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Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.

Non-sedating antihistamines

Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.

Seasonal Allergic Rhinitis-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 2 to 11 years

• Suspension: 30 mg or 5 ml twice daily
• In case of impaired renal function: 30 mg or 5 ml once daily

Chronic Idiopathic Urticaria-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily 
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 6 months to less than 2 years:

• Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
• In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily

Children from 2 to 11 years:

• Suspension: 30 mg or 5 ml (1 tsp) twice daily
• In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily

Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.

Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.

Caution should be exercised in elderly patient and patient with decreased renal function.

Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.

US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.

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

Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.

Non-sedating antihistamines

Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.

Seasonal Allergic Rhinitis-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 2 to 11 years

• Suspension: 30 mg or 5 ml twice daily
• In case of impaired renal function: 30 mg or 5 ml once daily

Chronic Idiopathic Urticaria-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily 
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 6 months to less than 2 years:

• Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
• In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily

Children from 2 to 11 years:

• Suspension: 30 mg or 5 ml (1 tsp) twice daily
• In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily

Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.

Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.

Caution should be exercised in elderly patient and patient with decreased renal function.

Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.

US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.

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

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs

Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.

Tablet: Adult:

• Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
• Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
• Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
• Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
• Typhoid fever: 500 mg twice daily (7 days)
• Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
• Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
• Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
• Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
• Gonorrhea: 500 mg as a single dose
• Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
• Meningitis: 500 mg as a single dose.
• Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.

Suspension: Pediatric: 10-20 mg/kg (max. 750 mg) twice daily (10 to 21 days). The duration of therapy depends on the type and severity of the infection.

Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.

For IV infusion:

• Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
• Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
• Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
• Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
• Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
• Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.

Instruction for the use of Ciprofloxacin IV infusion-

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

Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. For acute infections the usual treatment period is 5 to 10 days. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have been disappeared.

Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.

It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.

Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.

Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.

Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.

Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.

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

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs

Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.

Tablet: Adult:

• Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
• Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
• Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
• Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
• Typhoid fever: 500 mg twice daily (7 days)
• Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
• Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
• Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
• Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
• Gonorrhea: 500 mg as a single dose
• Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
• Meningitis: 500 mg as a single dose.
• Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.

Suspension: Pediatric: 10-20 mg/kg (max. 750 mg) twice daily (10 to 21 days). The duration of therapy depends on the type and severity of the infection.

Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.

For IV infusion:

• Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
• Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
• Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
• Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
• Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
• Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.

Instruction for the use of Ciprofloxacin IV infusion-

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

Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. For acute infections the usual treatment period is 5 to 10 days. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have been disappeared.

Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.

It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.

Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.

Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.

Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.

Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.

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

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs

Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.

Tablet: Adult:

• Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
• Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
• Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
• Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
• Typhoid fever: 500 mg twice daily (7 days)
• Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
• Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
• Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
• Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
• Gonorrhea: 500 mg as a single dose
• Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
• Meningitis: 500 mg as a single dose.
• Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.

Suspension: Pediatric: 10-20 mg/kg (max. 750 mg) twice daily (10 to 21 days). The duration of therapy depends on the type and severity of the infection.

Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.

For IV infusion:

• Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
• Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
• Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
• Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
• Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
• Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.

Instruction for the use of Ciprofloxacin IV infusion-

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

Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. For acute infections the usual treatment period is 5 to 10 days. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have been disappeared.

Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.

It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.

Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.

Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.

Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.

Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.

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

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs

Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.

Tablet: Adult:

• Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
• Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
• Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
• Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
• Typhoid fever: 500 mg twice daily (7 days)
• Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
• Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
• Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
• Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
• Gonorrhea: 500 mg as a single dose
• Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
• Meningitis: 500 mg as a single dose.
• Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.

Suspension: Pediatric: 10-20 mg/kg (max. 750 mg) twice daily (10 to 21 days). The duration of therapy depends on the type and severity of the infection.

Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.

For IV infusion:

• Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
• Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
• Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
• Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
• Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
• Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.

Instruction for the use of Ciprofloxacin IV infusion-

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

Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. For acute infections the usual treatment period is 5 to 10 days. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have been disappeared.

Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.

It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.

Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.

Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.

Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.

Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.

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

Montelukast Sodium is indicated for:

• Prophylaxis and chronic treatment of asthma
• Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
• Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Leukotriene receptor antagonists

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT₁). The cysteinyl leukotrienes (LTC₄, LTD₄, LTE₄) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.

Adults & adolescents (15 years & older)-

• Asthma & Allergic Rhinitis: 10 mg/day 
• Exercise-Induced Bronchoconstriction: 10 mg/day

Pediatric patients (6 to 14 years)-

• Asthma & Allergic Rhinitis: 5 mg/day 
• Exercise-Induced Bronchoconstriction: 5 mg/day

Pediatric patients (6 months to 5 years)-

• Asthma & Allergic Rhinitis: 4 mg/day 
• Exercise-Induced Bronchoconstriction: Not recommended

Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. For prevention of Acute prevention of Exercise-Induced Bronchoconstriction, a single dose should be taken at least 2 hours before exercise.

Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.

Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.

Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.

Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.

Montelukast is contraindicated in patients who are hypersensitive to any component of this product.

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.

With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.

With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.

There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.

There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

Montelukast Sodium is indicated for:

• Prophylaxis and chronic treatment of asthma
• Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
• Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Leukotriene receptor antagonists

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT₁). The cysteinyl leukotrienes (LTC₄, LTD₄, LTE₄) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.

