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Vaccines, Anti-sera & Immunoglobulin

Anti-D immunoglobulin prevents a rhesus-negative mother from actively forming antibodies to foetal rhesus-positive RBCs that may pass into the maternal circulation during childbirth, abortion, or certain other sensitising events. It is also used in idiopathic thrombocytopenic purpura to prevent excessive bleeding.

One dose 250 mcg should be given IM immediately or as soon as possible after delivery, or abortion of a Rh-positive child, preferably within 48 hours, but not later than 72 hours post-partum.

Following any potentially sensitizing episode (e.g stillbirth, amniocentesis) up to 20 weeks of gestation 125 mcg per episode (after 20 weeks of gestation, 250 mcg) immediately or within 72 hours.

For antenatal prophylaxis 250 mcg should be given in week 28 & also week 34 of pregnancy. The injection must only be given deep intramuscularly. Do not inject intravenously.

Hypersensitivity reactions such as hives, wheezing, urticaria, Pain and tenderness at inj site. Fever, chills, nausea, facial flushing, headache.

Splenectomised or rhesus-negative patients, in whom the resultant haemolysis may exacerbate pre-existing anaemia. Hypersensitivity.

For postpartum usage, it is to be used only for maternal admin. Not for rhesus-positive individuals. Patients should be observed for 20 minutes after admin.

Live vaccines should only be admin at least 3 mth after the last dose of immunoglobulin admin.

Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Should be stored in cool and dry place.

Ribavirin is indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with other antiviral drugs in patients with compensated liver disease not previously treated with interferon alpha and in adult CHC patients coinfected with HIV. Ribavirin should not be used alone.

Hepatic viral infections (Hepatitis C)

Ribavirin is a synthetic nucleoside which has inhibitory action against respiratory syncytial virus, influenza virus and herpes simplex virus. The mechanism of action is not clear. It may act at several sites including cellular enzymes to interfere with viral nucleic acid synthesis. The mono- and triphosphate derivatives are known to be responsible for the antiviral action of the compound.

The recommended duration of treatment for patients previously untreated with interferon is 24 to 48 weeks. After 24 weeks of treatment virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV RNA below the limit of detection of the assay by 24 weeks. There are no safety and efficacy data on treatment for longer than 48 weeks in the previously untreated patient population. In patients who relapse following interferon therapy, the recommended duration of treatment is 24 weeks. There are no safety and efficacy data on treatment for longer than 24 weeks in the relapse patient populations.

Ribavirin + Interferon: Genotype Ribavirin Daily Interferon alpha-2a Duration or interferon alpha-2b.

• All <75 kg: (400+600) mg 3 MIU 3 times weekly 48 weeks Genotypes subcutaneously (Genotype1&4)
• >75 kg: (600+600) mg 24 weeks (Genotype2&3)

Ribavirin + Peg-Interferon: Genotype Ribavirin Daily Peg-Interferon alpha-2a Duration or Peg-interferon alpha-2b:

• 1 & 4 < 75 kg: (400+600) mg 180 gm once weekly 48 weeks
• > 75 kg: (600+600) mg subcutaneously 2 & 3 (400+400) mg 24 weeks

Ribavirin may be administered without regard to food, but should be administered in a consistent manner. Drink plenty of water while being treated with this medication; drinking water will decrease the risk of serious side effects.

The most common adverse reactions in adults receiving combination therapy are psychiatric and central nervous system effects, severe ocular disorder, dental and periodontal disorders & growth inhibition in children and adolescents that may be irreversible in some patients. The most common adverse reactions in pediatric subjects were similar to those seen in adults.

Women who are pregnant. Ribavirin may cause fetal harm when administered to a pregnant woman. Ribavirin is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients with hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia). In combination with didanosine. Reports of fatal hepatic failure, as well as peripheral neuropathy, pancreatitis and symptomatic hyperlactatemia/lactic acidosis have been reported in clinical trials.

Birth defects and fetal death with ribavirin: Do not use in pregnancy and for 6 months after treatment. Patients must have a negative pregnancy test prior to therapy, use at least 2 forms of contraception and undergo monthly pregnancy tests. For a male patient, it is very important for his female partner to avoid becoming pregnant during treatment and during the 7 months after treatment and do not have sex with a pregnant women.

