Find Medicines

This is indicated for the symptomatic relief of upper respiratory tract disorders accompanied by productive cough which benefits from the administration of a nasal decongestant, a histamine H1 receptor antagonist and an expectorant combination.

Combined cough expectorants

Pseudoephedrine is a decongestant as well as a bronchodilator for the upper respiratory tract, which gives symptomatic relief of nasal congestion. Pseudoephedrine is both an α-and β-adrenergic receptor agonist. It causes vasoconstriction via direct stimulation of α-adrenergic receptors of the respiratory mucosa. It also directly stimulates β-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility.

Like ephedrine, pseudoephedrine releasing norepinephrine from its storage sites, an indirect effect. This is its main and direct mechanism of action. The displaced noradrenaline is released into the neuronal synapse where it is free to activate the postsynaptic adrenergic receptors.

Guaifenesin reduces the viscosity of tenacious sputum and is used as an expectorant. It increases the hydration of respiratory tract, thereby increasing the volume and reducing the viscosity of bronchial secretions.

Triprolidine is an antihistamine; it is used for the symptomatic relief of hypersensitivity reactions including rhinitis, conjunctivitis and urticaria.

Adult and Children over 12 years: 10 ml (2 teaspoonful) three times a day.
Children 6-12 years: 5 ml (1 teaspoonful) three times a day.
Children 2-5 years: 2.5 ml (1/2 teaspoonful) three times a day.

A physician’s advice is preferred before administering this preparation to children aged less than 2 years.

CNS depression or excitation, drowsiness (reported most frequently), sleep disturbances, hallucinations (rarely reported), skin rashes with or without irritation, tachycardia, dryness of mouth, nose and throat have occasionally been reported.

This is contraindicated in the cases of known hypersensitivity to any of its constituents, cardiovascular disease including hypertension, lower respiratory symptoms including asthma, monoamine oxidase inhibitor (MAOI) therapy.

As with any other antihistamine therapy, Pseudoephedrine, guaiphenasine & triprolidine may cause drowsiness. If affected, patients should be advised not to drive or operate machinery. Concomitant administration of alcohol or other centrally acting sedatives should be avoided. Although Pseudoephedrine has no pressor effects in normotensive patients but Pseudoephedrine, guaiphenasine & triprolidine should be used with caution to patients suffering from mild to moderate hypertension. Moreover, caution should also be exercised in the following disease conditions - hypertension and heart disease, diabetes, hyperthyroidism, elevated intra-ocular pressure, prostatic enlargement, severe renal and hepatic impairment. This preparation should not be used for persistent or chronic cough, which occurs with smoking, asthma or emphysema or where excessive secretions accompany cough, unless directed by a physician.

Concomitant use of Pseudoephedrine, guaiphenasine & triprolidine with sympathomimetic agents such as decongestants, tricyclic antidepressants, appetite suppressants and amphetamine-like psychostimulants or with monoamine oxidase inhibitors which interfere with the catabolism of sympathomimetic amines may occasionally cause a rise in blood pressure. Because of its pseudoephedrine content, Pseudoephedrine, guaiphenasine & triprolidine partially reverse the hypotensive action of drugs which interfere with sympathetic activity including guanethidine, methyldopa, alpha-adrenergic blocking agents.

Although pseudoephedrine, triprolidine and guaiphenesin have been in widespread use of many years without apparent ill consequence, there are no specific data on their use during pregnancy. Caution should therefore be exercised by balancing the potential benefits of treatment of the mother against any possible hazards to the developing fetus.

The effects of acute toxicity from Pseudoephedrine, guaiphenasine & triprolidine may include drowsiness, irritability, restlessness, lethargy, dizziness, gastrointestinal discomfort, respiratory depression, convulsion, tremor, tachycardia and hypertension. Incase of overdose, necessary measures should be taken to maintain and support respiration and control convulsion. Gastric lavage may be undertaken if indicated. Catheterization of bladder may be necessary.

Store below 25° C. Protect from light. Do not refrigerate.

Fluticasone Furoate Nasal Spray is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older.

Fluticasone Furoate inhalation powder is indicated for the once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 5 years and older. This is not indicated for the relief of acute bronchospasm.

Nasal Steroid Preparations

Fluticasone Furoate is a synthetic trifluorinated corticosteroid with potent anti inflammatory activity. Like other corticosteroids Fluticasone Furoate is found to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g.- histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.

Fluticasone Furoate Nasal Spray:

• Adults & Children over 12 years: 2 sprays in each nostril once a day. In some cases 2 sprays into each nostril twice daily, not exceeding 4 sprays.
• Children under 12 years (2-11 Years): 1 spray in each nostril once a day. Patients should use Fluticasone Furoate nasal spray at regular intervals as directed since its effectiveness depends on its regular use.
• Children (under 2 years of age): There are no data to recommend use of Fluticasone Furoate Nasal Spray for the treatment of seasonal or perennial allergic rhinitis in children under 2 years of age.

Fluticasone Furoate Inhalation Capsule: should be administered as 1 inhalation once daily by the orally inhaled route. Fluticasone Furoate should be used at the same time every day. Do not use fluticasone furoate more than 1 time every 24 hours.

• Adults and Adolescents Aged 12 Years and Older: The starting dosage for Fluticasone Furoate should be based upon patients' asthma severity.
• The usual recommended starting dose for adults and adolescents aged 12 years and older not on an inhaled corticosteroid (ICS) is 100 mcg.
• For other adults and adolescents aged 12 years and older, the starting dose should be based on previous asthma drug therapy and disease severity.
• For adults and adolescents aged 12 years and older who do not respond to Fluticasone Furoate 100 mcg after 2 weeks of therapy, replacement with Fluticasone Furoate 200 mcg may provide additional asthma control.

If a dosage regimen of Fluticasone Furoate fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, e.g., replacing the current strength of Fluticasone Furoate with a higher strength, initiating an ICS and long- acting beta 2 -agonist (LABA) combination product, or initiating oral corticosteroids, should be considered.

The highest recommended daily dose in adults and adolescents aged 12 years and older is 200 mcg. After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to help reduce the possibility of side effects.

Pediatric Patients Aged 5 to 11 Years: The recommended dosage for children aged 5 to 11 years is 50 mcg administered once daily

How to use the Nasal Spray-

• Shake the bottle gently and remove the dust cover.
• Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
• Gently blow the nose to clear the nostrils.
• Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
• Breathe out through your mouth.
• Repeat the above steps in the same/ other nostril for consecutive doses.

Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-

• Remove the dust cover.
• Gently pull off the nasal applicator.
• Wash the applicator and dust cover in warm water.
• Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
• Gently push the applicator back on the top of the bottle and re-fix the dust cover.

Fluticasone Furoate nasal spray is absorbed less into the rest of the body, therefore fewer side effects are seen. With the nasal spray, drying of the nose and an increase in the incidence of nosebleeds may occur.

Most common adverse reactions of Fluticasone Furoate inhalation capsule reported in ≥5% of adult and adolescent subjects are nasopharyngitis, bronchitis, upper respiratory tract infection, and headache. Most common adverse reactions reported in ≥3% of pediatric subjects aged 5 to 11 years are pharyngitis, bronchitis, and viral infection.

Fluticasone Furoate nasal spray is contraindicated in patients with a hypersensitivity to any of its ingredients.

Rarely, immediate hypersensitivity reactions or contact dermatitis may occur after the administration of Fluticasone Furoate nasal spray. Rare instances of wheezing, nasal septum perforation, cataracts, glaucoma and increased intraocular pressure have been reported following the intranasal application of corticosteroids, including Fluticasone Furoate. Although systemic effects have been minimal with recommended doses of Fluticasone Furoate nasal spray, potential risk increases with larger doses. Therefore, larger than recommended doses of Fluticasone Furoate nasal spray should be avoided.

Potent inhibitors of cytochrome P450 3A4 (CYP3A4) may increase exposure to Fluticasone Furoate. Coadministration of ritonavir is not recommended. Use caution with coadministration of other potent CYP3A4 inhibitors, such as ketoconazole.

Special instruction: Patients should be instructed that the device must be primed: before first use, and if the cap is left off or if the device does not seem to be working or if the nasal spray has not been used for 30 days or more. In order to prime the device, the nasal spray needs to be shaken vigorously for about 10 seconds with the cap on. The patient must then press the button firmly all the way in, approximately 6 times until a fine mist is seen. Once primed, the patient must shake the nasal spray vigorously each time before use.

Use in pregnancy: Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Fluticasone Furoate nasal spray should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus.

Use in lactation: It is not known whether Fluticasone Furoate is excreted in human breast milk. However, since other corticosteroids have been detected in human milk, caution should be exercised when Fluticasone Furoate is administered to a nursing woman.

Geriatric use: In general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Use in hepatic impairment: Use Fluticasone Furoate with caution in patients with severe hepatic impairment.

Use in renal impairment: No dosage adjustment is required in patients with renal impairment.

Store at a temperature not exceeding 30°C. Do not refrigerate. Protect from light and moisture. Keep out of the reach of children.

Mast Cell Stabiliser, Ophthalmic Non-Steroid drugs

Sodium Cromoglycate 2% sterile Eye Drops inhibits the release of chemical mediators from sensitised mast cells and is capable of rapid phosphorylation of mast cell protein. The exact mechanism of action of the drug remains to be elucidated but Sodium Cromoglycate appears to modulate the allergic response to antigen antibody interactions in a way which prevents the subsequent formation or release of toxic or inflammatory mediators. Sodium Cromoglycate 2% Eye Drops appears to act mainly through a local effect on the mucous of the eye. Approximately 0.03% of an ophthalmic dose of Sodium Cromoglycate 2% Eye Drops is absorbed systemically. Sodium Cromoglycate 2% Eye Drops prevent, release of mediators of type-I allergic reactions, including histamine and slow reacting substance of anaphylaxis (SRS-A) from sensitised mast cells after the antigen antibody union has taken place. The drug does not inhibit the binding of IgE to mast cells nor the interaction between cell bound IgE and the specific antigen; instead Sodium Cromoglycate suppresses the release of substances (e.g. histamine, SRS-A) in response to this reaction. The drug also inhibits Type-III (late allergic, Arthus) reactions.

The usual dosage of Sodium Cromoglycate 2% Eye Drops in adults and children over 4 years of age or older is 1 or 2 drops in each eye 4-6 times daily at regular intervals. The recommended frequency of administration should not be exceeded. Patients should be advised that the therapeutic effects of Sodium Cromoglycate 2% Eye Drops depend on administration of the drug at regular intervals.

The most frequent adverse effect reported with use of Sodium Cromoglycate 2% Eye Drops is transient ocular stinging or burning upon instillation of the drug.

Sodium Cromoglycate 2% Eye Drops is contraindicated in individuals who have shown hypersensitivity to the drug or any of the ingredients.

Sodium Cromoglycate 2% Eye Drops contains benzalkonium chloride and patients should be advised not to wear soft contact lenses during treatment with Sodium Cromoglycate 2% Eye Drops.

Sodium Cromoglycate has no known drug interactions.

In animal studies, Sodium Cromoglycate has produced adverse effects on the foetus only in high parenteral doses. There was no evidence of impaired fertility in reproduction studies in animals. Healthy infants have been born to women who received Sodium Cromoglycate throughout pregnancy; nevertheless, there is insufficient evidence to establish the safety in pregnancy. It should be used during pregnancy only when clearly needed. Since it is not known if Sodium Cromoglycate is distributed into milk in humans, the drug should be used with caution in nursing women.

Overdose is unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.

Sodium Cromoglycate 2% Eye Drops should be protected from direct sunlight and stored at a temperature less than 30˚C; any unused ophthalmic solution should be discarded 4 weeks after opening the cap of the bottle.

Antacids

This is the combination of Sodium Alginate and Potassium Bicarbonate. Sodium Alginate is a naturally occurring substance. It reacts with the acid in the stomach to form a gel. Potassium Bicarbonate also reacts with the acid in the stomach to form bubbles of carbon dioxide. These bubbles are trapped by the gel formed by Sodium Alginate and they allow the gel to float like a raft on top of the stomach contents. The raft prevents acid in the stomach from flowing back into the esophagus. This relieves the symptoms of reflux such as heartburn. The mode of action of this is physical and does not depend on absorption into the systemic circulation. The raft lasts for up to 4 hours on top of the stomach contents and is then broken down in the digestive system and excreted in the feces.

Tablet:

• Adults and children over 12 years: 1-2 tablets 3-4 times daily, after meals and before bedtime.
• Children 6-12 years: ½-1 tablet 3-4 times daily, after meals and before bedtime.

Suspension:

• Adults and children 12 years and above: 5-10 ml (1-2 teaspoonfuls) 3-4 times daily, after meals and before bedtime.
• Children 2-12 years: 2.5-5ml (½-1 teaspoonful) 3-4 times daily, after meals and before bedtime.

