Human Health Division (HHD) Products
Product List by Generic Name
Clascoterone
Composition:
Clascon cream: Each gram cream contains Clascoterone INN 10 mg.
Indication:
Clascon cream is indicated for the topical treatment of acne vulgaris in patients of 12 years of age and older.
Dose & Administration:
Clean the affected area gently then apply a thin uniform layer of Clascon cream twice per day in the morning and evening to the affected area. Avoid accidental transfer of Clascon cream into eyes, mouth or other mucous membranes. If contact with mucous membranes occurs, this should be rinsed thoroughly with water or as directed by the physician.
Calcium (Coral) + Vitamin D3
Composition:
Kindical™-D Tablet: Each film coated tablet contains Calcium Carbonate (derived from coral source) USP 1250 mg equivalent to elemental Calcium 500 mg and Vitamin D3 200 IU as Cholecalciferol USP.
Kindical™-DX Tablet: Each film coated tablet contains Calcium Carbonate (derived from coral source) USP 1500 mg equivalent to elemental Calcium 600 mg and Vitamin D3 400 IU as Cholecalciferol USP
Indication:
Kindical™-D & Kindical™-DX are indicated for the treatment & prevention of osteoporosis, osteomalacia, tetany, hypoparathyroidism, disorders of osteogenesis. Also used as supplement in case of inadequate intake of Calcium in childhood diet, rickets, pregnancy and lactation, elderly patients. Other indications include pancreatitis, phosphate binder in chronic renal failure etc.
Dose & Administration:
One tablet once or twice daily with plenty of water or as directed by the physician. Taking in full stomach ensures better absorption or as directed by the physician.
Clonazepam
Composition
Conpan ODT 0.5 : Each orally disintegrating tablet contains Clonazepam USP 0.5 mg.
Conpan ODT 1 : Each orally disintegrating tablet contains Clonazepam USP 1 mg.
Conpan ODT 2 : Each orally disintegrating tablet contains Clonazepam USP 2 mg.
Indications
Clonazepam is indicated in all forms of epilepsy, status epilepticus, infantile spasms,
myoclonic seizures, akinetic and atonic seizures, partial seizures, bipolar affective
disorder, panic attacks etc.
Dose & Administration
The standard dose of clonazepam must be individually adjusted according to the patient's
clinical response and tolerance of the drug. As a general rule, Clonazepam is started with
low single dose in a new patient. Adults: 1mg (elderly, 0.5 mg), initially at night for 4
nights, increased according to response over 2-4 weeks to usual maintenance dose of 4-8
mg which is usually given at night as a single dose or may be given in 3-4 divided doses if
necessary. Children: Up to 1 year, initially 0.25 mg, increased as above to usual
maintenance dose of 0.5-1 mg, 1-5 years initially 0.25 mg, increased as above to 1-3 mg,
5-12 years, initially 0.5 mg, increased as above to 3-6 mg.
Direction for administration of Conpan Orally Disintegrating Tablet:
This tablet must be handled with dry hand. The tablet to be placed on tongue and let it be
dissolved. It should not be chewed, broken, or crushed. Like other conventional oral
tablets, it also can be swallowed with a glass of water or as directed by the physician.
Clonidine
Composition
Clonipres™ 0.1 Tablet: Each tablet contains Clonidine Hydrochloride USP 0.1 mg.
Indication
Clonidine is indicated in the treatment of hypertension. It may be employed alone or
concomitantly with other anti-hypertensive agents.
Other uses include:
i) Menopausal flushing
ii) Attention deficit hyperactivity disorder
iii) Opioid withdrawal & Alcohol withdrawal syndrome
iv) Tourette's syndrome
Dosage & Administration
Adult: The dose of Clonidine must be adjusted according to the patient's individual blood
pressure response.
Initial dose: 0.1 mg twice a day (morning & bed time). Elderly patients may be benefited
from a lower initial dose.
