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CNS stimulant drugs

Citicoline is a naturally occurring substance that is an essential intermediate in the synthesis of structural phospholipids of cell membrane. Oral dose of Citicoline is metabolized to choline & cytidine. These then enter into the systemic circulation, cross the blood-brain barrier and recombine to form Citicoline within the central nervous system. Citicoline activates the biosynthesis of structural phospholipids in the neuronal membrane, promotes rapid repair of injured cell surface & mitochondrial membrane & increases the level of various neurotransmitters like acetylcholine & dopamine. Citicoline has neuroprotective effects in situations of hypoxia & ischemia, as well as improved learning & memory performance in animal models for the aging brain. Citicoline inhibits the activation of Phospholipase A2 to prevent apoptotic & necrotic cell death.

Oral:

• Immediate treatment of stroke due to a clot (ischemic stroke): 500-2000 mg of Citicoline per day, start within 24 hours of stroke.
• For decline in thinking skills due to stroke: 1000-2000 mg of Citicoline per day.
• Chronic cerebrovascular disease: 1000 mg daily in divided dose with or between meals for ongoing disease of the blood vessels that serve the brain.

Injection:

• 1 to 2 injections daily.
• Adjust dosage according to the severity.
• Can be administered through intramuscular (IM), or intravenous (IV) [ 3 to 5 minutes] route.

Occasionally Citicoline may exert stimulating action of the parasympathetic system as well as a fleeting & discrete hypotensive effect.

Patients with hypertonic of the parasympathetic nervous system.

In case of persistent intracranial hemorrhage, it is recommended not to exceed the dose of 1000 mg of Citicoline daily.

Citicoline may enhance the effects of levodopa, carbidopa & entacapone. Citicoline must not be administered with products containing meclophenoxate.

There are no adequate & well controlled studies of Citicoline during pregnancy & lactation. Citicoline should be used during pregnancy & lactation only if the potential benefits justify the potential risks.

Geriatric use: No dosage adjustment is required & the usual dose can be administered.

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

CNS stimulant drugs

Citicoline is a naturally occurring substance that is an essential intermediate in the synthesis of structural phospholipids of cell membrane. Oral dose of Citicoline is metabolized to choline & cytidine. These then enter into the systemic circulation, cross the blood-brain barrier and recombine to form Citicoline within the central nervous system. Citicoline activates the biosynthesis of structural phospholipids in the neuronal membrane, promotes rapid repair of injured cell surface & mitochondrial membrane & increases the level of various neurotransmitters like acetylcholine & dopamine. Citicoline has neuroprotective effects in situations of hypoxia & ischemia, as well as improved learning & memory performance in animal models for the aging brain. Citicoline inhibits the activation of Phospholipase A2 to prevent apoptotic & necrotic cell death.

Oral:

• Immediate treatment of stroke due to a clot (ischemic stroke): 500-2000 mg of Citicoline per day, start within 24 hours of stroke.
• For decline in thinking skills due to stroke: 1000-2000 mg of Citicoline per day.
• Chronic cerebrovascular disease: 1000 mg daily in divided dose with or between meals for ongoing disease of the blood vessels that serve the brain.

Injection:

• 1 to 2 injections daily.
• Adjust dosage according to the severity.
• Can be administered through intramuscular (IM), or intravenous (IV) [ 3 to 5 minutes] route.

Occasionally Citicoline may exert stimulating action of the parasympathetic system as well as a fleeting & discrete hypotensive effect.

Patients with hypertonic of the parasympathetic nervous system.

In case of persistent intracranial hemorrhage, it is recommended not to exceed the dose of 1000 mg of Citicoline daily.

Citicoline may enhance the effects of levodopa, carbidopa & entacapone. Citicoline must not be administered with products containing meclophenoxate.

There are no adequate & well controlled studies of Citicoline during pregnancy & lactation. Citicoline should be used during pregnancy & lactation only if the potential benefits justify the potential risks.

Geriatric use: No dosage adjustment is required & the usual dose can be administered.

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

It is indicated for the relief of symptoms associated with seasonal & perennial allergic rhinitis. It is also indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria and allergen induced asthma.

Sedating Anti-histamine

Cetirizine Hydrochloride is a potent H1 receptor antagonist without any significant anticholinergic and antiserotonic effects. At pharmacologically active dose levels, it has almost no drowsiness effect and does not cause behavioral changes. It inhibits the histamine-mediated early phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the late phase of the allergic reaction.

Pharmacokinetics: Cetirizine 10 mg achieves peak plasma concentrations of 257 mcg/L within one hour of administration (980 mcg/L in children). Food does not affect the extent of absorption, but it may slightly reduce the rate. Peak blood levels 0.3 micrograms/ml are reached between thirty & sixty minutes after administration of 10 mg dose of Cetirizine. Its plasma half-life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30 ml/minute and the excretion half-life is approximately nine hours.

