Clarithromycin (Sanis Health, 125 mg, 250 mg): Uses, Side Effects and Dosage

What is CLARITHROMYCIN used for?

• CLARITHROMYCIN is used to treat certain infections like pneumonia (lung infection), middle ear infections, and infections of the skin and throat that are caused by bacteria.
• It is used to treat mycobacterial infections. Mycobacteria are a group of bacteria that cause several diseases.

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.

How does CLARITHROMYCIN work?

CLARITHROMYCIN is an antibiotic that kills bacteria in your body.

What are the ingredients in CLARITHROMYCIN?

Medicinal ingredients: Clarithromycin.

Non-medicinal ingredients: Artificial and natural fruit flavour, carbopol, castor oil, citric acid, hydroxypropyl methylcellulose phthalate, maltodextrin, potassium sorbate, povidone, silicon dioxide, sucrose or sugar, titanium dioxide and xanthan gum.

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 healthcare professional may give you CLARITHROMYCIN. If this happens, they will discuss the risks to your baby with you. Talk to your healthcare professional 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 healthcare professional about all the medicines you take.

CLARITHROMYCIN comes in the following dosage forms:

125 mg / 5mL and 250 mg / 5mL granules for oral suspension (provided in liquid form by your pharmacist).

Do not use CLARITHROMYCIN if:

• You/ your child are allergic to clarithromycin or any of the other ingredients in CLARITHROMYCIN.
• You/ your child are allergic to another medicine called erythromycin or any other medicines from a class of antibiotics called macrolides (such as azithromycin or telithromycin).

• You/ your child are taking any of the following medications:

  • Ergotamine, dihydroergotamine (for migraine); Lovastatin, simvastatin, lomitapide (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 CLARITHROMYCIN, possibly leading to an irregular heartbeat. Deaths have occurred.
• You/ your child had liver problems after taking CLARITHROMYCIN, or any other medicine containing clarithromycin, in the past.
• You/ your child have severe liver failure in combination with kidney problems.
• You/ your child have a history of heart disturbance or irregular heartbeat such as arrhythmias, QT prolongation or torsades de pointes.
• You/ your child have low levels of potassium in the blood (hypokalemia) or low levels of magnesium in the blood (hypomagnesemia).

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:

• Or your child has now or has had health problems in the past.
• Or your child has or develops severe diarrhea as this may be a sign of a more serious condition.
• Or your child has kidney problems.
• Or your child has liver problems.
• Or your child are taking medicines called digoxin (for heart failure); atorvastatin or pravastatin (for high cholesterol); or midazolam (a sedative).
• Or your child 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 healthcare professional will decide if you/ your child should take this medication.
• Or your child are allergic to other medicines, foods, dyes, or preservatives.
• Or your child have hereditary problems of fructose intolerance, glucose/galactose malabsorption or sucrose/maltase insufficiency since this product contains sucrose.
• Are pregnant, trying to get pregnant or think you might be pregnant.
• Are breastfeeding or planning to breastfeed. CLARITHROMYCIN can pass into your breastmilk and harm your baby.
• Or your child have a condition called myasthenia gravis which is a chronic disease that causes muscle weakness. CLARITHROMYCIN may make your myasthenia gravis worse.
• Or your child are taking CLARITHROMYCIN and oral medicines for diabetes (such as gliclazide, glyburide) and / or with insulin as this can result in serious low blood sugar levels (hypoglycemia). Discuss with your healthcare professional how you should monitor your blood sugar levels.
• Or your child are taking warfarin, as there is a risk of serious bleeding with CLARITHROMYCIN.
• Or your child 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.
• Or your child are taking CLARITHROMYCIN and medicines used to prevent blood clots such as dabigatran, rivaroxaban and apixaban, particularly if your healthcare professional has told you that you/ your child are at high risk of bleeding.

Other warnings you should know about:

Serious heart problems:

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 healthcare professional if you are elderly, have risk factors, or you / your child:

• Have heart disease, heart problems or slow heartbeat.
• Are taking other medicines which are known to cause serious disturbances in heart rhythm.
• Have disturbances in the levels of salts (electrolytes) in your blood, such as low levels of magnesium (hypomagnesemia).

Antibiotic resistance and HIV:

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 healthcare professional.

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.

The following may interact with 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, lomitapide (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).
• Rivaroxaban, apixaban (to prevent blood clots).
• 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).

How to take CLARITHROMYCIN:

• Always take it exactly how your / your child's healthcare professional has told you.
• Your / your child's healthcare professional will tell you how much CLARITHROMYCIN to take and when to take it.
• How much you / your child are prescribed will depend on the condition you / your child have.
• You / your child can take CLARITHROMYCIN with or without meals.
• CLARITHROMYCIN will be prepared in liquid form by your pharmacist.
• Shake prior to each use to ensure resuspension.

Usual dose:

The recommended daily dose of CLARITHROMYCIN is 15 mg / kg / day, in divided doses every 12 hours. The daily dose should not to exceed 1000 mg. The usual duration of treatment is for 5 to 10 days.

Overdose:

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

Missed Dose:

• If you / your child miss a dose, take / give it as soon as you remember.
• If it is almost time for your / your child's next dose, the missed dose should not be taken.
• Take / give to your child the next dose when you would normally take / give it.
• Never take / give to your child a double dose to make up for a missed dose.

What are possible side effects from using CLARITHROMYCIN?

These are not all the possible side effects you may have when taking CLARITHROMYCIN. If you experience any side effects not listed here, tell 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

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store reconstituted product between 15 and 30ºC and use within 14 days. Do not refrigerate. Any reconstituted unused medication should be discarded after 14 days. The graduated syringe included in the package should be rinsed between uses. Do not leave syringe in bottle. Do not store reconstituted suspension in syringe.

Keep out of reach and sight of children.

If you want more information about CLARITHROMYCIN:

• 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: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website (www.sanis.com), or by calling 1-866-236-4076.

Last Revised: February 18, 2022