Nucleoside reverse transcriptase inhibitors or reduce dose or discontinue interferon, ribavirin or both with worsening toxicities

Azathioprine: Concomitant use of azathioprine with ribavirin has been reported to induce severe pancytopenia and may increase the risk of azathioprine-related myelotoxicity.

Pregnancy Category X. Ribavirin produced significant embryocidal and/or teratogenic effects in all animal species in which adequate studies have been conducted. Malformations of the skull, palate, eye, jaw, limbs, skeleton and gastrointestinal tract were noted. The incidence and severity of teratogenic effects increased with escalation of the drug dose. Survival of fetuses and offspring was reduced.

Nursing Mothers: It is not known whether Ribavirin is excreted in human milk. Because many drugs are excreted in human milk and to avoid any potential for serious adverse reactions in nursing infants from ribavirin, a decision should be made either to discontinue nursing or therapy with Ribavirin, based on the importance of the therapy to the mother.

Pediatric Use: Safety and effectiveness of Ribavirin in combination with Peginterferon has not been established in pediatric patients below the age of 3 years.

Geriatric Use: The risk of toxic reactions to this drug may be greater in patients with impaired renal function. The dose of Ribavirin should be reduced in patients with creatinine clearance less than or equal to 50 ml/min; and the dose of Interferon should be reduced in patients with creatinine clearance less than 30 ml/min.

Keep out of the reach of children. Keep in a cool & dry place. Protect from light.

Specific combined vitamin preparations

Vitamin-B complex contains the most important members of the vitamin B group in pure form and in therapeutically balanced proportions. The members of the vitamin B group contained in Vitamin-B complex are components of enzyme systems that regulate various stages of carbohydrate, fat and protein metabolism, each of the components playing a specific biological role. Deficiency of B vitamin causes glossitis, stomatitis, cheilosis, polyneuritis, beriberi, pellagra and vascularisation of cornea.

Tablet/ capsule: usual recommended dose is 1-2 tablet/capsule 3 times daily or as directed by the physician.

Syrup: 2-3 teaspoonful daily or as directed by the physician.

Injection: It is for intramuscular and intravenous administration. Usual recommended dose is 2 ml daily or as directed by the physician. In addition with Thiamine, Riboflavin, Nicotinamide, Pyridoxine; injectable dosage from contains D-Panthenol 5 mg.

Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in Vitamin-B complex. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended level has been associated with gastrointestinal intolerance in some patients.

Vitamin-B complex is contraindicated in patients hypersensitive to any of its components.

As little as 5 mg pyridoxine daily can decrease the efficacy of levodopa in the treatment of parkinsonism. Therefore, Vitamin-B complex is not recommended for patients undergoing such therapy

It is safe to use Vitamin-B complex in pregnancy and lactation.

To prevent and to treat deficiencies of vitamin B2 such as cheilosis, angular stomatitis, glossitis, keratitis, seborrhoeic dermatitis.

Vitamin-B preparations

Riboflavin or vitamin B2 is an easily absorbed, water-soluble micronutrient with a key role in maintaining human health. Like the other B vitamins, it supports energy production by aiding in the metabolising of fats, carbohydrates, and proteins. Vitamin B2 is also required for red blood cell formation and respiration, antibody production, and for regulating human growth and reproduction. It is essential for healthy skin, nails, hair growth and general good health, including regulating thyroid activity. Riboflavin also helps in the prevention or treatment of many types of eye disorders, including some cases of cataracts.

Binds to riboflavin hydrogenase, riboflavin kinase, and riboflavin synthase. Riboflavin is the precursor of flavin mononucleotide (FMN, riboflavin monophosphate) and flavin adenine dinucleotide (FAD). The antioxidant activity of riboflavin is principally derived from its role as a precursor of FAD and the role of this cofactor in the production of the antioxidant reduced glutathione. Reduced glutathione is the cofactor of the selenium-containing glutathione peroxidases among other things. The glutathione peroxidases are major antioxidant enzymes. Reduced glutathione is generated by the FAD-containing enzyme glutathione reductase.

For treating low levels of riboflavin (riboflavin deficiency) in adults: 5-30 mg of riboflavin daily in divided doses.

For preventing migraine headaches: 400 mg of riboflavin (Vitamin B2) per day. It may take up to three months to get best results.

For preventing cataracts: approximately 2.6 mg of riboflavin (Vitamin B2)

Riboflavin is likely safe for most people. In some people, Riboflavin can cause the urine to turn a yellow- orange color. When taken in high doses, Riboflavin might cause diarrhea, an increase in urine, and other side effects.

