amoxicillin reference
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(amoxicillin · DailyMed)
Registered Tanzania · TMDA

Spamox 500

Amoxicillin Trihydrate equivalent to Amoxicillin 500 mg,Colloidal Silicon Dioxide BP Eq. to Silicon mg,Magnesium Stearate mg,Purified talc mg

TAN 06,448 J01H SPA Capsules 500 alimentary tract and metabolism INN generic

What it does

Amoxicillin is an antibiotic used to treat infections caused by bacteria.

Commonly used for: infections of the ear, nose, and throat, urinary tract infections, pneumonia, skin infections

Read more in plain English ↓

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

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

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Sourcing - Kenya only

Registration & product details

Registration no.
TAN 06,448 J01H SPA
Registration date
2021-06-13
Expiry date
2026-06-12
Status
Registered/Compliant
Active ingredient
Amoxicillin Trihydrate equivalent to Amoxicillin 500 mg,Colloidal Silicon Dioxide BP Eq. to Silicon mg,Magnesium Stearate mg,Purified talc mg
Dosage form
Capsules
Strength
500
Pack size
-
Therapeutic class
-
ATC class (WHO)
A02BD - Combinations for eradication of Helicobacter pylori
RxNorm RxCUI
723
Manufacturer / MAH
Sparsh Bio-tech
Country of origin
INDIA
Manufacturer location
PLOT NO.1, SURVEY NO.242/243,244, VILLAGE LAKHABAVAD, Gujarat 361006, India

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:38:02 · updated 2026-06-08 06:37:43

Drug Interactions

7
Check interactions

Severe (1)

Penicillins - increases risk of adverse effects

Valproate increases the risk of adverse effects when given with penicillins (pivmecillinam). Avoid.

Severe Anecdotal

Unknown (6)

Amoxicillin - increases risk of skin rash

Allopurinol increases the risk of skin rash when given with penicillins (amoxicillin, ampicillin).

Unknown Study

Penicillins - increases risk of skin rash

Allopurinol increases the risk of skin rash when given with penicillins (amoxicillin, ampicillin).

Unknown Study

Penicillins - increases exposure

Leflunomide is predicted to increase the exposure to penicillins (benzylpenicillin).

Unknown Theoretical

Penicillins - increases exposure

Nitisinone is predicted to increase the exposure to penicillins (benzylpenicillin).

Unknown Study

Penicillins - increases exposure

Teriflunomide is predicted to increase the exposure to penicillins (benzylpenicillin).

Unknown Study

Phenindione - increases risk of bleeding events

Penicillins are predicted to increase the risk of bleeding events when given with phenindione.

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: class

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

About amoxicillin

Amoxicillin is an antibiotic used to treat infections caused by bacteria.

What it treats

  • infections of the ear, nose, and throat
  • urinary tract infections
  • pneumonia
  • skin infections

How it works

It kills bacteria or stops their growth, helping to clear up infections.

Who it's for

Amoxicillin is suitable for adults and children who have bacterial infections.

Drug class

Penicillins

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

About colloidal

Colloidal solutions are often used in various medical treatments and can help improve the delivery of certain medications.

What it treats

  • supporting hydration
  • helping with nutrient absorption
  • improving medication effectiveness

How it works

Colloidal solutions contain small particles that can help carry and deliver substances in the body more effectively.

Who it's for

Adults and children who need assistance with hydration or nutrient delivery.

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

About dioxide

Dioxide is used in various medical applications, but specific details about its class or interactions are not provided.

How it works

The exact mechanism of action for dioxide is not specified, but it generally serves various therapeutic roles in medicine.

Who it's for

Dioxide may be suitable for individuals needing treatment related to its specific applications, but more information is needed to identify specific patient groups.

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

About purified

Purified ingredients are often used in various medicines to ensure safety and effectiveness by removing impurities.

What it treats

  • various medical conditions

How it works

Purified ingredients help in delivering the intended effects of the medicine without the risk of contaminants.

Who it's for

People who need medications with safe and effective ingredients.

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

About silicon

Silicon is a mineral that may help support healthy bones and connective tissues.

What it treats

  • bone health
  • joint health
  • skin health

How it works

Silicon helps form collagen, which is important for maintaining the strength and elasticity of bones and tissues.

Who it's for

Silicon is for individuals looking to support their bone and joint health.

