Download MOXYPEN® 250 mg MOXYPEN® FORTE 500 mg MOXYPEN

2009 ‫ ינואר‬:‫ עלון מאושר‬."‫"פורמט עלון זה נקבע ע"י משרד הבריאות ותוכנו נבדק ואושר‬
“This leaflet format has been determined by the Ministry of Health and the content thereof has been
checked and approved.” Date of approval: January 2009.
MOXYPEN® 250 mg
CAPSULES
MOXYPEN® FORTE 500 mg
CAPSULES
MOXYPEN® FORTE 250
POWDER FOR THE PREPARATION OF SUSPENSION
Composition
Moxypen 250 mg Capsules
Each capsule contains:
Active Ingredient
Amoxicillin
250 mg
Moxypen Forte 500 mg Capsules
Each capsule contains:
Active Ingredient
Amoxicillin
500 mg
Other Ingredients
Magnesium stearate, EEC erythrosine E 127, FD&C Blue # 2, titanium dioxide,
gelatin, shellac, propylene glycol, sodium hydroxide (component in printing ink),
povidone.
Moxypen Forte 250 Powder for the Preparation of Suspension
Each teaspoonful (5 ml) of suspension contains:
Active Ingredient
Amoxicillin
250 mg
Other Ingredients
Sucrose, silicon dioxide, sprayed dried mask flavor, sodium citrate anhydrous,
xanthan gum, sodium benzoate, FD&C Red # 40.
Purified water added for reconstitution.
Moxypen Forte suspension contains about 3 g.sucrose (2,916.90 mg) per 5 ml.
Sodium content: 3.20 mg per 5 ml.
Mechanism of Action
Moxypen is a broad-spectrum semisynthetic penicillin. It is bactericidal against
sensitive organisms during the stage of active multiplication and acts by inhibiting the
biosynthesis of bacterial cell wall mucopeptides.
Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed from the
gastrointestinal tract following oral administration. Its absorption is unaffected by
food, and it may therefore be taken without regard to meals.
Amoxicillin diffuses readily into most body tissues and fluids but not into the brain
and spinal fluid, except when the meninges are inflamed. It achieves good
penetration into bronchial secretions and also achieves high urinary concentrations of
the unchanged antibiotic.
The wide range of organisms sensitive to the bactericidal action of Moxypen
include:
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Gram-Positive
Streptococcus fecalis, Streptococcus pneumoniae, Streptococcus pyrogenes,
Streptococcus viridans, Staphylococus aureus (penicillin-sensitive), Listeria
monocytogenes.
Gram-Negative
Hemophilus influenzae, Escherichia coli, Proteus mirabilis, Salmonella species,
Shigella species, Bordetella pertussis, Brucella species, Neisseria gonorrhea,
Neisseria menigitidis.
Indications
Infections caused by amoxicillin-susceptible organisms including upper respiratory
tract infections, chest infections, urinary tract infections, skin and soft tissue
infections, and gonorrhea.
Moxypen may be used for the prevention of bacteremia associated with procedures
such as dental extraction in patients at risk of developing bacterial endocarditis.
Contraindications
Known hypersensitivity to a penicillin-type drug, or to other β-lactam antibiotics,
e.g., cephalospoprins.
This drug should not be administered to babies born to mothers with a history of
hypersensitivity to a penicillin-type drug.
Warnings
Serious and occasionally even fatal hypersensitivity reactions due to penicillin
therapy have been reported. Although anaphylaxis is more frequent following
parenteral therapy, it has occurred in patients receiving oral penicillins. Such
reactions are more likely to occur in individuals with a history of hypersensitivity to
penicillins and/or a history of sensitivity to multiple allergens. There have also been
reports of individuals with a history of penicillin hypersensitivity experiencing severe
reactions when treated with cephalosporins.
Therefore before initiating therapy with this drug, careful inquiry should be made
concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other
allergens, because of the risk of anaphylactoid reactions.
If an allergic reaction occurs, the drug should be discontinued and appropriate
therapy instituted.
Serious anaphylactoid reactions require immediate emergency treatment with
adrenaline. Oxygen, intravenous steroids and airway management including
intubation, should also be administered as indicated.
