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Naproxen & Esomeprazole is indicated for the relief of signs & symptoms of-

• Osteoarthritis
• Rheumatoid arthritis
• Ankylosing spondylitis &
• To decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.

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

This consists of an immediate release Esomeprazole Magnesium layer & an enteric-coated Naproxen core. As a result, Esomeprazole is released first into the stomach, prior to the dissolution of Naproxen in the small intestine.

Naproxen is a NSAID with analgesic & antipyretic properties. The mechanism of action of Naproxen is to inhibit the prostaglandin synthesis. Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H⁺/k⁺ -ATPase in the gastric parietal cell by acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.

Carefully consider the potential benefits & risks of this tablet & other treatment options before deciding to use this tablet. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. If a dose of Esomeprazole lower than a total daily dose of 40 mg is more appropriate, a different treatment should be considered.

Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis-

• Adults: One tablet twice daily of either: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole

Juvenile Idiopathic Arthritis in Adolescent Patients 12 Years of Age & Older-

• Weight greater than 50 kg: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole
• Weight 38 kg to less than 50 kg: One tablet twice daily of 375 mg naproxen/20 mg of esomeprazole.

Do not split, chew, crush or dissolve the tablet. This tablet is to be taken at least 30 minutes before meals.

In general, this preparation is well tolerated. The most common adverse reactions in clinical trials (>5%): erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, nausea etc.

Patients with known CV disease/risk factors may be at greater risk. This tablet should be used with caution in patients with fluid retention or heart failure.

With medicine:

• Concomitant use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors, diuretics & beta-blockers
• Concomitant use of this tablet and warfarin may result in an increased risk of a bleeding complication.
• Esomeprazole inhibits gastric acid secretion & may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg. Ketoconazole, iron salts and digoxin).

With food & others: Administration of Naproxen & Esomeprazole together with high-fat food in healthy volunteers does not affect the extent of absorption of naproxen but significantly prolongs t_max by 10 hours and decreases peak plasma concentration (C_max) by about 12%

Pregnancy category C. In late pregnancy, it should be avoided because it may cause premature closure of the ductus arteriosus. This tablet should not be used in nursing mothers due to the Naproxen component.

Elderly patients: Studies indicate that although the total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Use caution when high doses are required & some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly use the lowest effective dose.

Patients with Moderate to Severe Renal impairment: Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance <30 ml/min).

Hepatic insufficiency: Monitor patients with mild to moderate hepatic impairment closely & consider a possible dose reduction based on the Naproxen component of this tablet. This is not recommended in patients with severe hepatic impairment because Esomeprazole dosage should not exceed 20 mg daily in these patients.

There is no clinical data on overdosage with this tablet.

Overdose of Naproxen: Significant naproxen overdosage may be characterized by lethargy, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alteration in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, vomiting etc.

Overdose of Esomeprazole: The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor and intermittent clonic convulsions etc.

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

Naproxen & Esomeprazole is indicated for the relief of signs & symptoms of-

• Osteoarthritis
• Rheumatoid arthritis
• Ankylosing spondylitis &
• To decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.

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

This consists of an immediate release Esomeprazole Magnesium layer & an enteric-coated Naproxen core. As a result, Esomeprazole is released first into the stomach, prior to the dissolution of Naproxen in the small intestine.

Naproxen is a NSAID with analgesic & antipyretic properties. The mechanism of action of Naproxen is to inhibit the prostaglandin synthesis. Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H⁺/k⁺ -ATPase in the gastric parietal cell by acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.

Carefully consider the potential benefits & risks of this tablet & other treatment options before deciding to use this tablet. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. If a dose of Esomeprazole lower than a total daily dose of 40 mg is more appropriate, a different treatment should be considered.

Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis-

• Adults: One tablet twice daily of either: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole

Juvenile Idiopathic Arthritis in Adolescent Patients 12 Years of Age & Older-

• Weight greater than 50 kg: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole
• Weight 38 kg to less than 50 kg: One tablet twice daily of 375 mg naproxen/20 mg of esomeprazole.

Do not split, chew, crush or dissolve the tablet. This tablet is to be taken at least 30 minutes before meals.

In general, this preparation is well tolerated. The most common adverse reactions in clinical trials (>5%): erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, nausea etc.

Patients with known CV disease/risk factors may be at greater risk. This tablet should be used with caution in patients with fluid retention or heart failure.

With medicine:

• Concomitant use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors, diuretics & beta-blockers
• Concomitant use of this tablet and warfarin may result in an increased risk of a bleeding complication.
• Esomeprazole inhibits gastric acid secretion & may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg. Ketoconazole, iron salts and digoxin).

