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Details for: APO-CLARITHROMYCIN

Company: APOTEX INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02274744APO-CLARITHROMYCINCLARITHROMYCIN250 MGTABLETORAL
02274752APO-CLARITHROMYCINCLARITHROMYCIN500 MGTABLETORAL
02413345APO-CLARITHROMYCIN XLCLARITHROMYCIN500 MGTABLET (EXTENDED-RELEASE)ORAL
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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

APO-CLARITHROMYCIN

  • APO-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 may 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 APO-CLARITHROMYCIN treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, APO-CLARITHROMYCIN should be taken exactly as directed. Misuse or overuse of APOCLARITHROMYCIN could lead to the growth of bacteria that will not be killed by APOCLARITHROMYCIN (resistance). This means that APO-CLARITHROMYCIN may not work for you in the future. Do not share your medicine.

APO-CLARITHROMYCIN XL

APO-CLARITHROMYCIN XL is used to treat certain infections like pneumonia, bronchitis and infections of the sinuses and throat that are caused by bacteria.
The efficacy and safety of APO-CLARITHROMYCIN XL in treating other infections for which APO-CLARITHROMYCIN are approved have not been established.
Antibacterial drugs like APO-CLARITHROMYCIN XL treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, APO-CLARITHROMYCIN XL should be taken exactly as directed. Misuse or overuse of APOCLARITHROMYCIN XL could lead to the growth of bacteria that will not be killed by APOCLARITHROMYCIN XL (resistance). This means that APO-CLARITHROMYCIN XL may not work for you in the future. Do not share your medicine.

What it does

APO-CLARITHROMYCIN

APO-CLARITHROMYCIN is an antibiotic that kills bacteria in your body.


APO-CLARITHROMYCIN XL

APO-CLARITHROMYCIN XL is an antibiotic that kills bacteria in your body.

When it should not be used

What the medicinal ingredient is

APO-CLARITHROMYCIN

Medicinal ingredients: Clarithromycin


APO-CLARITHROMYCIN XL

Medicinal ingredients: Clarithromycin.

What the non-medicinal ingredients are

APO-CLARITHROMYCIN

Non-medicinal ingredients: colloidal silicon dioxide, crospovidone, D & C yellow #10, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol, stearic acid, sunset yellow (250 mg only) and titanium dioxide.

APO-CLARITHROMYCIN XL

Non-medicinal ingredients: D & C yellow #10, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol, potassium bitartrate, sorbitol crystalline and titanium dioxide.

What dosage form it comes in

APO-CLARITHROMYCIN

APO-CLARITHROMYCIN comes in the following dosage forms:

  • APO-CLARITHROMYCIN is available in 250 mg and 500 mg strengths,

APO-CLARITHROMYCIN XL

APO-CLARITHROMYCIN XL comes in the following dosage forms:

  • APO-CLARITHROMYCIN XL is available in 500 mg strength.
Warnings and precautions

APO-CLARITHROMYCIN

Serious Warnings and Precautions

  • APO-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 APO-CLARITHROMYCIN. If this happens, they will discuss the risks to your baby with you. Talk to your doctor before taking APO-CLARITHROMYCIN if you are pregnant or think you might be pregnant.
  • Taking APO-CLARITHROMYCIN along with certain other drugs may lead to serious safety issues. Talk to your doctor about all the medicines you take.

APO-CLARITHROMYCIN

Do not use APO-CLARITHROMYCIN if:

  • You are allergic to clarithromycin or any of the other ingredients in APOCLARITHROMYCIN.
  • 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); Domperidone (for gastrointestinal disorders).
    • Pimozide, ergotamine, dihydroergotamine and colchicine can interact with APO-CLARITHROMYCIN, possibly leading to an irregular heartbeat. Deaths have occurred.
  • You had liver problems after taking APO-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).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-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 or pravastatin (for high cholesterol); or midazolam (a sedative).
  • Are taking a medicine called quetiapine (for schizophrenia, bipolar depression). Serious and life-threatening 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. APO-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 or have risk factors such as:

  • Heart disease, heart problems, or 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 APO-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

APO-CLARITHROMYCIN

The following may interact with APO-CLARITHROMYCIN:

  • 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).
  • Domperidone (used for gastrointestinal disorders).
  • 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, ibrutinib (cancer treatment).


