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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.

Bromhexine is indicated in the treatment of respiratory tract disorders associated with productive cough. This include-

• Tracheobronchitis
• Bronchitis with emphysema
• Bronchiectasis
• Bronchitis with bronchospasm
• Chronic inflammatory pulmonary conditions and
• Pneumoconiosis.

Cough expectorants & mucolytics

Bromhexine Hydrochloride is an oral mucolytic agent. It disrupts the structure of acid mucopolysaccharide fibres in mucoid sputum and produces less viscous mucus, which makes easier the expectoration. It is rapidly & completely absorbed from the gastrointestinal tract. It is widely distributed into the body tissues.

The recommended doses for adults and children are stated below:

• Adult & Children over 12 years: 10 ml (2 teaspoons) 3 times daily
• Children 6-12 years: 5 ml (1 teaspoon) 3 times daily
• Children 2-6 years: 2.5 ml (1/2 teaspoon) 3 times daily
• Bromhexine Hydrochloride is not recommended for children under 2 years of age without advice.

Gastrointestinal side effects may occur occasionally. A transient rise in serum aminotransferase values has been reported. Other reported side effects include-headache, vertigo (dizziness) and allergic reactions.

It is contraindicated in known hypersensitivity to Bromhexine Hydrochloride or any of the ingredients of this product.

Since mucolytics may disrupt the gastric mucosa bromhexine should be used with care in patients with a history of peptic ulcer disease. Care is also advisable in asthmatic patients. Clearance of bromhexine and its metabolites may be reduced in patients with severe hepatic or renal impairment.

There are no known significant interactions with other drugs.

Use in Pregnancy: Special care is recommended during pregnancy. The benefits of bromhexine must be assessed against possible effects on children.

Use in Lactation: Bromhexine is expected to enter breast milk. Therefore it is not recommended that bromhexine be taken by lactating mothers.

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

Mupirocin ointment is indicated for the topical treatment of impetigo (skin diseases) due to Staphylococcus aureus and Streptococcus pyogenes. It is also indicated in folliculitis, furunculosis.

Topical Antibiotic preparations

Mupirocin is a naturally occurring antibiotic. This antibacterial agent is produced by fermentation using the organism Pseudomonas fluorescens. It is active against a wide range of bacteria (e.g. Staphylococcus aureus including methicillin-resistant strains and Streptococcus pyogenes) those responsible for the majority of skin infections. It is also active against gram-negative pathogens, such as Escherichia coli and Haemophilus influenzae. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase.

A small amount of Bactropen ointment should be applied to the affected area 3 times daily for up to 10 days. The safety and effectiveness of Mupirocin ointment have been established in the age range of 2 months to 16 years.

Reported side effects are burning, stinging or pain, itching and some patient may be suffered rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis and increased exudate.

The drug is contraindicated in individuals with a history of hypersensitivity reactions to Mupirocin or any of the components of the preparation.

Mupirocin ointment is not for ophthalmic or intra-nasal use. As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. When Mupirocin is used on the face care should be taken to avoid the eyes. This is not suitable in conjunction with cannulae and at the site of central venous cannulation. In the event of a sensitization or severe local irritation from Mupirocin ointment, usage should be discontinued and appropriate alternative therapy for the infection instituted. Mixing of Mupirocin ointment with other preparations causes risk of dilution, resulting in a reduction of the antibacterial activity and potential loss of stability of the Mupirocin in the ointment.

No drug interaction has been identified with Mupirocin ointment.

Reproduction studies on Mupirocin ointment in animals have revealed no evidence of harm to the foetus. As there is no clinical experience on it’s use during pregnancy, Mupirocin ointment should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.

It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mupirocin ointment is administered to a nursing woman.

There is currently limited data with overdose of Mupirocin ointment. In the event of overdose, the patient should be treated supportively with appropriate monitoring as necessary.

Keep below 25° C temperature, protected from light and moisture. Do not keep in freeze. Keep out of the reach of children.

Mupirocin ointment is indicated for the topical treatment of impetigo (skin diseases) due to Staphylococcus aureus and Streptococcus pyogenes. It is also indicated in folliculitis, furunculosis.

