Human Health Division (HHD) Products
Product List by Brand Name
Torcox
COMPOSITION
Torcox™ 60 Tablet : Each film coated tablet contains Etoricoxib INN 60 mg.
Torcox™ 90 Tablet : Each film coated tablet contains Etoricoxib INN 90 mg.
Torcox™ 120 Tablet : Each film coated tablet contains Etoricoxib INN 120 mg.
INDICATION
Torcox™ (Etoricoxib) is indicated for relief of pain and inflammation in -• Osteoarthritis
• Rheumatoid arthritis
• Ankylosing spondylitis
• Other chronic musculoskeletal disorders
• Acute gout
• Primary dysmenorrhoea &
• Dental pain
DOSE AND ADMINISTRATION
Pain and inflammation in Osteoarthritis:
• Child 16-17 years: 30 mg once daily, increased if necessary to 60 mg once daily
• Adult: 30 mg once daily, increased if necessary to 60 mg once daily. Pain and inflammation in rheumatoid arthritis & Ankylosing spondylitis:
• Child 16-17 years: 60 mg once daily, increased if necessary to 90 mg once daily.
Adult: 60 mg once daily, increased if necessary to 90 mg once daily.
Acute gout:
• Child 16-17 years: 120 mg once daily for maximum 8 days
• Adult: 120 mg once daily for maximum 8 days
Dental pain:
• 90-120 mg once daily for maximum 8 days.
Primary dysmenorrhoea
• 120 mg once daily for maximum 8 days
or as directed by the physician
Trizin
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.
Toma
Composition
Toma™ Tablet: Each tablet contains Ketotifen Fumarate BP equivalent to 1 mg Ketotifen.
Toma™ Syrup: Each 5 ml syrup contains Ketotifen Fumarate BP equivalent to 1mg Ketotifen
Indication
• Prophylactic treatment of bronchial asthma.
• Allergic rhinitis ( seasonal and perennial).
• Allergic conjunctivitis.
• Allergic conditions such as hay fever, itchy rash.
Dose & Administration
Adult: 1 mg twice daily with food. If necessary the dose may be increased to 2mg twice daily in severe cases.
Children above 2 years: 1 mg twice daily with food.
From 6 month to 2 years: 0.05 mg (0.25 ml) per kg of body weight twice daily.
Use in elderly: Same as adult dose.
Missed dose: If a dose is missed, should be taken as soon as possible. If it is almost time for the next dose, skip the missed dose and the regular dosing schedule should be maintained. Dose should not be doubled in case of a missed dose.
Patient's known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician
Tabis Plus
Composition:
Tabis™ Plus 2.5 Tablet: Each film coated tablet contains Bisoprolol Fumarate USP 2.5 mg and Hydrochlorothiazide BP 6.25 mg.
Tabis™ Plus 5 Tablet: Each film coated tablet contains Bisoprolol Fumarate USP 5 mg and Hydrochlorothiazide BP 6.25 mg.
Indication:
Tabis™ Plus is indicated for the management of hypertension.
Dose & Administration:
The initial dose is 2.5/6.25 mg once daily. Subsequent titration (14 day intervals) may be carried out with Tabis™ Plus tablets up to the maximum recommended dose
20/12.5 mg once daily as appropriate.
Tabis
Composition
Tabis™ 2.5 Tablet: Each film coated tablet contains Bisoprolol Fumarate USP 2.5 mg.
Tabis™ 5 Tablet: Each film coated tablet contains Bisoprolol Fumarate USP 5 mg
Indications
• Hypertension
• Angina
• Adjunct in stable moderate to severe heart failure.
Dose & Administration
Hypertension: The dose of Bisoprolol must be individualized to the needs of the patient. The usual starting dose is 5 mg once daily. In some patients, 2.5 mg may be an appropriate starting dose. If the antihypertensive effect of 5 mg is inadequate, the dose may be increased to 10 mg and then, if
necessary, to 20 mg once daily.
Angina: Usually 10 mg once daily (5 mg may be adequate in some patients) max 20 mg daily.
Heart Failure: Initially 1.25 mg once daily (in the morning) for 1 week then, if well tolerated, increased to 2.5 mg once daily for 1 week, then 3.75 mg once daily for 1 week, then 5 mg once daily for 4 weeks, then 7.5 mg once daily for 4 weeks, then 10 mg once daily, max 10 mg daily.
Or as directed by the physician
Topcef
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.