Maintenance dose: Further increments of 0.1 mg per day may be made at weekly
intervals if necessary, until the desired result is achieved. The therapeutic dose most
commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses.
In renal impairment, dose of Clonidine Hydrochloride must be adjusted according to the
degree of impairment & patient should be monitored carefully.
Menopausalflushing :0.1 mg to 0.4 mg daily
Attention deficit hyperactivity disorder :5 mcg/kg/day for 8 weeks
Alcohol withdrawal :0.3 to 0.6 mg every 6 hourly
Tourette's syndrome / 0.15 mg to 0.2 mg daily or as directed by the physician
Cefaclor
Composition:
Navacef™ 250 Capsule: Each capsule contains Cefaclor Monohydrate USP equivalent to 250 mg of Cefaclor.
Navacef™ 500 Capsule: Each capsule contains Cefaclor Monohydrate USP equivalent to 500 mg of Cefaclor.
Navacef™ PFS (100 ml): Each 5 ml contains Cefaclor Monohydrate USP equivalent to 125 mg of Cefaclor.
Navacef™ PFS (60 ml): Each 5 ml contains Cefaclor Monohydrate USP equivalent to 125 mg of Cefaclor.
Navacef™ Paediatric Drops (15 ml): Each 1.25 ml contains Cefaclor Monohydrate USP equivalent to 125 mg of Cefaclor
Indication
Respiratory Tract Infections: Pneumonia, bronchitis, pharyngitis, tonsillitis, otitis media.
Uninary Tract Infections: Pylonephritis, cystitis etc.
Skin & Soft Tissue Infections: Impetigo, pyodema, cellulitis, pruritis etc.
Dosage & Administration
Adults: 250 mg three times daily (Dose should be doubled in severe cases, max. 4 g daily). Children
over 1 month: 20 mg/kg/ day in three divided doses (Dose should be doubled in severe cases, max 1
g daily). 1-5 years: 125 mg three times daily, over 5 years: 250 mg three times daily, (Dose should be
doubled in severe cases), or as directed by the physician.
Cefuroxime
Composition
Fixcef 250 Tablet: Each film coated tablet contains Cefuroxime Axetil BP equivalent to Cefuroxime 250 mg.
Fixcef™ 500 Tablet: Each film coated tablet contains Cefuroxime Axetil BP equivalent to Cefuroxime 500 mg.
Indication
Pharyngitis/tonsillitis, Acute bacterial otitis media, Acute bacterial maxillary sinusitis.
Acute bacterial exacerbations of chronic bronchitis and secondary bacterial infection of acute bronchitis,
Uncomplicated skin and skin-structure infections, Uncomplicated urinary tract infections,
Uncomplicated gonorrhoea (urethral and endocervical), Early lyme disease (erythema migrans).
Dosage & Administration
For oral administration
Fixcef™ Plus Tablet: The usual course of therapy with Cefuroxime-Clavulanic acid tablets is 5 to 7 days for treatment of
bronchitis and 7 to 10 days for other infections. Adolescents andAdults (13 years and older)
Cefuroxime + Clavulanic Acid
Composition
Fixcef Plus 250 Tablet: Each film coated tablet contains Cefuroxime Axetil BP equivalent to Cefuroxime 250 mg and Diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 62.5 mg.
Fixcef™ Plus 500 Tablet: Each film coated tablet contains Cefuroxime Axetil BP equivalent to Cefuroxime 500 mg and Diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 125 mg.
Indication
Pharyngitis/tonsillitis, Acute bacterial otitis media, Acute bacterial maxillary sinusitis.
Acute bacterial exacerbations of chronic bronchitis and secondary bacterial infection of acute bronchitis, Uncomplicated skin and skin-structure infections, Uncomplicated urinary tract infections, Uncomplicated gonorrhoea (urethral and endocervical), Early
lyme disease (erythema migrans).
