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This is indicated in Aid in Hysteroscopy, Thromboembolic disorders, Prophylaxis of pulmonary embolism or venous thrombosis in moderate- to high-risk patients undergoing surgery, Prophylaxis of postoperative thromboembolic disorders, Hypovolaemic shock.

Plasma expanders

Dextran produce expansion of plasma volume. It also reduces blood viscosity and inhibits sludging or aggregation of red blood cells.

Sodium chloride is the major extracellular cation. It is important in electrolyte and fluid balance, osmotic pressure control and water distribution as it restores sodium ions. It is used as a source of electrolytes and water for hydration, treatment of metabolic acidosis, priming solution in haemodialysis and treatment of hyperosmolar diabetes. It is also used as diluents for infusion of compatible drug additives.

Intrauterine-
Aid in hysteroscopy:

• Adult: As dextran 70: 50-100 mL of a 32% solution instilled into the uterus as a rinsing and dilatation fluid.

Intravenous-
Thromboembolic disorders:

• Adult: As dextran 40: Initially, 500 ml of a 10% solution in sodium chloride 0.9% or glucose 5% infused over 4-6 hr, followed by 500 ml infused over 4-6 hr on the next and subsequent alternate days for not more than 10 days.
• Child: As dextran 40: Up to 5 ml/kg in infants and 10 ml/kg in children.

Intravenous-
Prophylaxis of pulmonary embolism or venous thrombosis in moderate- to high-risk patients undergoing surgery:

• Adult: As dextran 70: Initially, 500-1000 mL of a 6% solution in sodium chloride 0.9% or glucose 5% infused over 4-6 hr during or immediately after surgery, followed by 500 mL on the next day and on subsequent alternate days for up to 2 wk after surgery in high-risk patients.

Intravenous-
Prophylaxis of postoperative thromboembolic disorders:

• Adult: As dextran 40: 500 ml of a 10% solution in sodium chloride 0.9% or glucose 5% infused over 4-6 hr during or at the end of the surgery. Dose may be repeated the following day and treatment may be continued on alternate days for up to 10 days in high-risk patient.
• Child: As dextran 40: Up to 10 ml/kg in children.

Intravenous-
Hypovolaemic shock:

• Adult: As dextran 40: Initially, 10 ml/kg given by rapid infusion as a 10% solution in sodium chloride 0.9% or glucose 5%. Doses may be given daily for up to 5 days. As dextran 70: Initially, 500-1000 mL of a 6% solution in sodium chloride 0.9% or glucose 5% infused at a rate of 20-40 mL/min. Maintenance: 10 ml/kg/day for3 days (Dextran 70).

GI disturbances; headache, dizziness; allergic reactions; raised liver enzyme values; alopecia; bone marrow suppression.

Hypersensitivity. Severe renal disease with oliguria or anuria. Marked cardiac decompensation. Pregnancy.

Lactation.

Dextran: Enzyme inducers e.g. phenytoin or carbamazepine and enzyme inhibitors e.g. cimetidine.

Sodium Chloride: May affect serum concentrations of lithium.

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.

Store at 25°C.

This is indicated in Aid in Hysteroscopy, Thromboembolic disorders, Prophylaxis of pulmonary embolism or venous thrombosis in moderate- to high-risk patients undergoing surgery, Prophylaxis of postoperative thromboembolic disorders, Hypovolaemic shock.

Plasma expanders

Dextran produce expansion of plasma volume. It also reduces blood viscosity and inhibits sludging or aggregation of red blood cells.

Sodium chloride is the major extracellular cation. It is important in electrolyte and fluid balance, osmotic pressure control and water distribution as it restores sodium ions. It is used as a source of electrolytes and water for hydration, treatment of metabolic acidosis, priming solution in haemodialysis and treatment of hyperosmolar diabetes. It is also used as diluents for infusion of compatible drug additives.

Intrauterine-
Aid in hysteroscopy:

• Adult: As dextran 70: 50-100 mL of a 32% solution instilled into the uterus as a rinsing and dilatation fluid.

Intravenous-
Thromboembolic disorders:

• Adult: As dextran 40: Initially, 500 ml of a 10% solution in sodium chloride 0.9% or glucose 5% infused over 4-6 hr, followed by 500 ml infused over 4-6 hr on the next and subsequent alternate days for not more than 10 days.
• Child: As dextran 40: Up to 5 ml/kg in infants and 10 ml/kg in children.

Intravenous-
Prophylaxis of pulmonary embolism or venous thrombosis in moderate- to high-risk patients undergoing surgery:

• Adult: As dextran 70: Initially, 500-1000 mL of a 6% solution in sodium chloride 0.9% or glucose 5% infused over 4-6 hr during or immediately after surgery, followed by 500 mL on the next day and on subsequent alternate days for up to 2 wk after surgery in high-risk patients.

Intravenous-
Prophylaxis of postoperative thromboembolic disorders:

• Adult: As dextran 40: 500 ml of a 10% solution in sodium chloride 0.9% or glucose 5% infused over 4-6 hr during or at the end of the surgery. Dose may be repeated the following day and treatment may be continued on alternate days for up to 10 days in high-risk patient.
• Child: As dextran 40: Up to 10 ml/kg in children.

