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Mupirocin ointment is indicated for the topical treatment of impetigo (skin diseases) due to Staphylococcus aureus and Streptococcus pyogenes. It is also indicated in folliculitis, furunculosis.

Topical Antibiotic preparations

Mupirocin is a naturally occurring antibiotic. This antibacterial agent is produced by fermentation using the organism Pseudomonas fluorescens. It is active against a wide range of bacteria (e.g. Staphylococcus aureus including methicillin-resistant strains and Streptococcus pyogenes) those responsible for the majority of skin infections. It is also active against gram-negative pathogens, such as Escherichia coli and Haemophilus influenzae. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase.

A small amount of Bactropen ointment should be applied to the affected area 3 times daily for up to 10 days. The safety and effectiveness of Mupirocin ointment have been established in the age range of 2 months to 16 years.

Reported side effects are burning, stinging or pain, itching and some patient may be suffered rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis and increased exudate.

The drug is contraindicated in individuals with a history of hypersensitivity reactions to Mupirocin or any of the components of the preparation.

Mupirocin ointment is not for ophthalmic or intra-nasal use. As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. When Mupirocin is used on the face care should be taken to avoid the eyes. This is not suitable in conjunction with cannulae and at the site of central venous cannulation. In the event of a sensitization or severe local irritation from Mupirocin ointment, usage should be discontinued and appropriate alternative therapy for the infection instituted. Mixing of Mupirocin ointment with other preparations causes risk of dilution, resulting in a reduction of the antibacterial activity and potential loss of stability of the Mupirocin in the ointment.

No drug interaction has been identified with Mupirocin ointment.

Reproduction studies on Mupirocin ointment in animals have revealed no evidence of harm to the foetus. As there is no clinical experience on it’s use during pregnancy, Mupirocin ointment should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.

It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mupirocin ointment is administered to a nursing woman.

There is currently limited data with overdose of Mupirocin ointment. In the event of overdose, the patient should be treated supportively with appropriate monitoring as necessary.

Keep below 25° C temperature, protected from light and moisture. Do not keep in freeze. Keep out of the reach of children.

Spirulina is used for the treatment and prevention of malnutrition, diabetes, arthritis, asthma, hyperglycemia, anemia, allergic rhinitis and to enhance immunity. Spirulina helps to maintain healthy eyes and skin.

Herbal and Nutraceuticals

Spirulina has such positive TTutritionafcontent that it is called the world's richest whole-food which can be found naturally. It is very high in protein with low calorie content (only coming in at 2.9 calories per gram) using this as a supplement for protein specifically this is less than % the amount of calories in protein per gram, Spirulina is the highest source of B-12, essential for healthy nerves and tissue, especially for vegetarians. Due to large amount of iron in spirulina, it helps to promote the creation of new red blood cells too. Not only does spirulina contain high protein content within it, but it also has nutrients in it which increase the body's ability to absorb protein, This means that it even makes any other protein being consumed by the person more effective than if they had just consumed the protein alone. ln this way, spirulina may even be a better source of protein than most meal. Spirulina contains a concentration of very single amino acid as well. These are amino acids that the body cannot survive without, but we cannot produce ourselves which means we have to get them through other dietary means. Spirulina contains approximately 100 nutrients and minerals. Furthermore it has fatty acids that help reduce bad cholesterol in our body and antioxidants that help strengthen our immune system, fight free radicals and slow down the aging process. It is recommended to people whose intake of nutritious food is anadequate.

How does it work-

• About 60% of spirulina dry weight is protein which is essential for growth and cell regeneration. Besides this it had sufficient vitamins and minerals within, With its high digestibility, spirulina has proven to fight malnutrition in impoverished communities by helping the body absorb nutrients when it has lost its ability to absorb normal forms of food.
• Every 10 grams of spirulina can supply up to 70% of the minimum daily requirements for iron. Being rich in iron, magnesium and trace minerals spirulina is easier to absorb than iron supplements to fight anemia effectively.
• Spirulina is rich in gamma-linolenic acid or GLA, a compound found in breast milk that helps develop healthier babies.
• Another health benefit of spirulina is that it stimulates beneficial flora like lactobacillus and bifidobacterial in our digestive tract to promote healthy digestion and proper bowel function. It acts as a natural cleanser by eliminating mercury and other deadly toxins commonly ingested by the body.

2 to 4 capsules daily or as advised by the physician.

Spirulina is generally well tolerated. Occasional diarrhea, gastrointestinal discomfort, such as nausea have been reported. Also there are few reports of allergic reactions to spirulina containing supplements.

Spirulina is contraindicated in those who are hypersensitive to any component of this product.

Before taking spirulina pregnant or breast-feeding women should talk to the physician.

There are no reports suggesting that spirulina interacts with any conventional medication.

Before taking spirulina pregnant or breast-feeding women should talk to the physician.

Store in a cool and dry place. Keep away from direct sunlight. Keep out of reach of the children.

Spirulina is used for the treatment and prevention of malnutrition, diabetes, arthritis, asthma, hyperglycemia, anemia, allergic rhinitis and to enhance immunity. Spirulina helps to maintain healthy eyes and skin.

Herbal and Nutraceuticals

Spirulina has such positive TTutritionafcontent that it is called the world's richest whole-food which can be found naturally. It is very high in protein with low calorie content (only coming in at 2.9 calories per gram) using this as a supplement for protein specifically this is less than % the amount of calories in protein per gram, Spirulina is the highest source of B-12, essential for healthy nerves and tissue, especially for vegetarians. Due to large amount of iron in spirulina, it helps to promote the creation of new red blood cells too. Not only does spirulina contain high protein content within it, but it also has nutrients in it which increase the body's ability to absorb protein, This means that it even makes any other protein being consumed by the person more effective than if they had just consumed the protein alone. ln this way, spirulina may even be a better source of protein than most meal. Spirulina contains a concentration of very single amino acid as well. These are amino acids that the body cannot survive without, but we cannot produce ourselves which means we have to get them through other dietary means. Spirulina contains approximately 100 nutrients and minerals. Furthermore it has fatty acids that help reduce bad cholesterol in our body and antioxidants that help strengthen our immune system, fight free radicals and slow down the aging process. It is recommended to people whose intake of nutritious food is anadequate.

How does it work-

• About 60% of spirulina dry weight is protein which is essential for growth and cell regeneration. Besides this it had sufficient vitamins and minerals within, With its high digestibility, spirulina has proven to fight malnutrition in impoverished communities by helping the body absorb nutrients when it has lost its ability to absorb normal forms of food.
• Every 10 grams of spirulina can supply up to 70% of the minimum daily requirements for iron. Being rich in iron, magnesium and trace minerals spirulina is easier to absorb than iron supplements to fight anemia effectively.
• Spirulina is rich in gamma-linolenic acid or GLA, a compound found in breast milk that helps develop healthier babies.
• Another health benefit of spirulina is that it stimulates beneficial flora like lactobacillus and bifidobacterial in our digestive tract to promote healthy digestion and proper bowel function. It acts as a natural cleanser by eliminating mercury and other deadly toxins commonly ingested by the body.

2 to 4 capsules daily or as advised by the physician.

Spirulina is generally well tolerated. Occasional diarrhea, gastrointestinal discomfort, such as nausea have been reported. Also there are few reports of allergic reactions to spirulina containing supplements.

Spirulina is contraindicated in those who are hypersensitive to any component of this product.

Before taking spirulina pregnant or breast-feeding women should talk to the physician.

There are no reports suggesting that spirulina interacts with any conventional medication.

Before taking spirulina pregnant or breast-feeding women should talk to the physician.

Store in a cool and dry place. Keep away from direct sunlight. Keep out of reach of the children.

Pitavastatin is indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG) and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia.

Other Anti-anginal & Anti-ischaemic drugs, Statins

Pitavastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.