Adults & adolescents (15 years & older)-

• Asthma & Allergic Rhinitis: 10 mg/day 
• Exercise-Induced Bronchoconstriction: 10 mg/day

Pediatric patients (6 to 14 years)-

• Asthma & Allergic Rhinitis: 5 mg/day 
• Exercise-Induced Bronchoconstriction: 5 mg/day

Pediatric patients (6 months to 5 years)-

• Asthma & Allergic Rhinitis: 4 mg/day 
• Exercise-Induced Bronchoconstriction: Not recommended

Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. For prevention of Acute prevention of Exercise-Induced Bronchoconstriction, a single dose should be taken at least 2 hours before exercise.

Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.

Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.

Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.

Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.

Montelukast is contraindicated in patients who are hypersensitive to any component of this product.

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.

With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.

With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.

There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.

There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

Aminoglycosides

Amikacin Sulfate is a semi-synthetic aminoglycoside antibiotic. Amikacin is active in vitro against pseudomonas species, Escherichia coli, Proteus species, Providencia species, Klebsiella-Enterobacter species, Acinetobacter species, and Citrobacter freundii. When strains of the above organisms are found to be resistant to other aminoglycosides, including Gentamicin, TobrAmykin and KanAmykin, many are susceptible to Amikacin. Amikacin sulfate is active in vitro against penicillinase and nonpenicillinase-producing Staphylococcus species including methicillin-resistant strains.

Adults and children: 15 mg/kg/day in two equally-divided doses (equivalent to 500 mg bid in adults). Use of the 100 mg is recommended for children for the accurate measurement of the appropriate dose.

Neonates and premature children: An initial loading dose of 10 mg/kg followed by 15 mg/kg/day in two equally divided doses.

Elderly: Amikacin is excreted by the renal route. Renal function should be assessed whenever possible and dosage adjusted as described under impaired renal function.

Life-threatening infections and/or those caused by Pseudomonas: The adult dose may be increased to 500 mg every eight hours but should neither exceed 1.5g/day nor be administered for a period longer than 10 days. A maximum total adult dose of 15g should not be exceeded.

Urinary tract infections (other than pseudomonal infections): 7.5mg/kg/day in two equally divided doses (equivalent to 250 mg b.i.d. in adults).

Impaired renal function: In patients with impaired renal function, the daily dose should be reduced and/or the intervals between doses increased to avoid accumulation of the drug.

Intramuscular or intravenous administration: For most infections the intramuscular route is preferred, but in life threatening infections, or in patients in whom intramuscular injection route is not feasible the intravenous route may be used.

Intraperitoneal use: Amikacin may be used as an irrigant after recovery from anesthesia in concentration of 0.25%.

The adverse effects have been reported with the use of Amikacin are tinnitus, vertigo, partial reversible or irreversible deafness, skin rash, drug fever, headache, paraesthesia, nausea and vomiting.

Amikacin Injection is contraindicated in patients with a known history of hypersensitivity to Amikacin, any constituents of the injection.

Since Amikacin is present in high concentrations in the renal excretory system, patients should be well hydrated to minimize chemical irritation of the renal tubules. If azotemia increases, treatment should be stopped. Monitoring of renal function during treatment with aminoglycosides is particularly important.

Concurrent administration of Amikacin with myorelaxants leads to potentiation of their effects and there is a possibility of cessation of the breathing. The combination with other Aminoglycoside antibiotics should be avoided because of the augmentation of their ototoxic and nephrotoxic effects. Concurrent administration of Amikacin with fast acting diuretics increases the risk of ototoxicity in patients with renal failure. Combination with Cephalosporins or Polymixins increases the risk of nephrotoxicity.

Amikacin rapidly crosses the placenta into the foetal circulation and amniotic fluid and there is a potential risk of ototoxicity in the foetus. There is no information available regarding the safety of this drug during breastfeeding.

Pediatric Use: Safety and effectiveness of Amikacin for injection in children or adolescents under 16 years have not been established

In the event of overdose or toxic reaction, peritoneal dialysis or haemodialysis will aid in the removal of Amikacin from the blood.

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

Amino acid is indicated as a source of amino acids for protein synthesis in patients needing intravenous nutrition. Amino acid is particularly suitable for patients with basal amino acid requirements. Amino acid is also indicated in faster recovery in surgery, burns, renal insufficiency, hepatic insufficiency and effective management of cancer.

Parenteral nutritional preparations

This IV solution is a sterile aqueous solution of crystalline Amino Acid and D-Sorbitol with electrolytes, which are necessary as the nitrogen source for parenteral nutrition. Nitrogen provided in the form of essential and non-essential amino acids. This IV solution contains all 18 essential and non-essential amino acids needed for protein synthesis. The amino acid composition is such that positive nitrogen balance can be achieved in the postoperative period and during extended periods of intravenous nutrition. The solution is clear, colorless to pale yellow colored, having a p H lying in the range of 5.0 to 7.0.

The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress).

• No or minor metabolic stress and normal nutritional state: 0.10-0.15 g nitrogen/kg/day, 
• Moderate metabolic stress with or without malnutrition: 0.15-0.20 g nitrogen/kg/day, 
• Severe catabolism as in burns, sepsis and trauma: up to 0.20-0.25 g nitrogen/kg/day. 

The dosage range 0.10-0.25 g nitrogen/kg/day corresponds to 15-35 ml Amino acids IV/kg/day. 

In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml Amino acids IV may be infused intravenously per 24 hours. Amino acids IV should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.

In children and infants: The rate of infusion is 28-35 ml/kg body weight per day is recommended, with a step-wise increase in the rate of administration during the frst week.