With food & others: Administration of Naproxen & Esomeprazole together with high-fat food in healthy volunteers does not affect the extent of absorption of naproxen but significantly prolongs t_max by 10 hours and decreases peak plasma concentration (C_max) by about 12%

Pregnancy category C. In late pregnancy, it should be avoided because it may cause premature closure of the ductus arteriosus. This tablet should not be used in nursing mothers due to the Naproxen component.

Elderly patients: Studies indicate that although the total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Use caution when high doses are required & some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly use the lowest effective dose.

Patients with Moderate to Severe Renal impairment: Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance <30 ml/min).

Hepatic insufficiency: Monitor patients with mild to moderate hepatic impairment closely & consider a possible dose reduction based on the Naproxen component of this tablet. This is not recommended in patients with severe hepatic impairment because Esomeprazole dosage should not exceed 20 mg daily in these patients.

There is no clinical data on overdosage with this tablet.

Overdose of Naproxen: Significant naproxen overdosage may be characterized by lethargy, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alteration in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, vomiting etc.

Overdose of Esomeprazole: The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor and intermittent clonic convulsions etc.

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

Angiotensin-converting enzyme (ACE) inhibitors

Enalapril, after hydrolysis to enalaprilate, inhibits Angiotensin Converting Enzyme (ACE). ACE is a peptidyl dipeptidase that catalyses the conversion of angiotensin I to the vasoconstrictor substance angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. The beneficial effects of enalapril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin aldosterone system

Hypertension: Initially 5 mg once daily if used alone or 2.5 mg daily if used in addition to diuretic, in elderly patients or in patients with renal impairment. Usual maintenance dose is 10-20 mg once daily. However, in severe hypertension it may be increased to a maximum of 40 mg once daily.

Heart failure (adjunct) and asymptomatic left ventricular dysfunction: Initially 2.5 mg under close medical supervision. Usual maintenance dose is 20 mg daily in 1-2 divided doses

Dizziness and headache are more commonly reported side effects. Fatigue and asthenia were reported in 2-3% of patients. Other side effects occurred in less than 2% of patients and included hypotension, orthostatic hypotension, syncope, nausea, diarrhoea, muscle cramps, rash and cough.

Less frequently renal dysfunction, renal failure and oliguria have been reported. Angioedema, hyperkalemia and hyponatremia have also been reported rarely

Aortic stenosis or outflow tract obstruction. Renovascular disease. Severe resistant HTN. Peripheral vascular disease or generalized atherosclerosis.

Assess renal function; regular WBC counts in patient w/ collagen vascular disease eg SLE & scleroderma. Patient receiving immunosuppressive therapy; those prone to salt or water depletion. Pregnancy.

Combination with other antihypertensive agents such as b blockers, Methyldopa, calcium antagonists and diuretics may increase the antihypertensive efficacy. Adrenergic blocking drugs should only be combined with Enalapril under careful supervision. Concomitant Propranolol may reduce the bioavailability of Enalapril, but this does not appear to be of any clinical significance. Concomitant therapy with Lithium may increase the serum Lithium concentration.

Category D: Contraindicated in pregnancy. The drug is excreted in trace amount in human milk and caution should be exercised if given to nursing mothers.

Use in the elderly (over 65 years): The starting dose should be 2.5 mg. Enaril is effective in the treatment of hypertension in the elderly. The dose should be titrated according to need for the control of blood pressure.

symptoms-

• Lightheadedness, dizziness, or fainting
• Decrease in urine output
• Drowsiness, headache, or back pain
• Slow or irregular heartbeat.

Management-

• Fluids through an intravenous line (IV)
• Medications to increase blood pressure
• Other treatments based on complications that occur
• Closely monitoring the heart and lungs.

It is indicated for the treatment and prophylaxis of Iron, Folic Acid and Zinc deficiency especially during pregnancy and lactation.

Iron, Vitamin & Mineral Combined preparation

This timed-release capsule is the combined preparation of Carbonyl Iron, Folic Acid and Zinc Sulphate Monohydrate. It contains Carbonyl Iron with not less than 98% Iron content. Carbinyl Iron, having high bioavailability and low toxicity is safer and more effective choice for iron supplementation.

Adult: One Capsule daily before food or as directed by the physician.

Gastrointestinal irritations such as nausea, anorexia, vomiting, discomfort, constipation and diarrhoea may occur. Patients may complain of dark stool. Carbonyl Iron pellets incorporated into the capsules to reduce the possibility of gastrointestinal irritations. Rarely there may be allergic reactions.

It is contraindicated in patients with known hypersensitivity to any of its component or those with Iron overload.

Special care should be taken in patients with Iron overload states, such as haemochromatosis, haemolytic anaemia or red blood cell aplasia. Failure to response to the treatment requires further investigations to exclude other causes of anaemia. In patients with renal failure there may be the risk of Zinc accumulation.

