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Proton Pump Inhibitor

Lansoprazole is a substituted benzimidazole, and is also known as PPI due to its property to block the final step of acid secretion by inhibiting H⁺/K⁺ ATPase enzyme system in gastric parietal cell. Both basal and stimulated acid are inhibited.

Benign gastric ulcer: 30 mg daily in the morning for 8 weeks.

Duodenal ulcer: 30 mg daily in the morning for 4 weeks; maintenance 15 mg.

NSAID-associated duodenal or gastric ulcer: 15-30 mg daily for 4 weeks, followed by a further 4 weeks if not fully healed.

Zollinger-Ellison syndrome (and other hypersecretory conditions): Initially 60 mg once daily adjusted according to response; daily doses of 120 mg or more is given in two divided doses.

Gastroesophageal reflux disease: 30 mg daily in the morning for 4 weeks, followed by a further 4 weeks if not fully healed; maintenance 15-30 mg daily.

Acid-related dyspepsia: 15-30 mg daily in the morning for 2-4 weeks.

Severe or irreversible adverse effects: The possible induction of carcinoid tumors by profound acid suppression, and a rise in serum gastrin may occur. There is a rise in serum gastrin levels in the first 3 months of treatment, which are then maintained though at a lower level than those found in pernicious anaemia. Long term treatment with a proton pump inhibitor in patients with Helicobacter pylori infection may accelerate the development of atrophic gastritis.

Symptomatic adverse effect: Dose dependent diarrhoea occurs with an incidence of about 4% at 30 mg per day, rising to 8% at 60 mg per day. Headache occurs in 2-3% of treated patients

Lansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.

Gastric malignancy should be ruled out. Hepatic impairment. Pregnancy and lactation.

Lansoprazole appears to be a selective inhibitor of the cytochrome P-450 monooxygenase system; there may be an effect on hepatic clearance, but there have been no reports to date of clinically relevant interactions. There is some uncertainty over the effect of Lansoprazole on the oral combined contraceptive pill. Further assessment is currently underway. Physiological changes similar to those found with Omeprazole are likely to take place because of the reduction in gastric acid, which is likely to influence the bacterial colonization of the stomach and duodenum and also vitamin B12 absorption.

Lansoprazole should be avoided in pregnancy unless there are compelling reasons.

Neonates:There is no relevant human data. The drug is not recommended for use with neonates.

Children: The youngest person to have received Lansoprazole in clinical trials was 13 years old.

The Elderly: No problems have been encoun- tered in clinical use and there has been no increase in adverse drug reaction in the elderly.

Store at 25° C.

Proton Pump Inhibitor

Lansoprazole is a substituted benzimidazole, and is also known as PPI due to its property to block the final step of acid secretion by inhibiting H⁺/K⁺ ATPase enzyme system in gastric parietal cell. Both basal and stimulated acid are inhibited.

Benign gastric ulcer: 30 mg daily in the morning for 8 weeks.

Duodenal ulcer: 30 mg daily in the morning for 4 weeks; maintenance 15 mg.

NSAID-associated duodenal or gastric ulcer: 15-30 mg daily for 4 weeks, followed by a further 4 weeks if not fully healed.

Zollinger-Ellison syndrome (and other hypersecretory conditions): Initially 60 mg once daily adjusted according to response; daily doses of 120 mg or more is given in two divided doses.

Gastroesophageal reflux disease: 30 mg daily in the morning for 4 weeks, followed by a further 4 weeks if not fully healed; maintenance 15-30 mg daily.

Acid-related dyspepsia: 15-30 mg daily in the morning for 2-4 weeks.

Severe or irreversible adverse effects: The possible induction of carcinoid tumors by profound acid suppression, and a rise in serum gastrin may occur. There is a rise in serum gastrin levels in the first 3 months of treatment, which are then maintained though at a lower level than those found in pernicious anaemia. Long term treatment with a proton pump inhibitor in patients with Helicobacter pylori infection may accelerate the development of atrophic gastritis.

Symptomatic adverse effect: Dose dependent diarrhoea occurs with an incidence of about 4% at 30 mg per day, rising to 8% at 60 mg per day. Headache occurs in 2-3% of treated patients

Lansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.

Gastric malignancy should be ruled out. Hepatic impairment. Pregnancy and lactation.

Lansoprazole appears to be a selective inhibitor of the cytochrome P-450 monooxygenase system; there may be an effect on hepatic clearance, but there have been no reports to date of clinically relevant interactions. There is some uncertainty over the effect of Lansoprazole on the oral combined contraceptive pill. Further assessment is currently underway. Physiological changes similar to those found with Omeprazole are likely to take place because of the reduction in gastric acid, which is likely to influence the bacterial colonization of the stomach and duodenum and also vitamin B12 absorption.

Lansoprazole should be avoided in pregnancy unless there are compelling reasons.

Neonates:There is no relevant human data. The drug is not recommended for use with neonates.

Children: The youngest person to have received Lansoprazole in clinical trials was 13 years old.

The Elderly: No problems have been encoun- tered in clinical use and there has been no increase in adverse drug reaction in the elderly.

Store at 25° C.

Total diet replacement or supplement in anorexia, illness, convalescence, pregnancy, lactation, old age, weight loss, fatigue, pre- & post-surgical conditions, oral pathology, cancer, transition from TPN & tube feeding for adults & older persons. Specialized nutrition with fiber for diabetic patients.

Oral nutritional preparations

No data has found

To prepare a 250 ml feeding, put 200 ml of cold water in a glass. Gradually add 6 level scoops (enclosed) of powder while stirring and mix until dissolved. When mixed as directed powder provides approx. 1 k.cal. per ml.

Hypersensitivity to any of the ingredient of this product.

There are no known drug interactions and none well documented

Pregnancy Category: Not Classified. FDA has not yet classified the drug into a specified pregnancy category.

Total diet replacement or supplement in anorexia, illness, convalescence, pregnancy, lactation, old age, weight loss, fatigue, pre- & post-surgical conditions, oral pathology, cancer, transition from TPN & tube feeding for adults & older persons. Specialized nutrition with fiber for diabetic patients.

Oral nutritional preparations

No data has found

To prepare a 250 ml feeding, put 200 ml of cold water in a glass. Gradually add 6 level scoops (enclosed) of powder while stirring and mix until dissolved. When mixed as directed powder provides approx. 1 k.cal. per ml.

Hypersensitivity to any of the ingredient of this product.

There are no known drug interactions and none well documented

Pregnancy Category: Not Classified. FDA has not yet classified the drug into a specified pregnancy category.

Total diet replacement or supplement in anorexia, illness, convalescence, pregnancy, lactation, old age, weight loss, fatigue, pre- & post-surgical conditions, oral pathology, cancer, transition from TPN & tube feeding for adults & older persons. Specialized nutrition with fiber for diabetic patients.

