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This is indicated for the symptomatic relief of upper respiratory tract disorders accompanied by productive cough which benefits from the administration of a nasal decongestant, a histamine H1 receptor antagonist and an expectorant combination.

Combined cough expectorants

Pseudoephedrine is a decongestant as well as a bronchodilator for the upper respiratory tract, which gives symptomatic relief of nasal congestion. Pseudoephedrine is both an α-and β-adrenergic receptor agonist. It causes vasoconstriction via direct stimulation of α-adrenergic receptors of the respiratory mucosa. It also directly stimulates β-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility.

Like ephedrine, pseudoephedrine releasing norepinephrine from its storage sites, an indirect effect. This is its main and direct mechanism of action. The displaced noradrenaline is released into the neuronal synapse where it is free to activate the postsynaptic adrenergic receptors.

Guaifenesin reduces the viscosity of tenacious sputum and is used as an expectorant. It increases the hydration of respiratory tract, thereby increasing the volume and reducing the viscosity of bronchial secretions.

Triprolidine is an antihistamine; it is used for the symptomatic relief of hypersensitivity reactions including rhinitis, conjunctivitis and urticaria.

Adult and Children over 12 years: 10 ml (2 teaspoonful) three times a day.
Children 6-12 years: 5 ml (1 teaspoonful) three times a day.
Children 2-5 years: 2.5 ml (1/2 teaspoonful) three times a day.

A physician’s advice is preferred before administering this preparation to children aged less than 2 years.

CNS depression or excitation, drowsiness (reported most frequently), sleep disturbances, hallucinations (rarely reported), skin rashes with or without irritation, tachycardia, dryness of mouth, nose and throat have occasionally been reported.

This is contraindicated in the cases of known hypersensitivity to any of its constituents, cardiovascular disease including hypertension, lower respiratory symptoms including asthma, monoamine oxidase inhibitor (MAOI) therapy.

As with any other antihistamine therapy, Pseudoephedrine, guaiphenasine & triprolidine may cause drowsiness. If affected, patients should be advised not to drive or operate machinery. Concomitant administration of alcohol or other centrally acting sedatives should be avoided. Although Pseudoephedrine has no pressor effects in normotensive patients but Pseudoephedrine, guaiphenasine & triprolidine should be used with caution to patients suffering from mild to moderate hypertension. Moreover, caution should also be exercised in the following disease conditions - hypertension and heart disease, diabetes, hyperthyroidism, elevated intra-ocular pressure, prostatic enlargement, severe renal and hepatic impairment. This preparation should not be used for persistent or chronic cough, which occurs with smoking, asthma or emphysema or where excessive secretions accompany cough, unless directed by a physician.

Concomitant use of Pseudoephedrine, guaiphenasine & triprolidine with sympathomimetic agents such as decongestants, tricyclic antidepressants, appetite suppressants and amphetamine-like psychostimulants or with monoamine oxidase inhibitors which interfere with the catabolism of sympathomimetic amines may occasionally cause a rise in blood pressure. Because of its pseudoephedrine content, Pseudoephedrine, guaiphenasine & triprolidine partially reverse the hypotensive action of drugs which interfere with sympathetic activity including guanethidine, methyldopa, alpha-adrenergic blocking agents.

Although pseudoephedrine, triprolidine and guaiphenesin have been in widespread use of many years without apparent ill consequence, there are no specific data on their use during pregnancy. Caution should therefore be exercised by balancing the potential benefits of treatment of the mother against any possible hazards to the developing fetus.

The effects of acute toxicity from Pseudoephedrine, guaiphenasine & triprolidine may include drowsiness, irritability, restlessness, lethargy, dizziness, gastrointestinal discomfort, respiratory depression, convulsion, tremor, tachycardia and hypertension. Incase of overdose, necessary measures should be taken to maintain and support respiration and control convulsion. Gastric lavage may be undertaken if indicated. Catheterization of bladder may be necessary.

Store below 25° C. Protect from light. Do not refrigerate.

Third generation Cephalosporins

Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).

Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
• Uncomplicated gonococcal infections: 250 mg IM as a single dose
• Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery

Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
• Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
• Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day

Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

Preparation of Solutions for Intramuscular / Intravenous Injections:

• For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
• For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.

The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).

Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.

Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.

No drug interactions have been reported.

Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.

Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).

There is no specific antidote. Treatment of overdosage should be symptomatic.

Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).

Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
• Uncomplicated gonococcal infections: 250 mg IM as a single dose
• Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery

Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
• Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
• Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day

Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

Preparation of Solutions for Intramuscular / Intravenous Injections:

• For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
• For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.

The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).

Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.

Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.

No drug interactions have been reported.

Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.

Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).

There is no specific antidote. Treatment of overdosage should be symptomatic.

Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).

Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
• Uncomplicated gonococcal infections: 250 mg IM as a single dose
• Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery

Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
• Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
• Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day

Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

Preparation of Solutions for Intramuscular / Intravenous Injections:

• For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
• For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.

The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).

Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.

Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.

No drug interactions have been reported.

Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.

Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).

There is no specific antidote. Treatment of overdosage should be symptomatic.

Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).

Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
• Uncomplicated gonococcal infections: 250 mg IM as a single dose
• Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery

Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
• Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
• Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day

Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

Preparation of Solutions for Intramuscular / Intravenous Injections:

• For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
• For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.

The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).

Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.

Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.

No drug interactions have been reported.

Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.

Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).

There is no specific antidote. Treatment of overdosage should be symptomatic.

Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).

Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
• Uncomplicated gonococcal infections: 250 mg IM as a single dose
• Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery

Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
• Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
• Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day

Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

Preparation of Solutions for Intramuscular / Intravenous Injections:

• For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
• For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.

The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).

Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.

Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.

No drug interactions have been reported.

Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.

Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).

There is no specific antidote. Treatment of overdosage should be symptomatic.

Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).

Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
• Uncomplicated gonococcal infections: 250 mg IM as a single dose
• Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery

Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
• Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
• Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day

Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

Preparation of Solutions for Intramuscular / Intravenous Injections:

• For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
• For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.

The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).

Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.

Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.

No drug interactions have been reported.

Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.

Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).

There is no specific antidote. Treatment of overdosage should be symptomatic.

Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).

Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
• Uncomplicated gonococcal infections: 250 mg IM as a single dose
• Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery

Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
• Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
• Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day

Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

Preparation of Solutions for Intramuscular / Intravenous Injections:

• For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
• For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.

The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).

Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.

Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.

No drug interactions have been reported.

Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.

Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).

There is no specific antidote. Treatment of overdosage should be symptomatic.

Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

Anti-diarrhoeal Antimicrobial drugs, Sulphonamides & Trimethoprim

Cotrimoxazole having broad spectrum bactericidal activity against a wide range of gram-positive & gram-negative bacteria and some protozoa. Co-trimoxazole containing Trimethoprim and Sulphamethoxazole in a 1:5 combination exerts its bactericidal action by the sequential blockade of two bacterial enzyme systems in the biosynthesis of folinic acid in the microorganism.

Cotrimoxazole double strength tablet: Over 12 years

• For mild to moderate infections: 1 tablet twice daily.
• For severe infections: 1.5 tablets twice daily.
• Long term therapy (>14 days): 0.5 tablet twice daily.
• Gonorrhoea: 2 tablets every 12 hours for two days or 2.5 tablets followed by a further dose of 2.5 tablets after 8 hours.

Cotrimoxazole tablet: over 12 years

• For mild to moderate infections: 2 tablets twice daily.
• For severe infections: 2 tablets thrice daily.
• Long term therapy: (>14 days): 1 tablet twice daily.

Cotrimoxazole suspension: Under 12 years

• 6-12 years: 2 teaspoonful twice daily.
• 6 month-5 years: 1 teaspoonful twice daily.
• 6 weeks-6 months: 0.5 teaspoonful twice daily.

The side effects like crystalluria, allergic reactions, haemolysis, thrombocytopenia, neutropenia, agranulocytosis etc. have been reported rarely with Sulphamethoxazole-Trimethoprim combination. Other side effects are less serious in nature such as malaise, headache, nausea and vomiting. These are normally transient and do not require withdrawal of treatment.

Prolonged full dose treatment with sulfamethoxazole-trimethoprim combination is associated with the risk of macrocytic anaemia due to the drug’s interference in the conversion of Folic acid into Folinic acid. If this occurs, it can be reversed by giving Folinic acid. Care should be taken when giving this combination to diabetic patients receiving sulphonylurea drug for possible potentiation of action of sulphonylurea.

Pregnancy and during the nursing period, because sulphonamides pass the placenta and are excreted in the breast milk and may cause kernicterus.

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

Anti-diarrhoeal Antimicrobial drugs, Sulphonamides & Trimethoprim

Cotrimoxazole having broad spectrum bactericidal activity against a wide range of gram-positive & gram-negative bacteria and some protozoa. Co-trimoxazole containing Trimethoprim and Sulphamethoxazole in a 1:5 combination exerts its bactericidal action by the sequential blockade of two bacterial enzyme systems in the biosynthesis of folinic acid in the microorganism.

Cotrimoxazole double strength tablet: Over 12 years

• For mild to moderate infections: 1 tablet twice daily.
• For severe infections: 1.5 tablets twice daily.
• Long term therapy (>14 days): 0.5 tablet twice daily.
• Gonorrhoea: 2 tablets every 12 hours for two days or 2.5 tablets followed by a further dose of 2.5 tablets after 8 hours.