Dosage & Administration
For oral administration
Fixcef™ Plus Tablet: The usual course of therapy with Cefuroxime-Clavulanic acid tablets is 5 to 7 days for treatment of bronchitis and 7 to 10 days for other infections. Adolescents andAdults (13 years and older)
Chloramphenicol + Dexamethasone
Composition
Stedex -C Sterile Eye/Ear Drops: Each ml drops contains
Chloramphenicol BP 5 mg & Dexamethasone Phosphate USP 1 mg..
Indications
Eye: For steroid-responsive inflammatory ocular condition for which a corticosteriod is indicated and where bacterial infection or a risk of bacterial ocular infection exists. For inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the
globe where the inherent risk of steroid use in certain infective conjunctivitis is accepted to obtain a diminution in edema and inflammation. For chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.
Ear: Otitis externa, Otitis media and chronic suppurative otitis media.
Dosage & Administration
Eye: 1 or 2 drops is instilled into the affected eyes every 3 or 4 hours, or more frequently if deemed advisable by the prescribing physician.
Administration should be continued day and night for the first 48 hours, after which the interval between applications may be increased. Treatment should be continued for at least 48 hours after the eye appears normal or as directed by the physician.
Ear: For all infections two to three drops every two to three hours initially. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely or as directed by the physician.
Cetrizine
Composition:
Trizin™ Sterile Eye Drops: Each ml contains Cetirizine
Dihydrochloride BP equivalent to Cetirizine 2.40 mg.
Preservative: Sodium Perborate BP 0.001%.
Indications:
Trizin™ Sterile Eye Drop is indicated for the treatment of
ocular itching associated with allergic conjunctivitis.
Dosage and administration:
The recommended dosage of Trizin™ Sterile Eye Drop is
to instill one drop in each affected eye twice daily
(approximately 8 hours apart) or directed by the
physician.
Carboxymethylcellulose
Presentation
Cfresh™ Liquigel: Each ml Sterile lubricant eye drops
contain Carboxymethylcellulose Sodium USP 10 mg.
Preservative: Sodium Perborate 0.001%
Indications
It is indicated for use as a lubricant in dry eye
(keratoconjunctivitis sicca) including relief of burning,
irritation and/or discomfort due to dryness of the eye.
Dosage and Application
Instill 1 or 2 drops in the affected eye(s) or as directed by the physician.
Clopidogrel + Aspirin
Composition:
Navix™ Plus Tablet: Each film coated tablet contains Clopidogrel Bisulfate USP equivalent to Clopidogrel 75 mg and Aspirin BP 75 mg.
Indication:
The preparation is used for the prevention of ischemic events, myocardial infarction, stroke and cardiovascular death in patients with acute coronary syndrome.
Dosage & Administration:
The recommended dose is once daily or as directed by the physician.
Clopidogrel
Composition:
Navix™ Tablet: Each film coated tablet contains Clopidogrel Bisulfate USP equivalent to 75 mg Clopidogrel.
Indication:
Clopidogrel is indicated for the reduction of atherosclerotic events (myocardial infarction, stroke and vascular death) and in patient with atherosclerosis documented recent stroke, recent myocardial infarction or established peripheral arterial disease (PAD).
Dosage & Administration:
The recommended dose of Clopidogrel is 75 mg once daily with or without food. No dosage adjustment is required for elderly patients or patients with renal disease or as directed by the physician.
Ceftriaxone
Composition
Topcef™ 250 mg IM Injection: Each vial contains dry substance
equivalent to 250 mg Ceftriaxone (as sterile Ceftriaxone Sodium BP)
with 2 ml Lidocaine Hydrochloride BP 1% Injection.
Topcef™ 500 mg IM/IV Injection: Each vial contains dry substance
equivalent to 500 mg Ceftriaxone (as sterile Ceftriaxone Sodium BP)
with 2 ml Lidocaine Hydrochloride BP 1% Injection for IM injection or 5
ml Water for Injection BP for IV injection.
