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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.

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.

This is indicated in the treatment of topical bacterial infections. This is particularly effective in atopic, contact stasis and infections, eczematoid dermatitis, neurodermatitis, eczema, anogenital pruritus. It may also be useful as an adjunct in certain pyodermas, such as impetigo, during specific systemic antibiotic therapy for these infections.

Ophthalmic and Topical antibacterial products

Bacitracin inhibits bacterial cell wall synthesis and is active against many gram-positive bacteria (e.g. staphylococci, streptococci, corynebacteria and Clostridia) and some gram-negative species (e.g. Neisseria and Haemophilus influenzae). They are often found in combinations in topical preparations as broad spectrum antibacterial agents.

Neomycin, an aminoglyoside with antimicrobial spectrum similar to gentamicin, binds to the 30S subunits of the bacterial ribosome, inhibiting protein synthesis and thereby disrupting DNA synthesis. It is active against many gram negative aerobes and against some strains of staphylococci.

Ointment: Before use, the area for application should be cleaned gently. Derbis such as pus or crusts should be removed from the affected area. Apply two to three times daily to the affected skin area.

Dusting Powder: Antibiotic powder is a non- sterile dusting powder and used for superficial skin infections. A light dusting of the powder to be applied to the affected skin area upto 4 times daily.

This preparation is usually well tolerated. In rare cases, allergic reactions may be occurred.

Hypersensitivity to any of its components.

Bacitracin & Neomycin antibiotic powder should not be used to large open wounds or to severely injured skin or on areas that exude large volumes of fluid as hard crusts may form. Since this skin ointment contains Neomycin, it should not be used for the treatment of otitis external when the eardrum is perforated because of risk of ototoxicity.

Patients considering self-medication with a topical anti-infective for deep or puncture wounds, animal bites, or serious burns should be advised to first consult a physician. Patients using the preparations for the prevention of infection in minor skin injuries (e.g., cuts, scrapes, burns) should be advised to discontinue the topical anti-infective preparation and consult a physician if the condition persists or worsens; it should not be used for longer than 1 week unless directed by a physician.

Bacitracin Zinc: Increased risk of nephrotoxicity when used with other nephrotoxic drugs. May enhance the action of neuromuscular-blocking agents.

Neomycin Sulphate: Additive nephrotoxic and neurotoxic effect with other aminoglycosides, bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin and viomycin. Enhanced toxicity with potent diuretics. May impair the absorption of other drugs. May enhance the effect of acarbose. May enhance the effect of non-depolarising muscle relaxants. May antagonise the parasympathomimetic effect of neostigmine and pyridostigmine. May increase the risk of hypocalcaemia in patients receiving bisphosphonates. May alter INR when givenwithanticoagulants. May inactivate oral typhoid vaccine.

The safe use of this preparation during pregnancy & lactation has not been established. Therefore it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Children and Infants: This ointment is suitable for use in children at the same dose as adults, but the dose should be reduced in infants. This ointment is not recommended for use in neonates.

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

Mebendazole is indicated for the treatment of threadworms, whipworms, roundworms and hookworms.

Anthelmintic

Mebendazole is a synthetic broad-spectrum anthelmintic that is active against most nematodes and some other worms. Mebendazole is principally used in the treatment of intestinal nematode infection. Mebendazole inhibits the formation of the worms' microtubules and causes the worms' glucose depletion. After oral administration about 2-10% of oral dose is absorbed from Gl tract and peak plasma concentration occurs within 30 minutes to 7 hours. Mebendazole is highly bound to plasma protein. Elimination half-life is 2.8 to 9 hours.

Adult and Child over 2 years-

• Threadworms: 100 mg or 1 teaspoonful: Single dose.
• Whipworms, Roundworms, Hookworms: 100 mg or 1 teaspoonful: Twice daily for 3 days.

If reinfection occurs the second dose may be needed after 2 weeks.

Mebendazole is contraindicated in patients with known hypersensitivity to Mebendazole, or to any component of the formulation.