Carbonyl Iron decreases the absorption of tetracycline antibiotics, quinolone antibiotics, levodopa, levothyroxine, methyldopa and penecillamine. Folic Acid interacts with antiepileptics, so plasma concentrations of phenobarbital, phenytoin and primidone are possibly reduced.

Use of any drug during first trimester of pregnancy should be avoided if possible. Thus administration of Iron during the first trimester requires definite evidence of Iron deficiency. Prophylaxis of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic acid is justified during the remainder of pregnancy.

Symptoms of Carbonyl Iron include decreased energy, nausea, abdominal pain, tarry stool, weak, rapid pulse, fever, coma, seizures.

Store below 30°C. and keep away from light and moisture. Keep all medicines out of the reach of children.

Triamcinolone & Combined preparations

Adults: This cream should be applied sparingly to the skin lesion no more than 2 times daily, preferably once in the morning and once in the evening. This cream should not be applied with an occlusive dressing, or to large areas of skin on the body. The duration of treatment with this cream should continue until the inflammatory symptoms subside but not longer than 2 weeks; after 2 weeks of therapy with this cream, continue therapy as needed with a preparation containing econazole or econazole nitrate alone.

Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight. Caution should be exercised.

Rarely, transient local mild irritation, itching & redness may occur immediately after application. Econazole has the minimal allergenic effect and is well tolerated, even by delicate skin. Adrenal suppression on long term continuous topical steroid therapy may occur, particularly in infants or children, or when occlusive dressings are applied. It should be noted that an infant's napkin may act as an occlusive dressing.

This Cream is contraindicated-

• In individuals who have shown hypersensitivity to any of its ingredients.
• Like any other dermatological preparation containing corticosteroids, this Cream is contraindicated in specific skin conditions such as tuberculous, varicella, herpes simplex or other viral infections of the skin, or fresh vaccination sites.
• Decubitus ulcers: Viral, bacterial or fungal skin infections (e.g. tuberculosis of the skin, syphilis of the skin, herpes simplex, herpes zoster, chickenpox).
• Rosacea and rosacea-like dermatitis.

• For external use only. This Cream is not for ophthalmic or oral use.
• If a reaction suggesting hypersensitivity or chemical irritation should occur, use of the medication should be discontinued.
• Corticosteroids applied to the skin can be absorbed in sufficient amounts to produce systemic effects, including adrenal suppression. Systemic absorption may be increased by various factors such as application over a large skin surface area, application to damaged skin, application under occlusive skin dressings and prolonged duration of therapy.
• Topical corticosteroids are associated with skin thinning and atrophy, striae, telangiectasis and purpura.
• Topical corticosteroids may lead to increased risk of dermatological superinfection or opportunistic infection.

Children: Increased caution is required when treating children. Compared to adults, the nature of a child's skin and the larger skin surface area relative to body weight may lead to an increased absorption of the corticosteroid via the child's skin. This cream should be used in children only for short periods of time (less than 2 weeks) and on small areas (less than 10% of body surface area).

Visual disturbance may be associated with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR).

Econazole: compound metabolized by CYP3A4/2C9 oral anticoagulants (warfarin & acenocoumarol).

Triamcinolone: lowering of plasma salicylates levels. Increased risk of Gl bleeding and ulceration with NSAIDs. Antagonised blood glucose-lowering effects of the antidiabetics. Increased risk of Hyperkalemia with amphotericin B, beta-blockers, potassium-depleting diuretics, theophylline. Increased clearance of the triamcinolone with ciclosporin, carbamazepine, phenytoin, barbiturate, rifampicin.

Pregnancy: Not the Econazole but the Triamcinolone Acetonide crosses the placenta and topical administration of corticosteroids during pregnancy can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established. However, topical steroids in large amounts or for prolonged periods
should not be used in pregnancy.

Lactation: Negligible amount of econazole and to some extent Triamcinolone may be excreted in small amounts in breast milk. So this cream should not be prescribed to the lactating mother or if prescribed lactation should be withheld during treatment.

This Cream is for cutaneous application only. Corticosteroids applied to the skin, including triamcinolone, can be absorbed in sufficient amounts to produce systemic effects. In the event of accidental ingestion, treat symptomatically. If this cream is accidentally applied to the eyes, wash with clean water or saline and seek medical attention if symptoms persist.

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

Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevation in serum aminotransferases (ALT or AST) or histologically active disease.

Hepatic viral infections (Hepatitis B)

By competing with the natural substrate deoxyguanosine triphosphate, entecavir functionally inhibits all three activities of the HBV polymerase (reverse transcriptase, rt):

• Base priming,
• Reverse transcription of the negative strand from the pregenomic messenger RNA, and
• Synthesis of the positive strand of HBV DNA. Upon activation by kinases, the drug can be incorporated into the DNA which has the ultimate effect of inhibiting the HBV polymerase activity.