The dose range for Pitavastatin is 1 to 4 mg orally once daily at any time of the day with or without food. The recommended starting dose is 2 mg and the maximum dose is 4 mg. After initiation or upon titration of Pitavastatin, lipid levels should be analyzed after 4 weeks and the dosage adjusted accordingly.

Dosage in Patients with Renal Impairment: Patients with moderate renal impairment and end–stage renal disease receiving hemodialysis should receive a starting dose of Pitavastatin 1 mg once daily and a maximum dose of Pitavastatin 2 mg once daily. Pitavastatin should not be used in patients with severe renal impairment.

Rhabdomyolysis, myopathy and Liver enzyme abnormalities.

Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including rash, pruritus and urticaria have been reported with Pitavastatin. Patients with active liver disease which may include unexplained persistent elevations of hepatic transaminase levels.

Pitavastatin should be prescribed with caution in patients with predisposing factors for myopathy. These factors include advanced age (>65 years), renal impairment, and inadequately treated hypothyroidism. Increase in serum transaminases have been reported with HMG-CoA reductase inhibitors, including Pitavastatin. In most cases, the elevations were transient and resolved or improved on continued therapy or after a brief interruption in therapy.

Cyclosporine: Co-administration of cyclosporine with Pitavastatin is contraindicated.

Erythromycin: Erythromycin significantly increased Pitavastatin exposure. In patients taking erythromycin, a dose of Pitavastatin 1 mg once daily should not be exceeded.

Rifampin: Rifampin significantly increased Pitavastatin exposure. In patients taking rifampin, a dose of Pitavastatin 2 mg once daily should not be exceeded.

Fibrates: Pitavastatin should be administered with caution when used concomitantly with gemfibrozil or other fibrates.

Warfarin: Pitavastatin had no significant pharmacokinetic interaction with warfarin.

Pregnancy Category X. Pitavastatin is contraindicated in women who are or may become pregnant. It is not known whether Pitavastatin is excreted in human milk, however, it has been shown that a small amount of another drug in this class passes into human milk.

There is no known specific treatment in the event of overdose of Pitavastatin. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Hemodialysis is unlikely to be of benefit due to high protein binding ratio of Pitavastatin.

Store in a cool and dry place, protect from light & moisture . Keep out of the reach of children.

Drugs acting on the Uterus

Uterine motility depends on the formation of the contractile protein actomyosin under the influence of the Ca²⁺ dependent phosphorylating enzyme myosin light-chain kinase. Oxytocin promotes contractions by increasing the intracellular Ca²⁺, which in turn activates myosin's light chain kinase. Oxytocin has specific receptors in the muscle lining of the uterus and the receptor concentration increases greatly during pregnancy, reaching a maximum in early labor at term.

Induction or Stimulation of Labor:

• The standard solution for infusion of Oxytocin is prepared by adding the contents of one 1ml vial containing 10 units of Oxytocin to 1000 ml of infusion fluids. The combined solution containing 10 mU (1mU=0.001U) of Oxytocin/ml is rotated in the infusion bottle for thorough mixing.
• The initial dose should be 0.5-1 mU/min (equal to 3-6 ml of the dilute Oxytocin solution per hour). At 30-60 minutes intervals the dose should be gradually increased in increments of 1-2 mU/min until the desired contraction pattern has been established. Once the desired frequency of contractions has been reached and labor has progressed to 5-6 cm dilation, the dose may be reduced by similar increments.
• At term, higher infusion rates should be given with great care and rates exceeding 9-10 mU/min are rarely required.
• Before term, when the sensitivity of the uterus is lower because of a lower concentration of Oxytocin receptors, a higher infusion rate may be required.

Control of Postpartum Uterine Bleeding:

• Intravenous Infusion (Drip Method): To control postpartum bleeding, 10 to 40 units of Oxytocin may be added to the bottle, depending on the amount of infusion fluids solution remaining (maximum 40 units to 1000 ml). Adjust infusion rate to sustain uterine contraction and control uterine atony.
• Intramuscular Administration: 1 mL (10 units) of Oxytocin can be given after the delivery of the placenta.

Treatment of Incomplete or Inevitable Abortion:

• Intravenous infusion of 10 units of Oxytocin added to 500 ml of a 0.9% sodium chloride solution may help the uterus contract after a suction or sharp curettage for an incomplete, inevitable or elective abortion.
• Subsequent to intra-amniotic injection of hypertonic saline, prostaglandins, urea etc., for mid trimester elective abortion, the injection-to-abortion time may be shortened by infusion of Oxytocin at the rate of 10 to 20 mU (20 to 40 drops) per minute. The total dose should not exceed 30 units in a 12-hour period due to the risk of water intoxication.

This drug is contraindicated in- significant cephalopelvic disproportion; unfavorable fetal positions or presentations which are undeliverable without conversion prior to delivery, e.g., transverse lies; in obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention; in cases of fetal distress where delivery is not imminent; hypertonic uterine patterns; hypersensitivity to the drug. Prolonged use in uterine inertia or severe toxemia is contraindicated. Oxytocin should not be used in cases where vaginal delivery is not indicated.

Oxytocin should not be administered in the following conditions: prematurity, borderline cephalopelvic disproportion, previous major surgery on the cervix or uterus including caesarean section, overdistention of the uterus, grand multiparity or invasive cervical carcinoma.

Severe hypertension has been reported when Oxytocin was given three to four hours following prophylactic administration of a vasoconstrictor in conjunction with caudal-block anesthesia. Cyclopropane anesthesia may modify Oxytocin’s cardiovascular effects, so as to produce unexpected results such as hypotension. Maternal sinus bradycardia with abnormal atrioventricular rhythms has also been noted when Oxytocin was used concomitantly with cyclopropane anesthesia.

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

Overdosage with Oxytocin depends essentially on uterine hyperactivity whether or not due to hypersensitivity to this agent. Hyperstimulation with strong (hypertonic) or prolonged (tetanic) contractions, or a resting tone of 15 to 20 mm H2O or more between contractions can lead to tumultuous labor, uterine rupture, cervical and vaginal lacerations, postpartum hemorrhage, utero-placental hypoperfusion, and variable deceleration of fetal heart, fetal hypoxia, hypercapnia, or death. Water intoxication with convulsions, which is caused by the inherent antidiuretic effect of Oxytocin, is a serious complication that may occur if large doses (40 to 50 mU/minute) are infused for long periods. Management consists of immediate discontinuation of Oxytocin and symptomatic and supportive therapy.

Infusion Fluids-

• 0.9% Sodium Chloride solution
• 5% Dextrose-in-water solution
• Ringer’s solution
• Hartmann’s solution (Ringer-lactate)

Store in between 2 to 8°C, in dark & frost free place. Keep out of the reach of children.

Drugs acting on the Uterus

Uterine motility depends on the formation of the contractile protein actomyosin under the influence of the Ca²⁺ dependent phosphorylating enzyme myosin light-chain kinase. Oxytocin promotes contractions by increasing the intracellular Ca²⁺, which in turn activates myosin's light chain kinase. Oxytocin has specific receptors in the muscle lining of the uterus and the receptor concentration increases greatly during pregnancy, reaching a maximum in early labor at term.

Induction or Stimulation of Labor:

• The standard solution for infusion of Oxytocin is prepared by adding the contents of one 1ml vial containing 10 units of Oxytocin to 1000 ml of infusion fluids. The combined solution containing 10 mU (1mU=0.001U) of Oxytocin/ml is rotated in the infusion bottle for thorough mixing.
• The initial dose should be 0.5-1 mU/min (equal to 3-6 ml of the dilute Oxytocin solution per hour). At 30-60 minutes intervals the dose should be gradually increased in increments of 1-2 mU/min until the desired contraction pattern has been established. Once the desired frequency of contractions has been reached and labor has progressed to 5-6 cm dilation, the dose may be reduced by similar increments.
• At term, higher infusion rates should be given with great care and rates exceeding 9-10 mU/min are rarely required.
• Before term, when the sensitivity of the uterus is lower because of a lower concentration of Oxytocin receptors, a higher infusion rate may be required.

