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This solution is used in Haemodialysis.

Haemodialysis solutions

Calcium chloride is used to prevent or treat negative calcium balance. It also regulates action potential excitation threshold to facilitate nerve and muscle performance.

Potassium chloride is a major cation of the intracellular fluid. It plays an active role in the conduction of nerve impulses in the heart, brain and skeletal muscle; contraction of cardiac skeletal and smooth muscles; maintenance of normal renal function, acid-base balance, carbohydrate metabolism and gastric secretion.

Sodium chloride is the major extracellular cation. It is important in electrolyte and fluid balance, osmotic pressure control and water distribution as it restores sodium ions. It is used as a source of electrolytes and water for hydration, treatment of metabolic acidosis, priming solution in haemodialysis and treatment of hyperosmolar diabetes. It is also used as diluents for infusion of compatible drug additives.

Magnessium Chloride acts as cofactor in numerous enzymatic reactions involving protein synthesis and carbohydrate metabolism; depresses CNS, blocks peripheral neuromuscular transmission, produces anticonvulsant effects.

Recommended dose: 5 liters concentrate per dialysis or as required.

Fluid and electrolyte imbalance, hypovolemia, hypotension or muscle cramping may occur.

Known hypersensitivity to any of the ingredients of this preparation.

It is used for hemodialysis purposes only. Do not use solution A or B alone. Discard container in case visible solid particles inside.

There are no known drug interactions and none well documented.

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

Bicarbonate Component [HCO3 Hemodialysis Solution] solution is indicated in renal failure, Chronic renal failure and Haemodialysis. Bicarbonate serves a crucial biochemical role in the physiological pH buffering system.

Haemodialysis solutions

Sodium chloride is the major extracellular cation. It is important in electrolyte and fluid balance, osmotic pressure control and water distribution as it restores sodium ions. It is used as a source of electrolytes and water for hydration, treatment of metabolic acidosis, priming solution in haemodialysis and treatment of hyperosmolar diabetes. It is also used as diluents for infusion of compatible drug additives. Sodium bicarbonate raises blood and urinary pH by dissociation to provide bicarbonate ions, which neutralises the hydrogen ion concentration. It also neutralises gastric acid via production of carbon dioxide.

Acidic component & Bicarbonate Component should be used in the dilution ratio of-

• Acidic component: 1.00 Volume
• Bicarbonate Component: 1.83 Volume
• Purified Water: 34.00 Volume

Known hypersensitivity to any of the ingredients of this preparation.

Sodium bicarbonate: Increases toxicity of amphetamines, ephedrine, pseudoephedrine, flecainide, quinidine and quinine. Decreases effects of lithium, chlorpropamide and salicylates due to increased clearance. May affect the absorption of certain drugs due to raised intra-gastric pH. Sodium chloride: May affect serum concentrations of lithium.

Keep out of reach of children. Not for Injection. Store below 30°C.

Anti-fibrinolytic drugs, Haemostatic drugs

This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.

The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.

Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.

Adults-

• The usual dose: 500-1000 mg 3 times daily.
• For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
• For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.

Children-

• For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
• For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.

Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure.

Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.

Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.

Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Tranexamic Acid should not be administered during known and presumed pregnancy. Tranexamic Acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.

Store in a dry place at 15-30°C, away from light and keep out of children's reach.

Anti-fibrinolytic drugs, Haemostatic drugs

This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.

The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.

Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.

Adults-

• The usual dose: 500-1000 mg 3 times daily.
• For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
• For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.

Children-

• For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
• For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.

Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure.

Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.

Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.

Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Tranexamic Acid should not be administered during known and presumed pregnancy. Tranexamic Acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.

Store in a dry place at 15-30°C, away from light and keep out of children's reach.

Anti-fibrinolytic drugs, Haemostatic drugs

This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.

The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.

Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.

Adults-

• The usual dose: 500-1000 mg 3 times daily.
• For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
• For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.

Children-

• For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
• For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.

Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure.

Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.

Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.

Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Tranexamic Acid should not be administered during known and presumed pregnancy. Tranexamic Acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.

Store in a dry place at 15-30°C, away from light and keep out of children's reach.

Rifaximin is indicaed in-

• Treatment of traveler's diarrhea by noninvasive strains of E. coli
• reduction in risk of overt hepatic encephalopathy
• bacterial overgrowth of irritable bowel syndrome.