Use in children: This is not recommended under 2 years of age.
Elderly: No dose modifications are necessary for this age group.
Hepatic Impairment: No dose modifications are necessary.
Renal Insufficiency: Caution if a highly restricted salt diet is necessary.

In addition to the desired effect of the drug, some side effects may appear such as: nausea, constipation, diarrhea or headache. In these cases consult a physician In case too big dosage has been taken, there might appear a sensation of swelling. In this case it is advisable to consult a physician.

Sodium alginate and potassium bicarbonate is contraindicated in patients with known hypersensitivity to these.

Sodium Alginate and Potassium Bicarbonate should be prescribed with caution in patients with renal impairment and congestive cardiac failure. Care needs to be taken in treating patients with hypercalcemia, nephrocalcinosis and recurrent calcium-containing renal calculi. There is a possibility of reduced efficacy in patients with very low levels of gastric acid. If symptoms do not improve after seven days, the clinical situation should be reviewed.

A time interval of 2 hours should be considered between this intake and the administration of other medicinal products, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates, and estramustine.

This combination (Sodium Alginate and Potassium Bicarbonate) can be used during pregnancy, if clinically needed. No known effect on breast-fed infants. This combination can be used during breastfeeding.

Overdosage with this formulation is a rare case. In case of overdose please consult with a registered physician.

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

For the treatment and prophylaxis of Sodium Chloride deficiency.

Oral electrolytes preparations

Sodium chloride is the principle salt involved in maintaining the osmotic tension of blood and tissues, changes in osmotic tension influence the movement of fluids and diffusion of salts in cellular tissue. Sodium Chloride tablet provides a source of sodium where a deficiency exists. Sodium chloride is readily absorbed from the gastro-intestinal tract. It is present in all body fluids but specially in the extracellular fluid. The amount of sodium lost (as sweat) is normally small. Osmotic balance is maintained by excretion of surplus amounts in the urine.

It is important that the tablet should be swallowed whole with water (approx. 70 ml per tablet where kidney function is normal to avoid hypernatremia), and not chewed.

Adults: For prophylaxis 8-16 tablets per day. For treatment dosage to be adjusted to individual needs up to a maximum of 40 tablets per day in case of severe salt depletion. For control of muscle cramps during routine maintenance haemodialysis usually 20-32 tablets per dialysis. In some cases of chronic renal salt-wasting, up to 40 tablets per day may be required with appropriate fluid intake.

Children: Dosage should be adjusted to individual needs.

Elderly: No special dosage adjustment.

No side effects have been reported with Sodium Chloride 300 mg tablet at the recommended dosage.

Sodium Chloride is contra-indicated in any situation where salt retention is undesirable, such as edema, heart disease, cardiac decompensation and primary or secondary aldosteronism; or where therapy is being given to produce salt and water loss.

No special warnings and precautions are required to maintain.

In hypertensive patients with chronic renal failure Sodium Chloride, 300 mg tablet may tend to impair the efficacy of antihypertensive drugs.

Use in Pregnancy: No additional precautions required during pregnancy.

Signs and symptoms: Excessive intake of sodium chloride can result in hypernatraemia. Symptoms of hypernatraemia include restlessness, weakness, thirst, reduced salivation and lachrymation, swollen tongue, flushing of the skin, pyrexia, dizziness, headache, oliguria, hypertension, tachycardia, delirium, hyperpnoea and respiratory arrest.

Treatment: Treatment requires the use of sodium-free liquids and the cessation of excessive sodium intake. In the event of a significant overdose serum sodium levels should be evaluated as soon as possible and appropriate steps taken to correct any abnormalities. The use of a loop diuretic e.g. frusemide (with potassium supplementation as required) may be appropriate in severe cases of hypernatraemia. Levels should be monitored until they return to normal.

Store below 30°C in a dry place protected from light. Keep out of reach of Children.

Management of acidosis in cardiac arrest. 
Management of metabolic acidosis in:

• Severe renal disease
• Uncontrolled diabetes
• Circulatory insufficiency from shock or dehydration
• Severe primary lactic acidosis

Alkalinization of urine.

Intravenous fluid preparations, Urinary Alkalinizing Agent

Sodium bicarbonate is a systemic alkalinizing agent. It increases plasma bicarbonate, buffers excess hydrogen ion concentration, and raises blood pH, thereby reversing the clinical manifestations of acidosis. It can also be used to replenish electrolyte imbalance as a treatment adjunct for severe diarrhea where the loss of bicarbonate can be significant.

Oral: The usual dose is 300 mg to 2 grams, 1 to 4 times daily.

Intravenous (Severe metabolic acidosis):

• Adult: By slow inj of a hypertonic solution of up to 8.4% (1000 mmol/L), or by continuous infusion of a weaker solution, usually 1.26% (150 mmol/L). For correction of acidosis during advanced cardiac life support procedures, 50 ml of an 8.4% solution may be given.
• Elderly: Dosage adjustments may be required.

This medication is generally well tolerated. However, high doses may cause headache, nausea or irritability. If any of these effects continue or become bothersome, inform your doctor. Notify your doctor if you develop: muscle weakness, slow reflexes, confusion, swelling of the feet or ankles, black tar-like stools, coffee-ground vomit. If you notice other effects not listed above, contact your doctor or pharmacist.

This drug is contraindicated in hypoventilatory states, chloride depletion owing to continuous gastric fluid loss, metabolic and/or respiratory alkalosis, hypocalcemia and diuretics known to produce hypochloremic alkalosis.

Pre-existing heart disease, kidney disease, liver disease, high blood pressure, any allergies.

This medication has the potential to interact with many medications. Should not take any other medication within 1 to 2 hours of taking an antacid. Potentially hazardous interactions with Corticosteroids and Corticotropin, Alkalis, Calcium, Diuretics and Potassium.

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.

Renal Impairment: Dosage adjustments may be required.
Hepatic Impairment: Dosage adjustments may be required.

If alkalosis results, the bicarbonate should be stopped and the patient managed according to the degree of alkalosis present. 0.9% sodium chloride injection intravenous may be given; potassium chloride also may be indicated if there is hypokalemia. Severe alkalosis may be accompanied by hyperirritability or tetany and these symptoms may be controlled by calcium gluconate. An acidifying agent such as ammonium chloride may also be indication in severe alkalosis.

Store in a cool & dry place protected from light. Keep out of reach of children.

Management of acidosis in cardiac arrest. 
Management of metabolic acidosis in:

• Severe renal disease
• Uncontrolled diabetes
• Circulatory insufficiency from shock or dehydration
• Severe primary lactic acidosis

Alkalinization of urine.