Intravenous-
Hypovolaemic shock:

• Adult: As dextran 40: Initially, 10 ml/kg given by rapid infusion as a 10% solution in sodium chloride 0.9% or glucose 5%. Doses may be given daily for up to 5 days. As dextran 70: Initially, 500-1000 mL of a 6% solution in sodium chloride 0.9% or glucose 5% infused at a rate of 20-40 mL/min. Maintenance: 10 ml/kg/day for3 days (Dextran 70).

GI disturbances; headache, dizziness; allergic reactions; raised liver enzyme values; alopecia; bone marrow suppression.

Hypersensitivity. Severe renal disease with oliguria or anuria. Marked cardiac decompensation. Pregnancy.

Lactation.

Dextran: Enzyme inducers e.g. phenytoin or carbamazepine and enzyme inhibitors e.g. cimetidine.

Sodium Chloride: May affect serum concentrations of lithium.

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.

Store at 25°C.

Temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• cough due to minor throat or bronchial irritation
• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• nasal congestion
• reduces swelling of nasal passages

Combined cough suppressants

This preparation is a mixture of antitussive, decongestant and antihistamine agent. Dextromethorphan is a safe, effective, non-narcotic antitussive agent which has a central action on the cough centre in the medulla. Although structurally related to Morphine, it has no analgesic and habit forming properties and in general it has little sedative activity. Phenylephrine is a decongestant that shrinks blood vessels in the nasal passage. It is used to treat nasal and sinus congestion of the tubes that drain fluid from inner ear. Triprolidine provides symptomatic relief in conditions believed to depend wholly or partly upon the triggered release of histamine. It is a potent competitive histamine H1-receptor antagonist of the pyrrolidine class with mild central nervous system depressant properties which may cause drowsiness.

Adults & Children 12 years of age and older: 1 teaspoonful (5 ml) every 4 hours, or as directed by a doctor.

Children 6 to under 12 years of age: ½ teaspoonful (2.5 ml) every 4 hours, or as directed by a doctor.

Children below 2 years old: Not to be used in children below 2 years old. To be used with caution, and as advised by the physician for children age 2 to 6 years.

Take with or without food. Take with food if it causes an upset stomach. Measure liquid doses carefully. Use the measuring device that comes with this medicine.

It may cause drowsiness, dottiness and constipation. Other side effects that may occur include GIT discomfort. No apparent evidence of physical dependence of the morphine type. Other less common side effects may include transient hypertension, dry mouth, restlessness, palpitations, allergic reactions such as rashes, tightness of chest, thickening of bronchial secretions, toxic psychosis and blood dyscrasia.

It should be avoided in patients with liver disease or asthmatic patients and is contraindicated in patients taking monoamine oxidase inhibitors or within 2 weeks from stopping such treatment, known hypersensitivity to phenylephrine hydrochloride, dextromethorphan hydrobromide and during acute attacks of asthma. It is contraindicated in patients with severe hypertension or severe coronary artery disease.

This preparation may cause drowsiness. If affected, do not drive motor vehicle or operate machinery. Avoid alcoholic drink while on this medication. Use with caution in patients with epilepsy, prostatic hypertrophy, glaucoma, hepatic disease, hypertension, heart disease, diabetes, hyperthyroidism, patients with stenosing peptic ulcer, pyloro-duodenal obstruction or bladder neck obstruction, unless under the medical advice and supervision. If symptoms do not improve within one week or accompanied with high fever, consult a physician before continuing use.

Taking certain MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking isocarboxazid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, or tranylcypromine during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Caution should be excercised while taking this drug with antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray), antispasmodics (e.g. atropine, belladonna alkaloids), beta blockers (e.g. metoprolol, atenolol), drugs for Parkinson’s disease (e.g. anticholinergics such as benztropine, trihexyphenidyl), guanethidine, certain inhaled anesthetics (e.g. halothane), methyldopa, reserpine, scopolamine, tricyclic antidepressants (e.g. amitriptyline, desipramine), anti seizure drugs (e.g. carbamazepine), medicine for sleep or anxiety (e.g. alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g. codeine), psychiatric medicines (e.g. chlorpromazine, risperidone, amitriptyline, trazodone).

As with any other drugs, use in pregnancy and lactation is best avoided.

In cases of over dosage, hospital admission is strongly advised. Over dosage may produce respiratory depression, paranoid psychosis, delusions, hallucinations, and convulsion. Treatment should include emptying the stomach by aspiration or gastric lavage. Nervous stimulation and convulsions should be treated with a sedative such as diazepam intramuscularly. If marked excitation is present, a sedative such as diazepam or a short-acting barbiturate may be given.

Severe over dosage of phenylephrine hydrochloride may produce hypertension and associated reflex bradycardia. Treatment measures include early gastric lavage and symptomatic and supportive measures. The hypertensive effects may be treated with an alpha-receptor blocking agent (such as phentolamine mesilate 6-10 mg) given intravenously, and the bradycardia treated with atropine, preferable only after the pressure has been controlled.

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

This sterile Eye Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.