Cotrimoxazole tablet: over 12 years

• For mild to moderate infections: 2 tablets twice daily.
• For severe infections: 2 tablets thrice daily.
• Long term therapy: (>14 days): 1 tablet twice daily.

Cotrimoxazole suspension: Under 12 years

• 6-12 years: 2 teaspoonful twice daily.
• 6 month-5 years: 1 teaspoonful twice daily.
• 6 weeks-6 months: 0.5 teaspoonful twice daily.

The side effects like crystalluria, allergic reactions, haemolysis, thrombocytopenia, neutropenia, agranulocytosis etc. have been reported rarely with Sulphamethoxazole-Trimethoprim combination. Other side effects are less serious in nature such as malaise, headache, nausea and vomiting. These are normally transient and do not require withdrawal of treatment.

Prolonged full dose treatment with sulfamethoxazole-trimethoprim combination is associated with the risk of macrocytic anaemia due to the drug’s interference in the conversion of Folic acid into Folinic acid. If this occurs, it can be reversed by giving Folinic acid. Care should be taken when giving this combination to diabetic patients receiving sulphonylurea drug for possible potentiation of action of sulphonylurea.

Pregnancy and during the nursing period, because sulphonamides pass the placenta and are excreted in the breast milk and may cause kernicterus.

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

This cream is indicated for the short-term treatment of moderate to severe melasma of the face, after starting the treatment avoid presence of sun. Use a sunscreen of at least SPF 30 or more.

Hydroquinone Preparations

This cream contains three active ingredients Fluocinolone Acetonide, Hydroquinone and Tretinoin. All of them are used to treat melasma. However, the mechanism of action of the active ingredients in This cream in the treatment of melasma is unknown but Fluocinolone Acetonide is a corticosteroid for topical dermatological use and is classified therapeutically as an anti-inflammatory. Hydroquinone is classified therapeutically as a depigmenting agent, which may interrupt one or more steps in the tyrosine-tyrosinase pathway of melanin synthesis. Tretinoin is classified therapeutically as a keratolytic agent.

This cream should be applied once daily at night. It should be applied at least 30 minutes before bedtime. Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply a thin film of the cream to the hyperpigmented areas of melasma including about ½ inch of normal-appearing skin surrounding each lesion. Rub lightly and uniformly into the skin. During the day, use sunscreen and wear protective clothing. Avoid sunlight exposure. Patients may use moisturizers and/or cosmetics during the day.

Pediatric Use: The safety and effectiveness of this cream in pediatric patients have not been established.

A very few patients may get severe allergic reactions from this cream. They may have trouble breathing or severe asthma attacks. While patients use this cream, skin may develop mild to moderate redness, peeling, burning, dryness or itching.

This cream is contraindicated in individuals with a history of hypersensitivity, allergy or intolerance to this product or any of its components.

This cream contains Hydroquinone and Tretinoin that may cause mild to moderate irritation. Local irritation, such as skin reddening, peeling, mild burning sensation, dryness and pruritus may be expected at the site of application. Transient skin reddening or mild burning sensation does not preclude treatment. If a reaction suggests hypersensitivity or chemical irritation, the use of the medication should be discontinued. This cream also contains the corticosteroid Fluocinolone Acetonide. Systemic absorption of topical corticosteroids can produce reversible Hypothalamic-Pituitary-Adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia and glucosuria can also be produced by systemic absorption of topical corticosteroid while on treatment. If HPA axis suppression is noted, the use of this cream should be discontinued. Recovery of HPA axis function generally occurs upon discontinuation of topical corticosteroids.

Avoid use of medicated or abrasive soaps, cleansers, soaps, cosmetics with drying effects, products with high concentration of alcohol, astringent & other irritants or keratolytic drugs. Also avoid concomitant use of medications with photosensitizing effects.

Pregnancy Category C. This cream contains the teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations and potential neurologic deficits. It is difficult to interpret the animal studies on teratogenicity with this cream, because the availability of the dermal applications in these studies cannot be assured and comparison with clinical dosing is not possible. There are no adequate and well controlled studies in pregnant women. This cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: Corticosteroids, when systemically administered, the drug appear in human milk. It is not known whether topical application of this cream could result in sufficient systemic absorption to produce detectable quantities of Fluocinolone Acetonide, Hydroquinone or Tretinoin in human milk. Because many drugs are secreted in human milk, caution should be exercised when this cream is administered to nursing women.

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

Triamcinolone is indicated for the treatment and prophylaxis of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 6 years of age and older.