Intravenous fluid preparations, Urinary Alkalinizing Agent

Sodium bicarbonate is a systemic alkalinizing agent. It increases plasma bicarbonate, buffers excess hydrogen ion concentration, and raises blood pH, thereby reversing the clinical manifestations of acidosis. It can also be used to replenish electrolyte imbalance as a treatment adjunct for severe diarrhea where the loss of bicarbonate can be significant.

Oral: The usual dose is 300 mg to 2 grams, 1 to 4 times daily.

Intravenous (Severe metabolic acidosis):

• Adult: By slow inj of a hypertonic solution of up to 8.4% (1000 mmol/L), or by continuous infusion of a weaker solution, usually 1.26% (150 mmol/L). For correction of acidosis during advanced cardiac life support procedures, 50 ml of an 8.4% solution may be given.
• Elderly: Dosage adjustments may be required.

This medication is generally well tolerated. However, high doses may cause headache, nausea or irritability. If any of these effects continue or become bothersome, inform your doctor. Notify your doctor if you develop: muscle weakness, slow reflexes, confusion, swelling of the feet or ankles, black tar-like stools, coffee-ground vomit. If you notice other effects not listed above, contact your doctor or pharmacist.

This drug is contraindicated in hypoventilatory states, chloride depletion owing to continuous gastric fluid loss, metabolic and/or respiratory alkalosis, hypocalcemia and diuretics known to produce hypochloremic alkalosis.

Pre-existing heart disease, kidney disease, liver disease, high blood pressure, any allergies.

This medication has the potential to interact with many medications. Should not take any other medication within 1 to 2 hours of taking an antacid. Potentially hazardous interactions with Corticosteroids and Corticotropin, Alkalis, Calcium, Diuretics and Potassium.

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.

Renal Impairment: Dosage adjustments may be required.
Hepatic Impairment: Dosage adjustments may be required.

If alkalosis results, the bicarbonate should be stopped and the patient managed according to the degree of alkalosis present. 0.9% sodium chloride injection intravenous may be given; potassium chloride also may be indicated if there is hypokalemia. Severe alkalosis may be accompanied by hyperirritability or tetany and these symptoms may be controlled by calcium gluconate. An acidifying agent such as ammonium chloride may also be indication in severe alkalosis.

Store in a cool & dry place protected from light. Keep out of reach of children.

For the treatment and prophylaxis of Sodium Chloride deficiency.

Oral electrolytes preparations

Sodium chloride is the principle salt involved in maintaining the osmotic tension of blood and tissues, changes in osmotic tension influence the movement of fluids and diffusion of salts in cellular tissue. Sodium Chloride tablet provides a source of sodium where a deficiency exists. Sodium chloride is readily absorbed from the gastro-intestinal tract. It is present in all body fluids but specially in the extracellular fluid. The amount of sodium lost (as sweat) is normally small. Osmotic balance is maintained by excretion of surplus amounts in the urine.

It is important that the tablet should be swallowed whole with water (approx. 70 ml per tablet where kidney function is normal to avoid hypernatremia), and not chewed.

Adults: For prophylaxis 8-16 tablets per day. For treatment dosage to be adjusted to individual needs up to a maximum of 40 tablets per day in case of severe salt depletion. For control of muscle cramps during routine maintenance haemodialysis usually 20-32 tablets per dialysis. In some cases of chronic renal salt-wasting, up to 40 tablets per day may be required with appropriate fluid intake.

Children: Dosage should be adjusted to individual needs.

Elderly: No special dosage adjustment.

No side effects have been reported with Sodium Chloride 300 mg tablet at the recommended dosage.

Sodium Chloride is contra-indicated in any situation where salt retention is undesirable, such as edema, heart disease, cardiac decompensation and primary or secondary aldosteronism; or where therapy is being given to produce salt and water loss.

No special warnings and precautions are required to maintain.

In hypertensive patients with chronic renal failure Sodium Chloride, 300 mg tablet may tend to impair the efficacy of antihypertensive drugs.

Use in Pregnancy: No additional precautions required during pregnancy.

Signs and symptoms: Excessive intake of sodium chloride can result in hypernatraemia. Symptoms of hypernatraemia include restlessness, weakness, thirst, reduced salivation and lachrymation, swollen tongue, flushing of the skin, pyrexia, dizziness, headache, oliguria, hypertension, tachycardia, delirium, hyperpnoea and respiratory arrest.

Treatment: Treatment requires the use of sodium-free liquids and the cessation of excessive sodium intake. In the event of a significant overdose serum sodium levels should be evaluated as soon as possible and appropriate steps taken to correct any abnormalities. The use of a loop diuretic e.g. frusemide (with potassium supplementation as required) may be appropriate in severe cases of hypernatraemia. Levels should be monitored until they return to normal.

Store below 30°C in a dry place protected from light. Keep out of reach of Children.

For the treatment and prophylaxis of Sodium Chloride deficiency.

Oral electrolytes preparations

Sodium chloride is the principle salt involved in maintaining the osmotic tension of blood and tissues, changes in osmotic tension influence the movement of fluids and diffusion of salts in cellular tissue. Sodium Chloride tablet provides a source of sodium where a deficiency exists. Sodium chloride is readily absorbed from the gastro-intestinal tract. It is present in all body fluids but specially in the extracellular fluid. The amount of sodium lost (as sweat) is normally small. Osmotic balance is maintained by excretion of surplus amounts in the urine.

It is important that the tablet should be swallowed whole with water (approx. 70 ml per tablet where kidney function is normal to avoid hypernatremia), and not chewed.

Adults: For prophylaxis 8-16 tablets per day. For treatment dosage to be adjusted to individual needs up to a maximum of 40 tablets per day in case of severe salt depletion. For control of muscle cramps during routine maintenance haemodialysis usually 20-32 tablets per dialysis. In some cases of chronic renal salt-wasting, up to 40 tablets per day may be required with appropriate fluid intake.

Children: Dosage should be adjusted to individual needs.

Elderly: No special dosage adjustment.

No side effects have been reported with Sodium Chloride 300 mg tablet at the recommended dosage.

Sodium Chloride is contra-indicated in any situation where salt retention is undesirable, such as edema, heart disease, cardiac decompensation and primary or secondary aldosteronism; or where therapy is being given to produce salt and water loss.

No special warnings and precautions are required to maintain.

In hypertensive patients with chronic renal failure Sodium Chloride, 300 mg tablet may tend to impair the efficacy of antihypertensive drugs.

