Find Medicines

Benzylpenicillin & Phenoxymethyl penicillin

Phenoxymethyl penicillin or penicillin V is acid-stable and is absorbed from the upper part of the small intestine. Of different forms of Phenoxymethyl penicillin, the potassium salt of Phenoxymethyl penicillin is best absorbed. This may be given with meals but maximum absorption is achieved when drug is administered orally at least 1 hour before or 2 hours after the meal. Phenoxymethyl penicillin offers a very convenient means of treating Grampositive infections. Phenoxymethyl penicillin has the distinct advantage over penicillin G in resistance to inactivation by gastric acid.

The dosage of Phenoxymethyl penicillin should be determined according to the sensitivity of the causative micro-organism and the severity of the infection, and adjusted to the clinical response of the patient.

Adults: 250-500 mg 6 hourly

Children (above 1 year):

• 125-250 mg 6 hourly
• 125 mg/5 ml powder for suspension: 1-2 teaspoonful (5-10 ml) 6 hourly
• 250 mg/5 ml powder for suspension: ½-1 teaspoonful (2.5-5 ml) 6 hourly

Infants (below 1 year):

• 62.5-125 mg 6 hourly.
• 125 mg/5 ml powder for suspension: ½-1 teaspoonful (2.5-5 ml) 6 hourly, or as prescribed by the physician.

Phenoxymethyl penicillin is best taken with an empty stomach, preferably at least 1 hour before or 2 hour after meal.

Phenoxymethyl Penicillin is best taken on an empty stomach, preferably one hour before meals. The tablets are swallowed without chewing with sufficient amounts of liquid. Before each use of this syrup, the bottle has to be shaken vigorously.

Occasionally, hypersensitivity reactions involving the skin (e.g. urticaria, morbilliform or scarlatiniform rashes, pruritus), eosinophilia or more serious allergic reactions, e.g. drug fever, vasculitis, serum sickness or interstitial nephritis, may develop. Anaphylactic or anaphylactoid reactions accompanied by, e.g- angioneurotic oedema, oedema of the larynx, bronchial spasm and shock may occur.

In the event of signs pointing to anaphylactic/anaphylactoid reactions, the treatment must be terminated immediately. In occasional instances, there may be skin rashes or inflammation of mucous membranes, especially in the region of the mouth (stomatitis); dryness of the mouth and disorders of taste may rarely occur.

The occurrence of severe bullous skin reactions- usually involving the mucosae- has been reported in isolated cases (Stevens-Johnson syndrome, Lyell's syndrome). Gastrointestinal disturbances with, e.g., nausea, vomiting, abdominal pain, loose stools, or diarrhoea may develop.

Diarrhoea may sometimes be a symptom of enterocolitis which may, in some cases, be haemorrhagic. A particular form of enterocolitis that can occur with antibiotics is pseudomembranous colitis (in most cases due to Clostridium diffcile). This must be considered in patients in whom severe, persistent diarrhoea occurs during treatment or in the initial weeks thereafter. Even if pseudomembranous colitis is only suspected, administration of Phenoxymethyl penicillin must be halted immediately. This type of colitis requires immediate and appropriate treatment by a physician. Drugs that inhibit intestinal peristalsis must not be taken in such cases. In isolated cases, particularly after high doses and prolonged administration, changes in blood picture such as reduction in the number of white blood cells (e.g.,leucopenia, granulocytopenia, agranulocytosis), erythrocytes (e.g., due to haemolytic anaemia), thrombocytes, or pancytopenia and myelosuppression may occur. During treatment for spirochaetal infections, Herxheimer's reaction characterized by the occurrence or worsening of general symptoms such as fever, chills, headache, and joint pains may develop. In isolated cases, drug-induced aseptic meningitis may occur.

In extremely rare cases, transient discolouration of the teeth may be seen during treatment with Phenoxymethyl penicillin. Administration of antibiotics, especially if prolonged, may lead to the proliferation of resistant micro organisms.

Beta-lactams predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.

Phenoxymethyl Penicillin must not be administered in patients with hypersensitivity to penicillins or any of the excipients of this. Phenoxymethyl Penicillin must not be used to treat patients with severe gastrointestinal disorders accompanied by vomiting and diarrhea.

The possibility of cross-allergy between cephalosporins and penicillins must be considered. When treating patients with heart diseases or serious electrolyte disturbances of other origin, the potassium content of Phenoxymethyl Penicillin may have to be considered. Beta-lactams predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.

Administration of antibiotics, especially if prolonged, may lead to the proliferation of resistant micro-organisms. The patient's condition must therefore be checked at regular intervals. If a secondary infection occurs, appropriate measures must be taken. In patients with diabetes mellitus, the sugar content of Phenoxymethyl Penicillin syrup must be taken into consideration.

There is no indication of impaired ability to drive, or to operate machinery. Beta-lactams predispose the patient to encephalopathy risk. In the case of adverse reactions such as encephalopathy (which may include convulsions, confusion, impairment of consciousness, movement disorders), the patient should not operate machines or drive a vehicle.

Food: Concurrent intake of food leads to a reduction in the rate of absorption. Therefore, Phenoxymethyl penicillin is best taken on an empty stomach, preferably one hour before meals, in order to reach the highest possible rate of absorption.

Drug interactions: Concomitant administration of penicillins may lead to increased levels of methotrexate in serum and potentiate its toxic effects. Monitoring of methotrexate serum levels is therefore necessary.

If diarrhoea occurs as a consequence of treatment with Phenoxymethyl penicillin, the absorption of other orally administered drugs may be disturbed and their effcacy may consequently be impaired. If penicillins are combined with bacteriostatic chemotherapeutics or antibiotics (e.g., tetracyclines, chloramphenicol), the activity of penicillins may be attenuated or abolished. Concurrent administration of probenecid inhibits the renal excretion of penicillins. Concurrent use of indomethacin, phenylbutazone, salicylates or sulfinpyrazone may cause elevated and prolonged serum levels of phenoxymethylpenicillin.

Administration of penicillins may cause a transient reduction in plasma concentrations of oestrogens and gestagens. The effectiveness of oral contraceptives is therefore uncertain.

The absorption of Phenoxymethyl penicillin may be reduced where intestinal sterilization with aminoglycosides (e.g. neomycin) has just been performed or is still in progress. Combined use of penicillins and oral anticoagulants (e.g. warfarin) may prolong prothrombin time/INR.

Interference with laboratory and diagnostic tests: Non-enzymatic urine glucose determinations and tests for urobilinogen may give false-positive results.

Phenoxymethylpenicillin crosses the placenta. Given the appropriate indication, this may be used at any time throughout pregnancy. Phenoxymethylpenicillin passes into the breast milk in small amounts. This may be used during lactation; however, diarrhoea and yeast colonization of mucous membranes may occur in the infant.

The toxicity of phenoxymethylpenicillin is low, and it has a broad therapeutic range. When a multiple therapeutic dose is taken orally once only, phenoxymethylpenicillin has no acute toxicity. There is a risk of encephalopathy in cases of administration of beta-lactam antibiotics, particularly in case of overdose or renal impairment. Special measures in the event of overdosage, other than discontinuation of the medication, are not required. Elimination of phenoxymethylpenicillin can be accomplished through haemodialysis.

Store in a cool and dry place, protect from light.