4-Quinolone preparations

Rifaximin is a semisynthetic, rifamycin-based non-systemic antibiotic. Very little of the drug will pass the gastrointestinal wall into the circulation as is common for other types of orally administered antibiotics. Rifaximin inhibits bacterial RNA synthesis by its action on the beta-subunit of the DNA-dependent RNA polymerase. It shows the same broad spectrum activity as rifamycin which exerts bactericidal action against many species of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.

Traveler's Diarrhea: For patients ≥12 years of age: 200 mg 3 times daily for 3 days.
Hepatic Encephalopathy: For patients ≥18 years of age: 550 mg 2 times daily.
Bacterial overgrowth of irritable bowel syndrome: 400 mg 3 times daily for 10 days or 550 mg 3 times daily for 14 days. Can be taken with or without food

Side effects include flatulence, headache, abdominal pain, rectal tenesmus, defecation urgency, nausea, constipation, pyrexia, vomiting. Reactions have been reported, including anaphylaxis, angioneurotic edema, and exfoliative dermatitis.

Contraindicated in patients with a hypersensitivity to Rifaximin or to any of the rifamycin antimicrobial agents, or any components of this product

Rifaximin is not found to be effective in patients with diarrhea complicated by fever and/or blood in the stools. Rifaximin therapy should be discontinued if diarrhea symptoms get worse or persist for more than 24-48 hours and alternative antibiotic therapy should be considered. Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

In an in vitro study has suggested that Rifaximin induces CYP3A4. However, in patients with normal liver function, Rifaximin at the recommended dosing regimen is not expected to induce CYP3A4.

Pregnancy category C. It is not known whether Rifaximin is excreted in human milk or not.

Renal Impairment: The pharmacokinetics of Rifaximin in patients with impaired renal function has not been studied.
Hepatic Impairment: The systemic exposure of Rifaximin was markedly elevated in patients with hepatic impairment compared to healthy subjects.

No specific information is available on the treatment of over dosage with Rifaximin. In case of over dosage, discontinue Rifaximin, treat symptomatically and institute supportive measures as required.

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

Rifaximin is indicaed in-

• Treatment of traveler's diarrhea by noninvasive strains of E. coli
• reduction in risk of overt hepatic encephalopathy
• bacterial overgrowth of irritable bowel syndrome.

4-Quinolone preparations

Rifaximin is a semisynthetic, rifamycin-based non-systemic antibiotic. Very little of the drug will pass the gastrointestinal wall into the circulation as is common for other types of orally administered antibiotics. Rifaximin inhibits bacterial RNA synthesis by its action on the beta-subunit of the DNA-dependent RNA polymerase. It shows the same broad spectrum activity as rifamycin which exerts bactericidal action against many species of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.

Traveler's Diarrhea: For patients ≥12 years of age: 200 mg 3 times daily for 3 days.
Hepatic Encephalopathy: For patients ≥18 years of age: 550 mg 2 times daily.
Bacterial overgrowth of irritable bowel syndrome: 400 mg 3 times daily for 10 days or 550 mg 3 times daily for 14 days. Can be taken with or without food

Side effects include flatulence, headache, abdominal pain, rectal tenesmus, defecation urgency, nausea, constipation, pyrexia, vomiting. Reactions have been reported, including anaphylaxis, angioneurotic edema, and exfoliative dermatitis.

Contraindicated in patients with a hypersensitivity to Rifaximin or to any of the rifamycin antimicrobial agents, or any components of this product

Rifaximin is not found to be effective in patients with diarrhea complicated by fever and/or blood in the stools. Rifaximin therapy should be discontinued if diarrhea symptoms get worse or persist for more than 24-48 hours and alternative antibiotic therapy should be considered. Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

In an in vitro study has suggested that Rifaximin induces CYP3A4. However, in patients with normal liver function, Rifaximin at the recommended dosing regimen is not expected to induce CYP3A4.

Pregnancy category C. It is not known whether Rifaximin is excreted in human milk or not.

Renal Impairment: The pharmacokinetics of Rifaximin in patients with impaired renal function has not been studied.
Hepatic Impairment: The systemic exposure of Rifaximin was markedly elevated in patients with hepatic impairment compared to healthy subjects.

No specific information is available on the treatment of over dosage with Rifaximin. In case of over dosage, discontinue Rifaximin, treat symptomatically and institute supportive measures as required.