General: Periodic assessment of organ system functions, including haematopoietic and hepatic, is advisable during prolonged therapy.

Information for Patients: Patients should be informed of the potential risk to the foetus in women taking mebendazole during pregnancy, especially during the first trimester. Patients should also be informed that cleanliness is important to prevent reinfection & transmission of the infection.

Preliminary evidence suggests that cimetidine inhibits mebendazole metabolism and may result in an increase in plasma concentration.

Mebendazole is not recommended in pregnant women. It is not known whether mebendazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a nursing mother.

Paediatric use: The drug has not been extensively studied in children under two years; therefore, in the treatment of children under two years the relative benefit/risk should be considered.

In the event of accidental overdosage, gastrointestinal complaints lasting up to a few hours may occur. Vomiting and purging should be induced.

Store in a cool (Below 25°C temperature) and dry place, protected from light. Keep out of the reach of children.

Mebendazole is indicated for the treatment of threadworms, whipworms, roundworms and hookworms.

Anthelmintic

Mebendazole is a synthetic broad-spectrum anthelmintic that is active against most nematodes and some other worms. Mebendazole is principally used in the treatment of intestinal nematode infection. Mebendazole inhibits the formation of the worms' microtubules and causes the worms' glucose depletion. After oral administration about 2-10% of oral dose is absorbed from Gl tract and peak plasma concentration occurs within 30 minutes to 7 hours. Mebendazole is highly bound to plasma protein. Elimination half-life is 2.8 to 9 hours.

Adult and Child over 2 years-

• Threadworms: 100 mg or 1 teaspoonful: Single dose.
• Whipworms, Roundworms, Hookworms: 100 mg or 1 teaspoonful: Twice daily for 3 days.

If reinfection occurs the second dose may be needed after 2 weeks.

Mebendazole is contraindicated in patients with known hypersensitivity to Mebendazole, or to any component of the formulation.

General: Periodic assessment of organ system functions, including haematopoietic and hepatic, is advisable during prolonged therapy.

Information for Patients: Patients should be informed of the potential risk to the foetus in women taking mebendazole during pregnancy, especially during the first trimester. Patients should also be informed that cleanliness is important to prevent reinfection & transmission of the infection.

Preliminary evidence suggests that cimetidine inhibits mebendazole metabolism and may result in an increase in plasma concentration.

Mebendazole is not recommended in pregnant women. It is not known whether mebendazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a nursing mother.

Paediatric use: The drug has not been extensively studied in children under two years; therefore, in the treatment of children under two years the relative benefit/risk should be considered.

In the event of accidental overdosage, gastrointestinal complaints lasting up to a few hours may occur. Vomiting and purging should be induced.

Store in a cool (Below 25°C temperature) and dry place, protected from light. Keep out of the reach of children.

Mebhydrolin Napadisylate is indicated in-

• Allergic disease or symptoms such as urticaria
• Pruritus of various origin
• Eczema
• Itching
• Drug rash
• Insect bites
• Allergic conjunctivitis
• Dermatitis of nutritional origin
• Hay fever,
• Vasomotor rhinitis
• Allergic asthma.

Sedating Anti-histamine

Mebhydrolin diminishes or abolishes the main actions of histamine in the body by blocking of histamine receptors.

Adults and children over 10 years: 2-6 tablets daily

Children-

• 5-10 years: 2-4 tablets daily
• 2-5 years: 1-3 tablets daily
• Up to 2 years: 1-2 tablets daily

Treatment should be given in several single doses daily. Mebhydrolin may be swallowed during or shortly after meals. For children, the tablet may be crushed and mixed with food.

Lassitude, dizziness, hypotension, muscular weakness, nausea, vomiting, diarrhoea or constipation, epigastric pain, headache, blurred vision, tinnitus, depression, nightmares, anorexia, dryness of the mouth, tightness of the chest, tingling, sedation, drowsiness etc. may occur.

The substance may cause drowsiness, if affected, driving or operating machinery & alcoholic drinks should be avoided.