Hypersensitivity to Riboflavin.

Riboflavin is non-toxic. No warnings or precautions have been established .

Drying medications (Anticholinergic drugs), Medications for depression (Tricyclic antidepressants), Phenobarbital, Probenecid.

Riboflavin is likely safe for pregnant or breastfeeding women when taken in the amounts recommended.

Store at a cool and dry place. Protect from light.

Macrolides

Dosage of Clindamycin Capsule:

• Serious Infections: 150 mg-300 mg every six hours.
• More severe infections: 300 mg-450 mg every six hours.

To avoid the possibility of oesophageal irritation, Clindacin capsules should be taken with a full glass of water.

Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC₉₀ for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.

Dosage of Clindamycin Powder for oral solution:

• Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
• Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
• More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

Dosage of Clindamycin IV/IM Injection:
Adults-

• Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
• More severe infections: 1200-2700 mg/day in 2-4 equal doses.
• For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
• Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.

Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower effective dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years):

• 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
• Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
• In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

The adverse effects have been reported with the use of clindamycin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.

Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.

Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.

Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.

Use in newborns and infants: When Clindamycin is administered to newborns and infants (birth to 16 years), appropriate monitoring of organ system functions is desirable.

Geriatric use: Dose adjustment of Clindamycin is not necessary.

Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.

Direction for reconstitution (powder for oral solution): Shake the bottle well to loosen the powder. Add 80 ml of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in solution. Keep the bottle tightly closed. The reconstituted solution should be used within 2 weeks if kept at room temperature.

Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.

• Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
• Single IM injections of greater than 600 mg are not recommended. Dilution is not required for intramuscular administration.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin phosphate Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

Physico-Chemical Stability of diluted solutions of Clindacin Injection-

• Room temperature: 16 days at 25°C.
• Refrigeration: 32 days at 4°C.

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

To prevent and to treat deficiencies of vitamin B2 such as cheilosis, angular stomatitis, glossitis, keratitis, seborrhoeic dermatitis.

Vitamin-B preparations

Riboflavin or vitamin B2 is an easily absorbed, water-soluble micronutrient with a key role in maintaining human health. Like the other B vitamins, it supports energy production by aiding in the metabolising of fats, carbohydrates, and proteins. Vitamin B2 is also required for red blood cell formation and respiration, antibody production, and for regulating human growth and reproduction. It is essential for healthy skin, nails, hair growth and general good health, including regulating thyroid activity. Riboflavin also helps in the prevention or treatment of many types of eye disorders, including some cases of cataracts.

Binds to riboflavin hydrogenase, riboflavin kinase, and riboflavin synthase. Riboflavin is the precursor of flavin mononucleotide (FMN, riboflavin monophosphate) and flavin adenine dinucleotide (FAD). The antioxidant activity of riboflavin is principally derived from its role as a precursor of FAD and the role of this cofactor in the production of the antioxidant reduced glutathione. Reduced glutathione is the cofactor of the selenium-containing glutathione peroxidases among other things. The glutathione peroxidases are major antioxidant enzymes. Reduced glutathione is generated by the FAD-containing enzyme glutathione reductase.

For treating low levels of riboflavin (riboflavin deficiency) in adults: 5-30 mg of riboflavin daily in divided doses.

For preventing migraine headaches: 400 mg of riboflavin (Vitamin B2) per day. It may take up to three months to get best results.

For preventing cataracts: approximately 2.6 mg of riboflavin (Vitamin B2)

Riboflavin is likely safe for most people. In some people, Riboflavin can cause the urine to turn a yellow- orange color. When taken in high doses, Riboflavin might cause diarrhea, an increase in urine, and other side effects.

Hypersensitivity to Riboflavin.

Riboflavin is non-toxic. No warnings or precautions have been established .

Drying medications (Anticholinergic drugs), Medications for depression (Tricyclic antidepressants), Phenobarbital, Probenecid.

Riboflavin is likely safe for pregnant or breastfeeding women when taken in the amounts recommended.

Store at a cool and dry place. Protect from light.

To prevent and to treat deficiencies of vitamin B2 such as cheilosis, angular stomatitis, glossitis, keratitis, seborrhoeic dermatitis.