Amoxicillin should be avoided if infectious mononucleosis is suspected since the
occurrence of a morbilliform rash has been associated with this condition following
the use of amoxicillin.
Pseudomembranous colitis has been reported with nearly all antibacterial agents,
including amoxicillin, and may range in severity from mild to life-threatening.
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 of clostridia. Clostridium difficile associated diarrhea (CDAD)has
been reported with use of nearly all antibacterial agents,including amoxicillin, and
may range in severity from mild diarrhea to fatal colitis.
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C.difficile produces toxins A and B which contribute to the development of CDAD.
Hypertoxin producing strains of C.difficile cause increased morbidity and mortality, as
these infections can be refractory to antimicrobial therapy and may require
colectomy. CDAD must be considered in all patients who present with diarrhea
following antibiotic use.Careful medical history is necessary since CDAD has been
reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against
C.difficile may need to be discontinued.Appropriate fluid and electrolyte
management, protein supplementation,antibiotic treatment of C.difficile, and surgical
evaluation should be instituted as clinically indicated.
After the diagnosis of 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
Clostridium difficile colitis.
Prolongation of prothrombin time has been reported rarely in patients receiving
amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are
prescribed concurrently.
In patients with reduced urine output crystalluria has been observed very rarely,
predominantly with parenteral therapy. During the administration of high doses of
amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in
order to reduce the possibility of amoxicillin crystalluria .
Use during Pregnancy
Reproduction studies have been performed in mice and rats at doses up to ten
(10) times the human dose and have revealed no evidence of impaired fertility or
harm to the fetus due to amoxicillin. There are, however, no adequate and wellcontrolled studies in pregnant women. Because animal reproduction studies are not
always predictive of human response, this drug should be used during pregnancy
only if clearly needed.
Use during Labor and Delivery
Oral ampicillin-class antibiotics are poorly absorbed during labor. Studies in guinea
pigs showed that intravenous administration of ampicillin slightly decreased the
uterine tone and frequency of contractions but moderately increased the height and
duration of contractions. However, it is not known whether use of amoxicillin in
humans during labor or delivery has immediate or delayed adverse effects on the
fetus, prolongs the duration of labor, or increases the likelihood that forceps delivery
or other obstetrical intervention or resuscitation of the newborn will be necessary.
Use in Breastfeeding
Since penicillins are excreted in breast milk, administration of this drug to nursing
mothers may lead to sensitization of their infants. Therefore, having taken into
account the importance of the drug to the mother, either discontinue nursing or
discontinue the drug.
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Use in Pediatrics
Penicillins are excreted largely unchanged by the kidney. Because renal function is
incompletely developed in infants, the rate of elimination of the drug tends to be slow.
Penicillin-type drugs should therefore be administered with caution, particularly in
neonates, and organ system function should be evaluated frequently.
Use in Patient with Impairment of Renal Function
In patients with renal impairment, the rate of excretion of amoxicillin will be reduced
depending on the degree of impairment and it may be necessary to reduce the total
daily unit amoxicillin dosage accordingly
Use in Geriatrics
This drug is known to be substantially excreted by the kidney, and the risk of toxic
reactions to this drug may be greater in patients with impaired renal function.Because
elderly patients are more likely to have decreased renal function,care should be
taken in dose selection,and it may be useful to monitor renal function.
Adverse Reactions
The following convention has been utilised for the classification of undesirable
effects:Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000,<1/100), rare
(>1/10,000, <1/1000), very rare (<1/10,000)
The majority of side effects listed below are not unique to amoxicillin and may occur
when using other pencillins.
Unless otherwise stated, the frequency of adverse events has been derived from
more than 30 years of post-marketing reports.
Infections and infestations
Very Rare:
Mucocutaneous candidiasis
Blood and lymphatic system disorders
Very rare:
Reversible leucopenia (including severe neutropenia or
agranulocytosis), reversible thrombocytopenia and
haemolytic anaemia.
Prolongation of bleeding time and prothrombin.
Immune system disorders
Very rare:
As with other antibiotics, severe allergic reactions,
including angioneurotic oedema, anaphylaxis, serum
sickness and hypersensitivity vasculitis.
