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

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

Cholagogues, Cholelitholytics & Hepatic Protectors, Herbal and Nutraceuticals

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

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

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

Contraindicated in patient with a known hypersensitivity to silymarin.

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

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

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

Silver Sulfadiazine cream is indicated in-

• The topical prophylaxis against bacterial colonization and infection in burn wounds.
• The topical antibacterial management of certain contaminated or infection-prone wounds, other than burns.

Topical Antibiotic preparations

The mechanism of Silver Sulfadiazine's antibacterial action has not been fully elucidated. After exposure to the drug, structural changes in the bacterial cell membrane occur, including distortion and enlargement of the cell and a weakening of the cell wall membrane. This is accompanied by reduced viability in sensitive strains. The silver sulfadiazine molecule dissociates and the silver moiety is bound to the bacterial cells. It is believed that, after penetrating the cell wall, the silver moiety is attached to deoxyribonucleic acid (DNA) and prevents bacterial cell proliferation. There is approximately 100 times more DNA in mammalian cells than in bacterial cells. It is thought that the ratio of silver sulfadiazine to bacterial DNA is sufficiently high to prevent bacterial division but the corresponding ratio to epithelial DNA is low enough not to block epithelial cell regeneration. The sulfadiazine moiety also provides a bacteriostatic action against sensitive organisms. In adults, up to 10% of the sulfadiazine may be absorbed and 60 to 85% of the absorbed amount is excreted in the urine. In children with 13% body surface area burns, the urinary sulfadiazine concentration was 31.8 mg/L.

The burn wounds are cleansed, and Silver Sulfadiazine is applied over the burn wound. The burn areas should be covered with Silver Sulfadiazine at all times. The cream should be applied once to twice daily to a thickness of approximately 1/16 inches or 1.5 mm. Whenever necessary; the cream should be reapplied to any areas from which it has been removed by patient activity. If individual patient requirements make dressings necessary, they may be used. Reapplication should be ensured immediately after hydrotherapy. Treatment with Silver Sulfadiazine should be continued until satisfactory healing is occurred, or until the burn site is ready for grafting. The drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.

Several cases of transient leukopenia have been reported in-patients receiving Silver Sulfadiazine therapy. Other infrequently occurring events include skin necrosis, erythema multiform, skin discoloration, burning sensation, rashes, and interstitial nephritis.

It is contraindicated in-patients who are hypersensitive to it or any of the other ingredients in the preparation. It should not be used on pregnant women approaching or at term, on premature infants, or on newborn infants during the first 2 months of life

General: If hepatic and renal functions become impaired and elimination of drug decreases, accumulation may occur and discontinuation of this should be weighed against the therapeutic benefit being achieved. In considering the use of topical proteolytic enzymes in conjunction with it, the possibility should be noted that silver might inactivate such enzymes.

Laboratory Tests: In the treatment of burn wounds involving extensive areas of the body, the serum sulfa concentrations may approach adult therapeutic levels (8 mg% to 12 mg%). Therefore, in these patients it would be advisable to monitor serum sulfa concentrations. Renal function should be carefully monitored and the urine should be checked for sulfa crystals.

Enzymatic debriding agents: Silver sulfadiazine may inactivate enzymatic debriding agents, thus the concomitant use of these compounds may be inappropriate.

Oral hypoglycemic agents and phenytoin: In patients with large area burns where serum sulfadiazine levels may approach therapeutic levels, the action of oral hypoglycemic agents and phenytoin may be potentiated and it is recommended that blood levels be monitored.

Cimetidine: In-patients with large area burns, it has been reported that co-administration of Cimetidine may increase the incidence of leukopenia.

Pregnancy Category B. This drug should be used during pregnancy only if clearly justified, especially in pregnant women approaching or at term. It is not known whether Silver Sulfadiazine is excreted in human milk. 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. Pediatric Use Safety and effectiveness in pediatric patients have not been established.

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

Specific combined vitamin preparations

This preparation contains 8 essential vitamins with Cod Liver Oil. This provides extra protection for the children. It ensures for getting enough vitamins for children that help them to be grown up strong & stay healthy. Cod Liver Oil contains Vitamin A, Vitamin D, EPA & DHA. Vitamin A is essential for the immune system, bone growth, night vision, cellular growth, testicular and ovarian function, Vitamin D is essential for the absorption and utilization of calcium, which is also required for skeletal growth. EPA and DHA; omega-3 fatty acids, which are converted in the body to produce prostaglandins that affect a wide variety of physiological processes due to their modulating effect on the action of hormones. Omega-3 fatty acids relieve the symptoms of osteoarthritis, rheumatoid arthritis which also enhances immune function and promotes healthy blood circulation. It is thought that EPA and DHA may reduce the risk of coronary heart disease. DHA seems essential for normal brain development in unborn babies.

1-12 Months: 2.5 ml (½ teaspoon) daily
1-4 Years: 5 ml (1 teaspoon) daily
4 years up: 7.5 ml (1½ teaspoon) daily
Adult: 10 ml (2 teaspoons) daily.

This syrup can be taken with water or milk.

Generally well tolerated. However, a few allergic reactions may be seen.

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

This medicine may accumulate in the body. So, should not be taken in overdose.