Vitamin-B preparations

Riboflavin or vitamin B2 is an easily absorbed, water-soluble micronutrient with a key role in maintaining human health. Like the other B vitamins, it supports energy production by aiding in the metabolising of fats, carbohydrates, and proteins. Vitamin B2 is also required for red blood cell formation and respiration, antibody production, and for regulating human growth and reproduction. It is essential for healthy skin, nails, hair growth and general good health, including regulating thyroid activity. Riboflavin also helps in the prevention or treatment of many types of eye disorders, including some cases of cataracts.

Binds to riboflavin hydrogenase, riboflavin kinase, and riboflavin synthase. Riboflavin is the precursor of flavin mononucleotide (FMN, riboflavin monophosphate) and flavin adenine dinucleotide (FAD). The antioxidant activity of riboflavin is principally derived from its role as a precursor of FAD and the role of this cofactor in the production of the antioxidant reduced glutathione. Reduced glutathione is the cofactor of the selenium-containing glutathione peroxidases among other things. The glutathione peroxidases are major antioxidant enzymes. Reduced glutathione is generated by the FAD-containing enzyme glutathione reductase.

For treating low levels of riboflavin (riboflavin deficiency) in adults: 5-30 mg of riboflavin daily in divided doses.

For preventing migraine headaches: 400 mg of riboflavin (Vitamin B2) per day. It may take up to three months to get best results.

For preventing cataracts: approximately 2.6 mg of riboflavin (Vitamin B2)

Riboflavin is likely safe for most people. In some people, Riboflavin can cause the urine to turn a yellow- orange color. When taken in high doses, Riboflavin might cause diarrhea, an increase in urine, and other side effects.

Hypersensitivity to Riboflavin.

Riboflavin is non-toxic. No warnings or precautions have been established .

Drying medications (Anticholinergic drugs), Medications for depression (Tricyclic antidepressants), Phenobarbital, Probenecid.

Riboflavin is likely safe for pregnant or breastfeeding women when taken in the amounts recommended.

Store at a cool and dry place. Protect from light.

To prevent and to treat deficiencies of vitamin B2 such as cheilosis, angular stomatitis, glossitis, keratitis, seborrhoeic dermatitis.

Vitamin-B preparations

Riboflavin or vitamin B2 is an easily absorbed, water-soluble micronutrient with a key role in maintaining human health. Like the other B vitamins, it supports energy production by aiding in the metabolising of fats, carbohydrates, and proteins. Vitamin B2 is also required for red blood cell formation and respiration, antibody production, and for regulating human growth and reproduction. It is essential for healthy skin, nails, hair growth and general good health, including regulating thyroid activity. Riboflavin also helps in the prevention or treatment of many types of eye disorders, including some cases of cataracts.

Binds to riboflavin hydrogenase, riboflavin kinase, and riboflavin synthase. Riboflavin is the precursor of flavin mononucleotide (FMN, riboflavin monophosphate) and flavin adenine dinucleotide (FAD). The antioxidant activity of riboflavin is principally derived from its role as a precursor of FAD and the role of this cofactor in the production of the antioxidant reduced glutathione. Reduced glutathione is the cofactor of the selenium-containing glutathione peroxidases among other things. The glutathione peroxidases are major antioxidant enzymes. Reduced glutathione is generated by the FAD-containing enzyme glutathione reductase.

For treating low levels of riboflavin (riboflavin deficiency) in adults: 5-30 mg of riboflavin daily in divided doses.

For preventing migraine headaches: 400 mg of riboflavin (Vitamin B2) per day. It may take up to three months to get best results.

For preventing cataracts: approximately 2.6 mg of riboflavin (Vitamin B2)

Riboflavin is likely safe for most people. In some people, Riboflavin can cause the urine to turn a yellow- orange color. When taken in high doses, Riboflavin might cause diarrhea, an increase in urine, and other side effects.

Hypersensitivity to Riboflavin.

Riboflavin is non-toxic. No warnings or precautions have been established .

Drying medications (Anticholinergic drugs), Medications for depression (Tricyclic antidepressants), Phenobarbital, Probenecid.

Riboflavin is likely safe for pregnant or breastfeeding women when taken in the amounts recommended.

Store at a cool and dry place. Protect from light.

To prevent and to treat deficiencies of vitamin B2 such as cheilosis, angular stomatitis, glossitis, keratitis, seborrhoeic dermatitis.