Ophthalmic steroid - antibiotic combined preparations

Like other amino-glycosides, the bactericidal activity of Tobramycin is accomplished by specific inhibition of normal protein synthesis in susceptible bacteria, but at the present time, very little is known about this action. It is thought that inhibition of protein synthesis is due to an action on ribosome that causes bacterial misreading of messenger RNA. The action of Dexamethasone is to inhibit the phospholipase A2, the first step in prostaglandin synthesis. Also Dexamethasone inhibits the chemo-tactic infiltration of neutrophils into the site of inflammation. The result is that its anti-inflammatory activity is 25 times greater and its overall therapeutic effectiveness 8-10 times greater than that of hydrocortisone.

Insert 1 drop into the conjunctival sac 3-5 times per day. During the initial 24 to 48 hours, the dosage may be increased to 1 drop every 2 hours.

The most frequent side effects to topical ocular Tobramycin are localized ocular toxicity and hypersensitivity, including lid itching and swelling and conjuntival erythema. The reactions due to the steroid component are elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsule cataract formation.

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and other viral disease of the cornea and conjunctiva. Mycobacterial infections of the eye caused by, but not limited to, acid-fast bacilli such as Mycobacterium tuberculosis, Mycobacterium leprae, or Mycobacterium avium. Fungal diseases of ocular structures. Untreated purulent infection of the eye. Hypersensitivity to any component of the medication.

Shake the bottle well before use. To prevent contamination do not touch the tip of the bottle to affected eye, eyelid or any surface of of the affected eye. Keep the bottle tightly closed after use.

No specific interaction studies were performed with this combination eye drops. In case of concomitant therapy with other topical ophthalmic medicines, an interval of 10 minutes should be allowed between successive applications.

Safety for use during pregnancy and lactation in humans has not been established

Use in paediatric: Safety and effectiveness in paediatric patients below 2 years have not been established.

Overdose of this eye drops may be flushed from the eye(s) with lukewarm tap water.

Store at room temperature. Close the bottle immediately after use. Do not use for longer than one month after opening the bottle.

This solution is indicated as a source of water, electrolytes and calories or as an alkalinizing agent.

Intravenous fluid preparations

This is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration.

As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations. The dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low weight infants, because of the increased risk of hyperglycemia/ hypoglycemia. Additives may be incompatible. Administration Procedure:

• Check infusion set and infusion solution prior to use
• Pull moderately to tear off the protective cover of the Eurohead
• Hold lightly the Eurohead but not the bag
• Open the flow regulator fully and hold the giving set on the top white area, but not the membrane venting region
• Insert the spike of the administration set to the Eurohead and fit the connector of the administration set firmly to the needle
• Gradually allow the fluid to flow down to the needle tip and close
• Remove the protective cover of the needle
• Locate the veinpuncture site and clean the site with an antiseptic solution, and then insert the needle
• Securely tape the puncture site
• Securely tape the wings and tubing
• Start infusion while adjusting drip speed.

Allergic reactions or anaphylactoid symptoms such as localized or generalized urticaria and pruritus; periorbital, facial, and/or laryngeal edema, coughing, sneezing, and/or difficulty with breathing have been reported during administration. The reporting frequency of these signs and symptoms is higher in women during pregnancy.

Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Do not uses if the solution is cloudy contain particles or date expired. Infusion of fluid should be immediately discontinued if rigor arises for any reason during the process.

There are no known drug interactions and none well documented.

Teratogenic effect and pregnancy category C. This solution should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk.

Pediatric Use: Safety and effectiveness of this solution in pediatric patients have not been established by adequate and well controlled trials.

Geriatric Use: Clinical studies of this solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Should be stored at controlled room temperature.

Dextromethorphan is indicated in Chronic dry cough or unproductive cough; Acute dry cough which is interfering with normal function or sleep.

Cough suppressant

Dextromethorphan suppresses the cough reflex by a direct action on the cough center in the medulla of the brain. Dextromethorphan shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist and acts as a non-competitive channel blocker. It is one of the widely used antitussives, and is also used to study the involvement of glutamate receptors in neurotoxicity.

Adults and Children over 12 years: 15 to 30 mg three to four times per day. However, 60 mg doses up to four times per day have been used without increased side effects.
Children between 6 and 12 years: 5-15 mg up to four times per day.
Children between 2 and 6 years: 2.5-5 mg up to four times per day.

Adverse effects with Dextromethorphan are rare, but nausea and dizziness sometimes occur. The drug produces no analgesia or addiction and little or no CNS depression. Excitation, confusion and respiratory depression may occur after overdosage.

Hypersensitivity to Dextromethorphan or any other component.

Do not use Dextromethorphan to control a cough that is associated with smoking, asthma, or emphysema, or a cough that is productive (produces sputum or phlegm).

The following medicines should be taken carefully while concomitantly use with Dextromethorphan: Amiodarone, Fluoexetine, Quinidine, CNS depressants and Monoamine oxidase (MAO) inhibitors.

Pregnancy: Adequate and well-controlled studies in human have not been done. However, Dextromethorphan has not been reported to cause birth defects.

Lactation: It is not known whether dextromethorphan passes into breast milk. However, Dextromethorphan has not been reported to cause problems in nursing babies.

Symptoms: In mild overdose, tachycardia, hypertension, vomiting, mydriasis, diaphoresis, nystagmus, euphoria, loss of motor coordination, and giggling; in moderate intoxication, in addition to those listed above, hallucinations and a plodding ataxic gait; in severely intoxication, agitation or somnolence.

