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First generation Cephalosporins

Cefadroxil inhibits bacterial cell wall synthesis by binding to 1 or more of the penicillin-binding proteins (PBPs) which in turn inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis and arresting cell wall assembly resulting in bacterial cell death.

Adult:

• Pharyngitis and Tonsillitis: 1 g per day in one or two divided doses.
• Urinary Tract Infections: 1 or 2 g per day in one or two divided doses.
• Skin and Skin Structure Infections: 1 g per day in one or two divided doses.

Children: 30 mg/kg daily in divided doses every 12 hours.

It may be taken with meals or on empty stomach. Administration with food may be helpful in diminishing potential gastrointestinal complaints.

Generally Cefadroxil is well tolerated. However, the most commonly reported side effects are gastrointestinal disturbances and hypersensitivity phenomena.

Cefadroxil is contraindicated in patients with a history of hypersensitivity to Cefadroxil or any of the ingredients of it.

Use of this antibiotic may cause pseudomembranous colitis; so caution should be taken during diagnosis in patients who develop diarrhea in association with Cefadroxil therapy.

There is no significant drug interaction with other drugs.

US FDA pregnancy category of Cefadroxil is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefadroxil have been shown to be excreted in human milk. So, caution should be exercised when Cefadroxil is administered during lactation.

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

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

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

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

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

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

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

4-Quinolone preparations

Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone antibiotic. Chemically, Levofloxacin is a chiral fluorinated carboxyquinolone. Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms.

The usual dose of Levofloxacin Tablets is 250 mg or 500 mg or 750 mg administered orally every 24 hours. Levofloxacin tablets can be administered without regard to food. Levofloxacin oral solution should be taken 1 hour before, or  2 hours after eating.

Levofloxacin injection should only be administered by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. The usual dose of Levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours. Since the Levofloxacin injections are for single-use only, any unused portion should be discarded. Additives or other medications should not be added to Levofloxacin Injection or infused simultaneously through the same intravenous line.

Adults:

• Acute sinusitis: 500 mg once daily for 10-14 days, or 750 mg once daily for 5 days
• Exacerbation of chronic bronchitis: 500 mg once daily for 7 days, or 750 mg once daily for 3 days (Uncomplicated), 750 mg once daily for 5 days (Complicated)
• Community-acquired pneumonia: 500 mg once daily for 7-14 days, or 750 mg once daily for 5 days
• Uncomplicated urinary-tract infections: 250 mg once daily for 3 days
• Complicated urinary-tract infections and acute pyelonephritis: 250 mg once daily for 7-10 days
• Uncomplicated skin and soft-tissue infections: 500 mg once daily for 7-10 days.
• Complicated skin and soft-tissue infections: 750 mg once daily for 7-14 days.
• Enteric fever: 500 mg once daily for 7-14 days.
• Diarrhea, cholera, shigellosis & enteritis: Mild to moderate case: 500 mg (single dose). Moderate to sever case: 500 mg once daily for 3 days

Children:

• Children 6 months to <5 years: 10 mg/kg every 12 hours.
• Children >5 years: 10 mg/kg every 24 hours

In each case, sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

Instructions for the Use of Levofloxacin Infusion-

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

Levofloxacin is generally well tolerated. However, a few side-effects can usually be seen. There is a risk of retinal detachment. Other side-effects include: nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side-effects that may be seen very rarely include tremors, depression, anxiety, confusion etc.

Levofloxacin is contraindicated in patients with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product.

The following measures should be taken during administration of Levofloxacin:

• Levofloxacin Injection should only be administered by slow intravenous infusion over a period of 60 or 90 minutes depending on the dosage.
• While administrating Levofloxacin, adequate amount of water should be taken to avoid concentrated form of urine.
• Dose adjustment should be exercised during Levofloxacin administration in presence of renal insufficiency.

No quinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Antacids, Iron and Adsorbents reduce absorption of Levofloxacin. NSAID may increase the risk of CNS stimulation. Warfarin may increase the risk of bleeding.

Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.

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

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

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

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

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

Vitamin B1, B6 & B12 is indicated for the treatment of vitamin B1, B6 & B12 deficiency syndrome. It is also indicated for the supportive treatment of neuritis & non-inflammatory diseases of the nerves, e.g.- Diabetic neuropathy, Peripheral neuralgin, Lumbago, Myalgia, Optic neuritis, Sciatica, Facial neuralgia, Intercostal neuralgia, Spinal pain.

Specific combined vitamin preparations

Vitamin B1 converts carbohydrates, fatty acids and amino acids into energy, promotes healthy nerves, improves mood, strengthens the heart. Vitamin B6 forms RBCs, helps cells to make proteins, manufactures neurotransmitters e.g. serotonin and releases stored forms of energy, helps to prevent CVS diseases and stroke, helps to lift depression and eases insomnia. Vitamin B12 is essential for cell replication and important for RBC production, prevents anemia, helps to prevent depression, reduces nerve pain, numbness, tingling and lowers the risk of heart diseases.

The vitamin ingredients are absorbed well in per oral reception. It is widely distributed to most tissues and appears in breast milk. Within the cell, thiamine is mostly present as diphosphate. Thiamine is not stored to any appreciable extent in the body and amounts in excess of the body’s requirements are excreted in the urine as unchanged thiamine or as metabolites. Pyridoxine, pyridoxal and pyridoxamine are readily absorbed from the GIT following oral administration and are converted to the active forms of pyridoxal phosphate an pyridoxamine phosphate. They are stored mainly in liver where there is oxidation to 4-pyridoxic acid and other inactive metabolites, which are excreted in urine. As the dose increases, proportionally greater amounts are excreted unchanged in the urine.