Adults and Children 6 years and older: 1 tablet or 2 teaspoonfuls daily (or 1 teaspoonful twice daily).

Children 2-6 years: 1 teaspoonful once daily or 1/2 teaspoonful twice daily.

Children 6 months to 2 years : 1/2 teaspoonful once daily. The dose in children 12-23 months of age can be increased to a maximum dose as 1/2 teaspoonful every 12 hours.

The most common side effects that occurred more frequently on Cetirizine is somnolence.

It is contraindicated in patients with a history of hypersensitivity to Cetirizine or hydroxyzine.

Caution should be exercised when driving a car or operating a heavy machinery.

No clinically significant drug interactions have been found with Theophylline, Azithromycin, Pseudoephedrine, Ketoconazole or Erythromycin and with other drugs.

US FDA Pregnancy Category of Cetirizine Hydrochloride is B. 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. Cetirizine Hydrochloride has been shown to be excreted in human milk. So, caution should be exercised when Cetirizine Hydrochloride is administered to a nursing woman.

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

It is indicated for the relief of symptoms associated with seasonal & perennial allergic rhinitis. It is also indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria and allergen induced asthma.

Sedating Anti-histamine

Cetirizine Hydrochloride is a potent H1 receptor antagonist without any significant anticholinergic and antiserotonic effects. At pharmacologically active dose levels, it has almost no drowsiness effect and does not cause behavioral changes. It inhibits the histamine-mediated early phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the late phase of the allergic reaction.

Pharmacokinetics: Cetirizine 10 mg achieves peak plasma concentrations of 257 mcg/L within one hour of administration (980 mcg/L in children). Food does not affect the extent of absorption, but it may slightly reduce the rate. Peak blood levels 0.3 micrograms/ml are reached between thirty & sixty minutes after administration of 10 mg dose of Cetirizine. Its plasma half-life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30 ml/minute and the excretion half-life is approximately nine hours.

Adults and Children 6 years and older: 1 tablet or 2 teaspoonfuls daily (or 1 teaspoonful twice daily).

Children 2-6 years: 1 teaspoonful once daily or 1/2 teaspoonful twice daily.

Children 6 months to 2 years : 1/2 teaspoonful once daily. The dose in children 12-23 months of age can be increased to a maximum dose as 1/2 teaspoonful every 12 hours.

The most common side effects that occurred more frequently on Cetirizine is somnolence.

It is contraindicated in patients with a history of hypersensitivity to Cetirizine or hydroxyzine.

Caution should be exercised when driving a car or operating a heavy machinery.

No clinically significant drug interactions have been found with Theophylline, Azithromycin, Pseudoephedrine, Ketoconazole or Erythromycin and with other drugs.

US FDA Pregnancy Category of Cetirizine Hydrochloride is B. 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. Cetirizine Hydrochloride has been shown to be excreted in human milk. So, caution should be exercised when Cetirizine Hydrochloride is administered to a nursing woman.

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

CNS stimulant drugs

Citicoline is a naturally occurring substance that is an essential intermediate in the synthesis of structural phospholipids of cell membrane. Oral dose of Citicoline is metabolized to choline & cytidine. These then enter into the systemic circulation, cross the blood-brain barrier and recombine to form Citicoline within the central nervous system. Citicoline activates the biosynthesis of structural phospholipids in the neuronal membrane, promotes rapid repair of injured cell surface & mitochondrial membrane & increases the level of various neurotransmitters like acetylcholine & dopamine. Citicoline has neuroprotective effects in situations of hypoxia & ischemia, as well as improved learning & memory performance in animal models for the aging brain. Citicoline inhibits the activation of Phospholipase A2 to prevent apoptotic & necrotic cell death.

Oral:

• Immediate treatment of stroke due to a clot (ischemic stroke): 500-2000 mg of Citicoline per day, start within 24 hours of stroke.
• For decline in thinking skills due to stroke: 1000-2000 mg of Citicoline per day.
• Chronic cerebrovascular disease: 1000 mg daily in divided dose with or between meals for ongoing disease of the blood vessels that serve the brain.

Injection:

• 1 to 2 injections daily.
• Adjust dosage according to the severity.
• Can be administered through intramuscular (IM), or intravenous (IV) [ 3 to 5 minutes] route.

Occasionally Citicoline may exert stimulating action of the parasympathetic system as well as a fleeting & discrete hypotensive effect.

Patients with hypertonic of the parasympathetic nervous system.

In case of persistent intracranial hemorrhage, it is recommended not to exceed the dose of 1000 mg of Citicoline daily.