Some drug interaction may occur with- Erythromycin, Conjugated estrogens, Sodium bicarbonate, Chloramphenicol etc.

Should be taken on physician's advice.

Keep in cool and dry place and away from light. Keep away from children

Anti-dyspeptic/Carminatives

Simethicone is used as an antiflatulent to relieve symptoms commonly referred to gas including upper GI bloating, pressure, fullness or stuffed feeling. The clinical use of Simeticone is based on its antifoaming properties. Its antifoaming action relieves flatulence by dispersing and preventing the formation of mucous surrounded gas pockets in the GI tract.

Simeticone acts in the stomach and intestines to change the surface tension of gas bubbles, enabling them to coalesce; thus gas is freed and eliminated more easily by belching or passing flatus. Simeticone aids in the elimination of gas from the GI tract and can be used to reduce postoperative gas pains. Simeticone can also be used prior to gastroscopy to enhance visualization and prior to radiography of the intestine to reduce gas shadows.

Take after meals and at bedtime. Can be given with infant's feeds. Shake the bottle well before each use.

Children less than 2 years of age: 20 mg (0.3 ml Simethicone Paediatric Drops) 4 times daily up to 240 mg/day (3.6 ml Simethicone Paediatric Drops).

Children 2-12 years of age: 40 mg (0.6 ml Simethicone Paediatric Drops) 4 times daily.

Adults:

• 40-125 mg (0.6 ml-1.9 ml Simethicone Paediatric Drops) 4 times daily, up to 500 mg/day (7.5 ml Simethicone Paediatric Drops) or
• 1-3 Simethicone chewable tablets; 4 times daily, up to 500 mg/day (12 Simethicone chewable tablets).

Simethicone is physiologically inert and no adverse effect has been noted after oral ingestion.

Do not exceed 12 doses per day except under the advice and supervision of a physician.

There is no evidence that Simethicone modifies the effect of other drugs. The defoaming effect of Simethicone is reduced by antacids such as Aluminium Hydroxide and Magnesium Carbonate, which absorb the Silicone.

Pregnant women: No data are available to suggest any harmful effects.

Lactating mother: Excretion of simethicone in breast milk has not been established, and would be most unlikely.

Should be stored in cool and dry place, protected from light. Keep the medicine out of the reach of children.

This is indicated to relieve symptoms of dyspepsia, heartburn, acid indigestion, sour stomach, gastroesophageal reflux and hiatal hernia. It is also prescribed in hyperacidity associated with peptic ulcers, gastritis and esophagitis. Magaldrate may be given to children if necessary. Also indicated for the relief of flatulence, abdominal distension and windy colic.

Antacids, Anti-dyspeptic/Carminatives

This is a combination of magaldrate and simethicone. Magaldrate (magnesium aluminium compound i.e. Hydroxymagnesium Aluminate), which neutralizes gastric acid extraordinarily quickly without raising the pH above 5-6. It also decreases the activity of pepsin in gastric secretion. Besides this, simethicone, the another component of Marlox Plus, enables the gas buble to coalesce and give relief from flatulence.

Tablet: 1-4 chewable tablets, 20 to 60 minutes after meals and at bedtime, or as directed by the physician.
Suspension: 2-4 teaspoonfuls (10-20 ml) of suspension, 20 to 60 minutes after meals and at bed time, or as directed by the physician.

Gastrointestinal side-effects are uncommon. Occasionally, if excessive amount is consumed, diarrhea, constipation or regurgitation may occur.

Magaldrate is contraindicated in patients with known hypersensitivity to magnesium and aluminium. It is also contraindicated in patients with impaired renal functions.

Care should be taken in decreased kidney function, hypophosphataemia and weak people.

It should not be used in patients taking any form of Tetracycline. The drug may cause reduced bio-availability or slower absorption of a number of drugs including propranolol, isoniazid, prednisolone and naproxen.

Magaldrate may be used in pregnancy if indicated however one should avoid excessive dosage. Magaldrate may pass into breast milk but has not been reported to cause problem in nursing babies.

Over dosage with this formulation is a rare case.

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

Anti-dyspeptic/Carminatives

Simethicone is used as an antiflatulent to relieve symptoms commonly referred to gas including upper GI bloating, pressure, fullness or stuffed feeling. The clinical use of Simeticone is based on its antifoaming properties. Its antifoaming action relieves flatulence by dispersing and preventing the formation of mucous surrounded gas pockets in the GI tract.

Simeticone acts in the stomach and intestines to change the surface tension of gas bubbles, enabling them to coalesce; thus gas is freed and eliminated more easily by belching or passing flatus. Simeticone aids in the elimination of gas from the GI tract and can be used to reduce postoperative gas pains. Simeticone can also be used prior to gastroscopy to enhance visualization and prior to radiography of the intestine to reduce gas shadows.

Take after meals and at bedtime. Can be given with infant's feeds. Shake the bottle well before each use.

Children less than 2 years of age: 20 mg (0.3 ml Simethicone Paediatric Drops) 4 times daily up to 240 mg/day (3.6 ml Simethicone Paediatric Drops).

Children 2-12 years of age: 40 mg (0.6 ml Simethicone Paediatric Drops) 4 times daily.