Vitamin-B preparations

Riboflavin or vitamin B2 is an easily absorbed, water-soluble micronutrient with a key role in maintaining human health. Like the other B vitamins, it supports energy production by aiding in the metabolising of fats, carbohydrates, and proteins. Vitamin B2 is also required for red blood cell formation and respiration, antibody production, and for regulating human growth and reproduction. It is essential for healthy skin, nails, hair growth and general good health, including regulating thyroid activity. Riboflavin also helps in the prevention or treatment of many types of eye disorders, including some cases of cataracts.

Binds to riboflavin hydrogenase, riboflavin kinase, and riboflavin synthase. Riboflavin is the precursor of flavin mononucleotide (FMN, riboflavin monophosphate) and flavin adenine dinucleotide (FAD). The antioxidant activity of riboflavin is principally derived from its role as a precursor of FAD and the role of this cofactor in the production of the antioxidant reduced glutathione. Reduced glutathione is the cofactor of the selenium-containing glutathione peroxidases among other things. The glutathione peroxidases are major antioxidant enzymes. Reduced glutathione is generated by the FAD-containing enzyme glutathione reductase.

For treating low levels of riboflavin (riboflavin deficiency) in adults: 5-30 mg of riboflavin daily in divided doses.

For preventing migraine headaches: 400 mg of riboflavin (Vitamin B2) per day. It may take up to three months to get best results.

For preventing cataracts: approximately 2.6 mg of riboflavin (Vitamin B2)

Riboflavin is likely safe for most people. In some people, Riboflavin can cause the urine to turn a yellow- orange color. When taken in high doses, Riboflavin might cause diarrhea, an increase in urine, and other side effects.

Hypersensitivity to Riboflavin.

Riboflavin is non-toxic. No warnings or precautions have been established .

Drying medications (Anticholinergic drugs), Medications for depression (Tricyclic antidepressants), Phenobarbital, Probenecid.

Riboflavin is likely safe for pregnant or breastfeeding women when taken in the amounts recommended.

Store at a cool and dry place. Protect from light.

To prevent and to treat deficiencies of vitamin B2 such as cheilosis, angular stomatitis, glossitis, keratitis, seborrhoeic dermatitis.

Vitamin-B preparations

Riboflavin or vitamin B2 is an easily absorbed, water-soluble micronutrient with a key role in maintaining human health. Like the other B vitamins, it supports energy production by aiding in the metabolising of fats, carbohydrates, and proteins. Vitamin B2 is also required for red blood cell formation and respiration, antibody production, and for regulating human growth and reproduction. It is essential for healthy skin, nails, hair growth and general good health, including regulating thyroid activity. Riboflavin also helps in the prevention or treatment of many types of eye disorders, including some cases of cataracts.

Binds to riboflavin hydrogenase, riboflavin kinase, and riboflavin synthase. Riboflavin is the precursor of flavin mononucleotide (FMN, riboflavin monophosphate) and flavin adenine dinucleotide (FAD). The antioxidant activity of riboflavin is principally derived from its role as a precursor of FAD and the role of this cofactor in the production of the antioxidant reduced glutathione. Reduced glutathione is the cofactor of the selenium-containing glutathione peroxidases among other things. The glutathione peroxidases are major antioxidant enzymes. Reduced glutathione is generated by the FAD-containing enzyme glutathione reductase.

For treating low levels of riboflavin (riboflavin deficiency) in adults: 5-30 mg of riboflavin daily in divided doses.

For preventing migraine headaches: 400 mg of riboflavin (Vitamin B2) per day. It may take up to three months to get best results.

For preventing cataracts: approximately 2.6 mg of riboflavin (Vitamin B2)

Riboflavin is likely safe for most people. In some people, Riboflavin can cause the urine to turn a yellow- orange color. When taken in high doses, Riboflavin might cause diarrhea, an increase in urine, and other side effects.

Hypersensitivity to Riboflavin.

Riboflavin is non-toxic. No warnings or precautions have been established .

Drying medications (Anticholinergic drugs), Medications for depression (Tricyclic antidepressants), Phenobarbital, Probenecid.

Riboflavin is likely safe for pregnant or breastfeeding women when taken in the amounts recommended.

Store at a cool and dry place. Protect from light.

To prevent and to treat deficiencies of vitamin B2 such as cheilosis, angular stomatitis, glossitis, keratitis, seborrhoeic dermatitis.

