Patient Medication Information: uses, side effects, how to take - Ratio-Clarithromycin
What the medication is used for:
ratio-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 bacteria called 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:
ratio-CLARITHROMYCIN is an antibiotic that kills bacteria in your body.
When it should not be used:
Do not take ratio-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 nonmedicinal ingredients are:).
Do not take ratio-CLARITHROMYCIN if you are taking astemizole*, cisapride*, pimozide, terfenadine*, ergotamine, or dihydroergotamine. These medicines can interact, possibly leading to a irregular heartbeat pattern; deaths have occurred.
* no longer marketed in Canada.
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, magnesium stearate, povidone, pregelatinized starch, silicon dioxide, and vanillin hydroxypropyl methylcellulose, hydroxypropyl methylcellulose/hypromellose, polyethylene glycol, maltodextrin, microcrystalline cellulose.
What dosage forms it comes in:
Film-coated tablets, 250 mg and 500 mg
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
ratio-CLARITHROMYCIN should not be used in pregnancy unless advised by your doctor due to potential hazards to the fetus. Do not take ratio-CLARITHROMYCIN without first talking to your doctor if you are breast-feeding a baby.
Before taking ratio-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 ratio-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 should follow closely the prescribed regimen.
| BEFORE you use ratio-CLARITHROMYCIN talk to | |
| your doctor or pharmacist: | |
| |
| in the past; | |
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| prescription medicines, nutritional supplements, or herbal | |
| products; ( see INTERACTIONS WITH THIS | |
| MEDICATION) | |
| |
| of a more serious condition; | |
| |
| |
| |
| pimozide, ergotamine, dihydroergotamine, digoxin, or | |
| colchicine. | |
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| difficulty breathing) to clarithromycin or any of the | |
ABOUT THIS MEDICINE
Product Monograph - ratio-CLARITHROMYCIN Page 77 of 78
nonmedicinal ingredients in ratio-CLARITHROMYCIN (see What the important nonmedicinal ingredients are), other medicines, foods, dyes, or preservatives;
- if you are pregnant, trying to get pregnant or are breast-feeding because clarithromycin has beend detected in human breast milk.
WHILE taking ratio-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.
INTERACTIONS WITH THIS MEDICATION
| Drugs that may interact with ratio-CLARITHROMYCIN | |
| include: | |
| Alaprazolam, alfentanil, astemizole/terfenadine, atorvastatin, | |
| aztazanavir, bromocriptine, carbamazepine, cilostazol, | |
| cisapride/pimozide, colchicine, cyclosporine, digoxin, | |
| disopyramide/quinidine, efavirenz, ergotamine/ | |
| dihydroergotamine, fluconazole, hexobarbital, itraconazole, | |
| lansoprazole/omeprazole, lovastatin/simvastatin, | |
| methylprednisolone, midazolam/triazolam, nevirapine, | |
| phenytoin, rifabutin/rifampin, rifapentine*, ritonavir/ | |
| indinavir, saquinavir, sildenafil, 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 MEDICINE |
Usual Adult Dose:
ratio-CLARITHROMYCIN may be taken with or without meals.
Respiratory Tract or Skin Infections:
The usual dosage of ratio-CLARITHROMYCIN is 250 mg to 500 mg every 12 hours for 7 to 14 days.
Infections with H. Pylori:
Triple Therapy: ratio-CLARITHROMYCIN + Omeprazole +Amoxillin
The recommended dose is the following for 10 days:
- ratio-CLARITHROMYCIN: 500 mg every 12 hours
- Omeprazole: 20 mg once daily
- Amoxicillin: 1 g every 12 hours
| Double Therapy: ratio-CLARITHROMYCIN + Omeprazole | |
| The recommended dose is the following for 14 days: | |
| |
| |
| followed by 20 mg omeprazole once daily for 14 days | |
MAC disease:
The recommended dose of ratio-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:
Contact your doctor or pharmacist if you have taken more than the recommended dose. Symptoms of ratio-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, ratio-CLARITHROMYCIN can cause side effects. The majority of side effects observed in clinical trials with ratio-CLARITHROMYCIN were of a mild and transient nature.
The following adverse reactions were reported during the clinical studies with clarithromycin, the medicinal ingredient (occuring 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 ratio-CLARITHROMYCIN are not common.
Product Monograph - ratio-CLARITHROMYCIN Page 78 of 78
| 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 call your doctor or pharmacist | |||
| Only if severe | In all cases | ||||
| Uncommon | Allergic | ||||
| reactions* | |||||
| Severe | |||||
| diarrhea | |||||
| Severe | |||||
| abdominal | |||||
| cramps | |||||
Irregular heart beat
T T | T T |
* 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 ratio- CLARITHROMYCIN, contact your doctor or pharmacist.
HOW TO STORE IT
Keep ratio-CLARITHROMYCIN and all medicines out of the reach of children.
Store at room temperature (15° - 25°C) in a tightly closed container. Protect from light. Do not use beyond expiry date.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, ratiopharm inc., at: 1-800-337-2584
Last revised: February 8, 2010.
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:
Report online at www.healthcanada.gc.ca/medeffect Call toll-free: 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program Health Canada
Postal Locator 0701C
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at
wwww.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of the side effect, contact your health professional. The Canada Vigiliance Program does not provide medical advice.