Klarisef

Klarisef Uses, Dosage, Side Effects, Food Interaction and all others data.

Klarisef is a macrolide antibiotic. It acts by inhibiting microsomal protein synthesis by binding to the 50S subunit of the bacterial ribosome. Klarisef is active against most gram-positive bacteria, Chlamydia, some gram-negative bacteria and Mycoplasmas.

Klarisef is a macrolide antibiotic whose spectrum of activity includes many gram-positive (Staphylococcus aureus, S. pneumoniae, and S. pyogenes) and gram-negative aerobic bacteria (Haemophilus influenzae, H. parainfluenzae, and Moraxella catarrhalis), many anaerobic bacteria, some mycobacteria, and some other organisms including Mycoplasma, Ureaplasma, Chlamydia, Toxoplasma, and Borrelia. Other aerobic bacteria that clarithromycin has activity against include C. pneumoniae and M. pneumoniae. Klarisef has an in-vitro activity that is similar or greater than that of erythromycin against erythromycin-susceptible organisms. Klarisef is usually bacteriostatic, but may be bactericidal depending on the organism and the drug concentration.

Trade Name Klarisef
Availability Prescription only
Generic Clarithromycin
Clarithromycin Other Names 6-O-methyl erythromycin, 6-O-methylerythromycin, 6-O-methylerythromycin A, Clarithromycin, Clarithromycina, Clarithromycine, Clarithromycinum, Claritromicina
Related Drugs amoxicillin, prednisone, omeprazole, pantoprazole, doxycycline, ciprofloxacin, cephalexin, metronidazole, azithromycin, clindamycin
Weight 250mg, 500mg
Type Tablet
Formula C38H69NO13
Weight Average: 747.9534
Monoisotopic: 747.476891299
Protein binding

~ 70% protein bound

Groups Approved
Therapeutic Class Macrolides
Manufacturer Hansel Pharmacueutical Pvt (ltd)
Available Country Pakistan
Last Updated: September 19, 2023 at 7:00 am
Klarisef
Klarisef

Uses

  • LRTIs for example, acute and chronic bronchitis and pneumonia.
  • URTIs for example, sinusitis and pharyngitis.
  • Community-acquired pneumonia, atypical pneumonia
  • Skin and soft tissue infection
  • Adjunct in the treatment of duodenal ulcers to eradicate of H. pylori

Klarisef is also used to associated treatment for these conditions: Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB), Acute maxillary sinusitis, Bacterial Infections, Bartonellosis, Community Acquired Pneumonia (CAP), Duodenal ulcer caused by helicobacter pylori, Infective Endocarditis, Lyme Disease, Mycobacterial Infections, Otitis Media (OM), Pertussis, Streptococcal Pharyngitis, Streptococcal tonsillitis, Uncomplicated skin and subcutaneous tissue bacterial infections

How Klarisef works

Klarisef is first metabolized to 14-OH clarithromycin, which is active and works synergistically with its parent compound. Like other macrolides, it then penetrates bacteria cell wall and reversibly binds to domain V of the 23S ribosomal RNA of the 50S subunit of the bacterial ribosome, blocking translocation of aminoacyl transfer-RNA and polypeptide synthesis. Klarisef also inhibits the hepatic microsomal CYP3A4 isoenzyme and P-glycoprotein, an energy-dependent drug efflux pump.

Dosage

Klarisef dosage

Klarisef may be given with or without meals.

Adults (12 years or above):

250 mg twice daily for 7 days. Dose may be increased to 500 mg twice daily for up to 14 days in pneumonia or severe infections.

Combination therapy for H. pylori infection:

Klarisef 500 mg (two 250 mg tablets or one 500 mg tablet) twice daily in combination with Amoxicillin 1000 mg twice daily and Omeprazole 20 mg twice daily should be continued for 10 days.

Children:

The usual recommended daily dosage is 15 mg/kg in 2 divided doses for 10 days.

