Details for: CLARITHROMYCIN
Company: SIVEM PHARMACEUTICALS ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02442469 | CLARITHROMYCIN | CLARITHROMYCIN | 250 MG | TABLET | ORAL |
| 02442485 | CLARITHROMYCIN | CLARITHROMYCIN | 500 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
- CLARITHROMYCIN is used to treat certain infections like pneumonia, bronchitis and infections of the sinuses, skin, and throat, that are caused by bacteria.
- It is used with other medicines to kill bacteria called Helicobacter pylori (H. pylori). This mat prevent duodenal ulcers from coming back. Duodenal ulcers are sores on the upper part of the small intestine.
- It is used to prevent and to treat MAC disease in patients with HIV. MAC is a short word for Mycobacterium avium complex, the bacteria that cause MAC disease.
Antibacterial drugs like CLARITHROMYCIN treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, CLARITHROMYCIN should be taken exactly as directed. Misuse or overuse of CLARITHROMYCIN could lead to the growth of bacteria that will not be killed by CLARITHROMYCIN (resistance). This means that CLARITHROMYCIN may not work for you in the future. Do not share your medicine.
What it does
CLARITHROMYCIN is an antibiotic that kills bacteria in your body.
When it should not be used
- You are allergic to clarithromycin or any of the other ingredients in CLARITHROMYCIN.
- You are allergic to another medicine called erythromycin or any other medicines from a class of antibiotics called macrolides (such as azithromycin or telithromycin).
- You are taking any of the following medications:
- Ergotamine, dihydroergotamine (for migraine); Lovastatin, simvastatin (for high cholesterol); Ticagrelor (for cardiovascular disease); Saquinavir (treatment for HIV); Oral midazolam (for trouble sleeping or agitation); Pimozide (for schizophrenia); colchicine (for gout).
- Pimozide, ergotamine, dihydroergotamine and colchicine can interact with CLARITHROMYCIN, possibly leading to an irregular heartbeat. Deaths have occurred.
- You had liver problems after taking CLARITHROMYCIN in the past.
- you have severe liver failure in combination with kidney impairment.
- You have a history of heart disturbance or irregular heartbeat such as arrhythmias, QT prolongation or torsades de pointes).
- You have hypokalaemia (low potassium levels in the blood).
What the medicinal ingredient is
Clarithromycin
What the non-medicinal ingredients are
Colloidal silica hydrated, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, opadry yellow (D&C Yellow #10 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, polyethylene glycol 4000, titanium dioxide) and powdered cellulose.
What dosage form it comes in
Tablets of 250 mg and 500 mg.
Warnings and precautions
Serious Warnings and Precautions
- CLARITHROMYCIN should not be used in pregnancy especially during the first 3 months. If there are no other medicines you can take for your infection, your doctor may give you CLARITHROMYCIN. If this happens, they will discuss the risks to your baby with you. Talk to your doctor before taking CLARITHROMYCIN if you are pregnant or think you might be pregnant..
- Taking CLARITHROMYCIN along with certain other drugs may lead to serious safety issues. Talk to your doctor about all the medicines you take.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CLARITHROMYCIN. Talk about any health conditions or problems you may have, including if you:
- Have now or have had health problems in the past.
- Have or develop severe diarrhea as this may be a sign of a more serious condition.
- Have kidney problems.
- Have liver problems.
- Are taking medicines called digoxin (for heart failure); atorvastatin, pravastatin (for high cholesterol); or midazolam (a sedative);
- Are taking a medicine called quetiapine (for schizophrenia, bipolar depression). Serious and lifethreatening side effects have occurred in people taking clarithromycin and quetiapine, including malignant neuroleptic syndrome (fever, rigid muscles, dizziness, fainting, and altered mental state). Your doctor will decide if you should take this medication.
- Are allergic to other medicines, foods, dyes, or preservatives.
- Are pregnant, trying to get pregnant or think you might be pregnant.
- Are breastfeeding or planning to breastfeed. Clarithromycin can get into your breastmilk and harm your baby.
- Have a condition called myasthenia gravis which is a chronic disease that causes muscle weakness. CLARITHROMYCIN may make your myasthenia gravis worse.
- Are taking clarithromycin and oral drugs for diabetes (such as gliclazide, glyburide) and / or with insulin as this can result in serious low blood sugar levels (hypoglycemia). Discuss with your doctor or pharmacist how you should monitor your blood sugar levels.
- Are taking warfarin, as there is a risk of serious bleeding with clarithromycin.
- Are taking triazolam, alprazolam or other benzodiazepines (midazolam). These should be used cautiously with clarithromycin due to the serious risk of effects on your brain and spinal cord.
Other warnings you should know about:
Use of antibiotics like clarithromycin have resulted in heart problems such as irregular heartbeat, torsades
de pointes and QT prolongation sometimes leading to death. Talk to your doctor if you are elderly and/or
have risk factors such as:
- Heart disease, heart problems, slow heartbeat.
- If you are taking other medicines which are known to cause serious disturbances in heart rhythm.
- If you have disturbances in the levels of salts (electrolytes) in your blood, such as low levels of magnesium (hypomagnesemia).
