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Anti-diarrhoeal Antimicrobial drugs, Macrolides

Erythromycin inhibits microsomal protein synthesis in susceptible organisms by inhibiting the translocation process. Specific binding to the 50S subunit or 70S ribosome occurs in these organisms but there is no binding to the stable 80S mammalian ribosome. Erythromycin is active against many Grampositive bacteria, some Gram-negative bacteria and against mycoplasmas and chlamydia.

Absorption: Erythromycin base is destroyed by acid and is therefore administered in the form of stable ester. The rates of absorption of the base and esters are diminished by the presence of food. The stearate is hydrolyzed in the intestine and the free erythromycin absorbed.

Blood concentration: After an oral dose of 500 mg. of the base of stearate, peak serum concentrations of 0.9 to 1.4 or 0.4 to 1.8 mg/ml. respectively are attained in 1 to 4 hours. Half-life: The serum half-life is 1.2 to 4 hours. In subjects with oliguria, the half-life is about 5 hours.

Distribution: Erythromycin is widely distributed throughout body tissue and fluids with some retention in the liver and spleen, protein binding of erythromycin base is 73%. Erythromycin enters the cerebrospinal fluid when the meninges are inflamed. It also crosses the placenta and is excreted in the milk.

Excretion: 5 to 15 % of the dose of erythromycin is excreted in the urine and large amounts of the unchanged active substance are excreted in the bile.

Adult and Children over 8 years: 250-500 mg every six hours for mild to moderate infections. This may be increased upto 4 gm. or more daily in severe cases.

Elderly: No special dosage recommendation. Erythromycin may be administered if desired, three times daily or twice daily by giving one-third or half of the total daily requirement 8 hourly or 12 hourly respectively.

Children aged 2 to 8 years: 250 mg. every six hours or 30-50 mg/kg body weight per day divided into four equal dosage.

Infants and Children upto 2 years: 500 mg. in divided doses or 30-50 mg/kg body weight in divided doses.

Allergic reactions are rare and mild although anaphylaxis has occurred. Occasionally there is abdominal discomfort after oral administration, sometimes with nausea and vomiting. This discomfort usually subsides after a few days without it being necessary to reduce the dosage.

Known hypersensitivity to Erythromycin.

Erythromycin should be given with care in patients with impaired hepatic function, as erythromycin is excreted principally in the bile.

Recent data from studies of erythromycin reveals that its use in patients who are receiving high dosage of theophylline may be associated with an increase of serum theophylline levels and potential theophylline toxicity. In such cases this dose of theophylline should be reduced.

Clinical and Laboratory studies have been shown no evidence in human of teratogenicity or toxicity. However, caution should be exercised when prescribing this drug to pregnant patients and lactating mothers since erythromycin crosses the placental barrier and is excreted in breast milk.

In case of overdosage, Erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted. Erythromycin is not removed by peritoneal dialysis or haemodialysis.

Direction for reconstitution of suspension: Shake the bottle to loosen powder. Add 60 ml or 100 ml of boiled and cooled water to the dry powder of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in suspension.

Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 7 days.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.

Other beta-lactam Antibiotics

The bactericidal activity of ertapenem results from the inhibition of cell wall synthesis and is mediated through ertapenem binding to penicillin binding proteins (PBPs). In Escherichia coli, it has strong affinity toward PBPs 1a, 1b, 2, 3, 4 and 5 with preference for PBPs 2 and 3. Ertapenem is stable against hydrolysis by a variety of beta-lactamases, including penicillinases, and cephalosporinases and extended spectrum beta-lactamases. Ertapenem is hydrolyzed by metallo-beta-lactamases.

Ertapenem should be infused over 30 minutes in both the Treatment and Prophylactic regimens. Dosing considerations should be made in adults with advanced or end-stage renal impairment and those on hemodialysis.

Treatment regimen:

• Adults and pediatric patients 13 years of age and older. The dosage should be 1 gram once a day intravenously or intramuscularly.
• Patients 3 months to 12 years of age should be administered 15 mg/kg twice daily (not to exceed 1 g/day intravenously or intramuscularly.)
• Intravenous infusion may be administered in adults and pediatrics for up to 14 days or intramuscular injection for up to 7 days.

Prophylaxis regimen for adults:

• 1 gram single dose given 1 hour prior to elective colorectal surgery.

Adults: The most common adverse reactions (≥5%) in patients treated with Ertapenem, including those who were switched to therapy with an oral antimicrobial, were diarrhea, nausea, headache and infused vein complication. In the prophylaxis indication, the overall adverse experience profile was generally comparable to that observed for ertapenem in other clinical trials.

Pediatrics: Adverse reactions in this population were comparable to adults. The most common adverse reactions (≥5%) in pediatric patients treated with Ertapenem, including those who were switched to therapy with an oral antimicrobial, were diarrhea, vomiting and infusion site pain.

Known hypersensitivity to product components or anaphylactic reactions to β-lactams. Due to the use of lidocaine HCl as a diluent, Ertapenem administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide-type.

Pregnancy Category B. There are, however, no adequate and well-controlled trials in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Ertapenem is excreted in human breast milk. Caution should be exercised when Ertapenem is administered to a nursing woman. Ertapenem should be administered to nursing mothers only when the expected benefit outweighs the risk.

Pediatric Use: Safety and effectiveness of Ertapenem in pediatric patients 3 months to 17 years of age are supported by evidence from adequate and well-controlled trials in adults, pharmacokinetic data in pediatric patients, and additional data from comparator-controlled trials in pediatric patients 3 months to 17 years of age.

Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function

Patients with Renal Impairment: Dosage adjustment is necessary in patients with creatinine clearance 30 mL/min or less.

Patients with Hepatic Impairment: The pharmacokinetics of ertapenem in patients with hepatic impairment have not been established.

No specific information is available on the treatment of overdosage with Ertapenem. Intentional overdosing of Ertapenem is unlikely. Intravenous administration of Ertapenem at a dose of 2 g over 30 min or 3 g over 1-2h in healthy adult volunteers resulted in an increased incidence of nausea. In clinical trials in adults, inadvertent administration of three 1 g doses of Ertapenem in a 24 hour period resulted in diarrhea and transient dizziness in one patient. In pediatric clinical trials, a single intravenous dose of 40 mg/kg up to a maximum of 2 g did not result in toxicity. In the event of an overdose, Ertapenem should be discontinued and general supportive treatment given until renal elimination takes place. Ertapenem can be removed by hemodialysis; the plasma clearance of the total fraction of ertapenem was increased 30% in subjects with end-stage renal disease when hemodialysis (4 hour session) was performed immediately following administration. However, no information is available on the use of hemodialysis to treat overdosage.

Ertapenem 1 g single dose should be prepared with diluent containers containing 50 mL or 100 mL of 0.9% Sodium Chloride Injection. When prepared with this diluent, Ertapenem for Injection maintains satisfactory potency for 6 hours at room temperature (25°C) or for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of Ertapenem should not be frozen.