Management: treatment is symptomatic and supportive. Naloxone may be useful in reversing toxicity.

Store at 15-30° C

This preparation temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• Non-productive cough due to minor throat or bronchial irritation
• Runny Nose
• Sneezing
• Itching of the nose or throat
• Itchy & watery eyes
• Nasal congestion

Combined cough suppressants

This preparation is a mixture of antitussive, decongestant and antihistamine agent. Dextromethorphan is a safe, effective, non-narcotic antitussive agent which has a central action on the cough centre in the medulla. Although structurally related to Morphine, it has no analgesic and habit forming properties and in general it has little sedative activity. Phenylephrine is a decongestant that shrinks blood vessels in the nasal passage. Phenylephrine is used for the temporary relief of stuffy nose, sinus, and ear symptoms caused by the common cold, flu, allergies, sinusitis & bronchitis. This medication works by decreasing swelling in the nose and ears, thereby lessening discomfort and making it easier to breathe. Triprolidine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, watery eyes, itchy eyes/nose/throat/skin, cough, runny nose, and sneezing. It is a potent competitive histamine H1-receptor antagonist of the pyrrolidine class with mild central nervous system depressant properties which may cause drowsiness. By antagonizing another natural substance acetylcholine, it helps dry up some body fluids to relieve symptoms such as watery eyes and runny nose.

Adults & Children over 12 years: 1 teaspoonful (5 ml) 4 times a day every 4 hours interval.

6-12 years: 1/2 teaspoonful 4 times a day every 4 hours interval.

Use in children and adolescents: A physician's advice should be obtained before administering this combination to children less than 6 years.

It may cause drowsiness and constipation. Other side effects that may occur include GIT discomfort. No apparent evidence of physical dependence of the morphine type.

It should be avoided in patients with liver disease or asthmatic patients and is contraindicated in patients taking monoamine oxidase inhibitors or within 2 weeks from stopping such treatment

This preparation may cause drowsiness. If affected, do not drive motor vehicle or operate machinery. Avoid alcoholic drink while on this medication. Use with caution in patients with epilepsy, prostatic hypertrophy, glaucoma, hepatic disease, hypertension, heart disease, diabetes, hyperthyroidism. If symptoms do not improve within one week or accompanied with high fever, consult a physician before continuing use.

Taking certain MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking isocarboxazid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, or tranylcypromine during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication.

There are no specific data on use of this combination during pregnancy & lactation.

In cases of over dosage, hospital admission is strongly advised. Over dosage may produce respiratory depression, paranoid psychosis, delusions, hallucinations and convulsion.

Store in a cool and dry place (below 30°C temperature), away from light. Keep out of the reach of children.

Intravenous fluid preparations

Dextrose is a form of glucose (sugar). Dextrose 5% in water is injected into a vein through an IV to replace lost fluids and provide carbohydrates to the body. Dextrose 5% in water is used to treat low blood sugar (hypoglycemia), insulin shock, or dehydration (fluid loss). Dextrose 5% in water is also given for nutritional support to patients who are unable to eat because of illness, injury, or other medical condition.

5% dextrose solution: The dose of Dextrose infusion is variable. It is dependent on individual patient requirements. For 5% dextrose solution, the dose frequently ranges from 500 to 1000 ml. The maximum rate of infusion that will not cause glycosuria is 0.5 g/kg/hour. About 95% is retained when the rate is 0.8 g/kg/hr. the maximum rate of glucose utilization is about 800 mg per kg body weight per hour.

25% dextrose solution: The volume and rate of infusion of dextrose solution will depend upon the requirements of the individual patient and the judgment of the physician. The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg/hr. The usual recommended flow rate for adult is 10-35 drops per minute infused intravenously. It should not be administered by SC or IM route. 25% dextrose solution should be infused through the largest available peripheral vein.

Do not take this medicine and tell your doctor if: You should not use this medication if you are allergic to dextrose. Before using dextrose 5% in water, tell your doctor if you have diabetes, breathing problems, an electrolyte imbalance, kidney or liver disease, a food or drug allergy, or if you receive regular blood transfusions.

Serum glucose concentration should be carefully monitored. Concurrent use of insulin may be needed in case of diabetic patients. Dextrose solution should not be mixed with whole blood as haemolysis and clumping may occur. Infusion of fluid should be immediately discontinued if rigor arises for any reasons during the process. Do not use if the solution is cloudy, contains particles, or after expiry date.

Take special care with dextrose. Check with your doctor before taking this medicine if: You should not use this medication if you are allergic to dextrose.

To make sure you can safely use dextrose 5% in water, tell your doctor if you have any of these other conditions:

• diabetes;
• breathing problems;
• an electrolyte imbalance (such as low levels of potassium in your blood);
• kidney or liver disease;
• any allergy to foods or medicines; or
• if you receive regular blood transfusions.

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

Dextrose is a form of glucose (sugar). Dextrose 5% in water is injected into a vein through an IV to replace lost fluids and provide carbohydrates to the body. Dextrose 5% in water is used to treat low blood sugar (hypoglycemia), insulin shock, or dehydration (fluid loss). Dextrose 5% in water is also given for nutritional support to patients who are unable to eat because of illness, injury, or other medical condition.