This preparation is usually well tolerated. Nausea occurs rarely. Vomiting, flushing and sweating have been observed during infusion of Amino acid at rates exceeding the recommended maximal rate. Transient increases liver test during intravenous nutrition have been reported. The reasons are at present unclear. Hypersensitivity reactions have been reported. As with all hypertonic infusion solutions, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of 10% fat emulsion. If given to severely ill, premature infants, hyperphenylalaninemia may occur.

This is contraindicated in patients with inborn errors of amino acids metabolism, severe liver dysfunction and in severe uremia when dialysis facilities are not available. Due to the content of glucose, Amino Acids IV infusion and 10% Glucose with Electrolytes is contraindicated in patients with hyperosmolar nonketotic diabetic coma.

IV infusion of amino acids is accompanied by increased urinary excretion of the trace elements copper and in particular zinc, which should be taken into account in the dosing of trace elements, particularly during long-term IV nutrition. Hyperphenylalaninemia may occur in severely ill, premature infants. In these patients, monitoring of the phenylalanine level is recommended and the infusion rate adjusted as needed. Amino Acids IV infusion and 10% Glucose with Electrolytes should be used with caution in patients with diabetes mellitus, severe heart failure or with renal function in combination with fluid restrictions or oliguria/anuria of another origin. In patients with hyperglycemia, administration of exogenous insulin might be necessary. In severely malnourished patients refeeding carbohydrates can trigger thiamine (vitamin B1 ) deficiency syndrome. Those at high risk are patients with a history of alcohol abuse, anorexia nervosa, prolonged fasting or starvation and pregnant women with hyperemesis gravidarum. In this kind of patients, parenteral nutrition containing glucose should be given with caution and parenteral administration of thiamine should be considered before and during the administration of glucose. Monitoring of serum potassium and blood glucose is recommended if Amino Acids IV infusion and 10% Glucose with electrolytes is infused rapidly or in a large quantity. For patients with hypophosphatemia, an additional supply of phosphate is recommended.

At the recommended dosage the amino acid have no pharmacological effects and is not expected to interact with other medicaments.

Successful and safe administration of amino acid solutions during pregnancy in the human has been reported. Animal reproduction studies have not been carried out with Amino acid.

If Amino Acids IV infusion and 10% Glucose with Electrolytes is administered at a higher rate than recommended, there is an augmented risk for nausea, vomiting and sweating. When peripheral veins are used thrombophlebitis may occur. Osmotic diuresis with dehydration may occur if the dosage recommendations are exceeded. There is also a risk of symptoms related to hyperglycemia with Amino Acids IV infusion and 10% Glucose with Electrolytes. In case of symptoms due to overdose, the infusion should be slowed down or discontinued.

Protect from light and store between 15°C to 25°C temperature. Avoid freezing. Keep out of reach of children.

Flupentixol and Melitracen tablet is indicated in-

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

Combined anxiolytics & anti-depressant drugs

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

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

Elderly patients: 1 tablet in the morning.

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

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

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

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

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

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

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

Amitriptyline Hydrochloride is indicated in-

• Depressive Illness: particularly where sedation is required.
• Nocturnal Enuresis in children.
• Prophylaxis of Migraine.
• Tension Headache.
• Chronic Pain.

Tricyclic Anti-depressant

The mechanism of action of this drug is not fully elucidated. It is suggested that amitriptyline inhibits the membrane pump mechanism responsible for the re-uptake of transmitter amines, such as norepinephrine and serotonin, thereby increasing their concentration at the synaptic clefts of the brain. These amines are important in regulating mood. The monoamine hypothesis in depression, one of the oldest hypotheses, postulates that deficiencies of serotonin (5-HT) and/or norepinephrine (NE) neurotransmission in the brain lead to depressive effects. This drug counteracts these mechanisms, and this may be the mechanism of amitriptyline in improving depressive symptoms. Whether its analgesic effects are related to its mood-altering activities or attributable to a different, less obvious pharmacological action (or a combination of both) is unknown.

Depression: Initially 75 mg (Elderly and Adolescents 30-75 mg) daily in divided doses or as a single dose at bedtime increased gradually as necessary to 150-200 mg; Child under 16 years not recommended for depression.

Nocturnal Enuresis: Child 7-10 years: 10-20 mg, 11-16 years: 25-50 mg at night; max. period of treatment (including gradual withdrawal) 3 months-full physical examination before the further course.

Prophylaxis of Migraine: 100 mg daily.

Tension Headache: 10-25 mg three times daily.

Amitriptyline is contraindicated in myocardial infarction, arrythmias, particularly heart block of any degree, mania and severe liver disease. Initially, sedation may affect the ability to drive or operate machinery.

It should be used with caution in patients with a history of epilepsy, glaucoma, urinary retention, cardiac disease, diabetes, pregnancy, hepatic impairment, thyroid disease, increased intra-ocular pressure and psychoses (may aggravate mania).

TCA enhances the sedative effect of alcohol and opioid analgesics. When TCA is used with Moxifloxacin or Terfenadine, it increases the risk of ventricular arrhythmias. Disulfirum and Cimetidine inhibit the metabolism of Amitriptyline. When TCA is used with diuretics, it enhances the risk of postural hypotension.

Pregnancy Category C. Amitriptyline has been shown to cross the placenta. Amitriptyline should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Amitriptyline is excreted into breast milk. Because of the potential for serious adverse reactions in nursing infants from Amitriptyline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Store in a cool and dry place, below 30°C. Protect from light and moisture.

Amitriptyline Hydrochloride is indicated in-

• Depressive Illness: particularly where sedation is required.
• Nocturnal Enuresis in children.
• Prophylaxis of Migraine.
• Tension Headache.
• Chronic Pain.