The recommended dose of Entecavir for chronic hepatitis B virus infection in nucleoside-treatment-naive adults and adolescents 16 years of age is 0.5 mg once daily. For Lamivudine-refractory or known Lamivudine or Telbivudine resistance mutations, the recommended dose of Entecavir is 1 mg once daily. For patients with decompensated liver disease (adult) the recommended dose of Entecavir is 1 mg once daily. Entecavir should be administered on an empty stomach (at least 2 hours after a meal or 2 hours before the next meal).

Missed Dose: If it is almost time for next dose, skip the missed dose and take the next dose at the proper time. Nobody should take a double dose to make up for the missed dose.

The most common adverse events are headache, fatigue, dizziness and nausea.

Entecavir is contraindicated in patients with previously demonstrated hypersensitivity to Entecavir or any component of the product.

Lactic acidosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals.

Exacerbations of hepatitis after discontinuation of treatment: Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including Entecavir.

Co-administration of Entecavir with Lamivudine or Adefovir dipivoxil did not result in significant drug interactions. The effects of co-administration of Entecavir with other drugs that are eliminated through renal or are known to affect renal function have not been evaluated and patients should be monitored closely for adverse events when coadministered with such drugs.

There are no data on the effect of Entecavir on the transmission of HBV from mother to infant. Therefore, appropriate care should be taken. It is not known whether it is excreted in human milk. Mothers should be instructed not to breastfeed if they are taking Entecavir.

Pediatric: Safety and effectiveness of Entecavir in pediatric patients below the age of 2 years have not been established.

Geriatric: Clinical studies of Entecavir did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. But care should be taken in dose selection, and it may be useful to monitor renal function.

Dose adjustment in renal impairment: Dose adjustment is recommended for patients with CrCl <50 ml/min including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) as shown below:

• CrCl ≥50 ml/min: 0.5 mg every 24 hours
• CrCl 30 to <50 ml/min: 0.5 mg every 48 hours
• CrCl 10 to <30 ml/min: 0.5 mg every 72 hours
• CrCl <10 ml/min or  Hemodialysis or CAPD: 0.5 mg every 7 days

There is no experience of Entecavir overdosage reported in patients. Healthy subjects who received up to 20 mg daily for up to 14 days and single doses up to 40 mg had no unexpected adverse events. If overdosage occurs, the patient must be monitored for evidence of toxicity and standard supportive treatment as necessary.

Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.

This medicine is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilized on levodopa/dopa decarboxylase (DDC) inhibitor treatment.

Antiparkinson drugs

Levodopa is the metabolic precursor of dopamine. It crosses the blood-brain barrier and is converted to dopamine in the brain. Carbidopa increases the amount of levodopa that is transported into the CNS by inhibiting the decarboxylation of peripheral levodopa. Entacapone is a selective inhibitor of COMT which alters the pharmacokinetics of levodopa, resulting to increased and more sustained levodopa serum levels.

Adults: The optimum daily dose must be determined by careful titration of levodopa in each patient. Patients should be instructed to take only 1 (one) tablet per dose administration. The maximum recommended daily dose of entacapone is 2,000 mg. Usually this combination is to be used in patients who are currently treated with corresponding doses of standard release Levodopa or Dopa Decarboxylase (DDC) inhibitor and entacapone.

May be taken with or without food. Keep a consistent diet. A change in diet to foods high in protein may delay levodopa absorption & reduce amount taken up in circulation. Excessive acidity also delays stomach emptying & thus delays levodopa absorption. Iron salts may also reduce amount of levodopa available to the body. Swallow whole.

Common side effects include dyskinesia, nausea, hyperkinesia, change in urine color, diarrhea and stomach pain. Other side effects may include diarrhea, sometimes severe; colitis; hallucinations; other mental disturbances; orthostatic hypotension; rhabdomyolysis; and symptoms resembling neuroleptic malignant syndrome (a condition characterized by high fever, muscle stiffness, and confusion); fibrosis; skin cancer, etc.

Narrow-angle glaucoma, phaeochromocytoma, history of neuroleptic malignant syndrome (NMS) and/ or non-traumatic rhabdomyolysis. Severe hepatic impairment. Concurrent use of or within 14 days of discontinuing non-selective MAOIs.

Levodopa, carbidopa and entacapone together may cause dizziness and symptomatic orthostatism. Therefore, caution should be exercised when driving or using machines. As with levodopa, periodic evaluations of hepatic, hematopoietic, cardiovascular and renal function are recommended during extended therapy.

