Patient Medication Information: uses, side effects, how to take - Riva-Clarithromycin (Laboratoire Riva, 250 mg)
ABOUT THIS MEDICATION
What the medication is used for:
RIVA-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:
RIVA-CLARITHROMYCIN is an antibiotic that kills bacteria in your body.
When it should not be used:
Do not take RIVA-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 RIVA-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 nonmedicinal ingredients are:
The nonmedicinal ingredients are the following: Croscarmellose Sodium, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Quinoline Yellow WS (D&C Yellow No. 10), Silicon Dioxide Colloidal, Talc, Titanium Dioxide and Triacetin. RIVA-CLARITHROMYCIN tablets does not contain Tartrazine.
What dosage forms it comes in:
This medicine comes in tablets (RIVA-CLARITHROMYCIN, 250 mg and 500 mg).
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
RIVA-CLARITHROMYCIN should not be used in pregnancy unless advised by your doctor due to potential hazards to the fetus. Do not take RIVA-CLARITHROMYCIN without first talking to your doctor if you are breast-feeding a baby.
Before taking RIVA-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 RIVA-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 RIVA-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, or colchicine.
if you have any unusual or allergic reaction (rash,
difficulty of breathing) to clarithromycin or any of the nonmedicinal ingredients in RIVA-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.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with RIVA-CLARITHROMYCIN include:
Alaprazolam, alfentanil, astemizole/terfenadine, atorvastatin, bromocriptine, carbamazepine, cilostazol, cisapride/pimozide, colchicine, cyclosporine, digoxin, disopyramide/quinidine, ergotamine/dihydroergotamine, fluconazole, hexobarbital, lansoprazole/omeprazole, lovastatin/simvastatin, methylprednisolone, midazolam/triazolam, phenytoin, rifabutin/rifampin, ritonavir/indinavir, sildenafil, tacrolimus, theophylline, valproate, vinblastine, warfarin/acenocoumarol, zidovudine and drugs metabolized by cytochrome P450 system
PROPER USE OF THIS MEDICATION
Usual Adult Dose:
RIVA-CLARITHROMYCIN may be taken with or without meals.
Respiratory Tract or Skin Infections:
The usual dosage of RIVA-CLARITHROMYCIN is 250 mg to 500 mg every 12 hours for 7 to 14 days.
Infections with H. Pylori:
Triple Therapy: RIVA-CLARITHROMYCIN + Omeprazole +Amoxillin The recommended dose is the following for 10 days:
- RIVA-CLARITHROMYCIN: 500 mg every 12 hours • Omeprazole: 20 mg once daily
- Amoxicillin: 1 g every 12 hours
Double Therapy: RIVA-CLARITHROMYCIN + Omeprazole The recommended dose is the following for 14 days: • RIVA-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 RIVA-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 RIVA-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, RIVA-CLARITHROMYCIN can cause side effects. The majority of side effects observed in clinical trials with 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 RIVA-CLARITHROMYCIN are not common.
| 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 RIVA-CLARITHROMYCIN, contact your doctor or pharmacist.
HOW TO STORE IT
Keep RIVA-CLARITHROMYCIN and all other medicines out of reach of children.
Store between 15° and 25°C in a tightly closed container. Protect from light. Do not use beyond the expiration date.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be obtained by contacting: Laboratoire Riva Inc. at: 1-800-363-7988
Last revised: March 18, 2010
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