Citicoline may enhance the effects of levodopa, carbidopa & entacapone. Citicoline must not be administered with products containing meclophenoxate.

There are no adequate & well controlled studies of Citicoline during pregnancy & lactation. Citicoline should be used during pregnancy & lactation only if the potential benefits justify the potential risks.

Geriatric use: No dosage adjustment is required & the usual dose can be administered.

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

It is indicated for the relief of symptoms associated with seasonal & perennial allergic rhinitis. It is also indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria and allergen induced asthma.

Sedating Anti-histamine

Cetirizine Hydrochloride is a potent H1 receptor antagonist without any significant anticholinergic and antiserotonic effects. At pharmacologically active dose levels, it has almost no drowsiness effect and does not cause behavioral changes. It inhibits the histamine-mediated early phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the late phase of the allergic reaction.

Pharmacokinetics: Cetirizine 10 mg achieves peak plasma concentrations of 257 mcg/L within one hour of administration (980 mcg/L in children). Food does not affect the extent of absorption, but it may slightly reduce the rate. Peak blood levels 0.3 micrograms/ml are reached between thirty & sixty minutes after administration of 10 mg dose of Cetirizine. Its plasma half-life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30 ml/minute and the excretion half-life is approximately nine hours.

Adults and Children 6 years and older: 1 tablet or 2 teaspoonfuls daily (or 1 teaspoonful twice daily).

Children 2-6 years: 1 teaspoonful once daily or 1/2 teaspoonful twice daily.

Children 6 months to 2 years : 1/2 teaspoonful once daily. The dose in children 12-23 months of age can be increased to a maximum dose as 1/2 teaspoonful every 12 hours.

The most common side effects that occurred more frequently on Cetirizine is somnolence.

It is contraindicated in patients with a history of hypersensitivity to Cetirizine or hydroxyzine.

Caution should be exercised when driving a car or operating a heavy machinery.

No clinically significant drug interactions have been found with Theophylline, Azithromycin, Pseudoephedrine, Ketoconazole or Erythromycin and with other drugs.

US FDA Pregnancy Category of Cetirizine Hydrochloride is B. 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. Cetirizine Hydrochloride has been shown to be excreted in human milk. So, caution should be exercised when Cetirizine Hydrochloride is administered to a nursing woman.

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

Ferric Citrate is a phosphate binder indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. Ferric Citrate is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis.

Oral Iron preparations

Hyperphosphatemia in chronic kidney disease on dialysis: Ferric iron binds dietary phosphate in the GI tract and precipitates as ferric phosphate. This compound is insoluble and is excreted in the stool. By binding phosphate in the GI tract and decreasing absorption, ferric citrate lowers the phosphate concentration in the serum.

Iron deficiency anemia in chronic kidney disease not on dialysis: Ferric iron is reduced from the ferric to the ferrous form by ferric reductase in the GI tract. After transport through the enterocytes into the blood, oxidized ferric iron circulates bound to the plasma protein transferrin, and can be incorporated into hemoglobin.

Hyperphosphatemia in chronic kidney disease on dialysis:

• Starting dose is 2 tablets orally 3 times per day with meals.
• Adjust dose by 1 to 2 tablets as needed to maintain serumphosphorus at target levels, up to a maximum of 12 tablets daily. Dose can be titrated at 1-week or longer intervals.

Iron deficiency anemia in chronic kidney disease not on dialysis:

• Starting dose is 1 tablet orally 3 times per day with meals.
• Adjust dose as needed to achieve and maintain hemoglobin goal, up to a maximum of 12 tablets daily.

Most common adverse reactions (incidence ≥5%) are discolored feces, diarrhea, constipation, nausea, vomiting, cough, abdominal pain, and hyperkalemia.

Ferric Citrate is contraindicated in patients with iron overload syndromes.

Iron absorption from Ferric Citrate may lead to excessive elevations in iron stores. Increases in serum ferritin and transferrin saturation (TSAT) levels were observed in clinical trials. In a 56-week safety and efficacy trial evaluating the control of serum phosphate levels in patients with chronic kidney disease on dialysis in which concomitant use of intravenous iron was permitted, 55 (19%) of patients treated with Ferric Citrate had a ferritin level >1500 ng/mL as compared with 13 (9%) of patients treated with active control. Assess iron parameters (e.g., serum ferritin and TSAT) prior to initiating Ferric Citrate and monitor iron parameters while on therapy. Patients receiving intravenous iron may require a reduction in dose or discontinuation of intravenous iron therapy.

When clinically significant drug interactions are expected, consider separation of the timing of administration. Consider monitoring clinical responses or blood levels of the concomitant medication.

There are no available data on Ferric Citrate use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. There are no human data regarding the effect of Ferric Citrate in human milk, the effects on the breastfed child, or the effects on milk production.

