water-soluble vitamins typically being excreted more readily than fat-soluble ones, which can accumulate in the body.

Pharmacokinetics

The absorption of vitamins varies; water-soluble vitamins are generally absorbed in the small intestine and excreted in urine, while fat-soluble vitamins require dietary fats for absorption and are stored in the liver and fatty tissues. The bioavailability of vitamins can be affected by dietary composition, age, and health status. Elimination half-lives also differ; for instance, vitamin C has a shorter half-life compared to vitamin A, which can persist in the body for longer periods.

Adverse effects

  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
  • Headache
  • Fatigue
  • Allergic reactions

Interactions

  • Fat-soluble vitamins (A, D, E, K) can accumulate and cause toxicity when taken in excess, especially with other supplements
  • Certain medications (e.g., anticoagulants) may interact with vitamin K
  • Vitamin C can enhance the absorption of iron supplements

Precautions

  • Use caution in patients with kidney disease when taking vitamin D
  • Monitor for signs of toxicity with high-dose vitamin supplementation
  • Consider dietary sources of vitamins before recommending supplements

Pregnancy

Vitamins are generally considered safe during pregnancy when taken at recommended dosages. However, excessive intake, particularly of fat-soluble vitamins, should be avoided.

Breast-feeding

Most vitamins are safe during breastfeeding at recommended doses, but excessive amounts can affect breast milk composition.

Storage

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

Formulations

  • Tablets
  • Capsules
  • Soft gels
  • Powders
  • Liquid solutions
  • Chewable tablets

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: docusate

PubChem CID 11339

Molecular formula: C20H38O7S

Mechanism of action

Recent studies suggest that docusate's mechanism of action is due largely to it's surfactant effect in the intestines, which allow fat and water into the feces to soften the stool. Docusate’s mechanism of action was investigated in 1985 on healthy patients. Docusate was added directly to the jejunum based on calculated concentrations of docusate in the jejunum. At this concentration, there was an increase in secretion of water, sodium, chloride, and potassium as well as a decrease in absorption of glucose and bicarbonate. Based on in vitro data, the authors suggested this effect was due to an increase in intracellular cyclic AMP either directly through docusate or E series prostaglandins.

Pharmacodynamics

Docusate sodium is a laxative and an anionic detergent that supposedly promotes incorporation of water and fats into stool through a reduction in surface tension, resulting in softer fecal mass. Docusate's onset of action is 6-72 hours orally and 2-15 minutes rectally. The effects of docusate are thought to be exerted locally in the jejunum.

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

This drug in other countries

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