If a hypersensitivity reaction is reported, the treatment
must be discontinued. (See also Skin and
subcutaneous tissue disorders)
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Nervous system disorders
Very rare:
Hyperkinesia, dizziness and convulsions. Convulsions
may occur in patients with impaired renal function or in
those receiving high doses.
Gastrointestinal disorders
Clinical Trial Data
*Common :
Diarrhoea and nausea.
*Uncommon :
Vomiting.
Post-marketing Data
Very rare:
Antibiotic associated colitis (including
pseudomembraneous colitis and haemorrhagic colitis).
Black hairy tongue
Superficial tooth discolouration has been reported in
children. Good oral hygiene may help to prevent tooth
discolouration as it can usually be removed by
brushing.
Hepato-biliary disorders
Very rare:
Hepatitis and cholestatic jaundice. A moderate rise in
AST and/or ALT.
The significance of a rise in AST and/or ALT is unclear.
Skin and subcutaneous tissue disorders
Clinical Trial Data
*Common :
Skin rash
*Uncommon :
Urticaria and pruritus
Post-marketing Data
Very rare :
Skin reactions such as erythema multiforme, Stevens
Johnson syndrome, toxic epidermal necrolysis, bullous
and exfoliative dermatitis and acute generalised
exanthematous pustulosis (AGEP)
(See also Immune system disorders).
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Renal and urinary tract disorders
Very rare :
Interstitial nephritis, . crystalluria .
* The incidence of these AEs was derived from clinical studies involving a total of
approximately 6,000 adult and paediatric patients taking amoxicillin.
Precautions
In the treatment of group A β-hemolytic streptococcal infections, therapy with this
drug should be continued for at least 10 days to help prevent the occurrence of acute
rheumatic fever or glomerulonephritis. Following completion of treatment, cultures
should be taken to determine whether streptococci have been eradicated.
As with any potent drug, periodic assessment of renal, hepatic and hematopoietic
functions should be made during prolonged therapy.
All patients with gonorrhea should have a serologic test for syphilis at the time of
diagnosis. Patients with amoxicillin should have a follow-up serologic test for syphilis
after 3 months.
The possibility of superinfection with mycotic or bacterial pathogens should be kept
in mind during therapy. If superinfection occurs, appropriate therapy should be
instituted.
As with any potent drug,periodic assessment of renal,hepatic and haematopoietic
function should be made during prolonged therapy.The possibility of superinfections
with mycotic or bacterial pathogens should be kept in mind during therapy.If
superinfections occur (usually involving Aerobacter, Pseudomonas or Candida), the
drug should be discontinued and/or appropriate therapy instituted.
Adequate fluid intake and urinary output must be maintained in patients receiving
high doses of amoxicillin.
Moxypen Forte 250 Suspensions contains about 3 g sucrose per 5 ml, therefore
caution should be exercised when administered to diabetics.
Drug Interactions
Penicillins/Chloramphenicol/Erythromycin/Tetracyclines/Sulfonamides: Since
bacteriostatic drugs may interfere with the bactericidal effect of penicillins in the
treatment of meningitis or other conditions where a rapid bactericidial effect is
necessary, it is best to avoid concurrent therapy.
Amoxicillin/Probenecid: Probenecid may decrease renal tubular secretion of
penicillin-type drugs including amoxicillin, resulting in increased blood levels pf
amoxicillin.
Amoxicillin/Oral Contraceptives: In common with other antibiotics, amoxicillin may
affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of
combined oral contraceptives.
Amoxicillin/Allopurinol: Concurrent administration of allopurinol during treatment with
amoxicillin can increase the likelihood of allergic skin reactions. It is not known
whether this potentiation of ampicillin rashes is due to allopurinol or the
hyperuricemia present in these patients. Similar reactions can be expected with
amoxicillin.
Amoxicillin/Anticoagulants: Prolongation of prothrombin time has been reported
rarely in patients receiving amoxicillin. Appropriate monitoring should be undertaken
when anticoagulants are prescribed concurrently.
Effects on ability to drive and use machines
Adverse effects on the ability to drive or operate machinery have not been observed
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Diagnostic Interference
Treatment with penicillins may result in false positive reactions when testing for the
presence of glucose in urine using Clinitest, Benedict's Solution or Fehling's Solution.