Topcef™ 1 g IM/IV Injection: Each vial contains dry substance
equivalent to 1 g Ceftriaxone (as sterile Ceftriaxone Sodium BP) with
3.5 ml Lidocaine Hydrochloride BP 1% Injection for IM injection or 10
ml Water for Injection BP for IV injection.
Topcef™ 2 g IV Injection: Each vial contains dry substance equivalent
to 2 g Ceftriaxone (as sterile Ceftriaxone Sodium BP) accompanied by
2 ampoules each contains 10 ml water for injection.
Pharmacology
Ceftriaxone is a broad-spectrum cephalosporin for intravenous or
intramuscular administration. Ceftriaxone is not absorbed after oral
application. Ceftriaxone has bactericidal activity that results from the
inhibition of bacterial cell wall synthesis. Ceftriaxone has a high degree
of stability in the presence of (S-lactamases produced by Gram-negative
and Gram-positive bacteria.
Indication
Topcef™ is indicated in sepsis, meningitis, neurosyphillis, abdominal
infections (peritonitis, infections of the biliary and gastrointestinal
tracts), infections of the bones, joints, soft tissue, skin and of wounds,
renal and urinary tract infections, respiratory tract infections, ear, nose
and throat infections, genital infections, including gonorrhoea,
perioperative prophylaxis of infections.
Dose and Administration
Adults and children over 12 years: The usual dose is 1-2 g of Topcef™
once daily (every 24 h). In severe cases, the dose may be raised to 4 g
once daily. Neonates, infants and children up to 12 years: Neonates
(up to 14 days): A daily dose of 20-50 mg/kg body weight, not to
exceed 50 mg/kg. Infants and children (15 days to 12 years): A daily
dose of 20-80 mg/kg. For children with body weights of 50 kg or more,
the usual adult dose should be used. Elderly patients: The dosage
recommended for adults require no modification in case of geriatric
patients. Duration of therapy: The usual duration of therapy is 4 to 14
days; in complicated infections, longer therapy may be required. When
treating infections caused by Streptococcus pyogenes, therapy should
be continued for at least 10 days. Meningitis: In bacterial meningitis in
infants and children, treatment begins with dose of 100 mg/kg (not to
exceed 4 g) once daily. Gonorrhoea: a single IM dose of 250 mg
Topcef™ is recommended. Perioperative prophylaxis: a single dose of
1-2 g depending on the risk of infection of 30-90 minutes prior to
surgery. In colorectal surgery, administration of Topcef™ with or without
a 5-nitroimidazole, e.g. Omidazole, has been proven effective.
Impaired renal and hepatic function: In patients with impaired renal
function, there is no need to reduce the dosage of Topcef™ provided
hepatic function is intact. In patients with liver damage, there is no
need for the dosage to be reduced provided renal function is intact Or
as directed by the physician.
Directions for use
IM Injection: For IM injection, Topcef™ 250 mg or 500 mg is dissolved
in 2 ml of 1% Lidocaine solution or 1 g Topcef™ in 3.5 ml of Lidocaine
1% solution and administered by deep intragluteal injection. It is
recommended that not more than 1 g be injected at one site. The
Lidocaine solution must never be administered intravenously. IV
Injection: For IV injection, Topcef™ 500 mg is dissolved in 5 ml,
Topcef™ 1 g in 10 ml & Topcef™ 2 g in 20 ml of sterile Water for
Injection. Verify sensitivity with test dose before administering injection.
The injection should be administered over 2-4 minutes, directly into the
vein or via the tubing of an intravenous infusion.
Contraindication
Ceftriaxone is contraindicated in patients with known allergy to the
cephalosporin class of antibiotics.
