Patient Medication Information: uses, side effects, how to take - Clarithromycin (Ranbaxy Pharmaceuticals Canada)
ABOUT THIS MEDICATION
What the medication is used for:
RAN-CLARITHROMYCIN is used to treat certain infections caused by bacteria, such as pneumonia, bronchitis, infections of the sinuses, skin, and throat.
When used with other medications, it can treat infection caused by a bacterium called Helicobacter pylori (H. pylori) and reduce the risk of duodenal ulcer recurrence. A duodenal ulcer is a sore on the lining of the duodenum, which is the beginning of the small intestine.
It can also be prescribed to prevent and combat MAC disease in patients with HIV. MAC is a short word for Mycobacterium avium complex, the germs that cause MAC disease.
What it does:
RAN-CLARITHROMYCIN is an antibiotic that kills bacteria in your body.
When it should not be used:
Do not take RAN-CLARITHROMYCIN if you have ever had an allergic reaction to it, or if you are sensitive to it or erythromycin, or other antibacterial agents of the same family or to any ingredient in the formulation. See (What the important non-medicinal ingredients are).
Do not take RAN-CLARITHROMYCIN if you are taking astemizole*, cisapride*, colchicine, pimozide, terfenadine*, ergotamine, dihydroergotamine, lovastatin or simvastatin. Astemizole*, cisapride*, pimozide, terfenadine*, ergotamine, dihydroergotamine and colchicine can interact with RAN-CLARITHROMYCIN, possibly leading to an irregular heartbeat pattern; deaths have occurred.
* no longer marketed in Canada.
Do not take RAN-CLARITHROMYCIN if you have ever developed liver problems after using clarithromycin.
Do not use RAN-CLARITHROMYCIN if you have a history of heart disturbance or irregular heart beat (arrhythmias, QT prolongation, torsade de points).
What the medicinal ingredient is:
The medicinal ingredient is clarithromycin.
What the important non-medicinal ingredients are:
The non-medicinal ingredients are the following: croscarmellose sodium, D&C yellow #10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, purified talc, silica, colloidal anhydrous; stearic acid and titanium dioxide.
What dosage forms it comes in:
This medicine comes in tablets (RAN-CLARITHROMYCIN, 250 mg and 500 mg).
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
RAN-CLARITHROMYCIN should not be used in pregnancy unless advised by your doctor due to potential hazards to the fetus. Do not take RAN- CLARITHROMYCIN without first talking to your doctor if you are breast-feeding a baby.
Before taking RAN- CLARITHROMYCIN, tell your doctor if you have liver or kidney disease. You may not be able to take clarithromycin, or you may require a lower dose and special monitoring during therapy. Talk to your doctor if RAN- CLARITHROMYCIN gives you prolonged and severe diarrhea.
The development of antibiotic resistance has been seen in patients with HIV receiving clarithromycin. To avoid failure of the treatment with a potential for developing antimicrobial resistance and a risk of failure with subsequent therapy, you/your child should follow closely the prescribed regimen.
BEFORE you use RAN- CLARITHROMYCIN talk to your doctor or pharmacist:
- about all health problems you have now or have had in the past;
- about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. See (INTERACTIONS WITH THIS MEDICATION);
- if you have or develop severe diarrhea as this may be a sign of a more serious condition;
- if you have kidney problems;
- if you have liver problems;
- if you are taking astemizole, terfenadine, cisapride, pimozide, ergotamine, dihydroergotamine, digoxin, colchicine, atorvastatin, pravastatin, lovastatin or simvastatin.
- if you have any unusual or allergic reaction (rash, difficulty breathing) to clarithromycin or any of the non-medicinal ingredients in RAN-CLARITHROMYCIN (see What the
- important non-medicinal ingredients are), other medicines, foods, dyes, or preservatives;
- if you are pregnant, trying to get pregnant or are breast-feeding because clarithromycin has been detected in human breast milk.
- if you are elderly with a history of liver or kidney problems and taking colchicine.
WHILE taking RAN-CLARITHROMYCIN, contact your doctor if:
- You develop symptoms of myasthenia gravis or the symptoms of your existing myasthenia gravis worsen. These symptoms could include muscle weakness that gets worse with activity and gets better with rest, drooping eyelid, blurred or double vision, difficulty chewing and swallowing, or trouble breathing.
