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Protear
Povidone Iodine
Protear
Povidone Iodine
Indications
Secondarily infected dermatoses
Indication detailsView
Cream or ointment:
Therapeutically: As an adjunct to systemic therapy in the following indications-
Powder: It is used for topical application in the following indications: Superficial wounds, Minor cuts, Burns, Abrasions, Lacerations, In the treatment and prevention of infections.
Ophthalmic Solution: Povidone is used for the symptomatic treatment of dry eye conditions including keratoconjunctivitis sicca. It is also given as a substitute for tear fluid in case of the unstable tear film or insufficient moistening of the eye surface.
Therapeutically: As an adjunct to systemic therapy in the following indications-
- Primary or secondary topical infections
- Infected surgical incisions
- Infected decubitus or stasis ulcers
- Pyodermas
- Secondarily infected dermatoses
- Infected traumatic lesions
- To prevent microbial contaminations in burns, incisions and other topical lesions
- For degerming skin in hyperalimentation, the umbilical area or circumcision
- Its use for abrasions, minor cuts, and wounds prevents the development of infections and permits wound healing.
- For the prevention and treatment of surface infections as well as to degerm the skin, mucous membrane and hyperalimentation procedures
- For seborrhea
- For preoperative and postoperative scrubbing and washing of hospital operating room and equipments
- For preoperative prepping of operative site, including the vagina
- For disinfection of wounds, burns, lacerations and abrasions
- As a prophylactic anti-infective agent in house, hospital & office procedures
- Postoperative application to incisions to help prevent infection
- In oral moniliasis (thrush); bacterial and mycotic skin infections, decubitus & stasis ulcers
- As a preoperative swab in the mouth & throat
- For the treatment of acute mucosal infections of the mouth and pharynx.
- For oral hygiene prior to, during and after dental and oral surgery.
Powder: It is used for topical application in the following indications: Superficial wounds, Minor cuts, Burns, Abrasions, Lacerations, In the treatment and prevention of infections.
Ophthalmic Solution: Povidone is used for the symptomatic treatment of dry eye conditions including keratoconjunctivitis sicca. It is also given as a substitute for tear fluid in case of the unstable tear film or insufficient moistening of the eye surface.
Therapeutic classView
Iodine compounds (Anti-septic Preparations)
PharmacologyView
Povidone Iodine is a complex of iodine and an organic polymer, povidone. This polymerization makes Povidone Iodine superior to ordinary elemental iodine. It prolongs the germicidal activity of iodine by liberating elemental iodine slowly. Consequently it has a lower toxicity than elemental iodine. It gives rapid microbicidal activity against both Gram-positive and Gram-negative bacteria, protozoa, viruses and fungi/yeasts. It is also sporicidal. It is the only microbicide with this broad spectrum of activity. It is non-staining, exerts prolong germicidal action and is also active in the presence of soap, blood, serum, pus, mucosal secretions and water.
DosageView
Cream or ointment:
Gargle & Mouthwash: Adults and children over 6 years of age: Use undiluted or diluted with an equal volume of warm water. Gargle or rinse with up to 10 mL for up to 30 seconds without swallowing. Repeat up to four times daily, for up to 14 consecutive days, or as advised by the Registered Dental Surgeon/Physician.
Surgical Scrub:
Ophthalmic Solution: 1 drop 4 times daily or as required, depending upon the severity of the disease, to be instilled into the conjunctival sac.
- For the treatment of infection: Apply once or twice daily or at dressing changes for a maximum of 14 days.
- For the prevention of infection: Apply once or twice a week for as long as necessary. The affected skin should be cleaned and dried and can be covered with a dressing or bandage.
Gargle & Mouthwash: Adults and children over 6 years of age: Use undiluted or diluted with an equal volume of warm water. Gargle or rinse with up to 10 mL for up to 30 seconds without swallowing. Repeat up to four times daily, for up to 14 consecutive days, or as advised by the Registered Dental Surgeon/Physician.