Symptomatic postural hypotension may occur when levodopa is added to the treatment of patients already receiving antihypertensive. Dose adjustment of the antihypertensive agent may be required. Dopamine receptor antagonists (e.g. some antipsychotics and antiemetics), phenytoin and papaverine may reduce the therapeutic effect of levodopa. Patients taking these medicinal products with levodopa/ carbidopa/ entacapone combination should be carefully observed for loss of therapeutic response. Since levodopa competes with certain amino acids, the absorption of Levodopa, Carbidopa & Entacapone may be impaired in some patients on high protein diet.

Pregnancy category C. The combination of levodopa/ carbidopa/ entacapone should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. The safety of this combination in the infant is not known. Women should not breast-feed during treatment with this combination.

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

Elderly: No dose adjustment is required for elderly patients.

Hepatic impaired patients: Should be administered cautiously to patients with mild to moderate hepatic impairment. Dose reduction may be needed.

Renally impaired patients: Should be administered cautiously to patients in severe renal impairment including those receiving dialysis therapy

The acute symptoms and signs of overdose include agitation, confusional state, coma, bradycardia, ventricular tachycardia, Cheyne Stokes respiration, discolorations of skin, tongue and conjunctiva, and chromaturia. Management of acute overdose with levodopa/ carbidopa/ entacapone combination is similar to acute overdose with levodopa. Pyridoxine, however, is not effective in reversing the actions of levodopa/ carbidopa/ entacapone combination. Hospitalization is advised and general supportive measures should be employed with immediate gastric lavage and repeated doses of charcoal over time.

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

This medicine is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilized on levodopa/dopa decarboxylase (DDC) inhibitor treatment.

Antiparkinson drugs

Levodopa is the metabolic precursor of dopamine. It crosses the blood-brain barrier and is converted to dopamine in the brain. Carbidopa increases the amount of levodopa that is transported into the CNS by inhibiting the decarboxylation of peripheral levodopa. Entacapone is a selective inhibitor of COMT which alters the pharmacokinetics of levodopa, resulting to increased and more sustained levodopa serum levels.

Adults: The optimum daily dose must be determined by careful titration of levodopa in each patient. Patients should be instructed to take only 1 (one) tablet per dose administration. The maximum recommended daily dose of entacapone is 2,000 mg. Usually this combination is to be used in patients who are currently treated with corresponding doses of standard release Levodopa or Dopa Decarboxylase (DDC) inhibitor and entacapone.

May be taken with or without food. Keep a consistent diet. A change in diet to foods high in protein may delay levodopa absorption & reduce amount taken up in circulation. Excessive acidity also delays stomach emptying & thus delays levodopa absorption. Iron salts may also reduce amount of levodopa available to the body. Swallow whole.

Common side effects include dyskinesia, nausea, hyperkinesia, change in urine color, diarrhea and stomach pain. Other side effects may include diarrhea, sometimes severe; colitis; hallucinations; other mental disturbances; orthostatic hypotension; rhabdomyolysis; and symptoms resembling neuroleptic malignant syndrome (a condition characterized by high fever, muscle stiffness, and confusion); fibrosis; skin cancer, etc.

Narrow-angle glaucoma, phaeochromocytoma, history of neuroleptic malignant syndrome (NMS) and/ or non-traumatic rhabdomyolysis. Severe hepatic impairment. Concurrent use of or within 14 days of discontinuing non-selective MAOIs.

Levodopa, carbidopa and entacapone together may cause dizziness and symptomatic orthostatism. Therefore, caution should be exercised when driving or using machines. As with levodopa, periodic evaluations of hepatic, hematopoietic, cardiovascular and renal function are recommended during extended therapy.

Symptomatic postural hypotension may occur when levodopa is added to the treatment of patients already receiving antihypertensive. Dose adjustment of the antihypertensive agent may be required. Dopamine receptor antagonists (e.g. some antipsychotics and antiemetics), phenytoin and papaverine may reduce the therapeutic effect of levodopa. Patients taking these medicinal products with levodopa/ carbidopa/ entacapone combination should be carefully observed for loss of therapeutic response. Since levodopa competes with certain amino acids, the absorption of Levodopa, Carbidopa & Entacapone may be impaired in some patients on high protein diet.

Pregnancy category C. The combination of levodopa/ carbidopa/ entacapone should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. The safety of this combination in the infant is not known. Women should not breast-feed during treatment with this combination.

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

Elderly: No dose adjustment is required for elderly patients.

Hepatic impaired patients: Should be administered cautiously to patients with mild to moderate hepatic impairment. Dose reduction may be needed.

Renally impaired patients: Should be administered cautiously to patients in severe renal impairment including those receiving dialysis therapy

The acute symptoms and signs of overdose include agitation, confusional state, coma, bradycardia, ventricular tachycardia, Cheyne Stokes respiration, discolorations of skin, tongue and conjunctiva, and chromaturia. Management of acute overdose with levodopa/ carbidopa/ entacapone combination is similar to acute overdose with levodopa. Pyridoxine, however, is not effective in reversing the actions of levodopa/ carbidopa/ entacapone combination. Hospitalization is advised and general supportive measures should be employed with immediate gastric lavage and repeated doses of charcoal over time.