Vitamin-B preparations

Riboflavin or vitamin B2 is an easily absorbed, water-soluble micronutrient with a key role in maintaining human health. Like the other B vitamins, it supports energy production by aiding in the metabolising of fats, carbohydrates, and proteins. Vitamin B2 is also required for red blood cell formation and respiration, antibody production, and for regulating human growth and reproduction. It is essential for healthy skin, nails, hair growth and general good health, including regulating thyroid activity. Riboflavin also helps in the prevention or treatment of many types of eye disorders, including some cases of cataracts.

Binds to riboflavin hydrogenase, riboflavin kinase, and riboflavin synthase. Riboflavin is the precursor of flavin mononucleotide (FMN, riboflavin monophosphate) and flavin adenine dinucleotide (FAD). The antioxidant activity of riboflavin is principally derived from its role as a precursor of FAD and the role of this cofactor in the production of the antioxidant reduced glutathione. Reduced glutathione is the cofactor of the selenium-containing glutathione peroxidases among other things. The glutathione peroxidases are major antioxidant enzymes. Reduced glutathione is generated by the FAD-containing enzyme glutathione reductase.

For treating low levels of riboflavin (riboflavin deficiency) in adults: 5-30 mg of riboflavin daily in divided doses.

For preventing migraine headaches: 400 mg of riboflavin (Vitamin B2) per day. It may take up to three months to get best results.

For preventing cataracts: approximately 2.6 mg of riboflavin (Vitamin B2)

Riboflavin is likely safe for most people. In some people, Riboflavin can cause the urine to turn a yellow- orange color. When taken in high doses, Riboflavin might cause diarrhea, an increase in urine, and other side effects.

Hypersensitivity to Riboflavin.

Riboflavin is non-toxic. No warnings or precautions have been established .

Drying medications (Anticholinergic drugs), Medications for depression (Tricyclic antidepressants), Phenobarbital, Probenecid.

Riboflavin is likely safe for pregnant or breastfeeding women when taken in the amounts recommended.

Store at a cool and dry place. Protect from light.

To prevent and to treat deficiencies of vitamin B2 such as cheilosis, angular stomatitis, glossitis, keratitis, seborrhoeic dermatitis.

Vitamin-B preparations

Riboflavin or vitamin B2 is an easily absorbed, water-soluble micronutrient with a key role in maintaining human health. Like the other B vitamins, it supports energy production by aiding in the metabolising of fats, carbohydrates, and proteins. Vitamin B2 is also required for red blood cell formation and respiration, antibody production, and for regulating human growth and reproduction. It is essential for healthy skin, nails, hair growth and general good health, including regulating thyroid activity. Riboflavin also helps in the prevention or treatment of many types of eye disorders, including some cases of cataracts.

Binds to riboflavin hydrogenase, riboflavin kinase, and riboflavin synthase. Riboflavin is the precursor of flavin mononucleotide (FMN, riboflavin monophosphate) and flavin adenine dinucleotide (FAD). The antioxidant activity of riboflavin is principally derived from its role as a precursor of FAD and the role of this cofactor in the production of the antioxidant reduced glutathione. Reduced glutathione is the cofactor of the selenium-containing glutathione peroxidases among other things. The glutathione peroxidases are major antioxidant enzymes. Reduced glutathione is generated by the FAD-containing enzyme glutathione reductase.

For treating low levels of riboflavin (riboflavin deficiency) in adults: 5-30 mg of riboflavin daily in divided doses.

For preventing migraine headaches: 400 mg of riboflavin (Vitamin B2) per day. It may take up to three months to get best results.

For preventing cataracts: approximately 2.6 mg of riboflavin (Vitamin B2)

Riboflavin is likely safe for most people. In some people, Riboflavin can cause the urine to turn a yellow- orange color. When taken in high doses, Riboflavin might cause diarrhea, an increase in urine, and other side effects.

Hypersensitivity to Riboflavin.

Riboflavin is non-toxic. No warnings or precautions have been established .

Drying medications (Anticholinergic drugs), Medications for depression (Tricyclic antidepressants), Phenobarbital, Probenecid.

Riboflavin is likely safe for pregnant or breastfeeding women when taken in the amounts recommended.

Store at a cool and dry place. Protect from light.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• Osteoarthritis: The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• Osteoarthritis: The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• Osteoarthritis: The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. Keep out of 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.

