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Ursodeoxycholic Acid is indicated for the treatment of

• Cholestasis (Jaundice)
• Viral Hepatitis
• Alcoholic Fatty Liver
• Primary Billiary Cirrhosis (PBC)
• Primary Sclerosing Cholangitis (PSC)
• Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis (NASH).

Anti-gallstones drugs: Bile Acids

Ursodeoxycholic Acid is a naturally occurring bile acid used to treat different hepatobilliary disorders. The activity of Ursodeoxycholic Acid is achieved through a decrease in secretion of cholesterol in bile. Ursodeoxycholic Acid achieves this through a few mechanisms: it reduces cholesterol absorption, suppresses liver cholesterol synthesis and it does not inhibit bile acid synthesis.

Therefore, alters bile composition from supersaturated to unsaturated. Ursodeoxycholic Acid also promotes the formation of liquid cholesterol crystal complexes which enhance removal of the cholesterol from the gallbladder into the intestine to be expelled. Ursodeoxycholic Acid improves cholestatic liver diseases by-

• Protecting cholangiocytes against cytotoxicity of hydrophobic bile acids
• Stimulating hepatobilliary secretion
• Protecting hepatocytes against bile acid-induced apoptosis

Ursodeoxycholic Acid is completely absorbed in the upper intestine. Time to peak serum concentration varies from 30 to 150 minutes. The rate of absorption ranges from 60-80%. After absorption Ursodeoxycholic Acid enters the portal vein and undergoes extraction from portal blood by liver where it is conjugated with amino acid & that may be either glycine or taurine and then secreted into the hepatic bile ducts. Small quantities of Ursodeoxycholic Acid appear in the circulation and very small amounts are excreted into urine. The biologic half life of Ursodeoxycholic Acid ranges from 3.5-5.8 days.

Dissolution of Gall stones: 8-12 mg/kg/day either as single night time dose or in divided doses.

Primary Billiary Cirrhosis: 10-15 mg/kg/day in 2-4 divided doses.

Acute Viral Hepatitis: 600 mg/day.

Alcoholic Fatty Liver: 300 mg/day.

Primary Sclerosing Cholangitis: 25-30 mg/kg/day.

Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis: 13-15 mg/kg/day.

Commonly reported side effects are nausea, vomiting, diarrhoea, gallstone opacilication, pruritus.

Non-functioning gall-bladder calcified and pigmented gallstones, inflammatory bowel disease.

It should be used cautiously in those with liver disease.

Ursodeoxycholic Acid should not be used with drugs, such as oestrogenic hormones, that increase bile cholesterol. Concomitant administration with bile-acid binding drugs including antacids, charcoal and cholestyramine should be avoided, since this may reduce the effectiveness of therapy with Ursodeoxycholic acid.

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. Problems have not been documented in humans regarding breast feeding.

Store below 25° C. Protected from light and moisture. Keep the medicine out of the reach of children.

Ursodeoxycholic Acid is indicated for the treatment of

• Cholestasis (Jaundice)
• Viral Hepatitis
• Alcoholic Fatty Liver
• Primary Billiary Cirrhosis (PBC)
• Primary Sclerosing Cholangitis (PSC)
• Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis (NASH).

Anti-gallstones drugs: Bile Acids

Ursodeoxycholic Acid is a naturally occurring bile acid used to treat different hepatobilliary disorders. The activity of Ursodeoxycholic Acid is achieved through a decrease in secretion of cholesterol in bile. Ursodeoxycholic Acid achieves this through a few mechanisms: it reduces cholesterol absorption, suppresses liver cholesterol synthesis and it does not inhibit bile acid synthesis.

Therefore, alters bile composition from supersaturated to unsaturated. Ursodeoxycholic Acid also promotes the formation of liquid cholesterol crystal complexes which enhance removal of the cholesterol from the gallbladder into the intestine to be expelled. Ursodeoxycholic Acid improves cholestatic liver diseases by-

• Protecting cholangiocytes against cytotoxicity of hydrophobic bile acids
• Stimulating hepatobilliary secretion
• Protecting hepatocytes against bile acid-induced apoptosis

Ursodeoxycholic Acid is completely absorbed in the upper intestine. Time to peak serum concentration varies from 30 to 150 minutes. The rate of absorption ranges from 60-80%. After absorption Ursodeoxycholic Acid enters the portal vein and undergoes extraction from portal blood by liver where it is conjugated with amino acid & that may be either glycine or taurine and then secreted into the hepatic bile ducts. Small quantities of Ursodeoxycholic Acid appear in the circulation and very small amounts are excreted into urine. The biologic half life of Ursodeoxycholic Acid ranges from 3.5-5.8 days.

Dissolution of Gall stones: 8-12 mg/kg/day either as single night time dose or in divided doses.

Primary Billiary Cirrhosis: 10-15 mg/kg/day in 2-4 divided doses.

Acute Viral Hepatitis: 600 mg/day.

Alcoholic Fatty Liver: 300 mg/day.

Primary Sclerosing Cholangitis: 25-30 mg/kg/day.

Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis: 13-15 mg/kg/day.

Commonly reported side effects are nausea, vomiting, diarrhoea, gallstone opacilication, pruritus.

Non-functioning gall-bladder calcified and pigmented gallstones, inflammatory bowel disease.

It should be used cautiously in those with liver disease.

Ursodeoxycholic Acid should not be used with drugs, such as oestrogenic hormones, that increase bile cholesterol. Concomitant administration with bile-acid binding drugs including antacids, charcoal and cholestyramine should be avoided, since this may reduce the effectiveness of therapy with Ursodeoxycholic acid.

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. Problems have not been documented in humans regarding breast feeding.

Store below 25° C. Protected from light and moisture. Keep the medicine out of the reach of children.

Ursodeoxycholic Acid is indicated for the treatment of

• Cholestasis (Jaundice)
• Viral Hepatitis
• Alcoholic Fatty Liver
• Primary Billiary Cirrhosis (PBC)
• Primary Sclerosing Cholangitis (PSC)
• Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis (NASH).

Anti-gallstones drugs: Bile Acids

Ursodeoxycholic Acid is a naturally occurring bile acid used to treat different hepatobilliary disorders. The activity of Ursodeoxycholic Acid is achieved through a decrease in secretion of cholesterol in bile. Ursodeoxycholic Acid achieves this through a few mechanisms: it reduces cholesterol absorption, suppresses liver cholesterol synthesis and it does not inhibit bile acid synthesis.