Oral nutritional preparations

No data has found

To prepare a 250 ml feeding, put 200 ml of cold water in a glass. Gradually add 6 level scoops (enclosed) of powder while stirring and mix until dissolved. When mixed as directed powder provides approx. 1 k.cal. per ml.

Hypersensitivity to any of the ingredient of this product.

There are no known drug interactions and none well documented

Pregnancy Category: Not Classified. FDA has not yet classified the drug into a specified pregnancy category.

Aluminium Hydroxide and Magnesium Hydroxide is indicated for Hyperacidity, peptic ulcer, gastritis, heartburn, sour stomach & dyspepsia.

Antacids

This drug is well-balanced combination of essential non-systemic antacids which excel in efficacy and palatability. These are dependable antacid preparations without acid rebound, constipating or cathertic effects. Both the preparations provide symptomatic relief of hyperacidity associated with heartburn, acid ingestion or sour stomach.

Aluminium hydroxide gel, a slow acting antacid and an adsorbent with prolonged effect, has high neutralizing power. Magnesium Hydroxide possesses a slow but sustained acid neutralizing property. Antacids of both tablet and suspension possess adsorbent property. They form a protecting coating over the ulcer surface facilitating its healing; thus protecting the sensitive mucosa of stomach and duodenum from further irritation.

Tablet: Two tablets 1-3 hours after meal and at bed time or as directed by the physician.

Suspension: 2 tea spoonful 1-3 hours after meal and at bed time or as directed by the physician.

Long term use of any antacid results in alkaluria, which may predispose to nephrolithiasis by forming precipitation of calcium phosphate.

This is contraindicated in hypophosphataemia. It is also contraindicated in alkalosis and hypermagnesaemia where abdominal distention may be due to partial or complete intestinal obstruction.

Antacids reduce the absorption of tetracycline when given concomitantly. These should not be used concomitantly

This drug inhibits the absorption of following drugs: Azithromycin, cefpodoxime, ciprofloxacin, isoniazid, rifampicin, norfloxacin, ofloxacin, pivampicillin, tetracyclines, Gabapentin and phenytoin, Itraconazole, ketoconazole, Chloroquine, hydroxychloroquine and Phenothiazines.

It is advised to avoid antacid preparations in the first trimester of pregnancy.

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

Antacids

This is the mixture of non-systemic acid neutralizing substances and antiflatulent. This preparation offers reliability as well as long action. Aluminium Hydroxide and Magnesium Hydroxide induce the relief of ulcer by neutralizing gastric acid secreted from parietal cells of the stomach. The clinical use of simethicone is based on its antifoam properties. Simethicone spreads on the surface of aqueous liquids, forming a film of low surface tension and causing collapse of foam bubbles. Simethicone repeatedly allows mucous surrounded gas bubbles in the GI tract to coalesce and be expelled.

This is used in the treatment of flatulence and meteorism for the elimination of gas, air or foam from the gastro-intestinal tract prior to radiography and for the relief of abdominal distension and dyspepsia.

Simethicone is physiologically inert; it does not appeared to be absorbed from the GI tract to interfere with gastric secretion or absorption of nutrients. Following oral administration, the drug is excreted unchanged in the feces.

Tablet: 1-2 tablets 1-3 hours after meal and at bed time or as directed by the physician.

Suspension: 1-2 teaspoonful 1-3 hours after meal and at bedtime or as directed by the physician.

Gastrointestinal side effects are uncommon. Occasionally, if excessive amount is consumed, diarrhea, constipation or regurgitation may occur.

This should not be administered in patients with renal failure or hypophosphataemia or in those who are severely debilitated. It is also contraindicated in alkalosis and hypermagnesaemia, where abdominal distention may be due to partial or complete intestinal obstruction.

This should be used with caution in patients with kidney disease.

All antacids may increase or decrease the rate and/or extent of absorption of concomitantly administered oral drugs. Antacids decrease the bioavailability of theophyline, tetracycline, quinolone antibiotics, isoniazide, ketoconazole, ethambutol, some antimuscarinic drugs, benzodiazepines, phenothiazines, ranitidine, indomethacine, nitrofurantoin, fluoride, phosphate, propanolol, atenolol, digoxins, vitamins etc. Antacids increase the bioavailability of some drugs; e.g. sulphonamides, levodopa, valproic acid, enteric coated aspirin etc.

It is advised to avoid antacid preparations in the first trimester of pregnancy.

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

Antacids

This is the mixture of non-systemic acid neutralizing substances and antiflatulent. This preparation offers reliability as well as long action. Aluminium Hydroxide and Magnesium Hydroxide induce the relief of ulcer by neutralizing gastric acid secreted from parietal cells of the stomach. The clinical use of simethicone is based on its antifoam properties. Simethicone spreads on the surface of aqueous liquids, forming a film of low surface tension and causing collapse of foam bubbles. Simethicone repeatedly allows mucous surrounded gas bubbles in the GI tract to coalesce and be expelled.

This is used in the treatment of flatulence and meteorism for the elimination of gas, air or foam from the gastro-intestinal tract prior to radiography and for the relief of abdominal distension and dyspepsia.

Simethicone is physiologically inert; it does not appeared to be absorbed from the GI tract to interfere with gastric secretion or absorption of nutrients. Following oral administration, the drug is excreted unchanged in the feces.

Tablet: 1-2 tablets 1-3 hours after meal and at bed time or as directed by the physician.

Suspension: 1-2 teaspoonful 1-3 hours after meal and at bedtime or as directed by the physician.

Gastrointestinal side effects are uncommon. Occasionally, if excessive amount is consumed, diarrhea, constipation or regurgitation may occur.

This should not be administered in patients with renal failure or hypophosphataemia or in those who are severely debilitated. It is also contraindicated in alkalosis and hypermagnesaemia, where abdominal distention may be due to partial or complete intestinal obstruction.

This should be used with caution in patients with kidney disease.

All antacids may increase or decrease the rate and/or extent of absorption of concomitantly administered oral drugs. Antacids decrease the bioavailability of theophyline, tetracycline, quinolone antibiotics, isoniazide, ketoconazole, ethambutol, some antimuscarinic drugs, benzodiazepines, phenothiazines, ranitidine, indomethacine, nitrofurantoin, fluoride, phosphate, propanolol, atenolol, digoxins, vitamins etc. Antacids increase the bioavailability of some drugs; e.g. sulphonamides, levodopa, valproic acid, enteric coated aspirin etc.

It is advised to avoid antacid preparations in the first trimester of pregnancy.

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

Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevation in serum aminotransferases (ALT or AST) or histologically active disease.

Hepatic viral infections (Hepatitis B)

By competing with the natural substrate deoxyguanosine triphosphate, entecavir functionally inhibits all three activities of the HBV polymerase (reverse transcriptase, rt):

• Base priming,
• Reverse transcription of the negative strand from the pregenomic messenger RNA, and
• Synthesis of the positive strand of HBV DNA. Upon activation by kinases, the drug can be incorporated into the DNA which has the ultimate effect of inhibiting the HBV polymerase activity.