Sertaconazole cream is indicated for the topical treatment of interdigital tinea pedis and other topical fungal infections in immunocompetent patients 12 years of age and older, caused by Trichophyton rubrum, Trichophyton mentagrophytes and Epidermophyton floccosum.

Drugs used in Vaginal and Vulval condition, Topical Antifungal preparations

Sertaconazole, an imidazole antifungal agent, inhibits fungal cytochrome P450-mediated 14 alpha-lanosterol demethylase enzyme. Ergosterol is the key component of fungal cell membranes and lack of this component leads to fungal cell injury by leakage of key constituents in the cytoplasm from the cell.

In the treatment of interdigital tinea pedis, Sertaconazole cream should be applied twice daily for 4 weeks. A sufficient amount of Sertaconazole cream should be applied to cover both the affected areas between the toes and the immediately surrounding healthy skin of patients with interdigital tinea pedis. Not for ophthalmic, oral, or intravaginal use.

Pediatric Use: The efficacy and safety of Fungitac cream 2% have not been established in pediatric patients below the age of 12 years.

Geriatric Use: Clinical trials of Fungitac cream 2% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Most common adverse reactions observed in clinical trials are contact dermatitis, dry skin, burning skin, application site skin tenderness.

Sertaconazole cream is contraindicated in patients who have a known or suspected hypersensitivity to sertaconazole nitrate or any of its components or other imidazoles.

Sertaconazole cream is for use on the skin only. If irritation develops, treatment should be discontinued and appropriate therapy instituted. Physicians should exercise caution when prescribing Sertaconazole cream to patients known to be sensitive to azole antifungals, since cross-reactivity may occur.

Potential interactions between Sertaconazole cream and other drugs have not been systematically evaluated.

There are no adequate & well-controlled studies conducted with Sertaconazole cream in pregnant women. Sertaconazole cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Sertaconazole cream is excreted in human milk. Caution should be exercised when prescribing Sertaconazole cream to a nursing woman.

There is no data availalble about overdose of Sertaconazole cream.

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

Other beta-lactam Antibiotics

The bactericidal activity of ertapenem results from the inhibition of cell wall synthesis and is mediated through ertapenem binding to penicillin binding proteins (PBPs). In Escherichia coli, it has strong affinity toward PBPs 1a, 1b, 2, 3, 4 and 5 with preference for PBPs 2 and 3. Ertapenem is stable against hydrolysis by a variety of beta-lactamases, including penicillinases, and cephalosporinases and extended spectrum beta-lactamases. Ertapenem is hydrolyzed by metallo-beta-lactamases.

Ertapenem should be infused over 30 minutes in both the Treatment and Prophylactic regimens. Dosing considerations should be made in adults with advanced or end-stage renal impairment and those on hemodialysis.

Treatment regimen:

• Adults and pediatric patients 13 years of age and older. The dosage should be 1 gram once a day intravenously or intramuscularly.
• Patients 3 months to 12 years of age should be administered 15 mg/kg twice daily (not to exceed 1 g/day intravenously or intramuscularly.)
• Intravenous infusion may be administered in adults and pediatrics for up to 14 days or intramuscular injection for up to 7 days.

Prophylaxis regimen for adults:

• 1 gram single dose given 1 hour prior to elective colorectal surgery.

Adults: The most common adverse reactions (≥5%) in patients treated with Ertapenem, including those who were switched to therapy with an oral antimicrobial, were diarrhea, nausea, headache and infused vein complication. In the prophylaxis indication, the overall adverse experience profile was generally comparable to that observed for ertapenem in other clinical trials.

Pediatrics: Adverse reactions in this population were comparable to adults. The most common adverse reactions (≥5%) in pediatric patients treated with Ertapenem, including those who were switched to therapy with an oral antimicrobial, were diarrhea, vomiting and infusion site pain.

Known hypersensitivity to product components or anaphylactic reactions to β-lactams. Due to the use of lidocaine HCl as a diluent, Ertapenem administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide-type.

Pregnancy Category B. There are, however, no adequate and well-controlled trials in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Ertapenem is excreted in human breast milk. Caution should be exercised when Ertapenem is administered to a nursing woman. Ertapenem should be administered to nursing mothers only when the expected benefit outweighs the risk.

Pediatric Use: Safety and effectiveness of Ertapenem in pediatric patients 3 months to 17 years of age are supported by evidence from adequate and well-controlled trials in adults, pharmacokinetic data in pediatric patients, and additional data from comparator-controlled trials in pediatric patients 3 months to 17 years of age.

Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function

Patients with Renal Impairment: Dosage adjustment is necessary in patients with creatinine clearance 30 mL/min or less.

Patients with Hepatic Impairment: The pharmacokinetics of ertapenem in patients with hepatic impairment have not been established.

No specific information is available on the treatment of overdosage with Ertapenem. Intentional overdosing of Ertapenem is unlikely. Intravenous administration of Ertapenem at a dose of 2 g over 30 min or 3 g over 1-2h in healthy adult volunteers resulted in an increased incidence of nausea. In clinical trials in adults, inadvertent administration of three 1 g doses of Ertapenem in a 24 hour period resulted in diarrhea and transient dizziness in one patient. In pediatric clinical trials, a single intravenous dose of 40 mg/kg up to a maximum of 2 g did not result in toxicity. In the event of an overdose, Ertapenem should be discontinued and general supportive treatment given until renal elimination takes place. Ertapenem can be removed by hemodialysis; the plasma clearance of the total fraction of ertapenem was increased 30% in subjects with end-stage renal disease when hemodialysis (4 hour session) was performed immediately following administration. However, no information is available on the use of hemodialysis to treat overdosage.

Ertapenem 1 g single dose should be prepared with diluent containers containing 50 mL or 100 mL of 0.9% Sodium Chloride Injection. When prepared with this diluent, Ertapenem for Injection maintains satisfactory potency for 6 hours at room temperature (25°C) or for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of Ertapenem should not be frozen.

Targeted Cancer Therapy

NSCLC: The recommended daily dose of Erlotinib for NSCLC is 150 mg taken on an empty stomach, i.e., at least one hour before or two hours after the ingestion of food. Treatment should continue until disease progression or unacceptable toxicity occurs.

Pancreatic Cancer: The recommended daily dose of Erlotinib for pancreatic cancer is 100 mg taken once daily in combination with gemcitabine. Take Erlotinib on an empty stomach, i.e., at least one hour before or two hours after the ingestion of food. Treatment should continue until disease progression or unacceptable toxicity occurs.

Reduce Erlotinib by 50 mg decrements: If severe reactions occur with concomitant use of strong CYP3A4 inhibitors (such as atazanavir, Clarithromycin, Indinavir, Itraconazole, Ketoconazole, Nefazodone, Nelfinavir, Ritonavir, Saquinavir, Telithromycin, Voriconazole or grapefruit or grapefruit juice] or when using concomitantly with an inhibitor of both CYP3A4 and CYP1A2 (e.g., Ciprofloxacin).

Increase Erlotinib by 50 mg increments as tolerated for: Concomitant use with CYP3A4 inducers, such as rifampin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, or St. John's Wort. Increase doses by 50 mg increments at 2 week intervals to a maximum of 450 mg. Avoid concomitant use, if possible.