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

This medicine is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilized on levodopa/dopa decarboxylase (DDC) inhibitor treatment.

Antiparkinson drugs

Levodopa is the metabolic precursor of dopamine. It crosses the blood-brain barrier and is converted to dopamine in the brain. Carbidopa increases the amount of levodopa that is transported into the CNS by inhibiting the decarboxylation of peripheral levodopa. Entacapone is a selective inhibitor of COMT which alters the pharmacokinetics of levodopa, resulting to increased and more sustained levodopa serum levels.

Adults: The optimum daily dose must be determined by careful titration of levodopa in each patient. Patients should be instructed to take only 1 (one) tablet per dose administration. The maximum recommended daily dose of entacapone is 2,000 mg. Usually this combination is to be used in patients who are currently treated with corresponding doses of standard release Levodopa or Dopa Decarboxylase (DDC) inhibitor and entacapone.

May be taken with or without food. Keep a consistent diet. A change in diet to foods high in protein may delay levodopa absorption & reduce amount taken up in circulation. Excessive acidity also delays stomach emptying & thus delays levodopa absorption. Iron salts may also reduce amount of levodopa available to the body. Swallow whole.

Common side effects include dyskinesia, nausea, hyperkinesia, change in urine color, diarrhea and stomach pain. Other side effects may include diarrhea, sometimes severe; colitis; hallucinations; other mental disturbances; orthostatic hypotension; rhabdomyolysis; and symptoms resembling neuroleptic malignant syndrome (a condition characterized by high fever, muscle stiffness, and confusion); fibrosis; skin cancer, etc.

Narrow-angle glaucoma, phaeochromocytoma, history of neuroleptic malignant syndrome (NMS) and/ or non-traumatic rhabdomyolysis. Severe hepatic impairment. Concurrent use of or within 14 days of discontinuing non-selective MAOIs.

Levodopa, carbidopa and entacapone together may cause dizziness and symptomatic orthostatism. Therefore, caution should be exercised when driving or using machines. As with levodopa, periodic evaluations of hepatic, hematopoietic, cardiovascular and renal function are recommended during extended therapy.

Symptomatic postural hypotension may occur when levodopa is added to the treatment of patients already receiving antihypertensive. Dose adjustment of the antihypertensive agent may be required. Dopamine receptor antagonists (e.g. some antipsychotics and antiemetics), phenytoin and papaverine may reduce the therapeutic effect of levodopa. Patients taking these medicinal products with levodopa/ carbidopa/ entacapone combination should be carefully observed for loss of therapeutic response. Since levodopa competes with certain amino acids, the absorption of Levodopa, Carbidopa & Entacapone may be impaired in some patients on high protein diet.

Pregnancy category C. The combination of levodopa/ carbidopa/ entacapone should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. The safety of this combination in the infant is not known. Women should not breast-feed during treatment with this combination.

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

Elderly: No dose adjustment is required for elderly patients.

Hepatic impaired patients: Should be administered cautiously to patients with mild to moderate hepatic impairment. Dose reduction may be needed.

Renally impaired patients: Should be administered cautiously to patients in severe renal impairment including those receiving dialysis therapy

The acute symptoms and signs of overdose include agitation, confusional state, coma, bradycardia, ventricular tachycardia, Cheyne Stokes respiration, discolorations of skin, tongue and conjunctiva, and chromaturia. Management of acute overdose with levodopa/ carbidopa/ entacapone combination is similar to acute overdose with levodopa. Pyridoxine, however, is not effective in reversing the actions of levodopa/ carbidopa/ entacapone combination. Hospitalization is advised and general supportive measures should be employed with immediate gastric lavage and repeated doses of charcoal over time.

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

Calcitriol is indicated in-

• Post-menopausal osteoporosis
• Renal osteodystrophy
• Postsurgical hypoparathyroidism
• Idiopathic hypoparathyroidism
• Pseudohypoparathyroidism
• Secondary hyperparathyroidism in patients with moderate to severe chronic renal failure (pre-dialysis)
• Vitamin D dependent rickets

Vitamin in bone formation, Vitamin-D preparations

Calcitriol is one of the most important active metabolites of vitamin D3. It is normally formed in the kidneys from its precursor, 25-hydroxycholecalciferol. Calcitriol promotes intestinal absorption of calcium and regulates bone mineralization. The key role of Calcitriol is the regulation of calcium homeostasis, which includes stimulation effects on osteoblastic activity in the skeleton.

The optimal daily dose of Calcitriol capsule must be carefully determined for each patient on the basis of serum calcium level.

