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Third generation Cephalosporins

Cefpodoxime is an oral 3rd generation cephalosporin, which has good stability to beta lactamases and activity against Gram negative and Gram positive bacteria. It is indicated for the treatment of infections either before the infecting organism has been identified. It is a prodrug its active metabolite is Cefpodoxime. Approximately 29 to 33% of Cefpodoxime excreted unchanged in the urine in 12 hours.

Adults and Adolescents (13 years and older)

• Pharyngitis/tonsillitis: 100 mg 12 hourly, 5 to 10 days
• Acute maxillary sinusitis: 200 mg 12 hourly, 10 day
• Community acquired pneumonia: 200 mg 12 hourly, 14 days
• Acute bacterial exacerbations of chronic bronchitis: 200 mg 12 hourly, 10 days
• Skin and skin structure: 400 mg 12 hourly, 7 to 14 days
• Uncomplicated urinary tract infection: 100 mg 12 hourly, 7 days
• Uncomplicated gonorrhea: single dose of 200 mg
• Rectal gonococcal infections in women: single dose of 200 mg

Infants and Pediatric Patients (2 months to 12 years)

• Acute otitis media: 5 mg/kg body weight 12 hourly, 5 days
• Pharyngitis /tonsillitis: 5 mg/kg body weight 12 hourly, 5 to 10 days
• Acute maxillary sinusitis: 5 mg/kg body weight 12 hourly, 10 days

Cefpodoxime has very few side effects. Possible side effects include gastrointestinal disorders (such as- diarrhea, nausea, vomiting and abdominal pain), rash, urticaria and itching.

Cefpodoxime is contraindicated in patients with known allergy to cephalosporins.

In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced. Cefpodoxime should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other antibiotics, prolonged use of Cefpodoxime may result in overgrowth of non-susceptible organisms.

Cefpodoxime concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels and the extent of absorption respectively. Renal excretion of Cefpodoxime is inhibit by probenecid.

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

Patients with severe renal impairment (creatinin clearance <30 ml/min) the dosing intervals should be increased to 24 hourly. The dosage adjustment is not require in cases of hepatic impairment.

Step 1: Shake the bottle well to loosen the powder.
Step 2: Add boiled and cooled water in the bottle.
Step 3: Shake until powder is completely mixed with water.

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

Anti-diarrhoeal Antimicrobial drugs, Macrolides

Erythromycin inhibits microsomal protein synthesis in susceptible organisms by inhibiting the translocation process. Specific binding to the 50S subunit or 70S ribosome occurs in these organisms but there is no binding to the stable 80S mammalian ribosome. Erythromycin is active against many Grampositive bacteria, some Gram-negative bacteria and against mycoplasmas and chlamydia.

Absorption: Erythromycin base is destroyed by acid and is therefore administered in the form of stable ester. The rates of absorption of the base and esters are diminished by the presence of food. The stearate is hydrolyzed in the intestine and the free erythromycin absorbed.

Blood concentration: After an oral dose of 500 mg. of the base of stearate, peak serum concentrations of 0.9 to 1.4 or 0.4 to 1.8 mg/ml. respectively are attained in 1 to 4 hours. Half-life: The serum half-life is 1.2 to 4 hours. In subjects with oliguria, the half-life is about 5 hours.

Distribution: Erythromycin is widely distributed throughout body tissue and fluids with some retention in the liver and spleen, protein binding of erythromycin base is 73%. Erythromycin enters the cerebrospinal fluid when the meninges are inflamed. It also crosses the placenta and is excreted in the milk.

Excretion: 5 to 15 % of the dose of erythromycin is excreted in the urine and large amounts of the unchanged active substance are excreted in the bile.

Adult and Children over 8 years: 250-500 mg every six hours for mild to moderate infections. This may be increased upto 4 gm. or more daily in severe cases.