- You develop symptoms of hepatitis (liver inflammation) such as abdominal pain, nausea, vomiting, yellowing of skin and eyes, dark urine etc. Stop taking the drug immediately.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with RAN-CLARITHROMYCIN includes:
Alfentanil, alprazolam, amlodipine, astemizole*/terfenadine*, atazanavir, atorvastatin, bromocriptine, carbamazepine, cilostazol, cisapride*/pimozide, colchicine, cyclosporine, digoxin, diltiazem, disopyramide/quinidine, efavirenz, ergotamine/ dihydroergotamine, etravirine, fluconazole, hexobarbital, insulin, itraconazole, lansoprazole/omeprazole, lovastatin/pravastatin/simvastatin, methylprednisolone, midazolam/triazolam, nateglinide, nevirapine, phenobarbital, phenytoin, pioglitazone, repaglinide, rifabutin/rifampin, rifapentine*, ritonavir/indinavir, rosiglitazone, rosuvastatin, saquinavir, sildenafil, St. John’s Wort (Hypericum perforatum), tacrolimus, tadalafil, theophylline, tolterodine, valproic acid, vardenafil, verapamil, vinblastine, warfarin/acenocoumarol, zidovudine and drugs metabolized by cytochrome P450 system.
* not marketed in Canada.
PROPER USE OF THIS MEDICATION
RAN-CLARITHROMYCIN tablets cannot be used in children less than 12 years old and the tablet cannot be divided or split in half.
Usual Adult Dose:
RAN-CLARITHROMYCIN may be taken with or without meals.
Respiratory Tract or Skin Infections:
The usual dosage of RAN-CLARITHROMYCIN is 250 mg to 500 mg every 12 hours for 7 to 14 days.
Infections with H. pylori:
Triple Therapy: RAN-CLARITHROMYCIN + Omeprazole +Amoxicillin
The recommended dose is the following for 10 days:
RAN-CLARITHROMYCIN: 500 mg every 12 hours
- Omeprazole: 20 mg once daily
- Amoxicillin: 1 g every 12 hours
Dual Therapy: RAN-CLARITHROMYCIN + Omeprazole
The recommended dose is the following for 14 days:
- RAN-CLARITHROMYCIN: 500 mg every 8 hours
- Omeprazole: 40 mg once daily
followed by 20 mg omeprazole once daily for 14 days
MAC disease:
The recommended dose of RAN-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:
| In case of overdose, contact your healthcare professional, hospital emergency department or regional poison control centre, even if there are no symptoms. Symptoms of RAN- CLARITHROMYCIN overdose are abdominal pain, vomiting, nausea, and diarrhea. |
Missed Dose:
If you miss a dose, take it as soon as you remember unless it is almost time for the next dose. In that case, skip the missed dose and take the next one as directed. Do not take double or extra doses.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, RAN-CLARITHROMYCIN can cause side effects. The majority of side effects observed in clinical trials with RAN-CLARITHROMYCIN were of a mild and transient nature.
The following adverse reactions were reported during the clinical studies with clarithromycin, the medicinal ingredient (occurring between 1% and 10% in clinical trials) or during post-marketing surveillance: abdominal pain, abnormal taste, diarrhea, ear disorder, flatulence, indigestion, headache, nausea, rash, vomiting. Talk to your doctor or pharmacist if any of these side effects persist or become bothersome.
Serious side effects from RAN-CLARITHROMYCIN are not common.
If dizziness, confusion or disorientation occur while taking RAN-CLARITHROMYCIN, do not drive or operate machinery.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||
| Symptom/effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency medical attention |
| Only if severe | In all cases | |
| Uncommon | ||
Allergic reactions* Severe diarrhea Severe abdominal cramps Irregular heart beat | ||
√ √ | √ √ | |
*Allergic reactions, with symptoms such as itching, skin eruptions, rash, sore throat, fever, swelling, skin rash, itchiness, difficulty breathing, lightheadedness/dizziness.
This is not a complete list of side effects. For any unexpected effects while taking RAN-CLARITHROMYCIN, contact your doctor or pharmacist.
HOW TO STORE IT
Keep RAN-CLARITHROMYCIN and all other medicines out of reach of children.
Store at room temperature between 15° C and 25° C in a tightly closed container. Protect from light. Do not use beyond the expiration date.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at http://www.healthcanada.gc.ca/medeffect NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
This document plus the full Product Monograph, prepared for health professionals can be found by contacting the sponsor, Ranbaxy Pharmaceuticals Canada Inc. at: 1-866-840-1340.
RANBAXY
Ranbaxy Pharmaceuticals Canada Inc.
2680 Matheson Blvd. E., Suite 200
Mississauga, Ontario L4W 0A5