clarithromycin reference
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(clarithromycin · DailyMed)
Registered Rwanda · Rwanda FDA

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Clarithromycin USP 250mg, Omeprazole BP 20mg and Tinidazole BP 500mg

Rwanda FDA-HMP-MA-1106 Combipack of Tablets & Capsules 250 mg, 20 mg, 500 mg 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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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.
Rwanda FDA-HMP-MA-1106
Registration date
20/04/2024
Expiry date
19/04/2029
Status
Registered
Active ingredient
Clarithromycin USP 250mg, Omeprazole BP 20mg and Tinidazole BP 500mg
Strength
250 mg, 20 mg, 500 mg
Pack size
7 x 1 x 6 Tablets & Capsules
Therapeutic class
-
ATC class (WHO)
J01FA - Macrolides
RxNorm RxCUI
21212
Manufacturer / MAH
Kopran
Applicant / LTR
KOPRAN LIMITED
Country of origin
INDIA
Manufacturer location
Parijat House, 1076, Post Box No.9917, Dr Elijah Moses Rd, Worli Naka, Upper Worli, Worli, Mumbai, Maharashtra 400018, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:18 · updated 2026-09-17 02:30:43

Drug Interactions

215
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 (52)

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 Rwanda Food and Drugs Authority (Rwanda). 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 omeprazole

Omeprazole is a medication that reduces stomach acid. It helps relieve symptoms associated with acid-related conditions.

What it treats

  • stomach ulcers
  • gastroesophageal reflux disease (GERD)
  • excessive stomach acid

How it works

Omeprazole works by blocking the production of stomach acid, which helps heal ulcers and reduce heartburn.

Who it's for

Omeprazole is for adults and children over a certain age who have problems with too much stomach acid.

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: 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: Omeprazole

BNF-referenced

Omeprazole is a proton pump inhibitor (PPI) that reduces gastric acid secretion by inhibiting the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cells. It is primarily used for the treatment of conditions associated with excessive gastric acid production, such as peptic ulcers and gastro-oesophageal reflux disease (GERD).

Indications

  • Gastric ulcer
  • Duodenal ulcer
  • Gastro-oesophageal reflux disease (GERD)
  • Severe oesophagitis
  • Helicobacter pylori eradication (in combination therapy)
  • Prevention of NSAID-associated gastric and duodenal ulcers
  • Zollinger-Ellison syndrome

Dosage

Adults: The usual dose for adults is 20 mg once daily for 4 weeks for duodenal ulcer and GERD. For gastric ulcer, the dose may be 20 mg to 40 mg once daily

Mechanism of action

Omeprazole works by specifically binding to the proton pump (H+/K+ ATPase) in the gastric parietal cells, leading to irreversible inhibition of acid secretion. This binding prevents the exchange of hydrogen ions for potassium ions, effectively reducing the production of gastric acid and promoting healing of acid-related conditions.

Pharmacodynamics

The pharmacodynamic effects of omeprazole manifest as a significant decrease in gastric acidity, which improves symptoms related to excessive acid secretion. The onset of action typically occurs within an hour of administration, with maximum effect seen within 2 to 4 days of continuous use. The duration of action allows for once-daily dosing in most indications.

Pharmacokinetics

Omeprazole is rapidly absorbed from the gastrointestinal tract, reaching peak plasma concentrations within 0.5 to 3.5 hours after oral administration. It is extensively metabolized in the liver via the cytochrome P450 system, primarily CYP2C19 and CYP3A4, leading to the formation of inactive metabolites. The elimination half-life is approximately 0.5 to 1 hour, but the effects on gastric acid secretion last much longer due to the irreversible nature of proton pump inhibition. Omeprazole is excreted mainly in the urine as metabolites, with less than 1% of the drug excreted unchanged.

Contra-indications

  • Hypersensitivity to omeprazole or any component of the formulation
  • Use with caution in patients with severe liver impairment

Adverse effects

  • Nausea
  • Vomiting
  • Diarrhea
  • Headache
  • Abdominal pain
  • Flatulence
  • Constipation
  • Dizziness
  • Fatigue
  • Rash
  • Muscle weakness
  • Gastrointestinal candidiasis
  • Aggression
  • Agitation
  • Bronchospasm
  • Encephalopathy

Interactions

  • Cenobamate may increase exposure to omeprazole
  • Fedratinib may increase exposure to omeprazole
  • Apalutamide may decrease exposure to omeprazole
  • Cilostazol may increase exposure to omeprazole

Precautions

  • Monitor patients for gastrointestinal symptoms
  • Use caution in patients with a history of liver disease
  • Consider potential for vitamin B12 deficiency with long-term use
  • Monitor for signs of Clostridium difficile infection in the colon

Pregnancy

Not known to be harmful during pregnancy, but should be used only if clearly needed.

Breast-feeding

Excreted in breast milk, caution is advised when administered to nursing mothers.

Storage

Store below 25 degrees Celsius. Protect from moisture. Keep out of reach of children.

Formulations

  • Orodispersible tablets
  • Gastro-resistant capsules
  • Intravenous injection
  • Oral suspension
BNF 85 (British National Formulary) p.105 BNF for Children 2019-2020 p.82 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: Omeprazole

PubChem CID 4594

Molecular formula: C17H19N3O3S

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.

This drug in other countries

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