Elderly: No special dosage recommendation. Erythromycin may be administered if desired, three times daily or twice daily by giving one-third or half of the total daily requirement 8 hourly or 12 hourly respectively.

Children aged 2 to 8 years: 250 mg. every six hours or 30-50 mg/kg body weight per day divided into four equal dosage.

Infants and Children upto 2 years: 500 mg. in divided doses or 30-50 mg/kg body weight in divided doses.

Allergic reactions are rare and mild although anaphylaxis has occurred. Occasionally there is abdominal discomfort after oral administration, sometimes with nausea and vomiting. This discomfort usually subsides after a few days without it being necessary to reduce the dosage.

Known hypersensitivity to Erythromycin.

Erythromycin should be given with care in patients with impaired hepatic function, as erythromycin is excreted principally in the bile.

Recent data from studies of erythromycin reveals that its use in patients who are receiving high dosage of theophylline may be associated with an increase of serum theophylline levels and potential theophylline toxicity. In such cases this dose of theophylline should be reduced.

Clinical and Laboratory studies have been shown no evidence in human of teratogenicity or toxicity. However, caution should be exercised when prescribing this drug to pregnant patients and lactating mothers since erythromycin crosses the placental barrier and is excreted in breast milk.

In case of overdosage, Erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted. Erythromycin is not removed by peritoneal dialysis or haemodialysis.

Direction for reconstitution of suspension: Shake the bottle to loosen powder. Add 60 ml or 100 ml of boiled and cooled water to the dry powder of 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 suspension.

Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 7 days.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.

Anti-dyspeptic/Carminatives

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

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

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

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

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

Adults:

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

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

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

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

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

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

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

Anti-dyspeptic/Carminatives

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

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

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

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

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

Adults:

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

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

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

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

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

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

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

Diphenhydramine is indicated for the treatment of followings:

• Seasonal, perennial, vasomotor rhinitis
• Urticaria, angioneurotic oedema, anaphylaxis
• Pruiritic conditions
• Premedication for emesis and motion sickness
• Miscellaneous like meniere's disease and parkinsonism

Sedating Anti-histamine

Diphenhydramine is an antihistamine with anticholinergic and sedative effects. It competes with histamine for H1-receptor sites on effector cells in the GI tract, blood vessels and respiratory tract.

Adult-

• Most allergic conditions: 25-50 mg three times a day with a further 50 mg at night.

Children-

• 1 to 5 years of age: 5 mg i.e., 2.5 ml of elixir 4 times a day
• More than 6 years of age: 10 mg i.e. 5 ml of elixir 4 times a day

Side effect includes sedation, dizziness, tinnitus, fatigue, ataxia, blurred vision, diplopia, euphoria, and epigastric discomfort.

Known hypersensitivity to Diphenhydramine Hydrochloride, Ammonium chloride is contra-indicated in presence of impaired hepatic or renal function.

Caution should be exercised with patients in whom drowsiness is undesirable e.g., drivers, machine operators. Concomitant consumption of alcohol or central nervous system (CNS) depressants will potentiate drowsiness.

Diphenhydramine administration significantly reduces the absorption of the antituberculous agent para-aminosalicyclic acid (PAS) from the gastrointestinal tract. CNS depressants may potentiate the sedative action of Diphenhydramine. Anticholinergic drugs may potentiate Diphenhydramine’s anticholinergic side effects.

Category B: There are no adequate and well controlled studies in pregnant women using diphenhydramine hydrochloride. Therefore, diphenhydramine hydrochloride should be used in pregnancy only if clearly needed. Diphenhydramine hydrochloride has been reported to be excreted in breast milk and thus, use of diphenhydramine hydrochloride in lactating mother is not recommended.

Symptoms: Impaired consciousness; psychosis, seizures, antimuscarinic symptoms (e.g. mydriasis, tachycardia, tachyarrhythmias), resp failure, rhabdomyolysis; acute delirium with visual and auditory hallucination (topical).