5% dextrose solution: The dose of Dextrose infusion is variable. It is dependent on individual patient requirements. For 5% dextrose solution, the dose frequently ranges from 500 to 1000 ml. The maximum rate of infusion that will not cause glycosuria is 0.5 g/kg/hour. About 95% is retained when the rate is 0.8 g/kg/hr. the maximum rate of glucose utilization is about 800 mg per kg body weight per hour.

25% dextrose solution: The volume and rate of infusion of dextrose solution will depend upon the requirements of the individual patient and the judgment of the physician. The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg/hr. The usual recommended flow rate for adult is 10-35 drops per minute infused intravenously. It should not be administered by SC or IM route. 25% dextrose solution should be infused through the largest available peripheral vein.

Do not take this medicine and tell your doctor if: You should not use this medication if you are allergic to dextrose. Before using dextrose 5% in water, tell your doctor if you have diabetes, breathing problems, an electrolyte imbalance, kidney or liver disease, a food or drug allergy, or if you receive regular blood transfusions.

Serum glucose concentration should be carefully monitored. Concurrent use of insulin may be needed in case of diabetic patients. Dextrose solution should not be mixed with whole blood as haemolysis and clumping may occur. Infusion of fluid should be immediately discontinued if rigor arises for any reasons during the process. Do not use if the solution is cloudy, contains particles, or after expiry date.

Take special care with dextrose. Check with your doctor before taking this medicine if: You should not use this medication if you are allergic to dextrose.

To make sure you can safely use dextrose 5% in water, tell your doctor if you have any of these other conditions:

• diabetes;
• breathing problems;
• an electrolyte imbalance (such as low levels of potassium in your blood);
• kidney or liver disease;
• any allergy to foods or medicines; or
• if you receive regular blood transfusions.

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

Dextrose is a form of glucose (sugar). Dextrose 5% in water is injected into a vein through an IV to replace lost fluids and provide carbohydrates to the body. Dextrose 5% in water is used to treat low blood sugar (hypoglycemia), insulin shock, or dehydration (fluid loss). Dextrose 5% in water is also given for nutritional support to patients who are unable to eat because of illness, injury, or other medical condition.

5% dextrose solution: The dose of Dextrose infusion is variable. It is dependent on individual patient requirements. For 5% dextrose solution, the dose frequently ranges from 500 to 1000 ml. The maximum rate of infusion that will not cause glycosuria is 0.5 g/kg/hour. About 95% is retained when the rate is 0.8 g/kg/hr. the maximum rate of glucose utilization is about 800 mg per kg body weight per hour.

25% dextrose solution: The volume and rate of infusion of dextrose solution will depend upon the requirements of the individual patient and the judgment of the physician. The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg/hr. The usual recommended flow rate for adult is 10-35 drops per minute infused intravenously. It should not be administered by SC or IM route. 25% dextrose solution should be infused through the largest available peripheral vein.

Do not take this medicine and tell your doctor if: You should not use this medication if you are allergic to dextrose. Before using dextrose 5% in water, tell your doctor if you have diabetes, breathing problems, an electrolyte imbalance, kidney or liver disease, a food or drug allergy, or if you receive regular blood transfusions.

Serum glucose concentration should be carefully monitored. Concurrent use of insulin may be needed in case of diabetic patients. Dextrose solution should not be mixed with whole blood as haemolysis and clumping may occur. Infusion of fluid should be immediately discontinued if rigor arises for any reasons during the process. Do not use if the solution is cloudy, contains particles, or after expiry date.

Take special care with dextrose. Check with your doctor before taking this medicine if: You should not use this medication if you are allergic to dextrose.

To make sure you can safely use dextrose 5% in water, tell your doctor if you have any of these other conditions:

• diabetes;
• breathing problems;
• an electrolyte imbalance (such as low levels of potassium in your blood);
• kidney or liver disease;
• any allergy to foods or medicines; or
• if you receive regular blood transfusions.

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.

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.

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

Dextrose is a form of glucose (sugar). Dextrose 5% in water is injected into a vein through an IV to replace lost fluids and provide carbohydrates to the body. Dextrose 5% in water is used to treat low blood sugar (hypoglycemia), insulin shock, or dehydration (fluid loss). Dextrose 5% in water is also given for nutritional support to patients who are unable to eat because of illness, injury, or other medical condition.

5% dextrose solution: The dose of Dextrose infusion is variable. It is dependent on individual patient requirements. For 5% dextrose solution, the dose frequently ranges from 500 to 1000 ml. The maximum rate of infusion that will not cause glycosuria is 0.5 g/kg/hour. About 95% is retained when the rate is 0.8 g/kg/hr. the maximum rate of glucose utilization is about 800 mg per kg body weight per hour.

25% dextrose solution: The volume and rate of infusion of dextrose solution will depend upon the requirements of the individual patient and the judgment of the physician. The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg/hr. The usual recommended flow rate for adult is 10-35 drops per minute infused intravenously. It should not be administered by SC or IM route. 25% dextrose solution should be infused through the largest available peripheral vein.