Pediatric Use: The safety and efficacy of Ferric Citrate have not been established in pediatric patients.

Geriatric Use: Clinical studies of Ferric Citrate included 292 subjects aged 65 years and older (104 subjects aged 75 years and older). Overall, the clinical study experience has not identified any obvious differences in responses between the elderly and younger patients in the tolerability or efficacy of Ferric Citrate.

No data are available regarding overdose of Ferric Citrate in patients. In patients with chronic kidney disease, the maximum dose studied was 2,520 mg ferric iron (12 tablets of Ferric Citrate) per day. Iron absorption from Ferric Citrate may lead to excessive elevations in iron stores, especially when concomitant intravenous iron is used.

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

This preparation is indicated in the following cases:

• To relieve discomfort in urinary tract infections
• To prevent kidney stone
• With uricosuric agent to prevent gout
• Acidosis caused by kidney diseases

Prevention of repeated kidney stone formation, Urinary Alkalinizing Agent

Potassium Citrate and Citric Acid oral solution is a stable and pleasant-tasting oral systemic alkalizer. Potassium Citrate is absorbed and metabolized to Potassium Bicarbonate, thus acting as a systemic alkalizer. This product alkalinizes the urine without producing a systemic alkalosis in recommended doses. It is highly palatable, pleasant tasting and tolerable, even when administered for long periods. Potassium Citrate does not neutralize the gastric juice or disturb digestion.

To relieve discomfort in UTI:

• Adults and children over 6 years: 10 ml 3 times daily, diluted with 1 glass of water.
• Children 1-6 years: 5 ml 3 times daily, diluted with ½ glass of water.

To prevent kidney stones, With a uricosuric agent to prevent gout, Acidosis caused by kidney diseases:

• Adults: 10-15 ml 4 times daily (or as directed by the physician) diluted with 1 glass of water.
• Pediatric: 5-10 ml 4 times daily (or as directed by the physician) diluted with ½ glass of water.

This solution is generally well tolerated without any unpleasant side effect when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of hyperkalemia or alkalosis. Potassium intoxication causes listlessness, weakness, mental confusion, tingling of extremities and other symptoms associated with a high concentration of Potassium in the serum.

The drug is contraindicated in severe renal impairment with oliguria or azotemia, untreated Addison's disease, acute dehydration, severe myocardial damage and hyperkalemia from any cause.

The solution should be used with caution in patients with low urinary output. It should be diluted adequately with water to minimize the possibility of gastrointestinal injury associated with the oral ingestion of concentrated Potassium salt preparations; and preferably, to take each dose after meals. Large doses may cause hyperkalemia and alkalosis, especially in the presence of renal disease.

Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors or cardiac glycosides may lead to toxicity.

No information is available regarding the use of this drug during pregnancy and lactation.

The administration of oral Potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, hyperkalemia can result. Hyperkalemia, when detected, must be treated immediately because lethal levels can be reached in a few hours. If hyperkalemia occurs, treatment measures will include the followings: (1) Elimination of foods or medications containing potassium. (2) The intravenous administration of 300 to 500 ml/hr of dextrose solution (10 to 25%), containing 10 units of insulin/20 gm dextrose. (3) The use of exchange resins, hemodialysis or peritoneal dialysis.

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

Calcitriol & Calcium combination is indicated for Osteoporosis, Hypoparathyroidism, Hypocalcaemia, Osteomalacia rickets, Renal osteodystrophy.

Specific mineral & vitamin combined preparations

Calcium salt can be used in the prevention and treatment of calcium deficiency states or negative calcium balance. It is also used as an adjunct in the prevention and treatment of osteoporosis.

Calcitriol promotes calcium absorption in the intestines and retention at the kidneys thus increasing serum calcium levels. It also increases renal tubule phosphate resorption consequently decreasing serum phosphatase levels, PTH levels and bone resorption.

Hyperparathyroidism in renal failure: 0.25 mcg/day or alternate day. May increase slowly.

Hypoparathyroidism or pseudohypoparathyroidism: 0.5-2 mcg once daily.

Vitamin D dependent rickets: 0.015-0.02 mcg/kg/day. Maintenance: 0.03-0.06 mcg/kg/day. Max: 2 mcg/day.

Hyperparathyroidism in dialysis patients: 0.5-4 mcg 3 times/wk. Max: 8 mcg 3 times/wk.

Hyperparathyroidism in renal failure: 0.5 mcg 3 times/wk, may increase by 0.25-0.5 mcg at 2-4 wk intervals. Maintenance: 0.5-3 mcg 3 times/wk.