Management: Supportive and symptomatic treatment. Convulsions and marked CNS stimulation may be treated with IV diazepam.

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

Macrolides

Roxithromycin inhibits protein synthesis by irreversibly binding to the 50s ribosomal subunits thus blocking the transpeptidation or translocation reactions of susceptible organisms resulting in stunted cell growth.

Adult dose: The usual dose for adults is one 300 mg tablet once daily or one 150 mg tablet twice a day for at least two days after resolution of symptoms, a normal course of therapy is between 5 and 10 days. Roxithromycin is best administered on empty stomach. In severe hepatic impairment the dose is 150 mg once daily.

Pediatric dose: The dose for children is 2.5 to 5 mg/kg body weight twice a day. The following general guidelines can be followed

• 6 to 11 Kg: 25 mg Roxithromycin 12 hourly.
• 12 to 23 Kg: 50 mg Roxithromycin 12 hourly.
• 24 to 40 Kg: 100 mg Roxithromycin 12 hourly.

A normal course of therapy is between 5 and 10 days.

Roxithromycin is well tolerated by patients of all age groups. Less than 4% of treated patients complain of side effects mainly nausea, abdominal pain, diarrhoea and hypersensitivity rash. Other side effects reported include vomiting, dizziness, headache, pruritus, dyspepsia, flatulence, tinnitus, vertigo and constipation. These are in general minor and do not necessitate withdrawal of therapy.

Roxithromycin should not be administered simultaneously with ergotamine or its derivatives as it may provoke arterial spasm and severe ischaemia.

Roxithromycin should not be used in patients with a history of hypersensitivity to the drug. In patients with hepatic diseases the dose of Roxithromycin should not exceed 150 mg twice a day.

Roxithromycin does not have any affinity for cytochrome P-450 binding sites and thus is unlikely to produce drug interaction mediated by this enzymatic system. Roxithromycin shows mild interaction with theophylline though this has not been found to produce clinically relevant effects. Alteration in the pharmacokinetics of carbamazepine or warfarin has not been found. Antacids, H2- receptor antagonists and food has no effect on the absorption of Roxithromycin.

The safety of Roxithromycin in pregnancy has not been established. It appears in breast milk in small amounts and dose not produce adverse effects in the breast fed infant.

Macrolides

Roxithromycin inhibits protein synthesis by irreversibly binding to the 50s ribosomal subunits thus blocking the transpeptidation or translocation reactions of susceptible organisms resulting in stunted cell growth.

Adult dose: The usual dose for adults is one 300 mg tablet once daily or one 150 mg tablet twice a day for at least two days after resolution of symptoms, a normal course of therapy is between 5 and 10 days. Roxithromycin is best administered on empty stomach. In severe hepatic impairment the dose is 150 mg once daily.

Pediatric dose: The dose for children is 2.5 to 5 mg/kg body weight twice a day. The following general guidelines can be followed

• 6 to 11 Kg: 25 mg Roxithromycin 12 hourly.
• 12 to 23 Kg: 50 mg Roxithromycin 12 hourly.
• 24 to 40 Kg: 100 mg Roxithromycin 12 hourly.

A normal course of therapy is between 5 and 10 days.

Roxithromycin is well tolerated by patients of all age groups. Less than 4% of treated patients complain of side effects mainly nausea, abdominal pain, diarrhoea and hypersensitivity rash. Other side effects reported include vomiting, dizziness, headache, pruritus, dyspepsia, flatulence, tinnitus, vertigo and constipation. These are in general minor and do not necessitate withdrawal of therapy.

Roxithromycin should not be administered simultaneously with ergotamine or its derivatives as it may provoke arterial spasm and severe ischaemia.

Roxithromycin should not be used in patients with a history of hypersensitivity to the drug. In patients with hepatic diseases the dose of Roxithromycin should not exceed 150 mg twice a day.

