International reference: 1 US FDA recall for this ingredient

Microbial Contamination of Non-Sterile Products (xylitol)

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

What it does

Acids are substances that can help in various medical conditions, often used to adjust pH levels in the body or treat certain diseases.

Commonly used for: stomach acid issues (acid reflux), metabolic disorders, certain types of infections

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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.
12231
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
PURE CRYSTALLINE AMINO ACIDS I.V INFUSION WITH XYLITOL.
Strength
-
Pack size
200 ML BOTTLE
Therapeutic class
NEW/INNOVATOR
Manufacturer / MAH
Harleys
Applicant / LTR
TIL HEALTHCARE PVT LTD
Country of origin
FOREIGN
Manufacturer location
63 Westlands Rd, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 21:57:27 · updated 2026-03-23 04:42:35

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

About acids

Acids are substances that can help in various medical conditions, often used to adjust pH levels in the body or treat certain diseases.

What it treats

  • stomach acid issues (acid reflux)
  • metabolic disorders
  • certain types of infections

How it works

Acids can help balance pH levels in the body and assist in digestion or treatment of specific conditions.

Who it's for

People experiencing issues related to stomach acid, metabolic problems, or specific infections.

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

About amino

Amino is a medication that may be used to support various health conditions. It works in the body to help improve certain functions.

What it treats

  • nutritional support
  • amino acid deficiency

How it works

Amino helps provide essential building blocks for proteins in the body, supporting overall health and well-being.

Who it's for

Amino is suitable for individuals needing extra nutritional support or those who have low levels of amino acids.

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

About crystalline

Crystalline is a type of medication used in various treatments.

How it works

Crystalline works by interacting with the body in a way that helps manage certain health conditions.

Who it's for

This medication may be suitable for individuals depending on their specific health needs and doctor's advice.

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

About pure

Pure is a substance that may have various uses depending on its form and application.

How it works

The exact way Pure works can vary widely based on its specific application.

Who it's for

People looking for a specific substance or product that is labeled as pure.

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

About xylitol

Xylitol is a sugar alcohol used as a sweetener that is often found in sugar-free products.

What it treats

  • tooth decay prevention
  • oral health
  • sugar substitute

How it works

Xylitol helps reduce the growth of harmful bacteria in the mouth, which can lead to cavities.

Who it's for

Suitable for people looking for a sugar alternative, especially those concerned about dental health.

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

Clinical monograph: acids

Acids are a broad class of compounds characterized by their ability to donate protons (H+) in aqueous solutions. They play crucial roles in various physiological processes and are involved in numerous biochemical pathways. Common examples include acetic acid, citric acid, and hydrochloric acid. Acids are essential in digestion, metabolic pathways, and as components of various pharmaceutical formulations.

Indications

  • Gastroesophageal reflux disease (GERD)
  • Peptic ulcers
  • Dyspepsia
  • Acid-base balance disorders

Dosage

Children: Refer to specific acid formulations and guidelines for dosing. General dosing depends on the acid and its clinical use.

Adults: Refer to specific acid formulations and guidelines for dosing. General dosing depends on the acid and its clinical use.

Mechanism of action

Acids exert their effects primarily by dissociating into protons and anions in solution, thereby lowering the pH of the surrounding environment. This proton donation can influence various physiological processes, including enzyme activity, ion transport, and cellular signaling pathways. For example, hydrochloric acid in the stomach aids in digestion and the absorption of certain nutrients.

Pharmacodynamics

The pharmacodynamic effects of acids are largely dependent on their concentration and the specific type of acid involved. Weak acids may dissociate partially, leading to a less pronounced effect, while strong acids fully dissociate, leading to significant changes in pH and potential tissue irritation. Acids can also interact with various receptors and enzymes, influencing metabolic pathways and physiological responses.

Pharmacokinetics

The pharmacokinetics of acids vary widely depending on their chemical structure. Strong acids, such as hydrochloric acid, do not significantly enter systemic circulation due to their rapid dissociation in aqueous environments. Weak acids may be absorbed through the gastrointestinal tract, where their absorption is influenced by pH, solubility, and the presence of food. Metabolism and excretion pathways also vary, with some acids being metabolized to bicarbonate or other metabolites before excretion, primarily via the kidneys.

Adverse effects

  • Gastrointestinal irritation
  • Nausea
  • Vomiting
  • Abdominal pain
  • Diarrhea
  • Electrolyte imbalance

Precautions

  • Use with caution in patients with renal impairment
  • Monitor for signs of gastrointestinal bleeding
  • Consider potential interactions with other medications that may affect gastrointestinal motility or pH levels

Pregnancy

The safety of various acids during pregnancy may vary; consult specific guidelines for each acid. Generally, use should be limited to essential cases.

