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Drugs for Haemolytic Hypoplastic & Renal Anemia

Epoetin beta is identical in its amino acid and carbohydrate composition to erythropoietin that has been isolated from the urine of anemic patients. Erythropoietin is a glycoprotein that stimulates the formation of erythrocytes from its committed progenitors. It acts as a mitosis-stimulating factor and differentiation hormone. Erythropoietin is a glycoprotein that, as a growth factor, primarily stimulates the formation of erythrocytes from its committed progenitors. It acts as a mitosis-stimulating factor and differentiation hormone.

Therapy with Recormon should be initiated by physicians experienced in the above- mentioned indications. As anaphylactoid reactions were observed in isolated cases, it is recommended that the first dose be administered under medical supervision. Substitution by any other biological medicinal product requires the consent of the prescribing physician.

Lyophilisate and solvent for solution for injection: The multidose preparation can be used for several patients. To avoid the risk of cross-infection, always follow aseptic techniques and use disposable sterile syringes and needles for each administration.

Solution for injection in pre-filled syringe: The Recormon pre-filled syringe is ready for use. Under no circumstances should more than one dose be administered per syringe; the medicinal product is for single use only.

Treatment of patients with anemia due to chronic kidney disease: The reconstituted solution can be administered subcutaneously or intravenously. In case of intravenous administration, the solution should be injected over approx. 2 minutes, e.g. in hemodialysis patients via the arterio-venous fistula at the end of dialysis. For non-hemodialysed patients, subcutaneous administration should always be preferred in order to avoid puncture of peripheral veins. In CKD patients, the aim of treatment is to reach a target Hb level of 10–12 g/dl. An Hb level of 12 g/dl should not be exceeded. If the rise in hemoglobin is greater than 2 g/dl (1.3 mmol/l) in 4 weeks, an appropriate dose reduction should be considered. In the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases, the weekly increase in Hb and the target Hb should be determined individually taking into account the clinical picture. Patients should be monitored closely to ensure that the lowest dose of Recormon is used to provide adequate control of the symptoms of anemia.

Rarely (≥1/10,000 to ≤1/1,000), skin reactions such as rash, pruritus, urticaria or injection site reactions may occur. In very rare cases (≤1/10,000) anaphylactoid reactions have been reported. However, in controlled clinical studies no increased incidence of hypersensitivity reactions was found. In very rare cases (≤1/10,000), particularly when starting treatment, flu-like symptoms such as fever, chills, headaches, pain in the limbs, malaise and/or bone pain have been reported. These reactions were mild or moderate in nature and subsided after a couple of hours or days.

Epoetin Beta is contraindicated in patients with:

• Known hypersensitivity to the active substance or any of the excipients.
• Poorly controlled hypertension.

In the indication "increasing the yield of autologous blood", Recormon must not be used
in patients who, in the month preceding treatment, have suffered a myocardial infarction
or stroke, patients with unstable angina pectoris, or patients who are at increased risk of
deep venous thrombosis such as those with a history of venous thromboembolic disease.

No dedicated clinical interaction studies have been performed. Clinical experience has not given evidence for potential interaction of Recormon with other medicinal products. In animal experiments epoetin did not increase the myelotoxicity of cytostatic medicinal products like etoposide, cisplatin, cyclophosphamide, and fluorouracil.

Pregnancy: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. For epoetin beta, all safety information with regard to exposure to Recormon during pregnancies has been gained from post-marketing experience. A review of the available post-marketing data does not show evidence of a causal association between harmful effects with respect to pregnancy, embryonal/fetal development or postnatal development and treatment with Recormon. However in the absence of clinical study data, caution should be exercised when prescribing to pregnant women.

Lactation: Only limited experience in human lactation has been gained. Endogeneous erythropoietin is excreted in breast milk and readily absorbed by the neonatal gastrointestinal tract. A decision on whether to continue or discontinue breastfeeding or to continue or discontinue therapy with epoetin beta should be made taking into account the benefit of breastfeeding to the child and the benefit of epoetin beta therapy to the woman.

Pediatric use: Results of pediatric clinical studies have shown that, on average, the younger the patients, the higher the Recormon doses required. Nevertheless, the recommended dosing schedule should be followed as the individual response cannot be predicted.

Geriatric use: No dedicated studies in geriatric patients were performed. A large proportion of geriatric patients were included in clinical trials with Recormon. A need for special dose adjustments in the geriatric population was not identified.

Hepatic Impairment: No dedicated clinical trials were conducted in patients with hepatic impairment. No special dosage Instructions are available.

The therapeutic range of Recormon is wide and individual response to therapy must be considered when Recormon treatment is initiated. Overdose can result in manifestations of an exaggerated pharmacodynamic effect, e.g. excessive erythropoiesis which may be associated with life-threatening complications of the cardiovascular system. In case of excessive hemoglobin levels, Recormon should be temporarily withheld. If clinically indicated, phlebotomy may be performed.

Store in a refrigerator 2°C–8°C. Keep the vial/cartridge/pre-filled syringe in the outer carton, in order to protect from light

Drugs for Haemolytic Hypoplastic & Renal Anemia

Epoetin beta is identical in its amino acid and carbohydrate composition to erythropoietin that has been isolated from the urine of anemic patients. Erythropoietin is a glycoprotein that stimulates the formation of erythrocytes from its committed progenitors. It acts as a mitosis-stimulating factor and differentiation hormone. Erythropoietin is a glycoprotein that, as a growth factor, primarily stimulates the formation of erythrocytes from its committed progenitors. It acts as a mitosis-stimulating factor and differentiation hormone.

Therapy with Recormon should be initiated by physicians experienced in the above- mentioned indications. As anaphylactoid reactions were observed in isolated cases, it is recommended that the first dose be administered under medical supervision. Substitution by any other biological medicinal product requires the consent of the prescribing physician.

Lyophilisate and solvent for solution for injection: The multidose preparation can be used for several patients. To avoid the risk of cross-infection, always follow aseptic techniques and use disposable sterile syringes and needles for each administration.

Solution for injection in pre-filled syringe: The Recormon pre-filled syringe is ready for use. Under no circumstances should more than one dose be administered per syringe; the medicinal product is for single use only.

