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Drugs for subcutaneous and mycoses

Itraconazole is an orally active triazole antifungal agent, having broad-spectrum activity and a favourable pharmacokinetic profile. Itraconazole inhibits cytochrome p-450 dependent enzymes resulting in impairment of the biosynthesis of ergoesterol, a major component of the cell membrane of yeast and fungal cells.

Tinea corporis, Tinea cruris: 100 mg daily for 2 weeks.

Tinea pedis, Tinea manus: 100 mg daily for 4 weeks.

Vulvovaginal candidiasis: 200 mg twice daily for 1 day or 200 mg daily for 3 days.

Fungal keratitis: 200 mg daily for 3 weeks.

Pityriasis versicolor: 200 mg daily for 1 week.

Oropharyngeal candidiasis: 100 mg daily (200 mg for AIDS patients) for 15 days.

Onychomycosis: 200 mg daily for 3 months; or 200 mg twice daily for 7 days (course), subsequent courses repeated after 21 day interval; fingernails 2 courses and toenails 3 courses.

Histoplasmosis: 200 mg 1-2 times daily.

Systemic Infections: (Aspergillosis, Candidiasis and Cryptococcus when other drugs are effective) 200 mg once daily, increased in invasive or in cryptococcal meningitis to 200 mg twice daily.

Antifungal prophylaxis: To prevent systemic fungal infection in severely neutropenic patients: 100mg daily. Or as directed by the physician.

Nausea, abdominal pain, dyspepsia, constipation, headache, dizziness, raised liver enzymes, hepatitis, cholestatic jaundice, peripheral neuropathy have been reported.

The drug is contraindicated in patients with a known history of hypersensitivity to it. The drug is also contraindicated in pregnant women and patients with known severe hepatic disease. It is also contraindicated with Rifampicin therapy.

Hepatic enzyme value should be monitored in patients with preexisting hepatic function abnormalities. It should also be done periodically in all patients receiving continuous treatment for more than one month or at any time a patients develops sign and symptoms suggestive liver dysfunction.

Itraconazole inhibits the metabolism of Cyclosporine and Warfarin. Interaction with Terfenadine, Phenobarbitone, Midazolam has been reported.

Not recommended during pregnancy & lactation, unless otherwise indicated by the physician.

The efficacy and safety of the Itraconazole capsule have not been established in pediatric patients.

There is no experience of overdosage with itraconazole.

Store below 30°C, away from light & in a dry place. Keep out of the reach of children.

Brinzolamide Ophthalmic Suspension is indicated as monotherapy, or as adjunctive therapy to beta-blockers in the treatment of elevated intraocular pressure in ocular hypertension, or open-angle glaucoma.

Drugs for miotics and glaucoma

Carbonic anhydrase (CA) is an enzyme found in many tissues of the body including the eye. It catalyses the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid. It exists as a number of isoenzymes, the most active being carbonic anhydrase II (CA-II), found primarily in red blood cells, but also in other tissues. Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humor secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fuid transport.

Following topical ocular administration, brinzolamide inhibits aqueous humor formation and reduces elevated intraocular pressure. Elevated intraocular pressure is a major risk factor in the pathogenesis of optic nerve damage and glaucomatous visual feld loss.

The recommended dose is one drops of this eye drop in the conjunctival sac of the affected eye(s) twice daily. Some patients may have a better response with one drop three times a day. Shake well before use.

Reported side effects are blurred vision and bitter, sour or unusual taste. Other side effects are blepharitis, dermatitis, dry eye, foreign body sensation, headache, hyperemia, ocular discharge, ocular discomfort, ocular keratitis, ocular pain, ocular pruritus and rhinitis.

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

In patients treated with oral carbonic anhydrase inhibitors, rare instances to drug interactions have occurred with high-dose salicylate therapy. Therefore, the potential for such drug interactions should be considered in patients receiving Brinzolamide.

Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Brinzolamide 1% ophthalmic suspension should be used during pregnancy only if the benefit justifies the potential risk to the fetus.

Use in lactation: It is not known whether Brinzolamide 1% ophthalmic suspension is excreted in human milk. So, lactating mother should discontinue nursing or to discontinue the drug, depending upon the importance of the drug to the mother.

