Human Health Division (HHD) Products

Product List by Generic Name
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Clonidine Hydrochloride

Composition

Clonipres ER 0.1 Tablet: Each Extended release tablet contains Clonidine Hydrochloride USP 0.1 mg.

Indications

Clonidine hydrochloride extended release tablet is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy.

Dosage and Administration

Attention deficit hyperactivity disorder : Clonidine ER 0.1 mg/day for 8 weeks

Ceftriaxone

Composition

TopcefTM 500 mg IM 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. TopcefTM 1 g IV Injection: Each vial contains dry substance equivalent to 1 g Ceftriaxone (as sterile Ceftriaxone Sodium BP) with 10 ml Water for Injection BP for IV injection. TopcefTM 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

TopcefTM 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

Dosage and Administration

Adults and children over 12 years: The usual dose is 1-2 g of TopcefTM 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 TopcefTM 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 TopcefTM with or without a 5-nitroimidazole, e.g. Ornidazole, has been proven effective. Impaired renal and hepatic function: In patients with impaired renal function, there is no need to reduce the dosage of TopcefTM 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. 

Ciprofloxacin

Composition

Floxacin 500 mg Tablet : Each tablet contains Ciprofloxacin Hydrochloride USP equivalent to 500 mg Ciprofloxacin.

 Indications

lInfectious diarrhoea lUrinary tract infection lTyphoid fever lLower respiratory tract infection lAcute sinusitis lBone and joint infection lChronic bacterial prostitis l Pyelonephritis l Gonococcal infection l Inhalational anthrax.

Calcium Carbonate + Vitamin D3

Introduction

Miracal-D is a prescription medicine. It is a combination of medicines that are prescribed to treat osteoporosis. It ensures the proper growth and functioning of the joints and bones. Miracal-D should be used in the dose and duration as prescribed by your doctor. It is advised to take this medicine at a fixed time. This medicine should not be taken in more than the recommended dose. This is usually a safe medicine with very minimal side effects but if you experience severe diarrhea, nausea, or vomiting or any symptoms of an allergic reaction, please consult your doctor. Before taking this medicine, tell your doctor if you have any other health conditions. Inform your doctor if you are taking any other medicines or if you are pregnant or breastfeeding.

Uses of Miracal-D

  • Nutritional deficiencies

Pharmacology

Miracal-D is a combination of two nutritional supplements: Calcium and Vitamin D3 which replenish the body's stores of important nutrients.



Carisoprodol

Composition

Somalax 250 Tablet: Each tablet contains Carisoprodol USP 250 mg. Somalax 350 Tablet: Each tablet contains Carisoprodol USP 350 mg.

Pharmacology

Carisoprodol is a centrally acting skeletal muscle relaxant that does not directly relax tense skeletal muscle in man. The mode of action of Carisoprodol in relieving acute muscle spasm of local origin has not been clearly identified, but may be related to its sedative properties. In animals, Carisoprodol has been shown to produce muscle relaxation by blocking interneuronal activity and depressing transmission of polysynaptic neurons in the spinal cord and the descending reticular formation of the brain. The onset of action is rapid and lasts four to six hours.

Indication

Somalax is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions.

Dosage & Administration

Adults (18 years and older): The recommended dose of Somalax is 250 mg to 350 mg 3-4 times daily (before or after meal and at bedtime) for up to 2-3 weeks or as directed by the physician.

Contraindication

Carisoprodol is contraindicated in patients with history of acute intermittent prophyria or a hypersensitivity reaction to carbamate such as Meprobamate.

Warnings & Precautions

Carisoprodol is metabolized in the liver and excreted by the kidney. To avoid its excess accumulation, caution should be exercised in administration to patients with compromised liver or kidney function & additive sedative effects is found when used with other CNS depressants including alcohol.

Side Effects

Common side effects are drowsiness, dizziness and headache.

Use in Pregnancy & Lactation

The safety of this drug in pregnancy or lactation has not been established. Therefore, use of this drug in pregnancy, in nursing mothers, or in women of childbearing potential requires that the potential benefits of the drug be weighed against the potential hazards to mother and child. Carisoprodol is present in breast milk of lactating mothers at concentrations two to four times that of maternal plasma. This factor should be taken into account when use of the drug is contemplated in breast-feeding patients.

Use in Children & Adolescents

The efficacy, safety and pharmacokinetics of Carisoprodol in paediatric patients less than 16 years of age have not been established.

Drug Interactions

• Caution should be exercised with patients who take other CNS depressants (eg.- alcohol, benzodiazepines, opioids, tricyclic antidepressants) with Carisoprodol.

• Co-administration of CYP2C19 inhibitors (Omeprazole, Fluvoxamine) with Carisoprodol could result in increased exposure of Carisoprodol. Co-administration of CYP2C19 inducers (Rifampin) with Carisoprodol may result in decreased exposure of Carisoprodol.

Overdosage

Overdosage of Carisoprodol commonly produces CNS depression. Death, coma, respiratory depression, hypotension, seizures have been reported with Carisoprodol overdosage. Basic life support measures should be instituted in Carisoprodol overdose. Induced emesis is not recommended due to the risk of CNS and respiratory depression. Gastric lavage should be considered soon after ingestion (within one hour). Circulatory support should be administered with volume infusion and vasopressor agents if needed. Seizures should be treated with intravenous benzodiazepines and the reoccurrence of seizures may be treated with phenobarbital. In cases of severe CNS depression, airway protective reflexes may be compromised and tracheal intubation should be considered for airway protection and respiratory support.

Storage

Store below 30°C., away from light and in a dry place. Keep all medicines out of the reach of children.

Packing

Somalax 250 Tablet: Each box contains 3x10 tablets in Alu-Alu blister pack and an insert.

Somalax 350 Tablet: Each box contains 3x10 tablets in Alu-Alu blister pack and an insert.

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.

Dosage & 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.

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
Adolescents & adults(13 years & above)
Pharyngitis or Tonsillitis 250 mg twice daily for5 - 10 days
Acute bacterial maxillary sinusitis 250 mg twice daily for10 days
Acute bacterial exacerbation of chronic bronchitis 250 - 500 mg twice daily for 10 days
Secondary bacterial infections of acute bronchitis 250 - 500 mg twice daily for 5 - 10 days
Uncomplicated skin & skin-structure infections 250 - 500 mg twice daily for 10 days
Uncomplicated urinary tract infection 125 - 250 mg twice daily for 7 - 10 days
Uncomplicated gonorrhea 1000 mg single dose
Lyme disease 500 mg twice daily for 20 days
Paediatric patients (Upto12 years)
Acute otitis media 250 mg twice daily for 10 days
Acute bacterial maxillary sinusitis 250 mg twice daily for 10 days

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.

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™ 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