Corticosteroid, Glucocorticoids, Nasal Steroid Preparations

The antiinflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition of arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes. Firstly, however, these glucocorticoids bind to the glucocorticoid receptors which translocate into the nucleus and bind DNA (GRE) and change genetic expression both positively and negatively. The immune system is suppressed by corticosteroids due to a decrease in the function of the lymphatic system, a reduction in immunoglobulin and complement concentrations, the precipitation of lymphocytopenia, and interference with antigen-antibody binding.

Triamcinolone Acetonide is a more potent derivative of Triamcinolone and is approximately 8 times more potent than prednisone. Corticosteroids are very effective in the treatment of allergic diseases in man. When given by intranasal spray, Triamcinolone Acetonide provides relief from allergy-induced watery nasal discharge (rhinorrhea), nasal congestion, postnasal drip, sneezing, and itching of the back of the throat.

Adults and children 12 years of age and older: The recommended dose is 220 µgm as 2 sprays in each nostril once daily. Once symptoms are controlled patients can be maintained on 110 µgm (1 spray in each nostril once daily). The minimum effective dose should be used to ensure continued control of symptoms.

Pediatric Patients aged 6 to 12 years: The recommended dose is 110 µgm as 1 spray in each nostril once daily. Triamcinolone spray is not recommended for children under 6 years of age.

How to use the Nasal Spray-

• Shake the bottle gently and remove the dust cover.
• Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
• Gently blow the nose to clear the nostrils.
• Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
• Breathe out through your mouth.
• Repeat the above steps in the same/ other nostril for consecutive doses.

Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-

• Remove the dust cover.
• Gently pull off the nasal applicator.
• Wash the applicator and dust cover in warm water.
• Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
• Gently push the applicator back on the top of the bottle and re-fix the dust cover.

The most commonly reported adverse reactions in clinical trials with Triamcinolone included those involving mucous membranes of the nose & throat. The most prevalent adverse reactions considered are rhinitis, headache, & pharyngitis. The nasopharyngeal adverse effects included epistaxis, nasal irritation, dry mucous membrane, naso-sinus congestion and sneezing although these are seen as frequently with placebo. As with other nasally inhaled corticosteroids, nasal septal perforation has been reported.

No specific contraindications but caution is required in patients with hypersensitivity to any constituents of the formulation.

If there is any reason to suppose that adrenal function is impaired, care must be taken while transferring patients from systemic steroid treatment to Triamcinolone. In clinical studies with Triamcinolone administered intranasally, the development of localized infections, on the nose, and pharynx with Candida albicans, has rarely occurred. When such an infection develops it may require treatment with appropriate local therapy and discontinuance of treatment with Triamcinolone. Because of the inhibitory effect of corticosteroids on wound healing in patients who have experienced recent nasal septal ulcers, nasal surgery of trauma, Triamcinolone should be used with caution until healing has occurred.

There are no adequate and well controlled studies in pregnant women with Triamcinolone. Because animal studies indicate a teratogenic effect, Triamcinolone should be used during pregnancy if the potential benefit justifies the potential benefit to fetus. It is not known whether Triamcinolone is excreted in human breast milk.

Like any other nasally administered corticosteroid, acute overdosing with Triamcinolone is unlikely in view of the total amount of active ingredient present

Store at a temperature not exceeding 25˚C. Protect from light and moisture. Keep out of the reach of children.

Angiotensin-converting enzyme (ACE) inhibitors

Ramipril is an angiotensin converting enzyme (ACE) inhibitor, which after hydrolysis to ramiprilat, blocks the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. So, inhibition of ACE by ramipril results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and decreased aldosterone secretion. Thus ramipril exerts its antihypertensive activity. It is also effective in the management of heart failure and reduction of the risk of stroke, myocardial infarction and death from cardiovascular events. It is long acting and well tolerated; so, can be used in long term therapy.

Dosage of Ramipril must be adjusted according to the patient tolerance and response.

Hypertension: For the management of hypertension in adults not receiving a diuretic, the usual initial dose of Ramipril is 1.25-2.5 mg once daily. Dosage generally is adjusted no more rapidly than at 2 week intervals. The usual maintenance dosage in adults is 2.5-20 mg daily given as a single dose or in 2 divided doses daily. If BP is not controlled with Ramipril alone, a diuretic may be added.

Congestive heart failure after myocardial infarction: In this case, Ramipril therapy may be initiated as early as 2 days after myocardial infarction. An initial dose of 2.5 mg twice daily is recommended, but if hypotension occurs, dose should be reduced to 1.25 mg twice daily. Therapy is then titrated to a target daily dose of 5 mg twice daily.