Adults:

• 40-125 mg (0.6 ml-1.9 ml Simethicone Paediatric Drops) 4 times daily, up to 500 mg/day (7.5 ml Simethicone Paediatric Drops) or
• 1-3 Simethicone chewable tablets; 4 times daily, up to 500 mg/day (12 Simethicone chewable tablets).

Simethicone is physiologically inert and no adverse effect has been noted after oral ingestion.

Do not exceed 12 doses per day except under the advice and supervision of a physician.

There is no evidence that Simethicone modifies the effect of other drugs. The defoaming effect of Simethicone is reduced by antacids such as Aluminium Hydroxide and Magnesium Carbonate, which absorb the Silicone.

Pregnant women: No data are available to suggest any harmful effects.

Lactating mother: Excretion of simethicone in breast milk has not been established, and would be most unlikely.

Should be stored in cool and dry place, protected from light. Keep the medicine out of the reach of children.

Anti-dyspeptic/Carminatives

Simethicone is used as an antiflatulent to relieve symptoms commonly referred to gas including upper GI bloating, pressure, fullness or stuffed feeling. The clinical use of Simeticone is based on its antifoaming properties. Its antifoaming action relieves flatulence by dispersing and preventing the formation of mucous surrounded gas pockets in the GI tract.

Simeticone acts in the stomach and intestines to change the surface tension of gas bubbles, enabling them to coalesce; thus gas is freed and eliminated more easily by belching or passing flatus. Simeticone aids in the elimination of gas from the GI tract and can be used to reduce postoperative gas pains. Simeticone can also be used prior to gastroscopy to enhance visualization and prior to radiography of the intestine to reduce gas shadows.

Take after meals and at bedtime. Can be given with infant's feeds. Shake the bottle well before each use.

Children less than 2 years of age: 20 mg (0.3 ml Simethicone Paediatric Drops) 4 times daily up to 240 mg/day (3.6 ml Simethicone Paediatric Drops).

Children 2-12 years of age: 40 mg (0.6 ml Simethicone Paediatric Drops) 4 times daily.

Adults:

• 40-125 mg (0.6 ml-1.9 ml Simethicone Paediatric Drops) 4 times daily, up to 500 mg/day (7.5 ml Simethicone Paediatric Drops) or
• 1-3 Simethicone chewable tablets; 4 times daily, up to 500 mg/day (12 Simethicone chewable tablets).

Simethicone is physiologically inert and no adverse effect has been noted after oral ingestion.

Do not exceed 12 doses per day except under the advice and supervision of a physician.

There is no evidence that Simethicone modifies the effect of other drugs. The defoaming effect of Simethicone is reduced by antacids such as Aluminium Hydroxide and Magnesium Carbonate, which absorb the Silicone.

Pregnant women: No data are available to suggest any harmful effects.

Lactating mother: Excretion of simethicone in breast milk has not been established, and would be most unlikely.

Should be stored in cool and dry place, protected from light. Keep the medicine out of the reach of children.

Broad spectrum penicillins

Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.

Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.

Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.

• Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
• Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
• Pneumonia: Recommended dose is 500-1000 mg three times daily.
• Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
• Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
• Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
• In renal impairment: it may be necessary to reduce the total daily dosage.

Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.

Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.

Amoxicillin is contraindicated in penicillin hypersensitive patients.

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.

Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

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

Amoxycillin 500 mg Injection:

• Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
• Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.

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

Broad spectrum penicillins

Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.

Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.

Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.

• Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
• Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
• Pneumonia: Recommended dose is 500-1000 mg three times daily.
• Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
• Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
• Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
• In renal impairment: it may be necessary to reduce the total daily dosage.

Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.

Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.

Amoxicillin is contraindicated in penicillin hypersensitive patients.

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.

Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

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

Amoxycillin 500 mg Injection:

• Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
• Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.

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

Broad spectrum penicillins

Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.

Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.

Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.

• Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
• Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
• Pneumonia: Recommended dose is 500-1000 mg three times daily.
• Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
• Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
• Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
• In renal impairment: it may be necessary to reduce the total daily dosage.

Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.

Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.

Amoxicillin is contraindicated in penicillin hypersensitive patients.

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.

Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

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

Amoxycillin 500 mg Injection:

• Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
• Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.

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

Broad spectrum penicillins

Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.

Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.

Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.

• Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
• Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
• Pneumonia: Recommended dose is 500-1000 mg three times daily.
• Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
• Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
• Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
• In renal impairment: it may be necessary to reduce the total daily dosage.

Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.

Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.

Amoxicillin is contraindicated in penicillin hypersensitive patients.

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.

Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

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

Amoxycillin 500 mg Injection:

• Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
• Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.

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

Broad spectrum penicillins

Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.

Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.

Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.

• Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
• Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
• Pneumonia: Recommended dose is 500-1000 mg three times daily.
• Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
• Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
• Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
• In renal impairment: it may be necessary to reduce the total daily dosage.

Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.

Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.

Amoxicillin is contraindicated in penicillin hypersensitive patients.

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.

Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

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

Amoxycillin 500 mg Injection:

• Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
• Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.

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

Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.

Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.

Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:

• Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
• Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
• Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
• Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
• Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
• Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia

Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.

Children:

• 10 mg/kg body weight once daily for 3 days for child over 6 months
• 200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
• 300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
• In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.

Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:

• 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
• The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
• Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.

