International reference: 6 US FDA recalls for this ingredient

Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity. (solvent)

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved (solvent)

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. (vehicle)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes (vehicle)

Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. (solvent)

Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. (solvent)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Tanzania.

Registered Tanzania · TMDA

SAOLE ORAL

Levamisol Hydrochloride 30 mg/ml,Oxyclozanide 60 mg/ml,Solvent/Vehicle Sufficient amount ml

TAN 25 VM 0308 Suspension, Oral 6/3 antiparasitic products, insecticides and repellents

What it does

This medicine is used to treat various health conditions. It's important to follow your healthcare provider's instructions when taking it.

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 25 VM 0308
Registration date
2025-05-23
Expiry date
2030-05-22
Status
Registered/Compliant
Active ingredient
Levamisol Hydrochloride 30 mg/ml,Oxyclozanide 60 mg/ml,Solvent/Vehicle Sufficient amount ml
Dosage form
Suspension, Oral
Strength
6/3
Pack size
-
Therapeutic class
-
ATC class (WHO)
P02CE - Imidazothiazole derivatives
RxNorm RxCUI
6371
Country of origin
CHINA
Manufacturer location
388 He Ping Dong Lu, Chang An Qu, Shi Jia Zhuang Shi, He Bei Sheng, China, 050015

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:44:18 · updated 2026-07-16 03:00:38

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

About amount

This medicine is used to treat various health conditions. It's important to follow your healthcare provider's instructions when taking it.

How it works

The medicine works by affecting certain processes in the body to help manage your condition.

Who it's for

This medicine is suitable for individuals who have specific health issues as determined by their healthcare provider.

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

About levamisol

Levamisol is a medication that helps treat certain infections and conditions related to the immune system.

What it treats

  • worm infections (helminthiasis)
  • immune system disorders

How it works

Levamisol enhances the body's immune response and helps eliminate parasites.

Who it's for

Levamisol is for individuals with specific infections caused by worms or those needing immune support.

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

About oxyclozanide

Oxyclozanide is a medication used to treat infections caused by certain parasites in animals. It is not commonly used in humans.

What it treats

  • parasitic infections
  • animal infections caused by flukes

How it works

Oxyclozanide works by killing the parasites that cause the infection.

Who it's for

This medication is primarily for use in animals and is not typically prescribed for humans.

Cautions

  • • Use only under veterinary guidance.
  • • Not suitable for all animal species.

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

About solvent

Solvent is a substance that can dissolve other materials. It is commonly used in various applications, including medications and industrial processes.

What it treats

  • used in medications
  • used in industrial processes

How it works

Solvents help to dissolve other substances, making them easier to mix or use in different applications.

Who it's for

Solvent is used by manufacturers and in certain medical formulations.

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

About sufficient

Sufficient is a medicine that helps manage certain conditions effectively.

How it works

Sufficient works by addressing the underlying issues of specific health conditions.

Who it's for

Sufficient is suitable for individuals with specific health needs as determined by a healthcare professional.

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

About vehicle

Vehicle is a term often used to describe a substance that helps deliver medication, but it does not have therapeutic effects on its own.

How it works

Vehicle acts as a medium to carry active ingredients in medicines, ensuring they are effectively delivered to the target area in the body.

Who it's for

Vehicle is used in various medications but does not treat any specific condition on its own.

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

Clinical monograph: amount

Amount, often referred to in the context of dosage, is a measure of the quantity of a drug administered to a patient. It is crucial in determining the therapeutic effects and minimizing the risk of adverse reactions. The amount of a drug can vary based on the condition being treated, the patient's age, weight, and overall health status.

Dosage

Children: Refer to specific drug information for paediatric dosing, which is often weight-based and varies according to the specific drug and indication.

Adults: Refer to specific drug information for adult dosing, which varies based on the drug's indication and formulation.

Mechanism of action

The mechanism of action for any specific drug referred to as 'amount' would depend on the active pharmaceutical ingredient contained within that formulation. Generally, drugs exert their effects by interacting with specific receptors or enzymes in the body, leading to a pharmacological response. This could involve agonism or antagonism of receptor sites, inhibition of enzymatic activity, or modulation of various physiological pathways.