Approximate Calculation of dose:

1. For 9kg body weight 2.5ml 12 hourly for 10 days

2. For 17kg body weight 5ml 12 hourly for 10 days

3. For 25kg body weight 7.5ml 12 hourly for 10 days

4. For 33kg body weight 10ml 12 hourly for 10 days

Direction for reconstitution of suspension:

Shake the bottle to loosen granules. Add 35 ml of boiled and cooled water with the help of the supplied cup, to the dry granules of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the granules is in suspension.

Note: Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator.

This may be given with or without meals.

The usual duration of treatment is 6 to 14 days.

Children older than 12 years: As for adults.

Eradication of H. pylori in patients with duodenal ulcers: Adults: The usual duration of treatment is 6 to 14 days.

45 ml of water is to be added to the granules in the bottle and shaken to yield 70 ml of reconstituted suspension. The concentration of clarithromycin in the reconstituted suspension is 125 mg per 5 ml.

Side Effects

The most frequently reported events in adults taking Klarisef were diarrhoea (3%), nausea (3%), abnormal taste (3%), dyspepsia (2%), abdominal pain/discomfort (2%), headache (2%) and oral monilia.

Toxicity

Symptoms of toxicity include diarrhea, nausea, abnormal taste, dyspepsia, and abdominal discomfort. Transient hearing loss with high doses has been observed. Pseudomembraneous colitis has been reported with clarithromycin use. Allergic reactions ranging from urticaria and mild skin eruptions to rare cases of anaphylaxis and Stevens-Johnson syndrome have also occurred. Rare cases of severe hepatic dysfunctions also have been reported. Hepatic failure is usually reversible, but fatalities have been reported. Klarisef may also cause tooth decolouration which may be removed by dental cleaning. Fetal abnormalities, such as cardiovascular defects, cleft palate and fetal growth retardation, have been observed in animals. Klarisef may cause QT prolongation.

Precaution

Caution should be taken in administering this antibiotic to patients with impaired hepatic and renal function. Prolonged or repeated use of Klarisef may result in an overgrowth of nonsusceptible bacteria or fungi. If superinfection occurs, Klarisef should be discontinued.

Pharmaceutical precaution

Klarisef tablet should be stored in a cool and dry place and away from sunlight.

Interaction

Concomitant use of Klarisef who are receiving Theophylline may be associated with an increase in serum Theophylline concentrations. Klarisef may alter the metabolism of Terfenadine. The effects of digoxin may be potentiated with concomitant administration of Klarisef. Klarisef resulted in decrease in serum levels of Rifabutin, followed by an increased risk of uveitis.

Food Interaction

  • Take with food. Food increases absorption.

[Minor] Grapefruit juice may delay the gastrointestinal absorption of clarithromycin but does not appear to affect the overall extent of absorption or inhibit the metabolism of clarithromycin.

The mechanism of interaction is unknown but may be related to competition for intestinal CYP450 3A4 and

In an open-label, randomized, crossover study consisting of 12 healthy subjects, coadministration with grapefruit juice increased the time to reach peak plasma concentration (Tmax) of both clarithromycin and 14-hydroxyclarithromycin (the active metabolite) by 80% and 104%, respectively, compared to water.

Other pharmacokinetic parameters were not significantly altered.

This interaction is unlikely to be of clinical significance.

Elimination Route

Klarisef is well-absorbed, acid stable and may be taken with food.

Half Life

3-4 hours

Elimination Route

After a 250 mg tablet every 12 hours, approximately 20% of the dose is excreted in the urine as clarithromycin, while after a 500 mg tablet every 12 hours, the urinary excretion of clarithromycin is somewhat greater, approximately 30%.

Pregnancy & Breastfeeding use

Klarisef is not recommended for pregnant women. Breast milk from mothers receiving Klarisef should not be given to infants until treatment is completed. Klarisef may be used in neonates and children in appropriate doses.

Contraindication

Hypersensitive to Klarisef, Erythromycin or any of the macrolide antibiotics. Patients receiving terfenadine who have pre-existing cardiac abnormalities or electrolyte disturbances.