Reconstitution procedure of suspension-

• Step 01: Shake the bottle well to loosen the powder.
• Step 02: Add boiled and cooled water up to the water mark of the bottle label.
• Step 03: Shake until powder is completely mixed with water.

Azithromycin should be taken at least 1 hour before or 2 hours after meal.

Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.

Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.

As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.

Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.

Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.

There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.

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

Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.

Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.

Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:

• Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
• Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
• Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
• Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
• Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
• Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia

Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.

Children:

• 10 mg/kg body weight once daily for 3 days for child over 6 months
• 200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
• 300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
• In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.

Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:

• 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
• The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
• Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.

Reconstitution procedure of suspension-

• Step 01: Shake the bottle well to loosen the powder.
• Step 02: Add boiled and cooled water up to the water mark of the bottle label.
• Step 03: Shake until powder is completely mixed with water.

Azithromycin should be taken at least 1 hour before or 2 hours after meal.

Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.

Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.

As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.

Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.

Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.

There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.

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

Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.

Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.

Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:

• Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
• Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
• Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
• Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
• Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
• Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia

Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.

Children:

• 10 mg/kg body weight once daily for 3 days for child over 6 months
• 200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
• 300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
• In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.

Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:

• 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
• The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
• Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.

Reconstitution procedure of suspension-

• Step 01: Shake the bottle well to loosen the powder.
• Step 02: Add boiled and cooled water up to the water mark of the bottle label.
• Step 03: Shake until powder is completely mixed with water.

Azithromycin should be taken at least 1 hour before or 2 hours after meal.

Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.

Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.

As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.

Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.

Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.

There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.

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

Aciclovir is indicated for-

• The treatment of viral infections due to Herpes simplex virus (type I & II) and Varicella zoster virus (herpes zoster & chicken pox).
• The treatment of Herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes and herpes labialis.
• The prophylaxis of Herpes simplex infections in immunocompromised patients

Herpes simplex & Varicella-zoster virus infections

Aciclovir is a synthetic purine derivative. Aciclovir exerts its antiviral effect on Herpes simplex virus (HSV) and Varicella-zoster virus by interfering with DNA synthesis and inhibiting viral replication. In cells infected with herpes virus, the antiviral activity of Aciclovir appears to depend principally on the intracellular conversion of the drug to Aciclovir Triphosphate. Aciclovir is converted to Aciclovir Monophosphate principally via virus coded thymidine kinase; the monophosphate is phosphorylated to the diphosphate via cellular guanylate kinase and then via another cellular enzyme to the triphosphate, which is the pharmacologically active form of the drug. 15-30% of an oral dose of the drug is absorbed from Gl tract. Peak plasma concentrations usually occur within 1.5-2 hours after oral administration. It is widely distributed into body tissues and fluids including the brain, saliva, lungs, liver, muscle, spleen, uterus, vaginal mucosa and secretions, CSF, and herpetic vesicular fluid. Aciclovir is excreted through the kidney by the glomerular filtration & tubular secretion.

Treatment of initial herpes simplex: 200 mg 5 times daily usually for 5 days.

For immunocompromised patients:

• Adult: 400 mg 5 times daily for 5 days (longer if new lesions appear during treatment or if healing is incomplete; increase dose to 800 mg 5 times daily for genital herpes in immunocompromised) or as directed by the registered physician.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Prevention of recurrence of herpes simplex:

• Adult: 200 mg 4 times daily or 400 mg twice daily possibly reduced to 200 mg 2 or 3 times daily and interrupted every 6-12 months.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Prophylactic treatment of herpes simplex in the immunocompromised patients:

• Adult: 200 to 400 mg 4 times daily.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Treatment of vericella (chicken pox):

• Adult and children over 40 kg: 800 mg 4 times daily for 5 days.
• Children below 40 kg: 20 mg/kg (maximum 800 mg) per dose orally 4 times daily (80 mg/kg/day) for 5 days.
• Children 1 month-2 years: 200 mg 4 times daily for 5 days.
• Children 2-5 years:400 mg 4 times daily for 5 days.
• Children 6-12 years:800 mg 4 times daily for 5 days.

Treatment of herpes zoster (Shingles): 800 mg 5 times daily for 7 days.

Treatment of initial rectal (Proctitis) herpes infections: An oral Aciclovir dosage of 400 mg 5 times daily for 10 days or until clinical resolution occurs has been recommended.

Renal Impairment: For patients with severe renal impairment, a reduction of the doses is recommended.

Rash, gastrointestinal disturbance, rise in bilirubin and liver-related enzymes, increase in blood urea and creatinine, decrease in hematological indices, headache, neurological reaction, fatigue.

Aciclovir is contraindicated in patients known to be hypersensitive to Aciclovir.

Aciclovir should be administered with caution in patients with renal impairment and doses should be adjusted according to creatinine clearance. Monitor neutrophil count at least twice weekly in neonates.

Probenecid reduces Aciclovir excretion and so increases plasma concentration and risk of toxicity.

Pregnancy category B. Aciclovir should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Caution should be exercised when it is administered to a nursing mother.

Should be stored below 25°C. It should be protected from light and moisture.Keep out of the reach of children.