Development of antibiotic resistance (where the medicine no longer works to kill bacteria) has been seen in
patients with HIV taking clarithromycin. To avoid this, you should always take your medicine as advised
by your doctor.
Driving and using machines:
If you feel dizzy, confused or disorientated while taking CLARITHROMYCIN, do not drive or operate
machines.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins,
minerals, natural supplements or alternative medicines.
Interactions with this medication
- Alfentanil (used during surgery).
- Alprazolam, hexobarbital, phenobarbital, midazolam, triazolam (sedative medications).
- Amlodipine, diltiazem, verapamil (calcium channel blockers often used for high blood pressure).
- Aripiprazole, pimozide, quetiapine, risperidone (for schizophrenia, bipolar depression).
- Atazanavir, indinavir, ritonavir, saquinavir, nevirapine, efavirenz, etravirine, zidovudine (treatments for HIV).
- Atorvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin (for high cholesterol).
- Bromocriptine (used for problems with your pituitary gland and Parkinson’s disease).
- Carbamazepine (for seizures, nerve pain or bipolar depression).
- Cilostazol, digoxin, quinidine, disopyramide, warfarin/acenocoumarol, ticagrelor (diseases of your blood vessels and heart).
- Colchicine (treatment for gout).
- Cyclosporine (used for psoriasis, rheumatoid arthritis and after organ transplant).
- Ergotamine, dihydroergotamine (often used for migraine headaches).
- Fluconazole, itraconazole (for fungal infections).
- Insulin, nateglinide, pioglitazone, repaglinide, rosiglitazone (for diabetes).
- Lansoprazole, omeprazole (proton pump inhibitors for heart burn and reflux).
- Methylprednisolone (an anti-inflammatory).
- Phenytoin, valproic acid (treatment of seizures and epilepsy).
- Rifabutin, rifampin (treatments for infections).
- Sildenafil, tadalafil, vardenafil (treatments for erectile dysfunction).
- St. John’s Wort (for depression).
- Tacrolimus (used after organ transplant).
- Theophylline (asthma and other lung problems).
- Tolterodine (treatment for overactive bladder).
- Vinblastine (cancer treatment).
Proper use of this medication
- Always take it exactly how your doctor has told you.
- Your doctor will tell you how much CLARITHROMYCIN to take and when to take it.
- How much you are prescribed will depend on the condition you have.
- You can take CLARITHROMYCIN with or without meals.
Usual Adult Dose
For respiratory tract infections and (like pneumonia, bronchitis and infections of the sinuses and throat)
Skin Infections:
The usual dosage of CLARITHROMYCIN is 250 mg to 500 mg every 12 hours for 7 to 14 days.
For infections with H. Pylori and treatment of duodenal ulcers (a sore in your intestine):
Triple Therapy: CLARITHROMYCIN + Omeprazole + Amoxicillin
The recommended dose is the following for 10 days:
- CLARITHROMYCIN: 500 mg every 12 hours
- Omeprazole: 20 mg once daily
- Amoxicillin: 1 g every 12 hours
For prevention and treatment of MAC disease in patients with HIV:
The recommended dose of CLARITHROMYCIN for prevention and treatment of MAC disease is 500 mg
every 12 hours.
Treatment of disseminated MAC infection (MAC infection spread through your whole body) in patients
with HIV should continue for life if improvement of symptoms is observed.
Overdose
Symptoms of CLARITHROMYCIN overdose are abdominal pain, vomiting, nausea and diarrhea.
Missed Dose
- If you miss a dose, take it as soon as you remember.
- If it is almost time for the next dose, do not take the missed dose.
- Take your next dose when you would normally take it.
- Never take a double dose to make up for a missed dose.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking CLARITHROMYCIN. If you
experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- abdominal pain
- abnormal taste
- diarrhea
- ear disorder (trouble hearing and ringing in your ears)
- flatulence
- indigestion
- headache
- nausea
- rash
- vomiting
| Symptom / effect | Talk with your healthcare professional Only if severe | Talk with your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Uncommon | |||
| Allergic reactions: itching, hives, rash, sore throat, fever, swelling, difficulty breathing, lightheadedness/dizziness, swelling of your tongue or throat, warm red skin or wheezing. | ✔ | ||
| Clostridium difficile colitis (bowel inflammation): severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness. | ✔ | ||
| Irregular heartbeat | ✔ | ||
| Myasthenia gravis: muscle weakness, drooping eyelid, vision changes, difficulty chewing and swallowing, trouble breathing | ✔ | ||
| Hepatitis (liver inflammation): abdominal pain, nausea, vomiting, yellowing of skin and eyes, dark urine. | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Keep CLARITHROMYCIN and all other medicines out of reach and sight of children.
Store at controlled room temperature between 15 and 30ºC in a tightly closed container. Protect from light. Do not use beyond the expiration date.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (www.canada.ca/en/health-canada.html); The sponsor’s website (www.sivem.ca), or by contacting the sponsor, Sivem Pharmaceuticals ULC, at: 1-855-788-3153
This leaflet was prepared by:
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
Last revised: January 28, 2019