Tablet: 1-3 Tablets per day or as advised by the physician.

Injection:

• In severe (acute) cases: 1 injection daily until the acute symptoms subside or taken as advised by the physician.
• In mild cases: 1 injection 2-3 times per week. Ampoules are preferably injected intramuscularly.

Use in children: There is no information on the use of this drug in children.

Generally well tolerated but allergic reactions may be observed in few cases.

Vitamin B1, Vitamin B6 and Vitamin B12 is contraindicated in patients on levodopa therapy, and in patients with hypersensitivity to any of the ingredients of the preparation.

Cyanocobalamin should not be given in patients with subacute degeneration of the spinal cord. Cyanocobalamin is not suitable form of vitamin B12 for the treatment of optic neuropathies associated with raised plasma concentrations of cyanocobalamin.

No drug interaction has been reported yet.

Oral tablet form is recommended but due to the presence of benzyl alcohol, injection is not recommended during pregnancy & lactation.

No overdosage symptoms are to be expected in the recommended dosage. If there is known overdose then treatment is symptomatic & supportive.

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

Vitamin in bone formation, Vitamin-D preparations

Colecalciferol (Vitamin D3) helps for the absorption & reabsorption of Calcium & Phosphorous. Vitamin D3 is essential for normal bone growth & to maintain bone density. It also reduces the severity of bacterial infection, improves lung function, prevents the risk of cancer (breast, colorectal) & helps to maintain adequate insulin levels for type 2 diabetes patients.

For capsule: Adults:

• Treatment of Vitamin D3 deficiency: 40000 IU once weekly for 7 weeks. Doses for maintenance therapy is 1400-2000 IU/day. To confirm the target level of 25 hydroxyvitamin D, measurement of it should be determined 3-4 months after initiating the maintenance therapy.
• Prevention of Vitamin D3 deficiency: 20000 IU every 4 weeks. Higher doses may be required in certain situations.
• Addition to specific therapy for osteoporosis: 20000 IU once a month.

For capsule: Children (12-18 years):

• Treatment of Vitamin D3 deficiency: 20000 IU once every 2 weeks for 6 weeks.
• Prevention of Vitamin D3 deficiency: 20000 IU every 6 weeks.

For film-coated tablet: 1000 IU (1-2 tablets) daily, or as directed by physician. Take the medicine with food or within 1 hour after a meal.

For oroflash or chewable tablets: 1000 IU to 2000 IU daily, or as directed by physician. Take the medicine with food or within 1 hour after a meal. Place the tablet in mouth swallow after chewing.

For Syrup:
For patients with risk of Cholecalciferol deficiency:

• 0-1 yr: 400 IU/ day (2 ml)
• >1 Yr: 600 lU/ day (3 ml)

For Cholecalciferol deficient patients:

• 0-1 yr: 2000 IU/ day (+50000 IU/week ) for 6 weeks
• 1 -18 yrs: 2000 IU/ day for 6 weeks.

Injection: Prevention: 

• Infants receiving Vitamin D enriched milk: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. every 6 months.
• Nursed infants or infants not receiving Vitamin D enriched milk or young children up to 5 years of age: 1 ampoule (1ml) i.e. 2,00000 I.U. every 6 months.
• Adolescents: 1 ampoule (1ml) i.e. 2,00000 I.U. every 6 months during winter.
• Pregnancy: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. from the 6th or 7th month of pregnancy.
• Elderly: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. every 3 months. Digestive disorders, concomitant treatment with antiepileptics & other particular condition not described above; 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. or 1 ampoule (1ml) i.e. 2,00000 I.U. every 3 or 6 months.

Injection: Vitamin D deficiency:

• 1 ampoule (1ml) i.e. 2,00000 I.U. which can be repeated 1 to 6 months later. Or, as directed by the registered physician.

The general side effects are hypercalcaemia, hypercalciuria, skin rash, pruritus, urticaria, nausea, abdominal pain.

It is contraindicated in patients with known hypersensitivity to Vitamin D3.

It should be used with caution in patients with impaired renal function.

It interferes with phenytoin, barbiturates, glucocorticoids, certain laxative (such as liquid paraffin), actinomycin and imidazole antifungal agents.

Studies have shown safe use of doses up to 4000 IU during pregnancy. The recommended daily intake for pregnant women is 400 IU, however, in women who are considered to be Vitamin D3 deficient a higher dose may be required. During pregnancy women should follow the advice of their medical practitioner as their requirements may vary depending on the severity of their disease and their response to treatment

Vitamin D3 and its metabolites are excreted in breast milk. Overdose in infants induced by nursing mothers has not been observed; however, when prescribing additional vitamin D3 to a breast-fed child the practitioner should consider the dose of any additional vitamin D3 given to the mother.

The safety & efficacy of Vitamin D3 in children under 12 years have not been established.

It can lead to hypervitaminosis D.

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

Vitamin in bone formation, Vitamin-D preparations

Colecalciferol (Vitamin D3) helps for the absorption & reabsorption of Calcium & Phosphorous. Vitamin D3 is essential for normal bone growth & to maintain bone density. It also reduces the severity of bacterial infection, improves lung function, prevents the risk of cancer (breast, colorectal) & helps to maintain adequate insulin levels for type 2 diabetes patients.

