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SUMOXIL, an
antibiotic, is used to treat a wide variety of infections,
including: gonorrhea, middle ear infections, skin infections,
upper and lower respiratory tract infections, and infections of
the genital and urinary tract. In combination with other drugs, it
is also used to treat duodenal ulcers caused by H. pylori bacteria
(ulcers in the wall of the small intestine near the exit from the
stomach).
SUMOXIL can be taken with or without food. If you are using
SUMOXIL suspension, shake it well before using.
Each Tablet contains: Antibacterials
SUMOXIL
Amoxicillin and Clavulanate potassium USP
Dosage form/s
Injection, Tablets and Syrup
Composition:
SUMOXIL Injection
Each vial contains
Amoxycillin Sodium IP sterile
equivalent to Amoxycillin ...... 1000 mg
Clavulanate potassium USP sterile
Clavulanic acid ....... 200 mg
SUMOXIL 625 Tablets
Each film-coated tablet contains
Amoxycillin trihydrate IP
equivalent to Amoxycillin . . . . . 500 mg
Clavulanic acid .................... 125 mg
(Present as clavulanate potassium USP)
colour :Titanium dioxide
SUMOXIL Syrup
Each 5 ml (on reconstitution)contains
Amoxycillin trihydrate IP
equivalent to Amoxycillin . . . . . 200 mg
Clavulanate Potassium USP
equivalent to Clavulanic acid ..... 28.5 mg
Pharmacology
Pharmacodynamics :
SUMOXIL is a formulation of amoxycillin and clavulanic acid.
Amoxycillin has a broad spectrum of bactericidal activity against
many gram-positive and gram-negative microorganisms. Amoxycillin
is, however, susceptible to degradation by (beta)-lactamases, and
therefore, the spectrum of activity does not include organisms
which produce these enzymes. The formulation of amoxycillin and
clavulanic acid in SUMOXIL protects amoxycillin from degradation
by (beta)-lactamase enzymes and effectively extends the antibiotic
spectrum of amoxycillin to include many bacteria normally
resistant to amoxycillin and other (beta)-lactam antibiotics.
Amoxycillin/clavulanic acid has been shown to be active against
most strains of the following microorganisms, both in vitro and in
clinical infections
Gram-Positive Microorganisms:
Aerobes
Staphylococcus aureus
Coagulase-negative Staphylococci
(including Staphyloccocci epidermidis )
Streptococcus pyogenes
Bacillus anthracis
Corynebacterium species
Streptococcus viridans
Enterococcus faecium
Enterococcus faecalis
Listeria monocytogenes
Streptococcus agalactiae
Anaerobes
Clostridium species
Peptococcus species
Peptostreptococcus species
Gram-Negative Microorganisms:
Aerobes
Escherichia coli
Proteus mirabilis
Proteus vulgaris
Klebsiella species
Salmonella species
Shigella species
Bordetella pertussis
Gardnerella vaginalis
Legionella species
Brucella species
Neisseria meningitidis
Neisseria gonorrhoeae
Haemophilus influenzae
Moraxella catarrhalis
Pasteurella multocida
Vibrio cholerae
Helicobacter pylori
Yersinia enterocolitica
Anaerobes
Bacteroides species including B. fragilis
Fusobacterium species
Pharmacokinetics :
Combining clavulanic acid with amoxycillin causes no appreciable
alteration of the pharmacokinetics of either drug compared with
their separate administration. After oral administration, both
components achieve maximum plasma concentration in about an hour.
Absorption is unaffected by food, milk, ranitidine or pirenzepine.
The tissue and body fluid distribution of both components is
generally adequate to achieve antibacterial levels, although the
concentrations may be somewhat low in bronchial secretions and
cerebrospinal fluid. The pharmacokinetic profile of amoxycillin
and clavulanic acid in children parallels that in adults.
Indications
SUMOXIL is indicated in the treatment of infections caused by
susceptible strains of the designated organisms in the conditions
listed below:
Lower Respiratory Tract Infections - caused by (beta)-lactamase
producing strains of H. influenzae and M. catarrhalis .
Otitis Media - caused by (beta)-lactamase producing strains of H.
influenzae and M. catarrhalis.
Sinusitis - caused by (beta)-lactamase producing strains of H.
influenzae and M. catarrhalis .
Skin and Skin Structure Infections - caused by (beta)-lactamase
producing strains of S. aureus, E. coli and Klebsiella spp.
Urinary Tract Infections - caused by (beta)-lactamase producing
strains of E. coli, Klebsiella spp. and Enterobacter spp.