Surgical Scrub:
- For Preoperative and Postoperative washing by Operating Personnel: Wet hands and forearms with water. Pour about 5 mL of Povidone Iodine Surgical Scrub on the palm of the hand and spread over both hands and forearms. Without adding more water, rub the Scrub thoroughly over all areas for about five minutes. Use a brush if desired. Clean thoroughly under fingernails. Add a little water and develop copious suds. Rinse thoroughly under running water. Complete the wash by scrubbing with another 5 mL of Povidone Iodine Surgical Scrub in the same way.
- For Preoperative use on Patients: After the skin area is shaved, wet it with water. Apply Povidone Iodine Surgical Scrub (1 mL is sufficient to cover an area of 20-30 square inches), develop lather and scrub thoroughly for about five minutes. Rinse off by aid of sterile gauze saturated with water.
- For use in the Physician's Office: Use for washing whenever a germicidal soap is required.
Ophthalmic Solution: 1 drop 4 times daily or as required, depending upon the severity of the disease, to be instilled into the conjunctival sac.
Side effectsView
Povidone Iodine may cause hypersensitivity reactions and irritation of the skin and mucous membranes. The application of povidone Iodine to severe burns or to large areas otherwise denuded of skin may produce systemic adverse effects such as metabolic acidosis, hypernatraemia, and impairment of renal function. It may interfere with thyroid function tests.
ContraindicationsView
It can cause hypersensitivity reactions. Regular use in patients with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis) or those receiving lithium therapy is to be avoided. In severely burnt patients serum iodide levels should be assessed due to possible hepatic and renal impairment. Povidone Iodine Powder should not be used in serious cavities and in Children under the age of 2 years.
PrecautionsView
Cream or ointment: In case of deep or puncture wounds or serious burns, consult Registered Physician. If redness, irritation, swelling or pain persists or increases or if infection occurs, discontinue use and consult Registered Physician.
Solution: In preoperative prepping, avoid 'pooling' beneath the patient. Prolonged exposure to wet solution may cause irritation or rarely, severe skin reactions. In case of deep or puncture wounds or serious burns, consult Registered Physician. If redness, irritation, swelling or pain persists or increases or if infection occurs, discontinue use and consult Registered Physician.
Gargle & Mouthwash: Regular use should be avoided as prolonged use may lead to the absorption of a significant amount of iodine. Do not use for more than 14 days. If sores or ulcers in the mouth do not heal within 14 days seek dental or medical advice. It is also not for use in children under 6 years of age. Regular use should be avoided in patients on concurrent lithium therapy.
Surgical Scrub: Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency. Regular use should be avoided in patients on concurrent lithium therapy. It can permanently discolor white gold jewellery and it is recommended that this type of jewellery should be removed before using this product.
Powder: Care must be taken when used on known iodine sensitivity, although do not normally react to Povidone-Iodine. Excess powder can be washed off readily with warm water. It should be used directly from the container. Not to be administered internally.
Ophthalmic Solution: Patients, who experience blurred vision after application of the eye drops, should not drive or use machinery until their vision has cleared. Contact lenses should not be worn during the instillation of the drug. After instillation, there should be an interval of at least 30 minutes before reinsertion.
Solution: In preoperative prepping, avoid 'pooling' beneath the patient. Prolonged exposure to wet solution may cause irritation or rarely, severe skin reactions. In case of deep or puncture wounds or serious burns, consult Registered Physician. If redness, irritation, swelling or pain persists or increases or if infection occurs, discontinue use and consult Registered Physician.
Gargle & Mouthwash: Regular use should be avoided as prolonged use may lead to the absorption of a significant amount of iodine. Do not use for more than 14 days. If sores or ulcers in the mouth do not heal within 14 days seek dental or medical advice. It is also not for use in children under 6 years of age. Regular use should be avoided in patients on concurrent lithium therapy.
Surgical Scrub: Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency. Regular use should be avoided in patients on concurrent lithium therapy. It can permanently discolor white gold jewellery and it is recommended that this type of jewellery should be removed before using this product.