Therefore, alters bile composition from supersaturated to unsaturated. Ursodeoxycholic Acid also promotes the formation of liquid cholesterol crystal complexes which enhance removal of the cholesterol from the gallbladder into the intestine to be expelled. Ursodeoxycholic Acid improves cholestatic liver diseases by-

• Protecting cholangiocytes against cytotoxicity of hydrophobic bile acids
• Stimulating hepatobilliary secretion
• Protecting hepatocytes against bile acid-induced apoptosis

Ursodeoxycholic Acid is completely absorbed in the upper intestine. Time to peak serum concentration varies from 30 to 150 minutes. The rate of absorption ranges from 60-80%. After absorption Ursodeoxycholic Acid enters the portal vein and undergoes extraction from portal blood by liver where it is conjugated with amino acid & that may be either glycine or taurine and then secreted into the hepatic bile ducts. Small quantities of Ursodeoxycholic Acid appear in the circulation and very small amounts are excreted into urine. The biologic half life of Ursodeoxycholic Acid ranges from 3.5-5.8 days.

Dissolution of Gall stones: 8-12 mg/kg/day either as single night time dose or in divided doses.

Primary Billiary Cirrhosis: 10-15 mg/kg/day in 2-4 divided doses.

Acute Viral Hepatitis: 600 mg/day.

Alcoholic Fatty Liver: 300 mg/day.

Primary Sclerosing Cholangitis: 25-30 mg/kg/day.

Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis: 13-15 mg/kg/day.

Commonly reported side effects are nausea, vomiting, diarrhoea, gallstone opacilication, pruritus.

Non-functioning gall-bladder calcified and pigmented gallstones, inflammatory bowel disease.

It should be used cautiously in those with liver disease.

Ursodeoxycholic Acid should not be used with drugs, such as oestrogenic hormones, that increase bile cholesterol. Concomitant administration with bile-acid binding drugs including antacids, charcoal and cholestyramine should be avoided, since this may reduce the effectiveness of therapy with Ursodeoxycholic acid.

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. Problems have not been documented in humans regarding breast feeding.

Store below 25° C. Protected from light and moisture. Keep the medicine out of the reach of children.

Ursodeoxycholic Acid is indicated for the treatment of

• Cholestasis (Jaundice)
• Viral Hepatitis
• Alcoholic Fatty Liver
• Primary Billiary Cirrhosis (PBC)
• Primary Sclerosing Cholangitis (PSC)
• Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis (NASH).

Anti-gallstones drugs: Bile Acids

Ursodeoxycholic Acid is a naturally occurring bile acid used to treat different hepatobilliary disorders. The activity of Ursodeoxycholic Acid is achieved through a decrease in secretion of cholesterol in bile. Ursodeoxycholic Acid achieves this through a few mechanisms: it reduces cholesterol absorption, suppresses liver cholesterol synthesis and it does not inhibit bile acid synthesis.

Therefore, alters bile composition from supersaturated to unsaturated. Ursodeoxycholic Acid also promotes the formation of liquid cholesterol crystal complexes which enhance removal of the cholesterol from the gallbladder into the intestine to be expelled. Ursodeoxycholic Acid improves cholestatic liver diseases by-

• Protecting cholangiocytes against cytotoxicity of hydrophobic bile acids
• Stimulating hepatobilliary secretion
• Protecting hepatocytes against bile acid-induced apoptosis

Ursodeoxycholic Acid is completely absorbed in the upper intestine. Time to peak serum concentration varies from 30 to 150 minutes. The rate of absorption ranges from 60-80%. After absorption Ursodeoxycholic Acid enters the portal vein and undergoes extraction from portal blood by liver where it is conjugated with amino acid & that may be either glycine or taurine and then secreted into the hepatic bile ducts. Small quantities of Ursodeoxycholic Acid appear in the circulation and very small amounts are excreted into urine. The biologic half life of Ursodeoxycholic Acid ranges from 3.5-5.8 days.

Dissolution of Gall stones: 8-12 mg/kg/day either as single night time dose or in divided doses.

Primary Billiary Cirrhosis: 10-15 mg/kg/day in 2-4 divided doses.

Acute Viral Hepatitis: 600 mg/day.

Alcoholic Fatty Liver: 300 mg/day.

Primary Sclerosing Cholangitis: 25-30 mg/kg/day.

Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis: 13-15 mg/kg/day.

Commonly reported side effects are nausea, vomiting, diarrhoea, gallstone opacilication, pruritus.

Non-functioning gall-bladder calcified and pigmented gallstones, inflammatory bowel disease.

It should be used cautiously in those with liver disease.

Ursodeoxycholic Acid should not be used with drugs, such as oestrogenic hormones, that increase bile cholesterol. Concomitant administration with bile-acid binding drugs including antacids, charcoal and cholestyramine should be avoided, since this may reduce the effectiveness of therapy with Ursodeoxycholic acid.

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. Problems have not been documented in humans regarding breast feeding.

Store below 25° C. Protected from light and moisture. Keep the medicine out of the reach of children.

Ursodeoxycholic Acid is indicated for the treatment of

• Cholestasis (Jaundice)
• Viral Hepatitis
• Alcoholic Fatty Liver
• Primary Billiary Cirrhosis (PBC)
• Primary Sclerosing Cholangitis (PSC)
• Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis (NASH).

Anti-gallstones drugs: Bile Acids

Ursodeoxycholic Acid is a naturally occurring bile acid used to treat different hepatobilliary disorders. The activity of Ursodeoxycholic Acid is achieved through a decrease in secretion of cholesterol in bile. Ursodeoxycholic Acid achieves this through a few mechanisms: it reduces cholesterol absorption, suppresses liver cholesterol synthesis and it does not inhibit bile acid synthesis.

Therefore, alters bile composition from supersaturated to unsaturated. Ursodeoxycholic Acid also promotes the formation of liquid cholesterol crystal complexes which enhance removal of the cholesterol from the gallbladder into the intestine to be expelled. Ursodeoxycholic Acid improves cholestatic liver diseases by-

• Protecting cholangiocytes against cytotoxicity of hydrophobic bile acids
• Stimulating hepatobilliary secretion
• Protecting hepatocytes against bile acid-induced apoptosis

Ursodeoxycholic Acid is completely absorbed in the upper intestine. Time to peak serum concentration varies from 30 to 150 minutes. The rate of absorption ranges from 60-80%. After absorption Ursodeoxycholic Acid enters the portal vein and undergoes extraction from portal blood by liver where it is conjugated with amino acid & that may be either glycine or taurine and then secreted into the hepatic bile ducts. Small quantities of Ursodeoxycholic Acid appear in the circulation and very small amounts are excreted into urine. The biologic half life of Ursodeoxycholic Acid ranges from 3.5-5.8 days.

Dissolution of Gall stones: 8-12 mg/kg/day either as single night time dose or in divided doses.

Primary Billiary Cirrhosis: 10-15 mg/kg/day in 2-4 divided doses.