Use in Pregnancy: No additional precautions required during pregnancy.

Signs and symptoms: Excessive intake of sodium chloride can result in hypernatraemia. Symptoms of hypernatraemia include restlessness, weakness, thirst, reduced salivation and lachrymation, swollen tongue, flushing of the skin, pyrexia, dizziness, headache, oliguria, hypertension, tachycardia, delirium, hyperpnoea and respiratory arrest.

Treatment: Treatment requires the use of sodium-free liquids and the cessation of excessive sodium intake. In the event of a significant overdose serum sodium levels should be evaluated as soon as possible and appropriate steps taken to correct any abnormalities. The use of a loop diuretic e.g. frusemide (with potassium supplementation as required) may be appropriate in severe cases of hypernatraemia. Levels should be monitored until they return to normal.

Store below 30°C in a dry place protected from light. Keep out of reach of Children.

Mast Cell Stabiliser, Ophthalmic Non-Steroid drugs

Sodium Cromoglycate 2% sterile Eye Drops inhibits the release of chemical mediators from sensitised mast cells and is capable of rapid phosphorylation of mast cell protein. The exact mechanism of action of the drug remains to be elucidated but Sodium Cromoglycate appears to modulate the allergic response to antigen antibody interactions in a way which prevents the subsequent formation or release of toxic or inflammatory mediators. Sodium Cromoglycate 2% Eye Drops appears to act mainly through a local effect on the mucous of the eye. Approximately 0.03% of an ophthalmic dose of Sodium Cromoglycate 2% Eye Drops is absorbed systemically. Sodium Cromoglycate 2% Eye Drops prevent, release of mediators of type-I allergic reactions, including histamine and slow reacting substance of anaphylaxis (SRS-A) from sensitised mast cells after the antigen antibody union has taken place. The drug does not inhibit the binding of IgE to mast cells nor the interaction between cell bound IgE and the specific antigen; instead Sodium Cromoglycate suppresses the release of substances (e.g. histamine, SRS-A) in response to this reaction. The drug also inhibits Type-III (late allergic, Arthus) reactions.

The usual dosage of Sodium Cromoglycate 2% Eye Drops in adults and children over 4 years of age or older is 1 or 2 drops in each eye 4-6 times daily at regular intervals. The recommended frequency of administration should not be exceeded. Patients should be advised that the therapeutic effects of Sodium Cromoglycate 2% Eye Drops depend on administration of the drug at regular intervals.

The most frequent adverse effect reported with use of Sodium Cromoglycate 2% Eye Drops is transient ocular stinging or burning upon instillation of the drug.

Sodium Cromoglycate 2% Eye Drops is contraindicated in individuals who have shown hypersensitivity to the drug or any of the ingredients.

Sodium Cromoglycate 2% Eye Drops contains benzalkonium chloride and patients should be advised not to wear soft contact lenses during treatment with Sodium Cromoglycate 2% Eye Drops.

Sodium Cromoglycate has no known drug interactions.

In animal studies, Sodium Cromoglycate has produced adverse effects on the foetus only in high parenteral doses. There was no evidence of impaired fertility in reproduction studies in animals. Healthy infants have been born to women who received Sodium Cromoglycate throughout pregnancy; nevertheless, there is insufficient evidence to establish the safety in pregnancy. It should be used during pregnancy only when clearly needed. Since it is not known if Sodium Cromoglycate is distributed into milk in humans, the drug should be used with caution in nursing women.

Overdose is unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.

Sodium Cromoglycate 2% Eye Drops should be protected from direct sunlight and stored at a temperature less than 30˚C; any unused ophthalmic solution should be discarded 4 weeks after opening the cap of the bottle.

Mast Cell Stabiliser, Ophthalmic Non-Steroid drugs

Sodium Cromoglicate inhibits the degranulation of sensitized mast cells which occurs after exposure to specific antigens. Sodium Cromoglicate acts by inhibiting the release of histamine and various membrane derived mediators of inflammation from mast cells. Sodium Cromoglicate has no vasoconstrictor or antihistaminic activity.

For eyes: For Child and Adult: 1 to 2 drops into each eye 2 to 3 times daily.
For nose: For Child and Adult: 1 drop to each nostril 2 to 3 times daily.

Transient stinging and burning may occur after instillation of this drops. Other symptoms of local irritation have been reported rarely.

This drop is contraindicated in patient with hypersensitivity to Sodium Cromoglicate .

As this drop contains benzalkonium chloride, patients should not wear contact lenses during treatment with this drop.

No evidence of interaction with other drugs has been observed.

Sodium Cromoglicate should be used with caution during pregnancy and only if the expected benefit to the mother is greater than any possible risk to the fetus. There are no known harmful effects when this medicine is used by breastfeeding mothers.

Overdose is unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.

Store at room temperature and protect from light. Any remaining contents should be discarded 4 weeks after opening. Do not touch dropper tip to any surface since this may contaminate the solution.

Management of acidosis in cardiac arrest. 
Management of metabolic acidosis in:

• Severe renal disease
• Uncontrolled diabetes
• Circulatory insufficiency from shock or dehydration
• Severe primary lactic acidosis

Alkalinization of urine.

Intravenous fluid preparations, Urinary Alkalinizing Agent

Sodium bicarbonate is a systemic alkalinizing agent. It increases plasma bicarbonate, buffers excess hydrogen ion concentration, and raises blood pH, thereby reversing the clinical manifestations of acidosis. It can also be used to replenish electrolyte imbalance as a treatment adjunct for severe diarrhea where the loss of bicarbonate can be significant.

Oral: The usual dose is 300 mg to 2 grams, 1 to 4 times daily.

Intravenous (Severe metabolic acidosis):

• Adult: By slow inj of a hypertonic solution of up to 8.4% (1000 mmol/L), or by continuous infusion of a weaker solution, usually 1.26% (150 mmol/L). For correction of acidosis during advanced cardiac life support procedures, 50 ml of an 8.4% solution may be given.
• Elderly: Dosage adjustments may be required.

This medication is generally well tolerated. However, high doses may cause headache, nausea or irritability. If any of these effects continue or become bothersome, inform your doctor. Notify your doctor if you develop: muscle weakness, slow reflexes, confusion, swelling of the feet or ankles, black tar-like stools, coffee-ground vomit. If you notice other effects not listed above, contact your doctor or pharmacist.

This drug is contraindicated in hypoventilatory states, chloride depletion owing to continuous gastric fluid loss, metabolic and/or respiratory alkalosis, hypocalcemia and diuretics known to produce hypochloremic alkalosis.