For capsule: Adults:

• Treatment of Vitamin D3 deficiency: 40000 IU once weekly for 7 weeks. Doses for maintenance therapy is 1400-2000 IU/day. To confirm the target level of 25 hydroxyvitamin D, measurement of it should be determined 3-4 months after initiating the maintenance therapy.
• Prevention of Vitamin D3 deficiency: 20000 IU every 4 weeks. Higher doses may be required in certain situations.
• Addition to specific therapy for osteoporosis: 20000 IU once a month.

For capsule: Children (12-18 years):

• Treatment of Vitamin D3 deficiency: 20000 IU once every 2 weeks for 6 weeks.
• Prevention of Vitamin D3 deficiency: 20000 IU every 6 weeks.

For film-coated tablet: 1000 IU (1-2 tablets) daily, or as directed by physician. Take the medicine with food or within 1 hour after a meal.

For oroflash or chewable tablets: 1000 IU to 2000 IU daily, or as directed by physician. Take the medicine with food or within 1 hour after a meal. Place the tablet in mouth swallow after chewing.

For Syrup:
For patients with risk of Cholecalciferol deficiency:

• 0-1 yr: 400 IU/ day (2 ml)
• >1 Yr: 600 lU/ day (3 ml)

For Cholecalciferol deficient patients:

• 0-1 yr: 2000 IU/ day (+50000 IU/week ) for 6 weeks
• 1 -18 yrs: 2000 IU/ day for 6 weeks.

Injection: Prevention: 

• Infants receiving Vitamin D enriched milk: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. every 6 months.
• Nursed infants or infants not receiving Vitamin D enriched milk or young children up to 5 years of age: 1 ampoule (1ml) i.e. 2,00000 I.U. every 6 months.
• Adolescents: 1 ampoule (1ml) i.e. 2,00000 I.U. every 6 months during winter.
• Pregnancy: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. from the 6th or 7th month of pregnancy.
• Elderly: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. every 3 months. Digestive disorders, concomitant treatment with antiepileptics & other particular condition not described above; 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. or 1 ampoule (1ml) i.e. 2,00000 I.U. every 3 or 6 months.

Injection: Vitamin D deficiency:

• 1 ampoule (1ml) i.e. 2,00000 I.U. which can be repeated 1 to 6 months later. Or, as directed by the registered physician.

The general side effects are hypercalcaemia, hypercalciuria, skin rash, pruritus, urticaria, nausea, abdominal pain.

It is contraindicated in patients with known hypersensitivity to Vitamin D3.

It should be used with caution in patients with impaired renal function.

It interferes with phenytoin, barbiturates, glucocorticoids, certain laxative (such as liquid paraffin), actinomycin and imidazole antifungal agents.

Studies have shown safe use of doses up to 4000 IU during pregnancy. The recommended daily intake for pregnant women is 400 IU, however, in women who are considered to be Vitamin D3 deficient a higher dose may be required. During pregnancy women should follow the advice of their medical practitioner as their requirements may vary depending on the severity of their disease and their response to treatment

Vitamin D3 and its metabolites are excreted in breast milk. Overdose in infants induced by nursing mothers has not been observed; however, when prescribing additional vitamin D3 to a breast-fed child the practitioner should consider the dose of any additional vitamin D3 given to the mother.

The safety & efficacy of Vitamin D3 in children under 12 years have not been established.

It can lead to hypervitaminosis D.

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

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

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

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

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

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

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

Fluorouracil is indicated alone or in combination for- 

• Carcinoma of the colon or rectum
• Carcinoma of the stomach and exocrine pancreas
• Carcinoma of the liver
• Carcinoma of the breast
• Carcinoma of the bladder
• Carcinoma of the lung
• Epithelial ovarian carcinoma
• Cervical carcinoma.

Fluorouracil is inactive as such in mammalian cells but is converted into the active 5-fluorodeoxyuridine monophosphate (FdUMP) by a variety of different metabolic pathways. The drug works by inhibiting the enzyme thymidylate kinase which results in reduced formation of thymidine and thus of DNA. The active metabolite FdUMP appears to form a stable complex with the folate cofactor N-5, 10-methylene tetrahydrofolate which inactivates thymidylate kinase. Fluorouracil as FdUMP is also incorporated into RNA which results in fluorination of RNA. The effect of fluorouracil on living cells is limited mainly to those in the proliferative phase but while cells in the G2 and S phase are most affected there may be effects at any stage of the cell cycle.

Intravenous 5-fluorouracil can be delivered by rapid intravenous bolus injection or slow infusion. The vial contents can rapidly be injected directly into a peripheral vein, the commonest schedules being: 12-13.5 mg/Kg (500 mg/m2) daily for 5 days repeated at 4-weekly intervals. Slow intravenous infusion requires the drug, to be diluted in 500 ml of dextrose 5% solution, then infused over 2-3 hr on 5 successive days.

For palliative management of cancer: Initial Dose: 12 mg/kg intravenously once daily for 4 successive days. Maximum Dose: 800 mg/day. If no toxicity is observed, 6 mg/kg may be administered on the 6th, 8th, 10th, and 12th day (No therapy is given on days 5, 7, 9, or 11). Discontinue at the end of day 12, even with no apparent toxicity.

Poor risk patients and those who are not in an adequate nutritional state: Initial Dose: 6 mg/kg/day for 3 days. Maximum Dose: 400 mg/day. If no toxicity is observed, 3 mg/kg may be administered on days 5, 7, and 9 (No therapy is to be administered on days 4, 6, or 8). Discontinue at the end of day 9, even with no apparent toxicity.