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

Flupentixol and Melitracen tablet is indicated in-

• Anxiety
• Depression
• Apathy
• Psychogenic depression.
• Depressive neurosses.
• Masked depression.
• Psychosomatic affections accompanied by anxiety and apathy.
• Menopausal depressions.
• Dysphoria and depression in alcoholics and drug addicts.

Combined anxiolytics & anti-depressant drugs

This consists of two well known and well proven compounds: flupentixol-a neuroleptic with anxiolytic and antidepressant properties of its own when given in small doses, and melitracen-a bipolar thymoleptic with activating properties in low doses. In combination the compounds render a preparation with antidepressant, anxiolytic and activating properties. Maximal serum concentration is reached in about 4 hours after oral administration of flupentixol and in about 4 hours after oral administration of melitracen. The biological half-life of flupentixol is about 35 hours and that of melitracen is about 19 hours. The combination of flupentixol and melitracen does not seem to influence the pharmacokinetic properties of the individual compounds.

Adults: Usually 2 tablets orally daily in the morning and noon. In severe cases, the morning dose may be increased to 2 tablets.

Elderly patients: 1 tablet in the morning.

Maintenance dose: Usually 1 tablet orally in the morning. In cases of insomnia or severe restlessness, additional treatment with a sedative in the acute phase is recommended.

In the recommended doses side effects are rare. These could be transient restlessness and insomnia.

If previously the patient has been treated with tranquillizers with sedative effect these should be withdrawn gradually.

This tablet may enhance the response to alcohol, barbiturates and other CNS depressants. Simultaneous administration of MAO-inhibitors may cause hypertensive crises. Neuroleptics and thymoleptics reduce the antihypertensive effect of guanethidine and similar acting compounds and thymoleptics enhance the effects of adrenaline and noradrenaline.

This tablet should preferably not be given during pregnancy and lactation.

In cases of overdosage the symptoms of intoxications by melitracen, especially of anticholinergic nature, dominate. More rarely extrapyramidal symptoms due to flupentixol occur. Symptomatic and Supportive. Gastric lavage should be carried out as soon as possible and activated charcoal may be administered. Measures aimed at supporting the respiratory and cardiovascular systems should be instituted. Epinephrine (adrenaline) must not be used for such patients. Convulsions may be treated with diazepam and extrapyramidal symptoms with biperiden.

Store at a temperature not exceeding 30°C in a dry place. Protect from light. Keep out of reach of children.

Paracetamol is indicated for fever, common cold and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain and post vaccination pain in children. It is also indicated for rheumatic & osteoarthritic pain and stiffness of joints.

Non opioid analgesics

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

Tablet:

• Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
• Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.

Extended Release Tablet:

• Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.

Syrup/Suspension:

• Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
• 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
• 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
• 6-12 years: 2-A teaspoonful 3 to 4 times daily.
• Adults: 4-8 teaspoonful 3 to 4 times daily.

Suppository:

• Children 3-12 months: 60-120 mg,4 times daily.
• Children 1-5 years: 125-250 mg 4 times daily.
• Children 6-12 years: 250-500 mg 4 times daily.
• Adults & children over 12 years: 0.5-1 gm 4 times daily.

Paediatric Drop:

• Children Upto 3 months: 0.5 ml (40 mg)
• 4 to 11 months: 1.0 ml (80 mg)
• 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.

Paracetamol tablet with actizorb technology: It dissolves up to five times faster than standard Paracetamol tablets. It is a fast acting and safe analgesic with marked antipyretic property. It is specially suitable for patients who, for any reason, can not tolerate aspirin or other analgesics.

• Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
• Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.

Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.

It is contraindicated in known hypersensitivity to Paracetamol.

Paracetamol should be given with caution to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver.

Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of Paracetamol. Alcohol can increase the hepatotoxicity of Paracetamol overdosage. Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Paracetamol levels by increasing first-pass metabolism or clearance.

Pregnancy category B according to USFDA. This drug should be used during pregnancy only if clearly needed

Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Paracetamol is indicated for fever, common cold and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain and post vaccination pain in children. It is also indicated for rheumatic & osteoarthritic pain and stiffness of joints.

Non opioid analgesics

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

Tablet:

• Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
• Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.

Extended Release Tablet:

• Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.

Syrup/Suspension:

• Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
• 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
• 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
• 6-12 years: 2-A teaspoonful 3 to 4 times daily.
• Adults: 4-8 teaspoonful 3 to 4 times daily.