Topical Antibiotic preparations

Mupirocin is a naturally occurring antibiotic. This antibacterial agent is produced by fermentation using the organism Pseudomonas fluorescens. It is active against a wide range of bacteria (e.g. Staphylococcus aureus including methicillin-resistant strains and Streptococcus pyogenes) those responsible for the majority of skin infections. It is also active against gram-negative pathogens, such as Escherichia coli and Haemophilus influenzae. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase.

A small amount of Bactropen ointment should be applied to the affected area 3 times daily for up to 10 days. The safety and effectiveness of Mupirocin ointment have been established in the age range of 2 months to 16 years.

Reported side effects are burning, stinging or pain, itching and some patient may be suffered rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis and increased exudate.

The drug is contraindicated in individuals with a history of hypersensitivity reactions to Mupirocin or any of the components of the preparation.

Mupirocin ointment is not for ophthalmic or intra-nasal use. As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. When Mupirocin is used on the face care should be taken to avoid the eyes. This is not suitable in conjunction with cannulae and at the site of central venous cannulation. In the event of a sensitization or severe local irritation from Mupirocin ointment, usage should be discontinued and appropriate alternative therapy for the infection instituted. Mixing of Mupirocin ointment with other preparations causes risk of dilution, resulting in a reduction of the antibacterial activity and potential loss of stability of the Mupirocin in the ointment.

No drug interaction has been identified with Mupirocin ointment.

Reproduction studies on Mupirocin ointment in animals have revealed no evidence of harm to the foetus. As there is no clinical experience on it’s use during pregnancy, Mupirocin ointment should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.

It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mupirocin ointment is administered to a nursing woman.

There is currently limited data with overdose of Mupirocin ointment. In the event of overdose, the patient should be treated supportively with appropriate monitoring as necessary.

Keep below 25° C temperature, protected from light and moisture. Do not keep in freeze. Keep out of the reach of children.

Mupirocin ointment is indicated for the topical treatment of impetigo (skin diseases) due to Staphylococcus aureus and Streptococcus pyogenes. It is also indicated in folliculitis, furunculosis.

Topical Antibiotic preparations

Mupirocin is a naturally occurring antibiotic. This antibacterial agent is produced by fermentation using the organism Pseudomonas fluorescens. It is active against a wide range of bacteria (e.g. Staphylococcus aureus including methicillin-resistant strains and Streptococcus pyogenes) those responsible for the majority of skin infections. It is also active against gram-negative pathogens, such as Escherichia coli and Haemophilus influenzae. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase.

A small amount of Bactropen ointment should be applied to the affected area 3 times daily for up to 10 days. The safety and effectiveness of Mupirocin ointment have been established in the age range of 2 months to 16 years.

Reported side effects are burning, stinging or pain, itching and some patient may be suffered rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis and increased exudate.

The drug is contraindicated in individuals with a history of hypersensitivity reactions to Mupirocin or any of the components of the preparation.

Mupirocin ointment is not for ophthalmic or intra-nasal use. As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. When Mupirocin is used on the face care should be taken to avoid the eyes. This is not suitable in conjunction with cannulae and at the site of central venous cannulation. In the event of a sensitization or severe local irritation from Mupirocin ointment, usage should be discontinued and appropriate alternative therapy for the infection instituted. Mixing of Mupirocin ointment with other preparations causes risk of dilution, resulting in a reduction of the antibacterial activity and potential loss of stability of the Mupirocin in the ointment.

No drug interaction has been identified with Mupirocin ointment.

Reproduction studies on Mupirocin ointment in animals have revealed no evidence of harm to the foetus. As there is no clinical experience on it’s use during pregnancy, Mupirocin ointment should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.

It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mupirocin ointment is administered to a nursing woman.

There is currently limited data with overdose of Mupirocin ointment. In the event of overdose, the patient should be treated supportively with appropriate monitoring as necessary.

Keep below 25° C temperature, protected from light and moisture. Do not keep in freeze. Keep out of the reach of children.

Mupirocin ointment is indicated for the topical treatment of impetigo (skin diseases) due to Staphylococcus aureus and Streptococcus pyogenes. It is also indicated in folliculitis, furunculosis.

