Human Health Division (HHD) Products
Product List by Therapeutic
Olmesartan + Amlodipine
Composition
OlmepinTM 20/5 Tablet:Each film coated tablet contains Olmesartan Medoxomil USP 20 mg & Amlodipine Besilate BP equivalent to Amlodipine 5 mg.
Olmepin TM 40/5 Tablet:Each film coated tablet contains Olmesartan Medoxomil USP 40 mg & Amlodipine Besilate BP equivalent to Amlodipine 5 mg.
Indication
OlmepinTM is indicated for the treatment of hypertension, alone or with other antihypertensive agents. OlmepinTM may also be used as initial therapy in patients
who are likely to need multiple antihypertensive agents to achieve their blood pressure goals.
Dose & Administration:
Initial Therapy: The usual starting dose of Olmesartan Medoxomil/Amlodipine Besilate is 20/5 mg one tablet once daily. The dosage can be increased after 1 to 2 weeks of
therapy to a maximum dose of 40/10 mg once daily as needed to control blood pressure. This combination may be taken with or without food. This combination may
be administered with other antihypertensive agents. Initial therapy with this combination products is not recommended in patients >75
years old or with hepatic impairment. Replacement therapy: Olmesartan Medoxomil/Amlodipine Besilate may be substituted for its individually titrated components. When substituting for individual components,
the dose of one or both of the components can be increased if blood pressure control has not been satisfactory.
Add-on Therapy: Olmesartan Medoxomil/Amlodipine Besilate may be used to provide additional blood pressure lowering for patients not adequately controlled with
Amlodipine (or another dihydropyridine Calcium Channel Blocker) alone or with Olmesartan Medoxomil (or another angiotensin II receptor blocker) alone Or as
directed by the physician
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.
Doxofylline
Composition:
Filodox™ SR Tablet : Each sustained release tablet contains Doxofylline INN 400 mg.
Filodox™ 400 Tablet : Each film coated tablet contains Doxofylline INN 400 mg.
Filodox™ 200 Tablet : Each film coated tablet contains Doxofylline INN 200 mg.
Filodox™ 100 ml Syrup : Each 5 ml syrup contains Doxofylline INN 100 mg.
Indications:
Filodox™ (Doxofylline) is used to treat asthma, COPD and bronchospasm.
Dosage and Administration:
Elderly: 200 mg Tablet two or three times daily.
Adults: 400 mg Tablet two or three times daily or as prescribed by physician.
Children 6 years over: 6 mg/ kg body weight two or three times daily.
If daily required dose is Doxofylline 400 mg then Filodox™ SR Tablet to be taken once daily or as directed by the physician.
Empagliflozin + Metformin
Composition
Glifomet Tablet: Each film coated tablet contains Empagliflozin INN 5 mg and Metformin Hydrochloride BP 500 mg.
Indication
Glifomet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type
2 diabetes mellitus when treatment with both Empagliflozin and Metformin Hydrochloride is
inappropriate. Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2
diabetes mellitus and established cardiovascular disease
Dose & Administration
• The starting dose of Glifomet should be based on the patient's current regimen.
• Take twice daily with meals, with gradual dose escalation to reduce the gastrointestinal side effects due to Metformin Hydrochloride.
• The maximum recommended dose is 12.5 mg empagliflozin /1 000 mg metformin hydrochloride twice daily.
• Assess renal function before initiating Glifomet. Do not initiate or continue Glifomet if creatinine levels are greater than or equal to 1.5 mg /dL for males or 1.4 mg /dL for females or if eGFR is below 45 mL /min II.73 m2 or as directed by the physician.
Ozenoxacin
Composition:
Zenocin Cream: Each gram cream contains Ozenoxacin INN 10 mg.
Indication:
Zenocin Cream is indicated for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and paediatric patients 2 months of age and older.
Dose & Administration:
Apply a thin layer of Zenocin cream topically to the affected area twice daily for five days or as directed by the physicians.
Omeprazole
Composition
Ometac™ 20: Each capsule contains Omeprazole BP 20 mg.
Ometac™ 40: Each capsule contains Omeprazole BP 40 mg.
Indications:
It is used for the treatment of oesophageal reflux disease, duodenal and benign gastric ulcer including those complicating NSAID therapy, Zollinger Ellison syndrome.
Dose & Administration:
Reflux Oesophagitis : The usual dose is 20 mg once daily for 4 weeks. For those patients not fully healed after the initial course ,a further 4-8 weeks treatment may require. Or as directed by the physician.
Amorolfine
Composition:
Curafin Cream: Each gram cream contains Amorolfine Hydrochloride BP equivalent to Amorolfine 2.5 mg.
