amoxicillin reference
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(amoxicillin · DailyMed)
Registered Tanzania · TMDA

Amoxicillin Trihydrate

Amoxicillin Trihydrate equivalent to Amoxicillin 250 mg,Dodecyl sulfate sodium mg,Magnesium Stearate mg,Sodium Starch Glycolate mg

TZ 14 H 0324 Capsules 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.

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.
TZ 14 H 0324
Registration date
2024-11-29
Expiry date
2029-11-28
Status
Registered/Compliant
Active ingredient
Amoxicillin Trihydrate equivalent to Amoxicillin 250 mg,Dodecyl sulfate sodium mg,Magnesium Stearate mg,Sodium Starch Glycolate mg
Dosage form
Capsules
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
A02BD - Combinations for eradication of Helicobacter pylori
RxNorm RxCUI
723
Manufacturer / MAH
Cspc Zhongnuo Pharmaceutical
Country of origin
CHINA

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:51:18 · updated 2026-10-22 03:00:45

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 dodecyl

Dodecyl is a compound used in various formulations, but specific details on its uses and effects are limited.

How it works

Information on how dodecyl works is not available.

Who it's for

Dodecyl may be included in products for different purposes, but specific patient groups are not identified.

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

About glycolate

Glycolate is a compound that may be used in various medical treatments.

How it works

Glycolate works by interacting with certain bodily processes, though specific details are not available.

Who it's for

Glycolate may be suitable for individuals needing treatment related to certain health conditions, but specific indications are not provided.

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

About starch

Starch is a carbohydrate that serves as a source of energy and is often used in various food products.

What it treats

  • energy source
  • dietary supplement

How it works

Starch is broken down by the body into glucose, which provides energy for daily activities.

Who it's for

Starch can be used by anyone needing extra energy in their diet, particularly those with increased energy needs.

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: dodecyl

BNF-referenced

Dodecyl, a straight-chain alkyl group derived from dodecanol, is primarily used in surfactants and detergents. It possesses hydrophobic properties due to its long carbon chain, making it effective in various applications including cleaning products, emulsifiers, and as a solubilizing agent. Its molecular formula is C12H25.

Indications

  • Surfactant in cleaning products
  • Emulsifier in cosmetic formulations
  • Solubilizing agent in pharmaceutical applications

Mechanism of action

Dodecyl acts primarily as a surfactant, reducing surface tension between different substances. It facilitates the emulsification of oils and water, allowing for better mixing and absorption. This action is largely attributed to its hydrophobic tail and hydrophilic head, which interact with both polar and non-polar substances.

Pharmacodynamics

Dodecyl demonstrates properties typical of surfactants, such as lowering surface tension and enhancing solubility of hydrophobic compounds in aqueous solutions. It can affect cell membranes due to its ability to integrate into lipid layers, which may influence cellular permeability and function.

Pharmacokinetics

The pharmacokinetics of dodecyl, including absorption, distribution, metabolism, and excretion, are not well-documented in clinical literature. However, due to its hydrophobic nature, it is expected to be poorly absorbed through the gastrointestinal tract when ingested, with potential for localized effects if applied topically. Further research is needed to fully understand its pharmacokinetic profile.

Pregnancy

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

Breast-feeding

Data on the excretion of dodecyl in human milk is not available. Exercise caution when administering to breastfeeding mothers.

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: glycolate

BNF-referenced

Glycolate is an intermediate in the metabolism of ethylene glycol, a compound that can cause toxicity when ingested. The toxicity arises primarily from its conversion to glycolic acid and other harmful metabolites. Glycolate and its relation to ethylene glycol's elimination kinetics have been studied, revealing important insights into their toxicokinetics in animal models.

Dosage

Children: Refer to specific clinical guidelines for dosing in children, as no standard paediatric dosage is specified in the provided resources.

Adults: Refer to specific clinical guidelines for dosing, as no standard adult dosage is specified in the provided resources.

Mechanism of action

Ethylene glycol toxicity results from its metabolism to glycolic acid and other toxic metabolites. Glycolate accumulates in the body and is eliminated more slowly than ethylene glycol itself. The renal excretion of both compounds plays a crucial role in their elimination, accounting for a significant portion of the administered dose.

Pharmacodynamics

The pharmacodynamics of glycolate are closely tied to its role as a metabolite of ethylene glycol. Its accumulation can lead to metabolic acidosis, although minimal clinical effects have been observed at low doses. The relationship between glycolate and ethylene glycol indicates that glycolate may contribute to the overall toxic effects of ethylene glycol ingestion.

