What are the possible side effects of Clarimicina?
Get emergency medical help if you have any of these signs of an allergic reaction to Clarimicina: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
headache with chest pain and severe dizziness, fast or pounding heartbeats, shortness of breath, fainting;
diarrhea that is watery or bloody;
fever, swollen glands, body aches, flu symptoms, new or worsening cough;
skin rash, easy bruising or bleeding, severe tingling, numbness, pain, muscle weakness;
problems with your hearing;
signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath; or
severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Older adults may be more likely to have heart rhythm side effects, including a life-threatening fast heart rate.
Clarimicina may also cause severe liver symptoms. Stop taking Clarimicina and call your doctor at once if you have any of these liver symptoms:
itching, tired feeling;
nausea, upper stomach pain, loss of appetite;
dark urine, clay colored stools; or
jaundice (yellowing of the skin or eyes).
Common Clarimicina side effects may include:
stomach pain, indigestion, gas;
vomiting, mild diarrhea;
unusual or unpleasant taste in your mouth;
headache, sleep problems (insomnia);
mild itching or rash; or
vaginal itching or discharge.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Clarimicina in details
A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
The most frequent and common adverse reactions related to Clarimicina therapy for both adult and pediatric populations are abdominal pain, diarrhea, nausea, vomiting and dysgeusia. These adverse reactions are consistent with the known safety profile of macrolide antibiotics.
There was no significant difference in the incidence of these gastrointestinal adverse reactions during clinical trials between the patient population with or without preexisting mycobacterial infections.
Adverse Reactions Observed During Clinical Trials of Clarimicina
The following adverse reactions were observed in clinical trials with Clarimicina at a rate greater than or equal to 1%:
In the acute exacerbation of chronic bronchitis and acute maxillary sinusitis studies overall gastrointestinal adverse events were reported by a similar proportion of patients taking either Clarimicina tablets or Clarimicina extended-release tablets; however, patients taking Clarimicina extended-release tablets reported significantly less severe gastrointestinal symptoms compared to patients taking Clarimicina tablets. In addition, patients taking Clarimicina extended-release tablets had significantly fewer premature discontinuations for drug-related gastrointestinal or abnormal taste adverse events compared to Clarimicina tablets.
In community-acquired pneumonia studies conducted in adults comparing Clarimicina to erythromycin base or erythromycin stearate, there were fewer adverse events involving the digestive system in Clarimicina-treated patients compared to erythromycin-treated patients (13% vs. 32%; p < 0.01). Twenty percent of erythromycin-treated patients discontinued therapy due to adverse events compared to 4% of Clarimicina-treated patients.
In two U.S. studies of acute otitis media comparing Clarimicina to amoxicillin/potassium clavulanate in pediatric patients, there were fewer adverse events involving the digestive system in Clarimicina-treated patients compared to amoxicillin/potassium clavulanate-treated patients (21% vs. 40%, p < 0.001). One-third as many Clarimicina-treated patients reported diarrhea as did amoxicillin/potassium clavulanate-treated patients.
The following adverse reactions have been identified during post approval use of Clarimicina. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders
Torsades de pointes, ventricular tachycardia, ventricular arrhythmia.
Ear and Labyrinth Disorders
Deafness was reported chiefly in elderly women and was usually reversible.
Pancreatitis acute, tongue discoloration, tooth discoloration was reported and was usually reversible with professional cleaning upon discontinuation of the drug. There have been reports of Clarimicina extended release tablets in the stool, many of which have occurred in patients with anatomic (including ileostomy or colostomy) or functional gastrointestinal disorders with shortened GI transit times. In several reports, tablet residues have occurred in the context of diarrhea. It is recommended that patients who experience tablet residue in the stool and no improvement in their condition should be switched to a different Clarimicina formulation (e.g., suspension) or another antibacterial drug.
Hepatic failure, jaundice hepatocellular. Adverse reactions related to hepatic dysfunction have been reported with Clarimicina.