Weakness; headache; somnolence; nausea; vomiting; dry mouth; constipation; muscle pain; bone pain; metallic taste; polyuria; polydipsia; anorexia; irritability; weight loss; nocturia; mild acidosis; reversible azotemia; generalized vascular calcification; nephrocalcinosis; conjunctivitis (calcific); pancreatitis; photophobia; rhinorrhoea; pruritus; hyperthermia; decreased libido; elevated BUN; albuminuria; hypercholesterolaemia; elevated AST and ALT; ectopic calcification; hypertension; cardiac arrhythmias.

Hypercalcaemia; evidence of vitamin D toxicity, pregnancy & lactation.

Idiopathic hypercalcaemia. Pediatric doses must be individualised and monitored under close medical supervision. Coronary disease, renal function impairment and arteriosclerosis, especially in the elderly. Hypoparathyroidism.

Calcium: Co-administration with thiazide diuretics or vit D may lead to milk-alkali syndrome and hypercalcaemia. Decreased absorption with corticosteroids. Decreases absorption of tetracyclines, atenolol, iron, quinolones, alendronate, Na fluoride, Zn and calcium-channel blockers. Enhances cardiac effects of digitalis glycosides and may precipitate digitalis intoxication.

Calcitriol: Hypermagnesaemia may develop in patients on chronic renal dialysis. Hypercalcaemia in patients on digitalis may precipitate cardiac arrhythmias. Intestinal absorption of calcitriol may be reduced by cholestyramine and colestipol. Phenytoin, barbiturates may decrease the T1/2 of calcitriol. May develop hypercalcaemia with thiazide diuretics.

Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

This preparation is indicated in the following cases:

• To relieve discomfort in urinary tract infections
• To prevent kidney stone
• With uricosuric agent to prevent gout
• Acidosis caused by kidney diseases

Prevention of repeated kidney stone formation, Urinary Alkalinizing Agent

Potassium Citrate and Citric Acid oral solution is a stable and pleasant-tasting oral systemic alkalizer. Potassium Citrate is absorbed and metabolized to Potassium Bicarbonate, thus acting as a systemic alkalizer. This product alkalinizes the urine without producing a systemic alkalosis in recommended doses. It is highly palatable, pleasant tasting and tolerable, even when administered for long periods. Potassium Citrate does not neutralize the gastric juice or disturb digestion.

To relieve discomfort in UTI:

• Adults and children over 6 years: 10 ml 3 times daily, diluted with 1 glass of water.
• Children 1-6 years: 5 ml 3 times daily, diluted with ½ glass of water.

To prevent kidney stones, With a uricosuric agent to prevent gout, Acidosis caused by kidney diseases:

• Adults: 10-15 ml 4 times daily (or as directed by the physician) diluted with 1 glass of water.
• Pediatric: 5-10 ml 4 times daily (or as directed by the physician) diluted with ½ glass of water.

This solution is generally well tolerated without any unpleasant side effect when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of hyperkalemia or alkalosis. Potassium intoxication causes listlessness, weakness, mental confusion, tingling of extremities and other symptoms associated with a high concentration of Potassium in the serum.

The drug is contraindicated in severe renal impairment with oliguria or azotemia, untreated Addison's disease, acute dehydration, severe myocardial damage and hyperkalemia from any cause.

The solution should be used with caution in patients with low urinary output. It should be diluted adequately with water to minimize the possibility of gastrointestinal injury associated with the oral ingestion of concentrated Potassium salt preparations; and preferably, to take each dose after meals. Large doses may cause hyperkalemia and alkalosis, especially in the presence of renal disease.

Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors or cardiac glycosides may lead to toxicity.

No information is available regarding the use of this drug during pregnancy and lactation.

The administration of oral Potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, hyperkalemia can result. Hyperkalemia, when detected, must be treated immediately because lethal levels can be reached in a few hours. If hyperkalemia occurs, treatment measures will include the followings: (1) Elimination of foods or medications containing potassium. (2) The intravenous administration of 300 to 500 ml/hr of dextrose solution (10 to 25%), containing 10 units of insulin/20 gm dextrose. (3) The use of exchange resins, hemodialysis or peritoneal dialysis.

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

Vitamin-C Preparations

vitamin C, the water-soluble vitamin, is readily absorbed from the gastrointestinal tract and is widely distributed in the body tissues. It is believed to be involved in biological oxidations and reductions used in cellular respiration. It is essential for the synthesis of collagen and intracellular material. Vitamin C deficiency develops when the dietary intake is inadequate and when increased demand is not fulfilled. Deficiency leads to the development of well defined syndrome known as scurvy, which is characterized by capillary fragility, bleeding (especially from small blood vessels and the gums), anaemia, cartilage and bone lesions and slow healing of wounds.