Control of Postpartum Uterine Bleeding:

• Intravenous Infusion (Drip Method): To control postpartum bleeding, 10 to 40 units of Oxytocin may be added to the bottle, depending on the amount of infusion fluids solution remaining (maximum 40 units to 1000 ml). Adjust infusion rate to sustain uterine contraction and control uterine atony.
• Intramuscular Administration: 1 mL (10 units) of Oxytocin can be given after the delivery of the placenta.

Treatment of Incomplete or Inevitable Abortion:

• Intravenous infusion of 10 units of Oxytocin added to 500 ml of a 0.9% sodium chloride solution may help the uterus contract after a suction or sharp curettage for an incomplete, inevitable or elective abortion.
• Subsequent to intra-amniotic injection of hypertonic saline, prostaglandins, urea etc., for mid trimester elective abortion, the injection-to-abortion time may be shortened by infusion of Oxytocin at the rate of 10 to 20 mU (20 to 40 drops) per minute. The total dose should not exceed 30 units in a 12-hour period due to the risk of water intoxication.

This drug is contraindicated in- significant cephalopelvic disproportion; unfavorable fetal positions or presentations which are undeliverable without conversion prior to delivery, e.g., transverse lies; in obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention; in cases of fetal distress where delivery is not imminent; hypertonic uterine patterns; hypersensitivity to the drug. Prolonged use in uterine inertia or severe toxemia is contraindicated. Oxytocin should not be used in cases where vaginal delivery is not indicated.

Oxytocin should not be administered in the following conditions: prematurity, borderline cephalopelvic disproportion, previous major surgery on the cervix or uterus including caesarean section, overdistention of the uterus, grand multiparity or invasive cervical carcinoma.

Severe hypertension has been reported when Oxytocin was given three to four hours following prophylactic administration of a vasoconstrictor in conjunction with caudal-block anesthesia. Cyclopropane anesthesia may modify Oxytocin’s cardiovascular effects, so as to produce unexpected results such as hypotension. Maternal sinus bradycardia with abnormal atrioventricular rhythms has also been noted when Oxytocin was used concomitantly with cyclopropane anesthesia.

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

Overdosage with Oxytocin depends essentially on uterine hyperactivity whether or not due to hypersensitivity to this agent. Hyperstimulation with strong (hypertonic) or prolonged (tetanic) contractions, or a resting tone of 15 to 20 mm H2O or more between contractions can lead to tumultuous labor, uterine rupture, cervical and vaginal lacerations, postpartum hemorrhage, utero-placental hypoperfusion, and variable deceleration of fetal heart, fetal hypoxia, hypercapnia, or death. Water intoxication with convulsions, which is caused by the inherent antidiuretic effect of Oxytocin, is a serious complication that may occur if large doses (40 to 50 mU/minute) are infused for long periods. Management consists of immediate discontinuation of Oxytocin and symptomatic and supportive therapy.

Infusion Fluids-

• 0.9% Sodium Chloride solution
• 5% Dextrose-in-water solution
• Ringer’s solution
• Hartmann’s solution (Ringer-lactate)

Store in between 2 to 8°C, in dark & frost free place. Keep out of the reach of children.

Pizotifen is indicated as prophylactic treatment of vascular headache of migraine type such as classical migraine, common migraine and cluster headache. It is not effective in relieving migraine attacks once in progress.

Anti-histamine Preparations, Other drugs for migraine

Pizotifen works by inhibiting the peripheral actions of serotonin and histamine in increasing the membrane permeability of cranial vessels and transudation of plasmakinin, while altering pain thresholds in migraines. By blocking 5-HT receptors, pizotifen attenuates the signalling of serotonin in causing cranial vasoconstriction, as well as serotonin-enhanced platelet function and aggregation. There is evidence that it also inhibits the peripheral actions of bradykinin. Pizotifen may inhibit serotonin reuptake by blood platelets, which affects the tonicity and decreases passive distension of extracranial arteries. The effects of pizotifen leading to appetite stimulation may be due to the drug acting at the metabolic level rather than a direct stimulation of the appetite centre.

Adults: Usually 1.5 mg daily. This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted to the individual patient requirements up to a maximum of 4.5 mg daily. Up to 3 mg may be given as a single dose.

Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.

The most common side effects are appetite stimulating effect, increase in body weight and drowsiness.

Pizotifen is contraindicated in patients with known hypersensitivity to any of its ingredients.

Urinary retention, renal impairment should be taken in consideration. Drowsiness may affect the performance driving vehicles & operation of machineries. Pizotifen enhances the action of alcohol.

The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by Pizotifen. Pizotifen antagonizes the hypotensive effect of adrenergic neurone blockers.

Information of using Pizotifen in pregnancy is limited, although no ill effects have been reported. The drug should therefore only be given during pregnancy if the potential benefit to mother justifies the potential risk to the fetus. The safety of Pizotifen during lactation has not been established, so mothers should avoid taking it when breast feeding.

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

Pitavastatin is indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG) and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia.

Other Anti-anginal & Anti-ischaemic drugs, Statins

Pitavastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.

The dose range for Pitavastatin is 1 to 4 mg orally once daily at any time of the day with or without food. The recommended starting dose is 2 mg and the maximum dose is 4 mg. After initiation or upon titration of Pitavastatin, lipid levels should be analyzed after 4 weeks and the dosage adjusted accordingly.

Dosage in Patients with Renal Impairment: Patients with moderate renal impairment and end–stage renal disease receiving hemodialysis should receive a starting dose of Pitavastatin 1 mg once daily and a maximum dose of Pitavastatin 2 mg once daily. Pitavastatin should not be used in patients with severe renal impairment.

Rhabdomyolysis, myopathy and Liver enzyme abnormalities.

Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including rash, pruritus and urticaria have been reported with Pitavastatin. Patients with active liver disease which may include unexplained persistent elevations of hepatic transaminase levels.

Pitavastatin should be prescribed with caution in patients with predisposing factors for myopathy. These factors include advanced age (>65 years), renal impairment, and inadequately treated hypothyroidism. Increase in serum transaminases have been reported with HMG-CoA reductase inhibitors, including Pitavastatin. In most cases, the elevations were transient and resolved or improved on continued therapy or after a brief interruption in therapy.

Cyclosporine: Co-administration of cyclosporine with Pitavastatin is contraindicated.

Erythromycin: Erythromycin significantly increased Pitavastatin exposure. In patients taking erythromycin, a dose of Pitavastatin 1 mg once daily should not be exceeded.

Rifampin: Rifampin significantly increased Pitavastatin exposure. In patients taking rifampin, a dose of Pitavastatin 2 mg once daily should not be exceeded.

Fibrates: Pitavastatin should be administered with caution when used concomitantly with gemfibrozil or other fibrates.

Warfarin: Pitavastatin had no significant pharmacokinetic interaction with warfarin.

Pregnancy Category X. Pitavastatin is contraindicated in women who are or may become pregnant. It is not known whether Pitavastatin is excreted in human milk, however, it has been shown that a small amount of another drug in this class passes into human milk.

There is no known specific treatment in the event of overdose of Pitavastatin. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Hemodialysis is unlikely to be of benefit due to high protein binding ratio of Pitavastatin.

Store in a cool and dry place, protect from light & moisture . Keep out of the reach of children.

Pitavastatin is indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG) and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia.

Other Anti-anginal & Anti-ischaemic drugs, Statins

Pitavastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.