Suppository:

• Children 3-12 months: 60-120 mg,4 times daily.
• Children 1-5 years: 125-250 mg 4 times daily.
• Children 6-12 years: 250-500 mg 4 times daily.
• Adults & children over 12 years: 0.5-1 gm 4 times daily.

Paediatric Drop:

• Children Upto 3 months: 0.5 ml (40 mg)
• 4 to 11 months: 1.0 ml (80 mg)
• 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.

Paracetamol tablet with actizorb technology: It dissolves up to five times faster than standard Paracetamol tablets. It is a fast acting and safe analgesic with marked antipyretic property. It is specially suitable for patients who, for any reason, can not tolerate aspirin or other analgesics.

• Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
• Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.

Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.

It is contraindicated in known hypersensitivity to Paracetamol.

Paracetamol should be given with caution to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver.

Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of Paracetamol. Alcohol can increase the hepatotoxicity of Paracetamol overdosage. Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Paracetamol levels by increasing first-pass metabolism or clearance.

Pregnancy category B according to USFDA. This drug should be used during pregnancy only if clearly needed

Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Vaccines, Anti-sera & Immunoglobulin

Neonates, infants and children upto 19 years of age: The recommended dose of Hepatitis B vaccine (rDNA) is >10 mcg of antigen protein in 0.5 ml.

Adults 19 years of age and older: The recommended dose of Hepatitis B vaccine (rDNA) is >20 mcg of antigen in 1 ml.

Primary immunization schedule for all ages:
The usual immunization schedule consists of 3 doses of vaccine-

• First dose: at elected date
• Second dose: 1 month after first dose
• Third dose: 6 months after first dose

or accelerated schedule consists of 4 doses of vaccine-

• First dose: at elected date
• Second dose: 1 month after first dose
• Third dose: 2 months after first dose
• Fourth dose: 12 months after first dose

Accelerated schedule confer protection more quickly and is expected to provide better patient compliance.

Neonate born to hepatitis B surface antigen-positive mother, 4 doses of 10 micrograms:

• First dose: at birth with Hepatitis B immunoglobulin injection (separate site)
• Second dose: 1 month after first dose
• Third dose: 2 months after first dose
• Fourth dose: 12 months after first dose

For travellers departing within 1 month, adult over 18 years,

• First dose: at elected date
• Second dose: 7 days after first dose
• Third dose: 21 days after first dose
• Fourth dose: 12 months after first dose

Renal insufficiency (including haemodialysis patients), adult and child over 16 years 4 doses of 40 micrograms-

• First dose: at the appropriate date
• Second dose: 1 month after first dose
• Third dose: 2 months after first dose
• Fourth dose: 6 months after first dose

Immunization schedule and booster doses may need to be adjusted in those with low antibody concentration.

Booster vaccinations: For persons with normal immune status who have been vaccinated, booster doses of
Hepatitis B vaccine has not been established. However, booster doses are recommended for hemodialysis patients or other immunocompromised persons.

Method of administration: Hepatitis B Vaccine is for intramuscular injection only. Do not inject intravenously. Hepatitis B Vaccine should be given intramuscularly in the deltoid muscle of adult and children or in the anterolateral aspect of thigh in children under 1 year.

Preparation for administration: The vaccine should be shaken well before use to obtain a homogenous turbid white suspension. Do not shake vigorously. The vaccine should be inspected visually for particulate matter and discoloration prior to administration. If either of these conditions exists, the vaccine should not be administered. The vaccine should be used as supplied; no dilution is necessary

Co-administration: Hepatitis B vaccine can be given at the same time with other vaccine as Diphtheria, Tetanus, Pertussis (DTP), Polio (OPV), Measles, Mumps and Rubella (MMR), Haemophilus influenzae b, Hepatitis A and BCG vaccines at separate sites and with separate syringes. It should not be mixed with other vaccines or medicinal products in the same syringe.

Hepatitis B vaccine is generally well tolerated. Most recipients of Hepatitis B vaccine experience some reactions upon vaccination. These are generally moderate and short. They mainly consist of local reactions at the injection site (erythema, induration and tenderness). Systemic reactions (malaise, headache, diarrhea, vomiting, myalgia and elevated temperature) are reported less commonly. In very rare cases allergic type reactions (pruritus, rash, urticaria) may be observed.

Hypersensitivity to any component of the vaccine, including yeast, is a contraindication. This vaccine is contraindicated in patients with previous hypersensitivity to any Hepatitis B virus containing vaccine.