Bone and Joint Infections :
Other infections e.g. intra-abdominal sepsis and dental infections
While SUMOXIL is indicated only for the conditions listed above,
infections caused by ampicillin-susceptible organisms are also
amenable to treatment with SUMOXIL due to its amoxycillin content.
Therefore, mixed infections caused by ampicillin-susceptible
organisms and (beta)-lactamase producing organisms susceptible to
SUMOXIL should not require the addition of another antibiotic.
Because amoxycillin has greater in vitro activity against S.
pneumoniae than does ampicillin or penicillin, the majority of S.
pneumoniae strains with intermediate susceptibility to ampicillin
or penicillin are fully susceptible to amoxycillin and SUMOXIL .
Dosage And Method of Administration
SUMOXIL Injection
SUMOXIL Intravenous may be administered either by intravenous
injection or intermittent infusion. It is not suitable for
intramuscular administration.
Usual dosages for the treatment of infection.
Adults and children over 12 years Usually 1.2 g thrice daily. In
more serious infections, increase frequency to 6 hourly intervals.
Maximum adult daily dose should not exceed 7.2 g IV route.
Children 3 months - 12 years Usually 30 mg/kg SUMOXIL 8 hourly.In
more serious infections, increase frequency to 6 hourly.
Each 30 mg of SUMOXIL I.V. provides 5 mg clavulanic acid and 25 mg
amoxycillin. Therapy can be started parenterally and continued
with the oral preparation. Treatment with SUMOXIL should not
extend beyond 14 days without review.
Dosage for Surgical Prophylaxis
Procedures lasting for less than 1 hour are covered in adults by
1.2 g SUMOXIL I.V. given at induction of anaesthesia. Longer
operation require subsequent doses of 1.2 g SUMOXIL I.V. (up to 4
doses in 24 hours), and this regimen can be continued for several
days if the procedure has significantly increased risk of
infection. Clear clinical signs of infection at operation will
require a normal course of intravenous or oral SUMOXIL therapy
post-operatively.
Renal Impairment
Adults
Mild impairment No change in doseage
Moderate impairment 1.2 g I. V stat followed by 600 mg I.V q 12
hourly
Severe impairment 1.2 g I. V stat followed by 600 mg I.V q 12
hourly . An additional 600 mg IV dose may need to be given during
dialysis and at the end of dialysis.
Children
Similar reductions in dosage should be made for children.
Hepatic Impairment
Dose with caution; monitor hepatic function at regular intervals.
Preparation
1.2 g vial : To reconstitute dissolve contents in 20 mL of Water
for Injection I.P. ( final volume 20.9 mL)
A transient pink colouration may appear during reconstitution.
Reconstituted solutions are normally a pale, straw colour.
Intravenous injection
The stability of SUMOXIL intravenous solution is concentration
dependent, thus SUMOXIL intravenous should be used immediately
upon reconstitution and given by slow intravenous injection over a
period of 3-4 minutes. SUMOXIL intravenous solutions should be
used within 20 minutes of reconstitution. SUMOXIL may be injected
directly into a vein or via a drip tube.
Intravenous infusion:
SUMOXIL intravenous may be infused in water for injection I.P. or
sodium chloride intravenous injection I.P. (0.9% w/v). Add without
delay*, 1.2 g reconstituted solution to 100 mL infusion fluid.
Infuse over 30-40 minutes and complete within 4 hours of
reconstitution.
Solutions should be made up to full infusion volume immediately
after reconstitution. Any residual antibiotic solutions should be
discarded.
Stability and Compatibility
Intravenous infusions of SUMOXIL may be given in a range of
different intravenous fluids. Satisfactory antibiotic
concentrations are retained at 5°C and at room temperature (25°C)
in the recommended volumes of the following infusions fluids. If
reconstituted and maintained at room temperature, infusions should
be completed within the time stated.
Reconstituted solutions should not be frozen.
Intravenous infusion fluids Stability period 25°C
Water for Injections I.P 4 hours
Sodium chloride Intravenous Infusion I.P. (0.9% w/v) 4 hours
Sodium Lactate Intravenous Infusion I.P. ( one sixth molar) 4
hours
Compound Sodium Chloride Intravenous Infusion I.P. (Ringers
solution) 3 hours
Compound Sodium Lactate Intravenous Infusion I.P. (Ringer-Lactate
Solution; Hartmann's Solution ) 3 hours
Potassium Chloride and Sodium Chloride
Intravenous infusion B.P. 3 hours
SUMOXIL is less stable in infusions containing glucose, dextran or
bicarbonate. Reconstituted solutions of SUMOXIL should therefore,
not be added to such infusions but may be injected into the drip
tubing, over a period of 3-4 minutes.