Topical Antibiotic preparations

Mupirocin is a naturally occurring antibiotic. This antibacterial agent is produced by fermentation using the organism Pseudomonas fluorescens. It is active against a wide range of bacteria (e.g. Staphylococcus aureus including methicillin-resistant strains and Streptococcus pyogenes) those responsible for the majority of skin infections. It is also active against gram-negative pathogens, such as Escherichia coli and Haemophilus influenzae. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase.

A small amount of Bactropen ointment should be applied to the affected area 3 times daily for up to 10 days. The safety and effectiveness of Mupirocin ointment have been established in the age range of 2 months to 16 years.

Reported side effects are burning, stinging or pain, itching and some patient may be suffered rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis and increased exudate.

The drug is contraindicated in individuals with a history of hypersensitivity reactions to Mupirocin or any of the components of the preparation.

Mupirocin ointment is not for ophthalmic or intra-nasal use. As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. When Mupirocin is used on the face care should be taken to avoid the eyes. This is not suitable in conjunction with cannulae and at the site of central venous cannulation. In the event of a sensitization or severe local irritation from Mupirocin ointment, usage should be discontinued and appropriate alternative therapy for the infection instituted. Mixing of Mupirocin ointment with other preparations causes risk of dilution, resulting in a reduction of the antibacterial activity and potential loss of stability of the Mupirocin in the ointment.

No drug interaction has been identified with Mupirocin ointment.

Reproduction studies on Mupirocin ointment in animals have revealed no evidence of harm to the foetus. As there is no clinical experience on it’s use during pregnancy, Mupirocin ointment should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.

It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mupirocin ointment is administered to a nursing woman.

There is currently limited data with overdose of Mupirocin ointment. In the event of overdose, the patient should be treated supportively with appropriate monitoring as necessary.

Keep below 25° C temperature, protected from light and moisture. Do not keep in freeze. Keep out of the reach of children.

Mupirocin ointment is indicated for the topical treatment of impetigo (skin diseases) due to Staphylococcus aureus and Streptococcus pyogenes. It is also indicated in folliculitis, furunculosis.

Topical Antibiotic preparations

Mupirocin is a naturally occurring antibiotic. This antibacterial agent is produced by fermentation using the organism Pseudomonas fluorescens. It is active against a wide range of bacteria (e.g. Staphylococcus aureus including methicillin-resistant strains and Streptococcus pyogenes) those responsible for the majority of skin infections. It is also active against gram-negative pathogens, such as Escherichia coli and Haemophilus influenzae. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase.

A small amount of Bactropen ointment should be applied to the affected area 3 times daily for up to 10 days. The safety and effectiveness of Mupirocin ointment have been established in the age range of 2 months to 16 years.

Reported side effects are burning, stinging or pain, itching and some patient may be suffered rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis and increased exudate.

The drug is contraindicated in individuals with a history of hypersensitivity reactions to Mupirocin or any of the components of the preparation.

Mupirocin ointment is not for ophthalmic or intra-nasal use. As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. When Mupirocin is used on the face care should be taken to avoid the eyes. This is not suitable in conjunction with cannulae and at the site of central venous cannulation. In the event of a sensitization or severe local irritation from Mupirocin ointment, usage should be discontinued and appropriate alternative therapy for the infection instituted. Mixing of Mupirocin ointment with other preparations causes risk of dilution, resulting in a reduction of the antibacterial activity and potential loss of stability of the Mupirocin in the ointment.

No drug interaction has been identified with Mupirocin ointment.

Reproduction studies on Mupirocin ointment in animals have revealed no evidence of harm to the foetus. As there is no clinical experience on it’s use during pregnancy, Mupirocin ointment should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.

It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mupirocin ointment is administered to a nursing woman.

There is currently limited data with overdose of Mupirocin ointment. In the event of overdose, the patient should be treated supportively with appropriate monitoring as necessary.

Keep below 25° C temperature, protected from light and moisture. Do not keep in freeze. Keep out of the reach of children.

