clarithromycin reference
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(clarithromycin · DailyMed)
Registered Kenya · PPB

H-CURE ES KIT

ESOMEPRAZOLE MAGNESIUM, CLARITHROMYCIN USP AND TINIDAZOLE

CTD 6061 ESOMEPRAZOLE 40MG, CLARITHROMYCIN 500MG AND TINIDAZOLE 500MG GENERIC/BIOSIMILARS antiinfectives for systemic use INN generic

What it does

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

Commonly used for: bacterial infections, chest infections (pneumonia), skin infections, ear infections (otitis media)

Read more in plain English ↓

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

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Registration & product details

Registration no.
CTD 6061
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
ESOMEPRAZOLE MAGNESIUM, CLARITHROMYCIN USP AND TINIDAZOLE
Strength
-
Pack size
KIT CONTAINS - ESOMEPRAZOLE 40MG 2 CAPS, CLARITHROMYCIN 500MG 2 TABLETS AND TINIDAZOLE 500MG 2 TABLETS
Therapeutic class
GENERIC/BIOSIMILARS
ATC class (WHO)
J01FA - Macrolides
RxNorm RxCUI
21212
Manufacturer / MAH
Crown Healthcare
Applicant / LTR
CROWN HEALTHCARE
Country of origin
FOREIGN
Manufacturer location
8a Kudirat Abiola Way, Oregun, Ikeja 101233, Lagos, Nigeria

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:25:58 · updated 2026-07-26 09:25:10

Drug Interactions

213
Check interactions

Pharmacodynamic Warnings

Clarithromycin appears in TABLE 9: Drugs that prolong the QT interval

Severe (35)

Acalabrutinib - increases exposure

Clarithromycin is predicted to increase the exposure to acalabrutinib. Avoid.

Severe Study

Alprazolam - increases exposure

Clarithromycin moderately increases the exposure to benzodiazepines (alprazolam). Avoid.

Severe Study

Antihistamines,non-Sedating - increases exposure

Clarithromycin is predicted to increase the exposure to antihistamines, non-sedating (mizolastine). Avoid.

Severe Study

Avapritinib - increases exposure

Clarithromycin is predicted to increase the exposure to avapritinib. Avoid.

Severe Study

Benzodiazepines - increases exposure

Clarithromycin moderately increases the exposure to benzodiazepines (alprazolam). Avoid.

Severe Study

Moderate (50)

Alfentanil - increases exposure

Clarithromycin is predicted to increase the exposure to opioids (alfentanil, buprenorphine, fentanyl, oxycodone). Monitor and adjust dose.

Moderate Study

Aminophylline - increases exposure

Clarithromycin is predicted to increase the exposure to aminophylline. Adjust dose.

Moderate Theoretical

Amlodipine - increases exposure

Clarithromycin is predicted to increase the exposure to calcium channel blockers (amlodipine, felodipine, lacidipine, nicardipine, nifedipine, nimodipine). Monitor and adjust dose.

Moderate Study

Antiarrhythmics - increases exposure

Clarithromycin is predicted to increase the exposure to antiarrhythmics (propafenone). Monitor and adjust dose.

Moderate Study

Anticholinesterases, Centrally Acting - increases exposure

Clarithromycin is predicted to increase the exposure to anticholinesterases, centrally acting (galantamine). Monitor and adjust dose.

Moderate Study

Unknown (128)

Abemaciclib - increases exposure

Clarithromycin is predicted to increase the exposure to abemaciclib. Avoid or adjust abemaciclib dose, p. 1056.

Unknown Study

Afatinib - increases exposure

Macrolides are predicted to increase the exposure to afatinib.

Unknown Study

Alitretinoin - increases exposure

Clarithromycin is predicted to increase the exposure to retinoids (alitretinoin). Adjust alitretinoin dose, p. 1382.

Unknown Theoretical

Almotriptan - increases exposure

Clarithromycin increases the exposure to triptans (almotriptan).

Unknown Study

Alphablockers - increases exposure

Clarithromycin is predicted to increase the exposure to alpha blockers (doxazosin).

Unknown Study

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

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

About clarithromycin

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

What it treats

  • bacterial infections
  • chest infections (pneumonia)
  • skin infections
  • ear infections (otitis media)

How it works

It works by stopping the growth of bacteria, helping your body to fight off the infection.