The effects of atropine and tricyclic anti-depressants may be enhanced by Mebhydrolin. It may mask the warning symptoms of damage caused by ototoxic drugs.

Safety in pregnancy and lactation has not been established.

Safety in pregnancy and lactation has not been established.

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

Albendazole is indicated in single and mixed infestations of-

• Hookworm (Ancylostoma, Necator)
• Roundworm (Ascaris)
• Threadworm (Enterobius)
• Whipworm (Trichuris)
• Strongyloides
• Tapeworm
• Opisthorchi
• Hydatid.

Anthelmintic

Albendazole is a broad spectrum anthelmintic. Albendazole exhibits vermicidal, ovicidal and larvicidal activities. The drug is thought to exert its anthelmintic effect by blocking glucose uptake in the susceptible helminths, thereby depleting the energy level until it becomes inadequate for survival. Immobilization is followed by the parasite. These events may be a consequence of the binding and subsequent inhibition of parasite tubulin polymerization by Albendazole and its metabolites, although the drug also binds to human tubulin. Albendazole is extensively metabolized, probably in the liver. Albendazole is poorly absorbed from the gastrointestinal tract but rapidly undergoes extensive first-pass metabolism. The principal metabolite albendazole sulphoxide has anthelmintic activity and a plasma half-life of about 8.5 hrs. It is excreted in the urine together with other metabolites.

Adults & children over 2 years:

• 400 mg (1 tablet or 10 ml suspension) as a single dose in cases of Enterobius vermicularis, Trichuris trichiura, Ascaris lumbricoides, Ancylostoma duodenale and Necator americanus.
• In cases of strongyloidiasis or taeniasis, 400 mg (1 tablet or 10 ml suspension) daily should be given for 3 consecutive days. If the patient is not cured on follow-up after three weeks, a second course of treatment is indicated. 

Children of 1-2 years: Recommended dose is a single dose of 200 mg (5 ml suspension).

Children under 1 year: Not recommended.

In Hydatid disease (Echinococcosis):

• Albendazole is given by mouth with meals in a dose of 400 mg twice daily for 28 days for patients weighing over 60 kg.
• A dose of 15 mg/kg body weight daily in two divided doses (to a maximum total daily dose of 800 mg) is used for patients weighing less than 60 kg.
• For cystic echinococcosis, the 28 days course may be repeated after 14 days without treatment, to a total of 3 treatment cycles.
• For alveolar echinococcosis, cycles of 28 days of treatment followed by 14 days without treatment, may need to continue for months or years.
• In giardiasis, 400 mg (1 tablet or 10 ml suspension) once daily for five days is used.

Gastrointestinal disturbances, headache, dizziness, changes in liver enzymes, rarely reversible alopecia; rash, fever, blood disorders including leucopenia and pancytopenia reported; allergic shock if cyst leakage; convulsion and meningism in cerebral disease.

Neonates: Albendazole is not normally used in neonates.

Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.

Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.

Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.

Blood counts and liver function tests before treatment and twice during each cycle; breastfeeding; exclude pregnancy before starting treatment. Albendazole should only be used in the treatment of Echinococcosis if there is constant medical supervision with regular monitoring of serum-transaminase concentrations and of leucocyte and platelet counts

No interaction involving Albendazole, either pharmacodynamic or pharmacokinetic, has been reported.

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

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

Albendazole is indicated in single and mixed infestations of-

• Hookworm (Ancylostoma, Necator)
• Roundworm (Ascaris)
• Threadworm (Enterobius)
• Whipworm (Trichuris)
• Strongyloides
• Tapeworm
• Opisthorchi
• Hydatid.