Prevention of major cardiovascular events: In this case, the recommended dose is 2.5 mg once daily for the first week of therapy and 5 mg once daily for the following 3 weeks; dosage then may be increased, as tolerated, to a maintenance dosage of 10 mg once daily.

Dosage in renal impairment:

• For patients with hypertension and renal impairment: The recommended initial dose is 1.25 mg Ramipril once daily. Subsequent dosage should be titrated according to individual tolerance and BP response, up to a maximum of 5 mg daily.
• For patients with heart failure and renal impairment: The recommended dose is 1.25 mg once daily. The dose may be increased to 1.25 mg twice daily and up to a maximum dose of 2.5 mg twice daily depending upon clinical response and tolerability.

Ramipril tablets have to be swallowed with sufficient amounts of liquid. The tablets must not be chewed or crushed. Absorption of Ramipril is not significantly affected by food. Ramipril may, therefore, be taken before, during or after a meal.

Ramipril is generally well tolerated. Dizziness, headache, fatigue and asthenia are commonly reported side effects. Other side effects occurring less frequently include symptomatic hypotension, cough, nausea, vomiting, diarrhoea, rash, urticaria, oliguria, anxiety, amnesia etc. Angioneurotic oedema, anaphylactic reactions and hyperkalaemia have also been reported rarely.

Ramipril must not be used

• in patients with hypersensitivity to ramipril, to any other ACE inhibitor, or any of the excipients of Ramipril.
• in patients with a history of angioedema.
• concomitantly with sacubitril/valsartan therapy. Do not initiate Ramipril until sacubitril/valsartan is eliminated from the body. In case of switch from Ramipril to sacubitril/valsartan, do not start sacubitril/valsartan until Ramipril is eliminated from the body.
• in patients with haemodynamically relevant renal artery stenosis, bilateral or unilateral in the single kidney.
• in patients with hypotensive or haemodynamically unstable states.
• with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment (creatinine clearance <60 ml/min).
• with angiotensin II receptor antagonists (AIIRAs) in patients with diabetic nephropathy.
• during pregnancy.

Concomitant use of ACE inhibitors and extracorporeal treatments leading to contact of blood with negatively charged surfaces must be avoided, since such use may lead to severe anaphylactoid reactions. Such extracorporeal treatments include dialysis or haemofiltration with certain high-fux (e.g. polyacrylonitril) membranes and low-density lipoprotein apheresis with dextran sulfate.

Ramipril should be used with caution in patients with impaired renal function, hyperkalaemia, hypotension, and impaired hepatic function.

Concomitant administration with diuretics may lead to serious hypotension and in addition dangerous hyperkalemia with potassium sparing diuretics. Concomitant therapy with lithium may increase the serum lithium concentration. Reduction in BP may affect the ability to drive and operate machinery and this may be exacerbated by alcohol. NSAIDs may reduce the antihypertensive effect of Ramipril and cause deterioration of renal function.

Ramipril must not be taken during pregnancy. Therefore, pregnancy must be excluded before starting treatment. Pregnancy must be avoided in cases where treatment with ACE inhibitors is indispensable. If the patient intends to become pregnant, treatment with ACE inhibitors must be discontinued, i.e. replaced by another form of treatment. If the patient becomes pregnant during treatment, medication with Ramipril must be replaced as soon as possible by a treatment regimen without ACE inhibitors. Otherwise, there is a risk of harm to the fetus. Ramipril is not recommended during breastfeeding.

Elderly: A reduced initial dose of 1.25 mg Ramipril daily must be considered.

Hepatic impairment: Treatment in these patients must therefore be initiated only under close medical supervision. The maximum permitted daily dose in such cases is 2.5 mg Ramipril.

Renal impairment: With a creatinine clearance between 50 and 20 ml/min per 1.73 m2 body surface area, the initial daily dose is generally 1.25 mg Ramipril. The maximum permitted daily dose, in this case, is 5 mg Ramipril. Patients with incompletely corrected fuid or salt depletion, in patients with severe hypertension, as well as in patients in whom a hypotensive reaction would constitute a particular risk, (e.g., with relevant stenoses of the coronary vessels or those supplying the brain) A reduced initial dose of 1.25 mg Ramipril daily must be considered.

Patients pretreated with a diuretic: Consideration must be given to discontinuing the diuretic for at least 2 to 3 days or- depending on the duration of action of the diuretic- longer before starting treatment with Ramipril, or at least to reducing the diuretic dose. The initial daily dose in patients previously treated with a diuretic is generally 1.25 mg Ramipril.

Sign and symptom: Overdosage may cause excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, and renal failure.