Tricyclic Anti-depressant

The mechanism of action of this drug is not fully elucidated. It is suggested that amitriptyline inhibits the membrane pump mechanism responsible for the re-uptake of transmitter amines, such as norepinephrine and serotonin, thereby increasing their concentration at the synaptic clefts of the brain. These amines are important in regulating mood. The monoamine hypothesis in depression, one of the oldest hypotheses, postulates that deficiencies of serotonin (5-HT) and/or norepinephrine (NE) neurotransmission in the brain lead to depressive effects. This drug counteracts these mechanisms, and this may be the mechanism of amitriptyline in improving depressive symptoms. Whether its analgesic effects are related to its mood-altering activities or attributable to a different, less obvious pharmacological action (or a combination of both) is unknown.

Depression: Initially 75 mg (Elderly and Adolescents 30-75 mg) daily in divided doses or as a single dose at bedtime increased gradually as necessary to 150-200 mg; Child under 16 years not recommended for depression.

Nocturnal Enuresis: Child 7-10 years: 10-20 mg, 11-16 years: 25-50 mg at night; max. period of treatment (including gradual withdrawal) 3 months-full physical examination before the further course.

Prophylaxis of Migraine: 100 mg daily.

Tension Headache: 10-25 mg three times daily.

Amitriptyline is contraindicated in myocardial infarction, arrythmias, particularly heart block of any degree, mania and severe liver disease. Initially, sedation may affect the ability to drive or operate machinery.

It should be used with caution in patients with a history of epilepsy, glaucoma, urinary retention, cardiac disease, diabetes, pregnancy, hepatic impairment, thyroid disease, increased intra-ocular pressure and psychoses (may aggravate mania).

TCA enhances the sedative effect of alcohol and opioid analgesics. When TCA is used with Moxifloxacin or Terfenadine, it increases the risk of ventricular arrhythmias. Disulfirum and Cimetidine inhibit the metabolism of Amitriptyline. When TCA is used with diuretics, it enhances the risk of postural hypotension.

Pregnancy Category C. Amitriptyline has been shown to cross the placenta. Amitriptyline should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Amitriptyline is excreted into breast milk. Because of the potential for serious adverse reactions in nursing infants from Amitriptyline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Store in a cool and dry place, below 30°C. Protect from light and moisture.

This is indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. Symptoms likely to respond in the first week of treatment include insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.

Combined anxiolytics & anti-depressant drugs

Amitriptyline is a tricyclic antidepressant and Chlordiazepoxide is an anxiolytic. Amitriptyline inhibits the reuptake of norepinephrine and serotonin in the brain. This interference with the reuptake is responsible for the antidepressant activity of Amitriptyline. Chlordiazepoxide works by enhancing GABA-mediated chloride influx through GABA receptor channels, causing membrane hyperpolarization. The net neuro-inhibitory effects result in the observed sedative and anxiolytic effect.

Optimum dosage varies with the severity of the symptoms and the response of the individual patient. When a satisfactory response is obtained, the dosage should be reduced to the smallest amount needed to maintain the remission. The larger portion of the total daily dose may be taken at bedtime. In some patients, a single dose at bedtime may be sufficient. This tablet in an initial dosage of 3 or 4 tablets daily in divided doses is satisfactory. Or directed by the physican.

Side effects: Many symptoms common to the depressive state, such as anorexia, fatigue, weakness, restlessness and lethargy, have been reported as side effects of treatment with this preparation.

Adverse reactions: Most frequently reported were drowsiness, dry mouth, constipation, blurred vision, dizziness and bloating. Less commonly included vivid dreams, impotence, tremor, confusion and nasal congestion.

This is contraindicated in patients with hypersensitivity to either benzodiazepines or tricyclic antidepressants. It should not be given concomitantly with a monoamine oxidase inhibitor.

Use with caution in patients with a history of seizures. Close supervision is required when this preparation is given to hyperthyroid patients or those on thyroid medication. The usual precautions should be observed when treating patients with impaired renal or hepatic function. All pediatric patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality and unusual changes in behavior.

Because of its Amitriptyline component, this preparation may block the antihypertensive action of guanethidine or compounds with a similar mechanism of action.

Safe use of this preparation during pregnancy and lactation has not been established.

Pediatric Use: Safety and effectiveness in the pediatric population have not been established. Anyone considering the use of Chlordiazepoxide and Amitriptyline Hydrochloride Tablets in a child or adolescent must balance the potential risks with the clinical need.

Geriatric Use: In elderly and debilitated patients it is recommended that dosage be limited to the smallest effective amount to preclude the development of ataxia, over sedation, confusion or anticholinergic effects.

Deaths may occur from overdosage with this class of drugs. Critical manifestations of Amitriptyline overdose include cardiac dysrhythmias, severe hypotension, convulsions and CNS depression, including coma. Manifestations of benzodiazepine overdosage include somnolence, confusion, coma and diminished reflexes.

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of Chlordiazepoxide. Generally, milder withdrawal symptoms (eg, dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Withdrawal symptoms (e.g., nausea, headache and malaise) have also been reported in association with abrupt Amitriptyline discontinuation.

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

Aminoglycosides

Amikacin Sulfate is a semi-synthetic aminoglycoside antibiotic. Amikacin is active in vitro against pseudomonas species, Escherichia coli, Proteus species, Providencia species, Klebsiella-Enterobacter species, Acinetobacter species, and Citrobacter freundii. When strains of the above organisms are found to be resistant to other aminoglycosides, including Gentamicin, TobrAmykin and KanAmykin, many are susceptible to Amikacin. Amikacin sulfate is active in vitro against penicillinase and nonpenicillinase-producing Staphylococcus species including methicillin-resistant strains.