Pharmacodynamics

Pharmacodynamics involves the study of the effects of drugs and their mechanisms of action. For a drug, the pharmacodynamic profile will depend on factors such as potency, efficacy, and the relationship between drug concentration and effect. The therapeutic window, which is the range of doses at which a drug is effective without causing toxicity, is also a critical aspect of pharmacodynamics.

Pharmacokinetics

Pharmacokinetics describes how the body absorbs, distributes, metabolizes, and excretes a drug. Key processes include absorption (how the drug enters the bloodstream), distribution (how it spreads through the body), metabolism (how the body chemically alters the drug), and excretion (how the drug is eliminated). Factors influencing pharmacokinetics include age, weight, organ function, and the presence of other medications.

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: levamisol

BNF-referenced

Levamisole is a synthetic imidazothiazole derivative primarily used as an anthelmintic agent for the treatment of various worm infestations. It exhibits immunomodulatory effects and is utilized in certain cancer therapies as an adjunct to enhance immune response. The drug is known for its agonistic activity on nicotinic acetylcholine receptors in nematode muscles, leading to paralysis of the parasites. Additionally, it plays a role in restoring immune function in immunocompromised patients.

Indications

  • Nematode infections
  • Ascariasis
  • Hookworm infections
  • Strongyloidiasis
  • Immunosuppression in certain cancer treatments

Dosage

Children: Refer to the BNF for Children for pediatric dosing information.

Adults: Refer to the BNF for specific dosing recommendations based on the condition being treated.

Mechanism of action

The mechanism of action of levamisole as an antiparasitic agent involves agonistic activity towards the L-subtype nicotinic acetylcholine receptors in nematode muscles, reducing the males' ability to control reproductive muscles and limiting copulation. As an immunomodulator, levamisole enhances immune function by stimulating T-cell activation and proliferation, increasing antibody formation, and potentiating the functions of monocytes, macrophages, and neutrophils.

Pharmacodynamics

Levamisole acts as an anthelmintic by targeting nematode nicotinic acetylcholine receptors, leading to paralysis of the worms. As an immunomodulator, it behaves as an immunostimulant, increasing natural killer (NK) cells and activated T-cells, particularly when used adjuvantly with fluorouracil in cancer treatment. Its ability to enhance immune responses makes it valuable in clinical settings where immune function is compromised.

Pharmacokinetics

Levamisole is well absorbed following oral administration, with peak plasma concentrations typically occurring within 1 to 2 hours. It undergoes extensive hepatic metabolism, and its metabolites are primarily excreted via the kidneys. The half-life of levamisole varies, but it is generally around 5 to 7 hours in healthy individuals. Due to its immunomodulatory properties, the pharmacokinetics can be influenced by the patient's immune status and concomitant medications.

Adverse effects

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Rash
  • Neutropenia
  • Hepatotoxicity

Interactions

  • Albendazole may have decreased exposure when used with levamisole
  • Ivermectin may have increased exposure when used with levamisole

Precautions

  • Use with caution in patients with a history of blood dyscrasias
  • Monitor for signs of infection due to potential immunosuppressive effects
  • Careful consideration should be given when prescribing to patients with liver impairment

Pregnancy

Levamisole should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus, as safety in pregnancy has not been established.

Breast-feeding

Levamisole is excreted in human milk; therefore, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother.

Storage

Store at room temperature, away from light and moisture.

Formulations

  • 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: oxyclozanide

BNF-referenced

Oxyclozanide is an anthelmintic agent primarily used in veterinary medicine for the treatment of liver fluke infections in livestock and also has applications in certain parasitic infections in humans. It is particularly effective against Fasciola hepatica and Fasciola gigantica, which are responsible for liver fluke disease.

Indications

  • Liver fluke infections (Fasciola hepatica, Fasciola gigantica)
  • Other trematode infections

Dosage

Children: Refer to the BNF for Children for specific dosing guidelines in the paediatric population.