Maintenance therapy: In instances where toxicity has not been a problem, it is recommended that therapy be continued using either of the following schedules:

• Repeat the dosage of the first course every 30 days after the last day of the previous course, or
• When the toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dose of 10 to 15 mg/kg/week as a single dose. Maximum Dose: 1g/week .The reaction by the patient to the previous course of therapy should be taken into account and the dosage should be adjusted accordingly.

Usual adult dose for cervical cancer: In combination with cisplatin 1 gm/m2 IV on day 1. The cycle is repeated every 21 days.

Usual pediatric dose for malignant disease: The manufacturer has reported that the safety and effectiveness of fluorouracil have not been established in children. However, the drug has been used in children following adult guidelines.

Intra-arterial infusion: Fluorouracil has also been given by intra-arterial infusion for adult in doses of 5 to 7.5 mg/kg body weight is dissolved in 20-100 ml of 5% Dextrose solution and administered 10-20 days by using an infusion pump.

Combination with radiation: Usual adult daily dose of 5-10 mg/kg body weight is given in combination with radiation according to systemic administration method or intra-arterial infusion method.

Combination with other anticancer drugs: Fluorouracil is used alone or in combination in the adjuvant treatment of breast and gastro-intestinal cancer, and palliation of inoperable malignant neoplasms, especially those of the gastro-intestinal tract, breast, head and neck, liver, genito-urinary system, and pancreas. It is also used with cyclophosphamide and methotrexate in the combination chemotherapy of breast cancer. A usual adult dose of 5 to 10 mg/kg body weight daily is given in combination with other anticancer drugs every day or intermittently once to twice a week by systemic administration method or intra-arterial infusion method.

Potentially life-threatening effects: Severe effects from 5-fluorouracil are related to the dosage and duration of therapy.

Cardiac effects: Occasional case reports associating 5-fluorouracil therapy with 'ischemic cardiac events' evidence against the autoimmune phenomenon is the fact that in several cases cardiotoxicity occurred within several hours of the first dose.

Hematological effects: Potentially lethal effects caused by severe hematological toxicity may develop within the first 10 days of treatment being instituted but generally resolves within 3 weeks. At the recommended dose and schedule it is rather uncommon for hematological toxicity to be severe. Any ontribute to severe effects from 5-fluorouracil on the blood-forming cells. Thus extensive prior irradiation or the concomitant use of cytotoxic drugs tend to exacerbate the severity of the hematological side effects of 5-fluorouracil.

Neurological effects: Effects on the central nervous system have been occasionally reported and cerebral ataxia is dose-dependent with an incidence of between 3.1 and 7%. Acute cerebellar syndromes and myelopathy have been described following intrathecal 5-fluorouracil. Neurological syndromes may occur rarely after carotid artery perfusion in head and neck cancer. Other effects Allergic reaction (including difficulty in breathing, closing of the throat, swelling of the lips, tongue, or face, or hives), decreased bone marrow function and blood problems (extreme fatigue, easy bruising or bleeding, black, bloody or tarry stools, or fever, chills, or signs of infection), hand-foot syndrome (tingling, pain, redness, swelling or tenderness of the hands and feet), severe vomiting, diarrhoea, frequent bowel movements or watery stools, or sores in the mouth or throat, or stomach pain or heartburn or black, bloody or tarry stools. Other less serious side effects may include mild to moderate nausea, vomiting or loss of appetite, balance problems, confusion, rash and itching, or temporary hair loss. Conjunctivitis, both acute and chronic can proceed to tear duct stenosis and ectropion following prolonged administration. Very chronic administration, extending beyond 3 months, of low dosage has been associated with low systemic toxicity but includes the possibility of painful and tender hands and feet associated with erythema of the extremities.

It is contraindicated in patients that are severely debilitated or in patients with bone marrow suppression due to either radiotherapy or chemotherapy. It is likewise contraindicated in pregnant or breastfeeding women. It should also be avoided in patients that do not have malignant illnesses.

5-fluorouracil is highly toxic drug with a narrow margin of safety. Therefore patients should be carefully supervised, since therapeutic response is unlikely to occur without some evidence of toxicity. Daily dose should not exceed 1 gram. Treatment should be discontinued promptly when one of the following signs of toxicity appears: Leucopenia (WBC under 3500/mm3). Thrombocytopenia (platelet under 100000/mm3). Stomatitis ( the first small ulceration at the inner margin of the lips is a signal for stopping treatment). Severe diarrhoea (frequent bowel movements and watery stools). Gastro-intestinal ulceration and bleeding.

Pre-treatment with cimetidine for 4 weeks led to increased plasma concentrations of fluorouracil following intravenous and oral administration in 6 patients. The effect was probably due to a combination of hepatic enzyme inhibition and reduced hepatic blood flow.

Fluorouracil is contraindicated throughout pregnancy. The literature pertaining to pregnancy and cytotoxic drugs is necessarily limited but it appears in general that risk of teratogenesis diminishes with the advancement of pregnancy. Therefore most cytotoxic drugs are absolutely contraindicated in the first trimester and 5-fluorouracil, used in the first trimester has been reported to cause multiple congenital abnormalities. There are many case reports, however, of pregnancy being conducted successfully with combination chemotherapy being given to the mother during the second and third trimesters. Because of the age of the population and the natural history of the tumors treated, most of the data on long-term follow-up pertain to therapy for leukemias. More data need to be accrued on the subsequent development of neonates before it is certain that any of these compounds are free of late effects.