Adults and children: 15 mg/kg/day in two equally-divided doses (equivalent to 500 mg bid in adults). Use of the 100 mg is recommended for children for the accurate measurement of the appropriate dose.

Neonates and premature children: An initial loading dose of 10 mg/kg followed by 15 mg/kg/day in two equally divided doses.

Elderly: Amikacin is excreted by the renal route. Renal function should be assessed whenever possible and dosage adjusted as described under impaired renal function.

Life-threatening infections and/or those caused by Pseudomonas: The adult dose may be increased to 500 mg every eight hours but should neither exceed 1.5g/day nor be administered for a period longer than 10 days. A maximum total adult dose of 15g should not be exceeded.

Urinary tract infections (other than pseudomonal infections): 7.5mg/kg/day in two equally divided doses (equivalent to 250 mg b.i.d. in adults).

Impaired renal function: In patients with impaired renal function, the daily dose should be reduced and/or the intervals between doses increased to avoid accumulation of the drug.

Intramuscular or intravenous administration: For most infections the intramuscular route is preferred, but in life threatening infections, or in patients in whom intramuscular injection route is not feasible the intravenous route may be used.

Intraperitoneal use: Amikacin may be used as an irrigant after recovery from anesthesia in concentration of 0.25%.

The adverse effects have been reported with the use of Amikacin are tinnitus, vertigo, partial reversible or irreversible deafness, skin rash, drug fever, headache, paraesthesia, nausea and vomiting.

Amikacin Injection is contraindicated in patients with a known history of hypersensitivity to Amikacin, any constituents of the injection.

Since Amikacin is present in high concentrations in the renal excretory system, patients should be well hydrated to minimize chemical irritation of the renal tubules. If azotemia increases, treatment should be stopped. Monitoring of renal function during treatment with aminoglycosides is particularly important.

Concurrent administration of Amikacin with myorelaxants leads to potentiation of their effects and there is a possibility of cessation of the breathing. The combination with other Aminoglycoside antibiotics should be avoided because of the augmentation of their ototoxic and nephrotoxic effects. Concurrent administration of Amikacin with fast acting diuretics increases the risk of ototoxicity in patients with renal failure. Combination with Cephalosporins or Polymixins increases the risk of nephrotoxicity.

Amikacin rapidly crosses the placenta into the foetal circulation and amniotic fluid and there is a potential risk of ototoxicity in the foetus. There is no information available regarding the safety of this drug during breastfeeding.

Pediatric Use: Safety and effectiveness of Amikacin for injection in children or adolescents under 16 years have not been established

In the event of overdose or toxic reaction, peritoneal dialysis or haemodialysis will aid in the removal of Amikacin from the blood.

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

Aminoglycosides

Amikacin Sulfate is a semi-synthetic aminoglycoside antibiotic. Amikacin is active in vitro against pseudomonas species, Escherichia coli, Proteus species, Providencia species, Klebsiella-Enterobacter species, Acinetobacter species, and Citrobacter freundii. When strains of the above organisms are found to be resistant to other aminoglycosides, including Gentamicin, TobrAmykin and KanAmykin, many are susceptible to Amikacin. Amikacin sulfate is active in vitro against penicillinase and nonpenicillinase-producing Staphylococcus species including methicillin-resistant strains.

Adults and children: 15 mg/kg/day in two equally-divided doses (equivalent to 500 mg bid in adults). Use of the 100 mg is recommended for children for the accurate measurement of the appropriate dose.

Neonates and premature children: An initial loading dose of 10 mg/kg followed by 15 mg/kg/day in two equally divided doses.

Elderly: Amikacin is excreted by the renal route. Renal function should be assessed whenever possible and dosage adjusted as described under impaired renal function.

Life-threatening infections and/or those caused by Pseudomonas: The adult dose may be increased to 500 mg every eight hours but should neither exceed 1.5g/day nor be administered for a period longer than 10 days. A maximum total adult dose of 15g should not be exceeded.

Urinary tract infections (other than pseudomonal infections): 7.5mg/kg/day in two equally divided doses (equivalent to 250 mg b.i.d. in adults).

Impaired renal function: In patients with impaired renal function, the daily dose should be reduced and/or the intervals between doses increased to avoid accumulation of the drug.

Intramuscular or intravenous administration: For most infections the intramuscular route is preferred, but in life threatening infections, or in patients in whom intramuscular injection route is not feasible the intravenous route may be used.

Intraperitoneal use: Amikacin may be used as an irrigant after recovery from anesthesia in concentration of 0.25%.

The adverse effects have been reported with the use of Amikacin are tinnitus, vertigo, partial reversible or irreversible deafness, skin rash, drug fever, headache, paraesthesia, nausea and vomiting.

Amikacin Injection is contraindicated in patients with a known history of hypersensitivity to Amikacin, any constituents of the injection.

Since Amikacin is present in high concentrations in the renal excretory system, patients should be well hydrated to minimize chemical irritation of the renal tubules. If azotemia increases, treatment should be stopped. Monitoring of renal function during treatment with aminoglycosides is particularly important.

Concurrent administration of Amikacin with myorelaxants leads to potentiation of their effects and there is a possibility of cessation of the breathing. The combination with other Aminoglycoside antibiotics should be avoided because of the augmentation of their ototoxic and nephrotoxic effects. Concurrent administration of Amikacin with fast acting diuretics increases the risk of ototoxicity in patients with renal failure. Combination with Cephalosporins or Polymixins increases the risk of nephrotoxicity.