Powder: Care must be taken when used on known iodine sensitivity, although do not normally react to Povidone-Iodine. Excess powder can be washed off readily with warm water. It should be used directly from the container. Not to be administered internally.
Ophthalmic Solution: Patients, who experience blurred vision after application of the eye drops, should not drive or use machinery until their vision has cleared. Contact lenses should not be worn during the instillation of the drug. After instillation, there should be an interval of at least 30 minutes before reinsertion.
InteractionsView
It exhibits interaction with strong alkali, sodium thiosulphate, sodium metabisulphite and thiomersal. Use with concurrent lithium therapy has been shown to exhibithypothyroidic effect.
Pregnancy & lactationView
Povidone Iodine Cream, Solution & Powder are not recommended for use during pregnancy because of the possibility of absorption of sufficient iodine to affect the fetal thyroid. American Academy of Pediatrics considers that the use of Povidone-Iodine is usually compatible with breast feeding. Consult Registered Physician. Regular use of Gargle & Mouthwash and Surgical Scrub should also be avoided in pregnant and lactating women.
There is no experience regarding the safety of the Povidone eye drops in human pregnancy or lactation. Administration during pregnancy and lactation is therefore not recommended, except for compelling reasons.
There is no experience regarding the safety of the Povidone eye drops in human pregnancy or lactation. Administration during pregnancy and lactation is therefore not recommended, except for compelling reasons.
StorageView
Store below 25°C. Do not freeze. Store in a cool and dry place, protected from light. Keep out of the reach of children. Do not touch the ophthalmic solution dropper tip to any surface as this may contaminate this preparation. Do not use it after one month of the first opening.
Protebon
Calcium Carbonate
Protebon
Calcium Carbonate
Indication detailsView
250 mg or 500 mg tablet: This is used for the treatment or prevention of calcium depletion in patients in whom dietary measures are inadequate. Conditions that may be associated with calcium deficiency include hypoparathyroidism, achlorhydria, chronic diarrhea, vitamin D deficiency, steatorrhea, sprue, pregnancy and lactation, menopause, pancreatitis, renal failure, alkalosis, and hyperphosphataemia. Calcium Carbonate is being used increasingly often to treat hyperphosphataemia in chronic renal failure as well as those on continuous ambulatory peritoneal dialysis (CAPD) and haemodialysis. Many patients are unable to tolerate sufficient doses for complete phosphate control and require additional measures such as stringent dietary phosphate restriction or relatively small doses of aluminium hydroxide. Calcium Carbonate containing preparations can provide short-term relief of dyspeptic systems but are no longer recommended for long-term treatment of peptic ulceration.
1000 mg tablet: This is indicated for the management of conditions associated with hyperidity and for fast relief of acid indigestion, heartburn, sour stomach and upset stomach.
1000 mg tablet: This is indicated for the management of conditions associated with hyperidity and for fast relief of acid indigestion, heartburn, sour stomach and upset stomach.
Therapeutic classView
Minerals in bone formation, Specific mineral preparations
PharmacologyView
Calcium carbonate reacts with gastric acid to produce a salt and water. For calcium carbonate the postulated chemical reaction is: CaCO3+2HCl = CaCl2+H2O+CO2. Two grams of calcium carbonate will readily bring 100 ml of hydrochloric acid to a pH above 6. The increase in gastric pH diminishes the activity of pepsin in the gastric secretion. Up to 30% of the oral calcium load may be absorbed.
DosageView
250 mg or 500 mg tablet: Calcium Carbonate is always used orally and when used as an antacid the recommended doses for adults are equivalent to 540-2000 mg Calcium Carbonate per day, doses for children being half of those for adults. As a dietary supplement, such as for the prevention of osteoporosis, 1250-3750 mg Calcium Carbonate (500-1500 mg calcium) daily is recommended in general, but again this will need to be tailored to the individual patient depending on any specific disease such as Calcium deficiency, malabsorption or parathyroid function. In pregnancy and lactation the recommended daily dose of calcium is 1200-1500 mg. In chronic renal failure the doses used vary from 2.5-9.0 gm Calcium Carbonate per day and need to be adjusted according to the individual patient. To maximize effective phosphate binding in this context the Calcium Carbonate should be given with meals.