Do not take this medicine and tell your doctor if: You should not use this medication if you are allergic to dextrose. Before using dextrose 5% in water, tell your doctor if you have diabetes, breathing problems, an electrolyte imbalance, kidney or liver disease, a food or drug allergy, or if you receive regular blood transfusions.

Serum glucose concentration should be carefully monitored. Concurrent use of insulin may be needed in case of diabetic patients. Dextrose solution should not be mixed with whole blood as haemolysis and clumping may occur. Infusion of fluid should be immediately discontinued if rigor arises for any reasons during the process. Do not use if the solution is cloudy, contains particles, or after expiry date.

Take special care with dextrose. Check with your doctor before taking this medicine if: You should not use this medication if you are allergic to dextrose.

To make sure you can safely use dextrose 5% in water, tell your doctor if you have any of these other conditions:

• diabetes;
• breathing problems;
• an electrolyte imbalance (such as low levels of potassium in your blood);
• kidney or liver disease;
• any allergy to foods or medicines; or
• if you receive regular blood transfusions.

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

Dextrose is a form of glucose (sugar). Dextrose 5% in water is injected into a vein through an IV to replace lost fluids and provide carbohydrates to the body. Dextrose 5% in water is used to treat low blood sugar (hypoglycemia), insulin shock, or dehydration (fluid loss). Dextrose 5% in water is also given for nutritional support to patients who are unable to eat because of illness, injury, or other medical condition.

5% dextrose solution: The dose of Dextrose infusion is variable. It is dependent on individual patient requirements. For 5% dextrose solution, the dose frequently ranges from 500 to 1000 ml. The maximum rate of infusion that will not cause glycosuria is 0.5 g/kg/hour. About 95% is retained when the rate is 0.8 g/kg/hr. the maximum rate of glucose utilization is about 800 mg per kg body weight per hour.

25% dextrose solution: The volume and rate of infusion of dextrose solution will depend upon the requirements of the individual patient and the judgment of the physician. The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg/hr. The usual recommended flow rate for adult is 10-35 drops per minute infused intravenously. It should not be administered by SC or IM route. 25% dextrose solution should be infused through the largest available peripheral vein.

Do not take this medicine and tell your doctor if: You should not use this medication if you are allergic to dextrose. Before using dextrose 5% in water, tell your doctor if you have diabetes, breathing problems, an electrolyte imbalance, kidney or liver disease, a food or drug allergy, or if you receive regular blood transfusions.

Serum glucose concentration should be carefully monitored. Concurrent use of insulin may be needed in case of diabetic patients. Dextrose solution should not be mixed with whole blood as haemolysis and clumping may occur. Infusion of fluid should be immediately discontinued if rigor arises for any reasons during the process. Do not use if the solution is cloudy, contains particles, or after expiry date.

Take special care with dextrose. Check with your doctor before taking this medicine if: You should not use this medication if you are allergic to dextrose.

To make sure you can safely use dextrose 5% in water, tell your doctor if you have any of these other conditions:

• diabetes;
• breathing problems;
• an electrolyte imbalance (such as low levels of potassium in your blood);
• kidney or liver disease;
• any allergy to foods or medicines; or
• if you receive regular blood transfusions.

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

Dextrose is a form of glucose (sugar). Dextrose 5% in water is injected into a vein through an IV to replace lost fluids and provide carbohydrates to the body. Dextrose 5% in water is used to treat low blood sugar (hypoglycemia), insulin shock, or dehydration (fluid loss). Dextrose 5% in water is also given for nutritional support to patients who are unable to eat because of illness, injury, or other medical condition.

5% dextrose solution: The dose of Dextrose infusion is variable. It is dependent on individual patient requirements. For 5% dextrose solution, the dose frequently ranges from 500 to 1000 ml. The maximum rate of infusion that will not cause glycosuria is 0.5 g/kg/hour. About 95% is retained when the rate is 0.8 g/kg/hr. the maximum rate of glucose utilization is about 800 mg per kg body weight per hour.

25% dextrose solution: The volume and rate of infusion of dextrose solution will depend upon the requirements of the individual patient and the judgment of the physician. The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg/hr. The usual recommended flow rate for adult is 10-35 drops per minute infused intravenously. It should not be administered by SC or IM route. 25% dextrose solution should be infused through the largest available peripheral vein.

Do not take this medicine and tell your doctor if: You should not use this medication if you are allergic to dextrose. Before using dextrose 5% in water, tell your doctor if you have diabetes, breathing problems, an electrolyte imbalance, kidney or liver disease, a food or drug allergy, or if you receive regular blood transfusions.

Serum glucose concentration should be carefully monitored. Concurrent use of insulin may be needed in case of diabetic patients. Dextrose solution should not be mixed with whole blood as haemolysis and clumping may occur. Infusion of fluid should be immediately discontinued if rigor arises for any reasons during the process. Do not use if the solution is cloudy, contains particles, or after expiry date.

Take special care with dextrose. Check with your doctor before taking this medicine if: You should not use this medication if you are allergic to dextrose.

To make sure you can safely use dextrose 5% in water, tell your doctor if you have any of these other conditions:

• diabetes;
• breathing problems;
• an electrolyte imbalance (such as low levels of potassium in your blood);
• kidney or liver disease;
• any allergy to foods or medicines; or
• if you receive regular blood transfusions.

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.