Specific combined vitamin preparations

Vitamin-B complex contains the most important members of the vitamin B group in pure form and in therapeutically balanced proportions. The members of the vitamin B group contained in Vitamin-B complex are components of enzyme systems that regulate various stages of carbohydrate, fat and protein metabolism, each of the components playing a specific biological role. Deficiency of B vitamin causes glossitis, stomatitis, cheilosis, polyneuritis, beriberi, pellagra and vascularisation of cornea.

Tablet/ capsule: usual recommended dose is 1-2 tablet/capsule 3 times daily or as directed by the physician.

Syrup: 2-3 teaspoonful daily or as directed by the physician.

Injection: It is for intramuscular and intravenous administration. Usual recommended dose is 2 ml daily or as directed by the physician. In addition with Thiamine, Riboflavin, Nicotinamide, Pyridoxine; injectable dosage from contains D-Panthenol 5 mg.

Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in Vitamin-B complex. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended level has been associated with gastrointestinal intolerance in some patients.

Vitamin-B complex is contraindicated in patients hypersensitive to any of its components.

As little as 5 mg pyridoxine daily can decrease the efficacy of levodopa in the treatment of parkinsonism. Therefore, Vitamin-B complex is not recommended for patients undergoing such therapy

It is safe to use Vitamin-B complex in pregnancy and lactation.

Specific combined vitamin preparations

Vitamin-B complex contains the most important members of the vitamin B group in pure form and in therapeutically balanced proportions. The members of the vitamin B group contained in Vitamin-B complex are components of enzyme systems that regulate various stages of carbohydrate, fat and protein metabolism, each of the components playing a specific biological role. Deficiency of B vitamin causes glossitis, stomatitis, cheilosis, polyneuritis, beriberi, pellagra and vascularisation of cornea.

Tablet/ capsule: usual recommended dose is 1-2 tablet/capsule 3 times daily or as directed by the physician.

Syrup: 2-3 teaspoonful daily or as directed by the physician.

Injection: It is for intramuscular and intravenous administration. Usual recommended dose is 2 ml daily or as directed by the physician. In addition with Thiamine, Riboflavin, Nicotinamide, Pyridoxine; injectable dosage from contains D-Panthenol 5 mg.

Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in Vitamin-B complex. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended level has been associated with gastrointestinal intolerance in some patients.

Vitamin-B complex is contraindicated in patients hypersensitive to any of its components.

As little as 5 mg pyridoxine daily can decrease the efficacy of levodopa in the treatment of parkinsonism. Therefore, Vitamin-B complex is not recommended for patients undergoing such therapy

It is safe to use Vitamin-B complex in pregnancy and lactation.

Multi-vitamin & Multi-mineral combined preparations, Specific mineral & vitamin combined preparations

Vitamins and minerals are essential for normal metabolic functions including hematopoiesis. The members of vitamin B-group are components of enzyme system that regulate various stages of carbohydrate, fat and protein metabolism, each of the components playing a specific biological role. Vitamin C is involved in tissue repair and collagen formation. Vitamin A plays an essential role in the function of retina and is essential for growth and differentiation of epithelial tissue. Vitamin E is an antioxidant which preserves essential cellular constituents. Vitamin D is supplemented for prevention and cure of nutritional and metabolic rickets and for treatment of hypoparathyroidism. Iron, Copper, Manganese, Zinc serve as catalysts in enzyme systems which perform vital cellular functions.

Orally one tablet daily for adult and children over 5 years of age or as directed by the physicians.

Side effects have been reported with specific vitamins & minerals, but at level substantially higher than those in this tablet. Iron has been associated with gastrointestinal intolerance in some patients.

This is contraindicated in patients hypersensitive to any of its components. This is not intended for treatment of severe specific deficiencies of vitamins or minerals. It is not recommended for patients undergoing treatment with levodopa as pyridoxine decreases the efficacy of levodopa. During the first trimester of pregnancy, larger doses of vitamin A (more than 10 tablets per day) may be teratogenic.

Not intended for treatment of pernicious anemia or other megaloblastic anemia where vitamin B12 is deficient.

During the first trimester of pregnancy, recommended daily dose should not be exceeded. Because larger doses of Vitamin-A (multiple tablets per day) may be teratogenic.

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

Cytarabine is indicated in Leukaemic meningitis, Induction and maintenance of remission in acute leukaemias

Cytotoxic Chemotherapy

Cytarabine inhibits deoxyribonucleic acid (DNA) synthesis specifically at the S-phase of the cell cycle. It also has an antiviral and immunosuppressant activity.

Intrathecal (Adult)-

• Leukaemic meningitis: 5-75 mg/m² or 30-100 mg once every 2-7 days to once daily for 4 or 5 days.
• For lymphomatous meningitis: 50 mg every 2 wk for 5 doses, then every 4 wk for 5 doses.

Parenteral (Adult)-
Induction and maintenance of remission in acute leukaemias: 

• As monotherapy: 200 mg/m² daily by continuous IV infusion for 5 days, at intervals of approx 2 wk.
• In combination therapy: 100 mg/m² bid by rapid IV inj or 100 mg/m² daily by continuous IV infusion both for 7 days. Maintenance: 1-1.5 mg/kg once or twice wkly via IV or SC.

Nausea, vomiting, fever, rash, diarrhoea, anorexia, oral and anal inflammation or ulceration, hepatic dysfunction, headache, weakness, confusion, thrombocytopenia, fatigue.

Patient with active meningeal infection.

Patient with previous drug-induced bone marrow suppression. Renal or hepatic impairment. Pregnancy and lactation.

May reduce efficacy of 5-fluorocytosine, digoxin, gentamicin. May increase risk of neurotoxicity with other cytotoxic agents (intrathecal).

Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Symptoms: Irreversible CNS toxicity and death. Severe arachnoiditis including encephalopathy.

Management: Therapy cessation followed by treatment of ensuing bone marrow depression including whole blood or platelet transfusion and antibiotics. Maintain vital functions.

Intravenous: Reconstitute with bacteriostatic water for inj (standard-dose), further dilute in 250-1,000 ml NaCl 0.9% or dextrose 5% in water for infusion.

Intrathecal: Reconstitute with preservative free NaCl 0.9%, further dilute with Elliot’s B soln, NaCl 0.9% or lactated Ringer’s inj to preferred final vol (up to 12 ml).

IV/SC: Store between 15-25°C. Intrathecal: Store between 2-8°C. Avoid freezing.

Cytarabine is indicated in Leukaemic meningitis, Induction and maintenance of remission in acute leukaemias

Cytotoxic Chemotherapy

Cytarabine inhibits deoxyribonucleic acid (DNA) synthesis specifically at the S-phase of the cell cycle. It also has an antiviral and immunosuppressant activity.

Intrathecal (Adult)-

• Leukaemic meningitis: 5-75 mg/m² or 30-100 mg once every 2-7 days to once daily for 4 or 5 days.
• For lymphomatous meningitis: 50 mg every 2 wk for 5 doses, then every 4 wk for 5 doses.

Parenteral (Adult)-
Induction and maintenance of remission in acute leukaemias: 

• As monotherapy: 200 mg/m² daily by continuous IV infusion for 5 days, at intervals of approx 2 wk.
• In combination therapy: 100 mg/m² bid by rapid IV inj or 100 mg/m² daily by continuous IV infusion both for 7 days. Maintenance: 1-1.5 mg/kg once or twice wkly via IV or SC.