Oral administration-

• For the prevention of scurvy: 1 tablet daily
• For the treatment of scurvy: 1-2 tablets daily; but dose may be increased depending on the severity of the condition.
• For the reduction of risk of stroke in the elderly: 1-2 tablets daily.
• In other cases: 1 tablet daily or as directed by the physician.
• Maximum safe dose is 2000 mg daily in divided doses.

Parenteral administration-

• Vitamin C is usually administered orally. When oral administration is not feasible or when malabsorption is suspected, the drug may be administered IM, IV, or subcutaneously. When given parenterally, utilization of the vitamin reportedly is best after IM administration and that is the preferred parenteral route.
• For intravenous injection, dilution into a large volume parenteral such as Normal Saline, Water for Injection, or Glucose is recommended to minimize the adverse reactions associated with intravenous injection.
• The average protective dose of vitamin C for adults is 70 to 150 mg daily. In the presence of scurvy, doses of 300 mg to 1 g daily are recommended. However, as much as 6 g has been administered parenterally to normal adults without evidence of toxicity.
• To enhance wound healing, doses of 300 to 500 mg daily for a week or ten days both preoperatively and postoperatively are generally considered adequate, although considerably larger amounts have been recommended. In the treatment of burns, doses are governed by the extent of tissue injury. For severe burns, daily doses of 1 to 2 g are recommended. In other conditions in which the need for vitamin C is increased, three to five times the daily optimum allowances appear to be adequate.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

Vitamin C has little toxicity and only mega-doses of vitamin C may cause diarrhoea, abdominal bloating, iron over-absorption that is harmful in patients with thalassaemia, sideroblastic anemia, and haemochromatosis; hyperoxaluria, hyperuricosuria, and hemolysis in patients with glucose-6 phosphate dehydrogenase deficiency. A pregnant woman taking more than 5 gm/day may suffer fetal abortion.

Ingestion of megadose (more than 1000 mg daily) of vitamin C during pregnancy has resulted in scurvy in neonates. Vitamin C in mega-doses has been contraindicated for patients with hyperoxaluria. Vitamin C itself is a reactive substance in the redox system and can give rise to false positive reactions in certain analytical tests for glucose, uric acid, creatine and occult blood.

Potentially hazardous interactions: Ascorbic acid is incompatible in solution with aminophylline, bleomycin, erythromycin, lactobionate, nafcillin, nitrofurantoin sodium, conjugated oestrogen, sodium bicarbonate, sulphafurazole diethanolamine, chloramphenicol sodium succinate, chlorthiazide sodium and hydrocortisone sodium succinate.

Useful interactions: Ascorbic acid increases the apparent half-life of paracetamol and enhances iron absorption from the gastrointestinal tract.

The drug is safe in normal doses in pregnant women, but a daily intake of 5 gm or more is reported to have caused abortion. The drug may be taken safely during lactation.

Should be stored in a dry place below 30˚C.

This capsule is indicated for the treatment and prophylaxis of iron, folic acid, zinc, vitamin-B complex and vitamin-C deficiency, especially during pregnancy and lactation.

Iron, Vitamin & Mineral Combined preparation

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

Use in Children & Adolescents: Upon consultation with a doctor, recommended to use in children & adolescents.

Allergic sensitization has been reported following oral administration of Folic acid. Oral iron preparation may cause constipation, particularly in older patients.

It is contraindicated in patients with a known hypersensitivity to any of the ingredients. Iron therapy is contraindicated in the presence of haemolytic anaemia.

Care should be taken in patients who may develop iron overload, such as those with hemochromatosis, hemolytic anemia or red cell aplasia. Iron chelates with tetracycline and absorption may be impaired.

Carbonyl Iron decreases the absorption of tetracycline antibiotics, quinolone antibiotics, levodopa, levothyroxine, methyldopa and penicillamine. 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 the pregnancy.

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

Store at temperature not exceeding 30°C in a dry place. Protect from moisture.

Aural steroid & antibiotic combined preparations

Dexamethasone is glucocorticoid. It has an anti-inflammatory and anti-allergic action. It is used topically in the treatment of inflammatory conditions of the anterior segment of the eye. It reduces prostaglandin synthesis by inhibiting the enzyme phospholipase A2. Also, Dexamethasone inhibits the chemotactic infiltration of neutrophils into the site of inflammation.

Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive organisms, possessing the greatest antibacterial activity of all quinolones. The bactericidal action of Ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA.

For Eye: 1 drop to be instilled into conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to 1 drop every two hours.

For Ear:

• Acute otitis media in pediatric patients with typanastomy tube: 4 drops instilled into the affected ear 2 times daily for 7 days.
• Acute otitis externa: 4 drops instilled into the affected ear 2 times daily for 7 days.

Frequency should be decreased gradually or warranted in clinical signs. Care should be taken not to discontinue therapy prematurely.