Tests based on enzymatic glucose oxidase reactions such as Clinistix or Test-Tape
are not affected.
A transient decrease in plasma concentration of total conjugated estriol, estriolglucuronide, conjugated estrone, and estradiol has been noted following
administration to pregnant women.
Information for Patients:
Patients should be counseled that antibacterial drugs,including amoxicillin, should
only be used to treat bacterial infections.They do not treat viral infections (e.g., the
common cold).When amoxicillin is prescribed to treat a bacterial infection, patients
should be told that although it is common to feel better early in the course of therapy,
the medication should be taken exactly as directed.Skipping doses or not completing
the full course of therapy may:(1) decrease the effectiveness of the immediate
treatment,and (2) increase the likelihood that bacteria will develop resistance and will
not be treatable by amoxicillin or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics which usually ends when the
antibiotic is discontinued.Sometimes after starting treatment with antibiotics, patients
can develop watery and bloody stools (with or without stomach cramps and fever)
even as late as 2 or more months after having taken the last dose of the antibiotic.If
this occurs, patients should contact their physician as soon as possible.
Dosage and Administration
Moxypen is not affected by food and may therefore be administered without regard
to meals.
With the exception of gonorrhea, treatment with Moxypen should be continued for a
minimum of 48-72 hours beyond the time at which the patient becomes
asymptomatic or evidence of bacterial eradication has been obtained.
In the treatment of group A β-hemolytic streptococcal infections, therapy with this
drug should be continued for at least 10 days to help prevent the occurrence of acute
rheumatic fever or glomerulonephritis.
Upper Respiratory Tract and Chest Infections
Adults and Children over 10 Years of Age
The recommended dosage is 250-500 mg 3 times daily, every 8 hours.
Infants and Children under 10 Years of Age
In infants under 2 years of age, the dosage is 62.5 mg 3 times daily, every 8 hours.
In children 2-10 years of age, the dosage is 125 mg 3 times daily, every 8 hours.
For more severe infections, the dosage may be increased to 250 mg 3 times daily.
The recommended dosage according to body weight is 20 mg/kg per day in divided
doses every 8 hours. For more severe infections, the dosage may be increased to
40 mg/kg body weight per day every 8 hours.
Skin and Soft-tissue Infections
Treat as for upper respiratory tract and chest infections.
Uncomplicated Lower Urinary Tract Infections
Adults
A single dose of 3 g may be administered.
Children
A single dose of 100 mg/kg body weight may be administered.
Gonorrhea
A single dose of 3 g may be administered.
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Prophylaxis of Bacterial Endocarditis (in dental procedures)
Adults and Children over 10 Years of Age
A single dose of 3 g about 1 hour prior to the procedure, to prevent bacteremia.
Children under 10 Years of Age
Half the adult dose.
Overdosage
Overdosage of penicillin drugs may cause neuromuscular hyperirritability or
convulsive seizures.
Interstitial nephritis resulting in oliguric renal failure has been reported in a small
number of patients after overdosage with amoxicillin. Renal impairment appears to
be reversible with cessation of drug administration. High blood levels may occur
more readily in patients with impaired renal function because of decreased renal
clearance of amoxicillin.
Discontinue medication, treat symptomatically, and institute supportive measures
as required. In patients with renal function impairment, the antibiotic may be removed
from the circulation by hemodialysis, not by peritoneal dialysis.
Pharmaceutical Precautions
Moxypen Forte 250 Suspension
Following reconstitution Moxypen Forte Suspension is stable for 14 days when kept
at room temperature or in a refrigerator. Any unused portion of the suspension must
be discarded thereafter.
Moxypen Capsules 250 mg and 500 mg
Store in a cool and dry place.
Registration Numbers:
Moxypen 250 mg Capsules: 130 87 30824 00.
Moxypen Forte 500 mg Capsules:130 22 30823 00.
Moxypen Forte 250 mg/5 ml Suspension: 132 01 31050 00.
Manufacturer
Novopharm Ltd.,
Toronto, Ontario,
Canada M1B 2K9.
Teva Group.
Importer
Salomon Levin & Elstein Ltd,
P.O.Box 3696, Petach Tikva 49133
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