1000 mg tablet: 2000-3000 mg tablet when symptoms occur; may be repeated hourly if needed or as directed by the physician.
1000 mg tablet: 2000-3000 mg tablet when symptoms occur; may be repeated hourly if needed or as directed by the physician.
Side effectsView
Orally administered Calcium Carbonate may be irritating to the GI tract. It may also cause constipation. Hypercalcaemia is rarely produced by administration of calcium alone, but may occur when large doses are given to patients with chronic renal failure.
ContraindicationsView
- Hypercalcaemia and hyperparathyroidism
- Hypercalciuria and nephrolithiasis
- Zollinger-Ellison syndrome
- Concomitant digoxin therapy (requires careful monitoring of serum calcium level)
InteractionsView
Calcium Carbonate may enhance the cardiac effects of digoxin and other cardiac glycosides, if systemic hypercalcaemia occurs. Calcium Carbonate may interfere with the absorption of concomitantly administered tetracycline preparations and in chronic renal failure modification of vitamin D therapy may be required to avoid hypercalcaemia when Calcium Carbonate is used as the primary phosphate binder.
Pregnancy & lactationView
Calcium containing drugs have been widely used in pregnancy by way of oral calcium supplementation or antacid therapy. Calcium Carbonate can be used in lactating women too.
Pediatric usageView
Use in children: Calcium carbonate has been extensively studied in children and infants with chronic renal failure and is both safe and effective.
Use in elderly: In case of elderly patients with renal failure when calcium carbonate is taken constipation may be troublesome one for this group. For this reason, monitoring of serum calcium and phosphate is of course indicated for elderly patients.
Use in elderly: In case of elderly patients with renal failure when calcium carbonate is taken constipation may be troublesome one for this group. For this reason, monitoring of serum calcium and phosphate is of course indicated for elderly patients.
StorageView
Store in a cool, dry place in controlled room temperature.
Protebon-D
Calcium Carbonate [Elemental source] + Vitamin D3
Protebon-D
Calcium Carbonate [Elemental source] + Vitamin D3
Indications
Rickets
Indication detailsView
This combination is used for treatment of osteoporosis, osteomalacia, rickets, tetany and in parathyroid disease. Calcium supplements are often used to ensure adequate dietary intake in conditions such as pregnancy & lactation, osteogenesis and tooth formation (adjunct with definite treatment) and therapy with anti-seizure medications. It is also used as routine supplement and phosphate binder in chronic renal failure.
Therapeutic classView
Specific mineral & vitamin combined preparations
PharmacologyView
This is the preparation of Calcium Carbonate and Vitamin D3 (Cholecalciferol). Calcium is necessary for many normal functions of our body, especially bone formation and maintenance. Vitamin D3 helps for the absorption & reabsorption of Calcium. Vitamin D3 also stimulates bone formation. Clinical studies showed that Calcium and Vitamin D3 all together helps in bone growth, and in prevention of osteoporosis & bone fracture.
DosageView
Calcium 500 mg and Vitamin D3 200 IU Tablet: 2 tablets daily or 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.
Calcium 500 mg and Vitamin D3 400 IU Tablet: 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.
Calcium 500 mg and Vitamin D3 400 IU Tablet: 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.
Side effectsView
It is generally well tolerated. If there is experience like nausea, vomiting, stomach cramps, dry mouth, increased thirst, increased urination while taking, noticed to physicians. Constipation may occur.
ContraindicationsView
It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.
PrecautionsView
If there is any pre-existing heart disease or kidney disease, precautions should be taken.
InteractionsView
It has possible interaction with calcium, aluminium or magnesium containing antacids & other calcium supplements, calcitriol & other vitamin D3 supplements; digoxin, tetracycline, doxycycline, minocycline or oxytetracycline.