Although no human data are available, electrolyte imbalance, development of an acidosis state, and possible nervous system effects may occur following oral administration of an overdose. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.

Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used more than four weeks after first opening of the bottle. Protect from freezing.

This is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Drugs for miotics and glaucoma

Brinzolamide is a carbonic anhydrase inhibitor which reduce intraocular pressure (IOP) by decreasing aqueous humor secretion in the ciliary processes of the eye.

Brimonidine Tartrate is an alpha 2 adrenergic receptor agonist which reduces IOP by decreasing aqueous humor production and increasing uveoscleral outflow.

Instill one drop in the affected eye(s) three times daily. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. Shake well before use.

The most commonly reported side effects include blurred vision, eye irritation, bad taste and dry mouth.

It is contraindicated in patients who are hypersensitivity to Brinzolamide, Brimonidine Tartrate, or to any ingredient in the formulation and Neonates and Infants (under the age of 2 years).

Shake well before use. For ophthalmic use only. Contact lenses should be removed during instillation of Brinzolamide and Brimonidine Tartrate ophthalmic suspension, but may be reinserted 15 minutes after instillation.

In patients treated with this drop rare instances to drug interactions have occurred with high-dose salicylate therapy, CNS Depressants, Antihypertensives/ Cardiac Glycosides, Tricyclic Antidepressants, Monoamine Oxidase Inhibitors. Therefore, the potential for such drug interactions should be considered in patients receiving Brinzolamide + Brimonidine Tartrate .

Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Brinzolamide and Brimonidine Tartrate ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether Brinzolamide or Brimonidine Tartrate are excreted in human milk. Caution should be exercised while giving this ophthalmic suspension to a nursing mother.

Use in children: Safety & effectiveness in children below the age of 2 years have not been established.

Use in elderly patients: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.

Although no human data are available, electrolyte imbalance, development of an acidotic state, and possible nervous system effects may occur following an oral overdose of Brinzolamide. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored. Very limited information exists on accidental ingestion of Brimonidine Tartrate in adults; the only adverse event reported to date has been hypotension. Symptoms of Brimonidine Tartrate overdose have been reported in neonates, infants, and children receiving Brimonidine Tartrate as part of medical treatment of congenital glaucoma or by accidental oral ingestion. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.

Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used more than one month after first opening of the bottle. Shake well before use & do not freeze.

This Eye Drops is indicated for the treatment of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta blockers.

Drugs for miotics and glaucoma

Dorzolamide, a carbonic anhydrase inhibitor, has actions similar to acetazolamide. By inhibiting carbonic anhydrase in the ciliary processes of the eye, dorzolamide decreases aqueous humor secretion. Used together, there is additional intraocular pressure reduction compared to using either component alone, but the reduction is not as much as concomitant admin of dorzolamide tid and timolol bid.

Timolol maleate, a nonselective β-adrenergic blocker, reduces aqueous humor formation.

Instill one drop in the conjunctival sac of the affected eye(s) twice daily.

Mild burning, ocular hyperemia, blurred vision may occur.

Contraindicated in patients who are hypersensitive to any of the components of this preparation.

For ophthalmic use only. Patients should remove their contact lenses prior to instilling this preparation and should not insert their lenses until 15 minutes after instillation of the preparation.

Additive hypotension and bradycardia with oral calcium channel blockers, catecholamine-depleting drugs or β-blockers, antiarrhythmics (e.g. amiodarone), digitalis glycosides, parasympathomimetics, narcotics and MAOIs. Additive systemic side effects with oral carbonic anhydrase or β-blockers; avoid concurrent use. Additive systemic β-blockade with CYP2D6 inhibitors (e.g. quinidine, SSRIs) and timolol.

Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. This Eye Drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 

Use in lactation: Caution should be exercised when This Eye Drops is administered to a nursing mother.

Use in children: Safety and effectiveness in children below the age of 2 years have not been established. 

Use in elderly patients: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.

Store between 15-30°C. Protect from light.

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.

Multi-vitamin & Multi-mineral combined preparations

This is a film coated tablet, which combines 32 high potency vitamins and minerals. This preparation maintains a healthy body and active life-style.

One tablet daily or as recommended by the physician.