Frequently reported adverse reactions are transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, photophobia, conjunctivitis/ keratitis, Periocular/ facial edema, foreign body sensation, blurred vision, tearing, dryness, and eye pain. Elevation of IOP with development of glaucoma, and delayed wound healing may rarely occur.

Known hypersensitivity to any ingredient of the product. Herpes simplex and other viral conditions, mycosis, glaucoma, newborn babies, fungal diseases of ocular or auricular structures.

Prolonged use may result in overgrowth of nonsusceptible organisms including fungi; in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision and posterior sub capsular cataract formation. Patients wearing contact lenses must not use the drops during the time the lenses are worn.

Specific drug interaction studies have not been conducted with ophthalmic Ciprofloxacin and Dexamethasone. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effects of the oral anticoagulant warfarin and its derivatives and have been associated with transient elevations in serum creatinine in patients receiving cyclosporin concomitantly.

Use in pregnancy: This should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in lactation: It is not known whether topical administration of corticosteroids would result in sufficient systemic absorption to produce detectable quantities in human milk. It is also not known whether ciprofloxacin is excreted in human milk following topical administration. Because many drugs are excreted in human milk, caution should be exercised when the combination is administered to a nursing woman.

Use in children: Safety & effectiveness for the use of this eye drops in children below the age of one year have not been established.

Store in a cool and dry place, away from light. Keep out of reach of children. Shake well before each use.

Aural Anti-bacterial preparations, Ophthalmic antibacterial drugs

Ciprofloxacin is a synthetic broad-spectrum antimicrobial agent for intravenous administration. The bactericidal action of Ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.

Corneal ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first 6 hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill 2 drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelization has not been occurred.

Bacterial conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.

Ear infections: For all infections, 2-3 drops every 2-3 hours initially, reducing the frequency of the instillation with control of infection. Treatment should be continued at least 7 days.

Local burning or discomfort, itching, foreign body sensation, crystalline precipitates, lid margin crusting, conjunctival hyperemia and a bad taste following administration. Photophobia and nausea may be reported.

Hypersensitivity to quinolone group of antibacterials or any of the components of the formulation.

Prolonged ocular use of Ciprofloxacin may result in overgrowth of non-susceptible organisms, including fungi. Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction.

Specific drug interaction studies have not been observed with ophthalmic Ciprofloxacin.

Do not use unless the potential benefits outweigh the potential risk during pregnancy. It is not known whether excretion in human milk occurs following topical ophthalmic administration. Caution should be exercised in the nursing mothers.

Pediatric use: Safety and effectiveness in children under 1 year of age have not been established.

A topical overdose may be flushed from the eye/s with warm tap water.

Store below 30° C in a cool and dry place protected from light. Keep out of reach of children. Do not touch the dropper tip to surfaces since this may contaminate the solution. Do not use after 30 days of first opening.

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs

Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.

Tablet: Adult:

• Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
• Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
• Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
• Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
• Typhoid fever: 500 mg twice daily (7 days)
• Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
• Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
• Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
• Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
• Gonorrhea: 500 mg as a single dose
• Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
• Meningitis: 500 mg as a single dose.
• Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.

Suspension: Pediatric: 10-20 mg/kg (max. 750 mg) twice daily (10 to 21 days). The duration of therapy depends on the type and severity of the infection.

Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.

For IV infusion:

• Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
• Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
• Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
• Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
• Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
• Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.

Instruction for the use of Ciprofloxacin IV infusion-

• Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible bags in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of bag.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend bag from hanger.
• Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Ciprofloxacin IV infusion.
• Open flow control clamp to expel air from set.Close clamp.
• Regulate rate of administration with flow control clamp

Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. For acute infections the usual treatment period is 5 to 10 days. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have been disappeared.

Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.

It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.

Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.

Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.

Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.

Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.

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

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs

Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.

Tablet: Adult:

• Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
• Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
• Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
• Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
• Typhoid fever: 500 mg twice daily (7 days)
• Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
• Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
• Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
• Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
• Gonorrhea: 500 mg as a single dose
• Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
• Meningitis: 500 mg as a single dose.
• Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.

Suspension: Pediatric: 10-20 mg/kg (max. 750 mg) twice daily (10 to 21 days). The duration of therapy depends on the type and severity of the infection.

Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.

For IV infusion:

• Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
• Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
• Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
• Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
• Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
• Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.

Instruction for the use of Ciprofloxacin IV infusion-

• Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible bags in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of bag.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend bag from hanger.
• Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Ciprofloxacin IV infusion.
• Open flow control clamp to expel air from set.Close clamp.
• Regulate rate of administration with flow control clamp

Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. For acute infections the usual treatment period is 5 to 10 days. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have been disappeared.

Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.

It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.

Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.

Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.

Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.

Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.

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

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs

Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.