Pregnancy & lactationView
This combination should be used as directed by physician during pregnancy or while breast-feeding.
Overdose effectsView
Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache, constipation.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Protebon-M
Calcium Carbonate + Vitamin D3 + Multimineral
Protebon-M
Calcium Carbonate + Vitamin D3 + Multimineral
Indications
Vitamin deficiency
Indication detailsView
This preparation is indicated in-
- Prevention and treatment of osteoporosis
- To maintain strong bone growth
- For proper functioning of heart, muscle and nerves
- As nutritional supplement
- For bone development and regeneration of bone
- Pregnancy & lactation
- Deficiency state of Calcium, Vitamin D3, Magnesium, Zinc, Copper, Manganese & Boron
Therapeutic classView
Specific mineral & vitamin combined preparations
PharmacologyView
Nutrition is the most important to prevent osteoporosis and other bone related diseases. Calcium, Magnesium & Vitamin D3 are the macronutrients for bone. Without Vitamin D3 very little Calcium is absorbed. Like Calcium, Magnesium increases bone strength and rigidity. Recent epidemiological studies showed that some micronutrients like Copper, Manganese, Zinc & Boron play an important role in bone health. Deficiency of the micronutrients is noticed in patients with osteoporosis.
DosageView
2 tablets per day, preferably 1 tablet in the morning and 1 tablet in the evening.
Side effectsView
It is generally well tolerated. If there is experience like nausea, vomiting, stomach cramps, dry mouth, increased thirst, increased urination while taking, noticed to physicians. Side effects from micronutrient are rare.
ContraindicationsView
It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.
PrecautionsView
If there is any pre-existing heart disease or kidney disease, precautions should be taken.
InteractionsView
It has possible interaction with Calcium, Aluminium or Magnesium containing Antacids & other Calcium supplements, Calcitriol & other Vitamin D3 supplements; Digoxin, Tetracycline, Doxycycline, Minocycline or Oxytetracycline.
Pregnancy & lactationView
This combination should be used as directed by physician during pregnancy or while breast-feeding.
Overdose effectsView
Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache & constipation.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Protebon-P
Calcium Orotate
Protebon-P
Calcium Orotate
Indications
Calcium suppliment
Indication detailsView
This medication is used to prevent or treat low blood calcium levels in people who do not get enough calcium from their diets. To fulfill the calcium deficiency or meet extra need of calcium, it may be used in conditions like osteoporosis osteomalacia, rickets, latent tetany, postmenopausal osteoporosis, senile osteoporosis, juvenile osteoporosis, drug (phenytoin, phenobarbital, or prednisone) induced osteoporosis, pregnancy and lactation, premenstrual syndrome (PMS), hypoparathyroidism and hip joint plastic surgery.
Calcium Orotate acts against a number of inflammatory diseases like arthritis, psoriasis, lupus, spondylitis, various cardiovascular ailments, encephalitis, retinitis, phlebitis, colitis, and multiple sclerosis. Calcium Orotate helps in controlling weight by suppressing the habit of frequent appetite of chronic overeaters. It is also beneficial in reducing the effects of mood swings and is proved to be quite effective in cognitive enhancement. Calcium Orotate protects the heart by enhancing the efficiency of cardiac muscles. Recent studies on calcium orotate indicate its potential to minimize the risk of colon cancer.
Calcium Orotate acts against a number of inflammatory diseases like arthritis, psoriasis, lupus, spondylitis, various cardiovascular ailments, encephalitis, retinitis, phlebitis, colitis, and multiple sclerosis. Calcium Orotate helps in controlling weight by suppressing the habit of frequent appetite of chronic overeaters. It is also beneficial in reducing the effects of mood swings and is proved to be quite effective in cognitive enhancement. Calcium Orotate protects the heart by enhancing the efficiency of cardiac muscles. Recent studies on calcium orotate indicate its potential to minimize the risk of colon cancer.