Penicillinase-resistant penicillins

Flucloxacillin is active against Gram-positive organisms including penicillinase producing strains. It has little activity against Gram-negative bacilli. Flucloxacillin acts by inhibiting the formation of cell wall of bacteria. Flucloxacillin is isoxazolyl penicillin which combined the properties of resistance to hydrolysis by penicillinase, gastric acid stability and activity against gram-positive bacteria. Flucloxacillin is a bactericidal antibiotic that is particularly useful against penicillinase-producing staphylococci. Flucloxacillin kills bacterial cellwall, thus interfering with peptidoglycan synthesis. Peptidoglycan is a heteropolymeric structure that provides the cell wall with its mechanical stability. The final stage of peptidoglycan synthesis involves the completion of the cross-linking with the terminal glycine residue of the pentaglycin bridge linking to the fourth residue of the pentapeptide (D-alanine). The transpeptidase enzyme that performs this step is inhibited by Flucloxacillin. As a result the bacterial cellwall is weakened, the cell swells and then ruptures. Flucloxacillin resists the action of bacterial penicillinase probably because of the steric hindrance induced by the acyl side chain which prevents the opening of the β- lactam ring.

Oral administration:

• Adult: 250 mg four times daily. Dosage may be doubled in severe infections. In osteomyelitis and endocarditis, up to 8 gm daily is used in 6-8 hourly divided doses.
• Children (2-10 years): 1/2 of adult dose.
• Children (Under 2 years): 1/4 of adult dose.

Parenteral administration:
Adult or Elderly:

• Intramuscular Injection: 250 mg four times daily.
• Intravenous Injection: 250 mg-1 g four times daily by slow injection over 3 to 4 minutes or by intravenous infusion.
• All systemic doses may be doubled in severe infections: doses up to 8 g daily have been suggested for endocarditis or osteomyelitis.

Children:

• 2-10 years: half of the adult dose.
• Under 2 years: a quarter of the adult dose.

Oral doses should be administered 1 hour before meal.

There have been some common side effects of gastrointestinal tract such as nausea, vomiting, diarrhoea, dyspepsia and other minor gastrointestinal disturbances. Besides these rashes, urticaria, purpura, fever, interstitial nephritis, hepatitis and cholestatic jaundice have been reported.

Flucloxacillin is contraindicated in penicillin hypersensitive patients.

Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction. Caution should also be exercised in the treatment of patients with an allergic diathesis.

Concurrent use of Flucloxacillin and may result in increased level of Flucloxacillin in blood for prolonged period.

US FDA Pregnancy Category of Flucloxacillin is B. There are, 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. Flucloxacillin have been shown to be excreted in human milk. So, caution should be exercised when Flucloxacillin is administered to a lactating mother.

In severe renal failure (creatinine clearance <10 ml/min), a reduction in dose or an extension of dose interval should be considered.

Flucloxacillin has been used in other routes in conjunction with systemic therapy. It has been administered in a dose of 250 mg to 500 mg daily by intraarticular injection, dissolved if necessary in a 0.5% solution of lignocaine hydrochloride, and by intrapleural injection in a dose of 250 mg daily. Using powder for injection, 125 mg-250 mg has been dissolved in 3 ml of sterile water and inhaled by nebuliser four times daily.

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

Mupirocin ointment is indicated for the topical treatment of impetigo (skin diseases) due to Staphylococcus aureus and Streptococcus pyogenes. It is also indicated in folliculitis, furunculosis.

Topical Antibiotic preparations

Mupirocin is a naturally occurring antibiotic. This antibacterial agent is produced by fermentation using the organism Pseudomonas fluorescens. It is active against a wide range of bacteria (e.g. Staphylococcus aureus including methicillin-resistant strains and Streptococcus pyogenes) those responsible for the majority of skin infections. It is also active against gram-negative pathogens, such as Escherichia coli and Haemophilus influenzae. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase.

A small amount of Bactropen ointment should be applied to the affected area 3 times daily for up to 10 days. The safety and effectiveness of Mupirocin ointment have been established in the age range of 2 months to 16 years.

Reported side effects are burning, stinging or pain, itching and some patient may be suffered rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis and increased exudate.