Nausea, vomiting, fever, rash, diarrhoea, anorexia, oral and anal inflammation or ulceration, hepatic dysfunction, headache, weakness, confusion, thrombocytopenia, fatigue.

Patient with active meningeal infection.

Patient with previous drug-induced bone marrow suppression. Renal or hepatic impairment. Pregnancy and lactation.

May reduce efficacy of 5-fluorocytosine, digoxin, gentamicin. May increase risk of neurotoxicity with other cytotoxic agents (intrathecal).

Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Symptoms: Irreversible CNS toxicity and death. Severe arachnoiditis including encephalopathy.

Management: Therapy cessation followed by treatment of ensuing bone marrow depression including whole blood or platelet transfusion and antibiotics. Maintain vital functions.

Intravenous: Reconstitute with bacteriostatic water for inj (standard-dose), further dilute in 250-1,000 ml NaCl 0.9% or dextrose 5% in water for infusion.

Intrathecal: Reconstitute with preservative free NaCl 0.9%, further dilute with Elliot’s B soln, NaCl 0.9% or lactated Ringer’s inj to preferred final vol (up to 12 ml).

IV/SC: Store between 15-25°C. Intrathecal: Store between 2-8°C. Avoid freezing.

Cytarabine is indicated in Leukaemic meningitis, Induction and maintenance of remission in acute leukaemias

Cytotoxic Chemotherapy

Cytarabine inhibits deoxyribonucleic acid (DNA) synthesis specifically at the S-phase of the cell cycle. It also has an antiviral and immunosuppressant activity.

Intrathecal (Adult)-

• Leukaemic meningitis: 5-75 mg/m² or 30-100 mg once every 2-7 days to once daily for 4 or 5 days.
• For lymphomatous meningitis: 50 mg every 2 wk for 5 doses, then every 4 wk for 5 doses.

Parenteral (Adult)-
Induction and maintenance of remission in acute leukaemias: 

• As monotherapy: 200 mg/m² daily by continuous IV infusion for 5 days, at intervals of approx 2 wk.
• In combination therapy: 100 mg/m² bid by rapid IV inj or 100 mg/m² daily by continuous IV infusion both for 7 days. Maintenance: 1-1.5 mg/kg once or twice wkly via IV or SC.

Nausea, vomiting, fever, rash, diarrhoea, anorexia, oral and anal inflammation or ulceration, hepatic dysfunction, headache, weakness, confusion, thrombocytopenia, fatigue.

Patient with active meningeal infection.

Patient with previous drug-induced bone marrow suppression. Renal or hepatic impairment. Pregnancy and lactation.

May reduce efficacy of 5-fluorocytosine, digoxin, gentamicin. May increase risk of neurotoxicity with other cytotoxic agents (intrathecal).

Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Symptoms: Irreversible CNS toxicity and death. Severe arachnoiditis including encephalopathy.

Management: Therapy cessation followed by treatment of ensuing bone marrow depression including whole blood or platelet transfusion and antibiotics. Maintain vital functions.

Intravenous: Reconstitute with bacteriostatic water for inj (standard-dose), further dilute in 250-1,000 ml NaCl 0.9% or dextrose 5% in water for infusion.

Intrathecal: Reconstitute with preservative free NaCl 0.9%, further dilute with Elliot’s B soln, NaCl 0.9% or lactated Ringer’s inj to preferred final vol (up to 12 ml).

IV/SC: Store between 15-25°C. Intrathecal: Store between 2-8°C. Avoid freezing.

Cytotoxic Chemotherapy

Carboplatin is an alkylating agent which binds covalently to DNA. It modifies the cell cycle by interfering with DNA structure and function.

Previously untreated patients: 400 mg/m² as single short term IV infusion over 15-60 min. Therapy should not be repeated until 4 wk after the previous course and/or until the neutrophil count is at least 2,000 cells/mm³ and the platelet count is at least 100,000 cells/mm³.

Patients previously treated with myelosuppresive therapy or patients with poor performance status: Reduce initial dosage by 20-25% (300-320 mg/m²).

Bone marrow suppression, gastrointestinal effects, nephrotoxicity, nervous system, ototoxicity, allergic reactions, alopecia, mucositis.

Carboplatin injection should not be employed in patients with severe bone marrow depression or significant bleeding. It is contraindicated in patients with a history of severe allergic reactions to cisplatin or other platinum containing compounds.

Much less renal toxicity than cisplatin so no need for a vigorousm hydration schedule or forced diuresis. If AUC dosing is not used, dose should be reduced to 250 mg/m² for creatinine clearance of 41 to 59 ml/min and to 200 mg/m² for clearance of 16 to 40 ml/min. Corticosteroids & antihistamines are employed to alleviate symptoms.

Administration of a liver vaccine may be dangerous during treatment with carboplatin. The renal effects of nephrotoxic compounds may be potentiated by carboplatin.

Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk

Renal Impairment:

• CrCl (16-40 ml/min)- 200 mg/m².
• CrCl (41-59 ml/min)- 250 mg/m².

150 mg injection should be reconstituted with 15 ml of sodium chloride solution (0.9%) or water for injection.

450 mg injection should be reconstituted with 45 ml of sodium chloride solution (0.9%) or water for injection.

The reconstituted solution should be diluted by 300 ml (for 150 mg) & 900 ml (for 450 mg) of 5% glucose for injection or 0.9% sodium chloride solution for infusition.

Store at 25° C. Protect from light.

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

Antacids

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

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

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

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

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

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

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

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

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

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

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

Antacids

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

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

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

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

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

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

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

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

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

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

Cytotoxic Chemotherapy

Gemcitabine is a synthetic pyrimidine nucleoside and cytarabine analogue which is metabolised intracellularly to active diphosphate and triphosphate nucleosides. It inhibits DNA synthesis by inhibiting DNA polymerase and ribonucleotide reductase. It also induces apoptosis and is primarily active against cells in the S-phase, but may also arrest cells at the G1-S border.

Intravenous (Adult)-

• Advanced non-small cell lung cancer: 1000 mg/m² on days 1, 8 and 15 of each 28-day cycle; or 1250 mg/m² on days 1 and 8 of each 21-day cycle.
• Pancreatic carcinoma: 1000 mg/m² once wkly for up to 7 wk followed by 1 wk of rest. Continue thereafter with once wkly infusions for 3 consecutive wk out of 4.
• Ovarian carcinoma: To be given before carboplatin: 1000 mg/m² on days 1 and 8 of each 21-day cycle.
• Breast cancer: Usually in combination with a taxane such as paclitaxel: 1250 mg/m² on days 1 and 8 of each 21-day cycle.
• Bladder cancer: To be given before cisplatin. 1000 mg/m² on days 1, 8 and 15 of each 28-day cycle.

Bone marrow suppression as manifested by leukopenia, thrombocytopenia, anaemia and myelosuppression. Mild GI effects; rashes; renal impairment, pulmonary toxicity, influenza-like symptoms; interstitial pneumonia, pulmonary oedema. Proteinuria, haematuria and haemolytic uraemic syndrome. Elevation of serum transaminase.