Proton Pump Inhibitor

Dexlansoprazole delayed-release capsule is a Proton Pump Inhibitor (PPI) which suppresses gastric acid secretion by specific inhibition of the (H⁺/K⁺)-ATPase in the gastric parietal cell. By acting specifically on the proton pump, Dexlansoprazole blocks the final step of acid production. It is the R-enantiomer of lansoprazole (A racemic mixture of the R- and S-enantiomers). Dexlansoprazole is supplied as a Dual Delayed Release (DDR) formulation in a capsule for oral administration. This capsule contains a mixture of two types of enteric coated granules with different pH-dependent dissolution profiles. The dual delayed release formulation in dexlansoprazole, plasma concentration-time profile with two distinct peaks; the first peak occurs 1 to 2 hours after administration, followed by a second peak within 4 to 5 hours. After oral administration, mean C_max and AUC value of Dexlansoprazole increased approximately dose proportionally. Dexlansoprazole is extensively metabolized in the liver and excreated by urine.

Dexlansoprazole dosing recommendations-

• Maintenance of Healed erosive esophagitis and relief of heartburn: 30 mg Once daily
• Symptomatic Non-Erosive GERD: 30 mg Once daily for 4 weeks
• Healing of erosive esophagitis: 60 mg Once daily for up to 8 weeks

Dexlansoprazole can be taken without regard to food. It should be swallowed whole.

Alternatively, Dexlansoprazole capsules can be administered as follows:

• Open capsule
• Sprinkle intact granules on one tablespoon
• Swallow immediately.

Granules should not be chewed.

If a capsule is missed at its usual time, it should be taken as soon as possible. But if it is too close to the time of the next dose, only the prescribed dose should be taken at the appointed time. A double dose should not be taken.

Common side effects: Diarrhea, abdominal pain, nausea, vomiting & flatulence.

Dexlansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.

Gastric Malignancy, Clostridium difficile Associated Diarrhea, Bone fracture, Hypomagnesemia, and concomitant use of Dexlansoprazole with Methotrexate.

With medicine: Atazanavir, Warfarin, Tacrolimus, Clopidogrel & Methotrexate. With food & others: No data available.

Pregnancy Category B. There is no adequate and well-controlled studies with Dexlansoprazole in pregnant women. There is no adequate and well-controlled studies with Dexlansoprazole in Lactating mother.

Use in children & adolescents: Safety and effectiveness of Dexlansoprazole in patients below 12 years age have not been established.

Geriatric use: No dose adjustment is necessary for elderly patients.

Renal impairment: No dose adjustment of Dexlansoprazole is necessary for patients with renal
impairment.

Hepatic impairment: No dose adjustment for Dexlansoprazole is necessary for patients with mild hepatic impairment. A maximum daily dose of Dexlansoprazole 30 mg should be considered for patients with moderate hepatic impairment.

There have been no reports of a significant overdose of Dexlansoprazole. Multiple doses of Dexlansoprazole 120 mg and a single dose of Dexlansoprazole 300 mg did not result in death or other severe adverse events.

Store below 30°C temperature & in a dry place, protected from light. Keep all medicines out of reach of children.

Proton Pump Inhibitor

Dexlansoprazole delayed-release capsule is a Proton Pump Inhibitor (PPI) which suppresses gastric acid secretion by specific inhibition of the (H⁺/K⁺)-ATPase in the gastric parietal cell. By acting specifically on the proton pump, Dexlansoprazole blocks the final step of acid production. It is the R-enantiomer of lansoprazole (A racemic mixture of the R- and S-enantiomers). Dexlansoprazole is supplied as a Dual Delayed Release (DDR) formulation in a capsule for oral administration. This capsule contains a mixture of two types of enteric coated granules with different pH-dependent dissolution profiles. The dual delayed release formulation in dexlansoprazole, plasma concentration-time profile with two distinct peaks; the first peak occurs 1 to 2 hours after administration, followed by a second peak within 4 to 5 hours. After oral administration, mean C_max and AUC value of Dexlansoprazole increased approximately dose proportionally. Dexlansoprazole is extensively metabolized in the liver and excreated by urine.

Dexlansoprazole dosing recommendations-

• Maintenance of Healed erosive esophagitis and relief of heartburn: 30 mg Once daily
• Symptomatic Non-Erosive GERD: 30 mg Once daily for 4 weeks
• Healing of erosive esophagitis: 60 mg Once daily for up to 8 weeks

Dexlansoprazole can be taken without regard to food. It should be swallowed whole.

Alternatively, Dexlansoprazole capsules can be administered as follows:

• Open capsule
• Sprinkle intact granules on one tablespoon
• Swallow immediately.

Granules should not be chewed.

If a capsule is missed at its usual time, it should be taken as soon as possible. But if it is too close to the time of the next dose, only the prescribed dose should be taken at the appointed time. A double dose should not be taken.

Common side effects: Diarrhea, abdominal pain, nausea, vomiting & flatulence.

Dexlansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.

Gastric Malignancy, Clostridium difficile Associated Diarrhea, Bone fracture, Hypomagnesemia, and concomitant use of Dexlansoprazole with Methotrexate.

With medicine: Atazanavir, Warfarin, Tacrolimus, Clopidogrel & Methotrexate. With food & others: No data available.