Roxithromycin does not have any affinity for cytochrome P-450 binding sites and thus is unlikely to produce drug interaction mediated by this enzymatic system. Roxithromycin shows mild interaction with theophylline though this has not been found to produce clinically relevant effects. Alteration in the pharmacokinetics of carbamazepine or warfarin has not been found. Antacids, H2- receptor antagonists and food has no effect on the absorption of Roxithromycin.

The safety of Roxithromycin in pregnancy has not been established. It appears in breast milk in small amounts and dose not produce adverse effects in the breast fed infant.

Macrolides

Roxithromycin inhibits protein synthesis by irreversibly binding to the 50s ribosomal subunits thus blocking the transpeptidation or translocation reactions of susceptible organisms resulting in stunted cell growth.

Adult dose: The usual dose for adults is one 300 mg tablet once daily or one 150 mg tablet twice a day for at least two days after resolution of symptoms, a normal course of therapy is between 5 and 10 days. Roxithromycin is best administered on empty stomach. In severe hepatic impairment the dose is 150 mg once daily.

Pediatric dose: The dose for children is 2.5 to 5 mg/kg body weight twice a day. The following general guidelines can be followed

• 6 to 11 Kg: 25 mg Roxithromycin 12 hourly.
• 12 to 23 Kg: 50 mg Roxithromycin 12 hourly.
• 24 to 40 Kg: 100 mg Roxithromycin 12 hourly.

A normal course of therapy is between 5 and 10 days.

Roxithromycin is well tolerated by patients of all age groups. Less than 4% of treated patients complain of side effects mainly nausea, abdominal pain, diarrhoea and hypersensitivity rash. Other side effects reported include vomiting, dizziness, headache, pruritus, dyspepsia, flatulence, tinnitus, vertigo and constipation. These are in general minor and do not necessitate withdrawal of therapy.

Roxithromycin should not be administered simultaneously with ergotamine or its derivatives as it may provoke arterial spasm and severe ischaemia.

Roxithromycin should not be used in patients with a history of hypersensitivity to the drug. In patients with hepatic diseases the dose of Roxithromycin should not exceed 150 mg twice a day.

Roxithromycin does not have any affinity for cytochrome P-450 binding sites and thus is unlikely to produce drug interaction mediated by this enzymatic system. Roxithromycin shows mild interaction with theophylline though this has not been found to produce clinically relevant effects. Alteration in the pharmacokinetics of carbamazepine or warfarin has not been found. Antacids, H2- receptor antagonists and food has no effect on the absorption of Roxithromycin.

The safety of Roxithromycin in pregnancy has not been established. It appears in breast milk in small amounts and dose not produce adverse effects in the breast fed infant.

Diphenhydramine is indicated for the treatment of followings:

• Seasonal, perennial, vasomotor rhinitis
• Urticaria, angioneurotic oedema, anaphylaxis
• Pruiritic conditions
• Premedication for emesis and motion sickness
• Miscellaneous like meniere's disease and parkinsonism

Sedating Anti-histamine

Diphenhydramine is an antihistamine with anticholinergic and sedative effects. It competes with histamine for H1-receptor sites on effector cells in the GI tract, blood vessels and respiratory tract.

Adult-

• Most allergic conditions: 25-50 mg three times a day with a further 50 mg at night.

Children-

• 1 to 5 years of age: 5 mg i.e., 2.5 ml of elixir 4 times a day
• More than 6 years of age: 10 mg i.e. 5 ml of elixir 4 times a day

Side effect includes sedation, dizziness, tinnitus, fatigue, ataxia, blurred vision, diplopia, euphoria, and epigastric discomfort.

Known hypersensitivity to Diphenhydramine Hydrochloride, Ammonium chloride is contra-indicated in presence of impaired hepatic or renal function.

Caution should be exercised with patients in whom drowsiness is undesirable e.g., drivers, machine operators. Concomitant consumption of alcohol or central nervous system (CNS) depressants will potentiate drowsiness.