Breast-feeding

Caution is advised when using acids during breastfeeding; consult specific guidelines for each acid.

Storage

Store in a cool, dry place away from direct sunlight. Keep tightly closed and 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: amino

Aminophylline is a compound that consists of theophylline and ethylenediamine, primarily used as a bronchodilator in the treatment of asthma, chronic obstructive pulmonary disease (COPD), and other conditions associated with reversible airway obstruction. It acts by relaxing the smooth muscles of the airways, thereby improving airflow and reducing the work of breathing.

Indications

  • Asthma
  • Chronic obstructive pulmonary disease (COPD)
  • Bronchospasm associated with respiratory conditions

Dosage

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

Adults: Refer to the BNF for specific adult dosing guidelines.

Mechanism of action

Aminophylline works as a phosphodiesterase inhibitor, leading to an increase in intracellular cyclic AMP (cAMP). This action results in the relaxation of bronchial smooth muscle, bronchodilation, and reduced airway resistance. It may also exert anti-inflammatory effects by inhibiting the release of inflammatory mediators from mast cells.

Pharmacodynamics

The pharmacodynamics of aminophylline involve its ability to enhance respiratory function by decreasing airway resistance, improving mucociliary clearance, and increasing respiratory muscle strength. Its therapeutic effects typically begin within 30 minutes of administration, with a peak effect occurring within 2 hours.

Pharmacokinetics

Aminophylline is rapidly absorbed following intravenous administration, with a bioavailability of approximately 100%. Its volume of distribution is large, indicating extensive tissue binding. The drug is metabolized primarily in the liver via cytochrome P450 enzymes, with a half-life ranging from 3 to 10 hours depending on patient factors, including age, liver function, and concurrent medications.

Interactions

  • aminoglycosides+agalsidasealfa: Severe (decreases effects)
  • aminoglycosides+agalsidasebeta: Severe (decreases effects)
  • betablockers,selective+aminophylline: Severe (increases risk of bronchospasm)
  • aminophylline+phosphodiesterasetype-: Severe (increases exposure)
  • stiripentol+aminophylline: Severe (increases exposure)
  • deferasirox+aminophylline: Severe (increases exposure)
  • aminophylline+roflumilast: Severe (increases exposure)
  • aciclovir+aminophylline: Moderate (increases exposure)
  • aminophylline+macrolides: Moderate (decreases exposure)
  • aminophylline+erythromycin: Moderate (decreases exposure)

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: crystalline

Crystalline refers to a form of a drug that has a well-defined geometric structure and is usually in a solid state. This form can influence the drug's stability, solubility, and bioavailability. Many medications can be found in crystalline forms, which may vary based on their chemical properties and intended route of administration.

Dosage

Children: Paediatric dosing for crystalline drugs is also specific to the particular drug and condition. For accurate paediatric doses, please consult the BNF for Children.

Adults: Dosing for crystalline drugs varies widely based on the specific medication and condition being treated. It is essential to refer to the BNF or relevant clinical guidelines for precise adult dosing recommendations.

Mechanism of action

The mechanism of action of crystalline drugs is largely dependent on the specific active pharmaceutical ingredient. In general, crystalline drugs dissolve in the biological fluids, releasing the active compound that interacts with cellular receptors or enzymes to exert their therapeutic effects. This process enhances the drug's pharmacological activity, as the crystalline form typically allows for more controlled release and absorption in the body.

Pharmacodynamics

Pharmacodynamics of crystalline drugs involves understanding how the drug affects the body. This includes the relationship between drug concentration and the resultant pharmacological effect. Factors such as the drug's affinity for its target, intrinsic activity, and the presence of other substances can influence the overall therapeutic outcome.

Pharmacokinetics

Pharmacokinetics of crystalline drugs encompasses the processes of absorption, distribution, metabolism, and excretion (ADME). The crystalline form can affect the rate of dissolution and, consequently, the absorption in the gastrointestinal tract. Once absorbed, the distribution is influenced by factors such as blood flow, tissue affinity, and plasma protein binding. Metabolism typically occurs in the liver, where the drug may be converted into active or inactive metabolites. Excretion primarily takes place via the kidneys.

Pregnancy

The safety of crystalline substance use during pregnancy has not been well studied. Use only if clearly needed and the benefits outweigh risks.