Generally, this preparation is well tolerated. Diarrhoea may occasionally occur during treatment with beta carotene and the skin may assume a slightly yellow discoloration. Vitamin C and vitamin E may cause diarrhoea and other gastrointestinal disturbances.

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

Long term intake of high level of vitamin A (excluding that sourced from beta carotene) may increase the risk of osteoporosis in postmenopausal women.

No drug interactions have been reported.

Recommended by the consultation with physician.

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.

Supplements & adjuvant therapy

Astaxanthin acts as an antioxidant by dual mode of action. It suppresses singlet oxygen and also inhibits lipid peroxidation. By these actions it reduces the harmful free radicals. Therefore acts as a very strong antioxidant. Astaxanthin is absorbed by passive diffusion into the intestinal epithelium alongside fatty acids. Then it is incorporated into lipoproteins, transported to the liver, via lymph and blood and partly resecreted with lipoproteins. More than 70% of the Astaxanthin is contained in high-density lipoprotein part of plasma. Highest concentration of Astaxanthin is in the small intestine, followed by subcutaneous fat, abdominal fat, spleen, liver, heart, kidney and skin and lowest in the muscles.

Adults (18 years and older): Daily dose is 4 mg. Should be taken along with or immediately prior to meals in the morning.

• 4 mg: As a strong antioxidant, improves cardiovascular health (Atherosclerosis, reduce cholesterol), improves immune function.
• 4-8 mg: Improves condition of skin, protects skin from sun damage (Reduce wrinkles, pimples and other signs of aging), improves recovery from central nervous systehn injuries and protects eyes from cataracts and macular degeneration.
• 8-12 mg: Reduces inflammation (Arthritis)
• 16 mg: Reduces risk of infertility

No severe side effects have been reported yet.

Contraindicated for those with known allergies to Astaxanthin.

Concomitant intake of Astaxanthin with Cholestyramine, Colestipol, Mineral oil, Orlistat may reduce the absorption rate of Astaxanthin.

Both pregnant women and lactating mothers should avoid Astaxanthin supplements as no data on safety has been found yet.

No case of overdose has occurred with Astaxanthin.

Store in cool and dry place, away from direct light. Keep out of reach of children.

Other Anti-anginal & Anti-ischaemic drugs, Statins

Atorvastatin is a selective inhibitor of HMG-CoA reductase. This enzyme is the rate-limiting enzyme responsible for the conversion of HMG-CoA to mevalonate, a precursor of sterols, including cholesterol. Atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.

Primary hypercholesterolaemia and combined hyperlipidaemia-

• Adults: Usually 10 mg once daily; if necessary, may be increased at intervals of at least 4 weeks to max. 80 mg once daily.
• Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 20 mg once daily.

Familial hypercholesterolaemia-

• Adults: Initially 10 mg daily, increased at intervals of at least 4 weeks to 40 mg once daily; if necessary, further increased to max. 80 mg once daily (or 40 mg once daily combined with anion-exchange resin in heterozygous familial hypercholesterolaemia).
• Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 80 mg once daily.

Prevention of cardiovascular events-

• Adults: Initially 10 mg once daily adjusted according to response.

Atorvastatin is generally well-tolerated. The most frequent side effects related to Atorvastatin are constipation, flatulence, dyspepsia, abdominal pain. Other side effects includes infection, headache, back pain, rash, asthenia, arthralgia, myalgia.

Atorvastatin should not be used in patient with hypersensitivity to any component of this medication. Atorvastatin is contraindicated in active liver disease or unexplained persistent elevations of serum transaminases. It is also contraindicated in patient with history of serious adverse reaction to prior administration of HMG-CoA reductase inhibitors.

Liver effects: Liver function tests should be performed before the initiation of treatment and periodically thereafter. Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol or have a history of liver disease. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.

The risk of myopathy during treatment with Atorvastatin is increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals and niacin. No clinically significant interactions were seen when Atorvastatin was administered with antihypertensives or hypoglycemic agents. Patients should be closely monitored if Atorvastatin is added to digoxin, erythromycin, oral contraceptives, colestipol, antacid and warfarin.

Pregnancy: Atorvastatin is contraindicated during pregnancy. Safety in pregnant women has not been established. No controlled clinical trials with atorvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. Animal studies have shown toxicity to reproduction. Maternal treatment with atorvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis. Atorvastatin should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with atorvastatin should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant

Lactation: It is not known whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.