Treatment of patients with anemia due to chronic kidney disease: The reconstituted solution can be administered subcutaneously or intravenously. In case of intravenous administration, the solution should be injected over approx. 2 minutes, e.g. in hemodialysis patients via the arterio-venous fistula at the end of dialysis. For non-hemodialysed patients, subcutaneous administration should always be preferred in order to avoid puncture of peripheral veins. In CKD patients, the aim of treatment is to reach a target Hb level of 10–12 g/dl. An Hb level of 12 g/dl should not be exceeded. If the rise in hemoglobin is greater than 2 g/dl (1.3 mmol/l) in 4 weeks, an appropriate dose reduction should be considered. In the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases, the weekly increase in Hb and the target Hb should be determined individually taking into account the clinical picture. Patients should be monitored closely to ensure that the lowest dose of Recormon is used to provide adequate control of the symptoms of anemia.

Rarely (≥1/10,000 to ≤1/1,000), skin reactions such as rash, pruritus, urticaria or injection site reactions may occur. In very rare cases (≤1/10,000) anaphylactoid reactions have been reported. However, in controlled clinical studies no increased incidence of hypersensitivity reactions was found. In very rare cases (≤1/10,000), particularly when starting treatment, flu-like symptoms such as fever, chills, headaches, pain in the limbs, malaise and/or bone pain have been reported. These reactions were mild or moderate in nature and subsided after a couple of hours or days.

Epoetin Beta is contraindicated in patients with:

• Known hypersensitivity to the active substance or any of the excipients.
• Poorly controlled hypertension.

In the indication "increasing the yield of autologous blood", Recormon must not be used
in patients who, in the month preceding treatment, have suffered a myocardial infarction
or stroke, patients with unstable angina pectoris, or patients who are at increased risk of
deep venous thrombosis such as those with a history of venous thromboembolic disease.

No dedicated clinical interaction studies have been performed. Clinical experience has not given evidence for potential interaction of Recormon with other medicinal products. In animal experiments epoetin did not increase the myelotoxicity of cytostatic medicinal products like etoposide, cisplatin, cyclophosphamide, and fluorouracil.

Pregnancy: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. For epoetin beta, all safety information with regard to exposure to Recormon during pregnancies has been gained from post-marketing experience. A review of the available post-marketing data does not show evidence of a causal association between harmful effects with respect to pregnancy, embryonal/fetal development or postnatal development and treatment with Recormon. However in the absence of clinical study data, caution should be exercised when prescribing to pregnant women.

Lactation: Only limited experience in human lactation has been gained. Endogeneous erythropoietin is excreted in breast milk and readily absorbed by the neonatal gastrointestinal tract. A decision on whether to continue or discontinue breastfeeding or to continue or discontinue therapy with epoetin beta should be made taking into account the benefit of breastfeeding to the child and the benefit of epoetin beta therapy to the woman.

Pediatric use: Results of pediatric clinical studies have shown that, on average, the younger the patients, the higher the Recormon doses required. Nevertheless, the recommended dosing schedule should be followed as the individual response cannot be predicted.

Geriatric use: No dedicated studies in geriatric patients were performed. A large proportion of geriatric patients were included in clinical trials with Recormon. A need for special dose adjustments in the geriatric population was not identified.

Hepatic Impairment: No dedicated clinical trials were conducted in patients with hepatic impairment. No special dosage Instructions are available.

The therapeutic range of Recormon is wide and individual response to therapy must be considered when Recormon treatment is initiated. Overdose can result in manifestations of an exaggerated pharmacodynamic effect, e.g. excessive erythropoiesis which may be associated with life-threatening complications of the cardiovascular system. In case of excessive hemoglobin levels, Recormon should be temporarily withheld. If clinically indicated, phlebotomy may be performed.

Store in a refrigerator 2°C–8°C. Keep the vial/cartridge/pre-filled syringe in the outer carton, in order to protect from light

Drugs for Haemolytic Hypoplastic & Renal Anemia

Epoetin beta is identical in its amino acid and carbohydrate composition to erythropoietin that has been isolated from the urine of anemic patients. Erythropoietin is a glycoprotein that stimulates the formation of erythrocytes from its committed progenitors. It acts as a mitosis-stimulating factor and differentiation hormone. Erythropoietin is a glycoprotein that, as a growth factor, primarily stimulates the formation of erythrocytes from its committed progenitors. It acts as a mitosis-stimulating factor and differentiation hormone.

Therapy with Recormon should be initiated by physicians experienced in the above- mentioned indications. As anaphylactoid reactions were observed in isolated cases, it is recommended that the first dose be administered under medical supervision. Substitution by any other biological medicinal product requires the consent of the prescribing physician.

Lyophilisate and solvent for solution for injection: The multidose preparation can be used for several patients. To avoid the risk of cross-infection, always follow aseptic techniques and use disposable sterile syringes and needles for each administration.

Solution for injection in pre-filled syringe: The Recormon pre-filled syringe is ready for use. Under no circumstances should more than one dose be administered per syringe; the medicinal product is for single use only.

Treatment of patients with anemia due to chronic kidney disease: The reconstituted solution can be administered subcutaneously or intravenously. In case of intravenous administration, the solution should be injected over approx. 2 minutes, e.g. in hemodialysis patients via the arterio-venous fistula at the end of dialysis. For non-hemodialysed patients, subcutaneous administration should always be preferred in order to avoid puncture of peripheral veins. In CKD patients, the aim of treatment is to reach a target Hb level of 10–12 g/dl. An Hb level of 12 g/dl should not be exceeded. If the rise in hemoglobin is greater than 2 g/dl (1.3 mmol/l) in 4 weeks, an appropriate dose reduction should be considered. In the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases, the weekly increase in Hb and the target Hb should be determined individually taking into account the clinical picture. Patients should be monitored closely to ensure that the lowest dose of Recormon is used to provide adequate control of the symptoms of anemia.

Rarely (≥1/10,000 to ≤1/1,000), skin reactions such as rash, pruritus, urticaria or injection site reactions may occur. In very rare cases (≤1/10,000) anaphylactoid reactions have been reported. However, in controlled clinical studies no increased incidence of hypersensitivity reactions was found. In very rare cases (≤1/10,000), particularly when starting treatment, flu-like symptoms such as fever, chills, headaches, pain in the limbs, malaise and/or bone pain have been reported. These reactions were mild or moderate in nature and subsided after a couple of hours or days.

Epoetin Beta is contraindicated in patients with:

• Known hypersensitivity to the active substance or any of the excipients.
• Poorly controlled hypertension.

In the indication "increasing the yield of autologous blood", Recormon must not be used
in patients who, in the month preceding treatment, have suffered a myocardial infarction
or stroke, patients with unstable angina pectoris, or patients who are at increased risk of
deep venous thrombosis such as those with a history of venous thromboembolic disease.