The recommended dose of Entecavir for chronic hepatitis B virus infection in nucleoside-treatment-naive adults and adolescents 16 years of age is 0.5 mg once daily. For Lamivudine-refractory or known Lamivudine or Telbivudine resistance mutations, the recommended dose of Entecavir is 1 mg once daily. For patients with decompensated liver disease (adult) the recommended dose of Entecavir is 1 mg once daily. Entecavir should be administered on an empty stomach (at least 2 hours after a meal or 2 hours before the next meal).

Missed Dose: If it is almost time for next dose, skip the missed dose and take the next dose at the proper time. Nobody should take a double dose to make up for the missed dose.

The most common adverse events are headache, fatigue, dizziness and nausea.

Entecavir is contraindicated in patients with previously demonstrated hypersensitivity to Entecavir or any component of the product.

Lactic acidosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals.

Exacerbations of hepatitis after discontinuation of treatment: Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including Entecavir.

Co-administration of Entecavir with Lamivudine or Adefovir dipivoxil did not result in significant drug interactions. The effects of co-administration of Entecavir with other drugs that are eliminated through renal or are known to affect renal function have not been evaluated and patients should be monitored closely for adverse events when coadministered with such drugs.

There are no data on the effect of Entecavir on the transmission of HBV from mother to infant. Therefore, appropriate care should be taken. It is not known whether it is excreted in human milk. Mothers should be instructed not to breastfeed if they are taking Entecavir.

Pediatric: Safety and effectiveness of Entecavir in pediatric patients below the age of 2 years have not been established.

Geriatric: Clinical studies of Entecavir did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. But care should be taken in dose selection, and it may be useful to monitor renal function.

Dose adjustment in renal impairment: Dose adjustment is recommended for patients with CrCl <50 ml/min including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) as shown below:

• CrCl ≥50 ml/min: 0.5 mg every 24 hours
• CrCl 30 to <50 ml/min: 0.5 mg every 48 hours
• CrCl 10 to <30 ml/min: 0.5 mg every 72 hours
• CrCl <10 ml/min or  Hemodialysis or CAPD: 0.5 mg every 7 days

There is no experience of Entecavir overdosage reported in patients. Healthy subjects who received up to 20 mg daily for up to 14 days and single doses up to 40 mg had no unexpected adverse events. If overdosage occurs, the patient must be monitored for evidence of toxicity and standard supportive treatment as necessary.

Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.

Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevation in serum aminotransferases (ALT or AST) or histologically active disease.

Hepatic viral infections (Hepatitis B)

By competing with the natural substrate deoxyguanosine triphosphate, entecavir functionally inhibits all three activities of the HBV polymerase (reverse transcriptase, rt):

• Base priming,
• Reverse transcription of the negative strand from the pregenomic messenger RNA, and
• Synthesis of the positive strand of HBV DNA. Upon activation by kinases, the drug can be incorporated into the DNA which has the ultimate effect of inhibiting the HBV polymerase activity.

The recommended dose of Entecavir for chronic hepatitis B virus infection in nucleoside-treatment-naive adults and adolescents 16 years of age is 0.5 mg once daily. For Lamivudine-refractory or known Lamivudine or Telbivudine resistance mutations, the recommended dose of Entecavir is 1 mg once daily. For patients with decompensated liver disease (adult) the recommended dose of Entecavir is 1 mg once daily. Entecavir should be administered on an empty stomach (at least 2 hours after a meal or 2 hours before the next meal).

Missed Dose: If it is almost time for next dose, skip the missed dose and take the next dose at the proper time. Nobody should take a double dose to make up for the missed dose.

The most common adverse events are headache, fatigue, dizziness and nausea.

Entecavir is contraindicated in patients with previously demonstrated hypersensitivity to Entecavir or any component of the product.

Lactic acidosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals.

Exacerbations of hepatitis after discontinuation of treatment: Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including Entecavir.

Co-administration of Entecavir with Lamivudine or Adefovir dipivoxil did not result in significant drug interactions. The effects of co-administration of Entecavir with other drugs that are eliminated through renal or are known to affect renal function have not been evaluated and patients should be monitored closely for adverse events when coadministered with such drugs.

There are no data on the effect of Entecavir on the transmission of HBV from mother to infant. Therefore, appropriate care should be taken. It is not known whether it is excreted in human milk. Mothers should be instructed not to breastfeed if they are taking Entecavir.

Pediatric: Safety and effectiveness of Entecavir in pediatric patients below the age of 2 years have not been established.

Geriatric: Clinical studies of Entecavir did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. But care should be taken in dose selection, and it may be useful to monitor renal function.

Dose adjustment in renal impairment: Dose adjustment is recommended for patients with CrCl <50 ml/min including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) as shown below:

• CrCl ≥50 ml/min: 0.5 mg every 24 hours
• CrCl 30 to <50 ml/min: 0.5 mg every 48 hours
• CrCl 10 to <30 ml/min: 0.5 mg every 72 hours
• CrCl <10 ml/min or  Hemodialysis or CAPD: 0.5 mg every 7 days

There is no experience of Entecavir overdosage reported in patients. Healthy subjects who received up to 20 mg daily for up to 14 days and single doses up to 40 mg had no unexpected adverse events. If overdosage occurs, the patient must be monitored for evidence of toxicity and standard supportive treatment as necessary.

Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.

Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevation in serum aminotransferases (ALT or AST) or histologically active disease.

Hepatic viral infections (Hepatitis B)

By competing with the natural substrate deoxyguanosine triphosphate, entecavir functionally inhibits all three activities of the HBV polymerase (reverse transcriptase, rt):

• Base priming,
• Reverse transcription of the negative strand from the pregenomic messenger RNA, and
• Synthesis of the positive strand of HBV DNA. Upon activation by kinases, the drug can be incorporated into the DNA which has the ultimate effect of inhibiting the HBV polymerase activity.

The recommended dose of Entecavir for chronic hepatitis B virus infection in nucleoside-treatment-naive adults and adolescents 16 years of age is 0.5 mg once daily. For Lamivudine-refractory or known Lamivudine or Telbivudine resistance mutations, the recommended dose of Entecavir is 1 mg once daily. For patients with decompensated liver disease (adult) the recommended dose of Entecavir is 1 mg once daily. Entecavir should be administered on an empty stomach (at least 2 hours after a meal or 2 hours before the next meal).

Missed Dose: If it is almost time for next dose, skip the missed dose and take the next dose at the proper time. Nobody should take a double dose to make up for the missed dose.

The most common adverse events are headache, fatigue, dizziness and nausea.

Entecavir is contraindicated in patients with previously demonstrated hypersensitivity to Entecavir or any component of the product.

Lactic acidosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals.

Exacerbations of hepatitis after discontinuation of treatment: Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including Entecavir.