Warning & Precaution
Ceftriaxone is excreted via both biliary and renal route. Patients with
renal failure normally require no adjustment in dosage when usual
doses of Ceftriaxone is administered but concentrations of drug in the
serum should be monitored periodically. If evidence of accumulation
exists, dosage should be decreased accordingly. Although transient
elevations in BUN and serum creatinine have been observed at
recommended dosage nephrotoxic potential of Ceftriaxone is similar to
that of other cephalosporins. Dosage adjustments should not be
necessary in patients with hepatic dysfunction; however, in patients
with both hepatic dysfunction and significant renal disease, Ceftriaxone
dosage should not exceed 2 gm daily without close monitoring of
serum concentrations. If superinfection occurs during therapy,
appropriate measures should be taken. Ceftriaxone should be
prescribed with caution with a history of gastrointestinal disease,
especially colitis.
Before administration of Ceftriaxone to patient, tolerability test should
be done with test dose and administration should be continued for 2 to
4 minutes.
Side Effects
Systemic side effects- Convulsion, Diarrhoea, nausea, vomiting,
stomatitis and glossitis, eosinophilia, leukopenia, granulocytopenia,
hemolytic anemia, thrombocytopenia, exanthema, allergic dermatitis,
pruritus, urticaria, edema, erythema multiforme, headache and
dizziness, increase in liver enzymes, gallbladder sludge, oliguria,
increase in serum creatinine, mycosis of the genital tract, shivering and
anaphylactic or anaphylactoid reactions. Pseudomembranous
enterocolitis and coagulation disorders have been reported as very rare
side effects. Local side effects- In rare cases, phlebitic reactions
occurred after IV administration. These may be minimized by slow (two
to four minutes) injection. Intramuscular injection without Lidocaine
solution is painful.
Use in Pregnancy and Lactation
Pregnancy: The safety of Ceftriaxone in the treatment of infections
during pregnancy has not been established. It should only be used
during pregnancy if the likely benefit out weighs the potential risk.
Lactation: Ceftriaxone is excreted in breast milk at low concentrations.
Caution should be exercised when Ceftriaxone is administered to a
nursing mother.
Use in Children & Adolescents
In vitro studies have shown that Ceftriaxone, like some other
cephalosporins, can displace bilirubin from serum albumin. Ceftriaxone
should not be administered to hyperbilirubinemic neonates, especially
prematures.
Drug Interaction
Two in vitro studies, one using adult plasma and the other neonatal
plasma from umbilical cord blood have been carried out to assess
interaction of ceftriaxone and calcium. Ceftriaxone concentrations up to
1mM (in excess of concentrations achieved in vivo following
administration of 2 grams ceftriaxone infused over 30 minutes) were
used in combination with calcium concentrations up to 12 mM (48
mg/dL). Recovery of ceftriaxone from plasma was reduced with
calcium concentrations of 6 mM (24 mg/dL) or higher in adult plasma or
4 mM (16 mg/dL) or higher in neonatal plasma. This may be reflective
of ceftriaxone-calcium precipitation.
Overdose
In the case of overdosage, drug concentration would not be reduced by
hemodialysis or peritoneal dialysis. There is no specific antidote.
Treatment of overdosage should be symptomatic.
Storage
Ceftriaxone sterile powder should be stored below 30°C and protected
from light. Reconstituted solutions retain their physical and chemical
stability for 6 hours at room temperature and for 24 hours at 5°C. As a
general rule, however the solutions should be used immediately after
preparation.
Packing
Topcef™' 250 mg IM Injection : Pack of 1 vial containing 250 mg
Ceftriaxone (as sterile Ceftriaxone Sodium BP) accompanied by one
ampoule of 2 ml Lidocaine Hydrochloride BP 1% Injection for IM
injection, a sterile disposable syringe (5 ml) with an alcohol preparation
pad, a strip bandage and a baby needle.
Topcef " 500 mg IV Injection : Pack of 1 vial containing 500 mg
Ceftriaxone (as sterile Ceftriaxone Sodium BP) accompanied by one
ampoule of 5 ml Water for Injection BP for IV injection, a sterile
disposable syringe (5 ml) with an alcohol preparation pad, a vein set
and a strip bandage.