Acute Viral Hepatitis: 600 mg/day.

Alcoholic Fatty Liver: 300 mg/day.

Primary Sclerosing Cholangitis: 25-30 mg/kg/day.

Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis: 13-15 mg/kg/day.

Commonly reported side effects are nausea, vomiting, diarrhoea, gallstone opacilication, pruritus.

Non-functioning gall-bladder calcified and pigmented gallstones, inflammatory bowel disease.

It should be used cautiously in those with liver disease.

Ursodeoxycholic Acid should not be used with drugs, such as oestrogenic hormones, that increase bile cholesterol. Concomitant administration with bile-acid binding drugs including antacids, charcoal and cholestyramine should be avoided, since this may reduce the effectiveness of therapy with Ursodeoxycholic acid.

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. Problems have not been documented in humans regarding breast feeding.

Store below 25° C. Protected from light and moisture. Keep the medicine out of the reach of children.

Ursodeoxycholic Acid is indicated for the treatment of

• Cholestasis (Jaundice)
• Viral Hepatitis
• Alcoholic Fatty Liver
• Primary Billiary Cirrhosis (PBC)
• Primary Sclerosing Cholangitis (PSC)
• Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis (NASH).

Anti-gallstones drugs: Bile Acids

Ursodeoxycholic Acid is a naturally occurring bile acid used to treat different hepatobilliary disorders. The activity of Ursodeoxycholic Acid is achieved through a decrease in secretion of cholesterol in bile. Ursodeoxycholic Acid achieves this through a few mechanisms: it reduces cholesterol absorption, suppresses liver cholesterol synthesis and it does not inhibit bile acid synthesis.

Therefore, alters bile composition from supersaturated to unsaturated. Ursodeoxycholic Acid also promotes the formation of liquid cholesterol crystal complexes which enhance removal of the cholesterol from the gallbladder into the intestine to be expelled. Ursodeoxycholic Acid improves cholestatic liver diseases by-

• Protecting cholangiocytes against cytotoxicity of hydrophobic bile acids
• Stimulating hepatobilliary secretion
• Protecting hepatocytes against bile acid-induced apoptosis

Ursodeoxycholic Acid is completely absorbed in the upper intestine. Time to peak serum concentration varies from 30 to 150 minutes. The rate of absorption ranges from 60-80%. After absorption Ursodeoxycholic Acid enters the portal vein and undergoes extraction from portal blood by liver where it is conjugated with amino acid & that may be either glycine or taurine and then secreted into the hepatic bile ducts. Small quantities of Ursodeoxycholic Acid appear in the circulation and very small amounts are excreted into urine. The biologic half life of Ursodeoxycholic Acid ranges from 3.5-5.8 days.

Dissolution of Gall stones: 8-12 mg/kg/day either as single night time dose or in divided doses.

Primary Billiary Cirrhosis: 10-15 mg/kg/day in 2-4 divided doses.

Acute Viral Hepatitis: 600 mg/day.

Alcoholic Fatty Liver: 300 mg/day.

Primary Sclerosing Cholangitis: 25-30 mg/kg/day.

Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis: 13-15 mg/kg/day.

Commonly reported side effects are nausea, vomiting, diarrhoea, gallstone opacilication, pruritus.

Non-functioning gall-bladder calcified and pigmented gallstones, inflammatory bowel disease.

It should be used cautiously in those with liver disease.

Ursodeoxycholic Acid should not be used with drugs, such as oestrogenic hormones, that increase bile cholesterol. Concomitant administration with bile-acid binding drugs including antacids, charcoal and cholestyramine should be avoided, since this may reduce the effectiveness of therapy with Ursodeoxycholic acid.

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. Problems have not been documented in humans regarding breast feeding.

Store below 25° C. Protected from light and moisture. Keep the medicine out of the reach of children.

Ursodeoxycholic Acid is indicated for the treatment of

• Cholestasis (Jaundice)
• Viral Hepatitis
• Alcoholic Fatty Liver
• Primary Billiary Cirrhosis (PBC)
• Primary Sclerosing Cholangitis (PSC)
• Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis (NASH).

Anti-gallstones drugs: Bile Acids

Ursodeoxycholic Acid is a naturally occurring bile acid used to treat different hepatobilliary disorders. The activity of Ursodeoxycholic Acid is achieved through a decrease in secretion of cholesterol in bile. Ursodeoxycholic Acid achieves this through a few mechanisms: it reduces cholesterol absorption, suppresses liver cholesterol synthesis and it does not inhibit bile acid synthesis.

Therefore, alters bile composition from supersaturated to unsaturated. Ursodeoxycholic Acid also promotes the formation of liquid cholesterol crystal complexes which enhance removal of the cholesterol from the gallbladder into the intestine to be expelled. Ursodeoxycholic Acid improves cholestatic liver diseases by-

• Protecting cholangiocytes against cytotoxicity of hydrophobic bile acids
• Stimulating hepatobilliary secretion
• Protecting hepatocytes against bile acid-induced apoptosis

Ursodeoxycholic Acid is completely absorbed in the upper intestine. Time to peak serum concentration varies from 30 to 150 minutes. The rate of absorption ranges from 60-80%. After absorption Ursodeoxycholic Acid enters the portal vein and undergoes extraction from portal blood by liver where it is conjugated with amino acid & that may be either glycine or taurine and then secreted into the hepatic bile ducts. Small quantities of Ursodeoxycholic Acid appear in the circulation and very small amounts are excreted into urine. The biologic half life of Ursodeoxycholic Acid ranges from 3.5-5.8 days.

Dissolution of Gall stones: 8-12 mg/kg/day either as single night time dose or in divided doses.

Primary Billiary Cirrhosis: 10-15 mg/kg/day in 2-4 divided doses.

Acute Viral Hepatitis: 600 mg/day.

Alcoholic Fatty Liver: 300 mg/day.

Primary Sclerosing Cholangitis: 25-30 mg/kg/day.

Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis: 13-15 mg/kg/day.

Commonly reported side effects are nausea, vomiting, diarrhoea, gallstone opacilication, pruritus.

Non-functioning gall-bladder calcified and pigmented gallstones, inflammatory bowel disease.

It should be used cautiously in those with liver disease.

Ursodeoxycholic Acid should not be used with drugs, such as oestrogenic hormones, that increase bile cholesterol. Concomitant administration with bile-acid binding drugs including antacids, charcoal and cholestyramine should be avoided, since this may reduce the effectiveness of therapy with Ursodeoxycholic acid.

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. Problems have not been documented in humans regarding breast feeding.

Store below 25° C. Protected from light and moisture. Keep the medicine out of the reach of children.