Co-administration of Entecavir with Lamivudine or Adefovir dipivoxil did not result in significant drug interactions. The effects of co-administration of Entecavir with other drugs that are eliminated through renal or are known to affect renal function have not been evaluated and patients should be monitored closely for adverse events when coadministered with such drugs.

There are no data on the effect of Entecavir on the transmission of HBV from mother to infant. Therefore, appropriate care should be taken. It is not known whether it is excreted in human milk. Mothers should be instructed not to breastfeed if they are taking Entecavir.

Pediatric: Safety and effectiveness of Entecavir in pediatric patients below the age of 2 years have not been established.

Geriatric: Clinical studies of Entecavir did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. But care should be taken in dose selection, and it may be useful to monitor renal function.

Dose adjustment in renal impairment: Dose adjustment is recommended for patients with CrCl <50 ml/min including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) as shown below:

• CrCl ≥50 ml/min: 0.5 mg every 24 hours
• CrCl 30 to <50 ml/min: 0.5 mg every 48 hours
• CrCl 10 to <30 ml/min: 0.5 mg every 72 hours
• CrCl <10 ml/min or  Hemodialysis or CAPD: 0.5 mg every 7 days

There is no experience of Entecavir overdosage reported in patients. Healthy subjects who received up to 20 mg daily for up to 14 days and single doses up to 40 mg had no unexpected adverse events. If overdosage occurs, the patient must be monitored for evidence of toxicity and standard supportive treatment as necessary.

Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.

Bacillus clausii spores is used for managing the alterations of the intestinal bacterial flora. Bacillus clausii spores restores the equilibrium of the intestinal flora changed during diarrhoea or in the course of thera-pies with antibiotics or chemo-therapy, contributing to correct the consequent dysvitaminosis (that is the imbalance of production and assimilation of the vitamins).

Other antibiotic

Bacillus clausii spores is a probiotic which is useful for the management of imbalance of intestinal bacterial flora due to diverse causes. The possible presence of corpuscles visible in the vials of Enterogermina is due to aggregates of Bacillus clausii spores and does not, therefore, indicate that the product has undergone any changes.

Adults: from 2 to 3 mini bottles a day
Children: from 1 to 2 mini bottles a day
Infants: from 1 to 2 mini bottles a day

Do not exceed the instructed doses without the advice of the professional. Bacillus clausii spores is presented in the form of  an oral suspension in water and is available as 5 ml mini bottles. One pack contains 10 ready-to-drink mini bottles.

Take Bacillus clausii spores at regular intervals during the day. Consult the professional if the condition recurs or if you have noticed any recent change in the nature of problems. Use only for brief periods of Management.

It is necessary to shake the mini bottle before use. To open the mini bottle rotate the upper part and detach it. Take the content as such or dilute it in water or other drinks (for example; Milk, Tea, Orange juice). Once open, consume it within a short period to avoid contamination of the suspension.

No side effects have been reported with the use of Enterogermina. However, it is important to communicate any undesirable effects.

Hypersensitivity towards the components or other closely related substances.

During antibiotic therapy, the product should be administered in the interval between one dose of antibiotic and the next. Keep out of the reach of children. Contact your doctor if the condition worsen after 2-3 days of usage.

Bacillus clausii spores can be used during pregnancy & lactation

Excessive doses of Enterogermina do not produce side effects. However, it is better to follow the recommended doses. While there are no particular problems associated with missing a dose, it is advisable to complete the daily dose for best results. Remember that the correct and careful administration increases its effectiveness.

The un-opened mini bottles of Enterogermina are stable for a period of 24 months. Do not use Enterogermina after the expiry date on the label. Store at a temperature not higher than 30°C.

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs

Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.

Tablet: Adult:

• Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
• Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
• Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
• Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
• Typhoid fever: 500 mg twice daily (7 days)
• Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
• Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
• Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
• Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
• Gonorrhea: 500 mg as a single dose
• Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
• Meningitis: 500 mg as a single dose.
• Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.

Suspension: Pediatric: 10-20 mg/kg (max. 750 mg) twice daily (10 to 21 days). The duration of therapy depends on the type and severity of the infection.

Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.

For IV infusion:

• Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
• Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
• Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
• Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
• Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
• Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.

Instruction for the use of Ciprofloxacin IV infusion-

• Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible bags in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of bag.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend bag from hanger.
• Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Ciprofloxacin IV infusion.
• Open flow control clamp to expel air from set.Close clamp.
• Regulate rate of administration with flow control clamp

Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. For acute infections the usual treatment period is 5 to 10 days. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have been disappeared.

Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.

It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.

Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.

Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.

Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.

Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.

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

This tablet contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan. This tablet inhibits neprilysin (neutral endopeptidase; NEP) via LBQ657, the active metabolite of the prodrug sacubitril, and blocks the angiotensin II type-1 (AT1 ) receptor via valsartan. The cardiovascular and renal effects of this tablet in heart failure patients are attributed to the increased levels of peptides that are degraded by neprilysin, such as natriuretic peptides, by LBQ657, and the simultaneous inhibition of the effects of angiotensin II by valsartan. Valsartan inhibits the effects of angiotensin II by selectively blocking the AT1 receptor, and also inhibits angiotensin II-dependent aldosterone release.

Adult Heart Failure: The recommended starting dose is 49/51 mg orally twice daily. Double the dose after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.

Reduce the starting dose to 24/26 mg twice daily for:

• Patients not currently taking an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents.
• Patients with severe renal impairment.
• Patients with moderate hepatic impairment.

Pediatric Heart Failure: Refer to Table 1 for the recommended dose for pediatric patients aged one year and older. Take the recommended dose orally twice daily. Adjust pediatric patient doses every 2 weeks, as tolerated by the patient.

Recommended Dose Titration-

Pediatric Patients Less than 40 kg:

• Starting: 1.6 mg/kg
• Second: 2.3 mg/kg
• Final: 3.1 mg/kg

Pediatric Patients At least 40 kg, less than 50 kg:

• Starting: 24/26 mg
• Second: 49/51 mg
• Final: 49/51 mg

Pediatric Patients At least 50 kg:

• Starting: 49/51 mg
• Second: 72/78 mg
• Final: 97/103 mg

The most common side effects are Angioedema, Hypotension, Impaired Renal Function, Hyperkalemia, Cough, Dizziness.

This combination is contraindicated:

• In patients with hypersensitivity to any component
• In patients with a history of angioedema related to previous ACE inhibitor or ARB therapy 
• With concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor 
• With concomitant use of aliskiren in patients with diabetes

This tablet may cause angioedema and must not be used in patients with a known history of angioedema related to previous ACEi or ARB therapy and in patients with hereditary angioedema.

This tablet lowers blood pressure and may cause symptomatic hypotension. Closely monitor serum creatinine, and down-titrate or interrupt this tablet in patients who develop a clinically significant decrease in renal function. In patients with renal artery stenosis, monitor renal function.

Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet. Dosage reduction or interruption of this tablet may be required.