Diphenhydramine administration significantly reduces the absorption of the antituberculous agent para-aminosalicyclic acid (PAS) from the gastrointestinal tract. CNS depressants may potentiate the sedative action of Diphenhydramine. Anticholinergic drugs may potentiate Diphenhydramine’s anticholinergic side effects.

Category B: There are no adequate and well controlled studies in pregnant women using diphenhydramine hydrochloride. Therefore, diphenhydramine hydrochloride should be used in pregnancy only if clearly needed. Diphenhydramine hydrochloride has been reported to be excreted in breast milk and thus, use of diphenhydramine hydrochloride in lactating mother is not recommended.

Symptoms: Impaired consciousness; psychosis, seizures, antimuscarinic symptoms (e.g. mydriasis, tachycardia, tachyarrhythmias), resp failure, rhabdomyolysis; acute delirium with visual and auditory hallucination (topical).

Management: Supportive and symptomatic treatment. Convulsions and marked CNS stimulation may be treated with IV diazepam.

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

Glucocorticoids

Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.

Adult-
Nephrotic Syndrome:

• Initial: 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks.
• Maintenance dose: 0.5 to 1 mg/kg/ dose given every other day for 3 to 6 months.

Anti-inflammatory: 5 to 60 mg per day in divided doses 1 to 4 times/day.

Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.

Allergic Conditions:

• Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
• Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
• Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
• Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
• Day 5: 5 mg PO before breakfast and at bedtime.
• Day 6: 5 mg PO before breakfast.

Pediatric-
Asthma:

• 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
• 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
• 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
• 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.

Anti-inflammatory: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Common side effects include increased appetite, indigestion, nervousness or restlessness. Less frequent or rare side effects are darkening or lightening of skin color, dizziness or lightheadedness, flushing of face or cheeks, hiccups, increased sweating, the sensation of spinning.

Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.

Precaution has to be taken in diabetes, hypertension, Psychological disturbances, osteoporosis, post-menopausal women, pregnancy and in chronic nephritis. Long-term use of Prednisolone can cause Cushing's habitus, hyperglycemia, muscular weakness, increased susceptibility to infection, delayed wound healing, and psychiatric disturbances.

The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.

This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.

Adverse effects related to prednisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the prednisone dose should be reduced gradually.

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

Intravenous fluid preparations, Parenteral nutritional preparations

Dose is variable. It depends on the clinical condition, age and body surface area of the patients.

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Do not take this medicine and tell your doctor if: Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

As the preparation contains Sodium Chloride, it should be administered with caution to patients with congestive heart failure, peripheral or pulmonary oedema, impaired renal function or pre-eclampsia. Serum glucose concentration should also be carefully monitored and concurrent use of insulin may be needed in case of diabetic patients. Infusion of fluid should be immediately discontinued if rigor arises for any reason during the process. Do not use if the solution is cloudy, contains particles, or after expiry date.

FDA pregnancy category C. It is not known whether dextrose 5% in water will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether dextrose 5% in water passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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

Intravenous fluid preparations, Parenteral nutritional preparations

Dose is variable. It depends on the clinical condition, age and body surface area of the patients.

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Do not take this medicine and tell your doctor if: Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

As the preparation contains Sodium Chloride, it should be administered with caution to patients with congestive heart failure, peripheral or pulmonary oedema, impaired renal function or pre-eclampsia. Serum glucose concentration should also be carefully monitored and concurrent use of insulin may be needed in case of diabetic patients. Infusion of fluid should be immediately discontinued if rigor arises for any reason during the process. Do not use if the solution is cloudy, contains particles, or after expiry date.

FDA pregnancy category C. It is not known whether dextrose 5% in water will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether dextrose 5% in water passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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

Specific mineral preparations

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

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

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

For dispersible tablet-

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

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

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

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

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

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

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

Glucocorticoids

Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.