Pharmacokinetics

The pharmacokinetics of glycolate indicate that it reaches peak plasma levels between 4-6 hours after the administration of ethylene glycol. The elimination half-life of ethylene glycol is approximately 1.7 hours in rats and 3.4 hours in dogs. Glycolate is predominantly eliminated through renal excretion, with about 5% of the dose being excreted unchanged.

Pregnancy

There is limited data on the safety of glycolate in pregnancy. Caution is advised.

Breast-feeding

Data on the excretion of glycolate in human milk is not available. Caution is advised.

Storage

Store at room temperature, away from light 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: starch

Starch is a polysaccharide carbohydrate consisting of a large number of glucose units joined by glycosidic bonds. It is a major energy source in the human diet and is found in numerous food sources such as grains, legumes, and tubers. In a clinical setting, starch can also be used as an excipient in various pharmaceuticals and is sometimes utilized in enteral nutrition formulations.

Indications

  • Nutritional supplementation
  • Energy source in enteral nutrition
  • Excipient in pharmaceutical formulations

Dosage

Children: Refer to specific guidelines or product inserts for dosing information, as it can vary based on the context of use.

Adults: Refer to specific guidelines or product inserts for dosing information, as it can vary based on the context of use.

Mechanism of action

Starch is broken down into glucose units by enzymes such as amylase during digestion. The glucose is then absorbed in the intestines and utilized for energy production in the body's cells. This pathway involves hydrolysis of the glycosidic bonds, converting starch into simpler sugars.

Pharmacodynamics

Starch primarily serves as an energy source. Its digestion and absorption lead to an increase in blood glucose levels, which provides energy for metabolic processes. In this context, it plays a crucial role in maintaining energy homeostasis in the body.

Pharmacokinetics

Starch is not absorbed in its polymeric form; it must first be enzymatically hydrolyzed into simpler sugars such as maltose and glucose. The digestion and absorption of starch occur predominantly in the small intestine, with glucose being readily absorbed into the bloodstream. The rate of absorption can vary depending on the type of starch and its physical form.

Adverse effects

  • Allergic reactions
  • Gastrointestinal discomfort
  • Diarrhea
  • Constipation

Precautions

  • Use with caution in individuals with known allergies to starch or starch derivatives
  • Monitor for gastrointestinal symptoms in patients with a history of digestive disorders

Pregnancy

Starch is generally considered safe for use during pregnancy. However, it should be consumed in moderation as part of a balanced diet.

Breast-feeding

Starch is deemed safe for nursing mothers when used in moderation as part of a balanced diet.

Storage

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

Formulations

  • Powder
  • Granules
  • Tablets
  • Suspensions

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: dodecyl

PubChem CID 5359624

Molecular formula: C12H25

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

Molecular reference: glycolate

PubChem CID 757

Molecular formula: C2H4O3

Mechanism of action

Ethylene glycol toxicity results from its metabolism to glycolic acid and other toxic metabolites. The accumulation of glycolate and the elimination kinetics of ethylene glycol and its metabolites are not well understood, so studies with male Sprague-Dawley rats and mixed breed dogs have been carried out. Ethylene glycol was administered by gavage to rats and dogs which were placed in metabolic cages for urine and blood sample collection at timed intervals. The peak plasma level of ethylene glycol occurred at 2 hr after dosing and that of glycolate between 4-6 hr. The rate of ethylene glycol elimination was somewhat faster in rats with a half-life of 1.7 hr compared to 3.4 hr in dogs. The maximum plasma level of glycolate was greater in rats although the pattern of accumulation was similar to that in dogs. Glycolate disappeared from the plasma at the same time as ethylene glycol, suggesting a slower rate of elimination of the metabolite than that of ethylene glycol. Renal excretion of ethylene glycol was an important route for its elimination accounting for 20-30% of the dose. Renal excretion of glycolate represented about 5% of the dose. Ethylene glycol induced an immediate, but short lived diuresis compared to that in control rats. Minimal clinical effects (mild acidosis with no sedation) were noted at these doses of ethylene glycol (1-2 g/kg) in both rats and dogs. The results indicate that the toxicokinetics of ethylene glycol and glycolate were similar in both species. The effect of 0.35 to 0.8 mmol/kg glycolic acid and 1.0 to 4.4 mmol/kg sodium glycolate on cyclopropane-epinephrine induced cardiac arrhythmias was examined using dogs. Doses of 0.35 to 0.5 mmol/kg glycolic acid increased the duration of arrhythmias in the 13 dogs tested, whereas doses >0.5 mmol/kg decreased or totally eliminated the arrhythmias in each of 11 dogs. Depression was observed for many of the dogs at higher doses. Sodium glycolate was much less effective in decreasing the arrhythmias, with 3 mmol/kg being required and its action being transient.

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.