The drug is contraindicated in individuals with a history of hypersensitivity reactions to Mupirocin or any of the components of the preparation.

Mupirocin ointment is not for ophthalmic or intra-nasal use. As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. When Mupirocin is used on the face care should be taken to avoid the eyes. This is not suitable in conjunction with cannulae and at the site of central venous cannulation. In the event of a sensitization or severe local irritation from Mupirocin ointment, usage should be discontinued and appropriate alternative therapy for the infection instituted. Mixing of Mupirocin ointment with other preparations causes risk of dilution, resulting in a reduction of the antibacterial activity and potential loss of stability of the Mupirocin in the ointment.

No drug interaction has been identified with Mupirocin ointment.

Reproduction studies on Mupirocin ointment in animals have revealed no evidence of harm to the foetus. As there is no clinical experience on it’s use during pregnancy, Mupirocin ointment should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.

It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mupirocin ointment is administered to a nursing woman.

There is currently limited data with overdose of Mupirocin ointment. In the event of overdose, the patient should be treated supportively with appropriate monitoring as necessary.

Keep below 25° C temperature, protected from light and moisture. Do not keep in freeze. Keep out of the reach of children.

Mupirocin ointment is indicated for the topical treatment of impetigo (skin diseases) due to Staphylococcus aureus and Streptococcus pyogenes. It is also indicated in folliculitis, furunculosis.

Topical Antibiotic preparations

Mupirocin is a naturally occurring antibiotic. This antibacterial agent is produced by fermentation using the organism Pseudomonas fluorescens. It is active against a wide range of bacteria (e.g. Staphylococcus aureus including methicillin-resistant strains and Streptococcus pyogenes) those responsible for the majority of skin infections. It is also active against gram-negative pathogens, such as Escherichia coli and Haemophilus influenzae. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase.

A small amount of Bactropen ointment should be applied to the affected area 3 times daily for up to 10 days. The safety and effectiveness of Mupirocin ointment have been established in the age range of 2 months to 16 years.

Reported side effects are burning, stinging or pain, itching and some patient may be suffered rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis and increased exudate.

The drug is contraindicated in individuals with a history of hypersensitivity reactions to Mupirocin or any of the components of the preparation.

Mupirocin ointment is not for ophthalmic or intra-nasal use. As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. When Mupirocin is used on the face care should be taken to avoid the eyes. This is not suitable in conjunction with cannulae and at the site of central venous cannulation. In the event of a sensitization or severe local irritation from Mupirocin ointment, usage should be discontinued and appropriate alternative therapy for the infection instituted. Mixing of Mupirocin ointment with other preparations causes risk of dilution, resulting in a reduction of the antibacterial activity and potential loss of stability of the Mupirocin in the ointment.

No drug interaction has been identified with Mupirocin ointment.

Reproduction studies on Mupirocin ointment in animals have revealed no evidence of harm to the foetus. As there is no clinical experience on it’s use during pregnancy, Mupirocin ointment should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.

It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mupirocin ointment is administered to a nursing woman.

There is currently limited data with overdose of Mupirocin ointment. In the event of overdose, the patient should be treated supportively with appropriate monitoring as necessary.

Keep below 25° C temperature, protected from light and moisture. Do not keep in freeze. Keep out of the reach of children.

Tramadol is used for the treatment of moderate to severe painful conditions. These include:

• Postoperative pain
• Colic and spastic pain
• Cancer pain
• Joint pain
• Neck and back pain
• Pain associated with osteoporosis.

Opioid analgesics

Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.

Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.

Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.

Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.

Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.

Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.

Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.

Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.

Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.

Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.

Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.

Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.

In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.

Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.

In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.

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

Central Depolarizing muscle relaxants, Centrally acting Skeletal Muscle Relaxants

Tolperisone Hydrochloride is a centrally acting muscle relaxant, which acts on the central nervous system and used mainly for the treatment of elevated muscle tone and tension as well as for certain circulation problems in the extremities.

The recommended dose is as follows:

• Adult: 50-150 mg three times daily according to the individual requirement and tolerance of the patient.
• Children (from 3 months to 6 years): 5 mg/kg/day in three divided doses.
• Children (from 6 to 14 years): 2-4 mg/kg/day in three divided doses. or, as directed by the registered physician.