Ursodeoxycholic Acid is indicated for the treatment of

• Cholestasis (Jaundice)
• Viral Hepatitis
• Alcoholic Fatty Liver
• Primary Billiary Cirrhosis (PBC)
• Primary Sclerosing Cholangitis (PSC)
• Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis (NASH).

Anti-gallstones drugs: Bile Acids

Ursodeoxycholic Acid is a naturally occurring bile acid used to treat different hepatobilliary disorders. The activity of Ursodeoxycholic Acid is achieved through a decrease in secretion of cholesterol in bile. Ursodeoxycholic Acid achieves this through a few mechanisms: it reduces cholesterol absorption, suppresses liver cholesterol synthesis and it does not inhibit bile acid synthesis.

Therefore, alters bile composition from supersaturated to unsaturated. Ursodeoxycholic Acid also promotes the formation of liquid cholesterol crystal complexes which enhance removal of the cholesterol from the gallbladder into the intestine to be expelled. Ursodeoxycholic Acid improves cholestatic liver diseases by-

• Protecting cholangiocytes against cytotoxicity of hydrophobic bile acids
• Stimulating hepatobilliary secretion
• Protecting hepatocytes against bile acid-induced apoptosis

Ursodeoxycholic Acid is completely absorbed in the upper intestine. Time to peak serum concentration varies from 30 to 150 minutes. The rate of absorption ranges from 60-80%. After absorption Ursodeoxycholic Acid enters the portal vein and undergoes extraction from portal blood by liver where it is conjugated with amino acid & that may be either glycine or taurine and then secreted into the hepatic bile ducts. Small quantities of Ursodeoxycholic Acid appear in the circulation and very small amounts are excreted into urine. The biologic half life of Ursodeoxycholic Acid ranges from 3.5-5.8 days.

Dissolution of Gall stones: 8-12 mg/kg/day either as single night time dose or in divided doses.

Primary Billiary Cirrhosis: 10-15 mg/kg/day in 2-4 divided doses.

Acute Viral Hepatitis: 600 mg/day.

Alcoholic Fatty Liver: 300 mg/day.

Primary Sclerosing Cholangitis: 25-30 mg/kg/day.

Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis: 13-15 mg/kg/day.

Commonly reported side effects are nausea, vomiting, diarrhoea, gallstone opacilication, pruritus.

Non-functioning gall-bladder calcified and pigmented gallstones, inflammatory bowel disease.

It should be used cautiously in those with liver disease.

Ursodeoxycholic Acid should not be used with drugs, such as oestrogenic hormones, that increase bile cholesterol. Concomitant administration with bile-acid binding drugs including antacids, charcoal and cholestyramine should be avoided, since this may reduce the effectiveness of therapy with Ursodeoxycholic acid.

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. Problems have not been documented in humans regarding breast feeding.

Store below 25° C. Protected from light and moisture. Keep the medicine out of the reach of children.

Ursodeoxycholic Acid is indicated for the treatment of

• Cholestasis (Jaundice)
• Viral Hepatitis
• Alcoholic Fatty Liver
• Primary Billiary Cirrhosis (PBC)
• Primary Sclerosing Cholangitis (PSC)
• Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis (NASH).

Anti-gallstones drugs: Bile Acids

Ursodeoxycholic Acid is a naturally occurring bile acid used to treat different hepatobilliary disorders. The activity of Ursodeoxycholic Acid is achieved through a decrease in secretion of cholesterol in bile. Ursodeoxycholic Acid achieves this through a few mechanisms: it reduces cholesterol absorption, suppresses liver cholesterol synthesis and it does not inhibit bile acid synthesis.

Therefore, alters bile composition from supersaturated to unsaturated. Ursodeoxycholic Acid also promotes the formation of liquid cholesterol crystal complexes which enhance removal of the cholesterol from the gallbladder into the intestine to be expelled. Ursodeoxycholic Acid improves cholestatic liver diseases by-

• Protecting cholangiocytes against cytotoxicity of hydrophobic bile acids
• Stimulating hepatobilliary secretion
• Protecting hepatocytes against bile acid-induced apoptosis

Ursodeoxycholic Acid is completely absorbed in the upper intestine. Time to peak serum concentration varies from 30 to 150 minutes. The rate of absorption ranges from 60-80%. After absorption Ursodeoxycholic Acid enters the portal vein and undergoes extraction from portal blood by liver where it is conjugated with amino acid & that may be either glycine or taurine and then secreted into the hepatic bile ducts. Small quantities of Ursodeoxycholic Acid appear in the circulation and very small amounts are excreted into urine. The biologic half life of Ursodeoxycholic Acid ranges from 3.5-5.8 days.

Dissolution of Gall stones: 8-12 mg/kg/day either as single night time dose or in divided doses.

Primary Billiary Cirrhosis: 10-15 mg/kg/day in 2-4 divided doses.

Acute Viral Hepatitis: 600 mg/day.

Alcoholic Fatty Liver: 300 mg/day.

Primary Sclerosing Cholangitis: 25-30 mg/kg/day.

Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis: 13-15 mg/kg/day.

Commonly reported side effects are nausea, vomiting, diarrhoea, gallstone opacilication, pruritus.

Non-functioning gall-bladder calcified and pigmented gallstones, inflammatory bowel disease.

It should be used cautiously in those with liver disease.

Ursodeoxycholic Acid should not be used with drugs, such as oestrogenic hormones, that increase bile cholesterol. Concomitant administration with bile-acid binding drugs including antacids, charcoal and cholestyramine should be avoided, since this may reduce the effectiveness of therapy with Ursodeoxycholic acid.

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. Problems have not been documented in humans regarding breast feeding.

Store below 25° C. Protected from light and moisture. Keep the medicine out of the reach of children.

Rupatadine is indicated for the symptomatic treatment of Seasonal & Perennial Allergic Rhinitis and Urticaria.

Non-sedating antihistamines

Rupatadine is a long-acting, non-sedative antagonist of histamine H1-receptors. It also antagonizes the platelet activating factor (PAF). Both histamine and PAF cause broncho constriction which leads to an increase in the vascular permeability and act as a mediator in the inflammatory process. With the dual mode of action, Rupatadine shows better therapeutic effect than an isolated antihistamine. Rupatadine possesses other anti allergic properties such as the inhibition of the degranulation of mast cells induced by immunological and non immunological stimuli and inhibition of the release of cytokines, particularly of the tumor necrosis factor alpha (TNF α) in human mastocytes and monocytes.

Adults and adolescents (over 12 years): The recommended dose is 10 mg once a day. Rupatadine may be taken with or without food.

Children aged 2 to 11 years:

• Children weighing 25 kg or more: 1 teaspoonful (5 ml) of the oral solution once daily with or without food.
• Children weighing equal or more than 10 kg to less than 25 kg: 1/2 teaspoonful (2.5 ml) oral solution once daily with or without food.