Amikacin rapidly crosses the placenta into the foetal circulation and amniotic fluid and there is a potential risk of ototoxicity in the foetus. There is no information available regarding the safety of this drug during breastfeeding.

Pediatric Use: Safety and effectiveness of Amikacin for injection in children or adolescents under 16 years have not been established

In the event of overdose or toxic reaction, peritoneal dialysis or haemodialysis will aid in the removal of Amikacin from the blood.

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

Amino acid is indicated as a source of amino acids for protein synthesis in patients needing intravenous nutrition. Amino acid is particularly suitable for patients with basal amino acid requirements. Amino acid is also indicated in faster recovery in surgery, burns, renal insufficiency, hepatic insufficiency and effective management of cancer.

Parenteral nutritional preparations

This IV solution is a sterile aqueous solution of crystalline Amino Acid and D-Sorbitol with electrolytes, which are necessary as the nitrogen source for parenteral nutrition. Nitrogen provided in the form of essential and non-essential amino acids. This IV solution contains all 18 essential and non-essential amino acids needed for protein synthesis. The amino acid composition is such that positive nitrogen balance can be achieved in the postoperative period and during extended periods of intravenous nutrition. The solution is clear, colorless to pale yellow colored, having a p H lying in the range of 5.0 to 7.0.

The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress).

• No or minor metabolic stress and normal nutritional state: 0.10-0.15 g nitrogen/kg/day, 
• Moderate metabolic stress with or without malnutrition: 0.15-0.20 g nitrogen/kg/day, 
• Severe catabolism as in burns, sepsis and trauma: up to 0.20-0.25 g nitrogen/kg/day. 

The dosage range 0.10-0.25 g nitrogen/kg/day corresponds to 15-35 ml Amino acids IV/kg/day. 

In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml Amino acids IV may be infused intravenously per 24 hours. Amino acids IV should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.

In children and infants: The rate of infusion is 28-35 ml/kg body weight per day is recommended, with a step-wise increase in the rate of administration during the frst week.

This preparation is usually well tolerated. Nausea occurs rarely. Vomiting, flushing and sweating have been observed during infusion of Amino acid at rates exceeding the recommended maximal rate. Transient increases liver test during intravenous nutrition have been reported. The reasons are at present unclear. Hypersensitivity reactions have been reported. As with all hypertonic infusion solutions, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of 10% fat emulsion. If given to severely ill, premature infants, hyperphenylalaninemia may occur.

This is contraindicated in patients with inborn errors of amino acids metabolism, severe liver dysfunction and in severe uremia when dialysis facilities are not available. Due to the content of glucose, Amino Acids IV infusion and 10% Glucose with Electrolytes is contraindicated in patients with hyperosmolar nonketotic diabetic coma.

IV infusion of amino acids is accompanied by increased urinary excretion of the trace elements copper and in particular zinc, which should be taken into account in the dosing of trace elements, particularly during long-term IV nutrition. Hyperphenylalaninemia may occur in severely ill, premature infants. In these patients, monitoring of the phenylalanine level is recommended and the infusion rate adjusted as needed. Amino Acids IV infusion and 10% Glucose with Electrolytes should be used with caution in patients with diabetes mellitus, severe heart failure or with renal function in combination with fluid restrictions or oliguria/anuria of another origin. In patients with hyperglycemia, administration of exogenous insulin might be necessary. In severely malnourished patients refeeding carbohydrates can trigger thiamine (vitamin B1 ) deficiency syndrome. Those at high risk are patients with a history of alcohol abuse, anorexia nervosa, prolonged fasting or starvation and pregnant women with hyperemesis gravidarum. In this kind of patients, parenteral nutrition containing glucose should be given with caution and parenteral administration of thiamine should be considered before and during the administration of glucose. Monitoring of serum potassium and blood glucose is recommended if Amino Acids IV infusion and 10% Glucose with electrolytes is infused rapidly or in a large quantity. For patients with hypophosphatemia, an additional supply of phosphate is recommended.

At the recommended dosage the amino acid have no pharmacological effects and is not expected to interact with other medicaments.

Successful and safe administration of amino acid solutions during pregnancy in the human has been reported. Animal reproduction studies have not been carried out with Amino acid.

If Amino Acids IV infusion and 10% Glucose with Electrolytes is administered at a higher rate than recommended, there is an augmented risk for nausea, vomiting and sweating. When peripheral veins are used thrombophlebitis may occur. Osmotic diuresis with dehydration may occur if the dosage recommendations are exceeded. There is also a risk of symptoms related to hyperglycemia with Amino Acids IV infusion and 10% Glucose with Electrolytes. In case of symptoms due to overdose, the infusion should be slowed down or discontinued.

Protect from light and store between 15°C to 25°C temperature. Avoid freezing. Keep out of reach of children.

This is indicated as a source of amino acids, glucose and electrolytes in adult and pediatric patients needing IV nutrition. This is particularly suitable for patients with basal amino acid requirements.

Parenteral nutritional preparations

A crystalline amino acid solution provides crystalline amino acids to promote protein synthesis and wound healing, and to reduce the rate of endogenous protein catabolism. Amino Acids given by central venous infusion in combination with concentrated dextrose, electrolytes, vitamins, trace metals, and ancillary fat supplements, constitutes total parenteral nutrition (TPN). Amino Acids can also be administered by peripheral vein with dextrose and maintenance electrolytes.