Anthelmintic

Albendazole is a broad spectrum anthelmintic. Albendazole exhibits vermicidal, ovicidal and larvicidal activities. The drug is thought to exert its anthelmintic effect by blocking glucose uptake in the susceptible helminths, thereby depleting the energy level until it becomes inadequate for survival. Immobilization is followed by the parasite. These events may be a consequence of the binding and subsequent inhibition of parasite tubulin polymerization by Albendazole and its metabolites, although the drug also binds to human tubulin. Albendazole is extensively metabolized, probably in the liver. Albendazole is poorly absorbed from the gastrointestinal tract but rapidly undergoes extensive first-pass metabolism. The principal metabolite albendazole sulphoxide has anthelmintic activity and a plasma half-life of about 8.5 hrs. It is excreted in the urine together with other metabolites.

Adults & children over 2 years:

• 400 mg (1 tablet or 10 ml suspension) as a single dose in cases of Enterobius vermicularis, Trichuris trichiura, Ascaris lumbricoides, Ancylostoma duodenale and Necator americanus.
• In cases of strongyloidiasis or taeniasis, 400 mg (1 tablet or 10 ml suspension) daily should be given for 3 consecutive days. If the patient is not cured on follow-up after three weeks, a second course of treatment is indicated. 

Children of 1-2 years: Recommended dose is a single dose of 200 mg (5 ml suspension).

Children under 1 year: Not recommended.

In Hydatid disease (Echinococcosis):

• Albendazole is given by mouth with meals in a dose of 400 mg twice daily for 28 days for patients weighing over 60 kg.
• A dose of 15 mg/kg body weight daily in two divided doses (to a maximum total daily dose of 800 mg) is used for patients weighing less than 60 kg.
• For cystic echinococcosis, the 28 days course may be repeated after 14 days without treatment, to a total of 3 treatment cycles.
• For alveolar echinococcosis, cycles of 28 days of treatment followed by 14 days without treatment, may need to continue for months or years.
• In giardiasis, 400 mg (1 tablet or 10 ml suspension) once daily for five days is used.

Gastrointestinal disturbances, headache, dizziness, changes in liver enzymes, rarely reversible alopecia; rash, fever, blood disorders including leucopenia and pancytopenia reported; allergic shock if cyst leakage; convulsion and meningism in cerebral disease.

Neonates: Albendazole is not normally used in neonates.

Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.

Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.

Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.

Blood counts and liver function tests before treatment and twice during each cycle; breastfeeding; exclude pregnancy before starting treatment. Albendazole should only be used in the treatment of Echinococcosis if there is constant medical supervision with regular monitoring of serum-transaminase concentrations and of leucocyte and platelet counts

No interaction involving Albendazole, either pharmacodynamic or pharmacokinetic, has been reported.

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

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

Mebendazole is indicated for the treatment of threadworms, whipworms, roundworms and hookworms.

Anthelmintic

Mebendazole is a synthetic broad-spectrum anthelmintic that is active against most nematodes and some other worms. Mebendazole is principally used in the treatment of intestinal nematode infection. Mebendazole inhibits the formation of the worms' microtubules and causes the worms' glucose depletion. After oral administration about 2-10% of oral dose is absorbed from Gl tract and peak plasma concentration occurs within 30 minutes to 7 hours. Mebendazole is highly bound to plasma protein. Elimination half-life is 2.8 to 9 hours.

Adult and Child over 2 years-

• Threadworms: 100 mg or 1 teaspoonful: Single dose.
• Whipworms, Roundworms, Hookworms: 100 mg or 1 teaspoonful: Twice daily for 3 days.

If reinfection occurs the second dose may be needed after 2 weeks.

Mebendazole is contraindicated in patients with known hypersensitivity to Mebendazole, or to any component of the formulation.

General: Periodic assessment of organ system functions, including haematopoietic and hepatic, is advisable during prolonged therapy.

Information for Patients: Patients should be informed of the potential risk to the foetus in women taking mebendazole during pregnancy, especially during the first trimester. Patients should also be informed that cleanliness is important to prevent reinfection & transmission of the infection.

Preliminary evidence suggests that cimetidine inhibits mebendazole metabolism and may result in an increase in plasma concentration.

Mebendazole is not recommended in pregnant women. It is not known whether mebendazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a nursing mother.