Common: Asthenia, dizziness, drowsiness. Uncommon: Appetite increased, arthralgia, back pain, concentration impaired, constipation, cough, diarrhea, dry throat, epistaxis, fever, gastrointestinal discomfort, increased risk of infection, irritability, malaise, myalgia, nasal dryness, nausea, oropharyngeal pain, rash, thirst, vomiting, weight increased. Rare: Palpitations, tachycardia.

Hypersensitivity to Rupatadine or to any of the excipients.

Rupatadine should be used with caution in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia or acute myocardial ischemia. Rupatadine should be used with caution in elderly patients (65 years and older). As there is no clinical experience in patients with impaired kidney or liver function, the use of Rupatadine 10 mg tablets is at present not recommended in these patients.

With medicine: The concomitant administration of Rupatadine 20 mg and ketoconazole or erythromycin increases the systemic exposure. Rupatadine should be used with caution when it is administered concomitantly with these drug substances and other inhibitors of the isozyme CYP3A4. Rupatadine should be used with caution when it is co-administered with statins, CNS depressants or alcohol.

With food: Grapefruit and Grapefruit juice should not be taken simultaneously with Rupatadine

There is no clinical data available on the exposure of Rupatadine during pregnancy. Pregnant women should therefore not use Rupatadine unless the potential benefit outweighs the potential risk for the infant. No information is available, whether Rupatadine is excreted in the mother's milk. Therefore, it should not be used during lactation, unless the potential benefits for the mother justify the potential risk to the infant.

Elderly: Rupatadine should be used with caution in elderly. No information is available that indicates the requirement of any dose adjustment in this population.

Children: Neither the safety nor the efficacy of Rupatadine has been established in patients less than 12 years of age.

Patients with renal or hepatic insufficiency: Use of Rupatadine is not recommended in patients with renal or hepatic insufficiency. As no relevant clinical data is available.

The most common adverse reaction was somnolence. If accidental ingestion of very high doses occurs, symptomatic treatment together with the required supportive measures should be given.

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

Rupatadine is indicated for the symptomatic treatment of Seasonal & Perennial Allergic Rhinitis and Urticaria.

Non-sedating antihistamines

Rupatadine is a long-acting, non-sedative antagonist of histamine H1-receptors. It also antagonizes the platelet activating factor (PAF). Both histamine and PAF cause broncho constriction which leads to an increase in the vascular permeability and act as a mediator in the inflammatory process. With the dual mode of action, Rupatadine shows better therapeutic effect than an isolated antihistamine. Rupatadine possesses other anti allergic properties such as the inhibition of the degranulation of mast cells induced by immunological and non immunological stimuli and inhibition of the release of cytokines, particularly of the tumor necrosis factor alpha (TNF α) in human mastocytes and monocytes.

Adults and adolescents (over 12 years): The recommended dose is 10 mg once a day. Rupatadine may be taken with or without food.

Children aged 2 to 11 years:

• Children weighing 25 kg or more: 1 teaspoonful (5 ml) of the oral solution once daily with or without food.
• Children weighing equal or more than 10 kg to less than 25 kg: 1/2 teaspoonful (2.5 ml) oral solution once daily with or without food.

Common: Asthenia, dizziness, drowsiness. Uncommon: Appetite increased, arthralgia, back pain, concentration impaired, constipation, cough, diarrhea, dry throat, epistaxis, fever, gastrointestinal discomfort, increased risk of infection, irritability, malaise, myalgia, nasal dryness, nausea, oropharyngeal pain, rash, thirst, vomiting, weight increased. Rare: Palpitations, tachycardia.

Hypersensitivity to Rupatadine or to any of the excipients.

Rupatadine should be used with caution in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia or acute myocardial ischemia. Rupatadine should be used with caution in elderly patients (65 years and older). As there is no clinical experience in patients with impaired kidney or liver function, the use of Rupatadine 10 mg tablets is at present not recommended in these patients.

With medicine: The concomitant administration of Rupatadine 20 mg and ketoconazole or erythromycin increases the systemic exposure. Rupatadine should be used with caution when it is administered concomitantly with these drug substances and other inhibitors of the isozyme CYP3A4. Rupatadine should be used with caution when it is co-administered with statins, CNS depressants or alcohol.

With food: Grapefruit and Grapefruit juice should not be taken simultaneously with Rupatadine

There is no clinical data available on the exposure of Rupatadine during pregnancy. Pregnant women should therefore not use Rupatadine unless the potential benefit outweighs the potential risk for the infant. No information is available, whether Rupatadine is excreted in the mother's milk. Therefore, it should not be used during lactation, unless the potential benefits for the mother justify the potential risk to the infant.

Elderly: Rupatadine should be used with caution in elderly. No information is available that indicates the requirement of any dose adjustment in this population.

Children: Neither the safety nor the efficacy of Rupatadine has been established in patients less than 12 years of age.

Patients with renal or hepatic insufficiency: Use of Rupatadine is not recommended in patients with renal or hepatic insufficiency. As no relevant clinical data is available.

The most common adverse reaction was somnolence. If accidental ingestion of very high doses occurs, symptomatic treatment together with the required supportive measures should be given.

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

Sedating Anti-histamine

Hydroxyzine Hydrochloride is an anxiolytic antihistamine of the piperazine class which is a H1 receptor antagonist. Hydroxyzine is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system. Primary skeletal muscle relaxation has been demonstrated experimentally. Bronchodilator activity and antihistaminic and analgesic effects have been demonstrated experimentally and confirmed clinically. An antiemetic effect, both by the apomorphine test and the veriloid test, has been demonstrated. Hydroxyzine is rapidly absorbed from the gastrointestinal tract and clinical effects are usually noted within 15 to 30 minutes after oral administration.

For symptomatic relief of anxiety and tension-

• Adults: 50-100 mg 4 times daily.
• Children (>6 years): 50-100 mg (5-10 teaspoonfuls) daily in divided doses.
• Children (<6 years): 50 mg (5 teaspoonfuls) daily in divided doses.

Pruritus due to allergic conditions-

• Adults: 25 mg 3 to 4 times daily.
• Children ( 6 years): 50-100 mg (5-10 teaspoonfuls) daily in divided doses.
• Children (<6 years): 50 mg (5 teaspoonfuls) daily in divided doses.

As a sedative (premedication and following general anesthesia)-

• Adults: 50-100 mg.
• Children: 0.6 mg/kg of body weight.