It is not known whether fluorouracil is excreted in human milk. Because fluorouracil inhibits DNA, RNA and protein synthesis, mothers should not nurse while receiving this drug.

Neonates: No dosage recommendations are made for neonates.

Children: Safety and effectiveness in children have not been established.

The elderly: No special precautions are required, doses being adjusted for the patient's weight and height.

Cases of deliberate overdose are unknown but excessive toxicity because of the hematological effects as described above. There is no specific antidote to 5-fluorouracil toxicity; treatment consists in supportive care. In addition to the hematological toxicity other toxicities will occur with overdose. Sign and symptoms are qualitatively similar to the side effects. Treatment should be performed promptly and appropriate drugs are given to control symptoms of overdose.

5-Fluorouracil is a cytotoxic anticancer drug and, caution should be exercised in handling 5-Fluorouracil. Special, trained personnel should reconstitute the drug. Preparation requires a room reserved for this purpose. The work surface should be covered with disposable plastic-backed absorbent paper. Smoking, eating and drinking are prohibited in the room. The handling staff must have a set of appropriate equipment, particularly long-sleeved coats, protective masks, caps, protective goggles, sterile disposable gloves, worktop protection sheets and waste collection containers and bags. If 5-Fluorouracil solution contacts the skin, wash the skin immediately and thoroughly with soap and water. Following topical exposure, events have included tingling, burning and redness. If 5-Fluorouracil contacts mucous membranes, the membranes should be flashed thoroughly with water. Pregnant women must be warned and avoid handling cytotoxic agents. All broken containers must be treated with the same precautions and regarded as contaminated waste. Contaminated waste is to be disposed of by incineration in rigid containers labeled for this purpose or must be destroyed as per the government rules.

Store the vial in original carton not exceeding 25℃. Do not refrigerate. Protect from light.

Fluorouracil is indicated alone or in combination for- 

• Carcinoma of the colon or rectum
• Carcinoma of the stomach and exocrine pancreas
• Carcinoma of the liver
• Carcinoma of the breast
• Carcinoma of the bladder
• Carcinoma of the lung
• Epithelial ovarian carcinoma
• Cervical carcinoma.

Fluorouracil is inactive as such in mammalian cells but is converted into the active 5-fluorodeoxyuridine monophosphate (FdUMP) by a variety of different metabolic pathways. The drug works by inhibiting the enzyme thymidylate kinase which results in reduced formation of thymidine and thus of DNA. The active metabolite FdUMP appears to form a stable complex with the folate cofactor N-5, 10-methylene tetrahydrofolate which inactivates thymidylate kinase. Fluorouracil as FdUMP is also incorporated into RNA which results in fluorination of RNA. The effect of fluorouracil on living cells is limited mainly to those in the proliferative phase but while cells in the G2 and S phase are most affected there may be effects at any stage of the cell cycle.

Intravenous 5-fluorouracil can be delivered by rapid intravenous bolus injection or slow infusion. The vial contents can rapidly be injected directly into a peripheral vein, the commonest schedules being: 12-13.5 mg/Kg (500 mg/m2) daily for 5 days repeated at 4-weekly intervals. Slow intravenous infusion requires the drug, to be diluted in 500 ml of dextrose 5% solution, then infused over 2-3 hr on 5 successive days.

For palliative management of cancer: Initial Dose: 12 mg/kg intravenously once daily for 4 successive days. Maximum Dose: 800 mg/day. If no toxicity is observed, 6 mg/kg may be administered on the 6th, 8th, 10th, and 12th day (No therapy is given on days 5, 7, 9, or 11). Discontinue at the end of day 12, even with no apparent toxicity.

Poor risk patients and those who are not in an adequate nutritional state: Initial Dose: 6 mg/kg/day for 3 days. Maximum Dose: 400 mg/day. If no toxicity is observed, 3 mg/kg may be administered on days 5, 7, and 9 (No therapy is to be administered on days 4, 6, or 8). Discontinue at the end of day 9, even with no apparent toxicity.

Maintenance therapy: In instances where toxicity has not been a problem, it is recommended that therapy be continued using either of the following schedules:

• Repeat the dosage of the first course every 30 days after the last day of the previous course, or
• When the toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dose of 10 to 15 mg/kg/week as a single dose. Maximum Dose: 1g/week .The reaction by the patient to the previous course of therapy should be taken into account and the dosage should be adjusted accordingly.

Usual adult dose for cervical cancer: In combination with cisplatin 1 gm/m2 IV on day 1. The cycle is repeated every 21 days.

Usual pediatric dose for malignant disease: The manufacturer has reported that the safety and effectiveness of fluorouracil have not been established in children. However, the drug has been used in children following adult guidelines.

Intra-arterial infusion: Fluorouracil has also been given by intra-arterial infusion for adult in doses of 5 to 7.5 mg/kg body weight is dissolved in 20-100 ml of 5% Dextrose solution and administered 10-20 days by using an infusion pump.

Combination with radiation: Usual adult daily dose of 5-10 mg/kg body weight is given in combination with radiation according to systemic administration method or intra-arterial infusion method.

Combination with other anticancer drugs: Fluorouracil is used alone or in combination in the adjuvant treatment of breast and gastro-intestinal cancer, and palliation of inoperable malignant neoplasms, especially those of the gastro-intestinal tract, breast, head and neck, liver, genito-urinary system, and pancreas. It is also used with cyclophosphamide and methotrexate in the combination chemotherapy of breast cancer. A usual adult dose of 5 to 10 mg/kg body weight daily is given in combination with other anticancer drugs every day or intermittently once to twice a week by systemic administration method or intra-arterial infusion method.