Paediatric use: The drug has not been extensively studied in children under two years; therefore, in the treatment of children under two years the relative benefit/risk should be considered.

In the event of accidental overdosage, gastrointestinal complaints lasting up to a few hours may occur. Vomiting and purging should be induced.

Store in a cool (Below 25°C temperature) and dry place, protected from light. Keep out of the reach of children.

Mebendazole is indicated for the treatment of threadworms, whipworms, roundworms and hookworms.

Anthelmintic

Mebendazole is a synthetic broad-spectrum anthelmintic that is active against most nematodes and some other worms. Mebendazole is principally used in the treatment of intestinal nematode infection. Mebendazole inhibits the formation of the worms' microtubules and causes the worms' glucose depletion. After oral administration about 2-10% of oral dose is absorbed from Gl tract and peak plasma concentration occurs within 30 minutes to 7 hours. Mebendazole is highly bound to plasma protein. Elimination half-life is 2.8 to 9 hours.

Adult and Child over 2 years-

• Threadworms: 100 mg or 1 teaspoonful: Single dose.
• Whipworms, Roundworms, Hookworms: 100 mg or 1 teaspoonful: Twice daily for 3 days.

If reinfection occurs the second dose may be needed after 2 weeks.

Mebendazole is contraindicated in patients with known hypersensitivity to Mebendazole, or to any component of the formulation.

General: Periodic assessment of organ system functions, including haematopoietic and hepatic, is advisable during prolonged therapy.

Information for Patients: Patients should be informed of the potential risk to the foetus in women taking mebendazole during pregnancy, especially during the first trimester. Patients should also be informed that cleanliness is important to prevent reinfection & transmission of the infection.

Preliminary evidence suggests that cimetidine inhibits mebendazole metabolism and may result in an increase in plasma concentration.

Mebendazole is not recommended in pregnant women. It is not known whether mebendazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a nursing mother.

Paediatric use: The drug has not been extensively studied in children under two years; therefore, in the treatment of children under two years the relative benefit/risk should be considered.

In the event of accidental overdosage, gastrointestinal complaints lasting up to a few hours may occur. Vomiting and purging should be induced.

Store in a cool (Below 25°C temperature) and dry place, protected from light. Keep out of the reach of children.

Mebendazole is indicated for the treatment of threadworms, whipworms, roundworms and hookworms.

Anthelmintic

Mebendazole is a synthetic broad-spectrum anthelmintic that is active against most nematodes and some other worms. Mebendazole is principally used in the treatment of intestinal nematode infection. Mebendazole inhibits the formation of the worms' microtubules and causes the worms' glucose depletion. After oral administration about 2-10% of oral dose is absorbed from Gl tract and peak plasma concentration occurs within 30 minutes to 7 hours. Mebendazole is highly bound to plasma protein. Elimination half-life is 2.8 to 9 hours.

Adult and Child over 2 years-

• Threadworms: 100 mg or 1 teaspoonful: Single dose.
• Whipworms, Roundworms, Hookworms: 100 mg or 1 teaspoonful: Twice daily for 3 days.

If reinfection occurs the second dose may be needed after 2 weeks.

Mebendazole is contraindicated in patients with known hypersensitivity to Mebendazole, or to any component of the formulation.

General: Periodic assessment of organ system functions, including haematopoietic and hepatic, is advisable during prolonged therapy.

Information for Patients: Patients should be informed of the potential risk to the foetus in women taking mebendazole during pregnancy, especially during the first trimester. Patients should also be informed that cleanliness is important to prevent reinfection & transmission of the infection.

Preliminary evidence suggests that cimetidine inhibits mebendazole metabolism and may result in an increase in plasma concentration.

Mebendazole is not recommended in pregnant women. It is not known whether mebendazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a nursing mother.

Paediatric use: The drug has not been extensively studied in children under two years; therefore, in the treatment of children under two years the relative benefit/risk should be considered.

In the event of accidental overdosage, gastrointestinal complaints lasting up to a few hours may occur. Vomiting and purging should be induced.