For storage at 5°C, the reconstituted solution should be added to
pre-refrigerated infusion bags which can be stored for up to 8
hours. Thereafter, the infusion should be administered immediately
after reaching room temperatures.
Oral Administration
Tablets should be swallowed whole without chewing. If required,
tablets may be broken in half and swallowed without chewing. To
minimize potential gastrointestinal intolerance, administer at the
start of a meal. The absorption of SUMOXIL is optimized when taken
at the start of a meal. Treatment should not be extended beyond 14
days without review.
SUMOXIL Tablets
Usual dosages for the treatment of infection.
Adults and Children over 12 years.
Mild to Moderate Infections
One 625 mg tablet twice a day.
Severe Infections :
One 1 g tablet twice a day.
Dentoalveolar abscess one SUMOXIL 625 mg tablet twice a day for
five days.
Renal Impairment
Adults
1 g tablet should only be used in patients with a glomerular
filtration rate >30 mL/min.
Mild impairment
( Creatinine clearance > 30 mL/min)
No change in dosage.
Moderate impairment
( Creatinine clearance 10-30 mL/min)
One 625 mg tablet twice a day. 1 g tablet should not be
administered.
Severe impairment
( Creatinine clearance <10 - 30 mL/min)
Not more than one 625 mg tablet every 24 hours.
Hepatic Impairment
Dose with caution; monitor hepatic function at regular intervals.
SUMOXIL 625mg and 1g tablets are not recommended in children of 12
years and under.
SUMOXIL Syrup
Usual dosages for the treatment of infection.
Patients aged 12 weeks (3 months) and older.
Mild to Moderate infections
25/3.6 mg/kg/day b.i.d
Severe Infections and Otitis media, sinusitis, lower respiratory
infections 45/6.4 mg/kg/day
b.i.d
Infants with immature kidney function
For infants with immature renal function SUMOXIL Syrup 228 mg/5 mL
is not recommended.
Renal Impairment
For children with GFR of > 30 mL/min no adjustment in dosage is
required. For children with a GFR of < 30 mL/min SUMOXIL Syrup
228/5 mL is not recommended.
Hepatic Impairment
Dose with caution; monitor hepatic function at regular intervals.
There is, as yet, insufficient evidence on which to base a dosage
recommendation.
Instructions for use/handling
At the time of dispending, the dry powder should be reconstituted
to form an oral suspension. To make up to 30 mL first shake the
bottle to loosen powder. Add water to 2/3 of fill-mark on bottle.
Replace the cap, and shake the bottle until all of the powder is
suspended. Add more water until the level of the fill line is
attained, and shake again. When first reconstituted, allow to
stand for 5 minutes to ensure full dispersion. After
reconstitution, keep in a refrigerator when not in use. Use the
reconstituted syrup within 7 days.
Contraindications :
SUMOXIL is contraindicated in patients with a history of allergic
reactions to any penicillin. Attention should be paid to possible
cross-sensitivity with other beta-lactam antibiotics , e.g.
cephalosporins. It is also contraindicated in patients with a
previous history of cholestatic jaundice/hepatic dysfunction
associated with amoxycillin- clavulanate.
Warnings and Precautions :
Before initiating therapy with SUMOXIL , careful inquiry should be
made concerning previous hypersensitivity reactions to penicillins,
cephalosporins, or other allergens. If an allergic reaction
occurs, SUMOXIL should be discontinued and the appropriate therapy
instituted. Pseudomembranous colitis has been reported with nearly
all antibacterial agents, including SUMOXIL , and has ranged in
severity from mild to life-threatening. 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 .
If the parenteral administration of high doses is necessary, the
sodium content must be taken into account in patients on a sodium
restricted diet.
Change in liver function tests have been observed in some patients
receiving amoxycillin- clavulanate. The clinical significance of
these changes is uncertain but SUMOXIL should be used with caution
in patients with evidence of severe hepatic dysfunction.
Cholestatic jaundice, which may be severe, but is usually
reversible, has been reported rarely. Signs and symptoms may not
become apparent for several weeks after treatment has ceased.
