Registered Tanzania · TMDA

ACTOLIND w GEL

Polyhexamethlene Biguanide and N, N-Bis (3-aminopropyl) didecylamine

TAN 24 AD 0137 Solution 0.1 INN generic

What it does

Biguanide is a type of medication mainly used to help manage blood sugar levels in people with diabetes.

Commonly used for: type 2 diabetes (non-insulin dependent diabetes), high blood sugar (hyperglycemia)

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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.
TAN 24 AD 0137
Registration date
2024-06-06
Expiry date
2029-06-05
Status
Registered/Compliant
Active ingredient
Polyhexamethlene Biguanide and N, N-Bis (3-aminopropyl) didecylamine
Dosage form
Solution
Strength
0.1
Pack size
-
Therapeutic class
-
RxNorm RxCUI
1918319
Manufacturer / MAH
-
Applicant / LTR
ACTO GmbH
Country of origin
-

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:53:45 · updated 2026-09-24 03:00:47

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About biguanide

Biguanide is a type of medication mainly used to help manage blood sugar levels in people with diabetes.

What it treats

  • type 2 diabetes (non-insulin dependent diabetes)
  • high blood sugar (hyperglycemia)

How it works

It helps lower blood sugar levels by improving the way the body uses insulin.

Who it's for

This medication is for adults and children over 10 years old who have type 2 diabetes.

Cautions

  • • Consult your doctor if you have kidney problems.
  • • Inform your doctor if you have liver disease.

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

About didecylamine

Didecylamine is a medication used to relieve symptoms caused by conditions such as coughs and colds.

What it treats

  • cough
  • cold symptoms

How it works

Didecylamine works by blocking certain signals in the brain that trigger coughing.

Who it's for

This medication is suitable for adults and children over a certain age, typically for those experiencing cough-related discomfort.

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

About polyhexamethlene

Polyhexamethylene is a chemical used in various medical and hygiene products, often for its antimicrobial properties.

What it treats

  • skin infections
  • wound care
  • antiseptic applications

How it works

It helps to kill or prevent the growth of bacteria and other germs.

Who it's for

It is suitable for use in adults and children who need treatment for certain skin conditions.

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

Clinical monograph: biguanide

BNF-referenced

Biguanide is an antidiabetic medication primarily used in the management of type 2 diabetes mellitus. It acts to improve glucose tolerance and lower blood sugar levels in patients. The most commonly known biguanide is metformin. Biguanides influence glucose metabolism and have a relatively low risk of causing hypoglycemia.

Indications

  • Type 2 diabetes mellitus
  • Polycystic ovary syndrome (off-label use)

Dosage

Children: For children aged 10 years and older, the starting dose is typically 500 mg orally once or twice daily, with gradual increases as needed and tolerated.

Adults: The usual initial dose of metformin is 500 mg orally twice daily or 850 mg once daily, which may be increased gradually based on glycemic control and tolerance.

Mechanism of action

Biguanides, particularly metformin, primarily work by decreasing hepatic glucose production and increasing insulin sensitivity in peripheral tissues. This leads to enhanced uptake and utilization of glucose by the tissues, thereby reducing blood glucose levels. The exact mechanism involves activation of AMP-activated protein kinase (AMPK), which plays a crucial role in energy homeostasis.

Pharmacodynamics

Biguanides lower blood glucose levels without increasing insulin secretion, which helps mitigate the risk of hypoglycemia. They also have beneficial effects on lipid profiles and may reduce the risk of macrovascular complications associated with diabetes. Metformin has been shown to have cardioprotective effects and may aid in weight management in patients with type 2 diabetes.

Pharmacokinetics

Biguanides are absorbed in the gastrointestinal tract, with peak plasma concentrations typically occurring 2 to 3 hours after administration. They are primarily excreted unchanged by the kidneys, and their half-life is approximately 6.2 hours. Renal function significantly affects the pharmacokinetics of biguanides, necessitating dosage adjustments in patients with renal impairment.

Contra-indications

  • Severe renal impairment
  • Acute or chronic metabolic acidosis
  • Diabetic ketoacidosis
  • Hypersensitivity to biguanides

Adverse effects

  • Gastrointestinal disturbances (nausea, vomiting, diarrhea)
  • Lactic acidosis
  • Vitamin B12 deficiency
  • Hypoglycemia (when used in combination with other antidiabetic medications)

Interactions

  • Cationic drugs (e.g., certain antihypertensives) may affect renal clearance
  • Alcohol can increase the risk of lactic acidosis
  • Diuretics may alter blood glucose levels

Precautions

  • Monitor renal function regularly
  • Use caution in patients with liver dysfunction
  • Discontinue before surgical procedures or radiological studies involving iodinated contrast

Pregnancy

Biguanides should only be used in pregnancy if the potential benefit justifies the potential risk to the fetus. Metformin is the preferred agent in gestational diabetes.