Who it's for

It is for adults and children with certain bacterial infections.

Drug class

Macrolides

Cautions

  • • Be cautious if you are taking other medications that affect heart rhythm.

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

About esomeprazole

Esomeprazole is a medication used to reduce stomach acid and help with digestive issues.

What it treats

  • gastroesophageal reflux disease (GERD)
  • stomach ulcers
  • excess stomach acid production

How it works

Esomeprazole works by blocking the production of acid in the stomach, helping to relieve symptoms and heal the stomach lining.

Who it's for

This medication is for adults and children who need help managing stomach acid-related conditions.

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

About tinidazole

Tinidazole is an antibiotic used to treat infections caused by certain parasites and bacteria.

What it treats

  • trichomoniasis (a sexually transmitted infection)
  • giardiasis (a type of intestinal infection)
  • amoebiasis (an infection caused by amoeba)

How it works

Tinidazole works by killing the harmful bacteria and parasites that cause infections.

Who it's for

Tinidazole is for adults and children who have specific types of infections.

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

Clinical monograph: Esomeprazole

BNF-referenced

Esomeprazole is a proton pump inhibitor (PPI) that is primarily used to reduce gastric acid secretion. It is effective in the treatment of various gastric acid disorders and ulcerations, including gastroesophageal reflux disease (GERD), erosive esophagitis, and the eradication of Helicobacter pylori to help prevent duodenal ulcer recurrence. Esomeprazole works by irreversibly inhibiting the H+/K+-ATPase enzyme in gastric parietal cells, leading to decreased gastric acid production. Its antisecretory effects can last longer than 24 hours, making it suitable for once-daily dosing.

Indications

  • Gastroesophageal reflux disease (GERD)
  • Erosive esophagitis
  • Peptic ulcers
  • Helicobacter pylori eradication
  • Zollinger-Ellison syndrome

Dosage

Adults: The usual oral dose

Mechanism of action

Esomeprazole exerts its stomach acid-suppressing effects by covalently binding to cysteine residues on the H+/K+-ATPase enzyme at the secretory surface of gastric parietal cells. This action inhibits both basal and stimulated gastric acid secretion irreversibly, requiring the synthesis of new enzyme to restore acid production. By blocking the final step of gastric acid production, esomeprazole reduces gastric acidity in a dose-dependent manner.

Pharmacodynamics

Esomeprazole is a substituted benzimidazole that inhibits gastric acid secretion without exhibiting anticholinergic or H2 receptor antagonistic properties. It is indicated for the treatment of GERD, healing of erosive esophagitis, and eradication of H. pylori to reduce duodenal ulcer recurrence. The suppression of gastric acid secretion is dose-related and effective against various stimuli that promote acid secretion.

Pharmacokinetics

Esomeprazole is rapidly absorbed after oral administration, with peak plasma concentrations typically occurring within 1-2 hours. It undergoes extensive hepatic metabolism primarily by the cytochrome P450 system, especially CYP2C19, resulting in several metabolites. The elimination half-life is approximately 1-2 hours, though its antisecretory effects last longer. It is excreted predominantly in the urine. Dose adjustments may be necessary in patients with hepatic impairment.

Contra-indications

  • Hypersensitivity to esomeprazole or any of its components
  • Concomitant use with rilpivirine-containing products

Adverse effects

  • Abdominal pain
  • Constipation
  • Diarrhea
  • Dizziness
  • Dry mouth
  • Headache
  • Insomnia
  • Nausea
  • Skin reactions
  • Vomiting
  • Bone fractures
  • Confusion
  • Depression
  • Drowsiness
  • Leucopenia
  • Malaise
  • Myalgia
  • Paraesthesia
  • Peripheral edema
  • Thrombocytopenia
  • Vertigo
  • Vision disorders
  • Agranulocytosis
  • Alopecia
  • Gynaecomastia
  • Hallucination
  • Hepatic disorders
  • Hyperhidrosis
  • Hyponatraemia
  • Nephritis
  • Tubulointerstitial nephritis
  • Pancytopenia
  • Photosensitivity reaction
  • Severe cutaneous adverse reactions (SCARs)
  • Stomatitis
  • Taste altered
  • Hypomagnesaemia

Interactions

  • Esomeprazole may increase the exposure to cannabidiol
  • Esomeprazole may increase the exposure to cilostazol

Precautions

  • Increased risk of fractures, particularly in the elderly and when used at high doses for over a year
  • Caution in patients at risk of osteoporosis; adequate intake of calcium and vitamin D is recommended
  • May increase the risk of gastrointestinal infections, including Clostridioides difficile
  • Symptoms of gastric cancer should be ruled out before treatment
  • Use with caution in patients with hepatic impairment

Pregnancy

Use with caution. The manufacturer advises avoiding use unless necessary since the effects on the fetus are not fully known.