Adults: Refer to the BNF for specific dosing recommendations as they may vary depending on the indication and patient condition.

Mechanism of action

Oxyclozanide exerts its anthelmintic effects by disrupting the energy metabolism of the helminths. It interferes with the oxidative phosphorylation process in the mitochondria of the parasites, leading to a depletion of ATP and subsequent paralysis and death of the worms.

Pharmacodynamics

Oxyclozanide has a selective action against specific stages of the liver fluke, causing immobilization and eventual death of the parasite. Its activity is enhanced in the presence of bile acids, which facilitate its uptake by the parasites. The drug exhibits a broad spectrum of activity against trematodes.

Pharmacokinetics

Oxyclozanide is absorbed from the gastrointestinal tract and undergoes hepatic metabolism. It is eliminated primarily through the feces, with a minor fraction excreted in urine. The pharmacokinetic profile shows a relatively short half-life, necessitating multiple doses for continued efficacy against fluke infections.

Pregnancy

No evidence of risk in humans. However, safety during pregnancy has not been established.

Breast-feeding

It is unknown whether oxyclozanide is excreted in human breast milk. Caution is advised.

Storage

Store in a cool, dry place, away from light. 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: solvent

Solvents are substances, typically liquids, used to dissolve a solute, resulting in a solution. They play a crucial role in various industrial, pharmaceutical, and laboratory processes. Common solvents include water, ethanol, acetone, and chloroform. In the pharmaceutical context, solvents can be used to prepare solutions for medications, facilitate drug absorption, or act as carriers for active ingredients.

Indications

  • Dilution of medications
  • Preparation of pharmaceutical formulations
  • Facilitation of drug absorption
  • Chemical reactions in laboratories
  • Industrial applications

Dosage

Children: Refer to specific product guidelines and BNF for Children for appropriate use.

Adults: Refer to specific product guidelines and BNF for appropriate use.

Mechanism of action

Solvents facilitate the dissolution of solutes by disrupting intermolecular forces, allowing for the formation of a homogeneous mixture. Depending on the solvent and solute, the mechanism may involve hydrogen bonding, van der Waals forces, or dipole-dipole interactions. In biological systems, solvents can influence the solubility and bioavailability of drugs, modifying their pharmacological effects.

Pharmacodynamics

The pharmacodynamics of solvents are closely related to their properties, such as polarity, viscosity, and boiling point. As solvents interact with biological membranes and tissues, they can affect drug release rates and absorption. The efficacy of a solvent in drug formulation may also determine the therapeutic outcomes by influencing the drug's stability and distribution in the body.

Pharmacokinetics

The pharmacokinetics of solvents involves their absorption, distribution, metabolism, and excretion (ADME) in the body. Solvents can be absorbed through various routes, including oral, dermal, or inhalation. Once in the system, they can rapidly distribute to tissues, depending on their chemical nature. Metabolism may occur in the liver, where solvents can be converted into less toxic compounds, while excretion usually takes place via the urinary system. The rate of these processes can be influenced by the solvent's properties and the presence of other substances.

Pregnancy

The safety of solvent use during pregnancy is not well established. Caution is advised, and risks should be weighed against benefits.

Breast-feeding

The effects of solvents during breastfeeding are not well studied. Caution is recommended due to potential risks to the infant.

Storage

Store in a cool, dry place away from direct sunlight and heat sources. Keep containers tightly closed to prevent contamination.

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: sufficient

Sufficient is a term that may refer to the adequacy or appropriateness of a drug's effect or dosage in a clinical context. Without a specific drug name, this entry focuses on general pharmacological principles rather than on a particular medication. It is essential to consider the pharmacological properties, clinical uses, and dosing guidelines of specific agents when evaluating their sufficiency for therapeutic purposes.

Dosage

Children: Refer to specific drug guidelines in the BNF for Children for appropriate dosing information.

Adults: Refer to specific drug guidelines in the BNF for appropriate dosing information.