This saline is indicated in-

• Acute fluid and electrolyte loss conditions such as cholera, acute diarrhea & vomiting
• Dehydration
• Severely low concentrations of salts in the blood (severe electrolyte depletion)

Oral electrolytes preparations

This saline contains essential electrolytes & carbohydrate (in the form of processed rice) which are vital for a dehydrating patient in conditions such as cholera, acute diarrhoea, vomiting & excessive sweating.

In the normal healthy intestine, there is a continuous exchange of water through the intestinal wall- up to 20 liters of water is secreted and very nearly as much is reabsorbed every 24 hours- this mechanism allows the absorption of soluble metabolites from digested food into the bloodstream.

In a state of diarrheal disease, the balance is upset and much more water is secreted than is reabsorbed causing a net loss to the body which can be as high as several liters a day. In addition to water, Chloride ion (CI^-), extracellular sodium ion (Na⁺) & intracellular potassium ion (K⁺) are also lost. This saline is effectively replenishes the lost electrolytes in the body.

The pharmacokinetics and therapeutic values of the substances of this saline are as follows:

• Glucose (comes from rice) facilitates the absorption of sodium (and hence water) on a 1:1 molar basis in the small intestine
• Sodium and potassium are needed to replace the body losses of these essential ions during diarrhoea and vomiting
• Citrate corrects the acidosis that occurs as a result of diarrhoea and dehydration

Rice, a carbohydrate is converted to glucose through digestion. Glucose is then absorbed through intestinal wall with salt. Addition of rice (instead of pure glucose) to this formula reduces the osmolarity of the solution,thus preventing additional loss of fluid through stools.

The dose depends on the severity of the dehydrating conditions of the patients. Recommended dose after each watery stool are as follows:

• 6 months to 2 years: 50 ml to 100 ml (10 to 20 Teaspoonfuls)
• 2 years to 9 years: 100 ml to 200 ml (20 to 40 teaspoonfuls)
• 10 years and above: 250 ml to 500 ml (1 to 2 glassfuls)

Precautions should be taken in case of significant overdose, especially for the following patients-

• Children less than 1 year of age.
• Patients with imbalance of salt concentrations in the blood (electrolyte imbalance).
• Patients with severely decreased kidney and liver function.

There is no known drug interaction reported.

Recommended in pregnancy & lactation, as there is no known harmful effects when this medicine is used.

Preparation for 250 ml Saline: Wash both hands with soap before preparing the saline. Add 250 ml (one glassful) hot boiled water into a jar. Then add full sachet of this saline (for 250 ml water) powder into the jar. Mix the powder well in the water until a milky white solution appears. Give the solution to the patient to drink as per the dose.

Preparation for 500 ml Saline: Wash both hands with soap before preparing the saline. Add 500 ml hot boiled water (two glassfuls) into a jar. Then add full sachet of this saline (for 500 ml water) powder into the jar. Mix the powder well in the water until a milky white solution appears. Give the solution to the patient to drink as per the dose.

Store in a cool & dry place, protected from light & moisture.

This saline is indicated in-

• Acute fluid and electrolyte loss conditions such as cholera, acute diarrhea & vomiting
• Dehydration
• Severely low concentrations of salts in the blood (severe electrolyte depletion)

Oral electrolytes preparations

This saline contains essential electrolytes & carbohydrate (in the form of processed rice) which are vital for a dehydrating patient in conditions such as cholera, acute diarrhoea, vomiting & excessive sweating.

In the normal healthy intestine, there is a continuous exchange of water through the intestinal wall- up to 20 liters of water is secreted and very nearly as much is reabsorbed every 24 hours- this mechanism allows the absorption of soluble metabolites from digested food into the bloodstream.

In a state of diarrheal disease, the balance is upset and much more water is secreted than is reabsorbed causing a net loss to the body which can be as high as several liters a day. In addition to water, Chloride ion (CI^-), extracellular sodium ion (Na⁺) & intracellular potassium ion (K⁺) are also lost. This saline is effectively replenishes the lost electrolytes in the body.

The pharmacokinetics and therapeutic values of the substances of this saline are as follows:

• Glucose (comes from rice) facilitates the absorption of sodium (and hence water) on a 1:1 molar basis in the small intestine
• Sodium and potassium are needed to replace the body losses of these essential ions during diarrhoea and vomiting
• Citrate corrects the acidosis that occurs as a result of diarrhoea and dehydration

Rice, a carbohydrate is converted to glucose through digestion. Glucose is then absorbed through intestinal wall with salt. Addition of rice (instead of pure glucose) to this formula reduces the osmolarity of the solution,thus preventing additional loss of fluid through stools.