Pregnancy Category B. There is no adequate and well-controlled studies with Dexlansoprazole in pregnant women. There is no adequate and well-controlled studies with Dexlansoprazole in Lactating mother.

Use in children & adolescents: Safety and effectiveness of Dexlansoprazole in patients below 12 years age have not been established.

Geriatric use: No dose adjustment is necessary for elderly patients.

Renal impairment: No dose adjustment of Dexlansoprazole is necessary for patients with renal
impairment.

Hepatic impairment: No dose adjustment for Dexlansoprazole is necessary for patients with mild hepatic impairment. A maximum daily dose of Dexlansoprazole 30 mg should be considered for patients with moderate hepatic impairment.

There have been no reports of a significant overdose of Dexlansoprazole. Multiple doses of Dexlansoprazole 120 mg and a single dose of Dexlansoprazole 300 mg did not result in death or other severe adverse events.

Store below 30°C temperature & in a dry place, protected from light. Keep all medicines out of reach of children.

Glucocorticoids

Deflazacort provides anti-inflammatory action by inhibiting Phospholipase A2 enzyme which is responsible for prostaglandin synthesis. Besides Deflazacort decreases the release of certain chemicals that are important in the immune system. By decreasing the release of these chemicals Deflazacort provides immunosuppressive action.

Adults-

• For acute disorders: Up to 120 mg/day Deflazacort may need to be given initially. Maintenance doses in most conditions are within the range of 3-18 mg/day.
• Rheumatoid arthritis: The maintenance dose is usually within the range of 3-18 mg/day. The smallest effective dose should be used and increased if necessary.
• Bronchial asthma: In the treatment of an acute attack, high doses of 48-72 mg/day may be needed depending on severity and gradually reduced once the attack has been controlled. For maintenance in chronic asthma, doses should be titrated to the lowest dose that controls symptoms.
• Other conditions: The dose of Deflazacort depends on clinical need titrated to the lowest effective dose for maintenance. Starting doses may be estimated on the basis of ratio of 5 mg prednisone or prednisolone to 6 mg.

Children: There has been limited exposure of children to Deflazacort in clinical trials. In children, the indications for glucocorticoids arethe same as for adults, but it is important that the lowest effective dosage is used. Alternate day administration may be appropriate. Doses of Deflazacort usually lie in the range 0.25-1.5 mg/kg/day.

The following ranges provide general guidance:

• Juvenile chronic arthritis: The usual maintenance dose is between 0.25-1.0 mg/kg/day.
• Nephrotic syndrome: Initial dose of usually 1.5 mg/kg/day followed by down titration according to clinical need.
• Bronchial asthma: On the basis of the potency ratio, the initial dose should be between 0.25-1.0 mg/kg on alternate days.

Deflazacort withdrawal: In patients who have received more than physiological doses of systemic corticosteroids (approximately 9 mg per day or equivalent) for greater than 3 weeks, withdrawal should not be abrupt. How dose reduction should be carried out depends largely on whether the disease is likely to relapse as the dose of systemic corticosteroids is reduced.

GI disturbances, musculoskeletal, endocrine, neuropsychiatric, ophthalmic, fluid and electrolyte disturbances; susceptible to infection, impaired healing, hypersensitivity, skin atrophy, striae, telangiectasia, acne, myocardial rupture following recent Ml, thromboembolism.

Hypersensitivity to or any of the ingredients. Patients receiving live virus immunization.

The following clinical conditions require special caution and frequent patient monitoring is necessary-

• Cardiac disease or congestive heart failure (except in the presence of active rheumatic carditis), hypertension, thromboembolic disorders. Glucocorticoids can cause salt and water retention and increased excretion of potassium. Dietary salt restriction and potassium supplementation may be necessary.
• Gastritis or oesophagitis, diverticulitis, ulcerative colitis if there is the probability of impending perforation, abscess or pyogenic infections, fresh intestinal anastomosis, active or latent peptic ulcer.
• Diabetes mellitus or family history, osteoporosis, myasthenia gravis, renal insufficiency.
• Emotional instability or psychotic tendency, epilepsy.
• Previous corticosteroid-induced myopathy.
• Liver failure.
• Hypothyroidism and cirrhosis, which may increase the glucocorticoid effect.
• Ocular herpes simplex because of possible corneal perforation.

Deflazacort is metabolized in the liver. It is recommended to increase the maintenance dose of Deflazacort if drugs which are liver enzyme inducers are co-administered, e.g. rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone and aminoglutethimide. For drugs which inhibit liver enzymes, (e.g. ketoconazole) it may be possible to reduce the maintenance dose of Deflazacort.

Pregnancy: Deflazacort does cross the placenta. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intrauterine growth retardation. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks.

Nursing Mother: Corticosteroids are excreted in breast milk, although no data are available for Deflazacort. Doses of up to 50 mg daily of Deflazacort are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression but the benefits of breastfeeding are likely to outweigh any theoretical risk.

Hepatic Impairment: In patients with hepatic impairment, blood levels of may be increased. Therefore the dose of Deflazacort should be carefully monitored and adjusted to the minimum effective dose.

Renal Impairment: In renally impaired patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary.

Elderly: In elderly patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary. The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age.

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