Herpes simplex & Varicella-zoster virus infections

Acyclovir exerts its antiviral e­ects on Herpes simplex virus and Varicella zoster virus by interfering with DNA synthesis and inhibiting viral replication. In cells infected with Herpes virus, the antiviral activity of Acyclovir appears to depend principally on the intracellular conversion of the drug to Acyclovir Triphosphate. Acyclovir is converted to Acyclovir Monophosphate principally via virus coded thymidine kinase, the monophosphate is phosphorylated to diphosphate via cellular guanylate kinase and then via other cellular enzymes to the Triphosphate, which is the pharmacologically active form of the drug.

• Herpes simplex infection: For normal or immunocompromised immune status: 5 mg/kg every 8 hours
• Very severe Herpes zoster infection (shingles): For normal immune status: 5 mg/kg every 8 hours
• Varicella zoster infection: For immunocompromised immune status: 10 mg/kg every 8 hours
• Herpes simplex encephalitis: For normal or immunocompromised immune status: 10 mg/kg every 8 hours

Each dose should be administered by slow intravenous infusion over a one-hour period.

It is recommended that Acyclovir IV Injection for Intravenous Infusion should be administered for five to seven days in the treatment of most infections and for at least ten days in the treatment of Herpes simplex encephalitis.

Acyclovir IV Injection after reconstitution may be injected directly into a vein over one hour by a controlled-rate infusion pump or be further diluted for administration by infusion. For intravenous infusion each vial of Acyclovir IV Injection should be reconstituted and then, wholly or in part according to the dosage required, added to and mixed with at least 50 mL-100 ml infusion solution. A maximum of 250 mg & 500 mg of Acyclovir may be added to 50 ml & 100 ml infusion solution respectively. After addition of Acyclovir IV Injection to an infusion solution the mixture should be shaken to ensure thorough mixing. Acyclovir IV Injection when diluted in accordance with the above schedule will give an Acyclovir concentration not greater than 0.5% w/v.

Acyclovir IV Injection is known to be compatible with the following infusion fluids and stable for up to 12 hours at room temperature (below 25°C) when diluted to a concentration not greater than 0.5% w/v Acyclovir.

• Sodium Chloride Intravenous Infusion BP (0.45% and 0.9% w/v)
• Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion
• Sodium Chloride (0.45% w/v) and Glucose (2.5% w/v) Intravenous Infusion
• Compound Sodium Lactate Intravenous Infusion BP (Hartmann's Solution)

Acyclovir IV Injection for Intravenous Infusion contains no preservative. Reconstitution and dilution should therefore be carried out immediately before use and any unused solution should be discarded. The solution should not be refrigerated.

Some infrequent adverse reactions are lethargy, obtundation, tremors, confusion, hallucinations, agitation, somnolence, psychosis, convulsions and coma, phlebitis, nausea, vomiting, reversible increases in liver-related enzymes, pruritus, urticaria, rashes, increases in blood urea and creatinine. Local inflammatory reactions may occur if Acyclovir IV Infusion is inadvertently infused into extracellular tissues.

Acyclovir IV Injection is contraindicated in patients known to be hypersensitive to Acyclovir or Valacyclovir.

Acyclovir IV injection is intended for intravenous infusion only and should not be used through any other route. Reconstituted Acyclovir IV Infusion has a pH of approximately 11.0 and should not be administered by mouth. Acyclovir IV injection as infusion must be given over a period of at least one hour in order to avoid renal tubular damage. It should not be administered as a bolus injection. Acyclovir IV infusion must be accompanied by adequate hydration. Since maximum urine concentration occurs within the first few hours following infusion, particular attention should be given to establish sufficient urine ‑ow during that period. Concomitant use of other nephrotoxic drugs, pre-existing renal disease and dehydration increase the risk of further renal impairment by Acyclovir. As Acyclovir has been associated with reversible encephalopathic changes, it should be used with caution in patients with neurological abnormalities, significant hypoxia or serious renal, hepatic or electrolyte abnormalities.

Co-administration of probenecid with Acyclovir has been shown to increase the mean Acyclovir half-life and the area under the concentration time curve. Urinary excretion and renal clearance correspondingly reduced. In patients over 60 years of age concurrent use of diuretics increases plasma levels of Acyclovir very significantly.

Pregnancy category B. There have been no adequate and well controlled studies concerning the safety of Acyclovir in pregnant women. It should not be used during pregnancy unless the benefits to the patient clearly outweigh the potential risks to the fetus. Acyclovir should only be administered to nursing mothers if the benefits to the mother outweigh the potential risks to the baby. There is no experience of the effect of Acyclovir on human fertility.

Pediatric use: The dose of Acyclovir IV injection in children aged 1-12 years should be calculated on the basis of body surface area. Children in this age group with Herpes simplex infections (except Herpes simplex encephalitis) or Varicella zoster infections should be given Acyclovir IV Infusion in doses of 250 mg/m² (equivalent to 5 mg/kg in adults). Immunocompromised children in this age group with Varicella zoster virus infection or with Herpes simplex encephalitis should be given Acyclovir IV Infusion in doses of 500 mg/m² (equivalent to 10 mg/kg in adults). Children with impaired renal function require an appropriately modified dose, according to the degree of impairment.
 
Geriatric use: No data are available on this age group. However, as creatinine clearance is often low in the elderly, special attention should be given to dosage reduction.