In Post-menopausal Osteoporosis: The recommended dose of Calcitriol capsule is 0.25 mcg twice daily.

In Renal Osteodystrophy (dialysis patients): The initial daily dose is 0.25 mcg of Calcitriol capsule. In patients with normal or only slightly reduced calcium levels, doses of 0.25 mcg every other day are sufficient.

In Hypoparathyroidism and Rickets: The recommended initial dosage of Calcitriol capsule is 0.25 mcg/day which given in the morning. If within 2-4 weeks satisfactory response is not observed by usual dose then dose may be increased at 2-4 weeks intervals.

The recommended intravenous initial dose of Calcitriol injection, depending on the severity of the hypocalcemia and/or secondary hyperparathyroidism, is 1 mcg (0.02 mcg/kg) to 2 mcg administered three times weekly, approximately every other day. Doses as small as 0.5 mcg and as large as 4 mcg three times weekly have been used as an initial dose. If a satisfactory response is not observed, the dose may be increased by 0.5 to 1 mcg at two to four week intervals.

Occasional symptoms include anorexia, headache, vomiting and constipation. Chronic effects may include dystrophy, fever, polyuria, dehydration, apathy and urinary tract infection.

Calcitriol is contraindicated in patients with known hypersensitivity to any of its ingredients. Calcitriol is also contraindicated in all diseases associated with hypercalcemia.

During Calcitriol therapy if the serum calcium levels rise to 1 mg/100 ml above normal or serum creatinine rises to >120 µmol/l, the dosage of Calcitriol should be substantially reduced or treatment stopped.

Concomitant treatment with a thiazide diuretics increases the risk of hypercalcemia. Calcitriol dosage must be determined with care in patients undergoing treatment with digitalis as hypercalcemia in such patients may precipitate cardiac arrhythmias. Magnesium containing drugs (e.g.,antacids) may cause hypermagnesemia.

There is no evidence that vitamin D is teratogenic in humans. Calcitriol may be used during pregnancy only if the benefits outweigh the potential risk to the fetus. Mothers may breast feed while taking Calcitriol but serum calcium levels of the mother and infant should be monitored.

Secondary hyperparathyroidism in patients with moderate to severe chronic renal failure (pre-dialysis)-

• The recommended initial dosage of Calcitriol is 0.25 mcg/day in adults and pediatric patients 3 years of age or older. This dosage may be increased if necessary to 0.5 mcg/day.
• For pediatric patients less than 3 years of age, the recommended initial dosage of Calcitriol is 10 to 15 ng/kg/day.
• In Elderly: No dosage adjustment are required.

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

Non-sedating antihistamines

This tablet is a preparation of Loratadine. Loratadine is a non-sedative histamine Hr receptor antagonist with antiallergic properties. Loratadine is a long-acting tricyclic antihistamine with selective peripheral Hi-receptor antagonistic activity and no central sedative or anticholinergic effect. It is rapidly effective and long-lasting, allowing once-a-day administration.

Adults and children over 12 years of age: One Loratadine tablet once daily. It is usually administered in the morning or when symptoms require treatment.

Children 2-12 years: Body weight over 30 kg: one Loratadine tablet once daily, below 30 kg: half Loratadine tablet once daily.

Below 2 years of age: Loratadine tablet is not recommended for use below 2 years of age since safety and efficacy has not been established.

During controlled clinical studies the incidence of adverse events, including sedation and anticholinergic effects observed with 10 mg Loratadine was comparable to that observed with placebo. Studies on the effect of Loratadine on actual driving performance, and on tests of cognitive and psychomotor functioning have shown it to be comparable to placebo.

Loratadine is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components.

Caution should be taken in patients with liver impairment or renal insufficiency (eGFR <30 ml/min).

There are no reports of potentially hazardous interactions with other drugs. In contrast to many other histamine H1 receptor antagonists, Loratadine has no potentiating effects when administered concurrently with alcohol, as measured by psychomotor performance studies. Concomitant therapy with drugs that inhibit or are metabolized by hepatic cytochromes P450 3A4 and 2D6 may elevate plasma concentrations of either drug and this mayifesult in adverse effects. Cimetidine inhibits both enzymes while erythromycin or ketoconazole inhibits P450 3A4. These drugs increase loratadine serum concentrations but no adverse effects are reported.

There is no experience of the use of Loratadine in human pregnancy. Therefore its use during pregnancy is not advisable. Loratadine is excreted in breast milk in a very small amount. So nursing mothers are advised not to take the drug.

In adults somnolence, tachycardia and headache have been reported with overdose greater than 10 mg. Extrapyramidal signs and palpitations have been reported in children with overdoses of greater than 10 mg. In the event of overdosage, general symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary. It would seem reasonable to treat patients presenting early after large overdoses with oral activated charcoal. The conscious patients may be induced to vomit or gastric lavage may be performed.