Concurrent cigarette smoking: Increase by 50 mg increments at 2 week intervals to a maximum of 300 mg. Immediately reduce the dose of Erlotinib to the recommended dose (150 mg or 100 mg daily) upon cessation of smoking.

The most common adverse reactions (20%) with Erlotinib from a pooled analysis of studies were rash, diarrhea, anorexia, fatigue, dyspnea, cough, nausea, and vomiting. The following serious adverse reactions, which may include fatalities.

• Interstitial Lung Disease (ILD)
• Renal Failure
• Hepatotoxicity with or without Hepatic Impairment
• Gastrointestinal Perforation
• Bullous and Exfoliative Skin Disorders
• Myocardial Infarction/Ischemia
• Cerebrovascular Accident
• Microangiopathic Hemolytic Anemia with Thrombocytopenia
• Ocular Disorders
• Hemorrhage in Patients Taking Warfarin

Anticoagulants: Interaction with coumarin-derived anticoagulants, including warfarin, leading to increased International Normalized Ratio (INR) and bleeding adverse reactions.

CYP3A4 inhibitors: Erlotinib is metabolized predominantly by CYP3A4. Co-treatment with the potent CYP3A4 inhibitor ketoconazole increased Erlotinib AUC by 67%. When Erlotinib was co-administered with Ciprofloxacin, an inhibitor of both CYP3A4 and CYP1A2, the Erlotinib exposure [AUC] and maximum concentration [Cmax] increased by 39% and 17%, respectively.

CYP3A4 inducers: Pre-treatment with the CYP3A4 inducer Rifampicin for 7-11 days prior to Erlotinib decreased Erlotinib AUC by 58% to 80%. Dose modifications are recommended.

Drugs affecting gastric pH: Co-administration of Erlotinib with omeprazole decreased Erlotinib AUC by 46% and co-administration of Erlotinib with Ranitidine 300 mg decreased Erlotinib AUC by 33%.

Pregnancy category D. Based on its mechanism of action, Erlotinib can cause fetal harm when administered to a pregnant woman. It is not known whether Erlotinib is present in human milk. Because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants from Erlotinib, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use: The safety and effectiveness of Erlotinib in pediatric patients have not been established.

Geriatric use: No overall differences in safety or efficacy were observed between subjects 65 years and older and those younger than 65.

Single oral doses of Erlotinib up to 1,000 mg in healthy subjects and weekly doses up to 1,600 mg in cancer patients have been tolerated. Repeated twice-daily doses of 200 mg single-agent Erlotinib in healthy subjects were poorly tolerated after only a few days of dosing. Based on the data from these studies, an unacceptable incidence of severe adverse reactions, such as diarrhea, rash, and liver transaminase elevation, may occur above the recommended dose. In case of suspected overdose, Erlotinib should be withheld and symptomatic treatment instituted.

Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture.

Targeted Cancer Therapy

NSCLC: The recommended daily dose of Erlotinib for NSCLC is 150 mg taken on an empty stomach, i.e., at least one hour before or two hours after the ingestion of food. Treatment should continue until disease progression or unacceptable toxicity occurs.

Pancreatic Cancer: The recommended daily dose of Erlotinib for pancreatic cancer is 100 mg taken once daily in combination with gemcitabine. Take Erlotinib on an empty stomach, i.e., at least one hour before or two hours after the ingestion of food. Treatment should continue until disease progression or unacceptable toxicity occurs.

Reduce Erlotinib by 50 mg decrements: If severe reactions occur with concomitant use of strong CYP3A4 inhibitors (such as atazanavir, Clarithromycin, Indinavir, Itraconazole, Ketoconazole, Nefazodone, Nelfinavir, Ritonavir, Saquinavir, Telithromycin, Voriconazole or grapefruit or grapefruit juice] or when using concomitantly with an inhibitor of both CYP3A4 and CYP1A2 (e.g., Ciprofloxacin).

Increase Erlotinib by 50 mg increments as tolerated for: Concomitant use with CYP3A4 inducers, such as rifampin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, or St. John's Wort. Increase doses by 50 mg increments at 2 week intervals to a maximum of 450 mg. Avoid concomitant use, if possible.

Concurrent cigarette smoking: Increase by 50 mg increments at 2 week intervals to a maximum of 300 mg. Immediately reduce the dose of Erlotinib to the recommended dose (150 mg or 100 mg daily) upon cessation of smoking.

The most common adverse reactions (20%) with Erlotinib from a pooled analysis of studies were rash, diarrhea, anorexia, fatigue, dyspnea, cough, nausea, and vomiting. The following serious adverse reactions, which may include fatalities.

• Interstitial Lung Disease (ILD)
• Renal Failure
• Hepatotoxicity with or without Hepatic Impairment
• Gastrointestinal Perforation
• Bullous and Exfoliative Skin Disorders
• Myocardial Infarction/Ischemia
• Cerebrovascular Accident
• Microangiopathic Hemolytic Anemia with Thrombocytopenia
• Ocular Disorders
• Hemorrhage in Patients Taking Warfarin

Anticoagulants: Interaction with coumarin-derived anticoagulants, including warfarin, leading to increased International Normalized Ratio (INR) and bleeding adverse reactions.

CYP3A4 inhibitors: Erlotinib is metabolized predominantly by CYP3A4. Co-treatment with the potent CYP3A4 inhibitor ketoconazole increased Erlotinib AUC by 67%. When Erlotinib was co-administered with Ciprofloxacin, an inhibitor of both CYP3A4 and CYP1A2, the Erlotinib exposure [AUC] and maximum concentration [Cmax] increased by 39% and 17%, respectively.

CYP3A4 inducers: Pre-treatment with the CYP3A4 inducer Rifampicin for 7-11 days prior to Erlotinib decreased Erlotinib AUC by 58% to 80%. Dose modifications are recommended.

Drugs affecting gastric pH: Co-administration of Erlotinib with omeprazole decreased Erlotinib AUC by 46% and co-administration of Erlotinib with Ranitidine 300 mg decreased Erlotinib AUC by 33%.

Pregnancy category D. Based on its mechanism of action, Erlotinib can cause fetal harm when administered to a pregnant woman. It is not known whether Erlotinib is present in human milk. Because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants from Erlotinib, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use: The safety and effectiveness of Erlotinib in pediatric patients have not been established.

Geriatric use: No overall differences in safety or efficacy were observed between subjects 65 years and older and those younger than 65.

Single oral doses of Erlotinib up to 1,000 mg in healthy subjects and weekly doses up to 1,600 mg in cancer patients have been tolerated. Repeated twice-daily doses of 200 mg single-agent Erlotinib in healthy subjects were poorly tolerated after only a few days of dosing. Based on the data from these studies, an unacceptable incidence of severe adverse reactions, such as diarrhea, rash, and liver transaminase elevation, may occur above the recommended dose. In case of suspected overdose, Erlotinib should be withheld and symptomatic treatment instituted.

Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture.

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.

Ertugliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Ertugliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, ertugliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

Prior to Initiation of Ertugliflozin: Assess renal function prior to initiation of Ertugliflozin and as clinically indicated. In patients with volume depletion, correct this condition before initiating Ertugliflozin.

Recommended Dosage:

• The recommended starting dose of Ertugliflozin is 5 mg once daily, taken in the morning, with or without food.
• For additional glycemic control, the dose may be increased to 15 mg once daily in patients tolerating Ertugliflozin.
• Use of Ertugliflozin is not recommended in patients with an eGFR less than 45 mL/min/1.73 m².
• Ertugliflozin is contraindicated in patients on dialysis.

Pediatric Use: The safety and effectiveness of Ertugliflozin in pediatric patients under 18 years of age have not been established.

Geriatrics: Higher incidence of adverse reactions related to reduced intravascular volume.

Renal Impairment: Higher incidence of adverse reactions related to reduced intravascular volume and renal function.

The following important adverse reactions are described elsewhere in the labeling:

• Ketoacidosis 
• Lower Limb Amputation 
• Volume Depletion
• Urosepsis and Pyelonephritis
• Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues
• Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene)
• Genital Mycotic Infections

Ketoacidosis: Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue, evaluate, and treat promptly. Before initiating, consider risk factors for ketoacidosis. Patients may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.

Lower Limb Amputation: Consider factors that may increase the risk of amputation before initiating Ertugliflozin. Monitor patients for infections or ulcers of lower limbs, and discontinue if these occur.

Volume Depletion: May result in acute kidney injury. Before initiating, assess and correct volume status in patients with renal impairment or low systolic blood pressure, elderly patients, or patients on diuretics. Monitor for signs and symptoms during therapy.

Urosepsis and Pyelonephritis: Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.

Hypoglycemia: Consider a lower dose of insulin or insulin secretagogue to reduce risk of hypoglycemia when used in combination.

Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, life-threatening cases have occurred in both females and males. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment.

Genital Mycotic Infections: Monitor and treat if indicated.

Based on animal data showing adverse renal effects, Ertugliflozin is not recommended during the second and third trimesters of pregnancy. There is no information regarding the presence of Ertugliflozin in human milk, the effects on the breastfed infant, or the effects on milk production. Ertugliflozin is present in the milk of lactating rats. Since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney. Because of the potential for serious adverse reactions in a breastfed infant, advise women that the use of Ertugliflozin is not recommended while breastfeeding.

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

Epirubicin Injection is an anthracycline topoisomerase II inhibitor indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer

Cytotoxic Chemotherapy

Epirubicin, an anthracycline with cytotoxic properties. It inhibits DNA and RNA synthesis by steric obstruction after intercalating between DNA base pairs that triggers DNA cleavage by by topoisomerase II. It also inhibits DNA helicase and generates cytotoxic free radicals.

Acute leukaemias; Lymphoma; Multiple myeloma; Solid tumours:

• As a single agent: 60-90 mg/m² 3-4 wkly.
• Max (total cumulative dose): 0.9-1 g/m².
• Palliative care: 12.5-25 mg/m² once wkly.

Adjuvant treatment in axillary-node positive breast cancer: Recommended starting doses: 100-120 mg/m² as a single dose on day 1 or as 2 divided doses on days 1 and 8 of each 28-day cycle. Repeat for 6 cycles.

Intravesical Local treatment of bladder carcinoma: As 0.1% soln: 50 mg/wk for 8 wk; reduce dose if chemical cystitis develops.

For carcinoma in-situ: 80 mg in 50 mL wkly.

For prevention of recurrence in patients who have undergone transurethral resection: 50 mg/wk for 4 wk, followed by 50 mg/mth for 11 mth; retain soln in the bladder for 1 hr during each administration.

In early breast cancer, acute adverse events occurring in ≥10% of patients are leucopenia, neutropenia, anemia, thrombocytopenia, amenhorrhea, lethargy, nausea/vomiting, mucositis, diarrhea, infection, conjunctivitis/keratitis, alopecia, local toxicity and rash/itch.

Long term adverse events occurring at a frequency of 1-2% are asymptomatic drops in LVEF and CHF and secondary leukemia.

Cardiac impairment, severe or recent Ml; previous full cumulative doses of anthracyclines. Hypersensitivity; severe hepatic dysfunction. Not for intravesical use where invasive tumours have penetrated the bladder wall; urinary infections, bladder inflammation or catheterisation problems. Pregnancy, lactation.

Previous extensive radiotherapy, bone infiltration by tumour, severe renal and hepatic dysfunction. May cause tumor lysis syndrome or radiation recall. Elderly women >70 yr. CV disease, hypertensive cardiomyopathy; monitor hematological and cardiac function regularly. Extravasation during IV admin may result in severe local tissue necrosis. Do not give via IM/SC routes as extravasation can lead to severe local necrosis

Paclitaxel and other anthracyclines. Cimetidine, heparin. Antineoplastic drugs, cardiotoxic drugs, radiation, hepatoactive drugs.

Discontinue nursing prior to taking Epirubicin. Not known if excreted in breast milk

Congestive heart failure after an acute myocardial infarction, Hypertension.

Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists

Eplerenone selectively binds to the mineralocorticoid receptor and blocks the binding of aldosterone, a key component in the renin-angiotensin-aldosterone-system, which is involved in the regulation of BP and pathophysiology of CV disease. Aldosterone binds to mineralocorticoid receptors in both epithelial (e.g. kidney, GI tract) and nonepithelial (e.g. heart, blood vessels, brain) tissues; causing increases in BP by inducing Na reabsorption, vascular remodelling, water retention, endothelial dysfunction and possibly other mechanisms.

Congestive Heart Failure after an acute Myocardial Infarction: The recommended dose of Eplerenone is 50 mg once daily. Treatment should be initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily preferably within 4 weeks as tolerated by the patient. Eplerenone may be administered with or without food.

Hypertension: Eplerenone may be used alone or in combination with other antihypertensive agents. The recommended starting dose of Eplerenone is 50 mg administered once daily. For patients with an inadequate blood pressure response to 50 mg once daily the dosage of Eplerenone should be increased to 50 mg twice daily. Higher dosages of Eplerenone are not recommended either because they have no greater effect on blood pressure than 100 mg or because they are associated with an increased risk of hyperkalemia.

Headache, dizziness, diarrhea, stomach pain, nausea, cough or flu-like symptoms may occur. Symptoms of a serious allergic reaction like: rash, itching, swelling, severe dizziness, trouble breathing can occur.

Eplerenone is contraindicated in-

• Hyperkalaemia
• Severe renal impairment (creatinine clearance less than 30 ml/min)
• Severe hepatic impairment
• Concomitant use with potent CYP3A4 inhibitors like Ketoconazole, Itraconazole, Nefazodone, Troleandomycin, Clarithromycin, Ritonavir, and Nelfinavir or other
• Potassium-sparing diuretics are also contraindicated

Eplerenone should be used with caution in hyperkalemia, severe kidney disease, diabetic patients with congestive heart failure after an acute myocardial infarction including those with proteinuria.

