New clav extra strength for the treatment of pediatric patients with recurrent or persistent acute otitis

 
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New – Clav Extra Strength

Composition :

Each 5 ml contains:
Active Ingredients: Amoxicillin Trihydrate 688.73mg (eq. to
600mg Amoxicillin base) & Potassium Clavulanate /silicon dioxide mixture (1:1)Eq. to 50.5mg Potassium Clavulanate (42.9mg Clavulanic acid).
Inactive ingredients: Avicel RC 591, carboxymethylcellulose
sodium, Sodium benzoate. SIlicon DIoxide, Colloidal silicon
dioxide , Aspartame,Sodium ,eitrate anhydrous, strawberry powder, Citric acid anhydrous , mannitol & Quinoline yellow

Clinical Particulars :
Indications :

new clav Extra is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis m~dia due to S. pneumOBiae (penicillin MIC~ $2 mcg/mL), H. influenzae
(including -Iactamase-produclng stral.nS), or M. catarrnalis
(incluc;Ung ~Iactama&e~producing strains) characterized by
the following risk factors:
– anttblotic exposure for acute otitis media within the preceding 3 months, and either of the following:
– age $2 years
– daycare attendance.
NOTE: Acute otitis media due to S. pneumomae alone can be
treated with amcxtclttin.
New-Olav Extra is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC <4 mcg/mL
Therapy may be instituted prior to obtaining the results from
bacteriological studies when there is reason to believe the infection may involxe both S. pneumoniae (penicillin MIC :$2 mcg/mL) and the p-Iactamase-producing organisms listed above. To reduce the development of drug-resistant bacteria and maintain the effectiveness of New-Clav Extra and other antibacterial drugs, New- Clav Extra should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they
should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Other New-Clav formulations are indicated for short-term treatment of bacterial infections at the following sites when caused by New-Clav susceptible organisms:
Upper respiratory tract infection (including ENT) e.g recurrent tonsillitis, sinusitis,otitis media typically caused by Streptococcus pneumonia, Haemophilus influenza, Moraxella catarrhaJis and Streptococcus pyogens. Lower respiratory tract infections e.g acute extrcerbations of chronic bronchitis, lobar and bronchopneumonia typically caused by Streptococcus pneumonia, Haemophillus
influenza and Moraxella catarrhal is. Genito-urinary tract infections: e.g cystitis, urethritls.pyelone- phritis, female genital infections typically caused Enterobacte- riaceae (mainly Eschericia cou-) Staphylococcus saprophyti- cus & Enterococcus species, and gonorrhea caused by Neisseria gonorrhoeae. Skin and soft tissue infections typically caused by Staphylo- coccus aureus, Streptococcus”‘p’yogens & Bacteroides specis.

Dosage and Administration :

Paediatric patients 3 months and older:
The recommended dose for New-Clav Extra is 90/6.4mg/kg/-
day in two divided doses at 12-hourly intervals for 10 days, (see chart below). There is no experience in paediatric patients weighing> 40kg, or in adults. There are no clinical data on New-Clav Extra in children under 3 months of age
Body Weight (kg)              Volume of New -CIa v Extra providmg

90/6.4mg/kg/day

8                                                             3.0 ml twice daily                              12                                                            4.5 ml twice daily                             16                                                            6.0 ml twice daily                             20                                                           7.5 ml twice daily                              24                                                            9.0 ml twice daily                            28                                                           10.5 ml twice daily                            32                                                           12.0 ml twice daily                            36                                                           13.5 ml twice daily

Hepatic Impairment :

Dose with caution; monitor hepatic function at regular intervals.
There are insufficient data on which to base a dosage recommendation.

Renal Impairment :

There are no dosing recommendations for New-Clav Extra in patients with renal impairment.
Method of Administration :To minimize the potential for gastrointestinal intolerance, New-Clav Extra should be taken at the start of a meal. Treatment should not be extended beyond 14 days without review.
Note: SHAKE ORAL SUSPENSION WELL BEFORE USING.

