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Our Therapy Areas
Our Therapy Areas
Clesstra Healthcare Pvt. Ltd. is focused on various key therapeutic areas which majorly includes
Pediatric Therapy, Critical therapy, Triple therapy for H.pylori, Antacid Therapy, Anti-infective
therapy and others. In addition, we are committed towards improving the health of patients with a
number of diseases, including Osteo-arthritis, Cardiovascular, CNS related, Respiratory, and
Gastrointestinal disorders.
Pediatric Therapy
Although a child’s parents would always make sure that their child is nourished in a hygienic
atmosphere, right from the birth, their little ones are often prone to one health problem or the
other.
During the growth stages a child encounters many diseases especially in the infant stage. Hence
during this stage any kind of health problem needs to be treated as soon as possible, because they
might hamper the development of the child, if left untreated.
It thus becomes very important for the parents to know about the common disorders observed in
children and their common medications.
Our Major Pedia Products Include
- Antibiotics- mainly cephalosporins
- Analgesics and Antipyretics
- Antitussives
- Multivitamins
We Supply pediatric medications in various dosage forms which majorly include
- Granules for Oral Suspensions in Sachets
- Oral Liquids: Syrups, Suspensions
- Lozenges
Antibiotic Medication:
Cephalosporins in Antibiotic Therapy: Cephalosporins
are ß- lactam antibiotics similar to penicillins.
Mechanism of action:
- Bactericidal action by preventing the cell wall synthesis.
- Similar to penicillins in their mode of action but they treat a broader range of bacterial
infections.
- They have structural similarities to penicillins and many people with allergies to penicillins
may also have allergic reactions to Cephalosporins.
Oral cephalosporins are well tolerated by most children.
Spectrum Of Activity:
| CLASSIFICATION |
SPECTRUM |
| I Generation : Cefazolin, Cephalexin, Cefadroxil, Cephradine |
Good activity against Gram +ve organisms; modest against Gram –ve
organisms. Streptococci (except Penicillinase resistant), Staphylococci (except Methicillin
resistant strain) |
| II Generation:Cefuroxime, Cefoxitin, Cefprozil, Cefaclor, Cefuroxime
axetil, Loracarbef, Cefotetan, Cefranide |
Improved activity against Gram –ve but much less active than III
generation cephalosporins. Gram –ve organisms Enterococcus, Klebsiella, Haemophilus influenza;
Not active against Gram +ve as I generation. |
| III Generation: Cefotaxime, Cefpodoxime, Ceftibuten, Cefdinir,
Ceftriaxone, Ceftizoxime, Cefoperazone, Ceftazidime |
Less active against Gram +ve than I generation. More active against
Enterobacteriaceae including ß lactamase producing bacteria. |
| IV generation: Cefepime, Cefpirome |
Extended spectrum of activity than III generation cephalosporins and have
increased stability against hydrolysis by ß-lactamases |
The efficacy of these newer oral cephalosporins in treating common
infections has been well established.
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Analgesics and Antipyretics:
Fever is treated variedly by the pediatricians.
Pediatricians majorly prefer paracetamol in order to lower the temperature by inhibiting the
prostaglandin synthesis.
- Paracetamol is considered the safest of all the antipyretic drugs. It is recommended that a
combination of physical therapy such as tepid sponging and paracetamol is best way of
controlling temperature.
Fever in many cases mostly associated with pain. Fever and pain are the most
common issues in the pediatric patient management.
- Acetaminophen, aspirin, and dipyrone are the most commonly used drugs for fever and pain
relief and are equivalent in their efficacy.
- The salicylates have anti-inflammatory effects making them appropriate for the treatment of
patients with juvenile rheumatoid arthritis, but they are gastric irritants, may impair
clotting, and, because of saturable kinetics, may lead to accumulation and toxicity.
- Acetaminophen is an effective antipyretic and analgesic with few side effects that is
toxic only in massive overdose.
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Antitussives:
Cough is a most common symptom among pediatric patients that can be self-limiting or persistent.
Cough can be classified based on the seviority as, Acute cough and Chronic Cough. Suppression of cough
may be disease-specific or symptom-related.
- Acute cough: There has been a long tradition in acute cough usually due to upper respiratory
tract infections to use symptom-related antitussives.
- Chronic Cough: In chronic cough, suppression of cough may be achieved by disease-specific
therapies, but in many patients it may be necessary to use symptomatic antitussives.
- The efficacy of some over-the-counter symptomatic antitussives is often no better than
that of a placebo.
- Patients with chronic cough need effective antitussives that could be used either on
demand or on a long-term basis.
Other than the conventional anticough medications, there are various complementary
and alternative medicines (CAMs) available for the treatment of cough and of the conditions associated
particularly asthma and upper respiratory tract infections.