May increase risk of hyperkalaemia with ACE inhibitors and/or angiotension receptor blocker, ciclosporin, tacrolimus, trimethoprim. May reduce antihypertensive effect with NSAIDs, glucocorticoids, tetracosactide. May enhance hypotensive effect of α1-blockers (e.g. alfuzosin, prazosin), TCAs, amifostine, baclofen, neuroleptics. May increase plasma level with mild to moderate CYP3A4 inhibitors (e.g. fluconazole, erythromycin, saquinavir, amiodarone, diltiazem, verapamil).

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Eplerenone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: The concentration of Eplerenone in human breast milk after oral administration is unknown. Because many drugs are excreted in human milk and because of the unknown potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use: The safety and effectiveness of Eplerenone has not been established in pediatric patients.

Geriatric use: No differences in overall incidence of effectivity or safety was observed in elderly patients.

Symptoms: Hyperkalaemia, hypotension.

Management: Symptomatic and supportive treatment. Admin activated charcoal. Initiate standard therapy for hyperkalaemia.

Store below 30°C in a cool and dry place, protected from light and moisture. Keep out of children’s reach.

Anti-diarrhoeal Antimicrobial drugs, Macrolides

Erythromycin inhibits microsomal protein synthesis in susceptible organisms by inhibiting the translocation process. Specific binding to the 50S subunit or 70S ribosome occurs in these organisms but there is no binding to the stable 80S mammalian ribosome. Erythromycin is active against many Grampositive bacteria, some Gram-negative bacteria and against mycoplasmas and chlamydia.

Absorption: Erythromycin base is destroyed by acid and is therefore administered in the form of stable ester. The rates of absorption of the base and esters are diminished by the presence of food. The stearate is hydrolyzed in the intestine and the free erythromycin absorbed.

Blood concentration: After an oral dose of 500 mg. of the base of stearate, peak serum concentrations of 0.9 to 1.4 or 0.4 to 1.8 mg/ml. respectively are attained in 1 to 4 hours. Half-life: The serum half-life is 1.2 to 4 hours. In subjects with oliguria, the half-life is about 5 hours.

Distribution: Erythromycin is widely distributed throughout body tissue and fluids with some retention in the liver and spleen, protein binding of erythromycin base is 73%. Erythromycin enters the cerebrospinal fluid when the meninges are inflamed. It also crosses the placenta and is excreted in the milk.

Excretion: 5 to 15 % of the dose of erythromycin is excreted in the urine and large amounts of the unchanged active substance are excreted in the bile.

Adult and Children over 8 years: 250-500 mg every six hours for mild to moderate infections. This may be increased upto 4 gm. or more daily in severe cases.

Elderly: No special dosage recommendation. Erythromycin may be administered if desired, three times daily or twice daily by giving one-third or half of the total daily requirement 8 hourly or 12 hourly respectively.

Children aged 2 to 8 years: 250 mg. every six hours or 30-50 mg/kg body weight per day divided into four equal dosage.

Infants and Children upto 2 years: 500 mg. in divided doses or 30-50 mg/kg body weight in divided doses.

Allergic reactions are rare and mild although anaphylaxis has occurred. Occasionally there is abdominal discomfort after oral administration, sometimes with nausea and vomiting. This discomfort usually subsides after a few days without it being necessary to reduce the dosage.

Known hypersensitivity to Erythromycin.

Erythromycin should be given with care in patients with impaired hepatic function, as erythromycin is excreted principally in the bile.

Recent data from studies of erythromycin reveals that its use in patients who are receiving high dosage of theophylline may be associated with an increase of serum theophylline levels and potential theophylline toxicity. In such cases this dose of theophylline should be reduced.

Clinical and Laboratory studies have been shown no evidence in human of teratogenicity or toxicity. However, caution should be exercised when prescribing this drug to pregnant patients and lactating mothers since erythromycin crosses the placental barrier and is excreted in breast milk.

In case of overdosage, Erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted. Erythromycin is not removed by peritoneal dialysis or haemodialysis.

Direction for reconstitution of suspension: Shake the bottle to loosen powder. Add 60 ml or 100 ml of boiled and cooled water to the dry powder of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in suspension.

Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 7 days.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.

Anti-diarrhoeal Antimicrobial drugs, Macrolides

Erythromycin inhibits microsomal protein synthesis in susceptible organisms by inhibiting the translocation process. Specific binding to the 50S subunit or 70S ribosome occurs in these organisms but there is no binding to the stable 80S mammalian ribosome. Erythromycin is active against many Grampositive bacteria, some Gram-negative bacteria and against mycoplasmas and chlamydia.

Absorption: Erythromycin base is destroyed by acid and is therefore administered in the form of stable ester. The rates of absorption of the base and esters are diminished by the presence of food. The stearate is hydrolyzed in the intestine and the free erythromycin absorbed.

Blood concentration: After an oral dose of 500 mg. of the base of stearate, peak serum concentrations of 0.9 to 1.4 or 0.4 to 1.8 mg/ml. respectively are attained in 1 to 4 hours. Half-life: The serum half-life is 1.2 to 4 hours. In subjects with oliguria, the half-life is about 5 hours.

Distribution: Erythromycin is widely distributed throughout body tissue and fluids with some retention in the liver and spleen, protein binding of erythromycin base is 73%. Erythromycin enters the cerebrospinal fluid when the meninges are inflamed. It also crosses the placenta and is excreted in the milk.

Excretion: 5 to 15 % of the dose of erythromycin is excreted in the urine and large amounts of the unchanged active substance are excreted in the bile.

Adult and Children over 8 years: 250-500 mg every six hours for mild to moderate infections. This may be increased upto 4 gm. or more daily in severe cases.

Elderly: No special dosage recommendation. Erythromycin may be administered if desired, three times daily or twice daily by giving one-third or half of the total daily requirement 8 hourly or 12 hourly respectively.

Children aged 2 to 8 years: 250 mg. every six hours or 30-50 mg/kg body weight per day divided into four equal dosage.

Infants and Children upto 2 years: 500 mg. in divided doses or 30-50 mg/kg body weight in divided doses.

Allergic reactions are rare and mild although anaphylaxis has occurred. Occasionally there is abdominal discomfort after oral administration, sometimes with nausea and vomiting. This discomfort usually subsides after a few days without it being necessary to reduce the dosage.

Known hypersensitivity to Erythromycin.

Erythromycin should be given with care in patients with impaired hepatic function, as erythromycin is excreted principally in the bile.

Recent data from studies of erythromycin reveals that its use in patients who are receiving high dosage of theophylline may be associated with an increase of serum theophylline levels and potential theophylline toxicity. In such cases this dose of theophylline should be reduced.

Clinical and Laboratory studies have been shown no evidence in human of teratogenicity or toxicity. However, caution should be exercised when prescribing this drug to pregnant patients and lactating mothers since erythromycin crosses the placental barrier and is excreted in breast milk.

In case of overdosage, Erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted. Erythromycin is not removed by peritoneal dialysis or haemodialysis.

Direction for reconstitution of suspension: Shake the bottle to loosen powder. Add 60 ml or 100 ml of boiled and cooled water to the dry powder of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in suspension.

Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 7 days.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.

Anti-diarrhoeal Antimicrobial drugs, Macrolides

Erythromycin inhibits microsomal protein synthesis in susceptible organisms by inhibiting the translocation process. Specific binding to the 50S subunit or 70S ribosome occurs in these organisms but there is no binding to the stable 80S mammalian ribosome. Erythromycin is active against many Grampositive bacteria, some Gram-negative bacteria and against mycoplasmas and chlamydia.

Absorption: Erythromycin base is destroyed by acid and is therefore administered in the form of stable ester. The rates of absorption of the base and esters are diminished by the presence of food. The stearate is hydrolyzed in the intestine and the free erythromycin absorbed.

Blood concentration: After an oral dose of 500 mg. of the base of stearate, peak serum concentrations of 0.9 to 1.4 or 0.4 to 1.8 mg/ml. respectively are attained in 1 to 4 hours. Half-life: The serum half-life is 1.2 to 4 hours. In subjects with oliguria, the half-life is about 5 hours.

Distribution: Erythromycin is widely distributed throughout body tissue and fluids with some retention in the liver and spleen, protein binding of erythromycin base is 73%. Erythromycin enters the cerebrospinal fluid when the meninges are inflamed. It also crosses the placenta and is excreted in the milk.

Excretion: 5 to 15 % of the dose of erythromycin is excreted in the urine and large amounts of the unchanged active substance are excreted in the bile.

Adult and Children over 8 years: 250-500 mg every six hours for mild to moderate infections. This may be increased upto 4 gm. or more daily in severe cases.

Elderly: No special dosage recommendation. Erythromycin may be administered if desired, three times daily or twice daily by giving one-third or half of the total daily requirement 8 hourly or 12 hourly respectively.

Children aged 2 to 8 years: 250 mg. every six hours or 30-50 mg/kg body weight per day divided into four equal dosage.

Infants and Children upto 2 years: 500 mg. in divided doses or 30-50 mg/kg body weight in divided doses.

Allergic reactions are rare and mild although anaphylaxis has occurred. Occasionally there is abdominal discomfort after oral administration, sometimes with nausea and vomiting. This discomfort usually subsides after a few days without it being necessary to reduce the dosage.

Known hypersensitivity to Erythromycin.

Erythromycin should be given with care in patients with impaired hepatic function, as erythromycin is excreted principally in the bile.

Recent data from studies of erythromycin reveals that its use in patients who are receiving high dosage of theophylline may be associated with an increase of serum theophylline levels and potential theophylline toxicity. In such cases this dose of theophylline should be reduced.

Clinical and Laboratory studies have been shown no evidence in human of teratogenicity or toxicity. However, caution should be exercised when prescribing this drug to pregnant patients and lactating mothers since erythromycin crosses the placental barrier and is excreted in breast milk.

In case of overdosage, Erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted. Erythromycin is not removed by peritoneal dialysis or haemodialysis.

Direction for reconstitution of suspension: Shake the bottle to loosen powder. Add 60 ml or 100 ml of boiled and cooled water to the dry powder of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in suspension.

Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 7 days.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.

Anti-diarrhoeal Antimicrobial drugs, Macrolides

Erythromycin inhibits microsomal protein synthesis in susceptible organisms by inhibiting the translocation process. Specific binding to the 50S subunit or 70S ribosome occurs in these organisms but there is no binding to the stable 80S mammalian ribosome. Erythromycin is active against many Grampositive bacteria, some Gram-negative bacteria and against mycoplasmas and chlamydia.

Absorption: Erythromycin base is destroyed by acid and is therefore administered in the form of stable ester. The rates of absorption of the base and esters are diminished by the presence of food. The stearate is hydrolyzed in the intestine and the free erythromycin absorbed.

Blood concentration: After an oral dose of 500 mg. of the base of stearate, peak serum concentrations of 0.9 to 1.4 or 0.4 to 1.8 mg/ml. respectively are attained in 1 to 4 hours. Half-life: The serum half-life is 1.2 to 4 hours. In subjects with oliguria, the half-life is about 5 hours.

Distribution: Erythromycin is widely distributed throughout body tissue and fluids with some retention in the liver and spleen, protein binding of erythromycin base is 73%. Erythromycin enters the cerebrospinal fluid when the meninges are inflamed. It also crosses the placenta and is excreted in the milk.

Excretion: 5 to 15 % of the dose of erythromycin is excreted in the urine and large amounts of the unchanged active substance are excreted in the bile.

Adult and Children over 8 years: 250-500 mg every six hours for mild to moderate infections. This may be increased upto 4 gm. or more daily in severe cases.

Elderly: No special dosage recommendation. Erythromycin may be administered if desired, three times daily or twice daily by giving one-third or half of the total daily requirement 8 hourly or 12 hourly respectively.

Children aged 2 to 8 years: 250 mg. every six hours or 30-50 mg/kg body weight per day divided into four equal dosage.

Infants and Children upto 2 years: 500 mg. in divided doses or 30-50 mg/kg body weight in divided doses.

Allergic reactions are rare and mild although anaphylaxis has occurred. Occasionally there is abdominal discomfort after oral administration, sometimes with nausea and vomiting. This discomfort usually subsides after a few days without it being necessary to reduce the dosage.

Known hypersensitivity to Erythromycin.

Erythromycin should be given with care in patients with impaired hepatic function, as erythromycin is excreted principally in the bile.

Recent data from studies of erythromycin reveals that its use in patients who are receiving high dosage of theophylline may be associated with an increase of serum theophylline levels and potential theophylline toxicity. In such cases this dose of theophylline should be reduced.

Clinical and Laboratory studies have been shown no evidence in human of teratogenicity or toxicity. However, caution should be exercised when prescribing this drug to pregnant patients and lactating mothers since erythromycin crosses the placental barrier and is excreted in breast milk.

In case of overdosage, Erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted. Erythromycin is not removed by peritoneal dialysis or haemodialysis.

Direction for reconstitution of suspension: Shake the bottle to loosen powder. Add 60 ml or 100 ml of boiled and cooled water to the dry powder of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in suspension.

Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 7 days.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.

Anti-diarrhoeal Antimicrobial drugs, Macrolides

Erythromycin inhibits microsomal protein synthesis in susceptible organisms by inhibiting the translocation process. Specific binding to the 50S subunit or 70S ribosome occurs in these organisms but there is no binding to the stable 80S mammalian ribosome. Erythromycin is active against many Grampositive bacteria, some Gram-negative bacteria and against mycoplasmas and chlamydia.

Absorption: Erythromycin base is destroyed by acid and is therefore administered in the form of stable ester. The rates of absorption of the base and esters are diminished by the presence of food. The stearate is hydrolyzed in the intestine and the free erythromycin absorbed.

Blood concentration: After an oral dose of 500 mg. of the base of stearate, peak serum concentrations of 0.9 to 1.4 or 0.4 to 1.8 mg/ml. respectively are attained in 1 to 4 hours. Half-life: The serum half-life is 1.2 to 4 hours. In subjects with oliguria, the half-life is about 5 hours.