Concurrent radical radiotherapy; pregnancy, lactation; hypersensitivity

Children, hepatic and renal impairment. May impair ability to drive or operate machinery. Discontinue on 1st sign of microangiopathic haemolytic anaemia. Prolonged infusion time (>60 minutes) and more frequent than wkly dosing may increase toxicity. Monitor CBC before every dose. Increased risk of haemolytic uraemic syndrome and/or thrombocytcpenic purpura which may lead to irreversible renal failure.

May increase the anticoagulant effect of warfarin when used together.

Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Store at 25° C.

Cytotoxic Chemotherapy

Gemcitabine is a synthetic pyrimidine nucleoside and cytarabine analogue which is metabolised intracellularly to active diphosphate and triphosphate nucleosides. It inhibits DNA synthesis by inhibiting DNA polymerase and ribonucleotide reductase. It also induces apoptosis and is primarily active against cells in the S-phase, but may also arrest cells at the G1-S border.

Intravenous (Adult)-

• Advanced non-small cell lung cancer: 1000 mg/m² on days 1, 8 and 15 of each 28-day cycle; or 1250 mg/m² on days 1 and 8 of each 21-day cycle.
• Pancreatic carcinoma: 1000 mg/m² once wkly for up to 7 wk followed by 1 wk of rest. Continue thereafter with once wkly infusions for 3 consecutive wk out of 4.
• Ovarian carcinoma: To be given before carboplatin: 1000 mg/m² on days 1 and 8 of each 21-day cycle.
• Breast cancer: Usually in combination with a taxane such as paclitaxel: 1250 mg/m² on days 1 and 8 of each 21-day cycle.
• Bladder cancer: To be given before cisplatin. 1000 mg/m² on days 1, 8 and 15 of each 28-day cycle.

Bone marrow suppression as manifested by leukopenia, thrombocytopenia, anaemia and myelosuppression. Mild GI effects; rashes; renal impairment, pulmonary toxicity, influenza-like symptoms; interstitial pneumonia, pulmonary oedema. Proteinuria, haematuria and haemolytic uraemic syndrome. Elevation of serum transaminase.

Concurrent radical radiotherapy; pregnancy, lactation; hypersensitivity

Children, hepatic and renal impairment. May impair ability to drive or operate machinery. Discontinue on 1st sign of microangiopathic haemolytic anaemia. Prolonged infusion time (>60 minutes) and more frequent than wkly dosing may increase toxicity. Monitor CBC before every dose. Increased risk of haemolytic uraemic syndrome and/or thrombocytcpenic purpura which may lead to irreversible renal failure.

May increase the anticoagulant effect of warfarin when used together.

Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Store at 25° C.

Cytarabine is indicated in Leukaemic meningitis, Induction and maintenance of remission in acute leukaemias

Cytotoxic Chemotherapy

Cytarabine inhibits deoxyribonucleic acid (DNA) synthesis specifically at the S-phase of the cell cycle. It also has an antiviral and immunosuppressant activity.

Intrathecal (Adult)-

• Leukaemic meningitis: 5-75 mg/m² or 30-100 mg once every 2-7 days to once daily for 4 or 5 days.
• For lymphomatous meningitis: 50 mg every 2 wk for 5 doses, then every 4 wk for 5 doses.

Parenteral (Adult)-
Induction and maintenance of remission in acute leukaemias: 

• As monotherapy: 200 mg/m² daily by continuous IV infusion for 5 days, at intervals of approx 2 wk.
• In combination therapy: 100 mg/m² bid by rapid IV inj or 100 mg/m² daily by continuous IV infusion both for 7 days. Maintenance: 1-1.5 mg/kg once or twice wkly via IV or SC.

Nausea, vomiting, fever, rash, diarrhoea, anorexia, oral and anal inflammation or ulceration, hepatic dysfunction, headache, weakness, confusion, thrombocytopenia, fatigue.

Patient with active meningeal infection.

Patient with previous drug-induced bone marrow suppression. Renal or hepatic impairment. Pregnancy and lactation.

May reduce efficacy of 5-fluorocytosine, digoxin, gentamicin. May increase risk of neurotoxicity with other cytotoxic agents (intrathecal).

Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Symptoms: Irreversible CNS toxicity and death. Severe arachnoiditis including encephalopathy.

Management: Therapy cessation followed by treatment of ensuing bone marrow depression including whole blood or platelet transfusion and antibiotics. Maintain vital functions.

Intravenous: Reconstitute with bacteriostatic water for inj (standard-dose), further dilute in 250-1,000 ml NaCl 0.9% or dextrose 5% in water for infusion.

Intrathecal: Reconstitute with preservative free NaCl 0.9%, further dilute with Elliot’s B soln, NaCl 0.9% or lactated Ringer’s inj to preferred final vol (up to 12 ml).

IV/SC: Store between 15-25°C. Intrathecal: Store between 2-8°C. Avoid freezing.

Drugs acting on the Uterus, Prostaglandin analogues

Misoprostol is extensively absorbed, and undergoes rapid de-esterification to its free acid, which is responsible for its clinical activity and, unlike the parent compound, is detectable in plasma. Maximum plasma concentrations of Misoprostol acid are diminished when the dose is taken with food and total availability of Misoprostol acid is reduced by use of concomitant antacid. Misoprostol has both antisecretory (inhibiting gastric acid secretion) and (in animals) mucosal protective properties. NSAIDs inhibit prostaglandin synthesis, and a deficiency of prostaglandins within the gastric mucosa may lead to diminishing bicarbonate and mucus secretion and may contribute to the mucosal damage caused by these agents. Misoprostol can increase bicarbonate and mucus production, but in man this has been shown at doses 200 meg and above that are also antisecretory. It is therefore not possible to tell whether the ability of Misoprostol to reduce the risk of gastric ulcer is the result of its antisecretory effect, its mucosal protective effect, or both.

Benign gastric and duodenal ulceration and NSAID associated ulceration: 800 mcg daily (in 2-4 divided doses) with breakfast or main meals and at bedtime; treatment should be continued for at least 4 weeks and may be continued for up to 8 weeks if required.

Prophylaxis of NSAID-induced gastric and duodenal ulcer: 200 mcg 2-4 times daily taken with NSAID. If this dose cannot be tolerated, a dose of 100 mcg can be used. Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician.

Induction of labor: Place 25 mcg in the posterior fornix of the vagina. Repeat after every 6 hours if necessary until the maximum dosage of 200 mcg total misoprostol is reached. Fetal heart rate and uterus contractions should be monitored. Alternatively, 100 mcg taken orally. If cervical ripening or active labor does not occur, repeated dose of 100-200 mcg of oral misoprostol is given every 4 hourly until labor is established (as evidenced by a Bishop score of 7 or more). Maximum number of dose is 6. Maternal vital signs, fetal heart rate and contractions should be monitored. Oxytocin can be started 4 hours after last dose of misoprostol. Physician should be notified for signs of fetal distress or tetanic uterine contractions. Oral misoprostol therapy should be monitored by Physician.

Prevention of postpartum hemorrhage: 600 mcg orally immediately following delivery.

Treatment of postpartum hemorrhage: 600 mcg orally or 1000 mcg per rectally.

Generally, Misoprostol is well tolerated. The most frequent adverse effects associated with Misoprostol therapy involve the GI tract such as diarrhea, abdominal pain, dyspepsia, flatulence, nausea, vomiting, rashes and dizziness. The incidence of diarrhea may be minimized by administering the drug after meal and at bedtime and by avoiding concomitant administration with a magnesium-containing or other laxative antacid.