Pre-existing heart disease, kidney disease, liver disease, high blood pressure, any allergies.

This medication has the potential to interact with many medications. Should not take any other medication within 1 to 2 hours of taking an antacid. Potentially hazardous interactions with Corticosteroids and Corticotropin, Alkalis, Calcium, Diuretics and Potassium.

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.

Renal Impairment: Dosage adjustments may be required.
Hepatic Impairment: Dosage adjustments may be required.

If alkalosis results, the bicarbonate should be stopped and the patient managed according to the degree of alkalosis present. 0.9% sodium chloride injection intravenous may be given; potassium chloride also may be indicated if there is hypokalemia. Severe alkalosis may be accompanied by hyperirritability or tetany and these symptoms may be controlled by calcium gluconate. An acidifying agent such as ammonium chloride may also be indication in severe alkalosis.

Store in a cool & dry place protected from light. Keep out of reach of children.

Management of acidosis in cardiac arrest. 
Management of metabolic acidosis in:

• Severe renal disease
• Uncontrolled diabetes
• Circulatory insufficiency from shock or dehydration
• Severe primary lactic acidosis

Alkalinization of urine.

Intravenous fluid preparations, Urinary Alkalinizing Agent

Sodium bicarbonate is a systemic alkalinizing agent. It increases plasma bicarbonate, buffers excess hydrogen ion concentration, and raises blood pH, thereby reversing the clinical manifestations of acidosis. It can also be used to replenish electrolyte imbalance as a treatment adjunct for severe diarrhea where the loss of bicarbonate can be significant.

Oral: The usual dose is 300 mg to 2 grams, 1 to 4 times daily.

Intravenous (Severe metabolic acidosis):

• Adult: By slow inj of a hypertonic solution of up to 8.4% (1000 mmol/L), or by continuous infusion of a weaker solution, usually 1.26% (150 mmol/L). For correction of acidosis during advanced cardiac life support procedures, 50 ml of an 8.4% solution may be given.
• Elderly: Dosage adjustments may be required.

This medication is generally well tolerated. However, high doses may cause headache, nausea or irritability. If any of these effects continue or become bothersome, inform your doctor. Notify your doctor if you develop: muscle weakness, slow reflexes, confusion, swelling of the feet or ankles, black tar-like stools, coffee-ground vomit. If you notice other effects not listed above, contact your doctor or pharmacist.

This drug is contraindicated in hypoventilatory states, chloride depletion owing to continuous gastric fluid loss, metabolic and/or respiratory alkalosis, hypocalcemia and diuretics known to produce hypochloremic alkalosis.

Pre-existing heart disease, kidney disease, liver disease, high blood pressure, any allergies.

This medication has the potential to interact with many medications. Should not take any other medication within 1 to 2 hours of taking an antacid. Potentially hazardous interactions with Corticosteroids and Corticotropin, Alkalis, Calcium, Diuretics and Potassium.

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.

Renal Impairment: Dosage adjustments may be required.
Hepatic Impairment: Dosage adjustments may be required.

If alkalosis results, the bicarbonate should be stopped and the patient managed according to the degree of alkalosis present. 0.9% sodium chloride injection intravenous may be given; potassium chloride also may be indicated if there is hypokalemia. Severe alkalosis may be accompanied by hyperirritability or tetany and these symptoms may be controlled by calcium gluconate. An acidifying agent such as ammonium chloride may also be indication in severe alkalosis.

Store in a cool & dry place protected from light. Keep out of reach of children.

Primary anti-epileptic drugs

Sodium Valproate, the active ingredient of this preparation is endowed with anti-epileptic activity against a variety of seizures. The mechanism by which Sodium Valproate exerts its anti-epileptic effects has not been established. However, it has been suggested that its activity is related to increase brain levels of gamma-aminobutyric acid (GABA).

Sodium Valproate tablets may be given once or twice daily. Sodium Valproate syrup should be given in divided doses.

Epilepsy-

• Adults: Initially 600 mg daily given in 2 divided doses, preferably after food, increasing by 200 mg/day at 3-day intervals to a maximum of 2.5 g daily in divided doses until control of seizure is achieved. Usual maintenance dose is 1-2 g daily (20-30 mg/kg daily)
• Children (up to 20 kg): Initially 20 mg/kg daily in divided doses, may be increased provided plasma concentrations monitored (above 40 mg/kg daily also monitor clinical chemistry and hematological parameters).
• Children (over 20 kg): Initially 400 mg daily in divided doses increased until control (usually in the range of 20-30 mg/kg daily) Maximum 35 mg/kg daily.

Febrile convulsion: 20-30 mg/kg/day in 3 divided doses.

Bipolar disorder: Initially 20-30 mg/kg/day in 2-3 divided doses; adjust dosage in 3-5 days. Maintenance dosage is 1000-2000 mg/day.

Prophylaxis of migraine: 300 mg twice daily, although some may require 1000 mg daily.

The most common side effects are anorexia, nausea and vomiting. However, these side effects are minimized with the use of enteric coated tablets. Effects on the CNS include sedation, ataxia and tremor. These symptoms occur infrequently and usually respond to a decrease in doses. Rash, alopecia and stimulation of appetite have been observed occasionally. Sodium Vaiproate has several effects on hepatic function of which elevation of liver enzymes in plasma is observed in up to 40% of patients and often occurs asymptomatically during the first few months of therapy. Rarely a fulminate hepatitis that may be fatal may develop. Children below 2 years of age with other medical conditions and those being treated with multiple antiepileptic agents are specially prone to suffer from hepatic injury, acute pancreatitis and hyperammonemia have also been frequently associated with the use of Sodium Valproate.

Sodium Valproate is contraindicated to patients who have known hypersensitivity to the drug and liver dysfunction. Use of Sodium Valproate is restricted during pregnancy and in women of childbearing potential.

Liver functions should be monitored before therapy and during first 6 months especially in patients most at risk, No undue potential for bleeding before starting and before major surgery must be ensured, Care should be taken in renal impairment, pregnancy, breast-feeding and systemic lupus erythematosus. Sodium Valproate is partially eliminated in the urine as a ketone metabolite, which may lead to a false interpretation of the urine ketone test. Sudden withdrawal of therapy should be avoided. Sodium Valproate should not be used during pregnancy and in women of childbearing potential.

Sodium Vaiproate appears to act as a non specific inhibitor of drug metabolism. Drugs to which it interacts most significantly are Phenobarbital, Phenytoin, Warfarin, Aspirin etc.