Side effects reported with the administration of Hydroxyzine Hhydrochloride are usually mild and transitory in nature. More common side effects include drowsiness, headache, psychomotor impairment, and antimuscarinic effects such as urinary retention, dry mouth, blurred vision, and gastrointestinal disturbances. Other rare side-effects of antihistamines include hypotension, palpitation, arrhythmias, extrapyramidal effects, dizziness, confusion, depression, sleep disturbances, tremor, convulsions, hypersensitivity reactions (including bronchospasm, angioedema, and anaphylaxis, rashes, and photosensitivity reactions), blood disorders, liver dysfunction, and angle-closure glaucoma.

Hydroxyzine is contraindicated in patients with a known hypersensitivity to Hydroxyzine or any of its ingredients.

The potentiating action of Hydroxyzine must be considered when the drug is used in conjunction with central nervous system depressants such as narcotics, non-narcotic analgesics, and barbiturates. Therefore, when central nervous system depressants are administered concomitantly with Hydroxyzine, their dosage should be reduced. Since drowsiness may occur with the use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking Hydroxyzine. Patients should be advised against the simultaneous use of other CNS depressant drugs and cautioned that the effect of alcohol may be increased.

Hydroxyzine may potentiate Meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. Simultaneous administration of Hydroxyzine with monoamine oxidase inhibitors should be avoided.

Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, Hydroxyzine is contraindicated in early pregnancy. It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, Hydroxyzine should not be given to nursing mothers.

Use in renal impairment patient: In case of renal impairment, half of the normal dose should be given.

Use in the elderly patient: In the elderly, it is advised to start with half the recommended dose due to the prolonged action.

The most common manifestation of Hydroxyzine overdosage is hypersedation. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.

If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. Hypotension, though unlikely, may be controlled with intravenous fluids and Levarterenol or Metaraminol. Epinephrine should not be used as Hydroxyzine counteracts its pressor action.

There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of overdosage with Hydroxyzine. However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. There is no practical method to quantitate Hydroxyzine in body fluids or tissue after its ingestion or administration.

Store in a cool & dry place. Protect from light. Keep out of the reach of children.

Sedating Anti-histamine

Hydroxyzine Hydrochloride is an anxiolytic antihistamine of the piperazine class which is a H1 receptor antagonist. Hydroxyzine is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system. Primary skeletal muscle relaxation has been demonstrated experimentally. Bronchodilator activity and antihistaminic and analgesic effects have been demonstrated experimentally and confirmed clinically. An antiemetic effect, both by the apomorphine test and the veriloid test, has been demonstrated. Hydroxyzine is rapidly absorbed from the gastrointestinal tract and clinical effects are usually noted within 15 to 30 minutes after oral administration.

For symptomatic relief of anxiety and tension-

• Adults: 50-100 mg 4 times daily.
• Children (>6 years): 50-100 mg (5-10 teaspoonfuls) daily in divided doses.
• Children (<6 years): 50 mg (5 teaspoonfuls) daily in divided doses.

Pruritus due to allergic conditions-

• Adults: 25 mg 3 to 4 times daily.
• Children ( 6 years): 50-100 mg (5-10 teaspoonfuls) daily in divided doses.
• Children (<6 years): 50 mg (5 teaspoonfuls) daily in divided doses.

As a sedative (premedication and following general anesthesia)-

• Adults: 50-100 mg.
• Children: 0.6 mg/kg of body weight.

Side effects reported with the administration of Hydroxyzine Hhydrochloride are usually mild and transitory in nature. More common side effects include drowsiness, headache, psychomotor impairment, and antimuscarinic effects such as urinary retention, dry mouth, blurred vision, and gastrointestinal disturbances. Other rare side-effects of antihistamines include hypotension, palpitation, arrhythmias, extrapyramidal effects, dizziness, confusion, depression, sleep disturbances, tremor, convulsions, hypersensitivity reactions (including bronchospasm, angioedema, and anaphylaxis, rashes, and photosensitivity reactions), blood disorders, liver dysfunction, and angle-closure glaucoma.

Hydroxyzine is contraindicated in patients with a known hypersensitivity to Hydroxyzine or any of its ingredients.

The potentiating action of Hydroxyzine must be considered when the drug is used in conjunction with central nervous system depressants such as narcotics, non-narcotic analgesics, and barbiturates. Therefore, when central nervous system depressants are administered concomitantly with Hydroxyzine, their dosage should be reduced. Since drowsiness may occur with the use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking Hydroxyzine. Patients should be advised against the simultaneous use of other CNS depressant drugs and cautioned that the effect of alcohol may be increased.

Hydroxyzine may potentiate Meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. Simultaneous administration of Hydroxyzine with monoamine oxidase inhibitors should be avoided.

Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, Hydroxyzine is contraindicated in early pregnancy. It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, Hydroxyzine should not be given to nursing mothers.

Use in renal impairment patient: In case of renal impairment, half of the normal dose should be given.

Use in the elderly patient: In the elderly, it is advised to start with half the recommended dose due to the prolonged action.

The most common manifestation of Hydroxyzine overdosage is hypersedation. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.

If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. Hypotension, though unlikely, may be controlled with intravenous fluids and Levarterenol or Metaraminol. Epinephrine should not be used as Hydroxyzine counteracts its pressor action.

There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of overdosage with Hydroxyzine. However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. There is no practical method to quantitate Hydroxyzine in body fluids or tissue after its ingestion or administration.

Store in a cool & dry place. Protect from light. Keep out of the reach of children.

Ulipristal Acetate is used before surgery to treat moderate to severe symptoms of uterine fibroids, which are noncancerous (benign) tumors of the womb (uterus). Ulipristal Acetate is used in adult women who have not yet reached menopause.

Drugs acting on the Uterus

Ulipristal acetate is a selective progesterone receptor modulator. It acts by blocking the receptor of a hormone in the body called progesterone, which is involved in controlling the growth of the lining of the womb. In some women, progesterone may promote the growth of fibroids, which may cause symptoms such as heavy uterine bleeding, anaemia and abdominal pain. When progesterone activity is blocked, fibroid cells stop dividing and eventually die which reduces the size of the fibroids and reduces the symptoms caused by them.

Ulipristal acetate is taken by mouth and the recommended dose is one tablet (5 mg) a day for up to three months. The three month treatment can be repeated but only once. Treatment should always be started during the first week of the menstrual cycle (period bleeding).

Common side effects are Endometrial thickening, Hot flush, Headache, Uterine haemorrhage

Contraindicated in patients with-

• Hypersensitivity to the active substance or to any of the excipients.
• Pregnancy and breastfeeding.
• Genital bleeding of unknown aetiology or for reasons other than uterine fibroids.
• Uterine, cervical, ovarian or breast cancer.

Ulipristal acetate should only be prescribed after careful diagnosis and Pregnancy should be precluded prior to treatment.