Misoprostol is contraindicated to anyone with a history of allergy to prostaglandins and it is also contraindicated in pregnancy.

In case of prevention and treatment of NSAID induced gastric and duodenal ulcer: Misoprostol is contraindicated in women who are pregnant, and should not be used in women of child bearing potential unless the patient requires NSAID therapy. Women of child bearing potential should be told that they must not be pregnant when Misoprostol therapy is initiated and they must use an effective contraception method while taking misoprostol.

In case of induction of labor: The pregnancy should have completed 38 weeks gestation by reliable dating, or lung maturity as evidenced by a L/S >2.0 or a positive phosphotidyl glycerol test, or completed 36 weeks gestation with a maternal or fetal medical indication for induction of labor. Induction of labor is contraindicated in acute fetal distress, abruptio placenta, placenta previa or unexplained vaginal bleeding. The fetus should be in vertex presentation.

There is no evidence of clinically significant interaction between Misoprostol and cardiac, pulmonary, CNS drugs and NSAID's. The bioavailability of Misoprostol is decreased with high doses of antacid.

Because of the abortifacient property of the Misoprostol component, it is contraindicated in women who are pregnant. It should not be used in women of childbearing potential unless the patient requires nonsteroidal anti-inflammatory drug (NSAID) therapy and is at high risk of developing gastric or duodenal ulceration or for developing complications from gastric or duodenal ulcers associated with the use of the NSAID. In such patients, it may be prescribed if the patient:

• has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
• is capable of complying with effective contraceptive measures.
• has received both oral and written warnings of the hazards of Misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake.
• will begin it only on the second or third day of the next normal menstrual period.

Excretion of the active metabolite (Misoprostol acid) into milk is possible but has not been studied. Because of the potential for serious adverse reactions in nursing infants, it is not recommended for use by nursing mothers.

Use in children: Safety and effectiveness of Misoprostol in children below the age of 18 years have not been established.

The toxic dose of Misoprostol in human has not been determined. Clinical signs that may indicate an overdose are a sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea and fever. Symptoms should be treated with supportive therapy.

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

Drugs acting on the Uterus, Prostaglandin analogues

Misoprostol is extensively absorbed, and undergoes rapid de-esterification to its free acid, which is responsible for its clinical activity and, unlike the parent compound, is detectable in plasma. Maximum plasma concentrations of Misoprostol acid are diminished when the dose is taken with food and total availability of Misoprostol acid is reduced by use of concomitant antacid. Misoprostol has both antisecretory (inhibiting gastric acid secretion) and (in animals) mucosal protective properties. NSAIDs inhibit prostaglandin synthesis, and a deficiency of prostaglandins within the gastric mucosa may lead to diminishing bicarbonate and mucus secretion and may contribute to the mucosal damage caused by these agents. Misoprostol can increase bicarbonate and mucus production, but in man this has been shown at doses 200 meg and above that are also antisecretory. It is therefore not possible to tell whether the ability of Misoprostol to reduce the risk of gastric ulcer is the result of its antisecretory effect, its mucosal protective effect, or both.

Benign gastric and duodenal ulceration and NSAID associated ulceration: 800 mcg daily (in 2-4 divided doses) with breakfast or main meals and at bedtime; treatment should be continued for at least 4 weeks and may be continued for up to 8 weeks if required.

Prophylaxis of NSAID-induced gastric and duodenal ulcer: 200 mcg 2-4 times daily taken with NSAID. If this dose cannot be tolerated, a dose of 100 mcg can be used. Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician.

Induction of labor: Place 25 mcg in the posterior fornix of the vagina. Repeat after every 6 hours if necessary until the maximum dosage of 200 mcg total misoprostol is reached. Fetal heart rate and uterus contractions should be monitored. Alternatively, 100 mcg taken orally. If cervical ripening or active labor does not occur, repeated dose of 100-200 mcg of oral misoprostol is given every 4 hourly until labor is established (as evidenced by a Bishop score of 7 or more). Maximum number of dose is 6. Maternal vital signs, fetal heart rate and contractions should be monitored. Oxytocin can be started 4 hours after last dose of misoprostol. Physician should be notified for signs of fetal distress or tetanic uterine contractions. Oral misoprostol therapy should be monitored by Physician.

Prevention of postpartum hemorrhage: 600 mcg orally immediately following delivery.

Treatment of postpartum hemorrhage: 600 mcg orally or 1000 mcg per rectally.

Generally, Misoprostol is well tolerated. The most frequent adverse effects associated with Misoprostol therapy involve the GI tract such as diarrhea, abdominal pain, dyspepsia, flatulence, nausea, vomiting, rashes and dizziness. The incidence of diarrhea may be minimized by administering the drug after meal and at bedtime and by avoiding concomitant administration with a magnesium-containing or other laxative antacid.

Misoprostol is contraindicated to anyone with a history of allergy to prostaglandins and it is also contraindicated in pregnancy.

In case of prevention and treatment of NSAID induced gastric and duodenal ulcer: Misoprostol is contraindicated in women who are pregnant, and should not be used in women of child bearing potential unless the patient requires NSAID therapy. Women of child bearing potential should be told that they must not be pregnant when Misoprostol therapy is initiated and they must use an effective contraception method while taking misoprostol.

In case of induction of labor: The pregnancy should have completed 38 weeks gestation by reliable dating, or lung maturity as evidenced by a L/S >2.0 or a positive phosphotidyl glycerol test, or completed 36 weeks gestation with a maternal or fetal medical indication for induction of labor. Induction of labor is contraindicated in acute fetal distress, abruptio placenta, placenta previa or unexplained vaginal bleeding. The fetus should be in vertex presentation.

There is no evidence of clinically significant interaction between Misoprostol and cardiac, pulmonary, CNS drugs and NSAID's. The bioavailability of Misoprostol is decreased with high doses of antacid.

Because of the abortifacient property of the Misoprostol component, it is contraindicated in women who are pregnant. It should not be used in women of childbearing potential unless the patient requires nonsteroidal anti-inflammatory drug (NSAID) therapy and is at high risk of developing gastric or duodenal ulceration or for developing complications from gastric or duodenal ulcers associated with the use of the NSAID. In such patients, it may be prescribed if the patient:

• has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
• is capable of complying with effective contraceptive measures.
• has received both oral and written warnings of the hazards of Misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake.
• will begin it only on the second or third day of the next normal menstrual period.

Excretion of the active metabolite (Misoprostol acid) into milk is possible but has not been studied. Because of the potential for serious adverse reactions in nursing infants, it is not recommended for use by nursing mothers.

Use in children: Safety and effectiveness of Misoprostol in children below the age of 18 years have not been established.

The toxic dose of Misoprostol in human has not been determined. Clinical signs that may indicate an overdose are a sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea and fever. Symptoms should be treated with supportive therapy.