Indication:
Curafin Cream is indicated for the treatment of Tinea pedis (athlete's foot), Tinea cruris, Tinea inguinalis,Tinea corporis,Tinea manuum & Pityriasis versicolor.
Dose & Administration:
To be applied to affected skin areas once daily following cleansing (in the evening).The treatment should be continued without interruption until clinical cure, and for 3 -5 days
thereafter. The required duration of treatment depends on the species of fungi and on the localization of the infection. In general, treatment should be continued for at least two
to three weeks. With foot mycoses, up to six weeks of therapy may be necessary or as directed by the physicians
Metformine
Composition:
NVmet™ 500 Tablet: Each film coated tablet contains Metformin Hydrochloride BP 500 mg.
NVmet™ 850 Tablet: Each film coated tablet contains Metformin Hydrochloride BP 850 mg.
NVmet™ 500 SR Tablet: Each sustained release tablet contains Metformin Hydrochloride BP 500 mg.
Indication:
NVmet™, as monotherapy, is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. NVmet™ is also indicated for use in combination with other agents, that do not result in adequate glycemic control.
Dose and administration:
Diabetes mellitus: Adult and child over 10 years initially 500 mg with breakfast for at least 1 week, then 500 mg with breakfast and evening meal for at least 1
week, then 500 mg with breakfast, lunch and evening meal; usual max. 2 g daily in divided doses.
Polycystic ovary syndrome: initially 500 mg with breakfast for 1 week, then 500 mg with breakfast and evening meal for 1 week, then 1.5-1.7 g daily in 2-3 divided doses or as directed by the physician.
Gliclazide
Composition:
Glix™ 80 Tablet: Each Tablet contains Gliclazide BP 80 mg.
Glix™ 30 MR Tablet: Each modified release tablet contains Gliclazide BP 30 mg.
Glix™ 60 MR Tablet: Each modified release tablet contains Gliclazide BP 60 mg.
Indication:
Indicated for the treatment of Type-2 Diabetes.
Dose & Administration:
Glix™ 80 Tablet: Initially 40-80 mg daily, adjusted according to response, increased if necessary up to 160 mg once daily. Dose to be taken with breakfast, dosage higher than 160 mg to be given in divided doses; maximum 320 mg per day.
Glix™ MR Tablet: Initially 30 mg daily, dose to be taken with breakfast, adjustdose according to response every 4 weeks (after 2 weeks if no decrease in blood glucose); maximum 120 mg per day. Or as directed by the physician.
Linagliptin + Metformin
Composition:
Diplin™ M 500 Tablet: Each film coated tablet contains Linagliptin INN 2.5 mg & Metformin Hydrochloride BP 500 mg.
Indications:
Diplin™ M 500 is a dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide combination product indicated as
an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when
treatment with both Linagliptin and Metformin is appropriate.
Dose & Administration:
The maximum recommended dose is Linagliptin 2.5 mg/Metformin Hydrochloride 1000 mg twice daily Or as directed by the physician.
Linagliptin
Composition:
Diplin™ 5 Tablet: Each film coated tablet contains Linagliptin INN 5 mg
Indication:
Diplin™ is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
Dose & Administration:
The recommended dose of Diplin™ is 5 mg once daily. No dosage adjustment is required for hepatic or kidney impaired patients. Or as directed by the physician.
Nortripline
Composition:
Nortin™ 10 Capsule: Each capsule contains Nortriptyline Hydrochloride BP equivalent to 10 mg Nortriptyline.
Nortin™ 25 Capsule: Each capsule contains Nortriptyline Hydrochloride BP equivalent to 25 mg Nortriptyline.
Indication:
Depressive illness, Panic disorder & Neuropathic pain.
Dosage & administration:
Depression, low dose initially increased as necessary to 75-100 mg daily in divided doses or as a single dose (max. 150 mg daily);
Adolescent and Elderly patient : 30- 50 mg daily in divided doses. Neuropathic pain, initially 10 mg daily at night, gradually increased if
necessary to 75 mg daily; higher doses under specialist supervision. Or as directed by the physician
Flupentixol+ Melitracen
Composition:
Meltix™ Tablet: Each film coated tablet contains Flupentixol
Dihydrochloride BP equivalent to 0.5 mg Flupentixol and Melitracen Hydrochloride INN equivalent to 10 mg Melitracen.
Indications:
It is indicated in various types of anxiety, depression and apathy.
These include-) Psychogenic depression
a. Depressive neurosis
b. Masked depression
c. Psychosomatic affections accompanied by anxiety and apathy.
d. Menopausal depressions
e. Dysphoria and depression in alcoholics and drug-addicts.