Breast-feeding

It is unknown if crystalline substances are excreted in human milk. Caution should be exercised when administering to breastfeeding women.

Storage

Store in a cool, dry place away from light. Keep tightly closed and 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: pure

Pure is a term often used to refer to substances that are not mixed with any other compounds. In pharmacology, 'pure' can apply to a drug that is synthesized to contain only the active pharmaceutical ingredient (API) without any impurities or additives. The purity of a drug is crucial for ensuring its safety, efficacy, and quality, especially in clinical settings where precise dosages and effects are necessary.

Dosage

Children: Refer to specific drug information for dosing recommendations, as it varies by substance.

Adults: Refer to specific drug information for dosing recommendations, as it varies by substance.

Mechanism of action

The mechanism of action for a pure substance depends on the specific drug in question. Generally, pure drugs exert their effects by interacting with specific receptors or enzymes in the body, modulating biochemical pathways, or altering physiological functions. For instance, some pure drugs may act as agonists or antagonists at neurotransmitter receptors, while others may inhibit enzymes involved in metabolic processes.

Pharmacodynamics

Pharmacodynamics describes how a drug affects the body and involves the relationship between drug concentration and effect. Pure substances can exhibit a range of pharmacodynamic effects depending on their chemical structure and mechanism of action. The efficacy, potency, and therapeutic window of pure drugs are critical factors that influence their clinical use. Additionally, pure drugs may have dose-dependent effects, where increased concentrations lead to heightened responses or increased side effects.

Pharmacokinetics

Pharmacokinetics involves the absorption, distribution, metabolism, and excretion (ADME) of a drug. Pure substances may demonstrate distinct pharmacokinetic profiles based on their chemical properties. For example, lipophilic drugs may be rapidly absorbed through cell membranes, while hydrophilic drugs may require transport mechanisms. Metabolism often occurs in the liver, where pure drugs are converted to active or inactive metabolites. Excretion typically occurs through urine or bile, and the half-life of a pure drug can influence dosing frequency and treatment duration.

Pregnancy

There is limited data on the safety of this drug during pregnancy. Consult healthcare professionals for advice.

Breast-feeding

It is unknown whether this drug is excreted in human milk. Use with caution and consult healthcare professionals.

Storage

Store in a cool, dry place away from light. Follow specific storage instructions on the product label.

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: xylitol

BNF-referenced

Xylitol is a five-carbon sugar alcohol (polyol) that is utilized primarily as a sugar substitute. It has a sweet taste similar to that of sucrose but with lower caloric content. Xylitol is commonly found in sugar-free chewing gums, mints, and dental care products due to its dental health benefits, including the reduction of cavity-causing bacteria. It is also used in various food products and pharmaceuticals.

Indications

  • Reduction of dental caries
  • Sugar substitute for diabetics
  • Management of dry mouth (xerostomia)

Dosage

Children: Refer to specific product guidelines, as dosing may vary based on the intended use.

Adults: Refer to specific product guidelines, as dosing may vary based on the intended use.

Mechanism of action

Xylitol is absorbed into the bloodstream and is metabolized primarily in the liver. It is converted to xylulose-5-phosphate, which plays a role in the pentose phosphate pathway, a crucial metabolic pathway involved in carbohydrate metabolism. This pathway contributes to energy production and the generation of ribose-5-phosphate, essential for nucleotide synthesis.

Pharmacodynamics

Xylitol's sweetening power is approximately 70% that of sucrose, but it does not cause an increase in blood glucose levels, making it suitable for individuals with diabetes. It exerts a dental protective effect by reducing the levels of Streptococcus mutans, the bacteria responsible for dental caries. Additionally, xylitol promotes remineralization of tooth enamel.

Pharmacokinetics

Following oral administration, xylitol is absorbed in the gastrointestinal tract and has a relatively low glycemic index. It is metabolized in the liver and excreted primarily in the urine. The half-life of xylitol in humans is not well defined, but it is known to be excreted relatively quickly due to its hydrophilic nature.

Adverse effects

  • gastrointestinal discomfort
  • diarrhea

Precautions

  • Use with caution in individuals with fructose intolerance.

Pregnancy

Xylitol is generally regarded as safe during pregnancy, but clinical data is limited.

Breast-feeding

Xylitol is considered safe during breastfeeding, but there is limited data on its effects.

Storage

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

Formulations

  • Chewing gum
  • Mints
  • Powder

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

This drug in other countries

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

South Africa 2 products