Adult-
Nephrotic Syndrome:

• Initial: 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks.
• Maintenance dose: 0.5 to 1 mg/kg/ dose given every other day for 3 to 6 months.

Anti-inflammatory: 5 to 60 mg per day in divided doses 1 to 4 times/day.

Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.

Allergic Conditions:

• Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
• Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
• Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
• Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
• Day 5: 5 mg PO before breakfast and at bedtime.
• Day 6: 5 mg PO before breakfast.

Pediatric-
Asthma:

• 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
• 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
• 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
• 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.

Anti-inflammatory: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Common side effects include increased appetite, indigestion, nervousness or restlessness. Less frequent or rare side effects are darkening or lightening of skin color, dizziness or lightheadedness, flushing of face or cheeks, hiccups, increased sweating, the sensation of spinning.

Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.

Precaution has to be taken in diabetes, hypertension, Psychological disturbances, osteoporosis, post-menopausal women, pregnancy and in chronic nephritis. Long-term use of Prednisolone can cause Cushing's habitus, hyperglycemia, muscular weakness, increased susceptibility to infection, delayed wound healing, and psychiatric disturbances.

The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.

This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.

Adverse effects related to prednisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the prednisone dose should be reduced gradually.

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

Prednisolone eye drops is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

Glucocorticoids

Prednisolone decreases inflammation by inhibition of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It suppresses the immune system by reducing the activity and production of the lymphocytes and eosinophils.

Adult: Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue the therapy before completing the course. 

Paediatric: Safety and effectiveness in pediatric patients have not been established.

Elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation and delayed wound healing.  Fungal and viral infections of the cornea are particularly may develop coincidentally with long-term applications of steroid.

Prednisolone Acetate is contraindicated in viral diseases of the cornea, conjunctiva and known hypersensitivity to any of the ingredients of this preparation or other corticosteroids.

Shake the bottle well before use. Prolonged use of corticosteroids may result in damage to the optic nerve and defects in vision. If this product is used for longer period of time, intraocular pressure should be routinely monitored.

No significant drug interactions have been reported.

Prednisolone Acetate is pregnancy category C. So, this drug should be used during pregnancy only if clearly needed. It is not known whether topical administration of corticosteroids would result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Prednisolone Acetate is administered to a nursing woman.

A one-time accidental overdose of Prednisolone Ophthalmic Suspension generally will not cause acute problems. Long time overdose may show general side-effects. In accidental overdose sufficient water should be taken to dilute the medication.

Store in a cool, dry place and protect from light. Keep out of the reach of children. Protect from freezing.  Shake well before using.

Glucocorticoids

Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.

Adult-
Nephrotic Syndrome:

• Initial: 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks.
• Maintenance dose: 0.5 to 1 mg/kg/ dose given every other day for 3 to 6 months.

Anti-inflammatory: 5 to 60 mg per day in divided doses 1 to 4 times/day.

Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.

Allergic Conditions:

• Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
• Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
• Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
• Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
• Day 5: 5 mg PO before breakfast and at bedtime.
• Day 6: 5 mg PO before breakfast.

Pediatric-
Asthma:

• 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
• 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
• 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
• 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.

Anti-inflammatory: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Common side effects include increased appetite, indigestion, nervousness or restlessness. Less frequent or rare side effects are darkening or lightening of skin color, dizziness or lightheadedness, flushing of face or cheeks, hiccups, increased sweating, the sensation of spinning.

Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.

Precaution has to be taken in diabetes, hypertension, Psychological disturbances, osteoporosis, post-menopausal women, pregnancy and in chronic nephritis. Long-term use of Prednisolone can cause Cushing's habitus, hyperglycemia, muscular weakness, increased susceptibility to infection, delayed wound healing, and psychiatric disturbances.

The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.

This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.

Adverse effects related to prednisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the prednisone dose should be reduced gradually.

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

Glucocorticoids

Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.

Adult-
Nephrotic Syndrome:

• Initial: 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks.
• Maintenance dose: 0.5 to 1 mg/kg/ dose given every other day for 3 to 6 months.