Potentially life-threatening effects: Severe effects from 5-fluorouracil are related to the dosage and duration of therapy.

Cardiac effects: Occasional case reports associating 5-fluorouracil therapy with 'ischemic cardiac events' evidence against the autoimmune phenomenon is the fact that in several cases cardiotoxicity occurred within several hours of the first dose.

Hematological effects: Potentially lethal effects caused by severe hematological toxicity may develop within the first 10 days of treatment being instituted but generally resolves within 3 weeks. At the recommended dose and schedule it is rather uncommon for hematological toxicity to be severe. Any ontribute to severe effects from 5-fluorouracil on the blood-forming cells. Thus extensive prior irradiation or the concomitant use of cytotoxic drugs tend to exacerbate the severity of the hematological side effects of 5-fluorouracil.

Neurological effects: Effects on the central nervous system have been occasionally reported and cerebral ataxia is dose-dependent with an incidence of between 3.1 and 7%. Acute cerebellar syndromes and myelopathy have been described following intrathecal 5-fluorouracil. Neurological syndromes may occur rarely after carotid artery perfusion in head and neck cancer. Other effects Allergic reaction (including difficulty in breathing, closing of the throat, swelling of the lips, tongue, or face, or hives), decreased bone marrow function and blood problems (extreme fatigue, easy bruising or bleeding, black, bloody or tarry stools, or fever, chills, or signs of infection), hand-foot syndrome (tingling, pain, redness, swelling or tenderness of the hands and feet), severe vomiting, diarrhoea, frequent bowel movements or watery stools, or sores in the mouth or throat, or stomach pain or heartburn or black, bloody or tarry stools. Other less serious side effects may include mild to moderate nausea, vomiting or loss of appetite, balance problems, confusion, rash and itching, or temporary hair loss. Conjunctivitis, both acute and chronic can proceed to tear duct stenosis and ectropion following prolonged administration. Very chronic administration, extending beyond 3 months, of low dosage has been associated with low systemic toxicity but includes the possibility of painful and tender hands and feet associated with erythema of the extremities.

It is contraindicated in patients that are severely debilitated or in patients with bone marrow suppression due to either radiotherapy or chemotherapy. It is likewise contraindicated in pregnant or breastfeeding women. It should also be avoided in patients that do not have malignant illnesses.

5-fluorouracil is highly toxic drug with a narrow margin of safety. Therefore patients should be carefully supervised, since therapeutic response is unlikely to occur without some evidence of toxicity. Daily dose should not exceed 1 gram. Treatment should be discontinued promptly when one of the following signs of toxicity appears: Leucopenia (WBC under 3500/mm3). Thrombocytopenia (platelet under 100000/mm3). Stomatitis ( the first small ulceration at the inner margin of the lips is a signal for stopping treatment). Severe diarrhoea (frequent bowel movements and watery stools). Gastro-intestinal ulceration and bleeding.

Pre-treatment with cimetidine for 4 weeks led to increased plasma concentrations of fluorouracil following intravenous and oral administration in 6 patients. The effect was probably due to a combination of hepatic enzyme inhibition and reduced hepatic blood flow.

Fluorouracil is contraindicated throughout pregnancy. The literature pertaining to pregnancy and cytotoxic drugs is necessarily limited but it appears in general that risk of teratogenesis diminishes with the advancement of pregnancy. Therefore most cytotoxic drugs are absolutely contraindicated in the first trimester and 5-fluorouracil, used in the first trimester has been reported to cause multiple congenital abnormalities. There are many case reports, however, of pregnancy being conducted successfully with combination chemotherapy being given to the mother during the second and third trimesters. Because of the age of the population and the natural history of the tumors treated, most of the data on long-term follow-up pertain to therapy for leukemias. More data need to be accrued on the subsequent development of neonates before it is certain that any of these compounds are free of late effects.

It is not known whether fluorouracil is excreted in human milk. Because fluorouracil inhibits DNA, RNA and protein synthesis, mothers should not nurse while receiving this drug.

Neonates: No dosage recommendations are made for neonates.

Children: Safety and effectiveness in children have not been established.

The elderly: No special precautions are required, doses being adjusted for the patient's weight and height.

Cases of deliberate overdose are unknown but excessive toxicity because of the hematological effects as described above. There is no specific antidote to 5-fluorouracil toxicity; treatment consists in supportive care. In addition to the hematological toxicity other toxicities will occur with overdose. Sign and symptoms are qualitatively similar to the side effects. Treatment should be performed promptly and appropriate drugs are given to control symptoms of overdose.

5-Fluorouracil is a cytotoxic anticancer drug and, caution should be exercised in handling 5-Fluorouracil. Special, trained personnel should reconstitute the drug. Preparation requires a room reserved for this purpose. The work surface should be covered with disposable plastic-backed absorbent paper. Smoking, eating and drinking are prohibited in the room. The handling staff must have a set of appropriate equipment, particularly long-sleeved coats, protective masks, caps, protective goggles, sterile disposable gloves, worktop protection sheets and waste collection containers and bags. If 5-Fluorouracil solution contacts the skin, wash the skin immediately and thoroughly with soap and water. Following topical exposure, events have included tingling, burning and redness. If 5-Fluorouracil contacts mucous membranes, the membranes should be flashed thoroughly with water. Pregnant women must be warned and avoid handling cytotoxic agents. All broken containers must be treated with the same precautions and regarded as contaminated waste. Contaminated waste is to be disposed of by incineration in rigid containers labeled for this purpose or must be destroyed as per the government rules.