Mechanism of action

The mechanism of action will vary significantly depending on the specific drug referred to as 'sufficient.' Generally, mechanisms of action may include receptor agonism or antagonism, enzyme inhibition, or modulation of signaling pathways within cells. Understanding the specific drug's pharmacodynamics is crucial for determining its therapeutic efficacy.

Pharmacodynamics

Pharmacodynamics involves the study of the biochemical and physiological effects of drugs and their mechanisms of action. It encompasses the interactions between drug molecules and target receptors, the resulting cellular responses, and the overall therapeutic effects observed in patients. The relationship between drug concentration and effect is fundamental to understanding drug efficacy and safety.

Pharmacokinetics

Pharmacokinetics describes how a drug is absorbed, distributed, metabolized, and excreted in the body. Key parameters include bioavailability, volume of distribution, clearance, and half-life. These factors influence dosing regimens and the timing of therapeutic effects. Individual patient characteristics, such as age, sex, organ function, and genetic factors, can also impact pharmacokinetic profiles.

Pregnancy

Consult with a healthcare provider before use. Insufficient data on safety.

Breast-feeding

Consult with a healthcare provider before use. Insufficient data on safety.

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.

Clinical monograph: vehicle

A vehicle in pharmacology refers to a substance that carries or delivers an active pharmaceutical ingredient (API) in a drug formulation. It typically comprises inert ingredients that help in the formulation process, ensuring the stability, solubility, and bioavailability of the API. Vehicles can include solvents, emulsifiers, and stabilizers, and they play a crucial role in the formulation of various dosage forms such as solutions, suspensions, ointments, and creams.

Indications

  • Used as a medium for drug delivery
  • Facilitates the formulation of various dosage forms
  • Aids in the stability and solubility of active pharmaceutical ingredients

Dosage

Children: Refer to specific drug formulation guidelines as dosing will vary based on the active ingredient and intended use.

Adults: Refer to specific drug formulation guidelines as dosing will vary based on the active ingredient and intended use.

Mechanism of action

Vehicles do not have a pharmacological effect on their own; their primary role is to facilitate the delivery of the active ingredient. Their composition and properties can influence absorption, distribution, metabolism, and excretion of the API, thus affecting the overall efficacy of the drug formulation.

Pharmacodynamics

Pharmacodynamics of vehicles primarily relates to their role in enhancing the solubility and stability of the active ingredients. They can affect the release rate of the drug, its absorption in the body, and the overall therapeutic effect. The choice of vehicle can significantly impact the pharmacological activity of the API, especially in topical applications.

Pharmacokinetics

As vehicles are typically inert substances, they do not undergo significant metabolic processes in the body. However, their physical and chemical properties, such as viscosity, polarity, and pH, can influence the pharmacokinetics of the active ingredients they carry. This includes factors such as absorption rates and distribution within the body.

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: levamisol

PubChem CID 26879

Molecular formula: C11H12N2S

Mechanism of action

The mechanism of action of levamisole as an antiparasitic agent appears to be tied to its agnositic activity towards the L-subtype nicotinic acetylcholine receptors in nematode muscles. This agonistic action reduces the capacity of the males to control their reproductive muscles and limits their ability to copulate. The mechanism of action of Levamisole as an anticancer drug in combination with fluorouracil is unknown. The effects of levamisole on the immune system are complex. The drug appears to restore depressed immune function rather than to stimulate response to above-normal levels. Levamisole can stimulate formation of antibodies to various antigens, enhance T-cell responses by stimulating T-cell activation and proliferation, potentiate monocyte and macrophage functions including phagocytosis and chemotaxis, and increase neutrophil mobility, adherence, and chemotaxis.

Pharmacodynamics

Levamisole is a synthetic imidazothiazole derivative that has been widely used in treatment of worm infestations in both humans and animals. As an anthelmintic, it probably works by targeting the nematode nicotinergic acetylcholine receptor. As an immunomodulator, it appears that Levamisole is an immunostimulant which has been shown to increase NK cells and activated T-cells in patients receiving this adjuvantly along with 5FU for Stage III colon cancer.

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

Molecular reference: oxyclozanide

PubChem CID 16779

Molecular formula: C13H6Cl5NO3

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.