The dose range for Pitavastatin is 1 to 4 mg orally once daily at any time of the day with or without food. The recommended starting dose is 2 mg and the maximum dose is 4 mg. After initiation or upon titration of Pitavastatin, lipid levels should be analyzed after 4 weeks and the dosage adjusted accordingly.

Dosage in Patients with Renal Impairment: Patients with moderate renal impairment and end–stage renal disease receiving hemodialysis should receive a starting dose of Pitavastatin 1 mg once daily and a maximum dose of Pitavastatin 2 mg once daily. Pitavastatin should not be used in patients with severe renal impairment.

Rhabdomyolysis, myopathy and Liver enzyme abnormalities.

Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including rash, pruritus and urticaria have been reported with Pitavastatin. Patients with active liver disease which may include unexplained persistent elevations of hepatic transaminase levels.

Pitavastatin should be prescribed with caution in patients with predisposing factors for myopathy. These factors include advanced age (>65 years), renal impairment, and inadequately treated hypothyroidism. Increase in serum transaminases have been reported with HMG-CoA reductase inhibitors, including Pitavastatin. In most cases, the elevations were transient and resolved or improved on continued therapy or after a brief interruption in therapy.

Cyclosporine: Co-administration of cyclosporine with Pitavastatin is contraindicated.

Erythromycin: Erythromycin significantly increased Pitavastatin exposure. In patients taking erythromycin, a dose of Pitavastatin 1 mg once daily should not be exceeded.

Rifampin: Rifampin significantly increased Pitavastatin exposure. In patients taking rifampin, a dose of Pitavastatin 2 mg once daily should not be exceeded.

Fibrates: Pitavastatin should be administered with caution when used concomitantly with gemfibrozil or other fibrates.

Warfarin: Pitavastatin had no significant pharmacokinetic interaction with warfarin.

Pregnancy Category X. Pitavastatin is contraindicated in women who are or may become pregnant. It is not known whether Pitavastatin is excreted in human milk, however, it has been shown that a small amount of another drug in this class passes into human milk.

There is no known specific treatment in the event of overdose of Pitavastatin. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Hemodialysis is unlikely to be of benefit due to high protein binding ratio of Pitavastatin.

Store in a cool and dry place, protect from light & moisture . Keep out of the reach of children.

Pivmecillinam is indicated for treatment of infections caused by mecillinam-sensitive organisms, e.g. acute cystitis, complicated urinary tract infections, salmonellosis, shigellosis, enteropathic E. coli diarrhoea, gram-negative septicaemia, billiary infections.

Mecillinams

Pivmecillinam belongs to a new class of penicillin-the amdinopenicillin. Pivmecillinam is a prodrug formulation of mecillinam which allows the drug to be administered by mouth. The prodrug form lacks antibacterial activity, but the active drug is liberated by enzymatic hydrolysis during absorption in the gastrointestinal tract.

Pivmecillinam is bactericidal. It acts by interfering with bacterial cell wall synthesis, but the site of action differs from that of other penicilins. Pivmecillinam is very active against Enterobacteriaceae. It is active against E. coli, Klebsiella, Proteus, Enterobacter, Salmonella, Shigella and Yersinia. Pivmecillinam has poor activity against Gram- positive organisms. It has poor activity against Pseudomonas aeruginosa and has practically no activity against Enterococcus faecalis.

Adults:

• The usual dose: 1-2 tablets 3 times daily according to severity of the infection.
• In acute uncomplicated cystitis: initially 400 mg then 200 mg every 8 hours for 3 days.
• In chronic or recurrent bacteriurea: 400 mg 6-8 hours.
• For the treatment of salmonellosis (including enteric fever): 1.2-2.4 gm daily for 14 days. To eliminate salmonella carriage, therapy may be prolonged for 2-4 weeks. In complicated urinary tract infection the usual treatment time is 1-2 weeks.
• For prophylactic treatment of recurrent urinary tract infections: 1 tablet every evening is recommended.

Children:

• Weighing less than 20 kg should be given 20-60 mg/kg divided into 3-4 daily doses. Those weighing more than 20 kg should receive normal adult dose.
• In shigellosis: 20 mg/kg 4 times a day for 5 days.
• For UTI: 20-40 mg/kg/day in 3-4 divided doses
• For salmonellosis: 30-60 mg/kg/day in 3-4 divided doses

The tablet should be taken with at least 50-100 ml fluid. As the bioavailability is practically unaffected by simultaneous food intake, This tablets are best taken with or immediately after a meal.

Pivmecillinam is generally well tolerated, even by patients with reduced kidney function. Upper gastrointestinal disturbances such as nausea, vomiting and diarrhoea or indigestion may occur when a dose has been given on an empty stomach. Skin rashes have been reported in some cases, but the characteristic ampicillin-rash has never been observed, nor has there been any evidence of hepato-, nephro-, or ototoxicity. The occurrence of anaphylaxis, though not yet reported, cannot be entirely excluded.

There have been no reports on allergy to Pivmecillinam among patients with a known history of hypersensitivity to penicillins and cephalosporins. Nevertheless, it seems reasonable to exclude such patients from treatment with Pivmecillinam until further experience has been gained.

As with other antibiotics, which are excreted mainly by the kidneys, raised blood levels of mecillinam may occur if repeated doses are given with impaired renal function.

Mecillinam concentrations approximately 1/3 of the serum levels have been found in the umbilical cord, and low but detectable amounts in the amniotic fluid. So, use of pivmecillinam in pregnancy should be avoided. Mecillinam is not excreted into the milk of lactating mother

Based on information available to date for patients with impaired renal function, the initial dose can remain unchanged as can the interval between doses. However, the amount administered as the maintenance dose should be changed according to the following criteria:

• CrCl 30 ml/min or greater: full dosage
• CrCl 10-30 ml/min: 50% dosage
• CrCl <10 ml/min: 25% dosage

Use of Pivmecillinam in infants under 3 months of age should be avoided.

There is no experience with over dosage of pivmecillinam. However, excessive doses are likely to cause nausea, vomiting and gastritis. Treatment should be restricted to symptomatic and supportive measures. If necessary haemodialysis will reduce the blood level.

Store at a cool and dry place, protect from light and moisture.

Pivmecillinam is indicated for treatment of infections caused by mecillinam-sensitive organisms, e.g. acute cystitis, complicated urinary tract infections, salmonellosis, shigellosis, enteropathic E. coli diarrhoea, gram-negative septicaemia, billiary infections.

Mecillinams

Pivmecillinam belongs to a new class of penicillin-the amdinopenicillin. Pivmecillinam is a prodrug formulation of mecillinam which allows the drug to be administered by mouth. The prodrug form lacks antibacterial activity, but the active drug is liberated by enzymatic hydrolysis during absorption in the gastrointestinal tract.

Pivmecillinam is bactericidal. It acts by interfering with bacterial cell wall synthesis, but the site of action differs from that of other penicilins. Pivmecillinam is very active against Enterobacteriaceae. It is active against E. coli, Klebsiella, Proteus, Enterobacter, Salmonella, Shigella and Yersinia. Pivmecillinam has poor activity against Gram- positive organisms. It has poor activity against Pseudomonas aeruginosa and has practically no activity against Enterococcus faecalis.

Adults:

• The usual dose: 1-2 tablets 3 times daily according to severity of the infection.
• In acute uncomplicated cystitis: initially 400 mg then 200 mg every 8 hours for 3 days.
• In chronic or recurrent bacteriurea: 400 mg 6-8 hours.
• For the treatment of salmonellosis (including enteric fever): 1.2-2.4 gm daily for 14 days. To eliminate salmonella carriage, therapy may be prolonged for 2-4 weeks. In complicated urinary tract infection the usual treatment time is 1-2 weeks.
• For prophylactic treatment of recurrent urinary tract infections: 1 tablet every evening is recommended.