In patients with renal impairment: Acyclovir should be administered with caution since the drug is excreted through the kidneys. The following modifications in dosage are suggested:

• CrCl: 25-50 ml/min: 5 or 10 mg/kg every 12 hours
• CrCl: 10-25 ml/min: 5 or 10 mg/kg every 24 hours
• CrCl: 0-10 ml/min: 2.5 or 5 mg/kg every 24 hours and after dialysis.

Overdosage of intravenous Acyclovir has resulted in elevations of serum creatinine, blood urea nitrogen and subsequent renal failure. Neurological effects including confusion, hallucinations, agitation, seizures and coma have been described in association with over dosage. Adequate hydration is essential to reduce the possibility of crystal formation in the urine. Hemodialysis significantly enhances the removal of Acyclovir from the blood and may, therefore, be considered an option in the management of overdose of Acyclovir.

It is recommended that Acyclovir IV Injection for Intravenous Infusion should be administered for five to seven days in the treatment of most infections and for at least ten days in the treatment of Herpes simplex encephalitis.

Each 250 mg vial of Acyclovir IV Injection should be reconstituted by the addition of 10 ml of either Water for Injection or Sodium Chloride Intravenous Infusion (0.9% w/v). This provides a solution containing 25 mg Acyclovir per ml.

Each 500 mg vial of Acyclovir IV Injection should be reconstituted by the addition of 10 ml of either Water for Injection or Sodium Chloride Intravenous Infusion (0.9% w/v). This provides a solution containing 50 mg Acyclovir per ml.

Store at 15°C to 25°C. Protected from light and moisture. Keep the medicine out of the reach of children.

Aciclovir is indicated for-

• The treatment of viral infections due to Herpes simplex virus (type I & II) and Varicella zoster virus (herpes zoster & chicken pox).
• The treatment of Herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes and herpes labialis.
• The prophylaxis of Herpes simplex infections in immunocompromised patients

Herpes simplex & Varicella-zoster virus infections

Aciclovir is a synthetic purine derivative. Aciclovir exerts its antiviral effect on Herpes simplex virus (HSV) and Varicella-zoster virus by interfering with DNA synthesis and inhibiting viral replication. In cells infected with herpes virus, the antiviral activity of Aciclovir appears to depend principally on the intracellular conversion of the drug to Aciclovir Triphosphate. Aciclovir is converted to Aciclovir Monophosphate principally via virus coded thymidine kinase; the monophosphate is phosphorylated to the diphosphate via cellular guanylate kinase and then via another cellular enzyme to the triphosphate, which is the pharmacologically active form of the drug. 15-30% of an oral dose of the drug is absorbed from Gl tract. Peak plasma concentrations usually occur within 1.5-2 hours after oral administration. It is widely distributed into body tissues and fluids including the brain, saliva, lungs, liver, muscle, spleen, uterus, vaginal mucosa and secretions, CSF, and herpetic vesicular fluid. Aciclovir is excreted through the kidney by the glomerular filtration & tubular secretion.

Treatment of initial herpes simplex: 200 mg 5 times daily usually for 5 days.

For immunocompromised patients:

• Adult: 400 mg 5 times daily for 5 days (longer if new lesions appear during treatment or if healing is incomplete; increase dose to 800 mg 5 times daily for genital herpes in immunocompromised) or as directed by the registered physician.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Prevention of recurrence of herpes simplex:

• Adult: 200 mg 4 times daily or 400 mg twice daily possibly reduced to 200 mg 2 or 3 times daily and interrupted every 6-12 months.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Prophylactic treatment of herpes simplex in the immunocompromised patients:

• Adult: 200 to 400 mg 4 times daily.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Treatment of vericella (chicken pox):

• Adult and children over 40 kg: 800 mg 4 times daily for 5 days.
• Children below 40 kg: 20 mg/kg (maximum 800 mg) per dose orally 4 times daily (80 mg/kg/day) for 5 days.
• Children 1 month-2 years: 200 mg 4 times daily for 5 days.
• Children 2-5 years:400 mg 4 times daily for 5 days.
• Children 6-12 years:800 mg 4 times daily for 5 days.

Treatment of herpes zoster (Shingles): 800 mg 5 times daily for 7 days.

Treatment of initial rectal (Proctitis) herpes infections: An oral Aciclovir dosage of 400 mg 5 times daily for 10 days or until clinical resolution occurs has been recommended.

Renal Impairment: For patients with severe renal impairment, a reduction of the doses is recommended.

Rash, gastrointestinal disturbance, rise in bilirubin and liver-related enzymes, increase in blood urea and creatinine, decrease in hematological indices, headache, neurological reaction, fatigue.

Aciclovir is contraindicated in patients known to be hypersensitive to Aciclovir.

Aciclovir should be administered with caution in patients with renal impairment and doses should be adjusted according to creatinine clearance. Monitor neutrophil count at least twice weekly in neonates.

Probenecid reduces Aciclovir excretion and so increases plasma concentration and risk of toxicity.

Pregnancy category B. Aciclovir should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Caution should be exercised when it is administered to a nursing mother.

Should be stored below 25°C. It should be protected from light and moisture.Keep out of the reach of children.

