Human Health Division (HHD) Products

Product List by Brand Name
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Droniva

Composition Droniva Tablet: Each film coated tablet contains Ibandronate Monosodium Monohydrate INN equivalent to Ibandronic Acid 150 mg.

Pharmacology: The action of Ibandronic Acid on bone tissue is based on its affinity for hydroxyapatite which is part of the mineral matrix of bone. Ibandronic Acid inhibits osteoclast activity and reduces bone resorption and turnover.

Indications: Droniva is indicated for the treatment and prevention of osteoporosis in postmenopausal women. Droniva increases bone mineral density (BMD) and reduces the incidence of vertebral fractures

 Dosage & Administration: The dose of Droniva is one 150 mg tablet once monthly on the same date of each month or as directed by the physician

Contraindication : Ibandronic Acid is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or to any of the excipients, hypocalcemia and inability to stand or sit upright for at least 1 hour. Warnings & Precautions Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting therapy with Ibandronic Acid. Adequate intake of calcium and vitamin D is important in all patients. It is not recommended for use in patients with severe renal impairment (creatinine clearance <30 ml/min).

Side Effects :The most common side effects include back pain, allergic reaction, dyspepsia, diarrhoea, nausea, vomiting, gastritis, myalgia, headache, dizziness, vertigo etc. Use in Pregnancy & Lactation Use in pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and foetus. Use in lactating mothers: It is not known whether it is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a lactating woman. Use in Children & Adolescant Safety and effectiveness in paediatric patients have not been established. Use in special groups Geriatric use: No overall differences in effectiveness or safety were observed between elderly patients and younger patients. Therefore, no dosage adjustment is necessary in the elderly. Hepatic Insufficiency: No studies have been performed to assess the pharmacokinetics of Ibandronic Acid in patients with hepatic impairment because lbandronic Acid is not metabolized in the human liver. Renal Insufficiency: It is not recommended for use in patients with severe renal impairment (creatinine clearance of < 30 ml/min).

Diplin M

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.

Diplin

Composition
Diplin 5 Tablet: Each film coated tablet contains Linagliptin INN 5 mg.

Pharmacology
Diplin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones. Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day and levels are increased in response to a meal. These hormones are rapidly inactivated by the enzyme, DPP-4. The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis. When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from
pancreatic beta cells by intracellular signaling pathways involving cyclic AMP. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, leading to reduce hepatic glucose production. By increasing and prolonging active incretin levels, Diplin increases insulin release and decreases glucagon levels in the circulation in a glucose-dependent manner.

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.

Desatrol

COMPOSITION :
Desatrol™Tablet : Each film coated tablet contains Desloratadine BP 5 mg.
Desatrol™Syrup : Each 5 ml syrup contains Desloratadine BP 2.5 mg.

INDICATION :
Allergic Rhinitis: Desatrol™ is indicated for the relief of the nasal and nonnasal symptoms of allergic rhinitis (seasonal and perennial).
Chronic idiopathic Urticaria: Desatrol™ is indicated for the symptomatic relief of pruritus, reduction in the number of hives and size of hives, in patients with chronic idiopathic urticaria.
DOSE AND ADMINISTRATION :
Tablet : In adults and children 12 years of age and over, the recommended dose is 5 mg once daily.
In patients with liver or renal impairment, a starting dose of one 5 mg tablet every other day is recommended.
Syrup : Children 2-5 years of age : 2.5 ml once daily, 6-11 years of age : 5 ml once daily. Adults and children 12 years of age and over : 10 ml once daily. It may be administered with or without food. Or as directed by the physician.


Dextac Capsule

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.

Duracef

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