These Complementary and Alternative medicines work by various mechanisms mainly:
- Peripherally, at the sites in the airways and lungs at which cough is being activated,
- In the brainstem, where the neural "cough center" is situated, or
- At the cerebral cortex, where cough can be initiated, suppressed or modified by conscious or
unconscious controls.
Many herbal extracts are known to show a true Antitussives action. Of nonherbal treatments, the few drugs such as Bromhexine, and strong opoidal analgesics have shown effective antitussive action.
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Multivitamins and Iron Supplements:
Anemia is a most commonly encountered condition among malnourished children.
Multiple causes are known to exist, but with a thorough history, a physical examination and limited
laboratory evaluation a specific diagnosis can usually be established.
The use of the mean corpuscular volume to classify the anemia as microcytic, normocytic or macrocytic
is a standard diagnostic approach.
The most common form of microcytic anemia is iron deficiency caused by reduced dietary intake.
- Treatment involves improvement in dietary habits, taking multivitamins, iron supplements or
increasing consumption of Vitamin C which facilitates Iron absorption from other sources.
Other than Iron deficiency, Vitamin D deficiency is also observed in children.
It is observed that breast feeding a child with increased pigmentation for at least 12 months and
direct sunshine exposure does not completely satisfy their vitamin D requirement because melanin
completes within 7-dehydrocholestrol, thus decreasing vitamin D synthesis.
- Vitamin D supplement should be administered to all exclusively or predominantly breast-feed
infants to prevent rickets.
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Our Major Pediatric Medications:
TOZEF: 125 mg Granules for Oral Suspension
Superior action in common bacterial infections
Generic: Cefuroxime Axetil 125 mg For Oral Suspension USP
Cefuroxime Axetil: An orally administered second generation cephalosporin
with a broad spectrum of activity against several Gram-positive and Gram-negative organisms.
Indications: Cefuroxime Axetil for Oral Suspension is indicated for the
treatment of pediatric patients 3 months to 12 years of age with mild to moderate infections caused
by susceptible strains of the designated microorganisms.
- Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
- Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae
(including beta-lactamase-producing strains), Moraxella catarrhalis (including
beta-lactamase-producing strains), or Streptococcus pyogenes.
- Impetigo caused by Staphylococcus aureus (including beta-lactamase-producing strains) or
Streptococcus pyogenes.
Spectrum of activity of Cefuroxime axetil
Aerobic Gram-positive Microorganisms:
Staphylococcus aureus
(including beta-lactamase–producing strains)
Streptococcus pneumoniae
Streptococcus pyogenes
Aerobic Gram-negative Microorganisms:
Escherichia coli
Haemophilus influenzae (including beta-lactamase-producing strains)
Haemophilus parainfluenzae
Klebsiella pneumoniae
Moraxella catarrhalis (including beta-lactamase-producing strains)
Neisseria gonorrhoeae (including beta-lactamase-producing strains)
Spirochetes: Borrelia burgdorferi.
Mechanism of action: Cefuroxime inhibits penicillin-binding proteins (PBPs),
which inturn, results in bacterial elongation and leakage, and eventually leads to cell death.
Dosage and administration: Cefuroxime Axetil for Oral Suspension may be
administered to pediatric patients ranging in age from 3 months to 12 years, according to dosages
in Table:
(Tozef Must be administered with food. Shake well each time before using.)
| Cefuroxime Axetil for Oral
Suspension |
| Population/Infection |
Dosage |
Daily Maximum Dose |
Daily Maximum Dose |
| Pediatric Patients (3 months
to 12 years) |
| Pharyngitis/tonsillitis |
20 mg/kg/day divided b.i.d. |
500 mg |
10 |
| Acute otitis media |
30 mg/kg/day divided b.i.d. |
1,000 mg |
10 |
| Acute bacterial maxillary sinusitis |
30 mg/kg/day divided b.i.d. |
1,000 mg |
10 |
| Impetigo |
30 mg/kg/day divided b.i.d. |
1,000 mg |
10 |
Dosage in Special population.
Patients With Renal Failure: The safety and efficacy of cefuroxime axetil in
patients with renal failure have not been established. Since cefuroxime is renally eliminated, its
half-life will be prolonged in patients with renal failure.
Adverse effects: The following side effects have been reported with the use
of Cefuroxime Axetil.
- General: The following hypersensitivity reactions have been reported:
anaphylaxis, angioedema, pruritus, rash, serum sickness-like reaction, and urticaria.
- Gastrointestinal: Pseudomembranous colitis.
- Hematologic: Hemolytic anemia, leukopenia, pancytopenia, and
thrombocytopenia.