APO-CLARITHROMYCIN XL

The following may interact with APO-CLARITHROMYCIN XL:

  • 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).
  • Domperidone (used for gastrointestinal disorders).
  • 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, ibrutinib (cancer treatment).
Proper use of this medication

PrAPO-CLARITHROMYCIN

How to take APO-CLARITHROMYCIN:

  • Always take it exactly how your doctor has told you.
  • Your doctor will tell you how much APO-CLARITHROMYCIN to take and when to take it.
  • How much you are prescribed will depend on the condition you have.
  • You can take APO-CLARITHROMYCIN with or without meals.

APO-CLARITHROMYCIN XL

How to take APO-CLARITHROMYCIN XL:

  • Take APO-CLARITHROMYCIN XL with food.
  • Swallow APO-CLARITHROMYCIN XL whole with a glass of water.
  • Do not break, chew or crush the tablets.


Usual Dose

PrAPO-CLARITHROMYCIN

For respiratory tract infections (like pneumonia, bronchitis and infections of the sinuses and throat) or Skin Infections:
The usual dose of APO-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):
The usual dose of APO-CLARITHROMYCIN is 500 mg every 12 hours for 10 days. You will take APO-CLARITHROMYCIN together with omeprazole (20 mg once a day) and amoxicillin (1 g every 12 hours).
For prevention and treatment of MAC disease in patients with HIV:
The usual dose of APO-CLARITHROMYCIN is 500 mg every 12 hours. Your doctor will tell you how long you should continue taking APO-CLARITHROMYCIN for.


APO-CLARITHROMYCIN XL

Usual Dose:
The usual adult dose is 2 x 500 mg tablets (1000 mg) every 24 hours for 5, 7 or 14 days.



Overdose

PrAPO-CLARITHROMYCIN

Symptoms of APO-CLARITHROMYCIN overdose are abdominal pain, vomiting, nausea and diarrhea.

If you think you have taken too much APO-CLARITHROMYCIN, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

APO-CLARITHROMYCIN XL

Overdose:
Symptoms of APO-CLARITHROMYCIN XL overdose are abdominal pain, vomiting, nausea and diarrhea

If you think you have taken too much APO-CLARITHROMYCIN XL, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms


Missed Dose

PrAPO-CLARITHROMYCIN

  • If you miss a dose, take it as soon as you remember.
  • If it is almost time for your 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.

APO-CLARITHROMYCIN XL

Missed Dose:

  • If you miss a dose, take it as soon as you remember.
  • If it is almost time for your 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

PrAPO-CLARITHROMYCIN

These are not all the possible side effects you may feel when taking APO-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
  • vomitting

APO-CLARITHROMYCIN XL

These are not all the possible side effects you may feel when taking APO-CLARITHROMYCIN XL. 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

If you see tablet residue in your stool, contact your doctor as your doctor may recommend a different clarithromycin formulation, especially if you have certain bowel conditions.

PrAPO-CLARITHROMYCIN

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional only if severe Talk to 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

PrAPO-CLARITHROMYCIN

Keep APO-CLARITHROMYCIN and all other medicines out of reach and sight of children. Store between 15 ºC to 30 ºC in a tightly closed container. Protect from light. Do not use beyond the expiration date.

APO-CLARITHROMYCIN XL

Keep APO-CLARITHROMYCIN XL and all other medicines out of the reach and sight of children.
Store between 15 ºC to 30 ºC in a tightly closed container. Protect from light. Do not use beyond expiration date.

Reporting side effects

PrAPO-CLARITHROMYCIN

You can report any suspected side effects associated with the use of health products to Health Canada by:

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.


APO-CLARITHROMYCIN XL

You can report any suspected side effects associated with the use of health products to Health Canada by:

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

PrAPO-CLARITHROMYCIN

Read this carefully before you start taking APO-CLARITHROMYCIN and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about APO-CLARITHROMYCIN.


If you want more information about APO-CLARITHROMYCIN:


This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Date of revision: December 03, 2018


APO-CLARITHROMYCIN XL

Read this carefully before you start taking APO-CLARITHROMYCIN XL and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about APO-CLARITHROMYCIN.


If you want more information about APO-CLARITHROMYCIN XL:


This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Date of revision: December 03, 2018


Date modified: