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Ebastine is indicated for the symptomatic treatment of:

• Seasonal and Perennial Allergic Rhinitis.
• Chronic Idiopathic Urticaria.

Non-sedating antihistamines

Ebastine is a long-acting and selective H1-histamine receptor antagonist. After repeated administration, inhibition of peripheral receptors remains at a constant level. Ebastine is rapidly absorbed and undergoes extensive first-pass metabolism following oral administration. Ebastine is almost totally converted to the pharmacologically active acid metabolite, carebastine.

Tablet:

• Adults (more than 12 years of age): 10 mg (one tablet) once daily.
• Children (6-12 years of age): 5 mg (half tablet) once daily.

Syrup:

• Children (2-5 years of age): 2.5 ml once daily (upto 5 ml in severe cases such as Perennial Allergic Rhinitis).
• Children (6-12 years of age): 5 ml once daily (upto 10 ml in severe cases such as Perennial Allergic Rhinitis).

Ebastine may be taken with or without food.

The most common side-effects are headache, dry mouth and drowsiness. Less commonly reported side effects include abdominal pain, dyspepsia, nausea and insomnia.

Patients with a known hypersensitivity to Ebastine or any of its ingredients.

Ebastine in combination with either ketoconazole or erythromycin increases in plasma level of ebastine and prolonged QTc interval. Ebastine does not interact with the pharmacokinetics of theophylline, warfarin, cimetidine, diazepam or alcohol. The sedation effect of alcohol and diazepam may be enhanced.

No clinically meaningful signs or symptoms were observed up to 100 mg given once daily. There is no specific antidote for Ebastine. In case of accidental overdoses, gastric lavage, monitoring of vital functions including ECG and symptomatic treatment should be carried out.

Store below 30°C at a cool and dry place, away from light. Keep out of reach of children

Bromfenac is indicated for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract extraction

Ophthalmic Non-Steroid drugs

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID). The mechanism of anti-inflammatory activity is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis and increased intraocular pressure.

Adults: 1 drop to the problem eye 2 times a day; treatment should start 24 hours after surgery and should continue for 2 weeks

Children: Use and dose must be determined by the doctor.

Pediatric Use: Safety and efficacy in pediatric patients below the age of 18 have not been established yet.

The most commonly reported adverse reactions following use of Bromfenac after cataract surgery include: abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache and iritis. These events were reported in 2-7% of patients

Bromfenac ophthalmic solution is contraindicated in patients with known hypersensitivity to any ingredients of the formulation.

All topical NSAIDs may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. It is recommended that Bromfenac ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. Bromfenac ophthalmic solution should not be administered while wearing contact lenses.

Bromfenac ophthalmic solution contains Sodium Sulfite, a compound that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

Pregnancy Category C. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Bromfenac ophthalmic solution is administered to a nursing mother.

Keep out of the reach of children. Store in a cool, dry place, away from heat and direct light.  Do not use more than 4 weeks after opening.

Second generation Cephalosporins

Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.

Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days 
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.

Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.

Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.

While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

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

Second generation Cephalosporins

Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.

Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days 
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.

Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.

Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.

While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

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

Second generation Cephalosporins

Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.

Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days 
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.

Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.

Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.

While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

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

Tenoxicam is indicated for the symptomatic treatment of the following painful inflammatory and degenerative disorders of the musculoskeletal system:

• Rheumatoid arthritis.
• Osteoarthritis.
• Arthrosis.
• Ankylosing spondylitis.
• Extra-articular disorders, e.g. tendinitis, bursitis, periarthritis of the shoulders (shoulder-hand syndrome) or hips, strains, and sprains.
• Acute gout.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Tenoxicam is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic properties and it also inhibits platelet aggregation. Tenoxicam inhibits prostaglandin biosynthesis. In-vitro tests of leukocyte peroxidase suggest that tenoxicam may act as a scavenger for active oxygen at the site of inflammation. Tenoxicam is a potent in-vitro inhibitor of human metalloproteinases (stromelysin and collagenase), which induce cartilage breakdown. These pharmacological effects explain, at least in part, the therapeutic benefit of Tenoxicam in the treatment of painful inflammatory and degenerative disorders of the musculoskeletal system. Tenoxicam showed no mutagenic, carcinogenic or teratogenic effects in animals. As with other prostaglandin inhibitors, renal and gastrointestinal effects, increased incidence of dystocia and delayed parturition were observed in animal safety studies.

Standard dosage: For all indications except acute gout, a daily dosage of 20 mg should be given at the same time of day.

In acute attacks of gout: The recommended dose for acute attacks of gout is 40 mg once daily for two days followed by 20 mg once daily for a further five days.

In the treatment of chronic disorders: The therapeutic effect of tenoxicam is evident early in treatment but there is a progressive increase in response over time. In chronic disorders, daily doses higher than 20 mg should be avoided since this would increase the frequency and intensity of unwanted reactions without significantly increasing efficacy. For patients needing long-term treatment, a reduction to a daily oral dose of 10 mg may be tried for maintenance.