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: Amoxicillin

BNF-referenced

Amoxicillin is a broad-spectrum antibiotic belonging to the penicillin class, effective against a variety of bacterial infections. It is commonly used to treat conditions such as urinary tract infections, sinusitis, community-acquired pneumonia, and salmonellosis.

Indications

  • Bacterial infections
  • Urinary tract infections
  • Sinusitis
  • Uncomplicated community-acquired pneumonia
  • Salmonellosis
  • Oral infections
  • Lyme disease (under expert supervision)
  • Acute exacerbation of bronchiectasis
  • Anthrax (treatment and post-exposure prophylaxis)

Dosage

Children: 1 month–11 years: 30 mg/kg 3 times a day for 21 days; children 1–4 years: 250 mg 3 times a day; children 5–11 years: 500 mg 3 times a day.

Adults: 500 mg 3 times a day; increased if necessary up to 1 g 3 times a day in severe infections.

Mechanism of action

Amoxicillin works by inhibiting bacterial cell wall synthesis, leading to cell lysis and death. It binds to penicillin-binding proteins (PBPs) located inside the bacterial cell wall, interfering with the transpeptidation process necessary for cell wall integrity.

Pharmacodynamics

Amoxicillin exhibits bactericidal activity against susceptible bacteria. Its action is time-dependent, meaning that its effectiveness is related to the duration of time that the drug concentration remains above the minimum inhibitory concentration (MIC) for the target pathogen.

Pharmacokinetics

Amoxicillin is well absorbed from the gastrointestinal tract, with peak plasma concentrations achieved within 1-2 hours after oral administration. It is widely distributed in body tissues and fluids, and it is excreted primarily via the kidneys. The elimination half-life is approximately 1 hour, and renal impairment may necessitate dosage adjustments.

Adverse effects

  • Skin rash
  • Gastrointestinal disturbances (nausea, vomiting, diarrhea)
  • Allergic reactions (including anaphylaxis)
  • Superinfection (due to resistant organisms)

Interactions

  • Allopurinol (increases risk of skin rash)

Precautions

  • History of penicillin allergy
  • Renal impairment (reduce dose)
  • Use with caution in patients with mononucleosis

Pregnancy

Use only if clearly needed; no adequate studies in pregnant women.

Breast-feeding

Amoxicillin is excreted in breast milk; use with caution.

Storage

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

Formulations

  • Phenoxymethylpenicillin 250mg/5ml oral solution
  • Phenoxymethylpenicillin 250 mg tablets
BNF for Children 2019-2020 p.373 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: colloidal

Colloidal solutions are mixtures in which small particles are dispersed throughout a continuous medium. They can be used in various medical applications, including as intravenous fluids for volume expansion and as drug delivery systems. Colloidal solutions can improve the solubility and stability of drugs, enhancing their therapeutic effects.

Indications

  • Hypovolemic shock
  • Severe burns
  • Postoperative fluid replacement
  • Sepsis
  • Trauma management

Dosage

Children: Refer to established guidelines for specific dosing, as it varies based on the type of colloidal solution used and the clinical condition being treated.

Adults: Refer to established guidelines for specific dosing, as it varies based on the type of colloidal solution used and the clinical condition being treated.

Mechanism of action

Colloidal solutions work by maintaining oncotic pressure in the blood, thus helping to retain fluid within the vascular system. This is primarily due to the large molecular weight of the colloidal particles, which cannot easily pass through capillary walls. The presence of colloids in the blood helps to draw water into the circulation, increasing blood volume and improving tissue perfusion.

Pharmacodynamics

The pharmacodynamics of colloidal solutions are centered on their ability to exert osmotic pressure, which helps maintain blood volume and pressure. This effect is particularly important in conditions such as hypovolemia and shock, where fluid replacement is necessary to restore hemodynamic stability. The efficacy of colloidal solutions can vary depending on the type of colloid used, as well as the underlying clinical condition being treated.

Pharmacokinetics

Colloidal solutions are typically administered intravenously and their pharmacokinetics can vary based on the specific formulation. Generally, colloids are distributed throughout the vascular compartment and have a longer duration of action compared to crystalloids, as they remain in circulation longer. The elimination of colloids is primarily through the reticuloendothelial system, where they are metabolized or eliminated by the liver and spleen. Factors such as particle size and composition can influence their distribution and clearance.