No dedicated clinical interaction studies have been performed. Clinical experience has not given evidence for potential interaction of Recormon with other medicinal products. In animal experiments epoetin did not increase the myelotoxicity of cytostatic medicinal products like etoposide, cisplatin, cyclophosphamide, and fluorouracil.

Pregnancy: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. For epoetin beta, all safety information with regard to exposure to Recormon during pregnancies has been gained from post-marketing experience. A review of the available post-marketing data does not show evidence of a causal association between harmful effects with respect to pregnancy, embryonal/fetal development or postnatal development and treatment with Recormon. However in the absence of clinical study data, caution should be exercised when prescribing to pregnant women.

Lactation: Only limited experience in human lactation has been gained. Endogeneous erythropoietin is excreted in breast milk and readily absorbed by the neonatal gastrointestinal tract. A decision on whether to continue or discontinue breastfeeding or to continue or discontinue therapy with epoetin beta should be made taking into account the benefit of breastfeeding to the child and the benefit of epoetin beta therapy to the woman.

Pediatric use: Results of pediatric clinical studies have shown that, on average, the younger the patients, the higher the Recormon doses required. Nevertheless, the recommended dosing schedule should be followed as the individual response cannot be predicted.

Geriatric use: No dedicated studies in geriatric patients were performed. A large proportion of geriatric patients were included in clinical trials with Recormon. A need for special dose adjustments in the geriatric population was not identified.

Hepatic Impairment: No dedicated clinical trials were conducted in patients with hepatic impairment. No special dosage Instructions are available.

The therapeutic range of Recormon is wide and individual response to therapy must be considered when Recormon treatment is initiated. Overdose can result in manifestations of an exaggerated pharmacodynamic effect, e.g. excessive erythropoiesis which may be associated with life-threatening complications of the cardiovascular system. In case of excessive hemoglobin levels, Recormon should be temporarily withheld. If clinically indicated, phlebotomy may be performed.

Store in a refrigerator 2°C–8°C. Keep the vial/cartridge/pre-filled syringe in the outer carton, in order to protect from light

Herbal and Nutraceuticals

Ginseng is an all-natural & clinically shown to increase body's oxygen uptake which is necessary to help make healthy energy. The pharmacological effects a) adaptogenic b) improvement of physical & mental performance. In human, some evidence suggests that ginseng can improve glycogen utilization, alcohol clearance, serum lipid level, and other metabolic parameters, which is taken as evidence of a pro-homeostasis, adaptogenic effect.

Capsule: One Panax Ginseng capsule one or two times a day or advised by the physician.
Syrup: 2 teaspoonfuls 2 times daily after meal or as directed by the registered physician.

Over Ginseng's many years of use, no serious side effects or drug interactions have been reported.

Ginseng can be taken with any other vitamin, minerals or herbal supplement. No known contraindications according to the German E Commission and World Health Organization (WHO). However, as with any supplement, consult with physician if you are taking prescription drugs.

Over stimulation and insomnia have also been reported with ginseng and anecdotal evidence suggests that excessive doses may mildly elevate blood pressure and/or cause hyper sexuality. Safety in young children or individuals with severe hepatic or renal disease is not known.

No known restrictions according to the American Herbal Products Association and the German E Commission, but controlled, long-term safety studies are lacking. In Traditional Chinese Medicine (TCM), ginseng root is included in prescriptions given during pregnancy, labor and postpartum.

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

This is indicated for the treatment and prophylaxis of Zinc, Iron, Folic Acid, B-vitamins and Vitamin-C deficiency especially during pregnancy and lactation.

Iron & Vitamin Combined preparations

Zinc sulfate precipitates protein and this is responsible for the astringent and weak antiseptic activity of Zn sulfate. It also produces mild vasodilation. Zinc sulfate can also be used orally or systemically as a zinc supplement. 220 mg of zinc sulfate (heptahydrate) contains 50 mg of elemental zinc.

Iron is an essential mineral, with several important roles in the body. For example, it helps to make red blood cells, which carry oxygen around the body. A lack of iron can lead to iron deficiency anaemia. Liver is a good source of iron, don't eat it if you are pregnant. This is because it is also rich in vitamin A which, in large amounts, can harm your unborn baby.

Folic acid is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoesis. It also promotes WBC and platelet production in folate-deficiency anaemia.

Nicotinamide is a vitamin B3 derivative. It is incorporated into coenzymes nicotinamide adenine dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate (NADP), which are involved in multiple cellular metabolic pathways.

Vitamin C is necessary for collagen formation and tissue repair; plays a role in oxidation/reduction reactions as well as other metabolic pathways including synthesis of catecholamines, carnitine, and steroids; also plays a role in conversion of folic acid to folinic acid.

Vitamin B complex: The building blocks for good health come from a variety of foods, even if they are from the same family of nutrients. Such is the case with vitamin B, a key player in maintaining cell health and keeping you energized.

Not all types of vitamin B do the same thing. Additionally, the different types of vitamin B all come from different types of foods.

Vitamin B deficiencies can lead to health problems. Sometimes a doctor will prescribe a supplement when they think you’re not getting enough.

One capsule daily. In more severe cases, 2 capsules a day may be required or as directed by the physician.

Generally well tolerated. However, a few allergic reactions may be seen.

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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

Recommended.

Accidental overdose of iron containing products is a leading cause of fatal poisoning in children below 6 years. Avoid higher doses if you have liver disease or haemochromatosis; excess can cause bloody diarrhea, vomiting, acidosis, darkened stools, abdominal pain. Symptoms may clear in a few hours.

Riboflavin is reported to be completely safe and no toxic symptoms have been reported so far. Higher doses of Nicotinamide may cause vomiting, diarrhea. Sensory neuropathy was observed in individuals consuming more than 200 mg Pyridoxine for very long periods. No case of Folic acid overdodage has been reported.

Acute ingestion of Ascorbic acid, even of massive doses, is unlikely to cause significant effects.

Zinc toxicity has been seen in both acute and chronic forms. Ingestion of 150 to 450 mg of zinc per day have been associated with low copper status, altered iron function, reduced immune function, and reduced levels of high-density lipoproteins. So, Zinc at its RDA dosages dose not cause any significant effect.

Store in a dry place below 25 °C. Protect from light.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• Osteoarthritis: The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

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

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• Osteoarthritis: The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

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

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• Osteoarthritis: The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

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

The ointment will help to relieve the symptom of pain caused by chronic anal fissures.