Warnings :

SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVllV
(ANAPHYLACTICI REACTIONS HAVE BEEN REPORTED IN
PATIENTS ON PENICILLIN THERAPY. THESE REACTIONS
ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A
HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A
HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS.
THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A
HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE
EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH
CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH
New-Clay Extra, CAREFUL INQUIRY SHOULD BE MADE
CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS
TO PENICILLlNS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, New Clay Extra SHOULD BE DISCONTINUED AND THE APPROPRI- ATE THERAPY INSTITUTED.
SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGE- MEN, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED Pseudomembranous colitis has been reported with nearly all antibacterial agents, including amoxicillin/clavulanate
potassium, and has ranged in severity from mild to life-threat-
ening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth 01 clostridia. Studies indicate that a toxin produced by Clostridium dilficile is one primary cause of -antibiotic-associated colitis: After the diagn.osis 01 pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. difficile colitis.
reversible. On rare occasions, deaths have been reported (less than 1 death reported per estimated 4 million prescriptions c, worldwide). These have generally been cases associated with serious underlying diseases or concomitant medications. New Clav extra strength shouldn’t be used in patients with phenylketonuria as it contains aspartame whtch act as a source of phenylketonuria.
Concomitant administration of amoxicillin and anticoagulants
from the coumarin class, may prolong the bleeding time. A dose  adjustment of anticoagulants may be necessary.

Precautions :

General: While amoxicillin/clavulanate possesses the characteristic low toxicity of the penicillin group of antibiotics, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic function, is advisable if therapy is for longer than the drug is approved for administration. A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash. Thus, ampicillin-claas antibiotics should not be administered to patients with mononucleosis.
The possibility of superinfections with mycotic or bacterial
pathogens should be kept in mind during therapy. If superinfec- tions occur (usually involving Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted.
Prescribing New Clav Extra in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Contraindications :

New-Clav Extra is contraindicated in patients with a history of
hypersensitivity to beta-Iactarns, e.g. penicillins and cephalospo-
rinsNew-Clav Extra is contra-indicated in patients with a pervious
history of Amoxicillin -associated jaundice/hepatic dysfunction.

Interactions :

– Concomitant use of probenecid is not recommended. Probene-
cid decreases the renal tubular secretion of amoxicillin.
– Concomitant use with New-Clav Extra may result in increased
and prolonged blood levels of amoxicillin but not of clavulanate.
– Concomitant use of allopurinol during treatment with amoxicillin
can increase likelihood of allergic skin reactions.
– There are no data on the concomitant use of New-Clav Extra and allopurinol.
– In common with other antibiotics, New-Clav Extra may affect the
gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.

Adverse Reactions :

New-Clav Extra is generally well tolerated. The majority of side
effects observed in pediatric clinical trials of acute otitis mediawere either mild or moderate, and transient in nature; 4.4% of patients discontinued therapy because of drug-related side effects. The most commonly reported side effects with probable or suspected relationship to New-Clav Extra were contact dermatitis, i.e., diaper rash (3.5%1, diarrhea (2.9%), vomiting (2.2%), moniliasis (1.4%), and rash (1.1%). The most common adverse experiences leading to withdrawal that were of probable or suspected relationship to New-Clav Extra were diarrhea (2.5%) and vomiting 11.4%).
The following adverse reactions have been reported for ampicillin-class antibiotics; Gastrointestinal: Diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis, glossitis, black “hairy· tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic /pseudomembranous colitis. Onset of pseudomem- branous colitis symptoms may occur during or after antibiotic treatment. Hypersensitivity Reactions; Skin rashes, pruritus, urticaria, angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, yalgia, and frequently fever), erythema multiforme (rarely Stevens-Johnson syndrome), acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and an occasional case of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported. These reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, the drug should be discontinued, unless the opinion of the physician dictates otherwise. Serious and occasion- al fatal hypersensitivity (anaphylactic) reactions can occur with oral penicillin. Liver: A moderate rise in AST (SGOT) and/or AL T (SGPT) has been noted in patients treated with ampicillin-class antibiotics, but the Significance of these findings is unknown. Hepatic dysfunction, including hepatitis and
cholestatic jaundice, increases in serum transaminases (AST
and/or AL T), serum bilirubin, and/or alkaline phosphatase, has
been infrequently reported with New Clav. It has been reported
more commonly in the elderly, in males, or in patients on prolonged treatment. Fhe histologic findings on liver biopsy-have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic-hepatocellular changes. The onset of signs/symp- toms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued. The hepatic dysfunction, which may be severe, is usually reversible. On rare occasions, deaths have been reported (less than 1 death reported per estimated 4 million prescriptions worldwide).
These cases have generally been associated with serious underlying diseases or concomitant medications.
Renal: Interstitial nephritis and hematuria have been reported
rarely. Crystalluria has also been reported. Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. A Slight thrombocyto- sis was noted in less than 1% of the patients treated with New-Clav Extra. There have been reports of increased
prothrombin time in patients receiving New-Clav Extra and
anticoagulant therapy concomitantly.
Central Nervous System: Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported rarely.
Miscellaneous:Tooth discoloration (brown, yellow, or gray staining) has been rarely reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases

Pregnancy and Lactation :

Use In Pregnancy
reproduction studies in animals (mice and rate at doses up to 10
times the human dose) with orally and parenterally administrated
New-Clav Extra have shown no teratogenic effects. In a single study in women with preterm, premature rupture of the foetal membrane .(pPROM), it was reported that prophylactic treatment WIth New-Clav Extra may be associated with an increased risk of necrotizing enterocolitis in neonates. As with all me~icines, use should be avoided in pregnancy, unless considered essential by the physician.
Use in lactation
New-Clav Extra may be administrated during the period of location. With the exception of the risk of sensitization associated with the excretion of trace quantities in breast milk, there are no known detrimental effects for the breast-fed infant

Effects on Ability to Drive and use Machines :

Adverse effects on the ability to operate machinery have not
been observed

Overdose :

Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte balance.
Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see warning and precautions) New-Clav Extra can be removed from the circulation by haemodialysis.
A prospective study of 51 paediatric patients at a poison control centre suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying.

PHARMACOLOGICAL PROPERTIES :

Pharmacodynamics
Amoxicillin is a semisynthetic antibiotic with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Amoxicl/in is, however, susceptible to degradation by B-Iactamases and, therefore, the spectrum of activity does not include organisms which produce these enzymes. Clavulanic acid is a B-lactarn, structurally related to the penicllins, which possesses the ability to inactivate a wide range of B-Iactamase enzymes
commonly found in microorganisms resistant to penicllins and cephalosporins. In particular, it has good activ!!y~gainst the-clinic-ally important plasmid mediated B-Iactamases frequently responsible for transferred drug resistance. The clavulanate component in New-Clav Extra protects amoxicillin from degradation by B-Iactmase enzymes and effectively extends the antibiotic spectrum of arnoxlcillin to include many bacteria normally resistant to arnoxicillin and other B-Iactam antibiotics. Thus, New-Clav Extra possesses the distinctive properties of a broad-spectrum antibiotic and a B-Iactamase inhibitor.
New-Clav Extra has been shown to be bactericidal to the.
following organisms including:
Gram-positive     aerobes: Streptococcus pneumoniae
(penicillin MIC     <4UG/ML); Staphylococcus aureus=
(methicillin-susceptible); Streptococcus pyogenes
Gram-negative aerobes: Haemophilus lnfluenaae and Moraxella catarrhaliss
egome members 0 these species of bacteria produce beta -lactamase, rendering .them insensitive to amoxicillin alone.

Pharmacokinetics :

Pharmacokinetics parameters are given below for New-CIav
Extra administered at 45mg/kg every 12 hours to paediatric patients

Formulation          C max                Tmax            AUC               T1/2
m /L                  hours)          mg.h/l          (hours)
New-Clav                                      Amoxicillin
Extra 600/42.9
Dosed at                      15.7                     2.0              59.8       1.4  45mg/kg                                        Clavulanatc
amoxicillin
12-hourly                    1.7                       1.1                   4.0          1.1

The Pharmacokinetics of the two components of New- clav         EXtra -are closely-matched. Both clavulanate and amoxicillin        have low levels of serum’ binding; about 70% remains free In the serum.

Special Precautions for Storage :     

The powder for oral suspension should be stored 10 well sealed container, in a dry place at or below 25 C Reconstituted suspensuions should be stored In a refrigerator (2_8°C) and used within 10 days.

PRODUCED BY :

Sigmatec pharmaceutical industries for al Andalous for Pharmaceutical  industries

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