Breast-feeding

Manufacturer advises avoiding use as esomeprazole is present in breast milk and may cause diarrhea in nursing infants. However, amounts are probably too small to be harmful.

Storage

Store in a cool, dry place below 25°C. Keep out of

BNF 85 (British National Formulary) p.102 BNF for Children 2019-2020 p.80 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: Tinidazole

BNF-referenced

Tinidazole is a synthetic antimicrobial drug with high efficacy against anaerobic bacteria and protozoa. It is primarily used to treat infections caused by Trichomonas vaginalis, Giardia duodenalis, and Entamoeba histolytica. Tinidazole has a longer duration of action compared to metronidazole, making it a suitable option for various infections.

Indications

  • Intestinal amoebiasis
  • Urogenital trichomoniasis
  • Giardiasis

Dosage

Children: For children aged 1 month to 11 years, the dosage is 50–75 mg/kg once, with a maximum of 2 g per dose. For children aged 12 to 17 years, the dosage is 2 g for a single dose, which may be repeated once if necessary.

Adults: The usual adult dosage is 2 g taken orally as a single dose for urogenital trichomoniasis or giardiasis, and 1.5 g to 2 g once daily for 3 to 6 days for intestinal amoebiasis.

Mechanism of action

Tinidazole acts as a prodrug and antiprotozoal agent. Its nitro group is reduced in Trichomonas by a ferredoxin-mediated electron transport system, generating free nitro radicals that covalently bind to DNA, causing DNA damage and cell death. The exact mechanism of action against Giardia and Entamoeba species is not fully understood but is believed to be similar to that of Trichomonas.

Pharmacodynamics

Tinidazole demonstrates in vitro and clinical activity against Trichomonas vaginalis, Giardia duodenalis (also known as G. lamblia), and Entamoeba histolytica. It does not exhibit significant activity against most strains of vaginal lactobacilli, which are beneficial bacteria in the vaginal flora.

Pharmacokinetics

Tinidazole is well absorbed following oral administration, with peak plasma concentrations occurring within 0.5 to 3 hours. It is extensively distributed throughout body tissues and fluids. The drug undergoes hepatic metabolism and is eliminated primarily through the urine, with a half-life of approximately 12 to 14 hours. Clinical and laboratory monitoring is advised if treatment extends beyond 10 days.

Adverse effects

  • Abdominal pain
  • Decreased appetite
  • Diarrhoea
  • Headache
  • Nausea
  • Skin reactions
  • Vertigo
  • Vomiting

Precautions

  • Clinical and laboratory monitoring is advised if treatment exceeds 10 days

Pregnancy

Manufacturer advises avoiding use in the first trimester.

Breast-feeding

Present in milk; the manufacturer advises avoiding breastfeeding during and for 3 days after stopping treatment.

Storage

Store below 25°C, protect from moisture.

Formulations

  • Tinidazole 500 mg tablets
  • Tinidazole oral suspension
BNF for Children 2019-2020 p.368 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: Clarithromycin

BNF-referenced

Clarithromycin is a macrolide antibiotic effective against a range of bacterial infections. It is primarily used in the treatment of community-acquired pneumonia, skin infections, and as a prophylactic measure for certain infections. Clarithromycin works by inhibiting bacterial protein synthesis, making it a crucial agent in combating gram-positive and some gram-negative bacteria.

Indications

  • Bacterial infections
  • Community-acquired pneumonia
  • Skin infections
  • Prophylaxis for certain infections

Dosage

Adults: 500 mg once daily for

Mechanism of action

Clarithromycin is metabolized to 14-OH clarithromycin, which is active. It penetrates bacterial cell walls and reversibly binds to domain V of the 23S ribosomal RNA of the 50S ribosomal subunit, blocking the translocation of aminoacyl-tRNA and inhibiting polypeptide synthesis. It may be bactericidal in high concentrations against susceptible organisms, particularly Streptococcus pyogenes, S. pneumoniae, Haemophilus influenzae, and Chlamydia trachomatis. Additionally, clarithromycin inhibits the hepatic microsomal CYP3A4 isoenzyme and P-glycoprotein.