Drugs used in Ano-rectal region

The principal pharmacologic action of glyceryl trinitrate is mediated via the release of nitric oxide. When glyceryl trinitrate ointment is applied by the intra-anal route,the internal anal sphincter becomes relaxed.Hypertonicity of the internal but not the external anal sphincter is a predisposing factor in the formation of anal fissures.

Nitroglycerin 0.4% ointment should be inserted into the anal cavity with an applicator.The ointment must be inserted at least 1 cm into the anus.The dose is to be applied intra-anally every twelve hours. Treatment may be continued until the pain abates,up to a maximum of 8 weeks.

Headache and dizziness is a common side effect experienced with Nitroglycerin 0.4% ointment. A possible side effect is reduced control over bowel movements and leaking of bowel motions although this is expected to be a rare event.

Headache and dizziness is a common side effect experienced with Nitroglycerin 0.4% ointment. A possible side effect is reduced control over bowel movements and leaking of bowel motions although this is expected to be a rare event.

Nitroglycerin 0.4% ointment should be used with caution in patients who have severe hepatic or renal disease.It should not be used if patient suffers from severe anemia, glaucoma, hypotension, increased intracranial pressure.

The following medicines may increase the blood pressure lowering effect of glyceryl trinitrate ointment-

• Medicines for depression 
• Medicines for erectile dysfunction 
• Medicines for high blood pressure 
• Diuretics
• Commonly used tranquillizers 
• Medicines used to treat heart problems 

There are no adequate data from the use of Nitroglycerin in pregnant women. Animal studies are inconclusive with respect to effects on pregnancy embryonal/foetal parturition and postnatal development. This ointment should not be used during pregnancy. It is not known whether Nitroglycerin is excreted in human milk. Due to the potential harmful effects on the breast fed child, the use of this ointment is not recommended during breast feeding.

Pediatric Use: It is not recommended for use in children and adolescents below 18 years of age due to lack of data on safety and efficacy

Accidental overdose may result in hypotension and reflex tachycardia. Because the hypotension associated with nitroglycerin overdose is the result of venodilation and arterial hypovolaemia, prudent therapy in this situation should be directed toward increasing central fluid volume. Excessive dosage may also give rise to methaemogiobinaemia. This should be treated with methylene blue infusion.

Store below 25°C. Do not freeze. Keep all medicines out of reach of the children.

Ketorolac Tromethamine is indicated for seasonal allergic conjunctivitis and for pain and inflammation in ocular surgery. It is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.

Non opioid analgesics, Non-Opioid Analgesics

Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) chemically related to indomethacin and tolmetin. Ketorolac tromethamine is a racemic mixture of [-]S- and [+]R-enantiomeric forms, with the S-form having analgesic activity. Its antiinflammatory effects are believed to be due to inhibition of both cylooxygenase-1 (COX-1) and cylooxygenase-2 (COX-2) which leads to the inhibition of prostaglandin synthesis leading to decreased formation of precursors of prostaglandins and thromboxanes from arachidonic acid. The resultant reduction in prostaglandin synthesis and activity may be at least partially responsible for many of the adverse, as well as the therapeutic, effects of these medications. Analgesia is probably produced via a peripheral action in which blockade of pain impulse generation results from decreased prostaglandin activity. However, inhibition of the synthesis or actions of other substances that sensitize pain receptors to mechanical or chemical stimulation may also contribute to the analgesic effect. In terms of the ophthalmic applications of ketorolac - ocular administration of ketorolac reduces prostaglandin E2 levels in aqueous humor, secondary to inhibition of prostaglandin biosynthesis.

For the treatment of relief of ocular itching due to seasonal allergic conjunctivitis, one drop (0.25 mg) four times a day. For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop should be applied to the affected eye(s) four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period. It has been safely administered in conjunction with other ophthalmic medications such as antibiotics, beta blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.

Transient stinging and burning on instillation, allergic reactions, corneal edema, iritis, ocular inflammation, ocular irritation, superficial keratitis and superficial ocular infections. Corneal infiltrates, corneal ulcer, eye dryness, headaches, and visual disturbance (blurry vision)

Contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.

All topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDS and topical steroids may increase the potential for healing problems. Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs. With some nonsteroidal antiinflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues in conjunction with ocular surgery.

No information available.

Pregnancy Category C: There is no adequate and well-controlled studies in pregnant women. The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The use of drug during late pregnancy should be avoided.

Nursing Mothers: Caution should be exercised when ophthalmic solution is administered to a nursing woman.

Pediatric Use: Safety and efficacy in pediatric patients below the age of 3 have not been established.

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

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

Finasteride is indicated for the treatment of male pattern hair loss (androgenic alopecia) in men only.

Miscellaneous topical agents

Finasteride, a competitive inhibitor of steroid Type II 5α reductase, an intracellular enzyme that converts the androgen testosterone into 5α dihydrotestosterone (DHT). Finasteride is a competitive and specific inhibitor of Type II 5α reductase, an intracellular enzyme that converts the androgen testosterone into DHT. Finasteride has no affinity for the androgen receptor and has no androgenic or antiandrogenic effects. Inhibition of Type II 5α reductase blocks the conversion of testosterone to DHT, resulting in significant decreases in serum and tissue DHT concentrations. In men with male pattern hair loss, the balding scalp contains miniaturised hair follicles and increased amounts of DHT compared with hairy scalp. Administration of Finasteride decreases scalp and serum DHT concentrations in these men.

The recommended dosage is 1 mg once a day. Recur may be administered with or without meals. In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit. Withdrawal of treatment leads to reversal of effect within 12 months.

Finasteride is well tolerated. In clinical studies, the following adverse reactions were reported as possibly drug related in >1% of patients treated for 12 months with Finasteride 1 mg daily : decreased libido (1.8%), erectile dysfunction (1.3%), ejaculation disorder (1.2%) and decreased volume of ejaculate (0.8%).

Hypersensitivity to any component of this medication. Finasteride use is also contraindicated in women and paediatric patient.

Caution should be used in the administration of Recur in patients with liver function abnormalities, as Finasteride is metabolised extensively in the liver. Women who are or may potentially be pregnant should not handle crushed or broken tablets of Recur.

No drug interactions of clinical importance have been identified.

No data found

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

Iron, Vitamin & Mineral Combined preparation

Adult or Elderly: 1 capsule daily. In more severe cases, 2 capsules daily may be required.

Children: Aged over 1 year: 1 capsule daily. The capsule may be opened and the pellets to be mixed with soft cool food, but they must not be chewed.