Therapeutic classView
Minerals in bone formation, Specific mineral preparations
PharmacologyView
This contains Calcium Orotate, a calcium supplement with a functional amino acid chelating ligand- orotic acid. Orotic acid assists the transport of calcium through cellular membrane structures, thus facilitating the intracellular uptake of calcium, particularly in bone. Calcium Orotate also helps in the maintenance of healthy cartilage. Furthermore, Orotate is involved in the synthesis of DNA (deoxyribonucleic acid) and RNA (ribonucleic acid) of the various calcium supplements on the market, Calcium Orotate gets high marks because of the compound's ability to penetrate complex cell membranes so that it can be metabolized in cartilage.
DosageView
Calcium Orotate 400 mg: As an addition to the daily diet, 2-3 tablets are usually recommended with meal or as directed by a physician.
Calcium Orotate 740 mg: As an addition to the daily diet, 1-2 tablets are usually recommended with meal or as directed by a physician.
Calcium Orotate 740 mg: As an addition to the daily diet, 1-2 tablets are usually recommended with meal or as directed by a physician.
Side effectsView
Bloating and swelling in the abdomen are common side effects of Calcium Orotate. Loss of appetite, upset stomach, constipation, nausea, vomiting, unusual weight loss, increased thirst/urination, weakness, unusual tiredness, formation of kidney stones may occur infrequently.
ContraindicationsView
Calcium Orotate is contraindicated in conditions like incomplete or infrequent bowel movements, kidney stone, kidney disease, increased activity of the parathyroid gland, high amount of Calcium in urine, high amount of Calcium in the blood, extreme loss of body water.
PrecautionsView
Before taking Calcium Orotate, precaution is needed if the patient is allergic to Calcium Orotate. This drug may contain inactive ingredients, which can cause allergic reactions or other problems. Precaution is needed before using this drug in kidney disease, kidney stones, little or no stomach acid (achlorhydria), heart disease, disease of the pancreas, sarcoidosis difficulty absorbing nutrition from food (malabsorption syndrome).
InteractionsView
Calcium can decrease absorption of the following drugs when taken together: biphosphonates (e.g., alendronate), quinolone antibiotics (e.g., ciprofloxacin, levofloxacin), and tetracycline antibiotics (e.g., doxycycline, minocycline), levothyroxine, phenytoin (an anticonvulsant), and tiludronate disodium (to treat Paget's disease). Thiazide-type diuretics can interact with Calcium supplements, increasing the risks of hypercalcemia and hypercalciuria. Both aluminum- and magnesium-containing antacids increase urinary calcium excretion. Mineral oil and stimulant laxatives decrease calcium absorption. Glucocorticoids, such as prednisone, can cause calcium depletion and eventually osteoporosis when they are used for months. Oral contraceptives as well as estrogen compounds reduce calcium. Anti-inflammatories such as NSAIDs, Aspirin, Ibuprofen deplete calcium. Corticosteroids deplete calcium.
Pregnancy & lactationView
Women who are pregnant and breast-feeding need more calcium. Pregnancy related high blood pressure is a common and serious risk for women and their babies, and taking supplemental forms of Calcium Orotate can help to reduce this risk.
StorageView
Keep out of the reach of children. Keep in a cool & dry place. Protect from light.
Protebon-P
Calcium Orotate
Protebon-P
Calcium Orotate
Indications
Calcium suppliment
Indication detailsView
This medication is used to prevent or treat low blood calcium levels in people who do not get enough calcium from their diets. To fulfill the calcium deficiency or meet extra need of calcium, it may be used in conditions like osteoporosis osteomalacia, rickets, latent tetany, postmenopausal osteoporosis, senile osteoporosis, juvenile osteoporosis, drug (phenytoin, phenobarbital, or prednisone) induced osteoporosis, pregnancy and lactation, premenstrual syndrome (PMS), hypoparathyroidism and hip joint plastic surgery.