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

Drugs acting on the Uterus, Prostaglandin analogues

Misoprostol is extensively absorbed, and undergoes rapid de-esterification to its free acid, which is responsible for its clinical activity and, unlike the parent compound, is detectable in plasma. Maximum plasma concentrations of Misoprostol acid are diminished when the dose is taken with food and total availability of Misoprostol acid is reduced by use of concomitant antacid. Misoprostol has both antisecretory (inhibiting gastric acid secretion) and (in animals) mucosal protective properties. NSAIDs inhibit prostaglandin synthesis, and a deficiency of prostaglandins within the gastric mucosa may lead to diminishing bicarbonate and mucus secretion and may contribute to the mucosal damage caused by these agents. Misoprostol can increase bicarbonate and mucus production, but in man this has been shown at doses 200 meg and above that are also antisecretory. It is therefore not possible to tell whether the ability of Misoprostol to reduce the risk of gastric ulcer is the result of its antisecretory effect, its mucosal protective effect, or both.

Benign gastric and duodenal ulceration and NSAID associated ulceration: 800 mcg daily (in 2-4 divided doses) with breakfast or main meals and at bedtime; treatment should be continued for at least 4 weeks and may be continued for up to 8 weeks if required.

Prophylaxis of NSAID-induced gastric and duodenal ulcer: 200 mcg 2-4 times daily taken with NSAID. If this dose cannot be tolerated, a dose of 100 mcg can be used. Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician.

Induction of labor: Place 25 mcg in the posterior fornix of the vagina. Repeat after every 6 hours if necessary until the maximum dosage of 200 mcg total misoprostol is reached. Fetal heart rate and uterus contractions should be monitored. Alternatively, 100 mcg taken orally. If cervical ripening or active labor does not occur, repeated dose of 100-200 mcg of oral misoprostol is given every 4 hourly until labor is established (as evidenced by a Bishop score of 7 or more). Maximum number of dose is 6. Maternal vital signs, fetal heart rate and contractions should be monitored. Oxytocin can be started 4 hours after last dose of misoprostol. Physician should be notified for signs of fetal distress or tetanic uterine contractions. Oral misoprostol therapy should be monitored by Physician.

Prevention of postpartum hemorrhage: 600 mcg orally immediately following delivery.

Treatment of postpartum hemorrhage: 600 mcg orally or 1000 mcg per rectally.

Generally, Misoprostol is well tolerated. The most frequent adverse effects associated with Misoprostol therapy involve the GI tract such as diarrhea, abdominal pain, dyspepsia, flatulence, nausea, vomiting, rashes and dizziness. The incidence of diarrhea may be minimized by administering the drug after meal and at bedtime and by avoiding concomitant administration with a magnesium-containing or other laxative antacid.

Misoprostol is contraindicated to anyone with a history of allergy to prostaglandins and it is also contraindicated in pregnancy.

In case of prevention and treatment of NSAID induced gastric and duodenal ulcer: Misoprostol is contraindicated in women who are pregnant, and should not be used in women of child bearing potential unless the patient requires NSAID therapy. Women of child bearing potential should be told that they must not be pregnant when Misoprostol therapy is initiated and they must use an effective contraception method while taking misoprostol.

In case of induction of labor: The pregnancy should have completed 38 weeks gestation by reliable dating, or lung maturity as evidenced by a L/S >2.0 or a positive phosphotidyl glycerol test, or completed 36 weeks gestation with a maternal or fetal medical indication for induction of labor. Induction of labor is contraindicated in acute fetal distress, abruptio placenta, placenta previa or unexplained vaginal bleeding. The fetus should be in vertex presentation.

There is no evidence of clinically significant interaction between Misoprostol and cardiac, pulmonary, CNS drugs and NSAID's. The bioavailability of Misoprostol is decreased with high doses of antacid.

Because of the abortifacient property of the Misoprostol component, it is contraindicated in women who are pregnant. It should not be used in women of childbearing potential unless the patient requires nonsteroidal anti-inflammatory drug (NSAID) therapy and is at high risk of developing gastric or duodenal ulceration or for developing complications from gastric or duodenal ulcers associated with the use of the NSAID. In such patients, it may be prescribed if the patient:

• has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
• is capable of complying with effective contraceptive measures.
• has received both oral and written warnings of the hazards of Misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake.
• will begin it only on the second or third day of the next normal menstrual period.

Excretion of the active metabolite (Misoprostol acid) into milk is possible but has not been studied. Because of the potential for serious adverse reactions in nursing infants, it is not recommended for use by nursing mothers.

Use in children: Safety and effectiveness of Misoprostol in children below the age of 18 years have not been established.

The toxic dose of Misoprostol in human has not been determined. Clinical signs that may indicate an overdose are a sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea and fever. Symptoms should be treated with supportive therapy.

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

This kit is indicated for early Menstrual Regulation (MR)/termination of pregnancy up to 9 weeks (63 days) of gestation.

Drugs acting on the Uterus, Prostaglandin analogues

Mifepristone: Mifepristone is a synthetic steroid with anti-progestational activity results from competitive interaction with progesterone at progesterone-receptor sites. Based on studies with various oral doses in several animal species, the compound inhibits the activity of endogenous or exogenous progesterone and the Menstrual Regulation (MR) results. During pregnancy, the compound sensitizes the myometrium to the contraction-inducing activity of prostaglandins.

Misoprostol: Misoprostol is a synthetic analogue of prostaglandin E1. It causes myometrial contraction by interacting with specific receptors on myometrial cells. This interaction results in a change in calcium concentration, thereby initiating muscle contraction. By interacting with prostaglandin receptors, Misoprostol causes the cervix to soften and the uterus to contract, resulting in the expulsion of the uterine contents.

This can only be prescribed by qualified medical professionals who are able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. The qualified medical professionals must also be able to provide surgical Intervention/MVA (Manual Vaccum Aspiration) in cases of incomplete abortion or severe bleeding or have made plans to provide such care through others and be able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.

Day 1 (First visit): Mifepristone administration: One tablet of Mifepristone (200 mg) is taken in a single oral dose under the supervision of a qualified medical professional in a clinic, medical office or hospital.

Day 2 (Second visit): Misoprostol administration: 24-48 hours after ingesting the Mifepristone tablet, the patient takes four 200 microgram tablets (800 micrograms) of Misoprostol buccally or sublingually. Misoprostol tablets can be administered by the patient herself (place two tablets on each side of cheeck & gum or under the tongue). She should wait for 30 minutes. During the period immediately following the administration of Misoprostol, the patient may need medication for cramps or gastrointestinal symptoms. The patient should be given instructions on what to do if significant discomfort, excessive bleeding or other adverse reactions occur and should be given a phone number to call if she has questions following the administration of Misoprostol.

Day 10 to 14 (Third visit): Post-treatment examination: Patients must return to the clinic, medical office or hospital within 10 to 14 days after the administration of mifepristone. This visit is very important to confirm by clinical examination or ultrasonographic scan that a complete termination of pregnancy has occurred.

Patients who have an ongoing pregnancy at this visit have a risk of fetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/termination of pregnancy failures.

Mifepristone: The treatment procedure is designed to induce vaginal bleeding and uterine cramping necessary for Menstrual Regulation (MR). Commonly reported side effects were nausea, vomiting and diarrhoea. Pelvic pain, fainting, headache, dizziness, and asthenia occurred rarely.

Misoprostol: Gastro-intestinal side-effects like diarrhoea, abdominal pain, nausea, flatulence, dyspepsia, headache, vomiting and constipation, shivering, hyperthermia, dizziness, pain due to uterine contractions, severe vaginal bleeding, shock, pelvic pain, uterine rupture (requiring surgical repair, hysterectomy and/or salpingo-oophorectomy).