The effect of Hepatitis B on fetal development or reproduction capacity has not been evaluated. However, it should only be used during pregnancy when there is a high risk of infection. Adequate human data on use during lactation and adequate animal reproduction studies are not available. It may be administered to nursing mothers only if clearly needed.

Keep out of the reach and sight of children. Store at +2°C to +8°C. Transportation should also be at +2°C to +8°C. Protect from light. Do not freeze.

Vaccines, Anti-sera & Immunoglobulin

Neonates, infants and children upto 19 years of age: The recommended dose of Hepatitis B vaccine (rDNA) is >10 mcg of antigen protein in 0.5 ml.

Adults 19 years of age and older: The recommended dose of Hepatitis B vaccine (rDNA) is >20 mcg of antigen in 1 ml.

Primary immunization schedule for all ages:
The usual immunization schedule consists of 3 doses of vaccine-

• First dose: at elected date
• Second dose: 1 month after first dose
• Third dose: 6 months after first dose

or accelerated schedule consists of 4 doses of vaccine-

• First dose: at elected date
• Second dose: 1 month after first dose
• Third dose: 2 months after first dose
• Fourth dose: 12 months after first dose

Accelerated schedule confer protection more quickly and is expected to provide better patient compliance.

Neonate born to hepatitis B surface antigen-positive mother, 4 doses of 10 micrograms:

• First dose: at birth with Hepatitis B immunoglobulin injection (separate site)
• Second dose: 1 month after first dose
• Third dose: 2 months after first dose
• Fourth dose: 12 months after first dose

For travellers departing within 1 month, adult over 18 years,

• First dose: at elected date
• Second dose: 7 days after first dose
• Third dose: 21 days after first dose
• Fourth dose: 12 months after first dose

Renal insufficiency (including haemodialysis patients), adult and child over 16 years 4 doses of 40 micrograms-

• First dose: at the appropriate date
• Second dose: 1 month after first dose
• Third dose: 2 months after first dose
• Fourth dose: 6 months after first dose

Immunization schedule and booster doses may need to be adjusted in those with low antibody concentration.

Booster vaccinations: For persons with normal immune status who have been vaccinated, booster doses of
Hepatitis B vaccine has not been established. However, booster doses are recommended for hemodialysis patients or other immunocompromised persons.

Method of administration: Hepatitis B Vaccine is for intramuscular injection only. Do not inject intravenously. Hepatitis B Vaccine should be given intramuscularly in the deltoid muscle of adult and children or in the anterolateral aspect of thigh in children under 1 year.

Preparation for administration: The vaccine should be shaken well before use to obtain a homogenous turbid white suspension. Do not shake vigorously. The vaccine should be inspected visually for particulate matter and discoloration prior to administration. If either of these conditions exists, the vaccine should not be administered. The vaccine should be used as supplied; no dilution is necessary

Co-administration: Hepatitis B vaccine can be given at the same time with other vaccine as Diphtheria, Tetanus, Pertussis (DTP), Polio (OPV), Measles, Mumps and Rubella (MMR), Haemophilus influenzae b, Hepatitis A and BCG vaccines at separate sites and with separate syringes. It should not be mixed with other vaccines or medicinal products in the same syringe.

Hepatitis B vaccine is generally well tolerated. Most recipients of Hepatitis B vaccine experience some reactions upon vaccination. These are generally moderate and short. They mainly consist of local reactions at the injection site (erythema, induration and tenderness). Systemic reactions (malaise, headache, diarrhea, vomiting, myalgia and elevated temperature) are reported less commonly. In very rare cases allergic type reactions (pruritus, rash, urticaria) may be observed.

Hypersensitivity to any component of the vaccine, including yeast, is a contraindication. This vaccine is contraindicated in patients with previous hypersensitivity to any Hepatitis B virus containing vaccine.

The effect of Hepatitis B on fetal development or reproduction capacity has not been evaluated. However, it should only be used during pregnancy when there is a high risk of infection. Adequate human data on use during lactation and adequate animal reproduction studies are not available. It may be administered to nursing mothers only if clearly needed.

Keep out of the reach and sight of children. Store at +2°C to +8°C. Transportation should also be at +2°C to +8°C. Protect from light. Do not freeze.