Possible side-effects include sometimes muscular weakness, headache, nausea, vomiting and rarely hypersensitivity reactions (itching, redness of the skin, skin rash) may occur.

It is contraindicated in patients with a history of hypersensitivity to any component of the product, myasthenia gravis and nursing mother.

In case of children, the prescribed dose and duration of treatment should closely be observed.

Concomitant use of methocarbamol with Tolperisone Hydrochloride has been reported to cause disturbance of visual accommodation.

Tolperisone Hydrochloride should be used in pregnancy according to the physician's advice. It should not be used during breast feeding.

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

H2 receptor antagonist

Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.

Ranitidine Tablet & Syrup:

Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.

Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.

Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.

Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.

Maintenance: 150 mg at night for preventing recurrences.

Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.

Ranitidine IV injection & IV Infusion:

Ranitidine injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.

In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Ranitidine injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.

Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day. Safety and effectiveness of Ranitidine injection have not been established in case of children.

Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.

Patients hypersensitive to Ranitidine

Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.

Delayed absorption and increased peak serum concentration with propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.

Pregnancy: Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.

Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.

Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.

Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.

Slow IV inj: Ranitidine 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln.

Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

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

Bromhexine is indicated in the treatment of respiratory tract disorders associated with productive cough. This include-

• Tracheobronchitis
• Bronchitis with emphysema
• Bronchiectasis
• Bronchitis with bronchospasm
• Chronic inflammatory pulmonary conditions and
• Pneumoconiosis.

Cough expectorants & mucolytics

Bromhexine Hydrochloride is an oral mucolytic agent. It disrupts the structure of acid mucopolysaccharide fibres in mucoid sputum and produces less viscous mucus, which makes easier the expectoration. It is rapidly & completely absorbed from the gastrointestinal tract. It is widely distributed into the body tissues.

The recommended doses for adults and children are stated below:

• Adult & Children over 12 years: 10 ml (2 teaspoons) 3 times daily
• Children 6-12 years: 5 ml (1 teaspoon) 3 times daily
• Children 2-6 years: 2.5 ml (1/2 teaspoon) 3 times daily
• Bromhexine Hydrochloride is not recommended for children under 2 years of age without advice.

Gastrointestinal side effects may occur occasionally. A transient rise in serum aminotransferase values has been reported. Other reported side effects include-headache, vertigo (dizziness) and allergic reactions.

It is contraindicated in known hypersensitivity to Bromhexine Hydrochloride or any of the ingredients of this product.

Since mucolytics may disrupt the gastric mucosa bromhexine should be used with care in patients with a history of peptic ulcer disease. Care is also advisable in asthmatic patients. Clearance of bromhexine and its metabolites may be reduced in patients with severe hepatic or renal impairment.

There are no known significant interactions with other drugs.

Use in Pregnancy: Special care is recommended during pregnancy. The benefits of bromhexine must be assessed against possible effects on children.

Use in Lactation: Bromhexine is expected to enter breast milk. Therefore it is not recommended that bromhexine be taken by lactating mothers.

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

Bambuterol is indicated for Bronchial asthma, chronic bronchitis, emphysema & other lung diseases where bronchospasm is a complicating factor.

Short-acting selective & β2-adrenoceptor stimulants

Bambuterol is an adrenergic β2 receptor agonist which predominantly stimulates β2 receptor, thus producing relaxation of bronchial smooth muscle, inhibition of release of endogenous spasmogens, inhibition of edema caused by endogenous mediators & increased mucocilliary clearance.

Adult or Elderly: The recommended initial dose 10 mg. The dose may be increased to 20 mg after 1-2 weeks depending on the clinical effect.

Children 2-5 years: The recommended normal dose 10 mg (10 ml syrup).

Children 6-12 years: The recommended normal dose 10 mg (10 ml syrup). The dose may be increased to 20 mg.

Common side effects are fatigue, nausea, palpitation, headache, dizziness & tremor.

Bambuterol is contraindicated in hepatic impairment, liver cirrhosis or severely impaired liver function.