Aciclovir is indicated for-

• The treatment of viral infections due to Herpes simplex virus (type I & II) and Varicella zoster virus (herpes zoster & chicken pox).
• The treatment of Herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes and herpes labialis.
• The prophylaxis of Herpes simplex infections in immunocompromised patients

Herpes simplex & Varicella-zoster virus infections

Aciclovir is a synthetic purine derivative. Aciclovir exerts its antiviral effect on Herpes simplex virus (HSV) and Varicella-zoster virus by interfering with DNA synthesis and inhibiting viral replication. In cells infected with herpes virus, the antiviral activity of Aciclovir appears to depend principally on the intracellular conversion of the drug to Aciclovir Triphosphate. Aciclovir is converted to Aciclovir Monophosphate principally via virus coded thymidine kinase; the monophosphate is phosphorylated to the diphosphate via cellular guanylate kinase and then via another cellular enzyme to the triphosphate, which is the pharmacologically active form of the drug. 15-30% of an oral dose of the drug is absorbed from Gl tract. Peak plasma concentrations usually occur within 1.5-2 hours after oral administration. It is widely distributed into body tissues and fluids including the brain, saliva, lungs, liver, muscle, spleen, uterus, vaginal mucosa and secretions, CSF, and herpetic vesicular fluid. Aciclovir is excreted through the kidney by the glomerular filtration & tubular secretion.

Treatment of initial herpes simplex: 200 mg 5 times daily usually for 5 days.

For immunocompromised patients:

• Adult: 400 mg 5 times daily for 5 days (longer if new lesions appear during treatment or if healing is incomplete; increase dose to 800 mg 5 times daily for genital herpes in immunocompromised) or as directed by the registered physician.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Prevention of recurrence of herpes simplex:

• Adult: 200 mg 4 times daily or 400 mg twice daily possibly reduced to 200 mg 2 or 3 times daily and interrupted every 6-12 months.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Prophylactic treatment of herpes simplex in the immunocompromised patients:

• Adult: 200 to 400 mg 4 times daily.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Treatment of vericella (chicken pox):

• Adult and children over 40 kg: 800 mg 4 times daily for 5 days.
• Children below 40 kg: 20 mg/kg (maximum 800 mg) per dose orally 4 times daily (80 mg/kg/day) for 5 days.
• Children 1 month-2 years: 200 mg 4 times daily for 5 days.
• Children 2-5 years:400 mg 4 times daily for 5 days.
• Children 6-12 years:800 mg 4 times daily for 5 days.

Treatment of herpes zoster (Shingles): 800 mg 5 times daily for 7 days.

Treatment of initial rectal (Proctitis) herpes infections: An oral Aciclovir dosage of 400 mg 5 times daily for 10 days or until clinical resolution occurs has been recommended.

Renal Impairment: For patients with severe renal impairment, a reduction of the doses is recommended.

Rash, gastrointestinal disturbance, rise in bilirubin and liver-related enzymes, increase in blood urea and creatinine, decrease in hematological indices, headache, neurological reaction, fatigue.

Aciclovir is contraindicated in patients known to be hypersensitive to Aciclovir.

Aciclovir should be administered with caution in patients with renal impairment and doses should be adjusted according to creatinine clearance. Monitor neutrophil count at least twice weekly in neonates.

Probenecid reduces Aciclovir excretion and so increases plasma concentration and risk of toxicity.

Pregnancy category B. Aciclovir should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Caution should be exercised when it is administered to a nursing mother.

Should be stored below 25°C. It should be protected from light and moisture.Keep out of the reach of children.

Herpes simplex & Varicella-zoster virus infections

Acyclovir exerts its antiviral e­ects on Herpes simplex virus and Varicella zoster virus by interfering with DNA synthesis and inhibiting viral replication. In cells infected with Herpes virus, the antiviral activity of Acyclovir appears to depend principally on the intracellular conversion of the drug to Acyclovir Triphosphate. Acyclovir is converted to Acyclovir Monophosphate principally via virus coded thymidine kinase, the monophosphate is phosphorylated to diphosphate via cellular guanylate kinase and then via other cellular enzymes to the Triphosphate, which is the pharmacologically active form of the drug.

• Herpes simplex infection: For normal or immunocompromised immune status: 5 mg/kg every 8 hours
• Very severe Herpes zoster infection (shingles): For normal immune status: 5 mg/kg every 8 hours
• Varicella zoster infection: For immunocompromised immune status: 10 mg/kg every 8 hours
• Herpes simplex encephalitis: For normal or immunocompromised immune status: 10 mg/kg every 8 hours

Each dose should be administered by slow intravenous infusion over a one-hour period.

It is recommended that Acyclovir IV Injection for Intravenous Infusion should be administered for five to seven days in the treatment of most infections and for at least ten days in the treatment of Herpes simplex encephalitis.

Acyclovir IV Injection after reconstitution may be injected directly into a vein over one hour by a controlled-rate infusion pump or be further diluted for administration by infusion. For intravenous infusion each vial of Acyclovir IV Injection should be reconstituted and then, wholly or in part according to the dosage required, added to and mixed with at least 50 mL-100 ml infusion solution. A maximum of 250 mg & 500 mg of Acyclovir may be added to 50 ml & 100 ml infusion solution respectively. After addition of Acyclovir IV Injection to an infusion solution the mixture should be shaken to ensure thorough mixing. Acyclovir IV Injection when diluted in accordance with the above schedule will give an Acyclovir concentration not greater than 0.5% w/v.