Adverse effects

  • Allergic reactions
  • Injection site reactions
  • Nausea
  • Vomiting
  • Headache
  • Fever

Precautions

  • Use with caution in patients with known allergies to any component of the formulation
  • Monitor for signs of hypersensitivity during administration
  • Consider volume overload in patients with cardiac or renal impairment

Pregnancy

The safety of colloidal solutions during pregnancy has not been established. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether colloidal solutions are excreted in human milk. Caution should be exercised when administering to breastfeeding mothers.

Storage

Store at room temperature, protect from light, and do not freeze. Keep out of reach of children.

Formulations

  • Colloidal silver
  • Colloidal gold
  • Colloidal iron
  • Other metal colloids

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: dioxide

Dioxide refers to a class of chemical compounds that contain two oxygen atoms bonded to another element or group. The most commonly referenced dioxide is carbon dioxide (CO2), a colorless, odorless gas produced by respiration in animals and plants and by the combustion of organic matter. In a clinical context, dioxides are often involved in various physiological processes and can play roles in drug mechanisms, particularly with respect to gas exchange and acid-base balance in the body.

Indications

  • Monitoring respiratory function
  • Assessment of metabolic status
  • Management of respiratory acidosis
  • Management of respiratory alkalosis

Dosage

Children: Dosing for interventions related to carbon dioxide levels in pediatric patients should be guided by clinical protocols and the BNF for Children.

Adults: Dosing for interventions related to carbon dioxide levels is typically based on clinical assessment and individual patient needs. Refer to clinical guidelines for specific scenarios.

Mechanism of action

Carbon dioxide acts primarily as a signaling molecule in the body, influencing respiratory drive and blood pH. It is produced during cellular respiration and is a critical component of the bicarbonate buffering system, which helps maintain acid-base homeostasis. Elevated levels of CO2 in the blood stimulate ventilation in the lungs, increasing the rate of gas exchange and facilitating the removal of excess CO2.

Pharmacodynamics

The pharmacodynamic effects of dioxides, particularly carbon dioxide, are closely related to its concentration in the blood. As CO2 levels increase, it leads to respiratory acidosis, which can stimulate the respiratory centers in the brain to increase ventilation. Conversely, low levels of CO2 can cause respiratory alkalosis, potentially leading to decreased respiratory drive. CO2 also plays a role in vasodilation and can affect blood flow and pressure through its influence on smooth muscle tone.

Pharmacokinetics

Carbon dioxide is produced endogenously during metabolic processes and is transported in the bloodstream primarily in three forms: dissolved in plasma, as bicarbonate ions (HCO3-), and bound to hemoglobin. The half-life of CO2 in the bloodstream is very short due to its rapid exchange with alveolar gas in the lungs. The elimination of CO2 occurs through exhalation, making it a dynamic component of respiratory physiology.

Pregnancy

Data on the effects of dioxide during pregnancy are limited. Caution is advised due to potential risks associated with exposure.

Breast-feeding

Limited data are available regarding the excretion of dioxide in human milk. Caution is recommended.

Storage

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

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: purified

Purified refers to a substance that has been processed to remove impurities, contaminants, or unwanted substances, resulting in a more concentrated and effective form of the original compound. In pharmacology, purified compounds are often used to enhance therapeutic efficacy and reduce adverse effects. The purification process can apply to a variety of substances, including drugs, biological products, and chemical compounds.

Dosage

Children: Refer to specific drug formulations and product labels as purified substances can vary widely in their use and dosing.

Adults: Refer to specific drug formulations and product labels as purified substances can vary widely in their use and dosing.

Mechanism of action

The mechanism of action for purified compounds varies widely depending on the specific substance. Generally, purified drugs exert their effects by interacting with specific biological targets, such as receptors, enzymes, or ion channels, leading to a desired therapeutic effect. This interaction can involve binding to receptors to activate or inhibit signaling pathways, modulating enzymatic activity, or altering physiological processes.

Pharmacodynamics

Pharmacodynamics describes the effects of a drug on the body and the relationship between drug concentration and effect. For purified drugs, this can involve dose-response relationships and the time course of their action. The purified form often enhances potency and reduces variability in response among patients, which can lead to more predictable therapeutic outcomes. The overall effect is determined by the drug's affinity for its target, the efficacy of the drug-receptor interaction, and the downstream signaling pathways activated as a result of this interaction.