Reduce the dose in renal impairment, avoid in cirrhosis and severe hepatic impairment. Caution should be observed in patients with severe cardiovascular disorder, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.

Succinylcholin, MAOIs (monoamine oxidase inhibitors), β2-blockers, corticosteroids, diuretics, muscle relaxants, sympathomimetic xanthine derivatives. Bambuterol may partly or totally inhibit the effect of β-blockers.

Pregnant women: There is no definite evidence of ill consequence during pregnancy. Nevertheless, the drug should not be used during the first trimester of pregnancy, unless the expected benefit is thought to outweigh any possible risk to the fetus.

Lactating mother: It is excreted in breast milk. So, patients taking this drug should not breast-feed.

Impaired renal function (GFR 50 ml/min): The recommended starting dose is 5 mg, which may be increased to 10 mg after one to two weeks, depending on the clinical effect.

Impaired hepatic function: Not recommended because of unpredictable conversion to terbutaline.

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

Bambuterol is indicated for Bronchial asthma, chronic bronchitis, emphysema & other lung diseases where bronchospasm is a complicating factor.

Short-acting selective & β2-adrenoceptor stimulants

Bambuterol is an adrenergic β2 receptor agonist which predominantly stimulates β2 receptor, thus producing relaxation of bronchial smooth muscle, inhibition of release of endogenous spasmogens, inhibition of edema caused by endogenous mediators & increased mucocilliary clearance.

Adult or Elderly: The recommended initial dose 10 mg. The dose may be increased to 20 mg after 1-2 weeks depending on the clinical effect.

Children 2-5 years: The recommended normal dose 10 mg (10 ml syrup).

Children 6-12 years: The recommended normal dose 10 mg (10 ml syrup). The dose may be increased to 20 mg.

Common side effects are fatigue, nausea, palpitation, headache, dizziness & tremor.

Bambuterol is contraindicated in hepatic impairment, liver cirrhosis or severely impaired liver function.

Reduce the dose in renal impairment, avoid in cirrhosis and severe hepatic impairment. Caution should be observed in patients with severe cardiovascular disorder, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.

Succinylcholin, MAOIs (monoamine oxidase inhibitors), β2-blockers, corticosteroids, diuretics, muscle relaxants, sympathomimetic xanthine derivatives. Bambuterol may partly or totally inhibit the effect of β-blockers.

Pregnant women: There is no definite evidence of ill consequence during pregnancy. Nevertheless, the drug should not be used during the first trimester of pregnancy, unless the expected benefit is thought to outweigh any possible risk to the fetus.

Lactating mother: It is excreted in breast milk. So, patients taking this drug should not breast-feed.

Impaired renal function (GFR 50 ml/min): The recommended starting dose is 5 mg, which may be increased to 10 mg after one to two weeks, depending on the clinical effect.

Impaired hepatic function: Not recommended because of unpredictable conversion to terbutaline.

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

Bambuterol is indicated for Bronchial asthma, chronic bronchitis, emphysema & other lung diseases where bronchospasm is a complicating factor.

Short-acting selective & β2-adrenoceptor stimulants

Bambuterol is an adrenergic β2 receptor agonist which predominantly stimulates β2 receptor, thus producing relaxation of bronchial smooth muscle, inhibition of release of endogenous spasmogens, inhibition of edema caused by endogenous mediators & increased mucocilliary clearance.

Adult or Elderly: The recommended initial dose 10 mg. The dose may be increased to 20 mg after 1-2 weeks depending on the clinical effect.

Children 2-5 years: The recommended normal dose 10 mg (10 ml syrup).

Children 6-12 years: The recommended normal dose 10 mg (10 ml syrup). The dose may be increased to 20 mg.

Common side effects are fatigue, nausea, palpitation, headache, dizziness & tremor.

Bambuterol is contraindicated in hepatic impairment, liver cirrhosis or severely impaired liver function.

Reduce the dose in renal impairment, avoid in cirrhosis and severe hepatic impairment. Caution should be observed in patients with severe cardiovascular disorder, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.