Administration of Mifepristone is contraindicated in patients with any one of the following conditions: History of allergy or known hypersensitivity to Mifepristone, Misoprostol or other prostaglandin, confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy), IUD in place, chronic adrenal failure, haemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyria, If a patient does not have adequate access to medical facilities equipped to provide emergency treatment of incomplete process, blood transfusions and emergency resuscitation during the period from the first visit until discharged by the administering physician.

The patient should not give combination of Mifepristone & Misoprostol to anyone else. The combination of Mifepristone & Misoprostol has been prescribed for the patient's specific condition, it may not be the correct treatment for another person, and may be dangerous to the other person if she is or were to become pregnant. Any Intra Uterine Device [IUD] should be removed before treatment with Mifepristone begins. Menstrual Regulation (MR) by surgery is recommended in cases when combination of Mifepristone & Misoprostol fails to cause Menstrual Regulation (MR). Patients who have an ongoing pregnancy at last visit have a risk of foetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/ termination of pregnancy failures.

Mifepristone: Although specific drug or food interactions with Mifepristone have not been studied, on the basis of this drug's metabolism by CYP 3A4, it is possible that Ketoconazole, Itraconazole, Erythromycin and grapefruit juice may inhibit its metabolism (increasing serum levels of mifepristone).

Misoprostol: Misoprostol has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Misoprostol does not exert clinically significant effects on the absorption,blood levels and antiplatelet effects of therapeutic doses of aspirin.

Pregnancy- Mifepristone: is indicated for Menstrual Regulation (MR) (through 63 days pregnancy) and has no other approved indication for use during pregnancy. Patients who have an ongoing pregnancy at the last visit have a risk of foetal malformation resulting from the treatment. Surgical termination is recommended to manage Menstrual Regulation (MR) treatment failures.

Lactation-

• Mifepristone: It is not known whether Mifepristone is excreted through human milk. Many hormones with a similar chemical structure, however, are excreted in breast milk. Since the effects of Mifepristone on infants are unknown, breast-feeding women should consult with their doctor to decide if they should discard their breast milk for a few days following administration of the medications.
• Misoprostol: Although it is not known whether Misoprostol or Misoprostol is excreted through human milk, Misoprostol should not be administered to nursing mothers because the potential excretion of misoprostol acid could cause diarrhoea in nursing infants.

Use in Patients with Hepatic Impairment: Patients with hepatic disease should receive a decreased dose of Misoprostol.

Use in Patients with Renal Impairment: No routine dosage adjustment is recommended of Misoprostol in older patients or patients with renal impairment but the dosage may need to be reduced if the usual dose is not tolerated.

Mifepristone: No serious adverse reactions were reported in tolerance studies in healthy nonpregnant female and healthy male subjects where Mifepristone was administered in single doses greater than threefold of 600mg for Menstrual Regulation (MR). If a patient ingests a massive overdose, she should be observed closely for signs of adrenal failure.

Misoprostol: Clinical signs that may indicate an overdose are a sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhoea, fever, palpitations, hypotension or bradycardia. Symptoms should be treated with supportive therapy. However, because Misoprostol is metabolized like a fatty acid, it is unlikely that dialysis would be the appropriate treatment for overdosage.

Store in a cool and dry place, protected from light.

Eltrombopag Olamine is indicated in Chronic Immune (Idiopathic) Thrombocytopenia, Chronic Hepatitis C-associated Thrombocytopenia, Severe Aplastic Anemia.

Haemostatic drugs

Eltrombopag is an orally bioavailable, small-molecule TPO-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor. Eltrombopag is a stimulator of STAT and JAK phosphorylation. Unlike recombinant TPO or romiplostim, Eltrombopag does not activate the AKT pathway in any way. It should be noted that when given to patients with aplastic anemia, other lineages besides platelet count were increased, suggesting that either eltrombopag enhanced the effect of TPO in vivo; or there is a yet uncovered mechanism of action at work.

Chronic Immune (Idiopathic) Thrombocytopenia-

• Adult and Pediatric Patients 6 Years and Older with ITP: Initiate Eltrombopag at a dose of 50 mg once daily, except in patients who are of East Asian ancestry (such as Chinese, Japanese, Taiwanese or Korean) or who have mild to severe hepatic impairment (Child-Pugh Class A,B,C). For patients of East Asian ancestry with ITP, initiate Eltrombopag at a reduced dose of 25 mg once daily. For patients with ITP and mild, moderate or severe hepatic impairment (Child-Pugh Class A,B,C), initiate Eltrombopag at a reduced dose of 25 mg once daily.
• For patients of East Asian ancestry with ITP and hepatic impairment (Child-Pugh Class A,B,C), consider initiating Eltrombopag at a reduced dose of 12.5 mg once daily. Pediatric Patients with ITP Aged 1 to 5 Years: Initiate Eltrombopag at a dose of 25 mg once daily.

Chronic Hepatitis C-associated Thrombocytopenia-

• Initiate Eltrombopag at a dose of 25 mg once daily. Monitoring and Dose Adjustment: Adjust the dose of Eltrombopag in 25-mg increments every 2 weeks as necessary to achieve the target platelet count required to initiate antiviral therapy. Monitor platelet counts every week prior to starting antiviral therapy. During antiviral therapy, adjust the dose of Eltrombopag to avoid dose reductions of Peginterferon. Monitor CBCs with differentials, including platelet counts, weekly during antiviral therapy until a stable platelet count is achieved. Monitor platelet counts monthly thereafter. Do not exceed a dose of 100 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy with Eltrombopag.

Severe Aplastic Anemia-

• Initiate Eltrombopag at a dose of 50 mg once daily. For patients with severe aplastic anemia of East Asian ancestry or those with mild, moderate or severe hepatic impairment (Child-Pugh Class A,B,C), initiate Eltrombopag at a reduced dose of 25 mg once daily.

The most common side effects of Eltrombopag in adults when used to treat chronic ITP are: In adult patients with ITP, the most common adverse reactions (greater than or equal to 5% and greater than placebo) were: nausea, diarrhea, upper respiratory tract infection, vomiting, increased ALT, myalgia and urinary tract infection. In pediatric patients age 1 year and older with ITP, the most common adverse reactions (greater than or equal to 10% and greater than placebo) were upper respiratory tract infection and nasopharyngitis.

In patients with chronic hepatitis C-associated thrombocytopenia, the most common adverse reactions (greater than or equal to 10% and greater than placebo) were: anemia, pyrexia, fatigue, headache, nausea, diarrhea, decreased appetite, influenza-like illness, asthenia, insomnia, cough, pruritus, chills, myalgia, alopecia and peripheral edema. In patients with severe aplastic anemia, the most common adverse reactions (greater than or equal to 20%) were: nausea, fatigue, cough, diarrhea and headache.

There are no contraindications for Eltrombopag

Hepatotoxicity: Monitor liver function before and during therapy.

Thrombotic or Thromboembolic Complications: Portal vein thrombosis has been reported in patients with chronic liver disease receiving Eltrombopag. Monitor platelet counts regularly.

Take Eltrombopag at least 2 hours before or 4 hours after any medications or products containing polyvalent cations such as antacids, calcium-rich foods and mineral supplements.