Dark stools are usual during iron therapy and nausea and other symptoms of gastrointestinal irritation such as anorexia, vomiting, discomfort, constipation and diarrhoea are sometimes encountered. Zinc may also produce a gastrointestinal upset. These timed-release capsules are designed to reduce the possibility of gastrointestinal irritation. There have been rare reports of allergic reactions

Do not use in patients hypersensitive to the components of the product or those with iron overload.

Care should be taken in patients who may develop Iron overloads, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. Failure to respond to treatment may indicate other causes of anaemia and should be further investigated. Iron & Zinc chelate with tetracycline and absorption of all three agents may be impaired. The absorption of Zinc may be reduced in the presence of Iron. Absorption of Iron may be impaired by penicillamine and by antacids. Such potential interactions can be reduced by separating the administration of each product by several hours. In patients with renal failure a risk of Zinc accumulation could exist.

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

Iron overdosage is dangerous, particularly in children and requires immediate attention. Gastric lavage should be carried out in the early stages, or if this is not possible vomiting should be induced. These procedures should not be undertaken where signs of the corrosive effects of zinc are present. Give oral desferrioxamine (2 gm for a child or 5 gm for an adult) and demulcent. If serum Iron levels at 4 hours or more post-ingestion are over 5mg/l in a child or 8 mg/l in adults, or if the patient is in shock of coma, intravenous desferrioxamine should be used. Zinc Sulphate in gross over dosage is corrosive. Symptoms are those of gastrointestinal irritation leading in severe cases to haemorrhage, corrosion of the mucosa and possible later stricture formation. Gastric lavage or emesis should be avoided. Demulcents such as milk should be given. Chelating agents such as Dimercaprol, Penicillamine or Edetic Acid have been recommended.

Symptomatic and supportive measures should be given as required. The timed-release capsule presentation may delay excessive absorption of Iron and Zinc and allow more time for initiation of appropriate counter-measure.

Protected from light and moisture, store below 30˚C. Keep out of reach of children.

This is indicated for the treatment and prophylaxis of Zinc, Iron, Folic Acid, B-vitamins deficiency, especially during pregnancy and lactation.

Iron & Vitamin Combined preparations

This is a special preparation of Iron Polymaltose Complex, Folic Acid, Zinc, and B vitamins. Iron Polymaltose Complex is a water soluble, macromolecular complex of poly nuclear iron (III) hydroxide and partially hydrolysed dextrin (Polymaltose). It does not interact with the food components and other medications and so there is no decrease in bioavailability of Iron Polymaltose Complex. This makes sure that with the consumption of this complex, iron gets utilized at a faster rate in the haemoglobin synthesis. Folic acid prevents neural tube defects. Zinc is essential for many metabolic processes, blood formation, wound healing and for immune system. Thiamine is essential for the functioning of the nervous and digestive systems. Riboflavin is important for digestion, immune system support and energy production. Pyridoxin is important for brain development, production of red blood cells, metabolism of proteins and to reduce morning sickness. Nicotinamide is important for energy, blood pressure and circulation.

One capsule daily. In more severe cases, 2 capsules a day may be required or as directed by the physician.

Generally well tolerated. However, a few allergic reactions may be seen.

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Care should be taken in patients who may develop iron overloads, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. Iron chelates with tetracycline and absorption may be impaired.

No drug interactions have been reported.

Recommended during pregnancy & lactation.

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children below 6 years. Avoid higher doses if you have liver disease or hemochromatosis; excess can cause bloody diarrhea, vomiting, acidosis, darkened stools, abdominal pain. Symptoms may clear in a few hours. Riboflavin is reported to be completely safe and no toxic symptoms have been reported so far. Higher doses of Nicotinamide may cause vomiting, diarrhea. Sensory neuropathy was observed in individuals consuming more than 200 mg Pyridoxine for very long periods. No case of Folic acid overdose has been reported. Zinc toxicity has been seen in both acute and chronic forms. Ingestion of 150 to 450 mg of zinc per day has been associated with low copper status, altered iron function, reduced immune function, and reduced levels of high-density lipoproteins. So, Zinc at its RDA dosage does not cause any significant effect.

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

Red Clover Isoflavones is indicated for menopausal women, for the relief of menopause symptoms. It helps to relieve symptoms of menopause such as hot flushes and night sweats. It menopause related osteoporosis and bone density loss. It maintenance of cholesterol level

Herbal and Nutraceuticals

Red clover Isoflavones are a naturally occurring element with a chemical structure similar to that of steroidal estrogens. Isoflavones mimic the human bodies natural estrogen. As a result, red clover Isoflavones interact with the human estrogen receptor. Red clover Isoflavones preferentially activate the beta estrogen receptors found in the brain, bones and cardiovascular system. Red clover Isoflavones show very little activity in the alpha estrogen receptors found in breast and uterine tissue.

The recommended dosage is 1-2 capsules per day depending on body weight and on the severity of symptoms. Each Red Clover Isoflavones capsule should be taken with a meal and at approximately the same time each day

No adverse reactions are known at the recommended dosage. Animal data showed that excessive may reduce fertility

It is recommended that the diet should not be supplemented with Isoflavonoid phytoestrogens during therapy with reproductive hormones including estrogen, progestogen and androgen because of the potential risk of competitive inhibition.

Efficacy of Tamoxifen is decreased if it is used concomitantly with red clover. Caution is advised if anti-coagulants, contraceptives, estrogen and progesterone like drugs are used with red clover.

Not recommended for use during pregnancy. Isoflavones are secreted in breast milk, so use during lactation is not recommended.

The product should be stored at room temperature out of direct sunlight. Keep the medicine out of reach of children.

Frusemide & Spironolactone combination is indicated in-

• Essential hypertension
• Chronic congestive heart failure
• Hepatic cirrhosis, with collection of fluid in the abdominal cavity (ascites)
• Swelling due to excess fluid retention (edema)
• Hyperaldosteronism
• Resistant edema associated with secondary hyperaldosteronism

Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists

Spironolactone (potassium sparing diuretic) and Furosemide (loop diuretic) have different but complementary mechanisms and sites of action. Therefore, when given together they produce additive or synergistic diuretic. The Furosemide component inhibits the Na+/K+/2Cl- co-transporter in the ascending Loop of Henle and blocks the reabsorption of sodium, potassium and chloride ions; thereby increasing the quantity of sodium and the volume of water excreted in the urine. This characteristically induces potassium loss. The spironolactone component inhibits the reabsorption of sodium in exchange for potassium at the distal tubule by antagonising the action of aldosterone so that sodium excretion is greatly favoured and the excess loss of potassium, induced by the Furosemide, is reduced

Furosemide 20 and spironolactone 50 mg: 1 to 4 tablets daily (20 to 80 mg of Furosemide and 50 to 200 mg of spironolactone) according to the patient’s response.