Succinylcholin, MAOIs (monoamine oxidase inhibitors), β2-blockers, corticosteroids, diuretics, muscle relaxants, sympathomimetic xanthine derivatives. Bambuterol may partly or totally inhibit the effect of β-blockers.

Pregnant women: There is no definite evidence of ill consequence during pregnancy. Nevertheless, the drug should not be used during the first trimester of pregnancy, unless the expected benefit is thought to outweigh any possible risk to the fetus.

Lactating mother: It is excreted in breast milk. So, patients taking this drug should not breast-feed.

Impaired renal function (GFR 50 ml/min): The recommended starting dose is 5 mg, which may be increased to 10 mg after one to two weeks, depending on the clinical effect.

Impaired hepatic function: Not recommended because of unpredictable conversion to terbutaline.

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

Cough expectorants & mucolytics

Ambroxol is the active metabolite of bromhexine and it has been proven that this metabolite possesses a greater bronchosecretolytic effect than bromhexine. It improves sputum rheology by hydrating mechanism leading to liquefaction of mucus in the lumen of respiratory tract, thus facilitating expectoration of mucus and reducing dyspnea. It stimulates production of phospholipids of surfactant by alveolar cells, thus contributing to the lowering of superficial tension in the alveoli. It also reduces bronchial hyperactivity. Ambroxol has anti inflammatory properties owing to the inhibitory effect on the production of cellular cytokines and arachidonic acid metabolites. In patients with COPD it traditionally improves airway patency.

Average daily dose (preferably after meal):

Pediatric Drops:

• 0-6 months: 0.5 ml 2 times a day
• 6-12 months: 1 ml 2 times a day
• 1-2 years: 1.25 ml 2 times a day

Syrup:

• 2-5 years: 2.5 ml (1/2 teaspoonful) 2-3 times a day
• 5-10 years: 5 ml (1 teaspoonful) 2-3 times a day
• 10 years and adults: 10 ml (2 teaspoonful) 3 times a day.

Sustained release capsule: Adult and children over 12 years old: 1 capsule once daily.

Gastrointestinal side effects like epigastric pain, stomach overfill feeling may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema have been reported.

Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.

Ambroxol should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.

Ambroxol should not be taken simultaneously with antitussives (e.g.Codeine) because phlegm, which has been liquefied by Ambroxol might not be expectorated.

Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use it in pregnancy, especially during the1st trimester. Safety during lactation has not been established yet.

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

Specific mineral preparations

Zinc sulphate monohydrate is an essential trace element and is involved in a number of body enzyme systems. The body needs zinc for normal growth and health. Zinc is also vital for sexual maturation and reproduction, dark vision adaptation, olfactory and gustatory activity, insulin storage & release and for a variety of host immune defenses. Zinc deficiency may lead to impaired immune function, delayed wound healing, a decrease in sense of taste and smell, a reduced ability to fight infections, poor night vision, increased risk of abortion, alopecia, mental lethargy, skin changes and poor development of reproductive organs.

Child under 10 kg: 5 ml (1 teaspoonful) 2 times daily after food.
Child between 10-30 kg: 10 ml (2 teaspoonfuls) 1-3 times daily after food.
Adults and child over 30 kg: 20 ml (4 teaspoonfuls) 1-3 times daily after food.

This drug is most effective if they are taken at least 1 hour before or 2 hour after meals. However, if causes stomach upset, this may be taken with a meal.

For dispersible tablet-

• Place the tablet in a teaspoon
• Add adequate amount of water
• Let the tablet dissolve completely
• Give the entire spoonful solution

Zinc may cause nausea, vomiting, diarrhoea, stomach upset, heartburn and gastritis.

It is contraindicated in those who are hypersensitive to any component of the ingredient of this preparation.

In acute renal failure, zinc accumulation may occur in body; so dose adjustment is needed.

Concomitant intake of a tetracycline and zinc may decrease the absorption of both the tetracycline and zinc. Similarly concomitant administration of zinc and quinolone drug may also decrease the absorption of both. Concomitant intake of penicillamine and zinc may decrese absorption of zinc.

The safety of this product in human pregnancy has not been established. Zinc crosses the placenta and is present in breast milk.

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.