Store in a cool (Below 25°C temperature) and dry place, protected from light. Keep out of the reach of children.

Mebendazole is indicated for the treatment of threadworms, whipworms, roundworms and hookworms.

Anthelmintic

Mebendazole is a synthetic broad-spectrum anthelmintic that is active against most nematodes and some other worms. Mebendazole is principally used in the treatment of intestinal nematode infection. Mebendazole inhibits the formation of the worms' microtubules and causes the worms' glucose depletion. After oral administration about 2-10% of oral dose is absorbed from Gl tract and peak plasma concentration occurs within 30 minutes to 7 hours. Mebendazole is highly bound to plasma protein. Elimination half-life is 2.8 to 9 hours.

Adult and Child over 2 years-

• Threadworms: 100 mg or 1 teaspoonful: Single dose.
• Whipworms, Roundworms, Hookworms: 100 mg or 1 teaspoonful: Twice daily for 3 days.

If reinfection occurs the second dose may be needed after 2 weeks.

Mebendazole is contraindicated in patients with known hypersensitivity to Mebendazole, or to any component of the formulation.

General: Periodic assessment of organ system functions, including haematopoietic and hepatic, is advisable during prolonged therapy.

Information for Patients: Patients should be informed of the potential risk to the foetus in women taking mebendazole during pregnancy, especially during the first trimester. Patients should also be informed that cleanliness is important to prevent reinfection & transmission of the infection.

Preliminary evidence suggests that cimetidine inhibits mebendazole metabolism and may result in an increase in plasma concentration.

Mebendazole is not recommended in pregnant women. It is not known whether mebendazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a nursing mother.

Paediatric use: The drug has not been extensively studied in children under two years; therefore, in the treatment of children under two years the relative benefit/risk should be considered.

In the event of accidental overdosage, gastrointestinal complaints lasting up to a few hours may occur. Vomiting and purging should be induced.

Store in a cool (Below 25°C temperature) and dry place, protected from light. Keep out of the reach of children.

Mebhydrolin Napadisylate is indicated in-

• Allergic disease or symptoms such as urticaria
• Pruritus of various origin
• Eczema
• Itching
• Drug rash
• Insect bites
• Allergic conjunctivitis
• Dermatitis of nutritional origin
• Hay fever,
• Vasomotor rhinitis
• Allergic asthma.

Sedating Anti-histamine

Mebhydrolin diminishes or abolishes the main actions of histamine in the body by blocking of histamine receptors.

Adults and children over 10 years: 2-6 tablets daily

Children-

• 5-10 years: 2-4 tablets daily
• 2-5 years: 1-3 tablets daily
• Up to 2 years: 1-2 tablets daily

Treatment should be given in several single doses daily. Mebhydrolin may be swallowed during or shortly after meals. For children, the tablet may be crushed and mixed with food.

Lassitude, dizziness, hypotension, muscular weakness, nausea, vomiting, diarrhoea or constipation, epigastric pain, headache, blurred vision, tinnitus, depression, nightmares, anorexia, dryness of the mouth, tightness of the chest, tingling, sedation, drowsiness etc. may occur.

The substance may cause drowsiness, if affected, driving or operating machinery & alcoholic drinks should be avoided.

The effects of atropine and tricyclic anti-depressants may be enhanced by Mebhydrolin. It may mask the warning symptoms of damage caused by ototoxic drugs.

Safety in pregnancy and lactation has not been established.

Safety in pregnancy and lactation has not been established.

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

Mebeverine is indicated for the:

• Symptomatic treatment of irritable bowel syndrome (IBS)
• Chronic irritable colon
• Spastic constipation
• Mucous colitis
• Colicky abdominal pain
• Persistent non-specific diarrhoea

Anticholinergics

For adults, elderly and children over 10 years:

• Mebeverine Hydrochloride 135 mg tablet: 1 tablet 03 times daily.
• Mebeverine Hydrochloride 200 mg capsule: 1 capsule 02 times daily.