Children:

• Weighing less than 20 kg should be given 20-60 mg/kg divided into 3-4 daily doses. Those weighing more than 20 kg should receive normal adult dose.
• In shigellosis: 20 mg/kg 4 times a day for 5 days.
• For UTI: 20-40 mg/kg/day in 3-4 divided doses
• For salmonellosis: 30-60 mg/kg/day in 3-4 divided doses

The tablet should be taken with at least 50-100 ml fluid. As the bioavailability is practically unaffected by simultaneous food intake, This tablets are best taken with or immediately after a meal.

Pivmecillinam is generally well tolerated, even by patients with reduced kidney function. Upper gastrointestinal disturbances such as nausea, vomiting and diarrhoea or indigestion may occur when a dose has been given on an empty stomach. Skin rashes have been reported in some cases, but the characteristic ampicillin-rash has never been observed, nor has there been any evidence of hepato-, nephro-, or ototoxicity. The occurrence of anaphylaxis, though not yet reported, cannot be entirely excluded.

There have been no reports on allergy to Pivmecillinam among patients with a known history of hypersensitivity to penicillins and cephalosporins. Nevertheless, it seems reasonable to exclude such patients from treatment with Pivmecillinam until further experience has been gained.

As with other antibiotics, which are excreted mainly by the kidneys, raised blood levels of mecillinam may occur if repeated doses are given with impaired renal function.

Mecillinam concentrations approximately 1/3 of the serum levels have been found in the umbilical cord, and low but detectable amounts in the amniotic fluid. So, use of pivmecillinam in pregnancy should be avoided. Mecillinam is not excreted into the milk of lactating mother

Based on information available to date for patients with impaired renal function, the initial dose can remain unchanged as can the interval between doses. However, the amount administered as the maintenance dose should be changed according to the following criteria:

• CrCl 30 ml/min or greater: full dosage
• CrCl 10-30 ml/min: 50% dosage
• CrCl <10 ml/min: 25% dosage

Use of Pivmecillinam in infants under 3 months of age should be avoided.

There is no experience with over dosage of pivmecillinam. However, excessive doses are likely to cause nausea, vomiting and gastritis. Treatment should be restricted to symptomatic and supportive measures. If necessary haemodialysis will reduce the blood level.

Store at a cool and dry place, protect from light and moisture.

Anti-coagulants, Anti-platelet drugs, Fibrinolytics (Thrombolytics), Oral Anti-coagulants

Apixaban acts by inhibiting coagulation, and thus prevents development of blood clots. As a result of FXa inhibition, apixaban prolongs clotting tests such as prothrombin time (PT), INR, and activated partial thromboplastin time (aPTT). Changes observed in these clotting tests at the expected therapeutic dose, however, are small, subject to a high degree of variability, and not useful in monitoring the anticoagulation effect of apixaban.

Recommended Dose: The recommended dose of Apixaban for most patients is 5 mg taken orally twice daily.

Dosage Adjustments: The recommended dose of Apixaban is 2.5 mg twice daily in patients with any 2 of the following characteristics: age ≥80 years, body weight ≤60 kg, serum creatinine ≥1.5mg/dl.

CYP3A4 and P-gp inhibitors: When Apixaban is coadministered with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) (e.g. ketoconazole, itraconazole, ritonavir, clarithromycin) the recommended dose is 2.5 mg twice daily.

Missed Dose: If a dose of Apixaban is not taken at the scheduled time, the dose should be taken as soon as possible on the same day and twice-daily administration should be resumed. The dose should not be doubled to make up for a missed dose.

Discontinuation for Surgery and Other Interventions: Apixaban should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. Apixaban should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled.

Switching from or to Apixaban: Switching from warfarin to Apixaban: Warfarin should be discontinued and Apixaban started when the international normalized ratio (INR) is below 2.0.

Switching from Apixaban to warfarin: Apixaban affects INR, so that INR measurements during co-administration with warfarin may not be useful for determining the appropriate dose of warfarin. If continuous anticoagulation is necessary, discontinue Apixaban and begin both a parenteral anticoagulant and warfarin at the time the next dose of Apixaban would have been taken, discontinuing the parenteral anticoagulant when INR reaches an acceptable range.

Switching between Apixaban and anticoagulants other than warfarin: Discontinue one being taken and begin the other at the next scheduled dose.

Apixaban can cause a skin rash or severe allergic reaction.

Apixaban is contraindicated in patients with the following conditions: Active pathological bleeding. Severe hypersensitivity reaction to Apixaban (i.e. anaphylactic reactions).

Increased Risk of Stroke with Discontinuation of Apixaban Discontinuing Apixaban in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from Apixaban to warfarin in clinical trials in patients with nonvalvular atrial fibrillation. If Apixaban must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.

Apixaban is a substrate of both CYP3A4 and P-gp. Inhibitors of CYP3A4 and P-gp increase exposure to Apixaban and increase the risk of bleeding. Inducers of CYP3A4 and P-gp decrease exposure to Apixaban and increase the risk of stroke.

Pregnancy: There are no adequate and well-controlled studies of Apixaban in pregnant women. Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery. Apixaban should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus.

Labor and Delivery: Safety and effectiveness of Apixaban during labor and delivery have not been studied in clinical trials. Consider the risks of bleeding and of stroke in using Apixaban in this condition.

Nursing Mothers: It is unknown whether Apixaban or its metabolites are excreted in human milk. Women should be instructed either to discontinue breastfeeding or to discontinue Apixaban therapy, taking into account the importance of the drug to the mother.

Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. Because patients with moderate hepatic impairment may have intrinsic coagulation abnormalities and there is limited clinical experience with Apixaban in these patients, dosing recommendations cannot be provided Apixaban is not recommended in patients with severe hepatic impairment

Renal Impairment: The dosing adjustment for moderate renal impairment is described above. No data inform use in patients with creatinine clearance <15 ml/min or on dialysis.

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

Geriatric Use: Of the total subjects in clinical studies of Apixaban, >69% were 65 and older, and >31% were 75 and older. The effects of Apixaban on the risk of stroke and major bleeding compared to warfarin were maintained in geriatric subjects.

There is no antidote to Apixaban. Overdose of Apixaban increases the risk of bleeding. Activated charcoal may be useful in the management of Apixaban overdose.

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

Anti-coagulants, Anti-platelet drugs, Fibrinolytics (Thrombolytics), Oral Anti-coagulants

Apixaban acts by inhibiting coagulation, and thus prevents development of blood clots. As a result of FXa inhibition, apixaban prolongs clotting tests such as prothrombin time (PT), INR, and activated partial thromboplastin time (aPTT). Changes observed in these clotting tests at the expected therapeutic dose, however, are small, subject to a high degree of variability, and not useful in monitoring the anticoagulation effect of apixaban.

Recommended Dose: The recommended dose of Apixaban for most patients is 5 mg taken orally twice daily.

Dosage Adjustments: The recommended dose of Apixaban is 2.5 mg twice daily in patients with any 2 of the following characteristics: age ≥80 years, body weight ≤60 kg, serum creatinine ≥1.5mg/dl.

CYP3A4 and P-gp inhibitors: When Apixaban is coadministered with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) (e.g. ketoconazole, itraconazole, ritonavir, clarithromycin) the recommended dose is 2.5 mg twice daily.

Missed Dose: If a dose of Apixaban is not taken at the scheduled time, the dose should be taken as soon as possible on the same day and twice-daily administration should be resumed. The dose should not be doubled to make up for a missed dose.

Discontinuation for Surgery and Other Interventions: Apixaban should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. Apixaban should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled.

Switching from or to Apixaban: Switching from warfarin to Apixaban: Warfarin should be discontinued and Apixaban started when the international normalized ratio (INR) is below 2.0.

Switching from Apixaban to warfarin: Apixaban affects INR, so that INR measurements during co-administration with warfarin may not be useful for determining the appropriate dose of warfarin. If continuous anticoagulation is necessary, discontinue Apixaban and begin both a parenteral anticoagulant and warfarin at the time the next dose of Apixaban would have been taken, discontinuing the parenteral anticoagulant when INR reaches an acceptable range.

Switching between Apixaban and anticoagulants other than warfarin: Discontinue one being taken and begin the other at the next scheduled dose.

Apixaban can cause a skin rash or severe allergic reaction.

Apixaban is contraindicated in patients with the following conditions: Active pathological bleeding. Severe hypersensitivity reaction to Apixaban (i.e. anaphylactic reactions).

Increased Risk of Stroke with Discontinuation of Apixaban Discontinuing Apixaban in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from Apixaban to warfarin in clinical trials in patients with nonvalvular atrial fibrillation. If Apixaban must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.

Apixaban is a substrate of both CYP3A4 and P-gp. Inhibitors of CYP3A4 and P-gp increase exposure to Apixaban and increase the risk of bleeding. Inducers of CYP3A4 and P-gp decrease exposure to Apixaban and increase the risk of stroke.

Pregnancy: There are no adequate and well-controlled studies of Apixaban in pregnant women. Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery. Apixaban should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus.

Labor and Delivery: Safety and effectiveness of Apixaban during labor and delivery have not been studied in clinical trials. Consider the risks of bleeding and of stroke in using Apixaban in this condition.

Nursing Mothers: It is unknown whether Apixaban or its metabolites are excreted in human milk. Women should be instructed either to discontinue breastfeeding or to discontinue Apixaban therapy, taking into account the importance of the drug to the mother.

Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. Because patients with moderate hepatic impairment may have intrinsic coagulation abnormalities and there is limited clinical experience with Apixaban in these patients, dosing recommendations cannot be provided Apixaban is not recommended in patients with severe hepatic impairment

Renal Impairment: The dosing adjustment for moderate renal impairment is described above. No data inform use in patients with creatinine clearance <15 ml/min or on dialysis.

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

Geriatric Use: Of the total subjects in clinical studies of Apixaban, >69% were 65 and older, and >31% were 75 and older. The effects of Apixaban on the risk of stroke and major bleeding compared to warfarin were maintained in geriatric subjects.

There is no antidote to Apixaban. Overdose of Apixaban increases the risk of bleeding. Activated charcoal may be useful in the management of Apixaban overdose.

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

Anti-coagulants, Anti-platelet drugs, Fibrinolytics (Thrombolytics), Oral Anti-coagulants

Apixaban acts by inhibiting coagulation, and thus prevents development of blood clots. As a result of FXa inhibition, apixaban prolongs clotting tests such as prothrombin time (PT), INR, and activated partial thromboplastin time (aPTT). Changes observed in these clotting tests at the expected therapeutic dose, however, are small, subject to a high degree of variability, and not useful in monitoring the anticoagulation effect of apixaban.

Recommended Dose: The recommended dose of Apixaban for most patients is 5 mg taken orally twice daily.

Dosage Adjustments: The recommended dose of Apixaban is 2.5 mg twice daily in patients with any 2 of the following characteristics: age ≥80 years, body weight ≤60 kg, serum creatinine ≥1.5mg/dl.

CYP3A4 and P-gp inhibitors: When Apixaban is coadministered with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) (e.g. ketoconazole, itraconazole, ritonavir, clarithromycin) the recommended dose is 2.5 mg twice daily.

Missed Dose: If a dose of Apixaban is not taken at the scheduled time, the dose should be taken as soon as possible on the same day and twice-daily administration should be resumed. The dose should not be doubled to make up for a missed dose.

Discontinuation for Surgery and Other Interventions: Apixaban should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. Apixaban should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled.

Switching from or to Apixaban: Switching from warfarin to Apixaban: Warfarin should be discontinued and Apixaban started when the international normalized ratio (INR) is below 2.0.

Switching from Apixaban to warfarin: Apixaban affects INR, so that INR measurements during co-administration with warfarin may not be useful for determining the appropriate dose of warfarin. If continuous anticoagulation is necessary, discontinue Apixaban and begin both a parenteral anticoagulant and warfarin at the time the next dose of Apixaban would have been taken, discontinuing the parenteral anticoagulant when INR reaches an acceptable range.

Switching between Apixaban and anticoagulants other than warfarin: Discontinue one being taken and begin the other at the next scheduled dose.

Apixaban can cause a skin rash or severe allergic reaction.

Apixaban is contraindicated in patients with the following conditions: Active pathological bleeding. Severe hypersensitivity reaction to Apixaban (i.e. anaphylactic reactions).

Increased Risk of Stroke with Discontinuation of Apixaban Discontinuing Apixaban in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from Apixaban to warfarin in clinical trials in patients with nonvalvular atrial fibrillation. If Apixaban must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.

Apixaban is a substrate of both CYP3A4 and P-gp. Inhibitors of CYP3A4 and P-gp increase exposure to Apixaban and increase the risk of bleeding. Inducers of CYP3A4 and P-gp decrease exposure to Apixaban and increase the risk of stroke.

Pregnancy: There are no adequate and well-controlled studies of Apixaban in pregnant women. Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery. Apixaban should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus.

Labor and Delivery: Safety and effectiveness of Apixaban during labor and delivery have not been studied in clinical trials. Consider the risks of bleeding and of stroke in using Apixaban in this condition.

Nursing Mothers: It is unknown whether Apixaban or its metabolites are excreted in human milk. Women should be instructed either to discontinue breastfeeding or to discontinue Apixaban therapy, taking into account the importance of the drug to the mother.

Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. Because patients with moderate hepatic impairment may have intrinsic coagulation abnormalities and there is limited clinical experience with Apixaban in these patients, dosing recommendations cannot be provided Apixaban is not recommended in patients with severe hepatic impairment

Renal Impairment: The dosing adjustment for moderate renal impairment is described above. No data inform use in patients with creatinine clearance <15 ml/min or on dialysis.

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

Geriatric Use: Of the total subjects in clinical studies of Apixaban, >69% were 65 and older, and >31% were 75 and older. The effects of Apixaban on the risk of stroke and major bleeding compared to warfarin were maintained in geriatric subjects.

There is no antidote to Apixaban. Overdose of Apixaban increases the risk of bleeding. Activated charcoal may be useful in the management of Apixaban overdose.

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

Anti-coagulants, Anti-platelet drugs, Fibrinolytics (Thrombolytics), Oral Anti-coagulants

Apixaban acts by inhibiting coagulation, and thus prevents development of blood clots. As a result of FXa inhibition, apixaban prolongs clotting tests such as prothrombin time (PT), INR, and activated partial thromboplastin time (aPTT). Changes observed in these clotting tests at the expected therapeutic dose, however, are small, subject to a high degree of variability, and not useful in monitoring the anticoagulation effect of apixaban.

Recommended Dose: The recommended dose of Apixaban for most patients is 5 mg taken orally twice daily.

Dosage Adjustments: The recommended dose of Apixaban is 2.5 mg twice daily in patients with any 2 of the following characteristics: age ≥80 years, body weight ≤60 kg, serum creatinine ≥1.5mg/dl.

CYP3A4 and P-gp inhibitors: When Apixaban is coadministered with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) (e.g. ketoconazole, itraconazole, ritonavir, clarithromycin) the recommended dose is 2.5 mg twice daily.

Missed Dose: If a dose of Apixaban is not taken at the scheduled time, the dose should be taken as soon as possible on the same day and twice-daily administration should be resumed. The dose should not be doubled to make up for a missed dose.

Discontinuation for Surgery and Other Interventions: Apixaban should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. Apixaban should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled.

Switching from or to Apixaban: Switching from warfarin to Apixaban: Warfarin should be discontinued and Apixaban started when the international normalized ratio (INR) is below 2.0.