Furosemide 40 and spironolactone 50 mg: For previously stabilized patients requiring a higher dosage of spironolactone and Furosemide, This tablet can be used at a dose of one to two tablets daily (Furosemide 40 to 80 mg and spironolactone 50 to 100 mg).

Use in children: Spironolactone and Furosemide is not suitable for use in children. Spironolactone and Furosemide may both be excreted more slowly in the elderly.

Spironolactone may give rise to headache and drowsiness and gastrointestinal distress, including cramp and diarrhoea. Ataxia, mental confusion, and skin rashes have been reported as side effect. Gynaecomastia is not uncommon and in rare cases breast enlargement may persist. Other endocrine disorders including hirsutism, deepening of the voice, menstrual irregularities and impotence. Transient increase in blood-urea-nitrogen concentrations may occur and mild acidosis has been reported. Spironolactone may cause hyponatremia and hyperkalemia. Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse with the possibility of vascular thrombosis and embolism particularly in elderly patients. Serious depletion of potassium and magnesium may lead to cardiac arrhythmias.

Contraindicated in patients with anuria, acute renal insufficiency, rapidly deteriorating or severe impairment of renal function (creatinine clearance <30 ml/min), hyperkalaemia, Addison's disease and in patients who are hypersensitive to Spironolactone, Furosemide or sulphonamides.

Caution should be taken in patients liable to electrolyte deficiency. This preparation should also be used with caution in diabetes, enlarged prostate, hypotension and in hypovolemia.

When taken together with ACE inhibitors or potassium salts there is an increased risk of hyperkalemia. Spironolactone increases the levels of cardiac glycosides such as digoxin in the blood and this may result in digitalis toxicity. Corticosteroids may cause hypokalemia if they are used with Spironolactone. The blood pressure lowering and diuretic effects of Furosemide may be reduced or abolished when used together with indomethacin and possibly other non-steroidal anti-inflammatory drugs (NSAIDs). Furosemide may increase the ototoxicity of aminoglycoside antibiotics. Simultaneous administration of sucralfate and Furosemide may reduce the natriuretic and anti-hypertensive effect of Furosemide.

Pregnancy: Spironolactone and its metabolites may cross the placental barrier. The use of spironolactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and fetus. Animal teratology studies indicate that Furosemide may cause fetal abnormalities. Therefore, Furosemide should only be used in women in child bearing age when appropriate contraceptive measures are taken or if the potential benefits justify the potential risks to the fetus.

Lactation: Metabolites of Spironolactone have been detected in breast milk. If use of Spironolactone is considered essential, an alternative method of infant feeding should be instituted. Furosemide is excreted in breast milk and breast-feeding should be discontinued if treatment is essential.

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

Frusemide & Spironolactone combination is indicated in-

• Essential hypertension
• Chronic congestive heart failure
• Hepatic cirrhosis, with collection of fluid in the abdominal cavity (ascites)
• Swelling due to excess fluid retention (edema)
• Hyperaldosteronism
• Resistant edema associated with secondary hyperaldosteronism

Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists

Spironolactone (potassium sparing diuretic) and Furosemide (loop diuretic) have different but complementary mechanisms and sites of action. Therefore, when given together they produce additive or synergistic diuretic. The Furosemide component inhibits the Na+/K+/2Cl- co-transporter in the ascending Loop of Henle and blocks the reabsorption of sodium, potassium and chloride ions; thereby increasing the quantity of sodium and the volume of water excreted in the urine. This characteristically induces potassium loss. The spironolactone component inhibits the reabsorption of sodium in exchange for potassium at the distal tubule by antagonising the action of aldosterone so that sodium excretion is greatly favoured and the excess loss of potassium, induced by the Furosemide, is reduced

Furosemide 20 and spironolactone 50 mg: 1 to 4 tablets daily (20 to 80 mg of Furosemide and 50 to 200 mg of spironolactone) according to the patient’s response.

Furosemide 40 and spironolactone 50 mg: For previously stabilized patients requiring a higher dosage of spironolactone and Furosemide, This tablet can be used at a dose of one to two tablets daily (Furosemide 40 to 80 mg and spironolactone 50 to 100 mg).

Use in children: Spironolactone and Furosemide is not suitable for use in children. Spironolactone and Furosemide may both be excreted more slowly in the elderly.

Spironolactone may give rise to headache and drowsiness and gastrointestinal distress, including cramp and diarrhoea. Ataxia, mental confusion, and skin rashes have been reported as side effect. Gynaecomastia is not uncommon and in rare cases breast enlargement may persist. Other endocrine disorders including hirsutism, deepening of the voice, menstrual irregularities and impotence. Transient increase in blood-urea-nitrogen concentrations may occur and mild acidosis has been reported. Spironolactone may cause hyponatremia and hyperkalemia. Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse with the possibility of vascular thrombosis and embolism particularly in elderly patients. Serious depletion of potassium and magnesium may lead to cardiac arrhythmias.

Contraindicated in patients with anuria, acute renal insufficiency, rapidly deteriorating or severe impairment of renal function (creatinine clearance <30 ml/min), hyperkalaemia, Addison's disease and in patients who are hypersensitive to Spironolactone, Furosemide or sulphonamides.

Caution should be taken in patients liable to electrolyte deficiency. This preparation should also be used with caution in diabetes, enlarged prostate, hypotension and in hypovolemia.

When taken together with ACE inhibitors or potassium salts there is an increased risk of hyperkalemia. Spironolactone increases the levels of cardiac glycosides such as digoxin in the blood and this may result in digitalis toxicity. Corticosteroids may cause hypokalemia if they are used with Spironolactone. The blood pressure lowering and diuretic effects of Furosemide may be reduced or abolished when used together with indomethacin and possibly other non-steroidal anti-inflammatory drugs (NSAIDs). Furosemide may increase the ototoxicity of aminoglycoside antibiotics. Simultaneous administration of sucralfate and Furosemide may reduce the natriuretic and anti-hypertensive effect of Furosemide.

Pregnancy: Spironolactone and its metabolites may cross the placental barrier. The use of spironolactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and fetus. Animal teratology studies indicate that Furosemide may cause fetal abnormalities. Therefore, Furosemide should only be used in women in child bearing age when appropriate contraceptive measures are taken or if the potential benefits justify the potential risks to the fetus.