Dosage & Administration:
Adults : Usually 2 tablets daily at morning and noon. In severe cases the
morning dose may be increased to 2 tablets.
Elderly patients : 1 tablet in the morning.
Maintenance dose : Usually 1 tablet in the morning. In cases of insomnia or severe restlessness additional treatment with a sedative in acute phase is recommended. 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
Cefuroxime + Clavulanic Acid
Composition
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)
Alogliptin
Composition
Aloglip 6.25 Tablet: Each film coated tablet contains Alogliptin Benzoate INN equivalent to Alogliptin 6.25 mg.
Aloglip 12.5 Tablet: Each film coated tablet contains Alogliptin Benzoate INN equivalent to Alogliptin 12.5 mg.
Aloglip 25 Tablet: Each film coated tablet contains Alogliptin Benzoate INN equivalent to Alogliptin 25 mg.
Indication
Aloglip is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes mellitus.
Dose & Administration
The recommended dose in patients with normal renal function or mild renal impairment is 25 mg once daily or as directed by the physicians.
Glucosamine + Diacerein
Composition:
Bonacerin™ Tablet: Each film coated tablet contains Glucosamine Sulfate Potassium Chloride USP equivalent to Glucosamine Sulfate 750 mg and Diacerein BP 50 mg.
Indications:
It is indicated for the treatment of Osteoarthritis, Rheumatoid arthritis & Joint injuries.
Dosage & Administration:
Adult & Children above 12 years: One tablet twice daily for 4-12 weeks, taken with food. Or as directed by the physician
Dexlansoprazole
Composition
Dextac™30 Capsule:Each capsule contains Dexlansoprazole INN 30 mg as enteric coated pellets.
Dextac™60 Capsule:Each capsule contains Dexlansoprazole INN 60 mg as enteric coated pellets.
Indication
• Healing of Erosive Esophagitis: Dextac™ (Dexlansoprazole) is indicated for healing of all grades of Erosive Esophagitis (EE) for up to 8 weeks.
• Maintenance of Healed Erosive Esophagitis: Dextac™ (Dexlansoprazole) is indicated to maintain healing of EE and relief of heartburn for up to 6 months.
• Symptomatic Non-Erosive Gastroesophageal Reflux Disease: Dextac™ (Dexlansoprazole) is indicated for the treatment of heartburn associated with symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD) for upto 4 weeks.
Dose & Administration
Important Administration Information
• Dextac™ (Dexlansoprazole) can be taken without regard to food or the timing of food.
• Dextac™ (Dexlansoprazole) should be swallowed whole.
Alternatively, Dextac™ (Dexlansoprazole) capsules can be administered as follows:
- Open capsule.
- Sprinkle intact granules on one table spoon.
- Swallow immediately. Granules should not be chewed.
Missed Dose: If a capsule is missed at its usual time, it should be taken as soon as possible. But
if it is too close to the time of the next dose, only the prescribed dose should be taken at the
appointed time. A double dose should not be taken. or as directed by the physicians.
Nattifine
Composition:
Nafgal Cream: Each gram cream contains Naftifine Hydrochloride USP 20 mg.
Indications:
Nafgal Cream is indicated for the treatment of interdigital tinea pedis, tinea cruris and tinea corporis caused by the organism Trichophyton rubrum.
Dosage & Administration:
Apply a thin layer of Nafgal Cream once-daily to the affected areas plus half inch margin of healthy surrounding skin for 2 weeks or as directed by the physician.
Luliconazole
Composition:
Lulider Cream: Each gram cream contains Luliconazole INN 10 mg.
Pharmacology:
Exact mechanism of action against dermatophytes is unknown, luliconazole
appears to inhibit ergosterol synthesis by inhibiting the enzyme lanosterol
demethylase. Inhibition of this enzyme's activity by azoles results in decreased
amounts of ergosterol, a constituent of fungal cell membranes and a
corresponding accumulation of lanosterol.
Indication:
Lulider Cream is indicated for the topical treatment of interdigital tinea pedis,
tinea cruris and tinea corporis, in patients 18 years of age and older.
Dose & Administration:
Tinea pedis: A thin layer of cream, 1% should be applied to the affected area and
approximately 1inch of the immediate surrounding area(s) once daily for two
weeks or as directed by the physician.
Tinea cruris or tinea corporis: A thin layer of cream, 1% should be applied to the
affected area and approximately 1inch of the immediate surrounding area(s)
once daily for one week or as directed by the physician.
Contraindication:
No information is available.