Switching from Apixaban to warfarin: Apixaban affects INR, so that INR measurements during co-administration with warfarin may not be useful for determining the appropriate dose of warfarin. If continuous anticoagulation is necessary, discontinue Apixaban and begin both a parenteral anticoagulant and warfarin at the time the next dose of Apixaban would have been taken, discontinuing the parenteral anticoagulant when INR reaches an acceptable range.

Switching between Apixaban and anticoagulants other than warfarin: Discontinue one being taken and begin the other at the next scheduled dose.

Apixaban can cause a skin rash or severe allergic reaction.

Apixaban is contraindicated in patients with the following conditions: Active pathological bleeding. Severe hypersensitivity reaction to Apixaban (i.e. anaphylactic reactions).

Increased Risk of Stroke with Discontinuation of Apixaban Discontinuing Apixaban in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from Apixaban to warfarin in clinical trials in patients with nonvalvular atrial fibrillation. If Apixaban must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.

Apixaban is a substrate of both CYP3A4 and P-gp. Inhibitors of CYP3A4 and P-gp increase exposure to Apixaban and increase the risk of bleeding. Inducers of CYP3A4 and P-gp decrease exposure to Apixaban and increase the risk of stroke.

Pregnancy: There are no adequate and well-controlled studies of Apixaban in pregnant women. Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery. Apixaban should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus.

Labor and Delivery: Safety and effectiveness of Apixaban during labor and delivery have not been studied in clinical trials. Consider the risks of bleeding and of stroke in using Apixaban in this condition.

Nursing Mothers: It is unknown whether Apixaban or its metabolites are excreted in human milk. Women should be instructed either to discontinue breastfeeding or to discontinue Apixaban therapy, taking into account the importance of the drug to the mother.

Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. Because patients with moderate hepatic impairment may have intrinsic coagulation abnormalities and there is limited clinical experience with Apixaban in these patients, dosing recommendations cannot be provided Apixaban is not recommended in patients with severe hepatic impairment

Renal Impairment: The dosing adjustment for moderate renal impairment is described above. No data inform use in patients with creatinine clearance <15 ml/min or on dialysis.

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

Geriatric Use: Of the total subjects in clinical studies of Apixaban, >69% were 65 and older, and >31% were 75 and older. The effects of Apixaban on the risk of stroke and major bleeding compared to warfarin were maintained in geriatric subjects.

There is no antidote to Apixaban. Overdose of Apixaban increases the risk of bleeding. Activated charcoal may be useful in the management of Apixaban overdose.

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

Sulfonylureas

Glipizide lowers blood glucose by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells. The extrapancreatic effects of Glipizide are increase in insulin sensitivity and decrease in hepatic glucose production.

Like any other oral hypoglycaemic agent, dosage of Glipizide is not fixed and may be adjusted through periodic monitoring of blood glucose level. Short term administration of Glipizide may be sufficient during periods of transient loss of control of blood glucose in patients, usually controlled well on diet.

In general, Glipizide should be given approximately 30 minutes before a meal to achieve the maximum reduction in postprandial hyperglycaemia.

• Initial dose: The recommended starting dose is 5 mg, given before breakfast. Geriatric patients or those with liver disease may be started on 2.5 mg.
• Dosage adjustments: Dosage adjustment may be done at intervals of several days by an increment of 2.5-5 mg, as determined by blood glucose response. If response to a single dose is not satisfactory, dividing that dose might prove effective. The maximum recommended once daily dose is 15 mg. Doses above 15 mg should ordinarily be divided and given before meals of adequate calorie content. The maximum recommended total daily dose is 40 mg.
• Maintenance: Some patients may be effectively controlled on a once daily regimen, while others show better response with divided dosing. Total daily dose above 30 mg have been safely given on bid basis to long term patients. Patients can usually be stabilized on a dosage ranging from 2.5 to 30 mg daily.

In elderly, debilitated or malnourished patients, and patients with impaired renal or hepatic function: The initial and maintenance dosing should be conservative to avoid hypoglycaemic reactions.

Patients receiving insulin: Many stable non-insulin-dependent diabetic patients receiving Insulin may be safely placed on Glipizide if the physician decides to do so.

Patients receiving other oral hypoglycaemic agents: As with other sulphonylurea, no transition period is necessary while transferring patients to Glipizide. Patients should be observed carefully for any possible hypoglycaemic effect due to overlapping of drug effects.

Pediatric Use: Safety and effectiveness in children have not been established.

The majority of side effects have been dose related, transient, and responded to dose reduction or withdrawal of the medication.

Gastrointestinal: Gastrointestinal complaints were reported with the following approximate incidences like nausea, diarrhoea, constipation and gastralgia. They appear to be dose related and usually disappear on division or reduction of dosage. Cholestatic jaundice may occur rarely with these kind of drugs and Glipizide should be discontinued if this occurs.

Dermatological: Allergic skin reactions including erythema, morbilliform or maculopapular eruption, urticaria, pruritus and eczema have been reported. They frequently disappear with continued therapy. However, if they persist, the drug should be discontinued.

Haematologic: Leucopenia, agranulocytosis, thrombocytopenia, haemolytic anaemia, aplastic anaemia and pancytopenia have been reported with sulphonylureas.

Metabolic: Hepatic porphyria and disulphiram like reactions have been reported with sulphonylurea.

Endocrine reactions: Cases of hyponatraemia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported with this and other sulphonylureas.

Miscellaneous: Dizziness, drowsiness and headache have been reported in patients treated with Glipizide. They are usually transient and seldom require discontinuation of therapy.

Glipizide is contraindicated in the following conditions :

• Patients who are hypersensitive to Glipizide or any component of the product
• Juvenile onset diabetes
• Severe or unstable ‘brittle’ diabetes
• Diabetes complicated by ketosis and acidosis, major surgery, severe sepsis or severe trauma
• Severe renal, hepatic or thyroid impairment, co-existent renal and hepatic disease

Hypoglycaemia: All sulphonylurea drugs are capable of producing severe hypoglycaemia. Proper patient selection, dosage and instructions are important to avoid hypoglycaemic episodes. Renal or hepatic insufficiency may cause elevated blood levels of Glipizide and the latter may also diminis gluconeogenic capacity, both of which increase the risk of serious hypoglycaemic reactions. Elderly, debilitated or malnourished patients and those with adrenal or pituitary insufficiency are particularly susceptible to the hypoglycaemic actions of glucose lowering drugs. Patients should be instructed to take their meals regularly and not to exercise excessively without additional calorie intake.

Renal and hepatic disease: The metabolism and excretion of Glipizide may be slowed in patients with impaired renal and/or hepatic function. These patients may suffer from prolonged hypoglycaemia and appropriate measures should be instituted.

Loss of control on blood glucose: When a patient stabilized on any antidiabetic regimen is exposed to stress such as fever, trauma, infection or surgery, a loss of control on blood glucose may occur. At that time it may be necessary to discontinue Glipizide and administer Insulin.

The effectiveness of any oral hypoglycaemic drug including Glipizide, in lowering blood glucose to a desired level, decreases in many patients over a period of time, which may be due to secondary failure, i.e., progression of the severity of the diabetes or diminished responsiveness to the drug.

The hypoglycaemic action of sulphonylurea may be potentiated by certain drugs including non-steroidal anti inflammatory agents and other drugs that are highly protein bound e.g., Salicylates, Sulphonamides, Chloramphenicol, Probenecid, Coumarins, Monoamine Oxidase Inhibitors, and β adrenergic blocking agents. When such drugs are administered to a patient receiving Glipizide, the patients should be observed closely for hypoglycaemia. When such drugs are withdrawn from a patient receiving Glipizide, the patient should be observed closely for loss of control on blood glucose.

Certain drugs tend to produce hyperglycaemia and may lead to loss of control on blood glucose. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, oestrogens, oral contraceptives, Phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs and Isoniazid. When such drugs are administered to or withdrawn from a patient receiving Glipizide, the patient should be closely observed for loss of control on blood glucose. Diabetic control may be altered also in patients treated with cyclophosphamide.