Lactation: Metabolites of Spironolactone have been detected in breast milk. If use of Spironolactone is considered essential, an alternative method of infant feeding should be instituted. Furosemide is excreted in breast milk and breast-feeding should be discontinued if treatment is essential.

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

Vildagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus as monotherapy and in dual combination with Metformin, a Sulphonylurea, a Thiazolidinedione, or Insulin when diet, exercise and a single antidiabetic agent do not result in adequate glycemic control.

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Vildagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones. Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal. These hormones are rapidly inactivated by the enzyme, DPP-4. The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis. When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, leading to reduced hepatic glucose production. By increasing and prolonging active incretin levels, Vildagliptin increases insulin release and decreases glucagon levels in the circulation in a glucose-dependent manner.

The recommended dose of Vildagliptin is-

• 50 mg or 100 mg daily for monotherapy.
• 50 mg twice daily (morning and evening) when used in dual combination with Metformin or a Thiazolidinedione;
• 50 mg once daily in the morning when used in dual combination with a Sulphonylurea.

Vildagliptin may be taken with or without a meal. No dosage adjustment is required in the elderly, or in patients with mild renal impairment.

Pediatric use: Vildagliptin is not recommended in patients 18 years of age.

The majority of adverse reactions were mild and transient, not requiring treatment discontinuations. A rare case of hepatic dysfunction is seen. Clinical trials of up to and more than 2 years duration did not show any additional safety signals or unforeseen risks when using this combination.

Vildagliptin is contraindicated in patients with:

• Hypersensitivity to the active substance or to any of the excipients
• Patients with moderate to severe renalImpairment
• Patients with Hepatic Impairment: patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotrasferase (AST) >3 times the upper limit of normal (ULN).
• Patients with type 1 diabetes

Caution should be exercised in patients aged 75 years and older due to limited clinical experience. It is recommended that LFTs are monitored prior to initiation of Vildagliptin, at three-monthly intervals in the first year and periodically thereafter. If transaminase levels are increased, patients should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormality returns to normal. If AST or ALT persists at 3xULN, Vildagliptin treatment should be stopped. Patients who develop jaundice or other signs of liver dysfunction should discontinue Vildagliptin. Following the withdrawal of treatment with Vildagliptin and LFT normalization, treatment with Vildagliptin should not be reinitiated. Due to limited clinical experience, use with caution in patients with congestive heart failure of New York Heart Association (NYHA) functional class I-II, and do not use in patients with NYHA functional class III IV.

In pharmacokinetic studies, no interactions were seen with pioglitazone, metformin, glibenclamide, digoxin, warfarin, amlodipine, ramipril, valsartan or simvastatin. As with other oral antidiabetic medicinal products the glucose-lowering effect of Vildagliptin may be reduced by certain active substances, including thiazides, corticosteroids, thyroid products and sympathomimetics.

Vildagliptin should not be used in pregnancy. Vildagliptin should not be used during lactation.

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

This tablet is indicated as an adjunct to diet and exercises to improve glycaemic control in patients with type 2 diabetes mellitus whose diabetes is not adequately controlled on Metformin Hydrochloride or Vildagliptin alone or who are already treated with the combination of Vildagliptin and Metformin Hydrochloride, as separate tablets.

Combination Oral hypoglycemic preparations

Vildagliptin acts primarily by inhibiting DPP-4 (Dipeptidyl peptidase-4), the enzyme responsible for the degradation of the incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide). The administration of Vildagliptin results in a rapid and complete inhibition of DPP-4 activity resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 and GIP. By increasing the endogenous levels of these incretin hormones, Vildagliptin increases insulin secretion from the pancreatic beta cell and decreases glucagon secretion from alpha cell. The enhanced increase in the insulin/glucagon ratio during hyperglycaemia due to increased incretin hormone levels results in a decrease in fasting and postprandial hepatic glucose production, leading to reduced glycaemia.

Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Glucomin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.

Adults: Based on the patient's current dose of Metformin, this combination may be initiated at twice daily, 1 tablet in the morning and the other in the evening. Patients receiving Vildagliptin and Metformin from separate tablets may be switched to this combination containing the same doses of each component. Doses higher than 100 mg of vildagliptin are not recommended. There is no clinical experience of Vildagliptin and Metformin in triple combination with other antidiabetic agents. Taking this combination with or just after food may reduce gastrointestinal symptoms associated with Metformin.

The most common side effects are headache, tremor, dizziness, nausea, hypoglycaemia etc.

This combination is contraindicated in patients with known hypersensitivity to Vildagliptin or Metformin Hydrochloride or to any of the excipients. It is contraindicated in patients with renal disease or renal dysfunction, acute myocardial infarction, and septicaemia. It is also contraindicated in patients with congestive heart failure patients and in patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. It should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.

Lactic acidosis can occur due to Metformin accumulation. If metabolic acidosis is suspected, treatment should be discontinued and the patient should be hospitalized immediately. Serum creatinine should be monitored at least once a year in patients with normal renal function and 2–4 times a year in patients with serum creatinine levels at the upper limit of normal and in elderly patients. Special caution should be exercised in elderly patients where renal function may become impaired (e.g. when initiating antihypertensives, diuretics or NSAIDs). It is recommended that Liver Function Tests (LFTs) are monitored prior to initiation of this drug, at three-monthly intervals in the first year and periodically thereafter. If transaminase levels are increased, patients should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormality return to normal. If AST or ALT persist at 3 x ULN, Vildagliptin & Metformin tablets should be stopped Patients who develop jaundice or other signs of liver dysfunction. Following withdrawal of treatment with Vildagliptin & Metformin and LFT normalization, treatment with Vildagliptin & Metformin should not be reinitiated. Vildagliptin & Metformin tablets should be discontinued 48 hours before elective surgery with general anaesthesia and should not usually be resumed earlier than 48 hours afterwards.

No clinically relevant pharmacokinetic interaction was observed when Vildagliptin (100 mg once daily) was co-administered with Metformin Hydrochloride (1,000 mg once daily). Vildagliptin has a low potential for drug interactions. Since Vildagliptin is not a cytochrome P (CYP) 450 enzyme substrate nor does it inhibit nor induces CYP 450 enzymes, it is not likely to interact with co-medications that are substrates, inhibitors or inducers of these enzymes. As a result of these studies no clinically relevant interactions with other oral antidiabetics (glibenclamide, pioglitazone, metformin hydrochloride), amlodipine, digoxin, ramipril, simvastatin, valsartan or warfarin were observed after co-administration with vildagliptin. On the other hand, furosemide, nifedipine and glyburide increase Cmax and blood AUC of Metformin with no change in renal clearance of Metformin.