Store the vial in original carton not exceeding 25℃. Do not refrigerate. Protect from light.

Ulipristal Acetate is indicated for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.

Drugs acting on the Uterus, Emergency Contraceptive Pill

Ulipristal Acetate is an orally-active synthetic SPRM that acts via high-affinity binding to the human progesterone receptor. The primary mechanism of action is inhibition or delay of ovulation. Data shows that even when taken immediately before ovulation is scheduled to occur, Ulipristal Acetate is able to postpone follicular rupture in some women.

One 30 mg tablet must be taken as soon as possible but no later than 120 hours of unprotected intercourse or contraceptive failure, with or without food. If vomiting occurs within 3 hours of intake, then another tablet needed to be taken. Ulipristal Acetate can be taken at any time of menstrual cycle.

Most common side-effects are headache, nausea, abdominal pain, dysmenorrhea, fatigue, dizziness, breast tenderness etc.

Ulipristal Acetate is contraindicated in case of hypersensitivity to active substances and in pregnancy.

Existing Pregnancy: Ulipristal Acetate is not indicated for termination of an existing pregnancy.

Ectopic Pregnancy: A history of ectopic pregnancy is not a contraindication to the use of this emergency contraceptive method.

Repeated Use: Ulipristal Acetate is for occasional use as an emergency contraceptive. It should not replace a regular method of contraception. Repeated use of Ulipristal Acetate within the same menstrual cycle is not recommended, as safety and efficacy of repeat use within the same cycle has not been evaluated.

Fertility Following Use: A rapid return of fertility is likely following treatment with Ulipristal Acetate for emergency contraception. So, to prevent pregnancy on a later episode of sexual intercourse one should use the barrier method (ex. Condom).

Effect on Menstrual Cycle: After Ulipristal Acetate intake, menses sometimes occur earlier or later than expected by a few days. In clinical trials, cycle length was increased by a mean of 2.5 days but returned to normal in the subsequent cycle. 7% of subjects reported menses occurring more than 7 days earlier than expected, and 19% reported a delay of more than 7 days. If there is a delay in the onset of expected menses beyond 1 week, a pregnancy test should be performed. 9% of women studied reported intermenstrual bleeding after the use of Ulipristal Acetate.

Ulipristal Acetate interacts with the following drugs: Barbiturates, Carbamazepine, Phenobarbital, Rifampicin, Itraconazole, Ketoconazole etc.

Contraindicated in suspected or existing pregnancy. Ulipristal Acetate excretes in breast milk. So breastfeeding is not recommended for one week after intake. Extremely limited data are available on the health of the fetus/newborn exposed to Ulipristal acetate.

Children and Adolescents: Limited safety and efficacy data available on women under 18 years old.

Hepatic Impairment: No studies have been conducted to evaluate the effect of hepatic disease on the disposition of Ulipristal Acetate.

Renal Impairment: No studies have been conducted to evaluate the effect of renal disease on the disposition of Ulipristal Acetate.

Experience with Ulipristal Acetate overdose is limited, in a clinical study, a single dose equivalent to four times Ulipristal Acetate was administered to a limited number of subjects without any adverse reactions.

Store in a dry and cool place, protected from sunlight. Do not freeze. Keep out of reach of children.

Vitamin-B preparations

Thiamine, in the form of thiamine pyrophosphate, is the coenzyme for decarboxylation of α-ketoglutaric acid. Thiamine deficiency affects the peripheral nervous system, the gastrointestinal tract, and the cardiovascular system. This vitamin is necessary for the optimal growth of infants and children. Thiamine is not stored in the body, and is regularly lost from tissues during short periods of deficiency. In order to maintain normal health, an adequate amount of thiamine is required every day. Deficiency of thiamine leads to fatigue, anorexia, gastrointestinal disturbance, tachycardia, irritability and neurological symptoms. Beriberi, a disease due to vitamin B1 deficiency, is common in alcoholics, in pregnant women receiving an inadequate diet, and in people with malabsorption syndrome, prolonged diarrhoea and hepatic disease.

Thiamine is well absorbed from the gastrointestinal tract and widely distributed throughout the body. Thiamine is rapidly absorbed from the upper small intestine. Thiamine is not stored in the body to any appreciable extent. Excess ingested thiamine appears in urine as intact thiamine or as pyrimidine, which arises from degradation of the thiamine molecule. The plasma half life of thiamine is 24 hours.

Prophylaxis: 3 to 10 mg daily.
Mild chronic deficiency: 10 to 25 mg daily.
Severe deficiency: 200 to 300 mg daily.

Vitamin B1 does not have adverse effects when given orally, but in a few fatal cases anaphylactic reactions have occurred after intravenous administration of large doses (400 mg) in sensitive patients, especially children, and in one case following an intramuscular dose of 125 mg. The risk of such reactions increases with repeated administration of the drug by parenteral route. Transient mild soreness may occur at the site of intramuscular administration

There is no absolute contraindication but the risk of anaphylaxis is increased by repeated parenteral administration. Mild allergic phenomena, such as sneezing or mild asthma are warning signs that further may give rise to anaphylactic shock. To avoid this possibility it is advisable to start a second course of injection with a dose considerably lower than that previously used. Because of the above, vitamin B1 injection should not be given intravenously except in the case of comatose patients. Once thiamine deficiency is corrected there is no need for parenteral administration or for the administration of amounts in excess of daily requirement.