Sodium Vaiproate crosses the placenta and in humans, exposure to valproate in the first trimester has been associated with neural tube defects such as anencephaly and spina bifida in newborn. Pregnant women treated with Sodium Vaiproate should be offered to estimate serum a-fetoprotein. Sodium Valproate is excreted in breast miik. However, breast-feeding by a mother taking Sodium Valproate probably causes no risk to the child.

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

Primary anti-epileptic drugs

Sodium Valproate, the active ingredient of this preparation is endowed with anti-epileptic activity against a variety of seizures. The mechanism by which Sodium Valproate exerts its anti-epileptic effects has not been established. However, it has been suggested that its activity is related to increase brain levels of gamma-aminobutyric acid (GABA).

Sodium Valproate tablets may be given once or twice daily. Sodium Valproate syrup should be given in divided doses.

Epilepsy-

• Adults: Initially 600 mg daily given in 2 divided doses, preferably after food, increasing by 200 mg/day at 3-day intervals to a maximum of 2.5 g daily in divided doses until control of seizure is achieved. Usual maintenance dose is 1-2 g daily (20-30 mg/kg daily)
• Children (up to 20 kg): Initially 20 mg/kg daily in divided doses, may be increased provided plasma concentrations monitored (above 40 mg/kg daily also monitor clinical chemistry and hematological parameters).
• Children (over 20 kg): Initially 400 mg daily in divided doses increased until control (usually in the range of 20-30 mg/kg daily) Maximum 35 mg/kg daily.

Febrile convulsion: 20-30 mg/kg/day in 3 divided doses.

Bipolar disorder: Initially 20-30 mg/kg/day in 2-3 divided doses; adjust dosage in 3-5 days. Maintenance dosage is 1000-2000 mg/day.

Prophylaxis of migraine: 300 mg twice daily, although some may require 1000 mg daily.

The most common side effects are anorexia, nausea and vomiting. However, these side effects are minimized with the use of enteric coated tablets. Effects on the CNS include sedation, ataxia and tremor. These symptoms occur infrequently and usually respond to a decrease in doses. Rash, alopecia and stimulation of appetite have been observed occasionally. Sodium Vaiproate has several effects on hepatic function of which elevation of liver enzymes in plasma is observed in up to 40% of patients and often occurs asymptomatically during the first few months of therapy. Rarely a fulminate hepatitis that may be fatal may develop. Children below 2 years of age with other medical conditions and those being treated with multiple antiepileptic agents are specially prone to suffer from hepatic injury, acute pancreatitis and hyperammonemia have also been frequently associated with the use of Sodium Valproate.

Sodium Valproate is contraindicated to patients who have known hypersensitivity to the drug and liver dysfunction. Use of Sodium Valproate is restricted during pregnancy and in women of childbearing potential.

Liver functions should be monitored before therapy and during first 6 months especially in patients most at risk, No undue potential for bleeding before starting and before major surgery must be ensured, Care should be taken in renal impairment, pregnancy, breast-feeding and systemic lupus erythematosus. Sodium Valproate is partially eliminated in the urine as a ketone metabolite, which may lead to a false interpretation of the urine ketone test. Sudden withdrawal of therapy should be avoided. Sodium Valproate should not be used during pregnancy and in women of childbearing potential.

Sodium Vaiproate appears to act as a non specific inhibitor of drug metabolism. Drugs to which it interacts most significantly are Phenobarbital, Phenytoin, Warfarin, Aspirin etc.

Sodium Vaiproate crosses the placenta and in humans, exposure to valproate in the first trimester has been associated with neural tube defects such as anencephaly and spina bifida in newborn. Pregnant women treated with Sodium Vaiproate should be offered to estimate serum a-fetoprotein. Sodium Valproate is excreted in breast miik. However, breast-feeding by a mother taking Sodium Valproate probably causes no risk to the child.

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

Primary anti-epileptic drugs

Sodium Valproate, the active ingredient of this preparation is endowed with anti-epileptic activity against a variety of seizures. The mechanism by which Sodium Valproate exerts its anti-epileptic effects has not been established. However, it has been suggested that its activity is related to increase brain levels of gamma-aminobutyric acid (GABA).

Sodium Valproate tablets may be given once or twice daily. Sodium Valproate syrup should be given in divided doses.

Epilepsy-

• Adults: Initially 600 mg daily given in 2 divided doses, preferably after food, increasing by 200 mg/day at 3-day intervals to a maximum of 2.5 g daily in divided doses until control of seizure is achieved. Usual maintenance dose is 1-2 g daily (20-30 mg/kg daily)
• Children (up to 20 kg): Initially 20 mg/kg daily in divided doses, may be increased provided plasma concentrations monitored (above 40 mg/kg daily also monitor clinical chemistry and hematological parameters).
• Children (over 20 kg): Initially 400 mg daily in divided doses increased until control (usually in the range of 20-30 mg/kg daily) Maximum 35 mg/kg daily.

Febrile convulsion: 20-30 mg/kg/day in 3 divided doses.

Bipolar disorder: Initially 20-30 mg/kg/day in 2-3 divided doses; adjust dosage in 3-5 days. Maintenance dosage is 1000-2000 mg/day.

Prophylaxis of migraine: 300 mg twice daily, although some may require 1000 mg daily.

The most common side effects are anorexia, nausea and vomiting. However, these side effects are minimized with the use of enteric coated tablets. Effects on the CNS include sedation, ataxia and tremor. These symptoms occur infrequently and usually respond to a decrease in doses. Rash, alopecia and stimulation of appetite have been observed occasionally. Sodium Vaiproate has several effects on hepatic function of which elevation of liver enzymes in plasma is observed in up to 40% of patients and often occurs asymptomatically during the first few months of therapy. Rarely a fulminate hepatitis that may be fatal may develop. Children below 2 years of age with other medical conditions and those being treated with multiple antiepileptic agents are specially prone to suffer from hepatic injury, acute pancreatitis and hyperammonemia have also been frequently associated with the use of Sodium Valproate.

Sodium Valproate is contraindicated to patients who have known hypersensitivity to the drug and liver dysfunction. Use of Sodium Valproate is restricted during pregnancy and in women of childbearing potential.

Liver functions should be monitored before therapy and during first 6 months especially in patients most at risk, No undue potential for bleeding before starting and before major surgery must be ensured, Care should be taken in renal impairment, pregnancy, breast-feeding and systemic lupus erythematosus. Sodium Valproate is partially eliminated in the urine as a ketone metabolite, which may lead to a false interpretation of the urine ketone test. Sudden withdrawal of therapy should be avoided. Sodium Valproate should not be used during pregnancy and in women of childbearing potential.