The is indicated in the following condition-

• Headache
• Migraine
• Toothache
• Neuralgia
• Feverishness
• Period pain
• Sore throat
• Backache
• Help to reduce the temperature
• Aches and pain of colds and flu

Non opioid analgesics

This is a combination of Paracetamol and Caffeine. Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Caffeine is an alkaloid which is a theophylline-like xanthine derivative. By intermolecular association with Paracetamol, Caffeine increases the solubility and transmembrane permeation of Paracetamol. In addition, Caffeine increases the pain threshold and tolerance of pain. Caffeine has also an intrinsic power to raise vessel tone in the brain, which provides another benefit to treat migraine and headache.

Adult dose: 1-2 tablets every 4-6 hours. Maximum dose: 8 tablets daily.
Child dose: Not recommended for children below 12 years.

Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leukopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.

Paracetamol is contraindicated in patients with severe renal function impairment and hepatic disease (Viral Hepatitis). Known hypersensitivity to paracetamol or caffeine.

Paracetamol & Caffeine should be given cautiously in the following cases: In patients with hepatic or renal failure, in patients taking other hepatotoxic medication. Prolonged use of the drug without consulting a physician should be avoided.

May reduce serum levels with anticonvulsants (e.g. phenytoin, barbiturates, carbamazepine). May enhance the anticoagulant effect of warfarin and other coumarins with prolonged use. Accelerated absorption with metoclopramide and domperidone. May increase serum levels with probenecid. May increase serum levels of chloramphenicol. May reduce absorption with colestyramine within 1 hr of admin. May cause severe hypothermia with phenothiazine.

Pregnant mothers should consult with doctors before taking Paracetamol & Caffeine. Paracetamol & Caffeine can be taken whilst breast feeding.

Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 40 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.

Store in a cool and dry place, protect from light and moisture.Keep all medicines out of the reach of the children.

L-Ornithine-L-Aspartate / Pancreatin is used for the treatment, control, prevention, & improvement of the following diseases, conditions and symptoms:

• Hepatic encephalopathy
• Digestion of food
• Inflammatory disease of the pancreas

Digestive Enzyme

Pancreatin is a preparation of Pancreatin having protease, lipase and amylase enzyme activity. Pancreatin hydrolyses fats to glycerol and fatty acids, changes protein into proteoses and derived substances and converts starch into dextrins and sugars. Pancreatin is employed in the conditions where the secretion of pancreatic juice is defcient.

Hepatic encephalopathy continues to be a major clinical problem and the current decade has not witnessed major therapeutic breakthroughs in this area. L-ornithine-L-aspartate (LOLA) is not frequently used as there are still some reservations about its benefits. The present study aimed to assess the effectiveness and safety of LOLA in the management of hepatic encephalopathy.

1-2 tablets daily

The following is a list of possible side-effects that may occur in medicines that contain L-Ornithine-L-Aspartate / Pancreatin. This is not a comprehensive list. These side-effects are possible, but do not always occur. Some of the side-effects may be rare but serious. Consult your doctor if you observe any of the following side-effects, especially if they do not go away.

• Nausea
• Vomiting
• Abdominal
• Stomach pain
• Bloating
• Diarrhea

Hypersensitivity to L-Ornithine-L-Aspartate / Pancreatin is a contraindication. In addition, L-Ornithine-L-Aspartate / Pancreatin should not be used if you have the following conditions:

• Gastrectomy
• Hypersensitivity
• Pancreatectomy
• Pregnant

Before using L-Ornithine-L-Aspartate / Pancreatin, inform your doctor about your current list of medications, over the counter products (e.g. vitamins, herbal supplements, etc.), allergies, pre-existing diseases, and current health conditions (e.g. pregnancy, upcoming surgery, etc.). Some health conditions may make you more susceptible to the side-effects of the drug. Take as directed by your doctor or follow the direction printed on the product insert. Dosage is based on your condition. Tell your doctor if your condition persists or worsens. Important counseling points are listed below.