This is most effective when taken 20 minutes before meals. After several weeks when the desired effect has been obtained, the dosage may be gradually reduced.

Missed dose: If a dose of this medicine is missed, that should be taken as soon as possible. However, if it is almost time for the next dose, then skip the missed dose and the regular dosing schedule should be maintained. Dose should not be doubled at the same time to compensate the missed dose.

Use in children: Mebeverine is not recommended for children under 10 years.

Generally Mebeverine is well tolerated. However, few side-effects like skin rash, urticaria and angioedema may appear

Hypersensitivity to the drug or any other ingredients.

Caution should be exercised in porphyria or allergic reaction to this or any other medicine of this group.

No teratogenicity has been shown in animal experiments. However, the usual precautions concerning the administration of any drug during pregnancy should be exercised. Mebeverine does not excrete in the breast milk after administering at therapeutic dose.

On theoretical grounds it may be predicted that CNS excitability will occur in case of overdosage. No specific antidote is known: gastric lavage and symptomatic treatment is recommended

Do not store above 30°C. Keep away from light and out of the reach of children.

β-Sitosterol has been used successfully in the treatment of the following wounds:

• Burn
• Leg ulcer
• Surgical wound
• Obstetric wound
• Cracked nipple

Herbal and Nutraceuticals

A thin layer of β-Sitosterol ointment should be applied to the whole burn/affected area 3-4 times daily.

No side effects to the product have been reported so far except for rare allergic reactions to sesame oil.

Avoid contact with eyes or mucous membrane. Avoid accidental ingestion. If swallowed, get medical treatment. β-Sitosterol ointment may vary its physical appearance during storage, especially during the hot season. But it does not lose its effcacy.

Store in a cool & dry place, below 30°C. Protect from direct sunlight & moisture. Keep the medicine out of the reach of children.

Topical retinoid and related preparations

This Ointment is used primarily to remove scars and repair damaged skin. It helps to relieve symptoms of scars including pruritus, skin chaps and functional restriction. The ointment is chiefly used to heal scar formation caused due to injury of the skin or due to various skin disorders.

Apply a thin layer of the ointment and gently massage the skin mark area for 5-10 minutes. Repeat 3 to 4 times daily. Continue using until the skin mark become soft and smooth. The duration of usages varies depending on the type of the skin, age and location of the skin mark.

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

Mebhydrolin Napadisylate is indicated in-

• Allergic disease or symptoms such as urticaria
• Pruritus of various origin
• Eczema
• Itching
• Drug rash
• Insect bites
• Allergic conjunctivitis
• Dermatitis of nutritional origin
• Hay fever,
• Vasomotor rhinitis
• Allergic asthma.

Sedating Anti-histamine

Mebhydrolin diminishes or abolishes the main actions of histamine in the body by blocking of histamine receptors.

Adults and children over 10 years: 2-6 tablets daily

Children-

• 5-10 years: 2-4 tablets daily
• 2-5 years: 1-3 tablets daily
• Up to 2 years: 1-2 tablets daily

Treatment should be given in several single doses daily. Mebhydrolin may be swallowed during or shortly after meals. For children, the tablet may be crushed and mixed with food.

Lassitude, dizziness, hypotension, muscular weakness, nausea, vomiting, diarrhoea or constipation, epigastric pain, headache, blurred vision, tinnitus, depression, nightmares, anorexia, dryness of the mouth, tightness of the chest, tingling, sedation, drowsiness etc. may occur.

The substance may cause drowsiness, if affected, driving or operating machinery & alcoholic drinks should be avoided.

The effects of atropine and tricyclic anti-depressants may be enhanced by Mebhydrolin. It may mask the warning symptoms of damage caused by ototoxic drugs.

Safety in pregnancy and lactation has not been established.

Safety in pregnancy and lactation has not been established.