There are no adequate and well controlled studies in pregnant women and therefore, this combination should not be used during pregnancy unless the potential benefit justifies the potential risk to the foetus. No studies have been conducted with the components of this combination. As it is not known whether Vildagliptin and/or Metformin Hydrochloride is excreted in human milk this combination should not be administered to breast-feeding women.

Use in pediatric patients: The safety and effectiveness of this combination in pediatric patients have not been established. Therefore, this combination is not recommended for use in children below 18 years of age.

Use in geriatric patients: As Metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking this combination should have their renal function monitored regularly. This combination should only be used in elderly patients with normal renal function.

Patients with renal impairment: This combination should not be used in patients with renal failure or renal dysfunction, e.g. serum creatinine levels > 1.5 mg/dl (>135 micro mol/L) in males and > 1.4 mg/dl (>110 micro mol/L) in females.

Patients with hepatic impairment: This combination is not recommended in patients with hepatic impairment including patients with a pre-treatment ALT or AST >3 X the upper limit of normal.

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

This tablet is indicated as an adjunct to diet and exercises to improve glycaemic control in patients with type 2 diabetes mellitus whose diabetes is not adequately controlled on Metformin Hydrochloride or Vildagliptin alone or who are already treated with the combination of Vildagliptin and Metformin Hydrochloride, as separate tablets.

Combination Oral hypoglycemic preparations

Vildagliptin acts primarily by inhibiting DPP-4 (Dipeptidyl peptidase-4), the enzyme responsible for the degradation of the incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide). The administration of Vildagliptin results in a rapid and complete inhibition of DPP-4 activity resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 and GIP. By increasing the endogenous levels of these incretin hormones, Vildagliptin increases insulin secretion from the pancreatic beta cell and decreases glucagon secretion from alpha cell. The enhanced increase in the insulin/glucagon ratio during hyperglycaemia due to increased incretin hormone levels results in a decrease in fasting and postprandial hepatic glucose production, leading to reduced glycaemia.

Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Glucomin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.

Adults: Based on the patient's current dose of Metformin, this combination may be initiated at twice daily, 1 tablet in the morning and the other in the evening. Patients receiving Vildagliptin and Metformin from separate tablets may be switched to this combination containing the same doses of each component. Doses higher than 100 mg of vildagliptin are not recommended. There is no clinical experience of Vildagliptin and Metformin in triple combination with other antidiabetic agents. Taking this combination with or just after food may reduce gastrointestinal symptoms associated with Metformin.

The most common side effects are headache, tremor, dizziness, nausea, hypoglycaemia etc.

This combination is contraindicated in patients with known hypersensitivity to Vildagliptin or Metformin Hydrochloride or to any of the excipients. It is contraindicated in patients with renal disease or renal dysfunction, acute myocardial infarction, and septicaemia. It is also contraindicated in patients with congestive heart failure patients and in patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. It should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.

Lactic acidosis can occur due to Metformin accumulation. If metabolic acidosis is suspected, treatment should be discontinued and the patient should be hospitalized immediately. Serum creatinine should be monitored at least once a year in patients with normal renal function and 2–4 times a year in patients with serum creatinine levels at the upper limit of normal and in elderly patients. Special caution should be exercised in elderly patients where renal function may become impaired (e.g. when initiating antihypertensives, diuretics or NSAIDs). It is recommended that Liver Function Tests (LFTs) are monitored prior to initiation of this drug, at three-monthly intervals in the first year and periodically thereafter. If transaminase levels are increased, patients should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormality return to normal. If AST or ALT persist at 3 x ULN, Vildagliptin & Metformin tablets should be stopped Patients who develop jaundice or other signs of liver dysfunction. Following withdrawal of treatment with Vildagliptin & Metformin and LFT normalization, treatment with Vildagliptin & Metformin should not be reinitiated. Vildagliptin & Metformin tablets should be discontinued 48 hours before elective surgery with general anaesthesia and should not usually be resumed earlier than 48 hours afterwards.

No clinically relevant pharmacokinetic interaction was observed when Vildagliptin (100 mg once daily) was co-administered with Metformin Hydrochloride (1,000 mg once daily). Vildagliptin has a low potential for drug interactions. Since Vildagliptin is not a cytochrome P (CYP) 450 enzyme substrate nor does it inhibit nor induces CYP 450 enzymes, it is not likely to interact with co-medications that are substrates, inhibitors or inducers of these enzymes. As a result of these studies no clinically relevant interactions with other oral antidiabetics (glibenclamide, pioglitazone, metformin hydrochloride), amlodipine, digoxin, ramipril, simvastatin, valsartan or warfarin were observed after co-administration with vildagliptin. On the other hand, furosemide, nifedipine and glyburide increase Cmax and blood AUC of Metformin with no change in renal clearance of Metformin.

There are no adequate and well controlled studies in pregnant women and therefore, this combination should not be used during pregnancy unless the potential benefit justifies the potential risk to the foetus. No studies have been conducted with the components of this combination. As it is not known whether Vildagliptin and/or Metformin Hydrochloride is excreted in human milk this combination should not be administered to breast-feeding women.

Use in pediatric patients: The safety and effectiveness of this combination in pediatric patients have not been established. Therefore, this combination is not recommended for use in children below 18 years of age.

Use in geriatric patients: As Metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking this combination should have their renal function monitored regularly. This combination should only be used in elderly patients with normal renal function.

Patients with renal impairment: This combination should not be used in patients with renal failure or renal dysfunction, e.g. serum creatinine levels > 1.5 mg/dl (>135 micro mol/L) in males and > 1.4 mg/dl (>110 micro mol/L) in females.

Patients with hepatic impairment: This combination is not recommended in patients with hepatic impairment including patients with a pre-treatment ALT or AST >3 X the upper limit of normal.

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

This is indicated in-

• Heart burn
• Abdominal pain due to gases
• Nausea
• Flatulence
• Dyspepsia
• Constipation

Herbal and Nutraceuticals

This is a unani medicine prepared with the valuable natural ingredients, which is highly effective in heart burn, flatulence, abdominal pain due to gases, dyspepsia and constipation. It discharges the excessive gas from stomach and bowels and improves the activity of digestive system.

1 tablet twice daily or as prescribed by the physician.

No significant side effect has been observed in therapeutic dosage.

There is no known contraindication.

Keep out of reach of the children.

Store at cool & dry place, away from direct sunlight.