SUMOXIL should be avoided if infectious mononucleosis is suspected
since the occurrence of morbilliform rash has been associated with
this condition following the use of amoxycillin. In patients with
moderate or severe renal impairment SUMOXIL Syrup 228 mg/5 mL is
not recommended. Erythematous rashes have been associated with
glandular fever in patients receiving amoxycillin. SUMOXIL should
be avoided if glandular fever is suspected. Prolonged use may also
occasionally result in overgrowth of non-susceptible organisms. In
patients with reduced urine output, crystalluria has been observed
very rarely, predominantly with parenteral therapy. During the
administration of high doses of amoxycillin, it is advisable to
maintain adequate fluid intake and urinary output in order to
reduce the possibility of amoxycillin crystalluria.
SUMOXIL Syrup 228 mg/5mL contains 12.5mg aspartame per 5mL dose
and therefore care should be taken in phenylketonuria.
While SUMOXIL 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 during prolonged therapy.
Drug Interactions
Probenecid :Probenecid decreases the renal tubular secretion of
amoxycillin. Concurrent use with SUMOXIL may result in increased
and prolonged blood levels of amoxycillin. Co-administration of
probenecid cannot be recommended.
Anticoagulants: Prolongation of bleeding time and prothrombin time
have been reported in some patients receiving amoxycillin/clavulanic
acid. SUMOXIL should be used with care in patients on
anti-coagulation therapy.
Allopurinol : The concurrent administration of allopurinol and
amoxycillin increases substantially the incidence of rashes in
patients receiving both drugs as compared to patients receiving
amoxycillin alone. There are no data with SUMOXIL and allopurinol
administered concurrently.
Contraceptives : In common with other broad-spectrum antibiotics,
SUMOXIL may reduce the efficacy of oral contraceptives.
Renal Impairment: Please refer dosage and administration.
Hepatic Impairment: Please refer dosage and administration .
Pregnancy (Category B) : There are no adequate and well-controlled
studies in pregnant women. This drug should be used during
pregnancy only if clearly needed.
Lactation : SUMOXIL may be administered during lactation. 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 infant.
Paediatrics: As per directions given in dosage and administration.
Undesirable Effects
Amoxycillin- clavulanate is generally well tolerated. The majority
of side effects observed in clinical trials were of a mild and
transient nature and less than 3% of patients discontinued therapy
because of drug-related side effects. From the original
premarketing studies, where both paediatric and adult patients
were enrolled, the most frequently reported adverse effects were
diarrhoea/loose stools (9%), nausea (3%), skin rashes and
urticaria (3%), vomiting (1%) and vaginitis (1%). The overall
incidence of side effects, and in particular diarrhoea, increased
with the higher recommended dose. Other less frequently reported
reactions include: Abdominal discomfort, flatulence, and headache.
Overdosage
Following overdosage, patients have experienced primarily
gastrointestinal symptoms including stomach and abdominal pain,
vomiting, and diarrhoea. Rash, hyperactivity, or drowsiness have
also been observed in a small number of patients.
In the case of overdosage, discontinue SUMOXIL , treat
symptomatically, and institute supportive measures as required. If
the overdosage is very recent and there is no contraindication, an
attempt at emesis or other means of removal of drug from the
stomach may be performed.
Interstitial nephritis resulting in oliguric renal failure has
been reported in a small number of patients after overdosage with
amoxycillin. Crystalluria, in some cases leading to renal failure,
has also been reported after amoxycillin overdosage in adults and
pediatric patients. In case of overdosage, adequate fluid intake
and diuresis should be maintained to reduce the risk of
amoxycillin crystalluria.
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 both amoxycillin and clavulanate. Both amoxycillin
and clavulanate are removed from the circulation by hemodialysis.
Incompatibilities
SUMOXIL intravenous should not be mixed with blood products, other
proteinaceous fluid such as protein hydrolysates or with
intravenous lipid emulsions. If SUMOXIL is prescribed concurrently
with an aminoglycoside, the antibiotics should not be mixed in the
syringe, intravenous fluid container or giving set because loss of
activity of the aminoglycoside can occur under these conditions.
Packaging information
SUMOXIL 625 Tablets Blister of 6 tablets
SUMOXIL Syrup Bottle of 30ml
SUMOXIL Injection Vial of 1.2g
Storage and handling instructions
SUMOXIL Injection store below 25° C.
SUMOXIL 625 tablets store in a dry place below 25 °C.
Note :This product
information is intended only for residents of the India.
Taj Pharmaceuticals Limited, medicines help to treat and prevent
a range of conditions—from the most common to the most
challenging—for people around the world.
Information for Health Care Professionals
*** Please consult local Prescribing
Information for any product before use. This website is an
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professional. Above brand is a trademark of the Taj group of
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