Distribution: Erythromycin is widely distributed throughout body tissue and fluids with some retention in the liver and spleen, protein binding of erythromycin base is 73%. Erythromycin enters the cerebrospinal fluid when the meninges are inflamed. It also crosses the placenta and is excreted in the milk.

Excretion: 5 to 15 % of the dose of erythromycin is excreted in the urine and large amounts of the unchanged active substance are excreted in the bile.

Adult and Children over 8 years: 250-500 mg every six hours for mild to moderate infections. This may be increased upto 4 gm. or more daily in severe cases.

Elderly: No special dosage recommendation. Erythromycin may be administered if desired, three times daily or twice daily by giving one-third or half of the total daily requirement 8 hourly or 12 hourly respectively.

Children aged 2 to 8 years: 250 mg. every six hours or 30-50 mg/kg body weight per day divided into four equal dosage.

Infants and Children upto 2 years: 500 mg. in divided doses or 30-50 mg/kg body weight in divided doses.

Allergic reactions are rare and mild although anaphylaxis has occurred. Occasionally there is abdominal discomfort after oral administration, sometimes with nausea and vomiting. This discomfort usually subsides after a few days without it being necessary to reduce the dosage.

Known hypersensitivity to Erythromycin.

Erythromycin should be given with care in patients with impaired hepatic function, as erythromycin is excreted principally in the bile.

Recent data from studies of erythromycin reveals that its use in patients who are receiving high dosage of theophylline may be associated with an increase of serum theophylline levels and potential theophylline toxicity. In such cases this dose of theophylline should be reduced.

Clinical and Laboratory studies have been shown no evidence in human of teratogenicity or toxicity. However, caution should be exercised when prescribing this drug to pregnant patients and lactating mothers since erythromycin crosses the placental barrier and is excreted in breast milk.

In case of overdosage, Erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted. Erythromycin is not removed by peritoneal dialysis or haemodialysis.

Direction for reconstitution of suspension: Shake the bottle to loosen powder. Add 60 ml or 100 ml of boiled and cooled water to the dry powder of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in suspension.

Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 7 days.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.

Anti-diarrhoeal Antimicrobial drugs, Macrolides

Erythromycin inhibits microsomal protein synthesis in susceptible organisms by inhibiting the translocation process. Specific binding to the 50S subunit or 70S ribosome occurs in these organisms but there is no binding to the stable 80S mammalian ribosome. Erythromycin is active against many Grampositive bacteria, some Gram-negative bacteria and against mycoplasmas and chlamydia.

Absorption: Erythromycin base is destroyed by acid and is therefore administered in the form of stable ester. The rates of absorption of the base and esters are diminished by the presence of food. The stearate is hydrolyzed in the intestine and the free erythromycin absorbed.

Blood concentration: After an oral dose of 500 mg. of the base of stearate, peak serum concentrations of 0.9 to 1.4 or 0.4 to 1.8 mg/ml. respectively are attained in 1 to 4 hours. Half-life: The serum half-life is 1.2 to 4 hours. In subjects with oliguria, the half-life is about 5 hours.

Distribution: Erythromycin is widely distributed throughout body tissue and fluids with some retention in the liver and spleen, protein binding of erythromycin base is 73%. Erythromycin enters the cerebrospinal fluid when the meninges are inflamed. It also crosses the placenta and is excreted in the milk.

Excretion: 5 to 15 % of the dose of erythromycin is excreted in the urine and large amounts of the unchanged active substance are excreted in the bile.

Adult and Children over 8 years: 250-500 mg every six hours for mild to moderate infections. This may be increased upto 4 gm. or more daily in severe cases.

Elderly: No special dosage recommendation. Erythromycin may be administered if desired, three times daily or twice daily by giving one-third or half of the total daily requirement 8 hourly or 12 hourly respectively.

Children aged 2 to 8 years: 250 mg. every six hours or 30-50 mg/kg body weight per day divided into four equal dosage.

Infants and Children upto 2 years: 500 mg. in divided doses or 30-50 mg/kg body weight in divided doses.

Allergic reactions are rare and mild although anaphylaxis has occurred. Occasionally there is abdominal discomfort after oral administration, sometimes with nausea and vomiting. This discomfort usually subsides after a few days without it being necessary to reduce the dosage.

Known hypersensitivity to Erythromycin.

Erythromycin should be given with care in patients with impaired hepatic function, as erythromycin is excreted principally in the bile.

Recent data from studies of erythromycin reveals that its use in patients who are receiving high dosage of theophylline may be associated with an increase of serum theophylline levels and potential theophylline toxicity. In such cases this dose of theophylline should be reduced.

Clinical and Laboratory studies have been shown no evidence in human of teratogenicity or toxicity. However, caution should be exercised when prescribing this drug to pregnant patients and lactating mothers since erythromycin crosses the placental barrier and is excreted in breast milk.

In case of overdosage, Erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted. Erythromycin is not removed by peritoneal dialysis or haemodialysis.

Direction for reconstitution of suspension: Shake the bottle to loosen powder. Add 60 ml or 100 ml of boiled and cooled water to the dry powder of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in suspension.

Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 7 days.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.

Anti-diarrhoeal Antimicrobial drugs, Macrolides

Erythromycin inhibits microsomal protein synthesis in susceptible organisms by inhibiting the translocation process. Specific binding to the 50S subunit or 70S ribosome occurs in these organisms but there is no binding to the stable 80S mammalian ribosome. Erythromycin is active against many Grampositive bacteria, some Gram-negative bacteria and against mycoplasmas and chlamydia.

Absorption: Erythromycin base is destroyed by acid and is therefore administered in the form of stable ester. The rates of absorption of the base and esters are diminished by the presence of food. The stearate is hydrolyzed in the intestine and the free erythromycin absorbed.

Blood concentration: After an oral dose of 500 mg. of the base of stearate, peak serum concentrations of 0.9 to 1.4 or 0.4 to 1.8 mg/ml. respectively are attained in 1 to 4 hours. Half-life: The serum half-life is 1.2 to 4 hours. In subjects with oliguria, the half-life is about 5 hours.

Distribution: Erythromycin is widely distributed throughout body tissue and fluids with some retention in the liver and spleen, protein binding of erythromycin base is 73%. Erythromycin enters the cerebrospinal fluid when the meninges are inflamed. It also crosses the placenta and is excreted in the milk.

Excretion: 5 to 15 % of the dose of erythromycin is excreted in the urine and large amounts of the unchanged active substance are excreted in the bile.

Adult and Children over 8 years: 250-500 mg every six hours for mild to moderate infections. This may be increased upto 4 gm. or more daily in severe cases.

Elderly: No special dosage recommendation. Erythromycin may be administered if desired, three times daily or twice daily by giving one-third or half of the total daily requirement 8 hourly or 12 hourly respectively.

Children aged 2 to 8 years: 250 mg. every six hours or 30-50 mg/kg body weight per day divided into four equal dosage.

Infants and Children upto 2 years: 500 mg. in divided doses or 30-50 mg/kg body weight in divided doses.