Management: Primary detoxifcation by, for example, gastric lavage, administration of adsorbents, sodium sulfate; (if possible during the frst 30 minutes). In the event of hypotension administration of α1-adrenergic agonists (e.g. norepinephrine, dopamine) or angiotensin II (angiotensinamide), which is usually available only in scattered research laboratories, must be considered in addition to volume and salt substitution.

Store at 30° or below, protect from light. Keep out of the reach of children. Do not use later than the date of expiry. To be dispensed only on the prescription of a registered physician.

Angiotensin-converting enzyme (ACE) inhibitors

Ramipril is an angiotensin converting enzyme (ACE) inhibitor, which after hydrolysis to ramiprilat, blocks the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. So, inhibition of ACE by ramipril results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and decreased aldosterone secretion. Thus ramipril exerts its antihypertensive activity. It is also effective in the management of heart failure and reduction of the risk of stroke, myocardial infarction and death from cardiovascular events. It is long acting and well tolerated; so, can be used in long term therapy.

Dosage of Ramipril must be adjusted according to the patient tolerance and response.

Hypertension: For the management of hypertension in adults not receiving a diuretic, the usual initial dose of Ramipril is 1.25-2.5 mg once daily. Dosage generally is adjusted no more rapidly than at 2 week intervals. The usual maintenance dosage in adults is 2.5-20 mg daily given as a single dose or in 2 divided doses daily. If BP is not controlled with Ramipril alone, a diuretic may be added.

Congestive heart failure after myocardial infarction: In this case, Ramipril therapy may be initiated as early as 2 days after myocardial infarction. An initial dose of 2.5 mg twice daily is recommended, but if hypotension occurs, dose should be reduced to 1.25 mg twice daily. Therapy is then titrated to a target daily dose of 5 mg twice daily.

Prevention of major cardiovascular events: In this case, the recommended dose is 2.5 mg once daily for the first week of therapy and 5 mg once daily for the following 3 weeks; dosage then may be increased, as tolerated, to a maintenance dosage of 10 mg once daily.

Dosage in renal impairment:

• For patients with hypertension and renal impairment: The recommended initial dose is 1.25 mg Ramipril once daily. Subsequent dosage should be titrated according to individual tolerance and BP response, up to a maximum of 5 mg daily.
• For patients with heart failure and renal impairment: The recommended dose is 1.25 mg once daily. The dose may be increased to 1.25 mg twice daily and up to a maximum dose of 2.5 mg twice daily depending upon clinical response and tolerability.

Ramipril tablets have to be swallowed with sufficient amounts of liquid. The tablets must not be chewed or crushed. Absorption of Ramipril is not significantly affected by food. Ramipril may, therefore, be taken before, during or after a meal.

Ramipril is generally well tolerated. Dizziness, headache, fatigue and asthenia are commonly reported side effects. Other side effects occurring less frequently include symptomatic hypotension, cough, nausea, vomiting, diarrhoea, rash, urticaria, oliguria, anxiety, amnesia etc. Angioneurotic oedema, anaphylactic reactions and hyperkalaemia have also been reported rarely.

Ramipril must not be used

• in patients with hypersensitivity to ramipril, to any other ACE inhibitor, or any of the excipients of Ramipril.
• in patients with a history of angioedema.
• concomitantly with sacubitril/valsartan therapy. Do not initiate Ramipril until sacubitril/valsartan is eliminated from the body. In case of switch from Ramipril to sacubitril/valsartan, do not start sacubitril/valsartan until Ramipril is eliminated from the body.
• in patients with haemodynamically relevant renal artery stenosis, bilateral or unilateral in the single kidney.
• in patients with hypotensive or haemodynamically unstable states.
• with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment (creatinine clearance <60 ml/min).
• with angiotensin II receptor antagonists (AIIRAs) in patients with diabetic nephropathy.
• during pregnancy.

Concomitant use of ACE inhibitors and extracorporeal treatments leading to contact of blood with negatively charged surfaces must be avoided, since such use may lead to severe anaphylactoid reactions. Such extracorporeal treatments include dialysis or haemofiltration with certain high-fux (e.g. polyacrylonitril) membranes and low-density lipoprotein apheresis with dextran sulfate.

Ramipril should be used with caution in patients with impaired renal function, hyperkalaemia, hypotension, and impaired hepatic function.

Concomitant administration with diuretics may lead to serious hypotension and in addition dangerous hyperkalemia with potassium sparing diuretics. Concomitant therapy with lithium may increase the serum lithium concentration. Reduction in BP may affect the ability to drive and operate machinery and this may be exacerbated by alcohol. NSAIDs may reduce the antihypertensive effect of Ramipril and cause deterioration of renal function.