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

Anti-fibrinolytic drugs, Haemostatic drugs

This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.

The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.

Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.

Adults-

• The usual dose: 500-1000 mg 3 times daily.
• For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
• For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.

Children-

• For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
• For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.

Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure.

Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.

Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.

Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Tranexamic Acid should not be administered during known and presumed pregnancy. Tranexamic Acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.

Store in a dry place at 15-30°C, away from light and keep out of children's reach.

Anti-fibrinolytic drugs, Haemostatic drugs

This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.

The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.

Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.

Adults-

• The usual dose: 500-1000 mg 3 times daily.
• For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
• For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.

Children-

• For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
• For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.

Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure.

Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.

Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.

Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Tranexamic Acid should not be administered during known and presumed pregnancy. Tranexamic Acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.

Store in a dry place at 15-30°C, away from light and keep out of children's reach.

Anti-fibrinolytic drugs, Haemostatic drugs

This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.

The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.

Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.

Adults-

• The usual dose: 500-1000 mg 3 times daily.
• For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
• For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.

Children-

• For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
• For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.

Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure.

Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.

Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.

Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Tranexamic Acid should not be administered during known and presumed pregnancy. Tranexamic Acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.

Store in a dry place at 15-30°C, away from light and keep out of children's reach.

Anti-platelet drugs

By decreasing platelet aggregation, Aspirin inhibits thrombus formation on the arterial side of the circulation, where thrombi are formed by platelet aggregation and anticoagulants have little effect. Aspirin is the analgesic of choice for headache, transient musculoskeletal pain and dysmenorrhoea. It has anti-inflammatory and antipyretic properties, which may be useful. Enteric-coated Aspirin reduces intestinal disturbance and gastrointestinal ulceration due to aspirin.

Pain, inflammatory diseases and as antipyretic: Aspirin 300 mg 1-3 tablets 6 hourly with a maximum daily dose of 4 gm.

Suspected acute coronary syndrome: 150 mg-300 mg immediately unless there are clear contraindications.

After myocardial infarction: Aspirin 150 mg daily for 1 month. Long-term use of aspirin in a dose of 75 mg daily is recommended thereafter.

Acute ischaemic stroke/Transient ischaemic stroke (TIA): The starting dose is 150 mg-300 mg daily and Aspirin 75 mg daily thereafter.

Following bypass surgery: 75 mg-300 mg daily starting 6 hours post-procedure.

Side effects for the usual dosage of Aspirin are mild including nausea, dyspepsia, gastrointestinal ulceration and bronchospasm etc.

Aspirin is contraindicated to the children (Reye's syndrome) less than 12 years, in breast-feeding and active peptic ulcer. It is also contraindicated in bleeding due to haemophilia, intracranial haemorrhage and other ulceration.

It should be administered cautiously in asthma, uncontrolled blood pressure, and pregnant women. It should be administered with caution to patients with a nasal polyp and nasal allergy.

Salicylates may enhance the effect of anticoagulants, oral hypoglycaemic agents, phenytoin and sodium valporate. They inhibit the uricosuric effect of probenecid and may increase the toxicity of sulphonamides. They may also precipitate bronchospasm or induce attacks of asthma in susceptible subjects.

It is especially important not to use aspirin during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Aspirin penetrates into breast milk. So, it should be administered with caution to lactating mothers.

Overdosage produces dizziness, tinnitus, sweating, nausea and vomiting, confusion and hyperventilation. Gross overdosage may lead to CNS depression with coma, cardiovascular collapse and respiratory depression. If the overdosage is suspected, the patient should be kept under observation for at least 24 hours, as symptoms and salicylate blood levels may not become apparent for several hours. Treatment of overdosage consists of gastric lavage and forced alkaline diuresis. Haemodialysis may be necessary in severe cases.

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

Primary anti-epileptic drugs

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

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

Epilepsy-

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

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

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

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

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

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

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

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

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

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

Primary anti-epileptic drugs

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

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

Epilepsy-

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

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

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

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

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

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

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

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

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

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

Primary anti-epileptic drugs

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

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

Epilepsy-

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

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

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

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

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

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

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

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

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

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

Primary anti-epileptic drugs

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

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

Epilepsy-

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

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

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

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

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

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

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

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

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

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

Macrolides

Dosage of Clindamycin Capsule:

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

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

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

Dosage of Clindamycin Powder for oral solution:

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

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

Dosage of Clindamycin IV/IM Injection:
Adults-

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

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

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

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

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

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

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

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

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

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

Geriatric use: Dose adjustment of Clindamycin is not necessary.

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

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

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

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

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

Physico-Chemical Stability of diluted solutions of Clindacin Injection-

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

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