Topcef™' 500 mg IM Injection : Pack of 1 vial containing 500 mg
Ceftriaxone (as sterile Ceftriaxone Sodium BP) accompanied by one
ampoule of 2 ml Lidocaine Hydrochloride BP 1% Injection for IM
injection, a sterile disposable syringe (5 ml) with an alcohol preparation
pad and a strip bandage.
Topcef " 1 g IV Injection : Pack of 1 vial containing 1 g Ceftriaxone
(as sterile Ceftriaxone Sodium BP) accompanied by one ampoule of 10
ml Water for Injection BP for IV injection, a sterile disposable syringe
(10 ml) with an alcohol preparation pad, a vein set and a strip bandage.
Topcef™' 1 g IM Injection : Pack of 1 vial containing 1 g Ceftriaxone
(as sterile Ceftriaxone Sodium BP) accompanied by one ampoule of
3.5 ml Lidocaine Hydrochloride BP 1% Injection for IM injection, a
sterile disposable syringe (5 ml) with an alcohol preparation pad and a
strip bandage.
Topcef™' 2 g IV Injection : Pack of 1 vial containing 2 g Ceftriaxone
(as sterile Ceftriaxone Sodium BP) accompanied by two ampoules of
10 ml Water for Injection BP, a sterile disposable syringe (20 ml) with
vein set, alcohol preparation pad and a strip bandage.
Cefixime
Composition:
Duracef™ 200 Capsule: Each capsule contains Cefixime Trihydrate BP equivalent to Cefixime 200 mg.
Duracef™ 400 Capsule: Each capsule contains Cefixime Trihydrate BP equivalent to Cefixime 400 mg.
Duracef™ 200 Tablet: Each film coated tablet contains Cefixime Trihydrate BP equivalent to Cefixime 200 mg.
Duracef™ DS PFS (50 ml): Each 5 ml reconstituted suspension contains Cefixime Trihydrate BP equivalent to Cefixime 200 mg.
Duracef™ PFS (50 ml): Each 5 ml reconstituted suspension contains Cefixime Trihydrate BP equivalent to Cefixime 100 mg.
Duracef™ PFS (30 ml): Each 5 ml reconstituted suspension contains Cefixime Trihydrate BP equivalent to Cefixime 100 mg.
Duracef™ Paediatric Drops (21 ml): Each ml reconstituted suspension contains Cefixime Trihydrate BP equivalent to Cefixime 25 mg.
Duracef™ Max PFS (10 ml): Each 5 ml reconstituted suspension contains Cefixime Trihydrate BP equivalent to Cefixime 500 mg.
Duracef™ Max PFS (20 ml): Each 5 ml reconstituted suspension contains Cefixime Trihydrate BP equivalent to Cefixime 500 mg.
Indications:
Otitis media- caused by Streptococcus pneumoniae (including Penicillinase resistant strains), Streptococcus pyogenes, Haemophilus influenzae (including beta-lactamase producing strains), Moraxella catarrhalis (including beta-lactamase producing strains). Pharyngitis/Tonsillitis- caused by Streptococcus pyogenes. Uncomplicated Urinary Tract infection- Caused by E. coli, Proteus mirabilis. Uncomplicated Gonorrhoea- Caused by N. gonorrhoeae (including Penicillinase & nonPenicillinase resistant strains).
Dosage and Administration:
Adults: The recommended dose is given as a single dose of 400 mg or 200 mg twice daily for 7-14 days according to the severity of infections. Uncomplicated Gonorrhoea. 400 mg single dose.
Children:
> 6 months: 8 mg /kg/ day in 1-2 divided doses
6 months-1 year: 75 mg daily
1-4 years: 100 mg daily
5-10 years: 200 mg daily
> 10 years: As same as adult dose or as directed by the physician