No hazardous drug interactions have been reported. Vitamin B1 acts synergistically with other vitamins of the B-complex group and its potential for causing adverse effects is considerably reduced.

The drug may be given safely to neonates, children, pregnant and lactating women and elderly patients.

Thiamine injection should be protected from light and moisture.

Minerals in bone formation, Specific mineral preparations

Calcium carbonate reacts with gastric acid to produce a salt and water. For calcium carbonate the postulated chemical reaction is: CaCO₃+2HCl = CaCl₂+H₂O+CO₂. Two grams of calcium carbonate will readily bring 100 ml of hydrochloric acid to a pH above 6. The increase in gastric pH diminishes the activity of pepsin in the gastric secretion. Up to 30% of the oral calcium load may be absorbed.

250 mg or 500 mg tablet: Calcium Carbonate is always used orally and when used as an antacid the recommended doses for adults are equivalent to 540-2000 mg Calcium Carbonate per day, doses for children being half of those for adults. As a dietary supplement, such as for the prevention of osteoporosis, 1250-3750 mg Calcium Carbonate (500-1500 mg calcium) daily is recommended in general, but again this will need to be tailored to the individual patient depending on any specific disease such as Calcium deficiency, malabsorption or parathyroid function. In pregnancy and lactation the recommended daily dose of calcium is 1200-1500 mg. In chronic renal failure the doses used vary from 2.5-9.0 gm Calcium Carbonate per day and need to be adjusted according to the individual patient. To maximize effective phosphate binding in this context the Calcium Carbonate should be given with meals.

1000 mg tablet: 2000-3000 mg tablet when symptoms occur; may be repeated hourly if needed or as directed by the physician.

Orally administered Calcium Carbonate may be irritating to the GI tract. It may also cause constipation. Hypercalcaemia is rarely produced by administration of calcium alone, but may occur when large doses are given to patients with chronic renal failure.

• Hypercalcaemia and hyperparathyroidism
• Hypercalciuria and nephrolithiasis
• Zollinger-Ellison syndrome
• Concomitant digoxin therapy (requires careful monitoring of serum calcium level)

When hypercalcaemia occurs, discontinuation of the drug is usually sufficient to return serum calcium concentrations to normal. Calcium salts should be used cautiously in patients with sarcoidosis, renal or cardiac disease, and in patients receiving cardiac glycosides.

Calcium Carbonate may enhance the cardiac effects of digoxin and other cardiac glycosides, if systemic hypercalcaemia occurs. Calcium Carbonate may interfere with the absorption of concomitantly administered tetracycline preparations and in chronic renal failure modification of vitamin D therapy may be required to avoid hypercalcaemia when Calcium Carbonate is used as the primary phosphate binder.

Calcium containing drugs have been widely used in pregnancy by way of oral calcium supplementation or antacid therapy. Calcium Carbonate can be used in lactating women too.

Use in children: Calcium carbonate has been extensively studied in children and infants with chronic renal failure and is both safe and effective.

Use in elderly: In case of elderly patients with renal failure when calcium carbonate is taken constipation may be troublesome one for this group. For this reason, monitoring of serum calcium and phosphate is of course indicated for elderly patients.

Store in a cool, dry place in controlled room temperature.

Specific mineral & vitamin combined preparations

This is the preparation of Calcium Carbonate and Vitamin D3 (Cholecalciferol). Calcium is necessary for many normal functions of our body, especially bone formation and maintenance. Vitamin D3 helps for the absorption & reabsorption of Calcium. Vitamin D3 also stimulates bone formation. Clinical studies showed that Calcium and Vitamin D3 all together helps in bone growth, and in prevention of osteoporosis & bone fracture.

Calcium 500 mg and Vitamin D3 200 IU Tablet: 2 tablets daily or 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.

Calcium 500 mg and Vitamin D3 400 IU Tablet: 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.

It is generally well tolerated. If there is experience like nausea, vomiting, stomach cramps, dry mouth, increased thirst, increased urination while taking, noticed to physicians. Constipation may occur.

It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.

If there is any pre-existing heart disease or kidney disease, precautions should be taken.

It has possible interaction with calcium, aluminium or magnesium containing antacids &  other calcium supplements, calcitriol & other vitamin D3 supplements; digoxin, tetracycline, doxycycline, minocycline or oxytetracycline.

This combination should be used as directed by physician during pregnancy or while breast-feeding.

Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache, constipation.

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

Specific mineral & vitamin combined preparations

This is the preparation of Calcium Carbonate and Vitamin D3 (Cholecalciferol). Calcium is necessary for many normal functions of our body, especially bone formation and maintenance. Vitamin D3 helps for the absorption & reabsorption of Calcium. Vitamin D3 also stimulates bone formation. Clinical studies showed that Calcium and Vitamin D3 all together helps in bone growth, and in prevention of osteoporosis & bone fracture.

Calcium 500 mg and Vitamin D3 200 IU Tablet: 2 tablets daily or 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.

Calcium 500 mg and Vitamin D3 400 IU Tablet: 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.

It is generally well tolerated. If there is experience like nausea, vomiting, stomach cramps, dry mouth, increased thirst, increased urination while taking, noticed to physicians. Constipation may occur.

It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.

If there is any pre-existing heart disease or kidney disease, precautions should be taken.

It has possible interaction with calcium, aluminium or magnesium containing antacids &  other calcium supplements, calcitriol & other vitamin D3 supplements; digoxin, tetracycline, doxycycline, minocycline or oxytetracycline.

This combination should be used as directed by physician during pregnancy or while breast-feeding.

Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache, constipation.

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