Special dosage instructions: In principle, the above dosage recommendations also apply to elderly patients and to patients suffering from kidney or liver disease. Because of lack of clinical experience, no dosage recommendations have so far been established for children and adolescents.

The tablets should be taken with a glass of water. It is preferable to take this medicine during or immediately after a meal.

Based on clinical trials including large numbers of patients, Tenoxicam proved to be well tolerated in the recommended dose. Usually, the undesirable effects reported were mild and transient. In a small proportion of patients, the interruption of treatment due to undesirable effects was necessary. Local tolerance of Tenoxicam given parenterally was good. The following undesirable effects have been reported:

Frequency is greater than 1%-

• Gastrointestinal tract: gastric, epigastric and abdominal discomfort, dyspepsia, heartburn, nausea.
• Central nervous system: dizziness, headache.

Frequency less than 1%-

• Gastrointestinal tract: constipation, diarrhea, stomatitis, gastritis, vomiting, ulcers, Gl-bleeding including hematemesis and melena.
• Central nervous system: fatigue, sleep disturbances, appetite loss, dry mouth, vertigo.
• Skin: itching (also in the anal region after rectal administration), erythema, exanthema, rash, urticaria.
• Urinary tract and kidneys: increase in BUN or creatinine, edema.
• Liver and biliary tract: increased liver enzyme activity.
• Cardiovascular system: palpitations.

Isolated cases (frequency less than 0.01%)-

• Gastrointestinal tract: Gl-perforation.
• Central nervous system: visual disturbances.
• Skin: Stevens-Johnson and Lyell's syndrome, photosensitivity reaction, vasculitis.
• Blood: anemia, agranulocytosis, leukopenia, thrombocytopenia.
• Hypersensitivity reactions: dyspnea, asthma, anaphylaxis, angioedema.
• Cardiovascular system: elevated blood pressure, mainly in patients treated with cardiovascular drugs.
• Liver/Biliary tract: hepatitis.

Tenoxicam must not be administered to patients:

• known to be hypersensitive to the drug;
• in whom salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs) induce symptoms of asthma, rhinitis, or urticaria;
• suffering or having suffered from the disease of the upper gastrointestinal tract, such as gastritis, gastric and duodenal ulcer.

NSAIDs inhibit renal prostaglandin synthesis and consequently may have an undesirable effect on renal hemodynamics and on salt and water balance. It is necessary to adequately monitor the patient with a special emphasis on cardiac and renal function (BUN, creatinine, development of edema, weight gain, etc.) when giving Tenoxicam to patients with conditions that could increase their risk of developing renal failure, such as pre-existing renal disease, impaired renal function in diabetics, hepatic cirrhosis, congestive heart failure, volume depletion or concomitant treatment with potentially nephrotoxic drugs, diuretics and corticosteroids. Tenoxicam inhibits platelet aggregation and may affect hemostasis. Tenoxicam has no significant influence on blood coagulation factors, coagulation time, prothrombin time or activated thromboplastin time. Patients having coagulation disorders or receiving drug therapy that interferes with hemostasis should, however, be carefully observed when Tenoxicam is administered. Any patient being treated with Tenoxicam who presents with symptoms of gastrointestinal disease should be closely monitored. If peptic ulceration or gastrointestinal bleeding occurs, Tenoxicam should be immediately withdrawn. If severe skin reactions (e.g. Lyell's or Stevens-Johnson syndrome) occur, the treatment should be discontinued immediately. Adverse eye findings have been reported with Tenoxicam. Thus ophthalmic evaluation is recommended for patients who develop visual disturbances. Because of the high plasma protein binding of tenoxicam, caution is required when plasma albumin levels are markedly reduced. In common with anti-inflammatory drugs, Tenoxicam may mask the usual signs of infection. Tenoxicam Tablets should not be given to patients who either dislike or do not tolerate milk products.

As in the case of other NSAIDs, salicylate displaces tenoxicam from protein-binding sites and increases clearance and volume of distribution of tenoxicam. Concurrent treatment with salicylate or other NSAIDs should be avoided because of increased risk of gastrointestinal undesirable reactions. The co-administration of some NSAIDs and methotrexate has been associated with reduced renal tubular secretion of methotrexate, higher plasma concentrations of methotrexate, and severe methotrexate toxicity. Therefore, caution should be exercised when Tenoxicam is administered concurrently with methotrexate. No clinically relevant interaction was found in the small number of patients receiving concomitant treatment with gold, penicillamine or probenecid. As Tenoxicam may decrease the renal clearance of lithium, their concomitant administration may lead to increased plasma levels and toxicity of lithium. The plasma levels of lithium should be closely monitored. As with NSAIDs in general, Tenoxicam should not be administered concurrently with K-sparing diuretics. There is a known interaction between these two classes of compounds, which may cause hyperkalemia and renal failure. No clinically significant interaction between Tenoxicam and furosemide was noted, but Tenoxicam attenuates the blood pressure-lowering effect of hydrochlorothiazide. As known from other NSAIDs, Tenoxicam might attenuate the antihypertensive effects of alpha-adrenergic blockers and ACE-inhibitors. No interactions have been reported between NSAIDs and centrally-acting alpha agonists or calcium channel blockers. There was no clinically relevant interaction when Tenoxicam was administered together with atenolol. During clinical trials no interaction was reported for patients treated concomitantly with digitalis products. Thus concurrent dosing of Tenoxicam and digoxin appears to be without major risk. No interaction has been found with concomitantly administered antacids, cimetidine, warfarin and phenprocoumon at the recommended dosages. The clinical effect of oral antidiabetic drugs (glibornuride, glibenclamide, tolbutamide) was likewise not modified by Tenoxicam. Nevertheless, careful monitoring is recommended when patients concomitantly receive anticoagulants or oral antidiabetic drugs. No clinically relevant interaction has been found between Tenoxicam and low molecular weight heparin.

NSAIDs have an inhibitory effect on prostaglandin synthesis and, when given during late pregnancy, may cause the closure of the fetal ductus arteriosus, prolong labor and delay parturition. Treatment during the third trimester of pregnancy should be avoided. Based on findings from single-dose administration, a very small amount (approximately 0.2%) of tenoxicam passes into breast milk. There is no evidence of adverse reactions in breast-fed infants of mothers taking Tenoxicam. Nevertheless, infants should be weaned or the drug discontinued.

Use in Children & adolescent: Tenoxicam is not recommended for use in patients under 16 years of age, as the dose and indications in this population have not been established.

Effects on ability to drive and use machines: Patients experiencing adverse events that might affect driving or using machines, such as vertigo, dizziness or visual disturbances should refrain from driving a car or using machines.

Although there is no experience of acute overdosage with Tenoxicam, it may be expected that the signs and symptoms mentioned under Undesirable effects would be more pronounced. Overdose should be countered by conventional measures to reduce absorption (e.g. gastrolavage and charcoal) and speed up elimination (e.g. cholestyramine).

Do not store above 30°C, protect from light & moisture. Keep out of the reach of children.

Gliclazide is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group). Gliclazide is used in a certain form of diabetes (type 2 diabetes Mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level.

Sulfonylureas

Gliclazide is a second generation sulfonylurea drug that has hypoglycaemic and potentially useful hematological properties. It stimulates the release of insulin from pancreatic β-cells by facilitating Ca⁺²  transport across the β-cell membranes and decreases hepatic glucose output.

Film-coated tablet: The usual initial dose is 40 to 80 mg daily. The dose can be increased up to 320 mg daily in divided doses when needed. The drug should be taken before meal. For children, Gliclazide is not used because it is contraindicated in juvenile-onset diabetes.

Modified release preparation: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose is determined by the doctor, depending on your blood and possibly urine sugar levels. Change in external factors (weight reduction, lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses.

The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. Gliclazide MR tablet is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your whole tablet(s) in one piece. Do not chew or crush. You must always eat a meal after taking your tablet(s).

If a combination therapy of gliclazide with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you. If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.

If you take more Gliclazide tablets than you should: If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia). The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, (for instance a child), has taken the product unintentionally. Unconscious patients must not be given food or drink. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.

If you forget to take Gliclazide tablet: It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Gliclazide MR tablet, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Gliclazide MR tablet: As the treatment for diabetes is usually lifelong, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Gliclazide can cause side effects, although not everybody gets them. The most commonly observed side effect is low blood sugar (hypoglycaemia). If left untreated these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, you should seek immediate medical attention.

Liver disorders: There have been isolated reports of abnormal iiver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.

Skin disorders: Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking, seek urgent advice from a doctor and tell him that you are taking this medicine. Exceptionally, signs of severe hypersensitivity reactions have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.

Blood disorders: Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued.

Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazide is taken with a meal as recommended.

Eye disorders: Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.

As for another sulfonylurea, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life-threatening liver failure in isolated cases.

Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.

Do not take Gliclazide:

• if you are allergic to gliclazide or to other medicines of the same group (sulfonylurea), or to other related medicines (hypoglycaemic sulfonamides)
• if you have insulin-dependent diabetes (type 1)
• if you have ketone bodies and sugar in your urine (this may mean you have diabetic ketoacidosis), a diabetic pre-coma or coma
• if you have severe kidney or liver disease
• if you are taking medicines to treat fungal infections
• if you are breastfeeding

Talk to your doctor before taking Gliclazide. You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, to observe the dietary regimen, have physical exercise and, where necessary, reduce weight During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary. In the first few weeks of treatment, the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. So particularly close medical monitoring is necessary.

Low blood sugar (Hypoglycaemia) may occur:

• if you take meals irregularly or skip meals altogether,
• if you are fasting
• if you are malnourished
• if you change your diet
• if you increase your physical activity and carbohydrate intake does not match this increase,
• if you drink alcohol, especially in combination with skipped meals,
• if you take other medicines or natural remedies at the same time,
• if you take too high doses of gliclazide,
• if you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, pituitary gland or adrenal cortex),
• if your kidney function or liver function is severely decreased.

if you have low blood sugar you may have the following symptoms: headache, intense hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness, poor concentration, reduced alertness and reaction time, depression, confusion, speech or visual disorders, tremor, sensory disturbances, dizziness and helplessness.

The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).

If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self-control, your breathing may be shallow and your heartbeat slowed down, you may become unconscious.

In most cases the symptoms of low blood sugar vanish very quickly when you consume .some form of sugar, (for instance, glucose tablets, sugar cubes, sweet juice, sweetened tea).

You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.

Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta-blockers).

If you are in stressful situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.

Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar when you have not complied with the treatment plan prescribed by your doctor if you take St. John’s Wort (Hypericum perforatum) preparations or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.

Blood glucose disturbances (low blood sugar and high bold sugar) can occur when Gliclazide is prescribed at the same time as medicines to a class of antibiotics called fluoroquinolone, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.

If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.

Gliclazide is not recommended for use in children due to lack of data.

Other medicines and Gliclazide: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the follow ng medicines is taken:

• other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists or insulin),
• antibiotics (sulphonamides, clarithromycin)
• medicines to treat high blood pressure or heart failure (beta-blockers. ACE-inhibitors such as captopril, or enalapril)
• medicines to treat fungal infections (miconazole, fluconazole)
• medicines to treat ulcers in the stomach or duodenum (H2 receptor antagonists),
• medicines to treat depression (monoamine oxidase inhibitors)
• painkiller or antirheumatics (phenylbutazone, ibuprofen)
• medicines containing alcohol

The blood-glucose-lowering effect of gliclazide may be weakened and raised blood sugar levels may occur when one of the following medicines is taken:

• medicines to treat disorders of the central nervous system (chlorpromazine)
• medicines reducing inflammation (corticosteroids)
• medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline)
• medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol)
• St John's Wort- Hypericum perforatum- preparations

Blood glucose disturbance (low blood sugar and high blood sugar) can occur when a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time as gliclazide especially in elderly patients.

Gliclazide may increase the effects of medicines that reduce blood clotting (warfarin).

Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking gliclazide.

Gliclazide with food and drink: Gliclazide can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.

Driving and using machines: Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (for instance when driving a car or using machines). Please ask your doctor whether you can drive a car if you:

• have frequent episodes of low blood sugar (hypoglycaemia)
• have few or no warning signals of low blood sugar (hypoglycaemia)

Gliclazide contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Gliclazide is not recommended for use during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You must not take Gliclazide while you are breastfeeding.

Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month. Store below 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.

Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics

Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.

Tablet-

Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.

Injection-

Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.

Single-Dose Treatment-
IM Dosing (Adult):

• Patients <65 years of age: One dose of 60 mg.
• Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.

IV Dosing (Adult):

• Patients <65 years of age: One dose of 30 mg.
• Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.

IV or IM Dosing (2 to 16 years of age):

• IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
• IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.

Multiple-Dose Treatment (IV or IM)-

• Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
• Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.

Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.

Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.

Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.

Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.

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

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

Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.

Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics

Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.

Tablet-

Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.

Injection-

Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.

Single-Dose Treatment-
IM Dosing (Adult):

• Patients <65 years of age: One dose of 60 mg.
• Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.

IV Dosing (Adult):

• Patients <65 years of age: One dose of 30 mg.
• Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.

IV or IM Dosing (2 to 16 years of age):

• IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
• IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.

Multiple-Dose Treatment (IV or IM)-

• Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
• Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.

Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.

Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.

Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.

Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.

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

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

Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.

Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics

Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.

Tablet-

Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.

Injection-

Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.

Single-Dose Treatment-
IM Dosing (Adult):

• Patients <65 years of age: One dose of 60 mg.
• Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.

IV Dosing (Adult):

• Patients <65 years of age: One dose of 30 mg.
• Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.

IV or IM Dosing (2 to 16 years of age):

• IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
• IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.

Multiple-Dose Treatment (IV or IM)-

• Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
• Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.

Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.

Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.

Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.

Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.

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

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

Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.

Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics

Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.

Tablet-

Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.

Injection-

Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.

Single-Dose Treatment-
IM Dosing (Adult):

• Patients <65 years of age: One dose of 60 mg.
• Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.

IV Dosing (Adult):

• Patients <65 years of age: One dose of 30 mg.
• Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.

IV or IM Dosing (2 to 16 years of age):

• IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
• IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.

Multiple-Dose Treatment (IV or IM)-

• Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
• Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.

Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.

Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.

Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.

Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.

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

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

Rifaximin is indicaed in-

• Treatment of traveler's diarrhea by noninvasive strains of E. coli
• reduction in risk of overt hepatic encephalopathy
• bacterial overgrowth of irritable bowel syndrome.

4-Quinolone preparations

Rifaximin is a semisynthetic, rifamycin-based non-systemic antibiotic. Very little of the drug will pass the gastrointestinal wall into the circulation as is common for other types of orally administered antibiotics. Rifaximin inhibits bacterial RNA synthesis by its action on the beta-subunit of the DNA-dependent RNA polymerase. It shows the same broad spectrum activity as rifamycin which exerts bactericidal action against many species of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.

Traveler's Diarrhea: For patients ≥12 years of age: 200 mg 3 times daily for 3 days.
Hepatic Encephalopathy: For patients ≥18 years of age: 550 mg 2 times daily.
Bacterial overgrowth of irritable bowel syndrome: 400 mg 3 times daily for 10 days or 550 mg 3 times daily for 14 days. Can be taken with or without food

Side effects include flatulence, headache, abdominal pain, rectal tenesmus, defecation urgency, nausea, constipation, pyrexia, vomiting. Reactions have been reported, including anaphylaxis, angioneurotic edema, and exfoliative dermatitis.

Contraindicated in patients with a hypersensitivity to Rifaximin or to any of the rifamycin antimicrobial agents, or any components of this product

Rifaximin is not found to be effective in patients with diarrhea complicated by fever and/or blood in the stools. Rifaximin therapy should be discontinued if diarrhea symptoms get worse or persist for more than 24-48 hours and alternative antibiotic therapy should be considered. Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

In an in vitro study has suggested that Rifaximin induces CYP3A4. However, in patients with normal liver function, Rifaximin at the recommended dosing regimen is not expected to induce CYP3A4.

Pregnancy category C. It is not known whether Rifaximin is excreted in human milk or not.

Renal Impairment: The pharmacokinetics of Rifaximin in patients with impaired renal function has not been studied.
Hepatic Impairment: The systemic exposure of Rifaximin was markedly elevated in patients with hepatic impairment compared to healthy subjects.

No specific information is available on the treatment of over dosage with Rifaximin. In case of over dosage, discontinue Rifaximin, treat symptomatically and institute supportive measures as required.

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

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, 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. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, 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. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Ifosfamide is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with Mesna for prophylaxis of hemorrhagic cystitis.

Cytotoxic Chemotherapy

Ifosfamide is converted to its active metabolites via hepatic microsomal enzymes. These active metabolites act as alkylating agents, disrupting DNA and protein synthesis of the target cells. It is routinely given with mesna to reduce urothelial toxicity.

Lymphoma, Sarcoma, Solid tumours: Different licensed dosage regimens are available.

• Regimen 1: 8-12 gm/m² divided over 3-5 days, repeat course every 2-4 wk.
• Regimen 2: 6 gm/m² divided over 5 days, repeat course every 3 wk.
• Regimen 3: 5-6 gm/m² (max: 10 gm), give as a single 24-hr infusion, repeat course every 3-4 wkly.

Germ cell testicular carcinoma: 1.2 gm/m²/day for 5 days via slow infusion over at least 30 minutes, repeat treatment every 3 wk or after recovery from haematological toxicity. To be given with mesna and adequate hydration of at least 2 L of oral or IV fluid per day.

Confusion, alopoecia, nausea, vomiting, phloebitis, somnolence, depression, hallucinations. Wound healing may be impaired during ifosfamide use.

Potentially Fatal: Severe myelosuppression, haemorrhagic cystitis, nephrotoxicity, cardiotoxicity, coma.

Hypersensitivity; severe bone-marrow depression. Pregnancy, lactation.

Hepatic or renal dysfunction, compromised bone marrow reserve. Use with mesna and ensure high oral/IV fluid intake to reduce urotoxic effects.

Causes enhanced toxicity with allopurinol, cisplatin. Ifosfamide enhances the anticoagulant effect of warfarin. CYP2A6 inducers (e.g. amobarbital, pentobarbital, phenobarbital, rifampin and secobarbital) may reduce serum levels of ifosfamide while the inhibitors (e.g. isoniazid, methoxsalen and miconazole) may increase its serum levels. CYP3A4 inducers (e.g. aminoglutethimide, carbamazepine, nafcillin, nevirapine, phenobarbital, phenytoin, and rifamycins) may reduce serum levels of ifosfamide while the inhibitors (e.g. azole antifungals, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid) may increase its serum levels.

Category D: There is positive evidence of human fetal 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).

Renal Impairment: CrCl <10: Administer 75% of dose.

Add 20 ml of sterile water for inj or sterile bacteriostatic water for inj containing benzyl alcohol or parabens for each 1 g of the drug to produce solutions of 50 mg/ml.

Store at 20-25° C.

Ifosfamide is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with Mesna for prophylaxis of hemorrhagic cystitis.

Cytotoxic Chemotherapy

Ifosfamide is converted to its active metabolites via hepatic microsomal enzymes. These active metabolites act as alkylating agents, disrupting DNA and protein synthesis of the target cells. It is routinely given with mesna to reduce urothelial toxicity.

Lymphoma, Sarcoma, Solid tumours: Different licensed dosage regimens are available.

• Regimen 1: 8-12 gm/m² divided over 3-5 days, repeat course every 2-4 wk.
• Regimen 2: 6 gm/m² divided over 5 days, repeat course every 3 wk.
• Regimen 3: 5-6 gm/m² (max: 10 gm), give as a single 24-hr infusion, repeat course every 3-4 wkly.

Germ cell testicular carcinoma: 1.2 gm/m²/day for 5 days via slow infusion over at least 30 minutes, repeat treatment every 3 wk or after recovery from haematological toxicity. To be given with mesna and adequate hydration of at least 2 L of oral or IV fluid per day.

Confusion, alopoecia, nausea, vomiting, phloebitis, somnolence, depression, hallucinations. Wound healing may be impaired during ifosfamide use.

Potentially Fatal: Severe myelosuppression, haemorrhagic cystitis, nephrotoxicity, cardiotoxicity, coma.

Hypersensitivity; severe bone-marrow depression. Pregnancy, lactation.

Hepatic or renal dysfunction, compromised bone marrow reserve. Use with mesna and ensure high oral/IV fluid intake to reduce urotoxic effects.

Causes enhanced toxicity with allopurinol, cisplatin. Ifosfamide enhances the anticoagulant effect of warfarin. CYP2A6 inducers (e.g. amobarbital, pentobarbital, phenobarbital, rifampin and secobarbital) may reduce serum levels of ifosfamide while the inhibitors (e.g. isoniazid, methoxsalen and miconazole) may increase its serum levels. CYP3A4 inducers (e.g. aminoglutethimide, carbamazepine, nafcillin, nevirapine, phenobarbital, phenytoin, and rifamycins) may reduce serum levels of ifosfamide while the inhibitors (e.g. azole antifungals, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid) may increase its serum levels.

Category D: There is positive evidence of human fetal 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).

Renal Impairment: CrCl <10: Administer 75% of dose.

Add 20 ml of sterile water for inj or sterile bacteriostatic water for inj containing benzyl alcohol or parabens for each 1 g of the drug to produce solutions of 50 mg/ml.

Store at 20-25° C.

Adjunct anti-epileptic drugs, Primary anti-epileptic drugs

Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). It does not bind directly to GABA_A, GABA_B or benzodiazepine receptors. Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of Pregabalin has not been fully elucidated, results in animal studies suggest that binding to the alpha2-delta subunit may be involved in Pregabalin's anti-nociceptive and antiseizure effects.

Neuropathic pain associated with diabetic peripheral neuropathy in adults (DPN): The maximum recommended dose of Pregabalin is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. The maximum recommended dose of Pregabalin CR capsule is 330 mg once daily.

Postherpetic neuralgia in adults (PHN): The recommended dose of Pregabalin is 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 75 mg two times a day or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate Pregabalin, may be treated with up to 300 mg two times a day or 200 mg three times a day (600 mg/day).

Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate Pregabalin CR capsule, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily. The maximum recommended dose of Pregabalin CR capsule is 660 mg once daily.

Management of fibromyalgia in adults: The recommended dose of Pregabalin is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day).

Neuropathic pain associated with spinal cord injury in adults: The recommended dose range of Pregabalin is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate Pregabalin may be treated with up to 300 mg two times a day.

Conversion from Pregabalin capsules to Pregabalin CR capsule tablet: When switching from Pregabalin capsules to Pregabalin CR capsule tablet on the day of the switch, instruct patients to take their morning dose of Pregabalin capsule as prescribed and initiate Pregabalin CR capsule therapy after an evening meal.

Pregabalin tablet total daily dose (dosed 2 or 3 times daily): Pregabalin CR capsule capsule dose (dosed once a day)

• 75 mg/daily: 82.5 mg/day
• 150 mg/daily: 165 mg/day
• 225 mg/daily: 247.5 mg/day
• 300 mg/daily: 330 mg/day
• 450 mg/daily: 495 mg/day
• 600 mg/daily: 660 mg/day

Route of administration: Pregabalin is taken in oral route. It can be taken with or without food. Pregabalin CR tablet should be administered after an evening meal. It should be swallowed whole and should not be split, crushed or chewed. If patients miss taking their dose of Pregabalin CR after an evening meal, then they should take their usual dose of Pregabalin CR prior to bedtime following a snack. If they miss taking the dose of Pregabalin CR prior to bedtime, then they should take their usual dose of Pregabalin CR following a morning meal. If they miss taking the dose of Pregabalin CR following the morning meal, then they should take their usual dose of Pregabalin CR at the usual time that evening following an evening meal. When discontinuing both Pregabalin and Pregabalin CR, it should be gradually tapered over a minimum of 1 week.

Most common side effects in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain and thinking abnormal (primarily difficulty with concentration/attention). Most common side effects in pediatric patients for the treatment of partial onset seizures are increased weight and increased appetite.

Pregabalin is contraindicated in patients with known hypersensitivity to Pregabalin or any of its components.

Angioedema (e.g., swelling of the throat, head and neck) can occur and may be associated with life threatening respiratory compromise requiring emergency treatment. Pregabalin should be discontinued immediately in these cases. Pregabalin should also be discontinued immediately if hypersensitivity reactions (e.g., hives, dyspnea and wheezing) occur. Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior. Respiratory depression may occur with pregabalin when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. Patients need to be monitored and dosage adjusted as appropriate. Pregabalin may cause dizziness and somnolence and impair patients ability to drive or operate machinery. Increased seizure frequency or other adverse reactions may occur if pregabalin is rapidly discontinued. Pregabalin should be withdrawn gradually over a minimum of 1 week. Pregabalin may cause peripheral edema. Caution should be exercised when coadministering pregabalin and thiazolidinedione antidiabetic agents.

Pregabalin is unlikely to be involved in significant pharmacokinetic drug interactions.

There are no adequate and well-controlled studies with pregabalin in pregnant women. Pregnant women should be advised of the potential risk to a fetus. Small amounts of pregabalin have been detected in the milk of lactating women. Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment with pregabalin.

Use in children and adolescents: Safety and effectiveness in pediatric patients have not been established for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, neuropathic pain associated with spinal cord injury and fibromyalgia. In case of adjunctive therapy for partial onset seizures, safety and effectiveness in pediatric patients below the age of 1 month have not been established. The safety and effectiveness of pregabalin extended-release tablet in pediatric patients have not been established.

In case of overdose with pregabalin, sign and symptoms are reduced consciousness, depression/anxiety, confusional state, agitation and restlessness. Seizures and heart block have also been reported. There is no specific antidote. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; usual precautions should be observed to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.

Keep in a cool & dry place (below 30°C), protected from light & moisture. Keep out of the reach of children.

Adjunct anti-epileptic drugs, Primary anti-epileptic drugs

Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). It does not bind directly to GABA_A, GABA_B or benzodiazepine receptors. Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of Pregabalin has not been fully elucidated, results in animal studies suggest that binding to the alpha2-delta subunit may be involved in Pregabalin's anti-nociceptive and antiseizure effects.

Neuropathic pain associated with diabetic peripheral neuropathy in adults (DPN): The maximum recommended dose of Pregabalin is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. The maximum recommended dose of Pregabalin CR capsule is 330 mg once daily.

Postherpetic neuralgia in adults (PHN): The recommended dose of Pregabalin is 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 75 mg two times a day or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate Pregabalin, may be treated with up to 300 mg two times a day or 200 mg three times a day (600 mg/day).

Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate Pregabalin CR capsule, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily. The maximum recommended dose of Pregabalin CR capsule is 660 mg once daily.

Management of fibromyalgia in adults: The recommended dose of Pregabalin is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day).

Neuropathic pain associated with spinal cord injury in adults: The recommended dose range of Pregabalin is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate Pregabalin may be treated with up to 300 mg two times a day.

Conversion from Pregabalin capsules to Pregabalin CR capsule tablet: When switching from Pregabalin capsules to Pregabalin CR capsule tablet on the day of the switch, instruct patients to take their morning dose of Pregabalin capsule as prescribed and initiate Pregabalin CR capsule therapy after an evening meal.

Pregabalin tablet total daily dose (dosed 2 or 3 times daily): Pregabalin CR capsule capsule dose (dosed once a day)

• 75 mg/daily: 82.5 mg/day
• 150 mg/daily: 165 mg/day
• 225 mg/daily: 247.5 mg/day
• 300 mg/daily: 330 mg/day
• 450 mg/daily: 495 mg/day
• 600 mg/daily: 660 mg/day

Route of administration: Pregabalin is taken in oral route. It can be taken with or without food. Pregabalin CR tablet should be administered after an evening meal. It should be swallowed whole and should not be split, crushed or chewed. If patients miss taking their dose of Pregabalin CR after an evening meal, then they should take their usual dose of Pregabalin CR prior to bedtime following a snack. If they miss taking the dose of Pregabalin CR prior to bedtime, then they should take their usual dose of Pregabalin CR following a morning meal. If they miss taking the dose of Pregabalin CR following the morning meal, then they should take their usual dose of Pregabalin CR at the usual time that evening following an evening meal. When discontinuing both Pregabalin and Pregabalin CR, it should be gradually tapered over a minimum of 1 week.

Most common side effects in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain and thinking abnormal (primarily difficulty with concentration/attention). Most common side effects in pediatric patients for the treatment of partial onset seizures are increased weight and increased appetite.

Pregabalin is contraindicated in patients with known hypersensitivity to Pregabalin or any of its components.

Angioedema (e.g., swelling of the throat, head and neck) can occur and may be associated with life threatening respiratory compromise requiring emergency treatment. Pregabalin should be discontinued immediately in these cases. Pregabalin should also be discontinued immediately if hypersensitivity reactions (e.g., hives, dyspnea and wheezing) occur. Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior. Respiratory depression may occur with pregabalin when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. Patients need to be monitored and dosage adjusted as appropriate. Pregabalin may cause dizziness and somnolence and impair patients ability to drive or operate machinery. Increased seizure frequency or other adverse reactions may occur if pregabalin is rapidly discontinued. Pregabalin should be withdrawn gradually over a minimum of 1 week. Pregabalin may cause peripheral edema. Caution should be exercised when coadministering pregabalin and thiazolidinedione antidiabetic agents.

Pregabalin is unlikely to be involved in significant pharmacokinetic drug interactions.

There are no adequate and well-controlled studies with pregabalin in pregnant women. Pregnant women should be advised of the potential risk to a fetus. Small amounts of pregabalin have been detected in the milk of lactating women. Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment with pregabalin.

Use in children and adolescents: Safety and effectiveness in pediatric patients have not been established for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, neuropathic pain associated with spinal cord injury and fibromyalgia. In case of adjunctive therapy for partial onset seizures, safety and effectiveness in pediatric patients below the age of 1 month have not been established. The safety and effectiveness of pregabalin extended-release tablet in pediatric patients have not been established.