Pharmacokinetics

Pharmacokinetics involves the absorption, distribution, metabolism, and excretion (ADME) of a drug. For purified substances, absorption can be more efficient due to the absence of impurities that may affect solubility or stability. Distribution may also be enhanced, leading to higher bioavailability. Metabolism can be influenced by the structure of the purified compound, as it may be metabolized more readily by liver enzymes. Excretion typically occurs through the kidneys or liver, depending on the molecular characteristics of the purified drug.

Pregnancy

Consult with a healthcare professional, as the safety of purified forms of medications during pregnancy may vary depending on the specific substance.

Breast-feeding

Consult with a healthcare professional, as the safety of purified forms of medications during breastfeeding may vary depending on the specific substance.

Storage

Store in a cool, dry place, away from light and moisture, and 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: silicon

BNF-referenced

Silicon, represented by the molecular formula Si, is a metalloid that plays a significant role in various biological processes, particularly in the formation of connective tissues and bone. It is thought to contribute to the structural integrity of collagen and other extracellular matrix components. Silicon is not classified as an essential element in the human diet, but it is involved in the metabolism of minerals and may affect bone health and formation.

Indications

  • Potential role in bone health
  • Support for connective tissue formation
  • May aid in mineral metabolism

Dosage

Children: There is no established clinical dosage for silicon in paediatric populations, as it is not classified as an essential nutrient.

Adults: There is no established clinical dosage for silicon in adults, as it is not classified as an essential nutrient.

Mechanism of action

Silicon is believed to enhance the synthesis of glycosaminoglycans and collagen, which are important for the structural integrity of connective tissues. It may also influence the activity of certain enzymes involved in bone mineralization, thus playing a role in maintaining bone density and health.

Pharmacodynamics

The pharmacodynamics of silicon is not fully elucidated; however, it is thought to involve the modulation of bone metabolism and the promotion of connective tissue health. Silicon may have a synergistic effect with other minerals, such as calcium and magnesium, aiding in their utilization and metabolism in the body.

Pharmacokinetics

The pharmacokinetics of silicon is complex, as it is not absorbed through typical gastrointestinal pathways. Instead, silicon is thought to be taken up in the form of silicates and then distributed throughout the body, particularly in connective tissues. The elimination of silicon occurs primarily through renal excretion, with some variations depending on dietary intake and individual metabolism.

Pregnancy

Silicon is generally considered safe during pregnancy, as it is a naturally occurring element in the human body. However, specific recommendations regarding supplementation should be followed based on the advice of a healthcare provider.

Breast-feeding

Silicon is present in breast milk in small amounts. Its safety during breastfeeding is generally regarded as acceptable, although supplementation should be approached with caution and under medical advice.

Storage

Silicon should be stored in a cool, dry place, protected from light and moisture. Follow specific storage recommendations provided by the manufacturer if available.

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: Amoxicillin

PubChem CID 33613

Molecular formula: C16H19N3O5S

Mechanism of action

Amoxicillin competitively inhibits penicillin-binding protein 1 and other high molecular weight penicillin binding proteins. Penicillin bind proteins are responsible for glycosyltransferase and transpeptidase reactions that lead to cross-linking of D-alanine and D-aspartic acid in bacterial cell walls. Without the action of penicillin binding proteins, bacteria upregulate autolytic enzymes and are unable to build and repair the cell wall, leading to bacteriocidal action. The penicillins and their metabolites are potent immunogens because of their ability to combine with proteins and act as haptens for acute antibody-mediated reactions. The most frequent (about 95 percent) or "major" determinant of penicillin allergy is the penicilloyl determinant produced by opening the beta-lactam ring of the penicillin. This allows linkage of the penicillin to protein at the amide group. "Minor" determinants (less frequent) are the other metabolites formed, including native penicillin and penicilloic acids. /Penicillins/ Amoxicillin is similar to penicillin in its bactericidal action against susceptible bacteria during the stage of active multiplication. It acts through the inhibition of cell wall biosynthesis that leads to the death of the bacteria.

Pharmacodynamics

Amoxicillin competitively inhibit penicillin binding proteins, leading to upregulation of autolytic enzymes and inhibition of cell wall synthesis. Amoxicillin has a long duration of action as it is usually given twice daily. Amoxicillin has a wide therapeutic range as mild overdoses are not associated with significant toxicity. Patients should be counselled regarding the risk of anaphylaxis, _Clostridium difficile_ infections, and bacterial resistance.

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

Molecular reference: silicon

PubChem CID 5461123

Molecular formula: Si

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.