Clarie DS 125/Clarie DS 250

Clarie DS 125/Clarie DS 250

clarithromycin

Manufacturer:

Ind-Swift

Distributor:

Ambica

Marketer:

Ambica
Full Prescribing Info
Contents
Clarithromycin.
Description
Clarie DS 125: Each 5 mL of reconstituted suspension contains: Clarithromycin granules equivalent to Clarithromycin 125 mg.
Clarie DS 250: Each 5 mL of reconstituted Clarie DS 250 suspension contains clarithromycin granules equivalent to clarithromycin 250 mg.
Action
Pharmacology: Pharmacokinetics: Clarithromycin is rapidly absorbed from the gastrointestinal tract after oral administration. In comparison, after an oral dose of 250 mg (125 mg/5 mL) suspension every 12 hours, approximately 40% is excreted in urine as clarithromycin. When 250 mg doses of clarithromycin as clarithromycin suspension were administered to fasting healthy adult subjects, peak plasma concentrations were attained around 3 hours after dosing. Steady-state peak plasma concentrations were attained in 2 to 3 days and were approximately 2 mcg/mL for clarithromycin and 0.7 mcg/mL for 14-OH clarithromycin when 250 mg doses of the clarithromycin suspension were administered every 12 hours. Elimination half-life of clarithromycin (3 to 4 hours) and that of 14-OH clarithromycin (5 to 7 hours) were similar to those observed at steady state following administration of equivalent doses of clarithromycin tablets.
For adult patients, the bioavailability of 10 mL of the 125 mg/5 mL suspension or 10 mL of the 250 mg/5 mL suspension is similar to a 250 mg or 500 mg tablet, respectively.
In children requiring antibiotic therapy, administration of 7.5 mg/kg q12h doses of clarithromycin as the suspension generally resulted in steady-state peak plasma concentrations of 3 to 7 mcg/mL for clarithromycin and 1 to 2 mcg/mL for 14-OH clarithromycin.
In HIV-infected children taking 15 mg/kg every 12 hours, steady state clarithromycin peak concentrations generally ranged from 6 to 15 mcg/mL.
Clarithromycin penetrates into the middle ear fluid of children with secretory otitis media.
In adults given 250 mg clarithromycin as suspension (n=22), food appeared to decrease mean plasma clarithromycin concentrations from 1.2 (±0.4) mcg/mL and the extent of absorption from 7.2 (±2.5) hr·mcg/mL to 6.5 (±3.7) hr·mcg/mL.
When children were administered a single oral dose of 7.5 mg/kg suspension, food increased mean peak plasma clarithromycin concentrations from 3.6 (±1.5) mcg/mL to 4.6 (±2.8) mcg/mL and the extent of absorption from 10.0 (±5.5) hr·mcg/mL to 14.2 (±9.4) hr·mcg/mL.
Microbiology: Clarithromycin exerts its antibacterial action by binding to the 50S ribosomal subunit of susceptible bacteria resulting in inhibition of protein synthesis.
Clarithromycin is active in vitro against a variety of aerobic and anaerobic Gram-positive and Gram-negative bacteria as well as most Mycobacterium avium complex (MAC) bacteria.
Additionally, the 14-OH Clarithromycin metabolite also has clinically significant antimicrobial activity. The 14-OH Clarithromycin is twice as active against Haemophilus influenzae microorganisms as the parent compound. However, for Mycobacterium avium complex (MAC) isolates the 14-OH metabolite is 4 to 7 times less active than Clarithromycin. The clinical significance of this activity against Mycobacterium avium complex is unknown.
Clarithromycin has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections (see Indications).
Gram-Positive Microorganisms: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes.
Gram-Negative Microorganisms: Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis.
Other Microorganisms: Mycoplasma pneumoniae, Chlamydophila pneumoniae (TWAR) [previously Chlamydia pneumoniae].
Mycobacteria: Mycobacterium avium complex (MAC) consisting of: Mycobacterium avium, Mycobacterium intracellulare.
Beta-lactamase production should have no effect on Clarithromycin activity.
Note: Most isolates of methicillin-resistant and oxacillin-resistant staphylococci are resistant to Clarithromycin.
Omeprazole/Clarithromycin dual therapy; ranitidine bismuth citrate/Clarithromycin dual therapy; omeprazole/Clarithromycin/amoxicillin triple therapy; and lansoprazole/Clarithromycin/amoxicillin triple therapy have been shown to be active against most strains of Helicobacter pylori in vitro and in clinical infections (see Indications).
Indications/Uses
Clarithromycin for oral suspension is indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions as listed as follows: Adults: Pharyngitis/Tonsillitis due to Streptococcus pyogenes (The usual drug of choice in the treatment and prevention of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route. Clarithromycin is generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present.)
Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
Community-Acquired Pneumonia due to Haemophilus influenzae, Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydia pneumoniae (TWAR).
Uncomplicated skin and skin structure infections due to Staphylococcus aureus, or Streptococcus pyogenes (Abscesses usually require surgical drainage).
Disseminated mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare.
It is given in the treatment of respiratory tract infections (including otitis media) and in skin and soft-tissue infections. It is also used for prophylaxis and treatment of opportunistic mycobacterial infections and has been used in the treatment of leprosy. It may also be given to eradicate Helicobacter pylori in the treatment regimens for peptic ulcer.
Dosage/Direction for Use
Clarithromycin Powder for Oral Suspension may be given with or without food.
Children: The usual recommended daily dosage is 15 mg/kg/day divided every 12 hours for 10 days. Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. However, in the presence of severe renal impairment with or without coexisting hepatic impairment, the dose should be halved or the dosing interval doubled.
Pediatric Dosage Guidelines: See table.

