Download Ursodex - The IBN SINA Pharmaceutical Industry Ltd.

Ursodex
Ursodeoxycholic Acid BP
Composition:
Ursodex-150 : Each film-coated tablet contains Ursodeoxycholic Acid BP 150 mg.
Ursodex-300 : Each film-coated tablet contains Ursodeoxycholic Acid BP 300 mg.
Description:
Ursodeoxycholic acid (Ursodex) reduces elevated liver enzyme levels by facilitating bile flow through the liver
and protecting liver cells. The main mechanism if anticholelithic. Although the exact process of ursodiol's
anticholelithic action is not completely understood, it is thought that the drug is concentrated in bile and
decreases biliary cholesterol by suppressing hepatic synthesis and secretion of cholesterol and by inhibiting
its intestinal absorption. The reduced cholesterol saturation permits the gradual solubilization of cholesterol
from gallstones, resulting in their eventual dissolution.
Indications and usage:
Ursodex is a superior drug for the treatment of Cholestasis (Jaundice), Acute Viral Hepatitis, Viral Hepatitis,
Chronic Hepatitis, Chronic Hepatitis C, Alcoholic Fatty Liver, Primary Billiary Cirrhosis (PBC), Primary
Sclerosing Cholangitis (PSC), Dissolution of gallstones and Non-alcoholic steato hepatitis (NASH).
Dosage & Administration:
Primary biliary cirrhosis: The recommended adult dosage for Ursodex in the treatment of PBC is 13-15
mg/kg/day administered in two to four divided doses with food.
Dissolution of gallstones: The recommended adult dose is 6-12 mg/kg/day as a single dose at bedtime.
Dosing regimen should be adjusted according to each patient's need at the discretion of the physician.
Contraindication:
Non-functioning gall-bladder calcified and pigmented gallstones, inflammatory bowel disease.
Use in pregnancy and lactation:
Pregnancy- Pregnancy Category-B.
No evidence of harm has been reported in pregnancy. It has been effectively used for the treatment of
cholestasis of pregnancy during the last trimester without any side effects.
Lactation: Problems have not been documented in humans regarding breast feeding. So patients taking the
drug during breast-feed to consults with doctors.
Pediatric use: Cholesterol rich gallstones are rare in children. Dosage should be related to body weight.
Geriatric use: There is no evidence which suggests the alteration in the adult dose but caution is advised.
Precaution: Caution should be exercised in patients with history of liver, gallbladder, pancreas, or bile duct
disorders, during pregnancy and breastfeeding.
Side-effect : Diarrhoea, constipation, stomach upset, indigestion, dizziness, vomiting, cough, sore throat,
runny nose, back pain, muscle and joint pain, hair loss.
Storage: Store at room temperature away from light and moisture.
Ursodex-150 : Each box contains 4 X 10 Tablets in blister pack.
Ursodex-300 : Each box contains 2 x 10 Tablets in blister pack.
Manufactured by:
The IBN SINA Pharmaceutical Industry Ltd.
lBwSlnA SnaTpuKGazipur . Bangladesh.
Danazol
Danazol USP
Composition:
Danazol-100: Each capsule contains Danazol USP 100 mg
Danazol-200: Each capsule contains Danazol USP 200 mg
Description:
Danazol is a preparation of Danazol. It is a weak impeded androgen with associated anabolic properties. It
inhibits gonadotropin-releasing hormone and gonadotropin secretion. This suppresses menstruation, inhibits
ovulation and causes regressive change in the vaginal smear and atrophic change in the endometrium.
Danazol has no estrogenic or progestogenic properties.
Indication:
Danazol is indicated for the following treatment
•Endometriosis
•Benign breast disease
•Severe cyclical mastalgia
•Menorrhagia
•Gynaecomastia
• Preoperative thinning of the endometrium before hysteroscopic endometrial ablation
Dosage and Administration:
Usually given in up to 4 divided doses; in women of child-bearing potential, treatment should start during
menstruation, preferably on first day.
Endometriosis:
200—800 mg daily in up to 4 divided doses, adjusted to achieve amenorrhoea, usually for 6 months (up to 9
months in some cases).
Menorrhagia:
I n menorrhagia daily doses of 100-200 mg have been found effective but 200 mg daily for 3 months is usually
sufficient to reduce menstrual blood flow to acceptable levels.
Severe cyclical mastalgia:
100-400 mg daily usually for 3-6 months.
Benign breast cysts: 300 mg daily usually for 3-6 months.
Gynaecomastia:
400 mg daily in up to 4 divided doses for 6 months (adolescents 200 mg daily, increased to 400 mg daily if no
response after 2 months).
For pre-operative thinning of endometrium: 400 mg-800 mg daily in up to 4 divided doses for 3-6 weeks.
Contraindication:
Danazol is contraindicated in Pregnancy and breast feeding, Impaired hepatic, Renal or cardiac function,
Thromboembolic disease, Androgen-dependent tumor, Abnormal vaginal bleeding, Hypersensitivity to
Danazol etc.
Children: Danazol is not used in children.
Use in Pregnancy and Lactation:
Pregnancy:
Pregnancy Category-X
Pregnant Women:
The drug should not be given to pregnant women, because of risk of virilization of a female fetus, particularly
when high doses are given for several weeks.
Lactating mother:
Patients taking the drug should not breast—feed.
Pediatric Use:
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use:
Clinical Studies of Danazol did not include sufficient numbers of subjects aged 65 and over to determine the
safety and effectiveness of Danazol in elderly patients.
Precaution:
Cardiac, hepatic or renal impairment, elderly, polycythaemia, epilepsy, diabetes mellitus, hypertension,
migraine, lipoprotein disorder, history of thrombosis or thromboembolic disease. If signs of virilization occur,
e.g. voice changes or hirsutism, therapy should be stopped immediately.
Side-Effect: Weight gain, Acne, Flushing, Sweating, Voice changes (hoarseness, change in pitch), abnormal
growth of body hair (in Women), vaginal dryness/ irritation, or decreased breast size may occur.
Storage: Store in cool,dry place and away from light. Keep out of reach of children.
Presentation:
Danazol-100: Each box contains 2 x 10 capsules in alu-alu blister pack.
Danazol-200: Each box contains 1x 10 capsules in alu-alu blister pack.
Industry Ltd.