Human Health Division (HHD) Products

Veterinary Division (VET)
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

Ibandronic Acid

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).

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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.
Itracon Oral Solution: Each 5 ml oral solution contains Itraconazole USP 50 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
P450 dependent enzymes resulting in impairment of the biosynthesis of Ergosterol, a major
component of the cell membrane of yeast and fungal cells.
Indications:
Itracon Capsule & Tablet: Tinea corporis, Tinea cruris, Tinea pedis, Tinea manuum,
Vulvovaginal candidiasis, Fungal keratitis, Pityriasis versicolor, Oropharyngeal candidiasis,
Onychomycosis, Histoplasmosis, Systemic Infections: Aspergillosis, Candidiasis and
Cryptococcal infection when other drugs are ineffective. Antifungal prophylaxis: To prevent
systemic fungal infection in severely neutropenic patients.
Itracon Oral Solution: It is indicated for the treatment of Oropharyngeal Candidiasis &
Esophageal Candidiasis.
Dosage & Administration:
Itracon Tablet & Capsule:
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 immuno-compromised 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: 200 mg once daily (Aspergillosis, Candidiasis and Cryptococcus infection
when other drugs are ineffective), 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.
Itracon Oral Solution: This solution should be vigorously swished in the mouth (10 ml at a time)
for several seconds and swallowed. The recommended dosage of Itracon oral solution for
Oropharyngeal Candidiasis is 200 mg (20 ml) daily for 1 to 2 weeks. The recommended
dosage of Itracon oral solution for Esophageal Candidiasis is 100 mg (10 ml) daily for a
minimum treatment of 3 weeks. Child Dose: 5 mg / kg once daily for 14 days. For oral use only
(for 1 month to 11 years of age) or as directed by the physician.

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