- Hepatobiliary Tract and Pancreas: Hepatic impairment including
hepatitis and cholestasis, jaundice.
- Neurologic: Seizure.
- Skin: Erythema multiforme, Stevens-Johnson syndrome, and toxic
epidermal necrolysis.
- Urologic: Renal dysfunction.
Overdoses and its treatment:Overdosage of cephalosporins can cause cerebral
irritation leading to convulsions. Serum levels of cefuroxime can be reduced by hemodialysis and
peritoneal dialysis.
Contraindication:Tozef is contraindicated in patients with known allergy to
the cephalosporin group of antibiotics.
Presentation:Tozef is available as 125 mg granules for Oral Suspension in
Sachets.
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FIXMA: 100 mg Granules for Oral suspension
Superior action in urinary tract infection
Generic: Cefixime for oral suspension USP 100 mg
Cefixime:
Most potent and broad spectrum cephalosporins
Stable in the presence of ß-lactamase
Spectrum of activity of Cefixime
Gram positive Organisms:Streptococcus pneumoniae, Streptococcus pyogeness.
Gram negative organisms : Haemophilus influenzae (beta-lactamase positive
and negative strains), moraxella catarrhalis (most of which are beta-lactamase positive),
Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae (including penicillinase-and
non-penicillinase-producing strains).
Indications:
Upper and lower respiratory tract infections: pharnygitis, tonsillitis,
bronchitis, bronchiectasis, secondary infection of chronic respiratory disease, nasosinusitis.
Uncomplicated urinary tract infections: Nephropyelitis, urocytitis,
cholecystitis.
Uncomplicated gonorrhoea: Gonorrheal urethritis.
Scarlet fever, Otitis media.
Mechanism of action: Cefixime inhibits penicillin-binding proteins (PBPs),
which in turn, results in bacterial elongation and leakage, and eventually leads to cell death.
Dosage and administration:
Route of Administration: Oral
Absorption of Cefixime is not significantly modified by the presence of food. The usual course of treatment is 7 days. This may be continued for up to 14 days if required.
Adults and Children over 10 Years: The recommended adult dosage is 200-400
mg daily according to the severity of infection, given either as a single dose or in two divided
doses.
The Elderly: Elderly patients may be given the same dose as recommended
for adults. Renal function should be assessed and dosage should be adjusted in severe renal
impairment.
Children (Use Pediatric Oral Suspension): The recommended dosage for children is 8 mg/kg/day administered as a single dose or in two divided doses. As a general guide for prescribing in children the following daily doses in terms of volume of Pediatric Oral Suspension are suggested:
6 months up to 1 year: 3.75 ml daily
Children 1-4 years: 5 ml daily
Children 5-10 years: 10 ml daily
Children weighing more than 50 kg or older than 10 years, should be treated with the recommended
adult dose (200 - 400 mg daily depending on the severity of infection).
The safety and efficacy of cefixime has not been established in children less than 6 months.
Dosage In Renal Impairment: Cefixime may be administered in the presence
of impaired renal function. Normal dose and schedule may be given in patients with creatinine
clearances of 20 ml/min or greater. In patients whose creatinine clearance is less than 20
ml/min, it is recommended that a dose of 200 mg once daily should not be exceeded. The dose
and regimen for patients who are maintained on chronic ambulatory peritoneal dialysis or
haemodialysis should follow the same recommendation as that for patients with creatinine
clearances of less than 20 ml/min.
Dosage in Special population:
There are no adequate and well controlled studies in pregnant women. Cefixime should therefore]
not be used in pregnancy or in nursing mothers unless considered essential by the physician.
Adverse Effects:
- Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical
trials were mild and self-limiting in nature.
- Gastrointestinal Disturbances: The most frequent side effects seen with cefixime are diarrhoea
and stool changes; diarrhoea has been more commonly associated with higher doses. Some cases of
moderate to severe diarrhoea have been reported; this has occasionally warranted cessation of
therapy. Cefixime should be discontinued if marked diarrhoea occurs. Other gastrointestinal side
effects seen less frequently are nausea, abdominal pain, dyspepsia, vomiting and flatulence.
Pseudomembranous colitis has been reported.
- Central Nervous System: Headache and dizziness.
- Hypersensitivity Reactions: Allergies in the form of rash, pruritus, urticaria, drug fever and
arthralgia have been observed. These reactions usually subsided upon discontinuation of therapy.
Rarely, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis have been
reported.
Contraindication: Fixma is contra-indicated in patients with known allergy
to the cephalosporin group of antibiotics.
Presentation: Fixma is available as 100 mg granules for Oral Suspension
in sachet, Box of 10 sachets.