Anti-inflammatory: 5 to 60 mg per day in divided doses 1 to 4 times/day.

Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.

Allergic Conditions:

• Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
• Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
• Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
• Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
• Day 5: 5 mg PO before breakfast and at bedtime.
• Day 6: 5 mg PO before breakfast.

Pediatric-
Asthma:

• 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
• 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
• 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
• 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.

Anti-inflammatory: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Common side effects include increased appetite, indigestion, nervousness or restlessness. Less frequent or rare side effects are darkening or lightening of skin color, dizziness or lightheadedness, flushing of face or cheeks, hiccups, increased sweating, the sensation of spinning.

Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.

Precaution has to be taken in diabetes, hypertension, Psychological disturbances, osteoporosis, post-menopausal women, pregnancy and in chronic nephritis. Long-term use of Prednisolone can cause Cushing's habitus, hyperglycemia, muscular weakness, increased susceptibility to infection, delayed wound healing, and psychiatric disturbances.

The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.

This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.

Adverse effects related to prednisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the prednisone dose should be reduced gradually.

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

Diphenhydramine is indicated for the treatment of followings:

• Seasonal, perennial, vasomotor rhinitis
• Urticaria, angioneurotic oedema, anaphylaxis
• Pruiritic conditions
• Premedication for emesis and motion sickness
• Miscellaneous like meniere's disease and parkinsonism

Sedating Anti-histamine

Diphenhydramine is an antihistamine with anticholinergic and sedative effects. It competes with histamine for H1-receptor sites on effector cells in the GI tract, blood vessels and respiratory tract.

Adult-

• Most allergic conditions: 25-50 mg three times a day with a further 50 mg at night.

Children-

• 1 to 5 years of age: 5 mg i.e., 2.5 ml of elixir 4 times a day
• More than 6 years of age: 10 mg i.e. 5 ml of elixir 4 times a day

Side effect includes sedation, dizziness, tinnitus, fatigue, ataxia, blurred vision, diplopia, euphoria, and epigastric discomfort.

Known hypersensitivity to Diphenhydramine Hydrochloride, Ammonium chloride is contra-indicated in presence of impaired hepatic or renal function.

Caution should be exercised with patients in whom drowsiness is undesirable e.g., drivers, machine operators. Concomitant consumption of alcohol or central nervous system (CNS) depressants will potentiate drowsiness.

Diphenhydramine administration significantly reduces the absorption of the antituberculous agent para-aminosalicyclic acid (PAS) from the gastrointestinal tract. CNS depressants may potentiate the sedative action of Diphenhydramine. Anticholinergic drugs may potentiate Diphenhydramine’s anticholinergic side effects.

Category B: There are no adequate and well controlled studies in pregnant women using diphenhydramine hydrochloride. Therefore, diphenhydramine hydrochloride should be used in pregnancy only if clearly needed. Diphenhydramine hydrochloride has been reported to be excreted in breast milk and thus, use of diphenhydramine hydrochloride in lactating mother is not recommended.

Symptoms: Impaired consciousness; psychosis, seizures, antimuscarinic symptoms (e.g. mydriasis, tachycardia, tachyarrhythmias), resp failure, rhabdomyolysis; acute delirium with visual and auditory hallucination (topical).

Management: Supportive and symptomatic treatment. Convulsions and marked CNS stimulation may be treated with IV diazepam.

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

4-Quinolone preparations

Pefloxcin is a synthetic antibacterial agent, belongs to fluoroquinolone group. It exerts its action by inhibiting the subunit-A of DNA gyrase (Topoisomerase II). Pefloxcin is bactericidal and has a broad spectrum of activity.

Adult with normal hepatic function: Pefloxcin 400 mg tablet 12 hourly (morning & evening) with meals to avoid gastrointestinal disturbances. An initial loading dose of 800 mg may be given in order to produce effective blood concentration more rapidly.