Acyclovir IV Injection is known to be compatible with the following infusion fluids and stable for up to 12 hours at room temperature (below 25°C) when diluted to a concentration not greater than 0.5% w/v Acyclovir.

• Sodium Chloride Intravenous Infusion BP (0.45% and 0.9% w/v)
• Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion
• Sodium Chloride (0.45% w/v) and Glucose (2.5% w/v) Intravenous Infusion
• Compound Sodium Lactate Intravenous Infusion BP (Hartmann's Solution)

Acyclovir IV Injection for Intravenous Infusion contains no preservative. Reconstitution and dilution should therefore be carried out immediately before use and any unused solution should be discarded. The solution should not be refrigerated.

Some infrequent adverse reactions are lethargy, obtundation, tremors, confusion, hallucinations, agitation, somnolence, psychosis, convulsions and coma, phlebitis, nausea, vomiting, reversible increases in liver-related enzymes, pruritus, urticaria, rashes, increases in blood urea and creatinine. Local inflammatory reactions may occur if Acyclovir IV Infusion is inadvertently infused into extracellular tissues.

Acyclovir IV Injection is contraindicated in patients known to be hypersensitive to Acyclovir or Valacyclovir.

Acyclovir IV injection is intended for intravenous infusion only and should not be used through any other route. Reconstituted Acyclovir IV Infusion has a pH of approximately 11.0 and should not be administered by mouth. Acyclovir IV injection as infusion must be given over a period of at least one hour in order to avoid renal tubular damage. It should not be administered as a bolus injection. Acyclovir IV infusion must be accompanied by adequate hydration. Since maximum urine concentration occurs within the first few hours following infusion, particular attention should be given to establish sufficient urine ‑ow during that period. Concomitant use of other nephrotoxic drugs, pre-existing renal disease and dehydration increase the risk of further renal impairment by Acyclovir. As Acyclovir has been associated with reversible encephalopathic changes, it should be used with caution in patients with neurological abnormalities, significant hypoxia or serious renal, hepatic or electrolyte abnormalities.

Co-administration of probenecid with Acyclovir has been shown to increase the mean Acyclovir half-life and the area under the concentration time curve. Urinary excretion and renal clearance correspondingly reduced. In patients over 60 years of age concurrent use of diuretics increases plasma levels of Acyclovir very significantly.

Pregnancy category B. There have been no adequate and well controlled studies concerning the safety of Acyclovir in pregnant women. It should not be used during pregnancy unless the benefits to the patient clearly outweigh the potential risks to the fetus. Acyclovir should only be administered to nursing mothers if the benefits to the mother outweigh the potential risks to the baby. There is no experience of the effect of Acyclovir on human fertility.

Pediatric use: The dose of Acyclovir IV injection in children aged 1-12 years should be calculated on the basis of body surface area. Children in this age group with Herpes simplex infections (except Herpes simplex encephalitis) or Varicella zoster infections should be given Acyclovir IV Infusion in doses of 250 mg/m² (equivalent to 5 mg/kg in adults). Immunocompromised children in this age group with Varicella zoster virus infection or with Herpes simplex encephalitis should be given Acyclovir IV Infusion in doses of 500 mg/m² (equivalent to 10 mg/kg in adults). Children with impaired renal function require an appropriately modified dose, according to the degree of impairment.
 
Geriatric use: No data are available on this age group. However, as creatinine clearance is often low in the elderly, special attention should be given to dosage reduction.

In patients with renal impairment: Acyclovir should be administered with caution since the drug is excreted through the kidneys. The following modifications in dosage are suggested:

• CrCl: 25-50 ml/min: 5 or 10 mg/kg every 12 hours
• CrCl: 10-25 ml/min: 5 or 10 mg/kg every 24 hours
• CrCl: 0-10 ml/min: 2.5 or 5 mg/kg every 24 hours and after dialysis.

Overdosage of intravenous Acyclovir has resulted in elevations of serum creatinine, blood urea nitrogen and subsequent renal failure. Neurological effects including confusion, hallucinations, agitation, seizures and coma have been described in association with over dosage. Adequate hydration is essential to reduce the possibility of crystal formation in the urine. Hemodialysis significantly enhances the removal of Acyclovir from the blood and may, therefore, be considered an option in the management of overdose of Acyclovir.

It is recommended that Acyclovir IV Injection for Intravenous Infusion should be administered for five to seven days in the treatment of most infections and for at least ten days in the treatment of Herpes simplex encephalitis.

Each 250 mg vial of Acyclovir IV Injection should be reconstituted by the addition of 10 ml of either Water for Injection or Sodium Chloride Intravenous Infusion (0.9% w/v). This provides a solution containing 25 mg Acyclovir per ml.

Each 500 mg vial of Acyclovir IV Injection should be reconstituted by the addition of 10 ml of either Water for Injection or Sodium Chloride Intravenous Infusion (0.9% w/v). This provides a solution containing 50 mg Acyclovir per ml.

Store at 15°C to 25°C. Protected from light and moisture. Keep the medicine out of the reach of children.