Hepatic impairment: Atorvastatin should be used with caution in patients with hepatic impairment.

Pediatric use: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day. Atorvastatin is not indicated in the treatment of patients below the age of 10 years.

Specific treatment is not available for atorvastatin overdose. The patient should be treated symptomatically and supportive measures instituted, as required. Liver function tests should be performed and serum CK levels should be monitored. Due to extensive atorvastatin binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.

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

Other Anti-anginal & Anti-ischaemic drugs, Statins

Atorvastatin is a selective inhibitor of HMG-CoA reductase. This enzyme is the rate-limiting enzyme responsible for the conversion of HMG-CoA to mevalonate, a precursor of sterols, including cholesterol. Atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.

Primary hypercholesterolaemia and combined hyperlipidaemia-

• Adults: Usually 10 mg once daily; if necessary, may be increased at intervals of at least 4 weeks to max. 80 mg once daily.
• Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 20 mg once daily.

Familial hypercholesterolaemia-

• Adults: Initially 10 mg daily, increased at intervals of at least 4 weeks to 40 mg once daily; if necessary, further increased to max. 80 mg once daily (or 40 mg once daily combined with anion-exchange resin in heterozygous familial hypercholesterolaemia).
• Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 80 mg once daily.

Prevention of cardiovascular events-

• Adults: Initially 10 mg once daily adjusted according to response.

Atorvastatin is generally well-tolerated. The most frequent side effects related to Atorvastatin are constipation, flatulence, dyspepsia, abdominal pain. Other side effects includes infection, headache, back pain, rash, asthenia, arthralgia, myalgia.

Atorvastatin should not be used in patient with hypersensitivity to any component of this medication. Atorvastatin is contraindicated in active liver disease or unexplained persistent elevations of serum transaminases. It is also contraindicated in patient with history of serious adverse reaction to prior administration of HMG-CoA reductase inhibitors.

Liver effects: Liver function tests should be performed before the initiation of treatment and periodically thereafter. Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol or have a history of liver disease. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.

The risk of myopathy during treatment with Atorvastatin is increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals and niacin. No clinically significant interactions were seen when Atorvastatin was administered with antihypertensives or hypoglycemic agents. Patients should be closely monitored if Atorvastatin is added to digoxin, erythromycin, oral contraceptives, colestipol, antacid and warfarin.

Pregnancy: Atorvastatin is contraindicated during pregnancy. Safety in pregnant women has not been established. No controlled clinical trials with atorvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. Animal studies have shown toxicity to reproduction. Maternal treatment with atorvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis. Atorvastatin should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with atorvastatin should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant

Lactation: It is not known whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.

Hepatic impairment: Atorvastatin should be used with caution in patients with hepatic impairment.

Pediatric use: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day. Atorvastatin is not indicated in the treatment of patients below the age of 10 years.

Specific treatment is not available for atorvastatin overdose. The patient should be treated symptomatically and supportive measures instituted, as required. Liver function tests should be performed and serum CK levels should be monitored. Due to extensive atorvastatin binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.

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

Other Anti-anginal & Anti-ischaemic drugs, Statins

Atorvastatin is a selective inhibitor of HMG-CoA reductase. This enzyme is the rate-limiting enzyme responsible for the conversion of HMG-CoA to mevalonate, a precursor of sterols, including cholesterol. Atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.

Primary hypercholesterolaemia and combined hyperlipidaemia-

• Adults: Usually 10 mg once daily; if necessary, may be increased at intervals of at least 4 weeks to max. 80 mg once daily.
• Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 20 mg once daily.

Familial hypercholesterolaemia-

• Adults: Initially 10 mg daily, increased at intervals of at least 4 weeks to 40 mg once daily; if necessary, further increased to max. 80 mg once daily (or 40 mg once daily combined with anion-exchange resin in heterozygous familial hypercholesterolaemia).
• Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 80 mg once daily.

Prevention of cardiovascular events-

• Adults: Initially 10 mg once daily adjusted according to response.

Atorvastatin is generally well-tolerated. The most frequent side effects related to Atorvastatin are constipation, flatulence, dyspepsia, abdominal pain. Other side effects includes infection, headache, back pain, rash, asthenia, arthralgia, myalgia.