Tablet: Adult:

• Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
• Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
• Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
• Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
• Typhoid fever: 500 mg twice daily (7 days)
• Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
• Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
• Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
• Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
• Gonorrhea: 500 mg as a single dose
• Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
• Meningitis: 500 mg as a single dose.
• Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.

Suspension: Pediatric: 10-20 mg/kg (max. 750 mg) twice daily (10 to 21 days). The duration of therapy depends on the type and severity of the infection.

Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.

For IV infusion:

• Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
• Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
• Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
• Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
• Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
• Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.

Instruction for the use of Ciprofloxacin IV infusion-

• Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible bags in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of bag.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend bag from hanger.
• Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Ciprofloxacin IV infusion.
• Open flow control clamp to expel air from set.Close clamp.
• Regulate rate of administration with flow control clamp

Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. For acute infections the usual treatment period is 5 to 10 days. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have been disappeared.

Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.

It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.

Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.

Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.

Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.

Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.

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

It is indicated for the relief of symptoms associated with seasonal & perennial allergic rhinitis. It is also indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria and allergen induced asthma.

Sedating Anti-histamine

Cetirizine Hydrochloride is a potent H1 receptor antagonist without any significant anticholinergic and antiserotonic effects. At pharmacologically active dose levels, it has almost no drowsiness effect and does not cause behavioral changes. It inhibits the histamine-mediated early phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the late phase of the allergic reaction.

Pharmacokinetics: Cetirizine 10 mg achieves peak plasma concentrations of 257 mcg/L within one hour of administration (980 mcg/L in children). Food does not affect the extent of absorption, but it may slightly reduce the rate. Peak blood levels 0.3 micrograms/ml are reached between thirty & sixty minutes after administration of 10 mg dose of Cetirizine. Its plasma half-life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30 ml/minute and the excretion half-life is approximately nine hours.

Adults and Children 6 years and older: 1 tablet or 2 teaspoonfuls daily (or 1 teaspoonful twice daily).

Children 2-6 years: 1 teaspoonful once daily or 1/2 teaspoonful twice daily.

Children 6 months to 2 years : 1/2 teaspoonful once daily. The dose in children 12-23 months of age can be increased to a maximum dose as 1/2 teaspoonful every 12 hours.

The most common side effects that occurred more frequently on Cetirizine is somnolence.

It is contraindicated in patients with a history of hypersensitivity to Cetirizine or hydroxyzine.

Caution should be exercised when driving a car or operating a heavy machinery.

No clinically significant drug interactions have been found with Theophylline, Azithromycin, Pseudoephedrine, Ketoconazole or Erythromycin and with other drugs.

US FDA Pregnancy Category of Cetirizine Hydrochloride is B. 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. Cetirizine Hydrochloride has been shown to be excreted in human milk. So, caution should be exercised when Cetirizine Hydrochloride is administered to a nursing woman.

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

It is indicated for the relief of symptoms associated with seasonal & perennial allergic rhinitis. It is also indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria and allergen induced asthma.

Sedating Anti-histamine

Cetirizine Hydrochloride is a potent H1 receptor antagonist without any significant anticholinergic and antiserotonic effects. At pharmacologically active dose levels, it has almost no drowsiness effect and does not cause behavioral changes. It inhibits the histamine-mediated early phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the late phase of the allergic reaction.

Pharmacokinetics: Cetirizine 10 mg achieves peak plasma concentrations of 257 mcg/L within one hour of administration (980 mcg/L in children). Food does not affect the extent of absorption, but it may slightly reduce the rate. Peak blood levels 0.3 micrograms/ml are reached between thirty & sixty minutes after administration of 10 mg dose of Cetirizine. Its plasma half-life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30 ml/minute and the excretion half-life is approximately nine hours.

Adults and Children 6 years and older: 1 tablet or 2 teaspoonfuls daily (or 1 teaspoonful twice daily).

Children 2-6 years: 1 teaspoonful once daily or 1/2 teaspoonful twice daily.

Children 6 months to 2 years : 1/2 teaspoonful once daily. The dose in children 12-23 months of age can be increased to a maximum dose as 1/2 teaspoonful every 12 hours.

The most common side effects that occurred more frequently on Cetirizine is somnolence.

It is contraindicated in patients with a history of hypersensitivity to Cetirizine or hydroxyzine.

Caution should be exercised when driving a car or operating a heavy machinery.

No clinically significant drug interactions have been found with Theophylline, Azithromycin, Pseudoephedrine, Ketoconazole or Erythromycin and with other drugs.

US FDA Pregnancy Category of Cetirizine Hydrochloride is B. 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. Cetirizine Hydrochloride has been shown to be excreted in human milk. So, caution should be exercised when Cetirizine Hydrochloride is administered to a nursing woman.

Keep in a dry place away from light and heat. 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.