Dual Blockade of the Renin-Angiotensin-Aldosterone System: Should not be used with an ACEi, aliskiren in patients with diabetes, and use with an ARB should be avoided.
Potassium-sparing Diuretics: Serum potassium level may be increased.
NSAIDs: Risk of renal impairment may be increased.
Lithium: Increased risk of lithium toxicity.

Pediatric Use: Safety and effectiveness have not been established in pediatric patients less than 1 year of age.

Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (>65 years) or very elderly (>75 years) patients compared to the overall population.
 
Hepatic Impairment: No dose adjustment is required when administering this tablet to patients with mild hepatic impairment (Child-Pugh A classification). This tablet is not recommended in patients with severe hepatic impairment, as no studies have been conducted in these patients.

Renal Impairment: No dose adjustment is required in patients with mild (eGFR 60 to 90 ml/min/1.73 m2) to moderate (eGFR 30 to 60 ml/min/1.73 m2) renal impairment. The recommended starting dose in patients with severe renal impairment (eGFR <30 ml/min/1.73 m2) is 24/26 mg twice daily.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (≥65 years) or very elderly (≥75 years) patients compared to the overall population

Renal Impairment:

• Severe: A starting dose of 24/26 mg twice-daily is recommended for patients with severe renal impairment (eGFR <30 mL/min/1.73 m²). Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
• Mild or moderate: No starting dose adjustment is needed for mild or moderate renal impairment.

Hepatic Impairment:

• Moderate: A starting dose of 24/26 mg twice-daily is recommended for patients with moderate hepatic impairment (Child-Pugh B classification). Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
• Mild: No starting dose adjustment is needed for mild hepatic impairment.
• Severe: Use in patients with severe hepatic impairment is not recommended.

Limited data are available with regard to overdosage in human subjects with this tablet. In healthy volunteers, a single dose of this tablet 583 mg sacubitril/617 mg valsartan, and multiple doses of 437 mg sacubitril/463 mg valsartan (14 days) have been studied and were well tolerated. Hypotension is the most likely result of overdosage due to the blood-pressure-lowering effects of this tablet. Symptomatic treatment should be provided. This tablet is unlikely to be removed by hemodialysis because of high protein binding.

Keep in a dry place and store below 30°C. Protect from moisture and keep out of the reach of children.

This tablet contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan. This tablet inhibits neprilysin (neutral endopeptidase; NEP) via LBQ657, the active metabolite of the prodrug sacubitril, and blocks the angiotensin II type-1 (AT1 ) receptor via valsartan. The cardiovascular and renal effects of this tablet in heart failure patients are attributed to the increased levels of peptides that are degraded by neprilysin, such as natriuretic peptides, by LBQ657, and the simultaneous inhibition of the effects of angiotensin II by valsartan. Valsartan inhibits the effects of angiotensin II by selectively blocking the AT1 receptor, and also inhibits angiotensin II-dependent aldosterone release.

Adult Heart Failure: The recommended starting dose is 49/51 mg orally twice daily. Double the dose after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.

Reduce the starting dose to 24/26 mg twice daily for:

• Patients not currently taking an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents.
• Patients with severe renal impairment.
• Patients with moderate hepatic impairment.

Pediatric Heart Failure: Refer to Table 1 for the recommended dose for pediatric patients aged one year and older. Take the recommended dose orally twice daily. Adjust pediatric patient doses every 2 weeks, as tolerated by the patient.

Recommended Dose Titration-

Pediatric Patients Less than 40 kg:

• Starting: 1.6 mg/kg
• Second: 2.3 mg/kg
• Final: 3.1 mg/kg

Pediatric Patients At least 40 kg, less than 50 kg:

• Starting: 24/26 mg
• Second: 49/51 mg
• Final: 49/51 mg

Pediatric Patients At least 50 kg:

• Starting: 49/51 mg
• Second: 72/78 mg
• Final: 97/103 mg

The most common side effects are Angioedema, Hypotension, Impaired Renal Function, Hyperkalemia, Cough, Dizziness.

This combination is contraindicated:

• In patients with hypersensitivity to any component
• In patients with a history of angioedema related to previous ACE inhibitor or ARB therapy 
• With concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor 
• With concomitant use of aliskiren in patients with diabetes

This tablet may cause angioedema and must not be used in patients with a known history of angioedema related to previous ACEi or ARB therapy and in patients with hereditary angioedema.

This tablet lowers blood pressure and may cause symptomatic hypotension. Closely monitor serum creatinine, and down-titrate or interrupt this tablet in patients who develop a clinically significant decrease in renal function. In patients with renal artery stenosis, monitor renal function.

Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet. Dosage reduction or interruption of this tablet may be required.

Dual Blockade of the Renin-Angiotensin-Aldosterone System: Should not be used with an ACEi, aliskiren in patients with diabetes, and use with an ARB should be avoided.
Potassium-sparing Diuretics: Serum potassium level may be increased.
NSAIDs: Risk of renal impairment may be increased.
Lithium: Increased risk of lithium toxicity.

Pediatric Use: Safety and effectiveness have not been established in pediatric patients less than 1 year of age.

Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (>65 years) or very elderly (>75 years) patients compared to the overall population.
 
Hepatic Impairment: No dose adjustment is required when administering this tablet to patients with mild hepatic impairment (Child-Pugh A classification). This tablet is not recommended in patients with severe hepatic impairment, as no studies have been conducted in these patients.

Renal Impairment: No dose adjustment is required in patients with mild (eGFR 60 to 90 ml/min/1.73 m2) to moderate (eGFR 30 to 60 ml/min/1.73 m2) renal impairment. The recommended starting dose in patients with severe renal impairment (eGFR <30 ml/min/1.73 m2) is 24/26 mg twice daily.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (≥65 years) or very elderly (≥75 years) patients compared to the overall population

Renal Impairment:

• Severe: A starting dose of 24/26 mg twice-daily is recommended for patients with severe renal impairment (eGFR <30 mL/min/1.73 m²). Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
• Mild or moderate: No starting dose adjustment is needed for mild or moderate renal impairment.

Hepatic Impairment:

• Moderate: A starting dose of 24/26 mg twice-daily is recommended for patients with moderate hepatic impairment (Child-Pugh B classification). Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
• Mild: No starting dose adjustment is needed for mild hepatic impairment.
• Severe: Use in patients with severe hepatic impairment is not recommended.

Limited data are available with regard to overdosage in human subjects with this tablet. In healthy volunteers, a single dose of this tablet 583 mg sacubitril/617 mg valsartan, and multiple doses of 437 mg sacubitril/463 mg valsartan (14 days) have been studied and were well tolerated. Hypotension is the most likely result of overdosage due to the blood-pressure-lowering effects of this tablet. Symptomatic treatment should be provided. This tablet is unlikely to be removed by hemodialysis because of high protein binding.

Keep in a dry place and store below 30°C. Protect from moisture and keep out of the reach of children.