• Avoid taking higher quantity than recommended dose
• Avoid use of this drug if allergic to it
• Consult your doctor before taking the drug in case of pregnancy or lactation
• Drink plenty of water when taking pancreatin
• Need doctor's consultation in abdominal cramps, blood in stools and loose motions
• Planning to get pregnant or breastfeeding

If you use other drugs or over the counter products at the same time, the effects of L-Ornithine-L-Aspartate / Pancreatin may change. This may increase your risk for side-effects or cause your drug not to work properly. Tell your doctor about all the drugs, vitamins, and herbal supplements you are using, so that you doctor can help you prevent or manage drug interactions. L-Ornithine-L-Aspartate / Pancreatin may interact with the following drugs and products:

• Herbal products
• Over-the-counter medicines
• Prandase
• Precose
• Vitamins

No data had found

This is indicated for the treatment of Hepatic Encephalopathy, Acute Liver Failure, Hyperammonemia due to Acute and Chronic Hepatitis, Fatty Liver, Alcoholic Liver damage, Adjunct to hepatotoxic drugs, Liver Cirrhosis, Post hepatitis convalescence etc.

Digestive Enzyme

L-Ornithine L-Aspartate is a stable combination of two important endogenous Amino Acids, L-Ornithine and L-Aspartate. After administration, it quickly breaks down into L-Ornithine and L-Aspartate. L-Ornithine being a substrate of urea cycle, converts toxic ammonia into non-toxic urea which is eliminated via kidneys, helping the diseased liver to carry out its normal function smoothly (detoxification). The process lowers the elevated level of ammonia in blood (hyperammonemia) which is a common problem in most of the liver diseases. L-Aspartate is an essential component of citric acid cycle which liberates energy (ATP), and thus helps in regeneration of damaged liver cells.

Sachet: 1-2 sachets granules is dissolved in a large amount of fluid (e.g. in a glass of water or juice) and is taken orally 3 times a day during or after meals.

Injection (Infusion Concentrate): The recommended dose is up to 20 gm (4 ampoules daily). In case of loss of consciousness (pre-coma) and clouding of consciousness (coma) up to 8 ampoules within 24 hours, depending on the severity of the condition.

Very rarely side effects like nausea and vomiting occur. These side effects are usually transient and do not necessitate the withdrawal of the drug.

Monitoring of serum and urinary urea levels at regular intervals should be done.

No data regarding the interactions of L-Ornithine L-Aspartate was found.

The administration in pregnancy and lactation should be avoided.

Store in a cool and dry place, keep away from light.

This is indicated for the treatment of Hepatic Encephalopathy, Acute Liver Failure, Hyperammonemia due to Acute and Chronic Hepatitis, Fatty Liver, Alcoholic Liver damage, Adjunct to hepatotoxic drugs, Liver Cirrhosis, Post hepatitis convalescence etc.

Digestive Enzyme

L-Ornithine L-Aspartate is a stable combination of two important endogenous Amino Acids, L-Ornithine and L-Aspartate. After administration, it quickly breaks down into L-Ornithine and L-Aspartate. L-Ornithine being a substrate of urea cycle, converts toxic ammonia into non-toxic urea which is eliminated via kidneys, helping the diseased liver to carry out its normal function smoothly (detoxification). The process lowers the elevated level of ammonia in blood (hyperammonemia) which is a common problem in most of the liver diseases. L-Aspartate is an essential component of citric acid cycle which liberates energy (ATP), and thus helps in regeneration of damaged liver cells.

Sachet: 1-2 sachets granules is dissolved in a large amount of fluid (e.g. in a glass of water or juice) and is taken orally 3 times a day during or after meals.

Injection (Infusion Concentrate): The recommended dose is up to 20 gm (4 ampoules daily). In case of loss of consciousness (pre-coma) and clouding of consciousness (coma) up to 8 ampoules within 24 hours, depending on the severity of the condition.

Very rarely side effects like nausea and vomiting occur. These side effects are usually transient and do not necessitate the withdrawal of the drug.

Monitoring of serum and urinary urea levels at regular intervals should be done.

No data regarding the interactions of L-Ornithine L-Aspartate was found.

The administration in pregnancy and lactation should be avoided.

Store in a cool and dry place, keep away from light.

This is indicated for the treatment of Hepatic Encephalopathy, Acute Liver Failure, Hyperammonemia due to Acute and Chronic Hepatitis, Fatty Liver, Alcoholic Liver damage, Adjunct to hepatotoxic drugs, Liver Cirrhosis, Post hepatitis convalescence etc.

Digestive Enzyme

L-Ornithine L-Aspartate is a stable combination of two important endogenous Amino Acids, L-Ornithine and L-Aspartate. After administration, it quickly breaks down into L-Ornithine and L-Aspartate. L-Ornithine being a substrate of urea cycle, converts toxic ammonia into non-toxic urea which is eliminated via kidneys, helping the diseased liver to carry out its normal function smoothly (detoxification). The process lowers the elevated level of ammonia in blood (hyperammonemia) which is a common problem in most of the liver diseases. L-Aspartate is an essential component of citric acid cycle which liberates energy (ATP), and thus helps in regeneration of damaged liver cells.