Pregnancy: Glipizide should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Prolonged severe hypoglycaemia (4-10 days) has been reported in neonates born to mothers who were receiving sulphonylurea (e.g., Glipizide) at the time of delivery. So, if Glipizide is used during pregnancy, it should be discontinued at least one month before the expected delivery date.

Lactation: Although it is not known whether Glipizide is excreted in human milk, some sulphonylurea drugs are known to be so. Breast feeding is not therefore recommended while taking this medication.

The tablets should be protected from moisture and humidity and stored at room temperature (below 30&deg; C).

Pizotifen is indicated as prophylactic treatment of vascular headache of migraine type such as classical migraine, common migraine and cluster headache. It is not effective in relieving migraine attacks once in progress.

Anti-histamine Preparations, Other drugs for migraine

Pizotifen works by inhibiting the peripheral actions of serotonin and histamine in increasing the membrane permeability of cranial vessels and transudation of plasmakinin, while altering pain thresholds in migraines. By blocking 5-HT receptors, pizotifen attenuates the signalling of serotonin in causing cranial vasoconstriction, as well as serotonin-enhanced platelet function and aggregation. There is evidence that it also inhibits the peripheral actions of bradykinin. Pizotifen may inhibit serotonin reuptake by blood platelets, which affects the tonicity and decreases passive distension of extracranial arteries. The effects of pizotifen leading to appetite stimulation may be due to the drug acting at the metabolic level rather than a direct stimulation of the appetite centre.

Adults: Usually 1.5 mg daily. This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted to the individual patient requirements up to a maximum of 4.5 mg daily. Up to 3 mg may be given as a single dose.

Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.

The most common side effects are appetite stimulating effect, increase in body weight and drowsiness.

Pizotifen is contraindicated in patients with known hypersensitivity to any of its ingredients.

Urinary retention, renal impairment should be taken in consideration. Drowsiness may affect the performance driving vehicles & operation of machineries. Pizotifen enhances the action of alcohol.

The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by Pizotifen. Pizotifen antagonizes the hypotensive effect of adrenergic neurone blockers.

Information of using Pizotifen in pregnancy is limited, although no ill effects have been reported. The drug should therefore only be given during pregnancy if the potential benefit to mother justifies the potential risk to the fetus. The safety of Pizotifen during lactation has not been established, so mothers should avoid taking it when breast feeding.

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

Pizotifen is indicated as prophylactic treatment of vascular headache of migraine type such as classical migraine, common migraine and cluster headache. It is not effective in relieving migraine attacks once in progress.

Anti-histamine Preparations, Other drugs for migraine

Pizotifen works by inhibiting the peripheral actions of serotonin and histamine in increasing the membrane permeability of cranial vessels and transudation of plasmakinin, while altering pain thresholds in migraines. By blocking 5-HT receptors, pizotifen attenuates the signalling of serotonin in causing cranial vasoconstriction, as well as serotonin-enhanced platelet function and aggregation. There is evidence that it also inhibits the peripheral actions of bradykinin. Pizotifen may inhibit serotonin reuptake by blood platelets, which affects the tonicity and decreases passive distension of extracranial arteries. The effects of pizotifen leading to appetite stimulation may be due to the drug acting at the metabolic level rather than a direct stimulation of the appetite centre.

Adults: Usually 1.5 mg daily. This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted to the individual patient requirements up to a maximum of 4.5 mg daily. Up to 3 mg may be given as a single dose.

Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.

The most common side effects are appetite stimulating effect, increase in body weight and drowsiness.

Pizotifen is contraindicated in patients with known hypersensitivity to any of its ingredients.

Urinary retention, renal impairment should be taken in consideration. Drowsiness may affect the performance driving vehicles & operation of machineries. Pizotifen enhances the action of alcohol.

The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by Pizotifen. Pizotifen antagonizes the hypotensive effect of adrenergic neurone blockers.

Information of using Pizotifen in pregnancy is limited, although no ill effects have been reported. The drug should therefore only be given during pregnancy if the potential benefit to mother justifies the potential risk to the fetus. The safety of Pizotifen during lactation has not been established, so mothers should avoid taking it when breast feeding.

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

Pizotifen is indicated as prophylactic treatment of vascular headache of migraine type such as classical migraine, common migraine and cluster headache. It is not effective in relieving migraine attacks once in progress.

Anti-histamine Preparations, Other drugs for migraine

Pizotifen works by inhibiting the peripheral actions of serotonin and histamine in increasing the membrane permeability of cranial vessels and transudation of plasmakinin, while altering pain thresholds in migraines. By blocking 5-HT receptors, pizotifen attenuates the signalling of serotonin in causing cranial vasoconstriction, as well as serotonin-enhanced platelet function and aggregation. There is evidence that it also inhibits the peripheral actions of bradykinin. Pizotifen may inhibit serotonin reuptake by blood platelets, which affects the tonicity and decreases passive distension of extracranial arteries. The effects of pizotifen leading to appetite stimulation may be due to the drug acting at the metabolic level rather than a direct stimulation of the appetite centre.

Adults: Usually 1.5 mg daily. This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted to the individual patient requirements up to a maximum of 4.5 mg daily. Up to 3 mg may be given as a single dose.

Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.

The most common side effects are appetite stimulating effect, increase in body weight and drowsiness.

Pizotifen is contraindicated in patients with known hypersensitivity to any of its ingredients.

Urinary retention, renal impairment should be taken in consideration. Drowsiness may affect the performance driving vehicles & operation of machineries. Pizotifen enhances the action of alcohol.

The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by Pizotifen. Pizotifen antagonizes the hypotensive effect of adrenergic neurone blockers.

Information of using Pizotifen in pregnancy is limited, although no ill effects have been reported. The drug should therefore only be given during pregnancy if the potential benefit to mother justifies the potential risk to the fetus. The safety of Pizotifen during lactation has not been established, so mothers should avoid taking it when breast feeding.

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

Pizotifen is indicated as prophylactic treatment of vascular headache of migraine type such as classical migraine, common migraine and cluster headache. It is not effective in relieving migraine attacks once in progress.

Anti-histamine Preparations, Other drugs for migraine

Pizotifen works by inhibiting the peripheral actions of serotonin and histamine in increasing the membrane permeability of cranial vessels and transudation of plasmakinin, while altering pain thresholds in migraines. By blocking 5-HT receptors, pizotifen attenuates the signalling of serotonin in causing cranial vasoconstriction, as well as serotonin-enhanced platelet function and aggregation. There is evidence that it also inhibits the peripheral actions of bradykinin. Pizotifen may inhibit serotonin reuptake by blood platelets, which affects the tonicity and decreases passive distension of extracranial arteries. The effects of pizotifen leading to appetite stimulation may be due to the drug acting at the metabolic level rather than a direct stimulation of the appetite centre.

Adults: Usually 1.5 mg daily. This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted to the individual patient requirements up to a maximum of 4.5 mg daily. Up to 3 mg may be given as a single dose.

Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.

The most common side effects are appetite stimulating effect, increase in body weight and drowsiness.

Pizotifen is contraindicated in patients with known hypersensitivity to any of its ingredients.

Urinary retention, renal impairment should be taken in consideration. Drowsiness may affect the performance driving vehicles & operation of machineries. Pizotifen enhances the action of alcohol.

The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by Pizotifen. Pizotifen antagonizes the hypotensive effect of adrenergic neurone blockers.

Information of using Pizotifen in pregnancy is limited, although no ill effects have been reported. The drug should therefore only be given during pregnancy if the potential benefit to mother justifies the potential risk to the fetus. The safety of Pizotifen during lactation has not been established, so mothers should avoid taking it when breast feeding.

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