This tablet contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan. This tablet inhibits neprilysin (neutral endopeptidase; NEP) via LBQ657, the active metabolite of the prodrug sacubitril, and blocks the angiotensin II type-1 (AT1 ) receptor via valsartan. The cardiovascular and renal effects of this tablet in heart failure patients are attributed to the increased levels of peptides that are degraded by neprilysin, such as natriuretic peptides, by LBQ657, and the simultaneous inhibition of the effects of angiotensin II by valsartan. Valsartan inhibits the effects of angiotensin II by selectively blocking the AT1 receptor, and also inhibits angiotensin II-dependent aldosterone release.

Adult Heart Failure: The recommended starting dose is 49/51 mg orally twice daily. Double the dose after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.

Reduce the starting dose to 24/26 mg twice daily for:

• Patients not currently taking an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents.
• Patients with severe renal impairment.
• Patients with moderate hepatic impairment.

Pediatric Heart Failure: Refer to Table 1 for the recommended dose for pediatric patients aged one year and older. Take the recommended dose orally twice daily. Adjust pediatric patient doses every 2 weeks, as tolerated by the patient.

Recommended Dose Titration-

Pediatric Patients Less than 40 kg:

• Starting: 1.6 mg/kg
• Second: 2.3 mg/kg
• Final: 3.1 mg/kg

Pediatric Patients At least 40 kg, less than 50 kg:

• Starting: 24/26 mg
• Second: 49/51 mg
• Final: 49/51 mg

Pediatric Patients At least 50 kg:

• Starting: 49/51 mg
• Second: 72/78 mg
• Final: 97/103 mg

The most common side effects are Angioedema, Hypotension, Impaired Renal Function, Hyperkalemia, Cough, Dizziness.

This combination is contraindicated:

• In patients with hypersensitivity to any component
• In patients with a history of angioedema related to previous ACE inhibitor or ARB therapy 
• With concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor 
• With concomitant use of aliskiren in patients with diabetes

This tablet may cause angioedema and must not be used in patients with a known history of angioedema related to previous ACEi or ARB therapy and in patients with hereditary angioedema.

This tablet lowers blood pressure and may cause symptomatic hypotension. Closely monitor serum creatinine, and down-titrate or interrupt this tablet in patients who develop a clinically significant decrease in renal function. In patients with renal artery stenosis, monitor renal function.

Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet. Dosage reduction or interruption of this tablet may be required.

Dual Blockade of the Renin-Angiotensin-Aldosterone System: Should not be used with an ACEi, aliskiren in patients with diabetes, and use with an ARB should be avoided.
Potassium-sparing Diuretics: Serum potassium level may be increased.
NSAIDs: Risk of renal impairment may be increased.
Lithium: Increased risk of lithium toxicity.

Pediatric Use: Safety and effectiveness have not been established in pediatric patients less than 1 year of age.

Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (>65 years) or very elderly (>75 years) patients compared to the overall population.
 
Hepatic Impairment: No dose adjustment is required when administering this tablet to patients with mild hepatic impairment (Child-Pugh A classification). This tablet is not recommended in patients with severe hepatic impairment, as no studies have been conducted in these patients.

Renal Impairment: No dose adjustment is required in patients with mild (eGFR 60 to 90 ml/min/1.73 m2) to moderate (eGFR 30 to 60 ml/min/1.73 m2) renal impairment. The recommended starting dose in patients with severe renal impairment (eGFR <30 ml/min/1.73 m2) is 24/26 mg twice daily.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (≥65 years) or very elderly (≥75 years) patients compared to the overall population

Renal Impairment:

• Severe: A starting dose of 24/26 mg twice-daily is recommended for patients with severe renal impairment (eGFR <30 mL/min/1.73 m²). Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
• Mild or moderate: No starting dose adjustment is needed for mild or moderate renal impairment.

Hepatic Impairment:

• Moderate: A starting dose of 24/26 mg twice-daily is recommended for patients with moderate hepatic impairment (Child-Pugh B classification). Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
• Mild: No starting dose adjustment is needed for mild hepatic impairment.
• Severe: Use in patients with severe hepatic impairment is not recommended.

Limited data are available with regard to overdosage in human subjects with this tablet. In healthy volunteers, a single dose of this tablet 583 mg sacubitril/617 mg valsartan, and multiple doses of 437 mg sacubitril/463 mg valsartan (14 days) have been studied and were well tolerated. Hypotension is the most likely result of overdosage due to the blood-pressure-lowering effects of this tablet. Symptomatic treatment should be provided. This tablet is unlikely to be removed by hemodialysis because of high protein binding.

Keep in a dry place and store below 30°C. Protect from moisture and keep out of the reach of children.

This tablet contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan. This tablet inhibits neprilysin (neutral endopeptidase; NEP) via LBQ657, the active metabolite of the prodrug sacubitril, and blocks the angiotensin II type-1 (AT1 ) receptor via valsartan. The cardiovascular and renal effects of this tablet in heart failure patients are attributed to the increased levels of peptides that are degraded by neprilysin, such as natriuretic peptides, by LBQ657, and the simultaneous inhibition of the effects of angiotensin II by valsartan. Valsartan inhibits the effects of angiotensin II by selectively blocking the AT1 receptor, and also inhibits angiotensin II-dependent aldosterone release.

Adult Heart Failure: The recommended starting dose is 49/51 mg orally twice daily. Double the dose after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.

Reduce the starting dose to 24/26 mg twice daily for:

• Patients not currently taking an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents.
• Patients with severe renal impairment.
• Patients with moderate hepatic impairment.

Pediatric Heart Failure: Refer to Table 1 for the recommended dose for pediatric patients aged one year and older. Take the recommended dose orally twice daily. Adjust pediatric patient doses every 2 weeks, as tolerated by the patient.

Recommended Dose Titration-

Pediatric Patients Less than 40 kg:

• Starting: 1.6 mg/kg
• Second: 2.3 mg/kg
• Final: 3.1 mg/kg

Pediatric Patients At least 40 kg, less than 50 kg:

• Starting: 24/26 mg
• Second: 49/51 mg
• Final: 49/51 mg

Pediatric Patients At least 50 kg:

• Starting: 49/51 mg
• Second: 72/78 mg
• Final: 97/103 mg

The most common side effects are Angioedema, Hypotension, Impaired Renal Function, Hyperkalemia, Cough, Dizziness.

This combination is contraindicated:

• In patients with hypersensitivity to any component
• In patients with a history of angioedema related to previous ACE inhibitor or ARB therapy 
• With concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor 
• With concomitant use of aliskiren in patients with diabetes

This tablet may cause angioedema and must not be used in patients with a known history of angioedema related to previous ACEi or ARB therapy and in patients with hereditary angioedema.

This tablet lowers blood pressure and may cause symptomatic hypotension. Closely monitor serum creatinine, and down-titrate or interrupt this tablet in patients who develop a clinically significant decrease in renal function. In patients with renal artery stenosis, monitor renal function.

Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet. Dosage reduction or interruption of this tablet may be required.