Adult with hepatic insufficiency: In patients with severe hepatic insufficiency or reduced blood supply to the liver, the daily doses should be readjusted by increasing the intervals between doses. Dosage need not to be reduced in renal insufficiency.

Duration of Treatment:

• Usually 5 to 10 days.
• For chronic prostatitis, cystic fibrosis & chronic Salmonella carriers: 14 days.
• For endocarditis: Up to 6 months.
• For chronic osteomyelitis: Up to 1 year.
• For gonorrhoea: 2 tablets single dose.

Occasionally observed reactions are - Gastrointestinal disturbance: Epigastric pain, nausea, vomiting, diarrhoea, dyspepsia. Central nervous system disturbance: Headache, insomnia. Hypersensitivity reaction: Skin rash, pruritis, photosensitization. Others: Myalgia and/or arthralgia, tendonitis, rupture of achilles tendon.

Pefloxacin is contraindicated in patients with known hypersensitivity to Quinolone, children under 15 years of age, pregnant and lactating mothers, patient with inborn glucose-6-phosphate dehydrogenase deficiency and patients with history of tendon lesion, tendonitis or tendon rupture.

Because of the risk of photosensitivity reaction, exposure to sunlight and ultraviolet radiation should be avoided during Pefloxacin therapy. Dosage readjustment is required in severe hepatic insufficiency. Patients should be informed of the possibility of pain in the achilles tendon.

When taken concomitantly with an Antacid containing Aluminium and/or Magnesium Hydroxide gel, absorption of Pefloxacin is reduced. So, concurrent administration of these agents with Pefloxacin should be avoided.

Pefloxacin has been assigned to pregnancy category C by the FDA.

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

4-Quinolone preparations

Pefloxcin is a synthetic antibacterial agent, belongs to fluoroquinolone group. It exerts its action by inhibiting the subunit-A of DNA gyrase (Topoisomerase II). Pefloxcin is bactericidal and has a broad spectrum of activity.

Adult with normal hepatic function: Pefloxcin 400 mg tablet 12 hourly (morning & evening) with meals to avoid gastrointestinal disturbances. An initial loading dose of 800 mg may be given in order to produce effective blood concentration more rapidly.

Adult with hepatic insufficiency: In patients with severe hepatic insufficiency or reduced blood supply to the liver, the daily doses should be readjusted by increasing the intervals between doses. Dosage need not to be reduced in renal insufficiency.

Duration of Treatment:

• Usually 5 to 10 days.
• For chronic prostatitis, cystic fibrosis & chronic Salmonella carriers: 14 days.
• For endocarditis: Up to 6 months.
• For chronic osteomyelitis: Up to 1 year.
• For gonorrhoea: 2 tablets single dose.

Occasionally observed reactions are - Gastrointestinal disturbance: Epigastric pain, nausea, vomiting, diarrhoea, dyspepsia. Central nervous system disturbance: Headache, insomnia. Hypersensitivity reaction: Skin rash, pruritis, photosensitization. Others: Myalgia and/or arthralgia, tendonitis, rupture of achilles tendon.

Pefloxacin is contraindicated in patients with known hypersensitivity to Quinolone, children under 15 years of age, pregnant and lactating mothers, patient with inborn glucose-6-phosphate dehydrogenase deficiency and patients with history of tendon lesion, tendonitis or tendon rupture.

Because of the risk of photosensitivity reaction, exposure to sunlight and ultraviolet radiation should be avoided during Pefloxacin therapy. Dosage readjustment is required in severe hepatic insufficiency. Patients should be informed of the possibility of pain in the achilles tendon.

When taken concomitantly with an Antacid containing Aluminium and/or Magnesium Hydroxide gel, absorption of Pefloxacin is reduced. So, concurrent administration of these agents with Pefloxacin should be avoided.

Pefloxacin has been assigned to pregnancy category C by the FDA.

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