• Contraception: Concomitant use of progestagen-only pills, a progestagen releasing intrauterine device or combined oral contraceptive pills is not recommended. Although a majority of women taking a therapeutic dose of ulipristal acetate have anovulation, a non-hormonal contraceptive method is recommended during treatment.
• Endometrial Changes: Endometrial Thickening or Progesterone receptor modulator Associated Endometrial Changes (PAEC). Ulipristal acetate has a specific pharmacodynamic action on the endometrium. An increase in thickness of the endometrium may occur. The thickness of the endometrium decreases to baseline levels upon treatment cessation. If the endometrial thickening persists beyond 3 months following the end of treatment and return of menstruations, this may need to be investigated as per usual clinical practice to exclude underlying conditions.
• Bleeding Pattern: Patients should be informed that treatment with ulipristal acetate usually leads to a significant reduction in menstrual blood loss or amenorrhea within the first 10 days of treatment. Should the excessive bleeding persist, patients should notify their physician.
• Asthma Patients: Use in women with severe asthma insufficiently controlled by oral glucocorticoids is not recommended.

Pregnancy Category X. Ulipristal acetate is contraindicated during pregnancy. Ulipristal acetate is excreted in human milk and is not recommended.

Hepatic Impairment: Ulipristal acetate is not recommended in patients with severe hepatic impairment unless the patient is closely monitored.

Renal Impairment: Renal impairment is not expected to significantly alter the elimination of ulipristal acetate. In the absence of specific studies, ulipristal acetate is not recommended for patients with moderate and severe renal impairment unless the patient is closely monitored.

Experience with ulipristal acetate overdose is limited. Single doses up to 200 mg and daily doses of 50 mg for 10 consecutive days were administered to a limited number of subjects, and no severe or serious adverse reactions were reported.

Keep protected from light & moisture, store below 25° C. Keep out of reach of children.

Loop diuretics

Furosemide is a monosulphonyl diuretic. It is an effective diuretic that retains its activity even in low glomerular filtration rate (GFR). Furosemide has a distinctive action on renal tubular function. It affects a peak diuresis far greater than that observed with other agents. Other features are (I) prompt onset of action (II) inhibition of sodium and chloride transport in the ascending limb of the loop of Henle and (III) independence of their action from acid-base balance changes. Furosemide acts primarily to inhibit electrolyte reabsorption in the thick ascending limb of the loop of Henle. Furosemide is readily absorbed from the gastrointestinal tract and considerable proportions are bound to plasma proteins. It is rapidly excreted in the urine. With an hour after intravenous injection, its effect is evident in about 5 minutes and last for about 2 hours.

Furosemide 40 mg Tablet-
Edema:

• Adults: The initial adult dose is 40 mg daily, reduced to 20 mg daily or 40mg on alternate days. In some patients daily doses of 80mg or higher (given in divided doses) may be required. The individually determined single dose should then be given once or twice daily (eg, at 8 am and 2 pm). For resistant edema, 80-120 mg daily. In patients with clinically severe edematous states the dose of furosemide may be carefully titrated up to 600 mg/day. When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable.
• Children: Neonate: 0.5-2 mg/kg every 12-24 hours (every 24 hours if postmenstrual age under 31 weeks).
• Child 1 month-12 years: 0.5-2 mg/kg 2-3 times daily (every 24 hours if postmenstrual age less than 31 weeks); higher doses may be required in resistant edema; max. 12 mg/kg daily, not to exceed 80 mg daily.
• Child 12-18 years:20-40 mg daily, increased in resistant edema to 80-120 mg daily.
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Hypertension:

• Adults: The usual initial dose of furosemide for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.
• Children: The usual dose is 1 - 3 mg/kg body weight daily up to a maximum dose of 40mg/day.
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Furosemide 250 mg Tablet: For selected patients with advanced chronic renal failure, diuretic therapy may be started with Furosemide orally. If conventional doses (80 to 160 mg orally) fail to produce an adequate diuresis, a single dose of 250 mg is given as a starting dose. If a satisfactory diuresis does not ensue within 4-6 hours, the initial dose may be doubled to 500 mg. The criterion of optimal dosage is a urinary output of at least 2.5 liters per day. A maximum daily dose of 1000 mg should not be exceeded.

Furosemide Syrup: Furosemide Liquid has an exceptionally wide therapeutic range, the effect being proportional to the dosage. Furosemide Liquid is best given as a single dose either daily or on alternate days. The usual initial daily dose is 40 mg. This may require adjustment until the effective dose is achieved as a maintenance dose. In mild cases, 20 mg daily or 40 mg on alternate days may be sufficient, whereas in cases of resistant edema, daily doses of 80 mg and above may be used as one or two daily, or intermittently. Severe cases may require gradual titration of the furosemide dosage up to 600 mg daily. The recommended maximum daily dose of furosemide administration is 1,500 mg.

Furosemide Injection-
Edema:

Adults: Doses of 20-50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they should be given by slow intravenous infusion. The recommended maximum daily dose of furosemide administration is 1,500 mg.

By slow intravenous injection:

• Neonate: 0.5-1 mg/kg every 12-24 hours (every 24 hours if postmenstrual age under 31 weeks).
• Child 1 month-12 years: 0.5-1 mg/kg repeated every 8 hours as necessary;maximum 2 mg/kg (max. 40 mg) every 8 hours.
• Child 12-18 years: 20-40 mg repeated every 8 hours as necessary; higher doses may be required in resistant cases.

By continuous intravenous infusion:

• Child 1 month-18 years: 0.1-2 mg/kg/hour (following cardiac surgery, initially 100 micrograms/kg/hour, doubled every 2 hours until urine output exceeds 1 mL/kg/hour).
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Hypertension:

• Adults: Doses of 20 to 50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they should be given by slow intravenous infusion. The recommended maximum daily dose of furosemide administration is 1,500 mg. Children: Parenteral doses for children range from 0.5-1.5 mg/kg body weight daily up to a maximum total daily dose of 20 mg.
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

As with other diuretics, electrolytes and water balance may be disturbed as a result of diuresis of prolonged therapy. Prolonged use can produce alkalosis. It may also cause uric acid retention and may rarely produce acute gout. Furosemide may provoke hyperglycemia and glycosuria.

Furosemide is contraindicated in anuria, electrolyte deficiency and pre-comatose states associated with liver cirrhosis. Hypersensitivity to furosemide or sulphonamides.

Patients with prostatic hypertrophy or impairment of micturition have an increased risk of developing acute retention. A marked fall in blood pressure may be seen when ACE inhibitors are added to furosemide therapy. The toxic effects of nephrotoxic antibiotics may be increased by concomitant administration of potent diuretics such furosemide.