Atorvastatin should not be used in patient with hypersensitivity to any component of this medication. Atorvastatin is contraindicated in active liver disease or unexplained persistent elevations of serum transaminases. It is also contraindicated in patient with history of serious adverse reaction to prior administration of HMG-CoA reductase inhibitors.

Liver effects: Liver function tests should be performed before the initiation of treatment and periodically thereafter. Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol or have a history of liver disease. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.

The risk of myopathy during treatment with Atorvastatin is increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals and niacin. No clinically significant interactions were seen when Atorvastatin was administered with antihypertensives or hypoglycemic agents. Patients should be closely monitored if Atorvastatin is added to digoxin, erythromycin, oral contraceptives, colestipol, antacid and warfarin.

Pregnancy: Atorvastatin is contraindicated during pregnancy. Safety in pregnant women has not been established. No controlled clinical trials with atorvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. Animal studies have shown toxicity to reproduction. Maternal treatment with atorvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis. Atorvastatin should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with atorvastatin should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant

Lactation: It is not known whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.

Hepatic impairment: Atorvastatin should be used with caution in patients with hepatic impairment.

Pediatric use: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day. Atorvastatin is not indicated in the treatment of patients below the age of 10 years.

Specific treatment is not available for atorvastatin overdose. The patient should be treated symptomatically and supportive measures instituted, as required. Liver function tests should be performed and serum CK levels should be monitored. Due to extensive atorvastatin binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.

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

Multi-vitamin & Multi-mineral combined preparations, Specific mineral & vitamin combined preparations

Vitamins and minerals are essential for normal metabolic functions including hematopoiesis. The members of vitamin B-group are components of enzyme system that regulate various stages of carbohydrate, fat and protein metabolism, each of the components playing a specific biological role. Vitamin C is involved in tissue repair and collagen formation. Vitamin A plays an essential role in the function of retina and is essential for growth and differentiation of epithelial tissue. Vitamin E is an antioxidant which preserves essential cellular constituents. Vitamin D is supplemented for prevention and cure of nutritional and metabolic rickets and for treatment of hypoparathyroidism. Iron, Copper, Manganese, Zinc serve as catalysts in enzyme systems which perform vital cellular functions.

Orally one tablet daily for adult and children over 5 years of age or as directed by the physicians.

Side effects have been reported with specific vitamins & minerals, but at level substantially higher than those in this tablet. Iron has been associated with gastrointestinal intolerance in some patients.

This is contraindicated in patients hypersensitive to any of its components. This is not intended for treatment of severe specific deficiencies of vitamins or minerals. It is not recommended for patients undergoing treatment with levodopa as pyridoxine decreases the efficacy of levodopa. During the first trimester of pregnancy, larger doses of vitamin A (more than 10 tablets per day) may be teratogenic.

Not intended for treatment of pernicious anemia or other megaloblastic anemia where vitamin B12 is deficient.

During the first trimester of pregnancy, recommended daily dose should not be exceeded. Because larger doses of Vitamin-A (multiple tablets per day) may be teratogenic.

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

Multi-vitamin & Multi-mineral combined preparations

This is a film coated tablet, which combines 32 high potency vitamins and minerals. This preparation maintains a healthy body and active life-style.

One tablet daily or as recommended by the physician.

Generally, this preparation is well tolerated. Diarrhoea may occasionally occur during treatment with beta carotene and the skin may assume a slightly yellow discoloration. Vitamin C and vitamin E may cause diarrhoea and other gastrointestinal disturbances.

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

Long term intake of high level of vitamin A (excluding that sourced from beta carotene) may increase the risk of osteoporosis in postmenopausal women.

No drug interactions have been reported.

Recommended by the consultation with physician.

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

This Syrup is indicated for the treatment and prevention of vitamin and minerals deficiencies.

Multi-vitamin & Multi-mineral combined preparations

This syrup contains balanced amounts of all the important vitamins, essential minerals and trace elements. Vitamins are essential substances that are supplied to the body in food. Minerals are indispensable for the metabolism and for growth and regeneration of the body. Finally, trace elements are vital substances which are required by the body in minute quantities but which are not always supplied in the daily food in adequate amounts.