Click on icon to see table/diagram/image

Mycobacterial Infections: Prophylaxis: The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children.
Treatment: Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.
Contraindications
Clarithromycin is contraindicated in patients with a known hypersensitivity to Clarithromycin, Erythromycin or any of the macrolide antibiotics. Concomitant administration of Clarithromycin with Cisapride, Pimozide, Astemizole or Terfenadine is contraindicated.
Special Precautions
Clarithromycin is principally excreted via the liver and kidney. In the presence of severe renal impairment with or without coexisting hepatic impairment, decreased dosage or prolonged dosing intervals may be appropriate.
Clarithromycin in combination with ranitidine bismuth citrate should not be used in patients with a history of acute porphyria and in patients with creatinine clearance of less than 25 mL/min.
Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate, if pregnancy occurs while taking this drug, the patients should be apprised of the potential hazard to the fetus.
Use in children: Safety and effectiveness of clarithromycin in pediatric patients under 6 months of age have been established. The safety of clarithromycin has not been studied in MAC patients under the age of 20 months. Neonatal and juvenile animals tolerated clarithromycin in a manner similar to adult animals. Young animals were slightly more intolerant to acute overdosage and to subtle reductions in erythrocytes, platelets and leukocytes but were less sensitive to toxicity in the liver, kidney, thymus, and genitalia. Clarithromycin tablets and oral suspension can be taken with or without food and can be taken with milk.
Use In Pregnancy & Lactation
Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate, if pregnancy occurs while taking this drug, the patients should be apprised of the potential hazard to the fetus.
Adverse Reactions
Diarrhea, nausea, abnormal taste, dyspepsia, abdominal pain, headache, allergic reaction, CNS effects. Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. However, in the presence of severe renal impairment with or without coexisting hepatic impairment, the dose should be halved or the dosing interval doubled.
Drug Interactions
Clarithromycin use in patients who are receiving theophylline may be associated with an increase of serum theophylline concentrations. Monitoring of serum theophylline concentrations should be considered for patients receiving high doses of theophylline. Concomitant administration of single doses of Clarithromycin and Carbamazepine has been shown to result in increased plasma concentrations of Carbamazepine. Blood level monitoring of Carbamazepine may be considered.
Concomitant administration of Clarithromycin with terfenadine increases the plasma concentration of active acid metabolite of terfenadine by three-fold than that obtained with the administration of terfenadine alone. Concomitant administration of Clarithromycin and oral anticoagulants may potentiate the effects of the oral anticoagulants. Prothrombin times should be carefully monitored while patients are receiving Clarithromycin and oral anticoagulants simultaneously.
Concomitant administration of single doses of Clarithromycin and ritonavir resulted in 77% increase in Clarithromycin AUC and 100% decrease in the AUC of 14-OH Clarithromycin. In patient with renal impairment, dosage adjustment during concomitant administration of these drugs should be considered.
As with other macrolides, Clarithromycin has been reported to increase concentrations of HMG-CoA reductase inhibitors (eg. Lovastatin and simvastatin) through inhibition of cytochrome P450 metabolism of these drugs. Rare reports of rhabdomyolysis have been reported in patients taking these drugs concomitantly. Simultaneous oral administration of Clarithromycin tablets and Zidovudine to HIV-infected adult patients resulted in decreased steady state of Zidovudine concentration. There have been reports of interactions of erythromycin and/or Clarithromycin with carbamazepine, cyclosporine, tacrolimus, hexobarbital, phenytoin, alfentanil, disopyramide, lovastatin, bromocriptine, valproate, terfenadine, cisapride, pimozide, rifabutin and astemizole.
Caution For Usage
Direction for Reconstitution: 27 mL of boiled and cooled water should be added to the granules in the bottle and shaken to yield 50 mL of reconstituted suspension.
Do not refrigerate. Shake well before use.
Storage
Store at temperatures not exceeding 25°C. Reconstituted suspension should be used within 14 days if stored between 15°C to 25°C. Protect from moisture.
MIMS Class
ATC Classification
J01FA09 - clarithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Clarie DS 125: Powd for oral susp 125 mg/5 mL x 50 mL x 1's.
Clarie DS 250: Powd for oral susp 250 mg/5 mL x 50 mL x 1's.
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