Adults: The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress). The requirements are 0.10-0.15g nitrogen/kg/day (no or minor metabolic stress and normal nutritional state), 0.15-0.20g nitrogen/kg/day (moderate metabolic stress with or without malnutrition) and up to 0.20-0.25g nitrogen/kg/day (severe catabolism as in burns, sepsis and trauma). The dosage range is 0.10-0.25 g nitrogen/kg/day corresponds to 11-27 ml/kg/day. In obese patients, the dose should be based on the estimated ideal weight. Depending upon the patient’s requirements, 1000-2000 ml may be infused intravenously per 24 hours. This should be infused slowly; at a rate not exceeding 500 ml in 3 hours corresponding to approximately at rates 1.4-2.8 ml (30-60 drops) per minute.

Infants and children: In infants & children, a maximal rate of infusion of 30 ml/kg body weight/day is recommended, with a step-wise increase in the rate of administration during the first week of treatment.

This preparation is usually well tolerated. Nausea occurs rarely. Vomiting, flushing and sweating have been observed during infusion of the solution at rates exceeding the recommended maximal rate. Transient increases in liver test during intravenous nutrition have been reported. The reasons are at present unclear. The underlying disease and the components and their amount in the intravenous feeding regimens have been suggested. Hypersensitivity reactions have been reported. As with all hypertonic infusion solution, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of 10% fat emulsion.

This preparation is contraindicated in patients with inborn errors of amino acids metabolism, severe liver damage & severe uremia when dialysis facilities are not available. Due to the content of the glucose, this preparation is contraindicated in patients with hyperosmolar nonketotic diabetic coma. This preparation is also contraindicated in patients with known hypersensitivity to any of its ingredients.

Hyperphenylalaninemia has been noted in severely ill, premature infants. In these patients, monitoring of the phenylalanine level is recommended and the infusion rate to be adjusted as needed. This preparation should be used with caution in patients with diabetes mellitus, severe heart failure or with renal function in combination with fluid restriction or oliguria/anuria of other origin. In patient with hyperglycemia, administration of exogenous insulin might be necessary. Do not use if the solution is turbid or contains particles. Discard any unused portion.

At the recommended dosage this solution has no pharmacological effect and is expected not to interact with other medicaments.

Successful and safe administration of amino acid solution during pregnancy in human has been reported. Animal reproduction studies have not been carried out with 7% amino acid IV infusion with 10% glucose & electrolytes.

Protect from light and store between 15°C to 25°C temperature. Avoid freezing. Keep away from the reach of children.

Amino acid is indicated as a source of amino acids for protein synthesis in patients needing intravenous nutrition. Amino acid is particularly suitable for patients with basal amino acid requirements. Amino acid is also indicated in faster recovery in surgery, burns, renal insufficiency, hepatic insufficiency and effective management of cancer.

Parenteral nutritional preparations

This IV solution is a sterile aqueous solution of crystalline Amino Acid and D-Sorbitol with electrolytes, which are necessary as the nitrogen source for parenteral nutrition. Nitrogen provided in the form of essential and non-essential amino acids. This IV solution contains all 18 essential and non-essential amino acids needed for protein synthesis. The amino acid composition is such that positive nitrogen balance can be achieved in the postoperative period and during extended periods of intravenous nutrition. The solution is clear, colorless to pale yellow colored, having a p H lying in the range of 5.0 to 7.0.

The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress).

• No or minor metabolic stress and normal nutritional state: 0.10-0.15 g nitrogen/kg/day, 
• Moderate metabolic stress with or without malnutrition: 0.15-0.20 g nitrogen/kg/day, 
• Severe catabolism as in burns, sepsis and trauma: up to 0.20-0.25 g nitrogen/kg/day. 

The dosage range 0.10-0.25 g nitrogen/kg/day corresponds to 15-35 ml Amino acids IV/kg/day. 

In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml Amino acids IV may be infused intravenously per 24 hours. Amino acids IV should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.

In children and infants: The rate of infusion is 28-35 ml/kg body weight per day is recommended, with a step-wise increase in the rate of administration during the frst week.

This preparation is usually well tolerated. Nausea occurs rarely. Vomiting, flushing and sweating have been observed during infusion of Amino acid at rates exceeding the recommended maximal rate. Transient increases liver test during intravenous nutrition have been reported. The reasons are at present unclear. Hypersensitivity reactions have been reported. As with all hypertonic infusion solutions, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of 10% fat emulsion. If given to severely ill, premature infants, hyperphenylalaninemia may occur.

This is contraindicated in patients with inborn errors of amino acids metabolism, severe liver dysfunction and in severe uremia when dialysis facilities are not available. Due to the content of glucose, Amino Acids IV infusion and 10% Glucose with Electrolytes is contraindicated in patients with hyperosmolar nonketotic diabetic coma.

IV infusion of amino acids is accompanied by increased urinary excretion of the trace elements copper and in particular zinc, which should be taken into account in the dosing of trace elements, particularly during long-term IV nutrition. Hyperphenylalaninemia may occur in severely ill, premature infants. In these patients, monitoring of the phenylalanine level is recommended and the infusion rate adjusted as needed. Amino Acids IV infusion and 10% Glucose with Electrolytes should be used with caution in patients with diabetes mellitus, severe heart failure or with renal function in combination with fluid restrictions or oliguria/anuria of another origin. In patients with hyperglycemia, administration of exogenous insulin might be necessary. In severely malnourished patients refeeding carbohydrates can trigger thiamine (vitamin B1 ) deficiency syndrome. Those at high risk are patients with a history of alcohol abuse, anorexia nervosa, prolonged fasting or starvation and pregnant women with hyperemesis gravidarum. In this kind of patients, parenteral nutrition containing glucose should be given with caution and parenteral administration of thiamine should be considered before and during the administration of glucose. Monitoring of serum potassium and blood glucose is recommended if Amino Acids IV infusion and 10% Glucose with electrolytes is infused rapidly or in a large quantity. For patients with hypophosphatemia, an additional supply of phosphate is recommended.