Immune System Disorders
Anaphylactic reaction, angioedema
Infections and Infestations
Prothrombin time prolonged, white blood cell count decreased, international normalized ratio increased. Abnormal urine color has been reported, associated with hepatic failure.
Metabolism and Nutrition Disorders
Hypoglycemia has been reported in patients taking oral hypoglycemic agents or insulin.
Musculoskeletal and Connective Tissue Disorders
Myopathy, rhabdomyolysis was reported and in some of the reports, Clarimicina was administered concomitantly with statins, fibrates, colchicine or allopurinol.
Psychotic disorder, confusional state, depersonalization, depression, disorientation, manic behavior, hallucination, abnormal behavior, abnormal dreams. These disorders usually resolve upon discontinuation of the drug.
There are no data on the effect of Clarimicina on the ability to drive or use machines. The potential for dizziness, vertigo, confusion and disorientation, which may occur with the medication, should be taken into account before patients drive or use machines.
Renal and Urinary Disorders
Nephritis interstitial, renal failure.
Skin and Subcutaneous Tissue Disorders
Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), Henoch-Schonlein purpura, acne.
There have been reports of colchicine toxicity with concomitant use of Clarimicina and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients.
What is the most important information I should know about Clarimicina?
Dizziness or confusion may occur while you take Clarimicina suspension. Use Clarimicina suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Be sure to use Clarimicina suspension for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
Clarimicina suspension only works against bacteria; it does not treat viral infections (eg, the common cold).
Long-term or repeated use of Clarimicina suspension may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
Mild diarrhea is common with antibiotic use. However, a more serious and sometimes fatal form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
Severe and sometimes fatal liver problems have been reported with Clarimicina suspension. This has usually been reversible when the medicine is stopped. Discuss any questions or concerns with your doctor. Tell your doctor right away if you experience symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness).
A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
Tell your doctor or dentist that you take Clarimicina suspension before you receive any medical or dental care, emergency care, or surgery.
Diabetes patients - Clarimicina suspension may rarely affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
There have been reports of tooth discoloration with the use of Clarimicina suspension. This has usually been reversible with a dental cleaning.
There have been reports of hearing loss with Clarimicina suspension, usually in elderly women. This has usually been reversible. Discuss any questions or concerns with your doctor.
Use Clarimicina suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially irregular heartbeat (prolonged QT interval).
Clarimicina suspension should be used with extreme caution in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Clarimicina suspension has been shown to cause harm to the fetus. Clarimicina suspension is not recommended for use during pregnancy except when no other antibiotics can be used. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Clarimicina suspension while you are pregnant. Clarimicina suspension is found in breast milk. If you are or will be breast-feeding while you use Clarimicina suspension, check with your doctor. Discuss any possible risks to your baby.
Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
Clarimicina is contraindicated in patients with a known hypersensitivity to Clarimicina, erythromycin, or any of the macrolide antibacterial drugs.
Concomitant administration of Clarimicina with cisapride and pimozide is contraindicated [seeDRUG INTERACTIONS (7)].
There have been postmarketing reports of drug interactions when Clarimicina is coadministered with cisapride or pimozide, resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes) most likely due to inhibition of metabolism of these drugs by Clarimicina. Fatalities have been reported.
Cholestatic Jaundice/Hepatic Dysfunction
Clarimicina is contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with prior use of Clarimicina.
Concomitant administration of Clarimicina and colchicine is contraindicated in patients with renal or hepatic impairment.
HMG-CoA Reductase Inhibitors
Do not use Clarimicina concomitantly with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis.
Concomitant administration of Clarimicina and ergotamine or dihydroergotamine is contraindicated.
Contraindications for Coadministered Drugs
For information about contraindications of other drugs indicated in combination with Clarimicina, refer to their full prescribing information (contraindications section).
DailyMed. "CLARITHROMYCIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
DTP/NCI. "clarithromycin: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
European Chemicals Agency - ECHA. "Clarithromycin: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Clarimicina are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Clarimicina. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported side effects
No survey data has been collected yet
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