In case of overdose with pregabalin, sign and symptoms are reduced consciousness, depression/anxiety, confusional state, agitation and restlessness. Seizures and heart block have also been reported. There is no specific antidote. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; usual precautions should be observed to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.

Keep in a cool & dry place (below 30°C), protected from light & moisture. Keep out of the reach of children.

Adjunct anti-epileptic drugs, Primary anti-epileptic drugs

Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). It does not bind directly to GABA_A, GABA_B or benzodiazepine receptors. Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of Pregabalin has not been fully elucidated, results in animal studies suggest that binding to the alpha2-delta subunit may be involved in Pregabalin's anti-nociceptive and antiseizure effects.

Neuropathic pain associated with diabetic peripheral neuropathy in adults (DPN): The maximum recommended dose of Pregabalin is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. The maximum recommended dose of Pregabalin CR capsule is 330 mg once daily.

Postherpetic neuralgia in adults (PHN): The recommended dose of Pregabalin is 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 75 mg two times a day or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate Pregabalin, may be treated with up to 300 mg two times a day or 200 mg three times a day (600 mg/day).

Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate Pregabalin CR capsule, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily. The maximum recommended dose of Pregabalin CR capsule is 660 mg once daily.

Management of fibromyalgia in adults: The recommended dose of Pregabalin is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day).

Neuropathic pain associated with spinal cord injury in adults: The recommended dose range of Pregabalin is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate Pregabalin may be treated with up to 300 mg two times a day.

Conversion from Pregabalin capsules to Pregabalin CR capsule tablet: When switching from Pregabalin capsules to Pregabalin CR capsule tablet on the day of the switch, instruct patients to take their morning dose of Pregabalin capsule as prescribed and initiate Pregabalin CR capsule therapy after an evening meal.

Pregabalin tablet total daily dose (dosed 2 or 3 times daily): Pregabalin CR capsule capsule dose (dosed once a day)

• 75 mg/daily: 82.5 mg/day
• 150 mg/daily: 165 mg/day
• 225 mg/daily: 247.5 mg/day
• 300 mg/daily: 330 mg/day
• 450 mg/daily: 495 mg/day
• 600 mg/daily: 660 mg/day

Route of administration: Pregabalin is taken in oral route. It can be taken with or without food. Pregabalin CR tablet should be administered after an evening meal. It should be swallowed whole and should not be split, crushed or chewed. If patients miss taking their dose of Pregabalin CR after an evening meal, then they should take their usual dose of Pregabalin CR prior to bedtime following a snack. If they miss taking the dose of Pregabalin CR prior to bedtime, then they should take their usual dose of Pregabalin CR following a morning meal. If they miss taking the dose of Pregabalin CR following the morning meal, then they should take their usual dose of Pregabalin CR at the usual time that evening following an evening meal. When discontinuing both Pregabalin and Pregabalin CR, it should be gradually tapered over a minimum of 1 week.

Most common side effects in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain and thinking abnormal (primarily difficulty with concentration/attention). Most common side effects in pediatric patients for the treatment of partial onset seizures are increased weight and increased appetite.

Pregabalin is contraindicated in patients with known hypersensitivity to Pregabalin or any of its components.

Angioedema (e.g., swelling of the throat, head and neck) can occur and may be associated with life threatening respiratory compromise requiring emergency treatment. Pregabalin should be discontinued immediately in these cases. Pregabalin should also be discontinued immediately if hypersensitivity reactions (e.g., hives, dyspnea and wheezing) occur. Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior. Respiratory depression may occur with pregabalin when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. Patients need to be monitored and dosage adjusted as appropriate. Pregabalin may cause dizziness and somnolence and impair patients ability to drive or operate machinery. Increased seizure frequency or other adverse reactions may occur if pregabalin is rapidly discontinued. Pregabalin should be withdrawn gradually over a minimum of 1 week. Pregabalin may cause peripheral edema. Caution should be exercised when coadministering pregabalin and thiazolidinedione antidiabetic agents.

Pregabalin is unlikely to be involved in significant pharmacokinetic drug interactions.

There are no adequate and well-controlled studies with pregabalin in pregnant women. Pregnant women should be advised of the potential risk to a fetus. Small amounts of pregabalin have been detected in the milk of lactating women. Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment with pregabalin.

Use in children and adolescents: Safety and effectiveness in pediatric patients have not been established for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, neuropathic pain associated with spinal cord injury and fibromyalgia. In case of adjunctive therapy for partial onset seizures, safety and effectiveness in pediatric patients below the age of 1 month have not been established. The safety and effectiveness of pregabalin extended-release tablet in pediatric patients have not been established.

In case of overdose with pregabalin, sign and symptoms are reduced consciousness, depression/anxiety, confusional state, agitation and restlessness. Seizures and heart block have also been reported. There is no specific antidote. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; usual precautions should be observed to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.

Keep in a cool & dry place (below 30°C), protected from light & moisture. Keep out of the reach of children.

Second generation Cephalosporins

Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.

Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days 
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.

Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.

Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.

While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

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