Driving a vehicle or performing other hazardous tasks: Some adverse effects (e.g. an undesirably pronounced fall in blood pressure) may impair the patient's ability to concentrate and react, and, therefore, constitute a risk in situations where these abilities are of special importance (e.g. operating a vehicle or machinery).

A marked fall in blood pressure may be seen when ACE inhibitors are added to furosemide therapy. Serum lithium levels may be increased when lithium is given concomitantly with furosemide. The toxic effects of nephrotoxic antibiotics may be increased by concomitant administration of potent diuretics such as furosemide.

Pregnancy category C. Furosemide should be cautiously used in cardiogenic shock complicated by pulmonary oedema and in the first trimester of pregnancy. Blood pressure and pulse during rapid diuresis should be monitored. Caution should be observed in patients liable to electrolyte deficiency. In case of nursing mother, furosemide may inhibit lactation or may pass into breast milk. In that case it should be used with caution.

Protect from light. Do not use it later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

It is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women caused by susceptible strains of Escherichia coli and Enterococcus faecalis.

Intracellular antibiotic

Fosfomycin has in vitro activity against a broad range of gram-positive and gram-negative aerobic microorganisms, associated with uncomplicated urinary tract infections. Fosfomycin Trometamol is a phosphonic acid derivative. It is a synthetic, broad spectrum, bactericidal antibiotic for oral administration. The bactericidal action of Fosfomycin is due to its inactivation of the enzyme enolpyruvyl transferase, thereby irreversibly blocking the condensation of uridine diphosphate N-acetylglucosamine with p-enolpyruvate, one of the first steps in bacterial cell wall synthesis.

The recommended dosage for women 18 years of age and older for acute cystitis is one sachet of Fosfomycin with or without food. This medicine should not used in children.

Preparation: At first pour the 100 ml purified water in a glass. Then add full contents of one Fosfomycin sachet into purified water and stir to dissolve completely. Drink full mixture immediately after preparation.

In clinical trials, the most frequently reported adverse events occurring in >1% of the study population regardless of drug relationship were: diarrhea 10.4%, headache 10.3%, vaginitis 7.6%, nausea 5.2%, rhinitis 4.5%, back pain 3.0%, dysmenorrhea 2.6%, pharyngitis 2.5%, dizziness 2.3%, abdominal pain 2.2%, pain 2.2%, dyspepsia 1.8%, asthenia 1.7%, and rash 1.4%.The following adverse events occurred in clinical trials at a rate of less than 1%, regardless of drug relationship: abnormal stools, anorexia, constipation, dry mouth, dysuria, ear disorder, fever, flatulence, flu syndrome, hematuria, infection, insomnia, lymphadenopathy, menstrual disorder, migraine, myalgia, nervousness, paresthesia, pruritus, SGPT increased, skin disorder, somnolence, and vomiting.

Fosfomycin is contraindicated in patients with known hypersensitivity to the drug and patients with severe renal insufficiency and patients undergoing haemodialysis.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Fosfomycin. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. Do not use more than one single dose of Fosfomycin to treat a single episode of acute cystitis. Repeated daily doses of Fosfomycin did not improve the clinical success or microbiological eradication rates compared to single dose therapy, but did increase the incidence of adverse events.

When Fosfomycin is coadministered with metoclopramide, which increases gastrointestinal motility, lowers the serum concentration and urinary excretion of fosfomycin. Other drugs that increase gastrointestinal motility may produce similar effects.

Fosfomycin is pregnancy category B. This drug should not be used during pregnancy unless the benefit outweighs the risk. A decision should be made to discontinue breastfeeding or to not administer the drug, taking into account the importance of the drug to the mother.

When Fosfomycin is coadministered with metoclopramide, which increases gastrointestinal motility, lowers the serum concentration and urinary excretion of fosfomycin. Other drugs that increase gastrointestinal motility may produce similar effects.

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light.

This tablet is indicated for-

• The management of moderate to moderately severe pain in adults.
• The short-term (five days or less) management of acute pain.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.

Tramadol is a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M₁ metabolite to μ-opioid receptors and weak inhibition of the reuptake of norepinephrine and serotonin. Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M₁ to μ-opioid receptors. Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro, as have some other opioid analgesics.These mechanisms may contribute independently to the overall analgesic profile of tramadol.

For the management of moderate to moderately severe pain: The recommended dose is 1 or 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.

In case of short-term (five days or less) management of acute pain: The recommended dose is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.

This tablet can be administered without regard to food.

The following adverse reactions may happen to this therapy: asthenia, fatigue, hot flushes, dizziness, headache, tremor, abdominal pain, constipation, diarrhea, dyspepsia, dry mouth, nausea, vomiting, anorexia, anxiety, confusion, euphoria, insomnia, nervousness, somnolence pruritus, rash, increased sweating etc.

Tramadol & Paracetamol combination tablets should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, paracetamol, any other component of this product, or opioids. This is contraindicated in any situation where opioids are contraindicated.

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. This combination
preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. This combination preparation is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied.

pediatric use: The safety and effectiveness of this combination preparation have not been studied in the pediatric population.

Geriatric use:  In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function; of concomitant disease and multiple drug therapy.

Use in Renal Disease: This combination preparation has not been studied in patients with impaired renal
function. In patients with creatinine clearances of less than 30 ml/min, it is recommended that the dosing interval of this combination preparation be increased but not to exceed 2 tablets every 12 hours.

Use in Hepatic Disease: This combination preparation has not been studied in patients with impaired hepatic function. The use of this combination preparation in patients with hepatic impairment is not recommended.

Store in a cool and dry place. Do not freeze. Keep all medicines out of the reach of children.

Tramadol is used for the treatment of moderate to severe painful conditions. These include:

• Postoperative pain
• Colic and spastic pain
• Cancer pain
• Joint pain
• Neck and back pain
• Pain associated with osteoporosis.

Opioid analgesics

Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.

Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.

Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.

Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.

Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.

Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.

Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.

Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.

Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.

Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.

Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.

Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.

In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.

Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.

In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Tramadol is used for the treatment of moderate to severe painful conditions. These include:

• Postoperative pain
• Colic and spastic pain
• Cancer pain
• Joint pain
• Neck and back pain
• Pain associated with osteoporosis.

Opioid analgesics

Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.

Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.

Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.

Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.

Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.

Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.

Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.

Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.

Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.

Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.

Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.

Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.

In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.

Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.

In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Tramadol is used for the treatment of moderate to severe painful conditions. These include:

• Postoperative pain
• Colic and spastic pain
• Cancer pain
• Joint pain
• Neck and back pain
• Pain associated with osteoporosis.

Opioid analgesics

Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.

Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.

Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.

Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.

Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.

Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.

Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.

Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.

Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.

Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.

Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.

Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.

In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.

Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.

In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.