Registered Tanzania · TMDA

Nebilong-2.5

Betadex (Betacyclodextrin 10.000 mg/6 mL,Betadex Sulfobutylether Sodium 20.000 mg/6 mL,Colloidal anhydrous silica 2.000 mg/6 mL,Croscarmellose Sodium 12.000 mg/6 mL,Dichloromethane q.s q.s,Dioctyl Sodium Sulpho Succinate 2.000 mg/6 mL,Isopropyl Alcohol q.s q.s,Lactose (Monohydrate 60.440 mg/6 mL,Magnesium Stearate 2.000 mg/6 mL,Microcrystalline cellulose 57.000 mg/6 mL,Nebivolol Hydrochloride equivalent to Nebivolol 2.5 mg/6 mL,Povidone (K-30) 5.000 mg/6 mL,Talc 2.000 mg/6 mL

TAN 23 HM 0342 Uncoated Tablets INN generic

What it does

Betadex is a compound used primarily to help improve the solubility of certain medications.

Commonly used for: improving medication solubility

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.
TAN 23 HM 0342
Registration date
2023-08-17
Expiry date
2028-08-16
Status
Registered/Compliant
Active ingredient
Betadex (Betacyclodextrin 10.000 mg/6 mL,Betadex Sulfobutylether Sodium 20.000 mg/6 mL,Colloidal anhydrous silica 2.000 mg/6 mL,Croscarmellose Sodium 12.000 mg/6 mL,Dichloromethane q.s q.s,Dioctyl Sodium Sulpho Succinate 2.000 mg/6 mL,Isopropyl Alcohol q.s q.s,Lactose (Monohydrate 60.440 mg/6 mL,Magnesium Stearate 2.000 mg/6 mL,Microcrystalline cellulose 57.000 mg/6 mL,Nebivolol Hydrochloride equivalent to Nebivolol 2.5 mg/6 mL,Povidone (K-30) 5.000 mg/6 mL,Talc 2.000 mg/6 mL
Dosage form
Uncoated Tablets
Strength
-
Pack size
-
Therapeutic class
-
RxNorm RxCUI
1362685
Manufacturer / MAH
Micro Labs
Applicant / LTR
Micro Labs Limited
Country of origin
INDIA
Manufacturer location
31, Race Course Rd, Madhava Nagar, Gandhi Nagar, Bengaluru, Karnataka 560001, India

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:45:06 · updated 2026-10-19 03:00:45

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

About betadex

Betadex is a compound used primarily to help improve the solubility of certain medications.

What it treats

  • improving medication solubility

How it works

Betadex helps dissolve other medicines, making them easier for the body to absorb.

Who it's for

Betadex is used for patients requiring medications that need improved solubility.

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

About talc

Talc is a mineral used primarily to absorb moisture and reduce friction. It is commonly found in various personal care products.

What it treats

  • skin irritation
  • diaper rash
  • chafing
  • sweating

How it works

Talc works by absorbing moisture and providing a smooth surface, which helps to prevent irritation and discomfort on the skin.

Who it's for

Talc is suitable for anyone needing relief from moisture-related skin issues, including babies and adults.

Cautions

  • • Avoid using on broken or irritated skin.
  • • Keep away from the eyes and mouth.

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

Clinical monograph: betadex

BNF-referenced

Betadex is a cyclic oligosaccharide, specifically a derivative of beta-cyclodextrin, which consists of seven glucose units linked by alpha-1,4-glycosidic bonds. It is often used as a solubilizing agent to enhance the bioavailability of poorly soluble drugs. Betadex forms inclusion complexes with various hydrophobic compounds, improving their solubility in aqueous solutions. This property makes it valuable in pharmaceutical formulations, particularly in parenteral and oral drug delivery systems.

Indications

  • Solubilization of poorly soluble drugs
  • Improving the bioavailability of hydrophobic medications
  • Pharmaceutical formulations requiring enhanced drug stability

Dosage

Children: Refer to the BNF for Children for dosage recommendations, as pediatric dosing must be determined based on age, weight, and the specific indication.

Adults: Refer to the specific product information or BNF for dosing guidance, as dosages can vary based on the formulation and the drug being solubilized.

Mechanism of action

Betadex functions primarily by forming inclusion complexes with hydrophobic drugs. The lipophilic drug molecules are encapsulated within the hydrophobic cavity of the betadex molecule, resulting in increased solubility and stability of the drug in solution. This mechanism enhances drug bioavailability, allowing for better therapeutic effects and reduced side effects associated with solubility issues.

Pharmacodynamics

The pharmacodynamics of betadex is largely related to its ability to solubilize and stabilize various drug compounds. By enhancing solubility, it increases the drug's absorption in systemic circulation, thus improving its pharmacological action. The formation of inclusion complexes can also modify the drug's release profile, potentially leading to altered pharmacokinetics and efficacy.

Pharmacokinetics

Betadex is not significantly absorbed through the gastrointestinal tract when administered orally. Its pharmacokinetics are influenced by its formulation and the nature of the drug it complexes with. Following injection, complexed drugs may exhibit altered distribution and elimination profiles, depending on the characteristics of both betadex and the drug. The excretion of betadex occurs primarily via the kidneys, with minimal metabolism.

Pregnancy

There is limited data on the use of betadex during pregnancy. Caution is advised.

Breast-feeding

Data on the excretion of betadex in human breast milk is not available. Caution is recommended.

Storage

Store at room temperature, away from light and moisture.

Formulations

  • {'name': 'Betadex', 'type': 'Powder for 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: talc

BNF-referenced

Talc is a mineral composed of magnesium, silicon, and oxygen, commonly used in various pharmaceutical applications due to its excellent absorptive properties. It is often employed as an excipient in drug formulations and as a bulking agent in tablets and powders. Talc is also utilized in some medical procedures, such as pleurodesis, to prevent the recurrence of pleural effusions.

Indications

  • Used as an excipient in drug formulations
  • Pleurodesis for the management of recurrent pleural effusions

Dosage

Children: Refer to specific guidelines for paediatric use, as dosing may differ based on age and clinical condition.

Adults: Refer to specific guidelines for the appropriate dosage in pleurodesis and other applications, as it may vary based on clinical context.

Mechanism of action

Talc exhibits very good absorptive properties, allowing it to absorb moisture and other substances effectively. This characteristic is particularly useful in pharmaceutical formulations, where it may enhance the stability and texture of the drug product.

Pharmacodynamics

Talc's primary pharmacodynamic effect is its ability to act as an inert filler and bulking agent in pharmaceutical preparations. It does not have any intrinsic pharmacological activity but serves to improve the physical properties of formulations, such as flowability and compressibility.

Pharmacokinetics

Talc is not absorbed systemically when used as an excipient or in medical procedures. Its effects are local, and it remains in the site of application, where it functions primarily as a mechanical agent. The pharmacokinetics of talc in the context of its use in pleurodesis involves its ability to promote adhesion of the pleural surfaces, thereby preventing fluid accumulation.

Pregnancy

Talc is classified as a substance with minimal systemic absorption, but safety during pregnancy has not been well established. Consult relevant guidelines.

Breast-feeding

Talc is not expected to be absorbed in significant amounts; however, caution is advised and consult guidelines.

Storage

Store in a cool, dry place, away from direct sunlight.

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: betadex

PubChem CID 444041

Molecular formula: C42H70O35

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

Molecular reference: talc

PubChem CID 165411828

Molecular formula: H2Mg3O12Si4

Mechanism of action

It has very good absorptive properties.

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.