Sachet: 1-2 sachets granules is dissolved in a large amount of fluid (e.g. in a glass of water or juice) and is taken orally 3 times a day during or after meals.

Injection (Infusion Concentrate): The recommended dose is up to 20 gm (4 ampoules daily). In case of loss of consciousness (pre-coma) and clouding of consciousness (coma) up to 8 ampoules within 24 hours, depending on the severity of the condition.

Very rarely side effects like nausea and vomiting occur. These side effects are usually transient and do not necessitate the withdrawal of the drug.

Monitoring of serum and urinary urea levels at regular intervals should be done.

No data regarding the interactions of L-Ornithine L-Aspartate was found.

The administration in pregnancy and lactation should be avoided.

Store in a cool and dry place, keep away from light.

Kabid Nawshadri is indicated in-

• Weakness of stomach and liver
• Hepatitis
• Indigestion

Herbal and Nutraceuticals

This is a judicious combination of Embelia (Embelia ribes), Chebulic myrobalan (Terminalia chebula), Ginger (Zingiber officinale), Black pepper (Piper nigrum) and other valuable natural ingredients. It is a well known hepatoprotective unani medicine. It strengthens the liver and helps to relieve jaundice, hepatitis & indigestion. This is also effective in anorexia, nausea and vomiting.

1-2 tablet(s) 2-3 times daily after meal or as prescribed by the physician.

No significant side effect has been observed in therapeutic dosage.

There is no known contraindication.

Keep out of reach of the children.

Store at cool and dry place, protect from light.

Silymarin (Milk thistle) is indicated for the treatment and prevention of-

• Liver disease, (non-alcoholic & alcoholic)
• Liver cirrhosis, (non-alcoholic & alcoholic)
• Infectious hepatitis
• Drug-induced hepatitis
• Liver disease secondary to diabetes mellitus
• Toxicity of narcotics
• Fatty liver
• Jaundice

Cholagogues, Cholelitholytics & Hepatic Protectors, Herbal and Nutraceuticals

Silymarin, a flavonoid complex of Silybum marianum or Milk thistle, is the biologically active component. It provides hepatocellular protection through toxin blockade at the membrane level, enhances protein synthesis, antioxidant activity, anti-fibrotic activity and possible anti-inflammatory or immunomodulating effects.

1 capsule 2 to 3 times daily or as directed by a physician.

Well tolerated in the recommended dose. Occasionally a mild laxative effect may observe.

Contraindicated in patient with a known hypersensitivity to silymarin.

Concomitant use of silymarin and butyrophenones or phenothiazines has resulted in the reduction of lipid peroxidation.

No experience is available about the use of Silymarin 70 mg or 140 mg during pregnancy and lactation. Therefore, if needed Silymarin 70 mg or 140 mg should be taken with caution according to the physician’s advice.

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

Silymarin (Milk thistle) is indicated for the treatment and prevention of-

• Liver disease, (non-alcoholic & alcoholic)
• Liver cirrhosis, (non-alcoholic & alcoholic)
• Infectious hepatitis
• Drug-induced hepatitis
• Liver disease secondary to diabetes mellitus
• Toxicity of narcotics
• Fatty liver
• Jaundice

Cholagogues, Cholelitholytics & Hepatic Protectors, Herbal and Nutraceuticals

Silymarin, a flavonoid complex of Silybum marianum or Milk thistle, is the biologically active component. It provides hepatocellular protection through toxin blockade at the membrane level, enhances protein synthesis, antioxidant activity, anti-fibrotic activity and possible anti-inflammatory or immunomodulating effects.

1 capsule 2 to 3 times daily or as directed by a physician.

Well tolerated in the recommended dose. Occasionally a mild laxative effect may observe.

Contraindicated in patient with a known hypersensitivity to silymarin.

Concomitant use of silymarin and butyrophenones or phenothiazines has resulted in the reduction of lipid peroxidation.

No experience is available about the use of Silymarin 70 mg or 140 mg during pregnancy and lactation. Therefore, if needed Silymarin 70 mg or 140 mg should be taken with caution according to the physician’s advice.

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