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BACCEF: Cefixime and Lactobacillus Spores For Oral Suspension
Superior action in urinary tract and respiratory tract infections.
Contents:
Each Sachet contains:
Cefixime Trihydrate USP eq. to
Cefixime 100 mg
Lactobacillus Acidophilus eq. to
Lactic Acid Bacillus 40 million spores
Baccef: Compared to other cephalosporins, bactericidal action of cefixime
results from inhibition of cell-wall synthesis. Cefixime is highly stable in presence of
beta-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins
due to the presence of beta-lactamase, may be susceptible to cefixime.
Indications: BACCEF is indicated for the treatment of the following
infections when caused by susceptible micro-organisms:
- Upper and lower respiratory tract infections: pharnygitis, tonsillitis, bronchitis,
bronchiectasis, secondary infection of chronic respiratory disease, nasosinusitis.
- Uncomplicated urinary tract infections: Nephropyelitis, urocytitis, cholecystitis.
- Uncomplicated gonorrhoea : Gonorrheal urethritis.
- Scarlet fever, Otitis media.
Spectrum of activity of Baccef
Gram positive Organisms: Streptococcus pneumoniae, Streptococcus pyogenes.
Gram –negative organisms : Haemophilus influenzae (beta-lactamase positive and
negative strains), moraxella catarrhalis (most of which are beta-lactamase positive), Escherichia
coli, Proteus mirabilis, Neisseria gonorrhoeae (including penicillinase-and non-penicillinase
-producing strains).
Mechanism of action: Cefixime inhibits penicillin-binding proteins (PBPs),
which in turn, results in bacterial elongation and leakage, and eventually leads to cell death.
Lactobacillus acidophilus therapy in the prevention and adjuvant therapy of certain infectious
diseases especially gastrointestinal disorders in children and adults is advocated in many parts of
the world. The recent emphasis on supplementation with lactobacilli is largely attributed to
information obtained regarding the beneficial effects of lactobacilli in preventing or minimizing
the severity of antibiotic associated diarrhoeal episodes.Most probiotics have been designated as
'generally recognised as safe'(GRAS).
Dosage and administration:
Route of Administration: Oral
Adults and Children over 10 Years: The recommended adult dosage is 200-400
mg daily according to the severity of infection, given either as a single dose or in two divided
doses.
The Elderly: Elderly patients may be given the same dose as recommended
for adults. Renal function should be assessed and dosage should be adjusted in severe renal
impairment.
Children (Use Paediatric Oral Suspension): The recommended dosage for
children is 8 mg/kg/day administered as a single dose or in two divided doses. As a general guide
for prescribing in children the following daily doses in terms of volume of Paediatric Oral
Suspension are suggested:
6 months up to 1 year: 3.75 ml daily
Children 1-4 years: 5 ml daily
Children 5-10 years: 10 ml daily
Children weighing more than 50 kg or older than 10 years should be treated with the recommended
adult dose (200 - 400 mg daily depending on the severity of infection).
The safety and efficacy of cefixime has not been established in children less than 6 months.
Dosage In Renal Impairment: BACCEF may be administered in the presence of
impaired renal function. Normal dose and schedule may be given in patients with creatinine
clearances of 20 ml/min or greater. In patients whose creatinine clearance is less than 20
ml/min, it is recommended that a dose of 200 mg once daily should not be exceeded. The dose and
regimen for patients who are maintained on chronic ambulatory peritoneal dialysis or
haemodialysis should follow the same recommendation as that for patients with creatinine
clearances of less than 20 ml/min.
Adverse Effects: Cefixime is generally well tolerated. The majority of
adverse reactions observed in clinical trials were mild and self-limiting in nature.
Gastrointestinal Disturbances: The most frequent side effects seen
with cefixime are diarrhoea and stool changes; diarrhoea has been more commonly associated with
higher doses. Some cases of moderate to severe diarrhoea have been reported; this has
occasionally warranted cessation of therapy. Cefixime should be discontinued if marked
diarrhoea occurs. Other gastrointestinal side effects seen less frequently are nausea,
abdominal pain, dyspepsia, vomiting and flatulence. Pseudomembranous colitis has been
reported.
Central Nervous System: Headache and dizziness.
Hypersensitivity Reactions: Allergies in the form of rash, pruritus,
urticaria, drug fever and arthralgia have been observed. These reactions usually subsided
upon discontinuation of therapy. Rarely, erythema multiforme, Stevens-Johnson syndrome and
toxic epidermal necrolysis have been reported.
Contraindication: BACCEF is contra-indicated in patients with
known allergy to the cephalosporin group of antibiotics.
Presentation:Baccef is available as 100mg granules for oral
suspension in sachet, Box of 10 sachets.
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