Allergic reactions are rare and mild although anaphylaxis has occurred. Occasionally there is abdominal discomfort after oral administration, sometimes with nausea and vomiting. This discomfort usually subsides after a few days without it being necessary to reduce the dosage.

Known hypersensitivity to Erythromycin.

Erythromycin should be given with care in patients with impaired hepatic function, as erythromycin is excreted principally in the bile.

Recent data from studies of erythromycin reveals that its use in patients who are receiving high dosage of theophylline may be associated with an increase of serum theophylline levels and potential theophylline toxicity. In such cases this dose of theophylline should be reduced.

Clinical and Laboratory studies have been shown no evidence in human of teratogenicity or toxicity. However, caution should be exercised when prescribing this drug to pregnant patients and lactating mothers since erythromycin crosses the placental barrier and is excreted in breast milk.

In case of overdosage, Erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted. Erythromycin is not removed by peritoneal dialysis or haemodialysis.

Direction for reconstitution of suspension: Shake the bottle to loosen powder. Add 60 ml or 100 ml of boiled and cooled water to the dry powder of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in suspension.

Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 7 days.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.

Anti-diarrhoeal Antimicrobial drugs, Macrolides

Erythromycin inhibits microsomal protein synthesis in susceptible organisms by inhibiting the translocation process. Specific binding to the 50S subunit or 70S ribosome occurs in these organisms but there is no binding to the stable 80S mammalian ribosome. Erythromycin is active against many Grampositive bacteria, some Gram-negative bacteria and against mycoplasmas and chlamydia.

Absorption: Erythromycin base is destroyed by acid and is therefore administered in the form of stable ester. The rates of absorption of the base and esters are diminished by the presence of food. The stearate is hydrolyzed in the intestine and the free erythromycin absorbed.

Blood concentration: After an oral dose of 500 mg. of the base of stearate, peak serum concentrations of 0.9 to 1.4 or 0.4 to 1.8 mg/ml. respectively are attained in 1 to 4 hours. Half-life: The serum half-life is 1.2 to 4 hours. In subjects with oliguria, the half-life is about 5 hours.

Distribution: Erythromycin is widely distributed throughout body tissue and fluids with some retention in the liver and spleen, protein binding of erythromycin base is 73%. Erythromycin enters the cerebrospinal fluid when the meninges are inflamed. It also crosses the placenta and is excreted in the milk.

Excretion: 5 to 15 % of the dose of erythromycin is excreted in the urine and large amounts of the unchanged active substance are excreted in the bile.

Adult and Children over 8 years: 250-500 mg every six hours for mild to moderate infections. This may be increased upto 4 gm. or more daily in severe cases.

Elderly: No special dosage recommendation. Erythromycin may be administered if desired, three times daily or twice daily by giving one-third or half of the total daily requirement 8 hourly or 12 hourly respectively.

Children aged 2 to 8 years: 250 mg. every six hours or 30-50 mg/kg body weight per day divided into four equal dosage.

Infants and Children upto 2 years: 500 mg. in divided doses or 30-50 mg/kg body weight in divided doses.

Allergic reactions are rare and mild although anaphylaxis has occurred. Occasionally there is abdominal discomfort after oral administration, sometimes with nausea and vomiting. This discomfort usually subsides after a few days without it being necessary to reduce the dosage.

Known hypersensitivity to Erythromycin.

Erythromycin should be given with care in patients with impaired hepatic function, as erythromycin is excreted principally in the bile.

Recent data from studies of erythromycin reveals that its use in patients who are receiving high dosage of theophylline may be associated with an increase of serum theophylline levels and potential theophylline toxicity. In such cases this dose of theophylline should be reduced.

Clinical and Laboratory studies have been shown no evidence in human of teratogenicity or toxicity. However, caution should be exercised when prescribing this drug to pregnant patients and lactating mothers since erythromycin crosses the placental barrier and is excreted in breast milk.

In case of overdosage, Erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted. Erythromycin is not removed by peritoneal dialysis or haemodialysis.

Direction for reconstitution of suspension: Shake the bottle to loosen powder. Add 60 ml or 100 ml of boiled and cooled water to the dry powder of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in suspension.

Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 7 days.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.

Anti-diarrhoeal Antimicrobial drugs, Macrolides

Erythromycin inhibits microsomal protein synthesis in susceptible organisms by inhibiting the translocation process. Specific binding to the 50S subunit or 70S ribosome occurs in these organisms but there is no binding to the stable 80S mammalian ribosome. Erythromycin is active against many Grampositive bacteria, some Gram-negative bacteria and against mycoplasmas and chlamydia.

Absorption: Erythromycin base is destroyed by acid and is therefore administered in the form of stable ester. The rates of absorption of the base and esters are diminished by the presence of food. The stearate is hydrolyzed in the intestine and the free erythromycin absorbed.

Blood concentration: After an oral dose of 500 mg. of the base of stearate, peak serum concentrations of 0.9 to 1.4 or 0.4 to 1.8 mg/ml. respectively are attained in 1 to 4 hours. Half-life: The serum half-life is 1.2 to 4 hours. In subjects with oliguria, the half-life is about 5 hours.

Distribution: Erythromycin is widely distributed throughout body tissue and fluids with some retention in the liver and spleen, protein binding of erythromycin base is 73%. Erythromycin enters the cerebrospinal fluid when the meninges are inflamed. It also crosses the placenta and is excreted in the milk.

Excretion: 5 to 15 % of the dose of erythromycin is excreted in the urine and large amounts of the unchanged active substance are excreted in the bile.

Adult and Children over 8 years: 250-500 mg every six hours for mild to moderate infections. This may be increased upto 4 gm. or more daily in severe cases.

Elderly: No special dosage recommendation. Erythromycin may be administered if desired, three times daily or twice daily by giving one-third or half of the total daily requirement 8 hourly or 12 hourly respectively.

Children aged 2 to 8 years: 250 mg. every six hours or 30-50 mg/kg body weight per day divided into four equal dosage.

Infants and Children upto 2 years: 500 mg. in divided doses or 30-50 mg/kg body weight in divided doses.

Allergic reactions are rare and mild although anaphylaxis has occurred. Occasionally there is abdominal discomfort after oral administration, sometimes with nausea and vomiting. This discomfort usually subsides after a few days without it being necessary to reduce the dosage.

Known hypersensitivity to Erythromycin.

Erythromycin should be given with care in patients with impaired hepatic function, as erythromycin is excreted principally in the bile.

Recent data from studies of erythromycin reveals that its use in patients who are receiving high dosage of theophylline may be associated with an increase of serum theophylline levels and potential theophylline toxicity. In such cases this dose of theophylline should be reduced.

Clinical and Laboratory studies have been shown no evidence in human of teratogenicity or toxicity. However, caution should be exercised when prescribing this drug to pregnant patients and lactating mothers since erythromycin crosses the placental barrier and is excreted in breast milk.

In case of overdosage, Erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted. Erythromycin is not removed by peritoneal dialysis or haemodialysis.

Direction for reconstitution of suspension: Shake the bottle to loosen powder. Add 60 ml or 100 ml of boiled and cooled water to the dry powder of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in suspension.

Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 7 days.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.