Ramipril must not be taken during pregnancy. Therefore, pregnancy must be excluded before starting treatment. Pregnancy must be avoided in cases where treatment with ACE inhibitors is indispensable. If the patient intends to become pregnant, treatment with ACE inhibitors must be discontinued, i.e. replaced by another form of treatment. If the patient becomes pregnant during treatment, medication with Ramipril must be replaced as soon as possible by a treatment regimen without ACE inhibitors. Otherwise, there is a risk of harm to the fetus. Ramipril is not recommended during breastfeeding.

Elderly: A reduced initial dose of 1.25 mg Ramipril daily must be considered.

Hepatic impairment: Treatment in these patients must therefore be initiated only under close medical supervision. The maximum permitted daily dose in such cases is 2.5 mg Ramipril.

Renal impairment: With a creatinine clearance between 50 and 20 ml/min per 1.73 m2 body surface area, the initial daily dose is generally 1.25 mg Ramipril. The maximum permitted daily dose, in this case, is 5 mg Ramipril. Patients with incompletely corrected fuid or salt depletion, in patients with severe hypertension, as well as in patients in whom a hypotensive reaction would constitute a particular risk, (e.g., with relevant stenoses of the coronary vessels or those supplying the brain) A reduced initial dose of 1.25 mg Ramipril daily must be considered.

Patients pretreated with a diuretic: Consideration must be given to discontinuing the diuretic for at least 2 to 3 days or- depending on the duration of action of the diuretic- longer before starting treatment with Ramipril, or at least to reducing the diuretic dose. The initial daily dose in patients previously treated with a diuretic is generally 1.25 mg Ramipril.

Sign and symptom: Overdosage may cause excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, and renal failure.

Management: Primary detoxifcation by, for example, gastric lavage, administration of adsorbents, sodium sulfate; (if possible during the frst 30 minutes). In the event of hypotension administration of α1-adrenergic agonists (e.g. norepinephrine, dopamine) or angiotensin II (angiotensinamide), which is usually available only in scattered research laboratories, must be considered in addition to volume and salt substitution.

Store at 30° or below, protect from light. Keep out of the reach of children. Do not use later than the date of expiry. To be dispensed only on the prescription of a registered physician.

It is indicated for the symptomatic relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. It is also indicated for the treatment of keratoconjunctivitis sicca.

Drugs for Dry eyes

This eye drop is an almost colorless, clear aqueous lubricant sterile ocular solution administered to the eye(s). After topical application of this eye drop, it spreads rapidly over the conjunctiva and cornea forming a lubricating and protective film. Polyethylene Glycol 400 increases the stability of tear film and due to greater muco-adhesive properties hypromellose helps the tear film to attach with the ocular surface. Glycerin restores moisture to the dry eye. Electrolytes which are similar to the natural tears maintain good corneal epithelial surface.

1 to 2 drops in the affected eye(s) up to 4 times daily.

Occasionally mild, transient burning or sticky sensation and very rarely irritation or hypersensitivity reactions reported. Blurred vision after application may occur.

This eye drops is contraindicated in patients with known hypersensitivity to any ingredient of the product.

Remove contact lenses before using this drug. Do not use if this solution changes color or becomes cloudy. Don't touch tip of container to any surface to avoid contamination and replace cap after each use.

If several medicines are to be administered to the eye, there should be an interval of at least 5 minutes between each application.

There is no experience regarding the safety of this eye drops in human pregnancy or lactation. If pregnant or breast feeding, ask a doctor before use.

Store at room temperature. It is desirable that the contents should not be used more than 4 weeks after first opening of the bottle.

Treatment and relief of symptoms associated with irritable bowel syndrome (spastic colon). Postoperative paralytic ileus in order to accelerate the resumption of the intestinal transit following abdominal surgery.

Anticholinergics

Trimebutine maleate is a noncompetitive spasmolytic agent. It possesses moderate opiate receptor affinity and has marked anti-serotonin activity especially on 'mu' receptors. It induces regulation of spontaneous activity and increases synchronization between electrophysiological spikes and contractions in isolated guinea pig strips of colon and ileum. However, it does not alter normal motility, but regulates abnormal intestinal activity.

For adults: 100 mg to 200 mg, 3 times per day before meals.

Trimebutine maleate is generally well tolerated. The infrequently reported adverse effects are as follows: dry mouth, foul taste, diarrhea, dyspepsia, epigastric pain, nausea, constipation, drowsiness, fatigue, dizziness, hot/cold sensations, headache etc.

Patients with known hypersensitivity to trimebutine maleate or any excipient.