Dual Blockade of the Renin-Angiotensin-Aldosterone System: Should not be used with an ACEi, aliskiren in patients with diabetes, and use with an ARB should be avoided.
Potassium-sparing Diuretics: Serum potassium level may be increased.
NSAIDs: Risk of renal impairment may be increased.
Lithium: Increased risk of lithium toxicity.

Pediatric Use: Safety and effectiveness have not been established in pediatric patients less than 1 year of age.

Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (>65 years) or very elderly (>75 years) patients compared to the overall population.
 
Hepatic Impairment: No dose adjustment is required when administering this tablet to patients with mild hepatic impairment (Child-Pugh A classification). This tablet is not recommended in patients with severe hepatic impairment, as no studies have been conducted in these patients.

Renal Impairment: No dose adjustment is required in patients with mild (eGFR 60 to 90 ml/min/1.73 m2) to moderate (eGFR 30 to 60 ml/min/1.73 m2) renal impairment. The recommended starting dose in patients with severe renal impairment (eGFR <30 ml/min/1.73 m2) is 24/26 mg twice daily.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (≥65 years) or very elderly (≥75 years) patients compared to the overall population

Renal Impairment:

• Severe: A starting dose of 24/26 mg twice-daily is recommended for patients with severe renal impairment (eGFR <30 mL/min/1.73 m²). Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
• Mild or moderate: No starting dose adjustment is needed for mild or moderate renal impairment.

Hepatic Impairment:

• Moderate: A starting dose of 24/26 mg twice-daily is recommended for patients with moderate hepatic impairment (Child-Pugh B classification). Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
• Mild: No starting dose adjustment is needed for mild hepatic impairment.
• Severe: Use in patients with severe hepatic impairment is not recommended.

Limited data are available with regard to overdosage in human subjects with this tablet. In healthy volunteers, a single dose of this tablet 583 mg sacubitril/617 mg valsartan, and multiple doses of 437 mg sacubitril/463 mg valsartan (14 days) have been studied and were well tolerated. Hypotension is the most likely result of overdosage due to the blood-pressure-lowering effects of this tablet. Symptomatic treatment should be provided. This tablet is unlikely to be removed by hemodialysis because of high protein binding.

Keep in a dry place and store below 30°C. Protect from moisture and keep out of the reach of children.

This tablet contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan. This tablet inhibits neprilysin (neutral endopeptidase; NEP) via LBQ657, the active metabolite of the prodrug sacubitril, and blocks the angiotensin II type-1 (AT1 ) receptor via valsartan. The cardiovascular and renal effects of this tablet in heart failure patients are attributed to the increased levels of peptides that are degraded by neprilysin, such as natriuretic peptides, by LBQ657, and the simultaneous inhibition of the effects of angiotensin II by valsartan. Valsartan inhibits the effects of angiotensin II by selectively blocking the AT1 receptor, and also inhibits angiotensin II-dependent aldosterone release.

Adult Heart Failure: The recommended starting dose is 49/51 mg orally twice daily. Double the dose after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.

Reduce the starting dose to 24/26 mg twice daily for:

• Patients not currently taking an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents.
• Patients with severe renal impairment.
• Patients with moderate hepatic impairment.

Pediatric Heart Failure: Refer to Table 1 for the recommended dose for pediatric patients aged one year and older. Take the recommended dose orally twice daily. Adjust pediatric patient doses every 2 weeks, as tolerated by the patient.

Recommended Dose Titration-

Pediatric Patients Less than 40 kg:

• Starting: 1.6 mg/kg
• Second: 2.3 mg/kg
• Final: 3.1 mg/kg

Pediatric Patients At least 40 kg, less than 50 kg:

• Starting: 24/26 mg
• Second: 49/51 mg
• Final: 49/51 mg

Pediatric Patients At least 50 kg:

• Starting: 49/51 mg
• Second: 72/78 mg
• Final: 97/103 mg

The most common side effects are Angioedema, Hypotension, Impaired Renal Function, Hyperkalemia, Cough, Dizziness.

This combination is contraindicated:

• In patients with hypersensitivity to any component
• In patients with a history of angioedema related to previous ACE inhibitor or ARB therapy 
• With concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor 
• With concomitant use of aliskiren in patients with diabetes

This tablet may cause angioedema and must not be used in patients with a known history of angioedema related to previous ACEi or ARB therapy and in patients with hereditary angioedema.

This tablet lowers blood pressure and may cause symptomatic hypotension. Closely monitor serum creatinine, and down-titrate or interrupt this tablet in patients who develop a clinically significant decrease in renal function. In patients with renal artery stenosis, monitor renal function.

Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet. Dosage reduction or interruption of this tablet may be required.

Dual Blockade of the Renin-Angiotensin-Aldosterone System: Should not be used with an ACEi, aliskiren in patients with diabetes, and use with an ARB should be avoided.
Potassium-sparing Diuretics: Serum potassium level may be increased.
NSAIDs: Risk of renal impairment may be increased.
Lithium: Increased risk of lithium toxicity.

Pediatric Use: Safety and effectiveness have not been established in pediatric patients less than 1 year of age.

Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (>65 years) or very elderly (>75 years) patients compared to the overall population.
 
Hepatic Impairment: No dose adjustment is required when administering this tablet to patients with mild hepatic impairment (Child-Pugh A classification). This tablet is not recommended in patients with severe hepatic impairment, as no studies have been conducted in these patients.

Renal Impairment: No dose adjustment is required in patients with mild (eGFR 60 to 90 ml/min/1.73 m2) to moderate (eGFR 30 to 60 ml/min/1.73 m2) renal impairment. The recommended starting dose in patients with severe renal impairment (eGFR <30 ml/min/1.73 m2) is 24/26 mg twice daily.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (≥65 years) or very elderly (≥75 years) patients compared to the overall population

Renal Impairment:

• Severe: A starting dose of 24/26 mg twice-daily is recommended for patients with severe renal impairment (eGFR <30 mL/min/1.73 m²). Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
• Mild or moderate: No starting dose adjustment is needed for mild or moderate renal impairment.

Hepatic Impairment:

• Moderate: A starting dose of 24/26 mg twice-daily is recommended for patients with moderate hepatic impairment (Child-Pugh B classification). Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
• Mild: No starting dose adjustment is needed for mild hepatic impairment.
• Severe: Use in patients with severe hepatic impairment is not recommended.

Limited data are available with regard to overdosage in human subjects with this tablet. In healthy volunteers, a single dose of this tablet 583 mg sacubitril/617 mg valsartan, and multiple doses of 437 mg sacubitril/463 mg valsartan (14 days) have been studied and were well tolerated. Hypotension is the most likely result of overdosage due to the blood-pressure-lowering effects of this tablet. Symptomatic treatment should be provided. This tablet is unlikely to be removed by hemodialysis because of high protein binding.

Keep in a dry place and store below 30°C. Protect from moisture and keep out of the reach of children.