This syrup is used for the prevention and rapid elimination of general vitamin deficiencies. This syrup is used when there is an increased need for vitamins and minerals, particularly during illness, at times of particular exertion and when increased performance is required.

The spectrum of essential nutrients supports healthy development, strong immune function, and emotional and mental vitality. Supplementing a child's diet is the only way to ensure that all nutritional needs are fulfilled.

This syrup provides the optimal dosage of the essential vitamins and minerals with trace elements for infants and children . The great taste makes taking supplements an easy part of a child's daily routine.

For infants up to 1 year: 1 teaspoon syrup daily
For children 1-4 years: 1-2 teaspoon syrup daily
For children 4-12 years: 2-3 teaspoon syrup daily
For adults: 3-4 teaspoon syrup daily

This syrup is generally well tolerated.

Contraindicated in patients who are hypersensitive to any of its components.

Supplement should not be used in over dosage or continuously except recommended by physicians.

No such interactions have been reported.

Specific information is not available.

Keep in cool, dry place and away from light.

This is specially formulated for the prevention and treatment of vitamin and mineral deficiencies for adults over 45 years of age. This Silver is also indicated to meet the increase demands of vitamin and minerals for adults over 45 years of age.

Multi-vitamin & Multi-mineral combined preparations

This preparation is a comprehensive well-balanced multivitamin and multimineral preparation scientifically adjusted and designed to serve as the complete nutritional program for the elderly people. This preparation maintains a healthy body and active lifestyle and keeps proper nutrition covered for elderly people

One tablet once daily with food or as indicated by the physician.

Generally, this preparation is well tolerated. Allergic sensitization has been reported following oral administration of folic acid. Vitamin C and vitamin E may cause diarrhea and other gastrointestinal disturbances.

This product is contraindicated in patients with known hypersensitivity to any of the ingredients. Do not take this product if taking other vitamin A supplements.

Long term intake of high levels of vitamin A (excluding that sourced from beta carotene) may increase the risk of osteoporosis in postmenopausal women.

No drug interactions have been reported.

Recommended by the consultation with physician.

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

This preparation is indicated for Age-related Eye Disease. This is an advanced new antioxidant supplement formulated to provide nutritional support for the eye. The formulation contains essential antioxidant vitamins, minerals, and Lutein.

Anti-oxidant Multivitamin Multimineral preparations, Antioxidant vitamins & minerals for eye

Vitamin C is highly concentrated in the lens compared to blood. A long term Vitamin C supplement use (10+ years) has been associated with reduced risk of cataract. Vitamin C has an important role in harmful free radicals scavenging activity.

In study, it is found that high serum Vitamin E concentrations have been associated with reduced risk of cataract (exact mechanism of action is not still established). As an antioxidant vitamin, it also plays an important role in harmful free radicals scavenging activity.

Lutein is a carotenoid, specially concentrated in the macula. Clinical and animaldata indicates that this caretenoid could protect the macula from oxidative or light damage.

Although exact mechanism of action is not clear but onelarge study has found that high levels of dietary Lutein is associated with relatively lower risk of AMD (Age-Related Macular Degeneration). Zinc is an essential trace element involved in many enzymes system.

Symptoms of less severe deficiency include distorted or absent perception of taste, smell and poor wound healing. Severe deficiency causes skin lesion, alopecia, diarrhea, increased susceptibility to infection and failure to thrive in children.

Copper plays important role in growth, skeletal integrity, and development of nervous system. As a part of various enzymes, it takes part in numerous metabolic conversions.

One capsule, one or two times daily or as directed by the physician

Large doses of Vitamin C are reported to cause diarrhoea and other gastrointestinal disturbances. Large doses of Vitamin E may cause diarrhoea, abdominal pain, and other gastrointestinal disturbances; fatigue and weakness have also been reported. Side effects of Zinc salt are abdominal pain and dyspepsia.

It is contraindicated in persons with a history of hypersensitivity to any of its ingredients.

Vitamin C should be given with care to patients with hyperoxaluria. In patients taking oral anticoagulants or oestrogen, Vitamin E should be given carefully because it has been found to antagonise the effects of vitamin K leading to an increase in blood clotting time in these patient

No drug interaction has been reported.

Recommended in Pregnancy & Lactation.

Store in a dry place below 25° C. Protect from light.

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.