Elderly, pregnancy and lactation

Trimebutine maleate increases the duration of d-tubocurarine-induced curarization. No other druginteractions have been observed during clinical trial or otherwise reported.

Although teratological studies have not shown any drug related adverse effects on the course and outcome of pregnancy, the use of trimebutine maleate in pregnant women is not recommended.

It is not known if trimebutine maleate passes into breast milk. This medication should be used while breast feeding only if the potential benefits outweigh risks to the nursing infants.

No evidence of overdosage have been reported to date. However, if overdosage should occur following oral administration, gastric lavage is recommended. Treatment should be made according to the symptoms observed.

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

Anti-oxidant Multivitamin preparations

Beta carotene of this tablet is converted to vitamin A (Retinol) when required. Retinol has several biochemical functions e.g. on retina, growth, tissue differentiation, immunological response. It has also some anti-cancer activity.

Vitamin C is the most powerful reducing agent known to be present in living tissues. Vitamin C deficiency produces scurvy. It is a cofactor in numerous biological processes. Vitamin C and molecular oxygen are essential for the conversion of proline to hydroxyproline, dopamine to noradrenaline . Vitamin C is also essential for the synthesis of adrenal steroid hormones. Vitamin C is important in the defense against infection and studies shown that vitamin C is important for the normal functioning of T-lymphocyte and leukocyte. Ascorbic acid has some antiinflammatory activity and protects cells against oxidation of essential molecules. In high doses, (1-2 g daily) ascorbic acid increases iron absorption.

vitamin E seems to be as a defense against oxidative stress and lipid peroxidation. In most cell membranes there is one molecule of tocopherol for every 1000 lipid molecules. Tocopherol mops up peroxide radicals and then needs a supply of reduced hydrogen to restore the steady-state situation. This is usually supplied by ascorbic acid or reduced glutathione.

This tablet is administered orally. The adult dose of this combination of antioxidant vitamin tablet is 1 tablet daily or as prescribed by the physician.

β carotene is comparatively safe even at high and prolonged exposure. Individuals who routinely ingest large amounts of carotenoids can develop hypercarotenosis, which is characterised by a yellowish colouration of the skin and a very high concentration of carotenoids in the plasma. This benign condition, although resembling jaundice, gradually disappears upon correcting the excessive intake of carotenoids.

Vitamin C is generally a safe drug for human use in normal doses. Larger doses may lead to gastrointestinal tract upset and renal stone formation.

Vitamin E is considered safe even in large doses. Doses over 800 mg may cause diarrhoea, abdominal pain or cramps, fatigue and reduced resistance to bacterial infection and transiently raised blood pressure.

Carocet is contraindicated in patients with hypersensitivity to any of its components.

There are some evidences that β carotene may cause harm to heavy smokers and alcoholics. Therefore, caution should be exercised in these cases. Vitamin C should be given with caution to patients with hyperoxaluria. Vitamin E should be used with caution in patients taking anticoagulant drugs, because vitamin E may enhance the anticoagulant activity of these drugs.

Cholestyramine, Colestipol, Neomycin cause decreased absorption of β carotene. Circulating vitamin C levels have been shown to be reduced during prolonged administration of oral contraceptives containing Oestrogen, Tetracycline and Aspirin. The decrease in vitamin C level may be due to drug induced impaired absorption or increased utilization of the vitamin for drug metabolism. Vitamin E may enhance the anticoagulant activity of anticoagulant drugs. High doses of vitamin E can impair intestinal absorption of vitamins A and K.

β carotene, vitamin C and vitamin E have no teratogenic effects in humans. However, like any other drugs caution should be taken in prescribing to pregnant women.

Should be stored in a dry place below 30˚C.

Other Antifungal preparations

Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.

Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal

• At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
• Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.

Injection-
Invasive Aspergillosisd :

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

Candidemia in nonneutropenic patients and other deep tissue Candida infections:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 3-4 mg/kg 12 hourly.

Scedosporiosis and Fusariosis:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.

Known hypersensitivity to Voriconazole or any other components of this drug-

• Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
• Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy

Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.

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

The efficacy to the children under 12 years of age is not established.

There is no data found about overdose of Voriconazole.

Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.

Other Antifungal preparations

Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.

Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal

• At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
• Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.

Injection-
Invasive Aspergillosisd :

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

Candidemia in nonneutropenic patients and other deep tissue Candida infections:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 3-4 mg/kg 12 hourly.

Scedosporiosis and Fusariosis:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.

Known hypersensitivity to Voriconazole or any other components of this drug-

• Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
• Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy

Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.

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

The efficacy to the children under 12 years of age is not established.

There is no data found about overdose of Voriconazole.

Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.

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.