Pregnancy Category C. There are no adequate and well controlled studies of Eltrombopag usein pregnancy. In animal reproduction and developmental toxicity studies, there was evidence ofembryolethality and reduced fetal weights at maternally toxic doses. Eltrombopag should beused in pregnancy only if the potential benefit to the mother justifies the potential risk to thefetus.

Nursing Mothers: It is not known whether Eltrombopag is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Eltrombopag, a decision should be made whether to discontinue nursing or to discontinue Eltrombopag taking into account the importance of Eltrombopag to the mother.

Pediatric Use:The safety and efficacy of Eltrombopag in pediatric patients 1 year and older with chronic ITP were evaluated in two double-blind, placebo-controlled. The pharmacokinetics of Eltrombopag has been evaluated in 168 pediatric patients 1 year and older with ITP dosed once daily for dosing recommendations for pediatric patients 1 year and older. The safety and efficacy ofEltrombopag in pediatric patients younger than 1 year with ITP have not yet been established. The safety and efficacy of Eltrombopag in pediatric patients with thrombocytopenia associated with chronic hepatitis C and severe aplastic anemia have not been established.

Geriatric Use: Of the 106 patients in two randomized clinical trials of Eltrombopag 50 mg in chronic ITP, 22% were 65 years of age and over, while 9% were 75 years of age and over. In the two randomized clinical trials of Eltrombopag in patients with chronic hepatitis C and thrombocytopenia, 7% were 65 years of age and over, while fewer than 1% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger patients in the placebo-controlled trials, but greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment: Hepatic impairment influences the exposure of Eltrombopag. Reduce the initial dose of Eltrombopag in patients with chronic ITP (adult and pediatric patients 6 years and older only) or severe aplastic anemia who also have hepatic impairment (Child-Pugh Class A, B, C). No dosage adjustment is necessary for patients with chronic hepatitis C and hepatic impairment.

Renal Impairment: No adjustment in the initial dose of Eltrombopag is needed for patients with renal impairment. Closely monitor patients with impaired renal function when administering Eltrombopag.

In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications.

In one report, a subject who ingested 5,000 mg of Eltrombopag had a platelet count increase to a maximum of 929 x 109/L at 13 days following the ingestion. The patient also experienced rash, bradycardia, ALT/AST elevations and fatigue. The patient was treated with gastric lavage, oral Lactulose, Intravenous fluids, Omeprazole, Atropine, Furosemide, Calcium, Dexamethasone, andPlasmapheresis; however, the abnormal platelet count and liver test abnormalities persisted for 3 weeks. After 2 months follow-up, all events had resolved without sequelae.

In case of an overdose, consider oral administration of a metal cation-containing preparation, such as Calcium, Aluminum, or Magnesium preparations to chelate Eltrombopag and thus limit absorption. Closely monitor platelet counts. Reinitiate treatment with Eltrombopag in accordance with dosing and administration recommendations.

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

Cytarabine is indicated in Leukaemic meningitis, Induction and maintenance of remission in acute leukaemias

Cytotoxic Chemotherapy

Cytarabine inhibits deoxyribonucleic acid (DNA) synthesis specifically at the S-phase of the cell cycle. It also has an antiviral and immunosuppressant activity.

Intrathecal (Adult)-

• Leukaemic meningitis: 5-75 mg/m² or 30-100 mg once every 2-7 days to once daily for 4 or 5 days.
• For lymphomatous meningitis: 50 mg every 2 wk for 5 doses, then every 4 wk for 5 doses.

Parenteral (Adult)-
Induction and maintenance of remission in acute leukaemias: 

• As monotherapy: 200 mg/m² daily by continuous IV infusion for 5 days, at intervals of approx 2 wk.
• In combination therapy: 100 mg/m² bid by rapid IV inj or 100 mg/m² daily by continuous IV infusion both for 7 days. Maintenance: 1-1.5 mg/kg once or twice wkly via IV or SC.

Nausea, vomiting, fever, rash, diarrhoea, anorexia, oral and anal inflammation or ulceration, hepatic dysfunction, headache, weakness, confusion, thrombocytopenia, fatigue.

Patient with active meningeal infection.

Patient with previous drug-induced bone marrow suppression. Renal or hepatic impairment. Pregnancy and lactation.

May reduce efficacy of 5-fluorocytosine, digoxin, gentamicin. May increase risk of neurotoxicity with other cytotoxic agents (intrathecal).

Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Symptoms: Irreversible CNS toxicity and death. Severe arachnoiditis including encephalopathy.

Management: Therapy cessation followed by treatment of ensuing bone marrow depression including whole blood or platelet transfusion and antibiotics. Maintain vital functions.

Intravenous: Reconstitute with bacteriostatic water for inj (standard-dose), further dilute in 250-1,000 ml NaCl 0.9% or dextrose 5% in water for infusion.

Intrathecal: Reconstitute with preservative free NaCl 0.9%, further dilute with Elliot’s B soln, NaCl 0.9% or lactated Ringer’s inj to preferred final vol (up to 12 ml).

IV/SC: Store between 15-25°C. Intrathecal: Store between 2-8°C. Avoid freezing.

Cytarabine is indicated in Leukaemic meningitis, Induction and maintenance of remission in acute leukaemias

Cytotoxic Chemotherapy

Cytarabine inhibits deoxyribonucleic acid (DNA) synthesis specifically at the S-phase of the cell cycle. It also has an antiviral and immunosuppressant activity.

Intrathecal (Adult)-

• Leukaemic meningitis: 5-75 mg/m² or 30-100 mg once every 2-7 days to once daily for 4 or 5 days.
• For lymphomatous meningitis: 50 mg every 2 wk for 5 doses, then every 4 wk for 5 doses.

Parenteral (Adult)-
Induction and maintenance of remission in acute leukaemias: 

• As monotherapy: 200 mg/m² daily by continuous IV infusion for 5 days, at intervals of approx 2 wk.
• In combination therapy: 100 mg/m² bid by rapid IV inj or 100 mg/m² daily by continuous IV infusion both for 7 days. Maintenance: 1-1.5 mg/kg once or twice wkly via IV or SC.

Nausea, vomiting, fever, rash, diarrhoea, anorexia, oral and anal inflammation or ulceration, hepatic dysfunction, headache, weakness, confusion, thrombocytopenia, fatigue.

Patient with active meningeal infection.

Patient with previous drug-induced bone marrow suppression. Renal or hepatic impairment. Pregnancy and lactation.

May reduce efficacy of 5-fluorocytosine, digoxin, gentamicin. May increase risk of neurotoxicity with other cytotoxic agents (intrathecal).

Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Symptoms: Irreversible CNS toxicity and death. Severe arachnoiditis including encephalopathy.

Management: Therapy cessation followed by treatment of ensuing bone marrow depression including whole blood or platelet transfusion and antibiotics. Maintain vital functions.

Intravenous: Reconstitute with bacteriostatic water for inj (standard-dose), further dilute in 250-1,000 ml NaCl 0.9% or dextrose 5% in water for infusion.

Intrathecal: Reconstitute with preservative free NaCl 0.9%, further dilute with Elliot’s B soln, NaCl 0.9% or lactated Ringer’s inj to preferred final vol (up to 12 ml).

IV/SC: Store between 15-25°C. Intrathecal: Store between 2-8°C. Avoid freezing.