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

Osmotic purgatives

Lactulose is a synthetic disaccharide. Lactulose is metabolized in the colon by the saccharolytic bacteria, producing low molecular weight organic acids (mainly lactic acid), which lowers the pH of the colon contents, promote the retention of water by an osmotic effect; thus increasing peristaltic activity. Lactulose is minimally absorbed; therefore, the pharmacokinetics of the absorbed material are not relevant to the principal therapeutic action.

In constipation ( chronic constipation):

• Adults: Initially 3-6 tea-spoons daily, In long-term therapy 1½-6 tea-spoons daily
• Children up to 14 years: Initially 3 tea-spoons daily, In long-term therapy 1-2 tea-spoons daily
• Infants and toddlers: Initially 1-2 tea-spoons daily, In long-term therapy 1 tea-spoon daily

In damaged intestinal flora:

• Adults: 1-2 tea-spoons daily
• Children: 1 tea-spoon daily

For reduction of blood ammonia level:

• Hyper-ammoniemia in hepatopathy: a maximum of 18-30 tea-spoons daily.
• In portal systemic encephalopathy: hourly doses of 6-9 tea-spoons of Lactulose solution may be used to induce the rapid laxation. When the laxative effect has been achieved, the dose may then be reduced.

Occasionally flatulence, cramp and abdominal discomfort can occur at the beginning of treatment; this is rapidly eliminated by reducing the dose. Overdose can result in diarrhoea. In abuse, loss of electrolytes (primarily potassium).

Hypersensitivity to either galactose and or lactose; galactose-free diet, gastro-cardial symptom complex, suspected intestinal obstruction.

Lactulose should be administered with care to patients who are intolerant to lactulose. The dose used in the treatment of (pre) coma hepaticum is usually much higher and may need to be taken into consideration for diabetics.

There is no significant drug interactions with lactulose. The glycosidic effect of cardiac glycosides can be intensified by potassium deficiency in abuse.

US FDA Pregnancy Category of Lactulose is B. Studies show that Lactulose has no adverse effects. Decisions regarding use during pregnancy and lactation must be made by registered physician.

There have been no reports of accidental overdosage. In the event of acute overdosage it is expected that diarrhoea and abdominal cramps would be the major symptoms.

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

Mebendazole is indicated for the treatment of threadworms, whipworms, roundworms and hookworms.

Anthelmintic

Mebendazole is a synthetic broad-spectrum anthelmintic that is active against most nematodes and some other worms. Mebendazole is principally used in the treatment of intestinal nematode infection. Mebendazole inhibits the formation of the worms' microtubules and causes the worms' glucose depletion. After oral administration about 2-10% of oral dose is absorbed from Gl tract and peak plasma concentration occurs within 30 minutes to 7 hours. Mebendazole is highly bound to plasma protein. Elimination half-life is 2.8 to 9 hours.

Adult and Child over 2 years-

• Threadworms: 100 mg or 1 teaspoonful: Single dose.
• Whipworms, Roundworms, Hookworms: 100 mg or 1 teaspoonful: Twice daily for 3 days.

If reinfection occurs the second dose may be needed after 2 weeks.

Mebendazole is contraindicated in patients with known hypersensitivity to Mebendazole, or to any component of the formulation.

General: Periodic assessment of organ system functions, including haematopoietic and hepatic, is advisable during prolonged therapy.

Information for Patients: Patients should be informed of the potential risk to the foetus in women taking mebendazole during pregnancy, especially during the first trimester. Patients should also be informed that cleanliness is important to prevent reinfection & transmission of the infection.

Preliminary evidence suggests that cimetidine inhibits mebendazole metabolism and may result in an increase in plasma concentration.

Mebendazole is not recommended in pregnant women. It is not known whether mebendazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a nursing mother.

Paediatric use: The drug has not been extensively studied in children under two years; therefore, in the treatment of children under two years the relative benefit/risk should be considered.

In the event of accidental overdosage, gastrointestinal complaints lasting up to a few hours may occur. Vomiting and purging should be induced.

Store in a cool (Below 25°C temperature) and dry place, protected from light. Keep out of the reach of children.