Pharmacodynamics

Clarithromycin exhibits a broad spectrum of activity against numerous gram-positive bacteria, including Staphylococcus aureus, Streptococcus pneumoniae, and Streptococcus pyogenes. It also shows activity against gram-negative bacteria such as Haemophilus influenzae and Moraxella catarrhalis, as well as against various anaerobic bacteria, mycobacteria, and other organisms like Mycoplasma, Ureaplasma, and Chlamydia. While typically bacteriostatic, it can sometimes demonstrate bactericidal properties depending on the concentration and the organism.

Pharmacokinetics

Clarithromycin is well absorbed after oral administration, with its bioavailability enhanced by food. It is extensively metabolized in the liver, primarily via CYP3A4, leading to active metabolites. The drug has a half-life of approximately 3 to 4 hours, but its active metabolite, 14-OH clarithromycin, has a longer half-life, contributing to its prolonged activity. Renal impairment can significantly affect its clearance, necessitating dosage adjustments in patients with reduced renal function.

Adverse effects

  • Nausea
  • Diarrhea
  • Abdominal pain
  • Dysgeusia
  • Headache
  • Rash
  • Liver enzyme elevations
  • QT prolongation

Interactions

  • Clarithromycin + acalabrutinib: Severe (increases exposure)
  • Clarithromycin + antiarrhythmics: Severe (increases exposure)
  • Clarithromycin + dronedarone: Severe (increases exposure)
  • Clarithromycin + non-sedating antihistamines: Severe (increases exposure)
  • Clarithromycin + mizolastine: Severe (increases exposure)
  • Clarithromycin + lurasidone: Severe (increases exposure)
  • Clarithromycin + quetiapine: Severe (increases exposure)
  • Clarithromycin + avapritinib: Severe (increases exposure)
  • Clarithromycin + benzodiazepines: Severe (increases exposure)
  • Clarithromycin + alprazolam: Severe (increases exposure)

Precautions

  • Caution in hepatic impairment
  • Use with caution in renal impairment
  • Monitor for signs of QT prolongation
  • Consider alternative therapy in patients with history of arrhythmias
  • Use with caution in patients with myasthenia gravis due to potential exacerbation

Pregnancy

Manufacturers advise use only if adequate alternatives are not available.

Breast-feeding

Present in milk; use only if no suitable alternatives.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

Formulations

  • Oral suspension 200 mg/5 mL
  • Capsules 250 mg
BNF 85 (British National Formulary) p.611 BNF for Children 2019-2020 p.362 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.

Molecular reference: Clarithromycin

PubChem CID 84029

Molecular formula: C38H69NO13

Mechanism of action

Clarithromycin is first metabolized to 14-OH clarithromycin, which is active and works synergistically with its parent compound. Like other macrolides, it then penetrates bacteria cell wall and reversibly binds to domain V of the 23S ribosomal RNA of the 50S subunit of the bacterial ribosome, blocking translocation of aminoacyl transfer-RNA and polypeptide synthesis. Clarithromycin also inhibits the hepatic microsomal CYP3A4 isoenzyme and P-glycoprotein, an energy-dependent drug efflux pump. Clarithromycin usually is bacteriostatic, although it may be bactericidal in high concentrations or against highly susceptible organisms. Bactericidal activity has been observed against Streptococcus pyogenes, S. pneumoniae, Haemophilus influenzae, and Chlamydia trachomatis. Clarithromycin inhibits protein synthesis in susceptible organisms by penetrating the cell wall and binding to 50S ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNA and inhibiting polypeptide synthesis. The site of action of clarithromycin appears to be the same as that of erythromycin, clindamycin, lincomycin, and chloramphenicol.

Pharmacodynamics

Clarithromycin is a macrolide antibiotic whose spectrum of activity includes many gram-positive (<i>Staphylococcus aureus, S. pneumoniae, and S. pyogenes</i>) and gram-negative aerobic bacteria (<i>Haemophilus influenzae, H. parainfluenzae, and Moraxella catarrhalis</i>), many anaerobic bacteria, some mycobacteria, and some other organisms including <i>Mycoplasma, Ureaplasma, Chlamydia, Toxoplasma</i>, and <i>Borrelia</i>. Other aerobic bacteria that clarithromycin has activity against include <i>C. pneumoniae and M. pneumoniae</i>. Clarithromycin has an in-vitro activity that is similar or greater than that of erythromycin against erythromycin-susceptible organisms. Clarithromycin is usually bacteriostatic, but may be bactericidal depending on the organism and the drug concentration.