Breast-feeding

Metformin is excreted in breast milk in small amounts. It is generally considered safe during breastfeeding.

Storage

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

Formulations

  • Tablets
  • Extended-release tablets
  • 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.

Clinical monograph: didecylamine

BNF-referenced

Didecylamine is a chemical compound with the molecular formula C20H43N. It is classified as a tertiary amine and is primarily used in industrial applications, such as surfactants and emulsifiers. Didecylamine is not widely used in clinical settings and its pharmacological properties are not fully established in medicinal literature.

Dosage

Children: Refer to specific clinical guidelines or consult the BNF for Children for appropriate dosing information.

Adults: Refer to specific clinical guidelines or consult the BNF for appropriate dosing information.

Mechanism of action

Didecylamine functions as a surfactant, reducing surface tension and enhancing the solubility of various compounds. It may also exhibit local anesthetic properties by blocking sodium channels, although detailed mechanisms in clinical use are not well documented.

Pharmacodynamics

As a surfactant, didecylamine can alter the physical properties of cell membranes, potentially affecting the absorption and distribution of co-administered drugs. Its local anesthetic effects may result in temporary numbness in localized areas, but the clinical significance of these effects is limited.

Pharmacokinetics

Information on the pharmacokinetics of didecylamine is sparse. However, as a tertiary amine, it is likely to undergo metabolism through N-dealkylation and other pathways in the liver. The specific absorption, distribution, metabolism, and excretion (ADME) parameters remain largely undefined.

Pregnancy

There is limited data on the use of didecylamine in pregnancy. It should be used only if clearly needed and the benefits outweigh any potential risks.

Breast-feeding

Caution is advised when using didecylamine during breastfeeding, as it is unknown whether it is excreted in human milk.

Storage

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

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: polyhexamethlene

Polyhexamethylene biguanide (PHMB) is a biocide and antimicrobial agent commonly used in disinfectants, antiseptics, and contact lens solutions. It exhibits broad-spectrum antimicrobial activity against bacteria, fungi, and viruses. PHMB is known for its use in wound care products, where it helps to prevent infections and promote healing. It is non-toxic and well-tolerated by human tissues, making it suitable for use in various medical and cosmetic applications.

Indications

  • Wound care management
  • Disinfection of skin and mucous membranes
  • Antiseptic for surgical procedures
  • Preservative in ophthalmic solutions
  • Treatment of minor skin infections

Dosage

Children: Refer to specific product guidelines for appropriate dosing information.

Adults: Refer to specific product guidelines for appropriate dosing information.

Mechanism of action

PHMB exerts its antimicrobial action primarily through disruption of microbial cell membranes. It binds to the negatively charged components of bacterial membranes, leading to cell lysis and death. This mechanism is largely due to its polycationic nature, which allows it to interact with and destabilize the lipid bilayer of bacteria, fungi, and some viruses. Additionally, PHMB may interfere with DNA replication and protein synthesis in microbes, contributing to its overall antimicrobial efficacy.

Pharmacodynamics

The pharmacodynamic profile of PHMB indicates its effectiveness against a wide range of pathogens, including Gram-positive and Gram-negative bacteria, yeasts, and some viruses. Its low minimum inhibitory concentrations (MICs) suggest potent activity. PHMB has a cumulative effect with repeated exposure, and it is known to remain effective in the presence of organic matter, which is significant for its use in clinical and environmental settings.

Pharmacokinetics

PHMB is poorly absorbed systemically when applied topically, which limits its systemic effects and potential toxicity. It is largely retained at the site of application, providing local antimicrobial activity. The elimination half-life of PHMB is not well defined due to its limited absorption; however, it is expected to be excreted primarily through the urine. The pharmacokinetics may vary based on the formulation and route of administration.

Adverse effects

  • Skin irritation
  • Hypersensitivity reactions
  • Allergic dermatitis

Precautions

  • Use with caution in patients with a history of sensitivity to similar compounds
  • Avoid contact with eyes and mucous membranes

Pregnancy

Safety in pregnancy has not been established. Use only if the benefits outweigh the risks.

Breast-feeding

There is limited information on the excretion of polyhexamethylene in breast milk. Caution is advised when used during breastfeeding.

Storage

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

Formulations

  • Topical solutions
  • Gels
  • Wipes

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: biguanide

PubChem CID 5939

Molecular formula: C2H7N5

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

Molecular reference: didecylamine

PubChem CID 14261

Molecular formula: C20H43N

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