Warning and Precaution:
Side Effects:
The most common adverse reaction (<1%) is application site reactions.
Use in Pregnancy and Lactation:
Pregnancy Category C.
Use in Children and Adolescents:
The safety and effectiveness of Lulider Cream, 1% in pediatric patients have not been established. The number of pediatric patients > 12 years of age were too small to adequately assess safety and efficacy.
Drug Interaction:
No information is available.
Overdose:
Storage:
Store below 30 C., away from light and in a dry place. Keep out of the reach of children.
Packing:
Lulider Cream: Each Pack has a laminated tube containing 10 g cream and an insert.
Lulider Cream: Each Pack has a laminated tube containing 30 g cream and an insert.
Itraconazole
Composition
Itracon 100 capsule: Each capsule contains Itraconazole pellets
equivalent to Itraconazole USP 100 mg.
Itracon 200 Tablet: Each film coated tablet contains Itraconazole USP
200 mg.
Pharmacology
Itracon is a preparation of Itraconazole, an orally active triazole
antifungal agent, having broad spectrum activity and favourable
pharmacokinetic profile. Itraconazole inhibits cytochrome p-450
dependent enzymes resulting in impairment of the biosynthesis of
ergoesterol, a major component of the cell membrane of yeast and
fungal cells.
Indication
Itracon 100 mg capsule: Tinea corporis, Tinea cruris, Tinea pedis,
Tinea manuum, Vulvovaginal candidiasis, Fungal keratitis, Pityriasis
versicolor, Oropharyngeal candidiasis, Onychomycosis, Histoplasmosis,
Systemic Infections: (Aspergillosis, Candidiasis and Cryptococcus
infection when other drugs are ineffective) Antifungal prophylaxis: To
prevent systemic fungal infection in severely neutropenic patients.
Itracon 200 mg tablet: It is an azole antifungal, indicated for the
treatment of onychomycosis of the toenail caused by Trichophyton
rubrum or T. mentagrophytes.
Dose & Administration
For oral use only
Tinea corporis, Tinea cruris : 100 mg daily for 2 weeks.
Tinea pedis, Tinea manuum : 100 mg daily for 4 weeks.
Vulvovaginal candidiasis : 200 mg twice daily for 1 day
Fungal keratitis : 200 mg daily for 3 weeks.
Pityriasis versicolor : 200 mg daily for 1 week.
Oropharyngeal candidiasis : 100 mg daily (200 mg for
immunocompromised patient
patients) for 15 days.
Onychomycosis: 200 mg daily for 3 months; or 200 mg twice daily for
7 days (course), subsequent courses to be repeated after 21 days
interval; fingernails 2 courses and toenails 3 courses.
Histoplasmosis: 200 mg 1-2 times daily.
Systemic Infections: (Aspergillosis, Candidiasis and Cryptococcus
infection when other drugs are ineffective) 200 mg once daily,
increased in invasive or in cryptococcal meningitis to 200 mg twice
daily.
Antifungal prophylaxis: To prevent systemic fungal infection in
severely neutropenic patients 100 mg daily.
Or as directed by the physician.
Contraindication
The drug is contraindicated in patients with known history of
hypersensitivity to it. The drug is also contraindicated in pregnant
women and patients with known severe hepatic disease. It is also
contraindicated with Rifampicin therapy.
Warnings and Precautions
Hepatic enzyme value should be monitored in patients with
pre-existing hepatic function abnormalities. It should also be monitored
periodically in all patients receiving continuous treatment for more than
one month or at any time a patient develops sign and symptoms
suggestive liver dysfunction.
Side Effects
Nausea, abdominal pain, dyspepsia, constipation, headache,
dizziness, raised liver enzymes, hepatitis, cholestatic jaundice,
peripheral neuropathy have been reported.
Use in Pregnancy and Lactation
Not recommended during pregnancy & lactation, unless otherwise
indicated by physician.
Use in Children & Adolescents
The efficacy and safety of Itraconazole capsule have not been
established in paediatric patients and adolescents.
Drug Interaction
Itraconazole inhibits the metabolism of Cyclosporine and Warfarin.
Interaction with Terfinadine, Phenobarbitone, Midazolam has been
reported.
Overdose
There is no experience of overdosage with itraconazole.
Storage
Store below 30°C, protected from light & in a dry place.
Keep all medicines out of the reach of children.
Packing
Itracon 100 capsule: Each box contains 6X4 capsules in Alu-Alu blister
pack and an insert.
Itracon 200 Tablet: Each box contains 2X10 tablets in Alu-Alu blister
pack and an insert.
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.
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.
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