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

Molecular reference: Esomeprazole

PubChem CID 9568614

Molecular formula: C17H19N3O3S

Mechanism of action

Esomeprazole exerts its stomach acid-suppressing effects by preventing the final step in gastric acid production by covalently binding to sulfhydryl groups of cysteines found on the (H+, K+)-ATPase enzyme at the secretory surface of gastric parietal cells. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. As the binding of esomeprazole to the (H+, K+)-ATPase enzyme is irreversible and new enzyme needs to be expressed in order to resume acid secretion, esomeprazole's duration of antisecretory effect that persists longer than 24 hours. Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. The S- and R-isomers of omeprazole are protonated and converted in the acidic compartment of the parietal cell forming the active inhibitor, the achiral sulphenamide. By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity. This effect is dose-related up to a daily dose of 20 to 40 mg and leads to inhibition of gastric acid secretion.

Pharmacodynamics

Esomeprazole is a compound that inhibits gastric acid secretion and is indicated in the treatment of gastroesophageal reflux disease (GERD), the healing of erosive esophagitis, and <i>H. pylori</i> eradication to reduce the risk of duodenal ulcer recurrence. Esomeprazole belongs to a new class of antisecretory compounds, the substituted benzimidazoles, that do not exhibit anticholinergic or H2 histamine antagonistic properties, but that suppress gastric acid secretion by specific inhibition of the H<sup>+</sup>/K<sup>+</sup> ATPase at the secretory surface of the gastric parietal cell. By doing so, it inhibits acid secretion into the gsatric lumen. This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus. Esomeprazole is the s-isomer of [DB00338], which is a racemate of the S- and R-enantiomer. Esomeprazole has been shown to inhibit acid secretion to a similar extent as [DB00338], without any significant differences between the two compounds _in vitro_. PPIs such as esomeprazole have also been shown to inhibit the activity of dimethylarginine dimethylaminohydrolase (DDAH), an enzyme necessary for cardiovascular health. DDAH inhibition causes a consequent accumulation of the nitric oxide synthase inhibitor asymmetric dimethylarginie (ADMA), which is thought to cause the association of PPIs with increased risk of cardiovascular events in patients with unstable coronary syndromes. Due to their good safety profile and as several PPIs are available over the counter without a prescription, their current use in North America is widespread. Long term use of PPIs such as esomeprazole has been associated with possible adverse effects, however, including increased susceptibility to bacterial infections (including gastrointestinal _C. difficile_), reduced absorption of micronutrients including iron and B12, and an increased risk of developing hypomagnesemia and hypocalcemia which may contribute to osteoporosis and bone fractures later in life.

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

Molecular reference: Tinidazole

PubChem CID 5479

Molecular formula: C8H13N3O4S

Mechanism of action

Tinidazole is a prodrug and antiprotozoal agent. The nitro group of tinidazole is reduced in <i>Trichomonas</i> by a ferredoxin-mediated electron transport system. The free nitro radical generated as a result of this reduction is believed to be responsible for the antiprotozoal activity. It is suggested that the toxic free radicals covalently bind to DNA, causing DNA damage and leading to cell death. The mechanism by which tinidazole exhibits activity against <i>Giardia</i> and <i>Entamoeba</i> species is not known, though it is probably similar. The nitro group of tinidazole is reduced by cell extracts of Trichomonas. As a result of this reduction a free nitro radical is generated which may be responsible for the antiprotozoal activity. The mechanism by which tinidazole exhibits activity against Giardia and Entamoeba species is not known.

Pharmacodynamics

Tinidazole is a synthetic antiprotozoal agent. Tinidazole demonstrates activity both in vitro and in clinical infections against the following protozoa: <i>Trichomonas vaginalis</i>, <i>Giardia duodenalis</i> (also termed <i>G. lamblia</i>), and <i>Entamoeba histolytica</i>. Tinidazole does not appear to have activity against most strains of vaginal lactobacilli.

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

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