Details for: TARO-CLARITHROMYCIN
Company: TARO PHARMACEUTICALS INC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02390442 | TARO-CLARITHROMYCIN | CLARITHROMYCIN | 125 MG / 5 ML | GRANULES FOR SUSPENSION | ORAL |
02390450 | TARO-CLARITHROMYCIN | CLARITHROMYCIN | 250 MG / 5 ML | GRANULES FOR SUSPENSION | 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
Taro-Clarithromycin is used to treat certain infectious like pneumonia (lung infection), otitis (middle ear infection), and pharyngitis (infections of 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 Taro-Clarithromycin treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, Taro-Clarithromycin should be taken exactly as directed. Misuse or overuse of Taro-Clarithromycin could lead to the growth of bacteria that will not be killed by Taro-Clarithromycin (resistance). This means that Taro-Clarithromycin may not work for you in the future. Do not share your medicine.
What it does
Taro-Clarithromycin is an antibiotic that kills bacteria in your body.
When it should not be used
- You / your child are allergic to clarithromycin or any other ingredients in Taro-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, dihudroergotamine (for migrane); 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 Taro-Clarithromycin, possibly leading to an irregular heartbeat. Deaths have occurred.
- You / your child had liver problems after taking Taro-Clarithromycin in the past.
- You / your child have sever liver failure in combination with kidney impairment.
- You / your child have a history of heart disturbance or irregular heartbeat such arrhythmias, OT prolongation or torsades de pointes.
- You / your child have hypokalaemia (low potassium levels in the blood).
What the medicinal ingredient is
Clarithromycin.
What the non-medicinal ingredients are
acetone, alginic acid, aspartame, castor oil, citric acid (anhydrous), colloidal silicon dioxide, croscarmellose sodium, flavour peppermint , flavour tutti frutti, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, maltodextrin, povidone, sodium benzoate, sodium chloride, sodium citrate (dihydrate), sucrose, titanium dioxide and xanthan gum.
What dosage form it comes in
(125 mg/5 mL and 250 mg/5 mL) granules for oral suspension (provided in liquid form by your pharmacist).
Warnings and precautions
Serious Warnings and Precautions
- Taro-Clarithromycin should not be used in pregnancy especially the first 3 months. If there are no other medicines you can take for your infection, your doctor may give you Taro-Clarithromycin. If this happens, they will discuss the risks to your baby with you. Talk to your doctor before taking Taro-Clarithromycin if you are pregnant or think you might be pregnant.
- Taking Taro-Clarithromycin along with certain other drugs may lead to serious safety issues. Talk to your doctor about all medicines you take.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Taro-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 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/ your child should take this medication.
- Or your child are allergic to other medicines, foods, dyes, or preservatives.
- 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 get 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. Taro-Clarithromycin may make your myasthenia gravis worse.
- Or your child 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.
- 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.
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, have risk factors, or you / your child:
- Has 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).
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 BIAXIN®, 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, ibrutinib (cancer treatment).
Proper use of this medication
How to take Taro-Clarithromycin
- Always take it exactly how your / your child’s doctor has told you.
- Your / your child’s doctor will tell you how much Taro-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 Taro-Clarithromycin with or without meals.
- Taro-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 Taro-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 Taro-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.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking Taro-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 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
Keep Taro-Clarithromycin and all other medicines out of reach and sight of children. Store dry powder at controlled room temperature 15° C to 30° C. Protect from light. Store the reconstituted suspension between 15°C and 25° C and use within 14 days. Do not refrigerate. Discard after 14 days. The graduated syringe used for dosage administration should be rinsed between uses. Do not leave syringe in bottle. Do not store reconstituted suspension in syringe.
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 manufacturer’s website (www.taro.ca), or by calling 1-800-268-1975.
This leaflet was prepared by:
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, ON L6T 1C1
Last revised: August 14, 2019