At the recommended dosage the amino acid have no pharmacological effects and is not expected to interact with other medicaments.

Successful and safe administration of amino acid solutions during pregnancy in the human has been reported. Animal reproduction studies have not been carried out with Amino acid.

If Amino Acids IV infusion and 10% Glucose with Electrolytes is administered at a higher rate than recommended, there is an augmented risk for nausea, vomiting and sweating. When peripheral veins are used thrombophlebitis may occur. Osmotic diuresis with dehydration may occur if the dosage recommendations are exceeded. There is also a risk of symptoms related to hyperglycemia with Amino Acids IV infusion and 10% Glucose with Electrolytes. In case of symptoms due to overdose, the infusion should be slowed down or discontinued.

Protect from light and store between 15°C to 25°C temperature. Avoid freezing. Keep out of reach of children.

Amino acid is indicated as a source of amino acids for protein synthesis in patients needing intravenous nutrition. Amino acid is particularly suitable for patients with basal amino acid requirements. Amino acid is also indicated in faster recovery in surgery, burns, renal insufficiency, hepatic insufficiency and effective management of cancer.

Parenteral nutritional preparations

This IV solution is a sterile aqueous solution of crystalline Amino Acid and D-Sorbitol with electrolytes, which are necessary as the nitrogen source for parenteral nutrition. Nitrogen provided in the form of essential and non-essential amino acids. This IV solution contains all 18 essential and non-essential amino acids needed for protein synthesis. The amino acid composition is such that positive nitrogen balance can be achieved in the postoperative period and during extended periods of intravenous nutrition. The solution is clear, colorless to pale yellow colored, having a p H lying in the range of 5.0 to 7.0.

The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress).

• No or minor metabolic stress and normal nutritional state: 0.10-0.15 g nitrogen/kg/day, 
• Moderate metabolic stress with or without malnutrition: 0.15-0.20 g nitrogen/kg/day, 
• Severe catabolism as in burns, sepsis and trauma: up to 0.20-0.25 g nitrogen/kg/day. 

The dosage range 0.10-0.25 g nitrogen/kg/day corresponds to 15-35 ml Amino acids IV/kg/day. 

In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml Amino acids IV may be infused intravenously per 24 hours. Amino acids IV should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.

In children and infants: The rate of infusion is 28-35 ml/kg body weight per day is recommended, with a step-wise increase in the rate of administration during the frst week.

This preparation is usually well tolerated. Nausea occurs rarely. Vomiting, flushing and sweating have been observed during infusion of Amino acid at rates exceeding the recommended maximal rate. Transient increases liver test during intravenous nutrition have been reported. The reasons are at present unclear. Hypersensitivity reactions have been reported. As with all hypertonic infusion solutions, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of 10% fat emulsion. If given to severely ill, premature infants, hyperphenylalaninemia may occur.

This is contraindicated in patients with inborn errors of amino acids metabolism, severe liver dysfunction and in severe uremia when dialysis facilities are not available. Due to the content of glucose, Amino Acids IV infusion and 10% Glucose with Electrolytes is contraindicated in patients with hyperosmolar nonketotic diabetic coma.

IV infusion of amino acids is accompanied by increased urinary excretion of the trace elements copper and in particular zinc, which should be taken into account in the dosing of trace elements, particularly during long-term IV nutrition. Hyperphenylalaninemia may occur in severely ill, premature infants. In these patients, monitoring of the phenylalanine level is recommended and the infusion rate adjusted as needed. Amino Acids IV infusion and 10% Glucose with Electrolytes should be used with caution in patients with diabetes mellitus, severe heart failure or with renal function in combination with fluid restrictions or oliguria/anuria of another origin. In patients with hyperglycemia, administration of exogenous insulin might be necessary. In severely malnourished patients refeeding carbohydrates can trigger thiamine (vitamin B1 ) deficiency syndrome. Those at high risk are patients with a history of alcohol abuse, anorexia nervosa, prolonged fasting or starvation and pregnant women with hyperemesis gravidarum. In this kind of patients, parenteral nutrition containing glucose should be given with caution and parenteral administration of thiamine should be considered before and during the administration of glucose. Monitoring of serum potassium and blood glucose is recommended if Amino Acids IV infusion and 10% Glucose with electrolytes is infused rapidly or in a large quantity. For patients with hypophosphatemia, an additional supply of phosphate is recommended.

At the recommended dosage the amino acid have no pharmacological effects and is not expected to interact with other medicaments.

Successful and safe administration of amino acid solutions during pregnancy in the human has been reported. Animal reproduction studies have not been carried out with Amino acid.

If Amino Acids IV infusion and 10% Glucose with Electrolytes is administered at a higher rate than recommended, there is an augmented risk for nausea, vomiting and sweating. When peripheral veins are used thrombophlebitis may occur. Osmotic diuresis with dehydration may occur if the dosage recommendations are exceeded. There is also a risk of symptoms related to hyperglycemia with Amino Acids IV infusion and 10% Glucose with Electrolytes. In case of symptoms due to overdose, the infusion should be slowed down or discontinued.

Protect from light and store between 15°C to 25°C temperature. Avoid freezing. Keep out of reach of children.