The dose depends on the severity of the dehydrating conditions of the patients. Recommended dose after each watery stool are as follows:

• 6 months to 2 years: 50 ml to 100 ml (10 to 20 Teaspoonfuls)
• 2 years to 9 years: 100 ml to 200 ml (20 to 40 teaspoonfuls)
• 10 years and above: 250 ml to 500 ml (1 to 2 glassfuls)

Precautions should be taken in case of significant overdose, especially for the following patients-

• Children less than 1 year of age.
• Patients with imbalance of salt concentrations in the blood (electrolyte imbalance).
• Patients with severely decreased kidney and liver function.

There is no known drug interaction reported.

Recommended in pregnancy & lactation, as there is no known harmful effects when this medicine is used.

Preparation for 250 ml Saline: Wash both hands with soap before preparing the saline. Add 250 ml (one glassful) hot boiled water into a jar. Then add full sachet of this saline (for 250 ml water) powder into the jar. Mix the powder well in the water until a milky white solution appears. Give the solution to the patient to drink as per the dose.

Preparation for 500 ml Saline: Wash both hands with soap before preparing the saline. Add 500 ml hot boiled water (two glassfuls) into a jar. Then add full sachet of this saline (for 500 ml water) powder into the jar. Mix the powder well in the water until a milky white solution appears. Give the solution to the patient to drink as per the dose.

Store in a cool & dry place, protected from light & moisture.

Ketotifen is indicated in the following conditions-

• For the prophylactic treatment of bronchial asthma.
• Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.
• For alleviating the complications of itching, pain and tenderness associated with neurofibroma.
• Symptomatic treatment of allergy such as hayfever, urticaria.

Cromoglycate & related drugs

Ketotifen has anti-allergic properties and has been used similarly, to sodium chromoglycate in the prophylactic treatment of asthma. It also has the properties of an antihistamine. Ketotifen possesses marked anti-anaphylactic properties and is effective in preventing an asthmatic attacks. Ketotifen exerts as sustained inhibitory effect on histamine reactions, which can be clearly dissociated from its anti-anaphylactic properties. Experimental investigations in asthmatic subjects have shown that Ketotifen is as effective orally as a selective mast cell stabilizer administered by inhalation. Antihistamines were ineffective in those tests. The effectiveness of Ketotifen has been studied in long-term clinical trials. Asthma attacks were reduced in number, severity and duration and in some cases, the patients were completely freed from attacks. Progressive reduction of corticosteroids and/or bronchodilators was also possible. The prophylactic activity of Ketotifen may take several weeks to become fully established. Ketotifen will not abort established attacks of asthma.

Adults: 1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily in severe cases.

Children above 3 years: 1 mg twice daily with food. Patients known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician.

Use in elderly: Same as adult dose or as advised by the physician.

Drowsiness and in isolated cases, dry mouth and slight dizziness may occur at the beginning of treatment but usually disappear spontaneously after a few days.

A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly with oral antidiabetic agent and it has been suggested that this combination should therefore be avoided. Although there is no evidence of any teratogenic effect, recommendations for Ketotifen in pregnancy or when breast feeding can not be given.

It is important to continue the previous treatment for a minimum of two weeks after starting Ketotifen to avoid the possibility of exacerbation of asthma. This applies specially to systemic corticosteroids and ACTH because of the possible existence of adrenocortical insufficiency in steroid dependent patient. If inter current infection occurs, Ketotifen treatment must be supplemented by specific antimicrobial therapy. During the first day of treatment with Ketotifen, reactions may be impaired and patients should be warned not to take charge of vehicle or machinery until the effect of Ketotifen treatment on the individual is known. Patients should be advised to avoid alcoholic drinks. Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohol.

Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohols. A reversible fall in the platelet count has been observed in a few patients receiving Tifen concomitantly with oral antidiabetic agents and it has been suggested that this combination should therefore be avoided.

Although there is no evidence of any teratogenic effect, Ketotifen in pregnancy and lactation is not recommended.

The reported features of overdosage include confusion, drowsiness, headache, bradycardia, respiratory depression etc. should be watched for. Elimination of the drug with gastric lavage or emessis is recommended. Otherwise, general supportive treatment is all that is required shall be instituted.

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