Special Warning

Klarisef may be used in neonates and children in appropriate doses.

Acute Overdose

Signs & Symptoms : Ingestion of large amounts of Klarisef can be expected to produce gastrointestinal symptoms. Symptoms of overdose may largely correspond to the profile of side effects.

Management: There is no specific antidote on overdose. Serum levels of Klarisef can not be reduced by haemodialysis or peritoneal dialysis.

Storage Condition

Store in a cool and dry place, protected from light.

Innovators Monograph

You find simplified version here Klarisef

Klarisef contains Clarithromycin see full prescribing information from innovator Klarisef Monograph, Klarisef MSDS, Klarisef FDA label

FAQ

What is Klarisef used for?

Klarisef is used to treat chest infections, such as pneumonia, skin problems such as cellulitis, and ear infections.It is also used to get rid of Helicobacter pylori, a bacteria that can cause stomach ulcers. Klarisef used to treat various bacterial infections. This includes strep throat, pneumonia, skin infections, H. pylori infection, and Lyme disease, among others.

How safe is Klarisef?

Klarisef can be taken by adults and children.Klarisef isn't suitable for some people. To make sure Klarisef is safe for you, tell your doctor if you have  allergic reaction to clarithromycin or any other medicines in the past.

Food and Drug Administration is advising caution before prescribing the antibiotic Klarisef  to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later.

How does Klarisef work?

Klarisef works by stopping the growth of bacteria. Antibiotics such as clarithromycin will not work for colds, flu, or other viral infections.

What are the common side effects of Klarisef?

Common side effects of Klarisef are include:

  • feeling sick (nausea)
  • diarrhoea and being sick (vomiting)
  • losing your appetite.
  • bloating and indigestion.
  • headaches.
  • difficulty sleeping (insomnia)

Is Klarisef safe during pregnancy?

Klarisef isn't normally recommended during pregnancy and while breastfeeding. But your doctor may prescribe it if the benefits of you taking it are greater than the risks.Klarisef is the antibiotic most often used in pregnancy.

Is Klarisef safe during breastfeeding?

Because of the low levels of Klarisef in breastmilk and safe administration directly to infants, it is acceptable in nursing mothers. The small amounts in milk are unlikely to cause adverse effects in the infant.

Can I drink alcohol with Klarisef?

You can drink alcohol while taking Klarisef.

Can I drive after taking Klarisef?

Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.

When should be taken of Klarisef?

Klarisef usual to take Klarisef twice a day once in the morning and once in the evening.

How quickly does Klarisef work?

You should feel better within a few days. For skin problems such as cellulitis, you may have to take the medicine for about 7 days before you see any improvement.

How long does Klarisef stay in my system?

Klarisef stays in the body for a period of about 8 to 12 hours.

Is Klarisef bad for the heart?

Klarisef may increase the long term risk of heart problems and death in patients with heart disease.

Is Klarisef safe for kidneys?

Klarisef do not cause direct nephrotoxicity in general, but erythromycin and Klarisef can influence kidney function secondary to interactions with other drugs.

Can I take Klarisef long term?

This prospective study demonstrated that 6-month treatment with Klarisef might be necessary to improve the clinical conditions of patients with DPB and Klarisef could be safely used for a long term.

What happens if I miss a dose of Klarisef?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose on Klarisef?

Seek emergency medical attention.Overdose symptoms may include severe stomach pain, nausea, vomiting, or diarrhea.

Who should not take Klarisef?

Your doctor will probably tell you not to take Klarisef  if you are taking one or more of these medications. Tell your doctor if you have or have ever had jaundice or other liver problems while taking Klarisef. Your doctor will probably tell you not to take Klarisef.

Is Klarisef good for Covid?

Klarisef seems likely that treatment of patients with COVID-19 with oral Klarisef will substantially increase their anti-inflammatory properties and decrease the chances for development of severe respiratory failure.

What happen If I stop taking Klarisef?

If you stop taking Klarisef too soon, or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

*** Taking medicines without doctor's advice can cause long-term problems.
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