This tablet contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan. This tablet inhibits neprilysin (neutral endopeptidase; NEP) via LBQ657, the active metabolite of the prodrug sacubitril, and blocks the angiotensin II type-1 (AT1 ) receptor via valsartan. The cardiovascular and renal effects of this tablet in heart failure patients are attributed to the increased levels of peptides that are degraded by neprilysin, such as natriuretic peptides, by LBQ657, and the simultaneous inhibition of the effects of angiotensin II by valsartan. Valsartan inhibits the effects of angiotensin II by selectively blocking the AT1 receptor, and also inhibits angiotensin II-dependent aldosterone release.

Adult Heart Failure: The recommended starting dose is 49/51 mg orally twice daily. Double the dose after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.

Reduce the starting dose to 24/26 mg twice daily for:

• Patients not currently taking an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents.
• Patients with severe renal impairment.
• Patients with moderate hepatic impairment.

Pediatric Heart Failure: Refer to Table 1 for the recommended dose for pediatric patients aged one year and older. Take the recommended dose orally twice daily. Adjust pediatric patient doses every 2 weeks, as tolerated by the patient.

Recommended Dose Titration-

Pediatric Patients Less than 40 kg:

• Starting: 1.6 mg/kg
• Second: 2.3 mg/kg
• Final: 3.1 mg/kg

Pediatric Patients At least 40 kg, less than 50 kg:

• Starting: 24/26 mg
• Second: 49/51 mg
• Final: 49/51 mg

Pediatric Patients At least 50 kg:

• Starting: 49/51 mg
• Second: 72/78 mg
• Final: 97/103 mg

The most common side effects are Angioedema, Hypotension, Impaired Renal Function, Hyperkalemia, Cough, Dizziness.

This combination is contraindicated:

• In patients with hypersensitivity to any component
• In patients with a history of angioedema related to previous ACE inhibitor or ARB therapy 
• With concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor 
• With concomitant use of aliskiren in patients with diabetes

This tablet may cause angioedema and must not be used in patients with a known history of angioedema related to previous ACEi or ARB therapy and in patients with hereditary angioedema.

This tablet lowers blood pressure and may cause symptomatic hypotension. Closely monitor serum creatinine, and down-titrate or interrupt this tablet in patients who develop a clinically significant decrease in renal function. In patients with renal artery stenosis, monitor renal function.

Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet. Dosage reduction or interruption of this tablet may be required.

Dual Blockade of the Renin-Angiotensin-Aldosterone System: Should not be used with an ACEi, aliskiren in patients with diabetes, and use with an ARB should be avoided.
Potassium-sparing Diuretics: Serum potassium level may be increased.
NSAIDs: Risk of renal impairment may be increased.
Lithium: Increased risk of lithium toxicity.

Pediatric Use: Safety and effectiveness have not been established in pediatric patients less than 1 year of age.

Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (>65 years) or very elderly (>75 years) patients compared to the overall population.
 
Hepatic Impairment: No dose adjustment is required when administering this tablet to patients with mild hepatic impairment (Child-Pugh A classification). This tablet is not recommended in patients with severe hepatic impairment, as no studies have been conducted in these patients.

Renal Impairment: No dose adjustment is required in patients with mild (eGFR 60 to 90 ml/min/1.73 m2) to moderate (eGFR 30 to 60 ml/min/1.73 m2) renal impairment. The recommended starting dose in patients with severe renal impairment (eGFR <30 ml/min/1.73 m2) is 24/26 mg twice daily.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (≥65 years) or very elderly (≥75 years) patients compared to the overall population

Renal Impairment:

• Severe: A starting dose of 24/26 mg twice-daily is recommended for patients with severe renal impairment (eGFR <30 mL/min/1.73 m²). Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
• Mild or moderate: No starting dose adjustment is needed for mild or moderate renal impairment.

Hepatic Impairment:

• Moderate: A starting dose of 24/26 mg twice-daily is recommended for patients with moderate hepatic impairment (Child-Pugh B classification). Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
• Mild: No starting dose adjustment is needed for mild hepatic impairment.
• Severe: Use in patients with severe hepatic impairment is not recommended.

Limited data are available with regard to overdosage in human subjects with this tablet. In healthy volunteers, a single dose of this tablet 583 mg sacubitril/617 mg valsartan, and multiple doses of 437 mg sacubitril/463 mg valsartan (14 days) have been studied and were well tolerated. Hypotension is the most likely result of overdosage due to the blood-pressure-lowering effects of this tablet. Symptomatic treatment should be provided. This tablet is unlikely to be removed by hemodialysis because of high protein binding.

Keep in a dry place and store below 30°C. Protect from moisture and keep out of the reach of children.

Anastrozole is indicated in-

• Treatment of early breast cancer in hormone receptor positive post-menopausal women.
• Adjuvant treatment of early breast cancer in hormone receptor positive
• postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.
• Reduction in the incidence of contralateral breast cancers in post menopausal women receiving Anastrozole as adjuvant treatment for early breast cancer.
• Treatment of advanced breast cancer in post-menopausal women.

Hormonal Chemotherapy

Anastrazole exerts its anti-estrogenic effects via selective and competitive inhibition of the aromatase enzyme found predominantly in the adrenal glands, liver, and fatty tissues. Many breast cancers are hormone receptor-positive, meaning their growth is stimulated and/or maintained by the presence of hormones such as estrogen or progesterone. In postmenopausal women, estrogen is primarily derived from the conversion of adrenally-produced androgens into estrogens by the aromatase enzyme- by competitively inhibiting the biosynthesis of estrogen at these enzymes, anastrozole effectively suppresses circulating estrogen levels and, subsequently, the growth of hormone receptor-positive tumours.

Adults Including the Elderly: One tablet (1 mg) to be taken orally once a day.
Children: The use of Anastrozole is not recommended in children, as efficacy has not been established
Renal Impairment: No dose change is recommended.
Hepatic Impairment: No dose change is recommended.

Very common side effects: Hot flushes, asthenia, joint stiffness, arthritis, headache, nausea, rash etc. Common side effects: Hair thinning, allergic reactions, diarrhea, vomiting, somnolence etc.

Anastrozole is not recommended for use in children or in pre-menopausal women as safety and efficacy have not been established in these groups of patients.

• Anastrozole has not been investigated in patients with severe hepatic or severe renal impairment. The potential risk/benefit to such patients should be carefully considered before administration of Anastrozole.
• As Anastrozole lowers circulating estrogen levels, it may cause a reduction in bone mineral density with a possible consequent increased risk of fracture.

Tamoxifen and/or other therapies containing estrogen should not be co-administered with Anastrozole.

Anastrozole must not be administered during pregnancy or lactation.

There is limited clinical experience of overdose of Anastrozole. There are no reports where a patient has taken a dose in excess of 60 mg. No toxicity was observed and no clinically relevant adverse effects have been seen.

Store in a cool & dry place, protected from light and moisture. Keep out of reach of children.