Sodium Vaiproate appears to act as a non specific inhibitor of drug metabolism. Drugs to which it interacts most significantly are Phenobarbital, Phenytoin, Warfarin, Aspirin etc.

Sodium Vaiproate crosses the placenta and in humans, exposure to valproate in the first trimester has been associated with neural tube defects such as anencephaly and spina bifida in newborn. Pregnant women treated with Sodium Vaiproate should be offered to estimate serum a-fetoprotein. Sodium Valproate is excreted in breast miik. However, breast-feeding by a mother taking Sodium Valproate probably causes no risk to the child.

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

Penicillinase-resistant penicillins

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

Oral administration:

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

Parenteral administration:
Adult or Elderly:

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

Children:

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

Oral doses should be administered 1 hour before meal.

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

Flucloxacillin is contraindicated in penicillin hypersensitive patients.

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

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

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

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

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

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

Penicillinase-resistant penicillins

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

Oral administration:

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

Parenteral administration:
Adult or Elderly:

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

Children:

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

Oral doses should be administered 1 hour before meal.

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

Flucloxacillin is contraindicated in penicillin hypersensitive patients.

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

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

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

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

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

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

Hepatocellular Carcinoma: Sorafenib is indicated for the treatment of patients with unresectablehepatocellular carcinoma (HCC).

Renal Cell Carcinoma: Sorafenib is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

Targeted Cancer Therapy

Sorafenib is a kinase inhibitor that decreases tumor cell proliferation in vitro. Sorafenib was shown to inhibit multiple intracellular (CRAF, BRAF and mutant BRAF) and cell surface kinases (KIT, FLT-3, RET, VEGFR-1, VEGFR-2, VEGFR-3, and PDGFR-ß). Several of these kinases are thought to be involved in tumor cell signaling, angiogenesis, and apoptosis. Sorafenib inhibited tumor growth and angiogenesis of human hepatocellular carcinoma and renal cell carcinoma, and several other human tumor xenografts in immunocompromised mice.

Advanced renal cell carcinoma: 400 mg bid. May continue until patient is no longer responding or unacceptable toxicity occurs.

Hepatic Impairment: No safety data is available for use in patients with Child-Pugh C hepatic impairment.

Should be taken on an empty stomach. May be taken with a low or moderate fat meal. If the patient intends to have a high fat meal, sorafenib should be taken on an empty stomach at least 1 hr before or 2 hr after meals. Swallow whole, do not chew/crush.

Rash and hand-foot skin reactions. Hypophosphataemia, hypertension, bleeding, tinnitus, depression and erectile dysfunction. Alopecia, pruritus, dry skin, erythema, acne, flushing, exfoliative dermatitis, hoarseness, GI disturbances, arthralgia, myalgia, asthenia, pain and peripheral neuropathy.

Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of Sorafenib. Sorafenib in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer

Interrupt teatment if patient develops cardiac infarction, ischaemia and/or bleeding fatalities. Regular monitoring of BP, CBC and platelet is recommended. Monitor INR in patients who are on treatment with warfarin. Adequate contraception should be used during and for at least 2 wk after stopping treatment. May need to discontinue treatment if severe or persistent hypertension occurs.

Inducers of isoenzyme CYP3A4 e.g. carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampicin may decrease sorafenib plasma concentration. Coadmin with sorafenib may increase the plasma concentration of doxorubicin and irinotecan.

Pregnancy category D There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

There is no specific treatment for Sorafenib overdose. The highest dose of Sorafenib studied clinically is 800 mg twice daily. The adverse reactions observed at this dose were primarily diarrhea and dermatologic. No information is available on symptoms of acute overdose in animals because of the saturation of absorption in oral acute toxicity studies conducted in animals. In cases of suspected overdose, Sorafenib should be withheld and supportive care instituted.

Store at 25° C.

Hepatocellular Carcinoma: Sorafenib is indicated for the treatment of patients with unresectablehepatocellular carcinoma (HCC).

Renal Cell Carcinoma: Sorafenib is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

Targeted Cancer Therapy

Sorafenib is a kinase inhibitor that decreases tumor cell proliferation in vitro. Sorafenib was shown to inhibit multiple intracellular (CRAF, BRAF and mutant BRAF) and cell surface kinases (KIT, FLT-3, RET, VEGFR-1, VEGFR-2, VEGFR-3, and PDGFR-ß). Several of these kinases are thought to be involved in tumor cell signaling, angiogenesis, and apoptosis. Sorafenib inhibited tumor growth and angiogenesis of human hepatocellular carcinoma and renal cell carcinoma, and several other human tumor xenografts in immunocompromised mice.

Advanced renal cell carcinoma: 400 mg bid. May continue until patient is no longer responding or unacceptable toxicity occurs.

Hepatic Impairment: No safety data is available for use in patients with Child-Pugh C hepatic impairment.

Should be taken on an empty stomach. May be taken with a low or moderate fat meal. If the patient intends to have a high fat meal, sorafenib should be taken on an empty stomach at least 1 hr before or 2 hr after meals. Swallow whole, do not chew/crush.

Rash and hand-foot skin reactions. Hypophosphataemia, hypertension, bleeding, tinnitus, depression and erectile dysfunction. Alopecia, pruritus, dry skin, erythema, acne, flushing, exfoliative dermatitis, hoarseness, GI disturbances, arthralgia, myalgia, asthenia, pain and peripheral neuropathy.

Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of Sorafenib. Sorafenib in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer

Interrupt teatment if patient develops cardiac infarction, ischaemia and/or bleeding fatalities. Regular monitoring of BP, CBC and platelet is recommended. Monitor INR in patients who are on treatment with warfarin. Adequate contraception should be used during and for at least 2 wk after stopping treatment. May need to discontinue treatment if severe or persistent hypertension occurs.

Inducers of isoenzyme CYP3A4 e.g. carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampicin may decrease sorafenib plasma concentration. Coadmin with sorafenib may increase the plasma concentration of doxorubicin and irinotecan.

Pregnancy category D There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

There is no specific treatment for Sorafenib overdose. The highest dose of Sorafenib studied clinically is 800 mg twice daily. The adverse reactions observed at this dose were primarily diarrhea and dermatologic. No information is available on symptoms of acute overdose in animals because of the saturation of absorption in oral acute toxicity studies conducted in animals. In cases of suspected overdose, Sorafenib should be withheld and supportive care instituted.

Store at 25° C.