Calcium Orotate acts against a number of inflammatory diseases like arthritis, psoriasis, lupus, spondylitis, various cardiovascular ailments, encephalitis, retinitis, phlebitis, colitis, and multiple sclerosis. Calcium Orotate helps in controlling weight by suppressing the habit of frequent appetite of chronic overeaters. It is also beneficial in reducing the effects of mood swings and is proved to be quite effective in cognitive enhancement. Calcium Orotate protects the heart by enhancing the efficiency of cardiac muscles. Recent studies on calcium orotate indicate its potential to minimize the risk of colon cancer.
Calcium Orotate acts against a number of inflammatory diseases like arthritis, psoriasis, lupus, spondylitis, various cardiovascular ailments, encephalitis, retinitis, phlebitis, colitis, and multiple sclerosis. Calcium Orotate helps in controlling weight by suppressing the habit of frequent appetite of chronic overeaters. It is also beneficial in reducing the effects of mood swings and is proved to be quite effective in cognitive enhancement. Calcium Orotate protects the heart by enhancing the efficiency of cardiac muscles. Recent studies on calcium orotate indicate its potential to minimize the risk of colon cancer.
Therapeutic classView
Minerals in bone formation, Specific mineral preparations
PharmacologyView
This contains Calcium Orotate, a calcium supplement with a functional amino acid chelating ligand- orotic acid. Orotic acid assists the transport of calcium through cellular membrane structures, thus facilitating the intracellular uptake of calcium, particularly in bone. Calcium Orotate also helps in the maintenance of healthy cartilage. Furthermore, Orotate is involved in the synthesis of DNA (deoxyribonucleic acid) and RNA (ribonucleic acid) of the various calcium supplements on the market, Calcium Orotate gets high marks because of the compound's ability to penetrate complex cell membranes so that it can be metabolized in cartilage.
DosageView
Calcium Orotate 400 mg: As an addition to the daily diet, 2-3 tablets are usually recommended with meal or as directed by a physician.
Calcium Orotate 740 mg: As an addition to the daily diet, 1-2 tablets are usually recommended with meal or as directed by a physician.
Calcium Orotate 740 mg: As an addition to the daily diet, 1-2 tablets are usually recommended with meal or as directed by a physician.
Side effectsView
Bloating and swelling in the abdomen are common side effects of Calcium Orotate. Loss of appetite, upset stomach, constipation, nausea, vomiting, unusual weight loss, increased thirst/urination, weakness, unusual tiredness, formation of kidney stones may occur infrequently.
ContraindicationsView
Calcium Orotate is contraindicated in conditions like incomplete or infrequent bowel movements, kidney stone, kidney disease, increased activity of the parathyroid gland, high amount of Calcium in urine, high amount of Calcium in the blood, extreme loss of body water.
PrecautionsView
Before taking Calcium Orotate, precaution is needed if the patient is allergic to Calcium Orotate. This drug may contain inactive ingredients, which can cause allergic reactions or other problems. Precaution is needed before using this drug in kidney disease, kidney stones, little or no stomach acid (achlorhydria), heart disease, disease of the pancreas, sarcoidosis difficulty absorbing nutrition from food (malabsorption syndrome).
InteractionsView
Calcium can decrease absorption of the following drugs when taken together: biphosphonates (e.g., alendronate), quinolone antibiotics (e.g., ciprofloxacin, levofloxacin), and tetracycline antibiotics (e.g., doxycycline, minocycline), levothyroxine, phenytoin (an anticonvulsant), and tiludronate disodium (to treat Paget's disease). Thiazide-type diuretics can interact with Calcium supplements, increasing the risks of hypercalcemia and hypercalciuria. Both aluminum- and magnesium-containing antacids increase urinary calcium excretion. Mineral oil and stimulant laxatives decrease calcium absorption. Glucocorticoids, such as prednisone, can cause calcium depletion and eventually osteoporosis when they are used for months. Oral contraceptives as well as estrogen compounds reduce calcium. Anti-inflammatories such as NSAIDs, Aspirin, Ibuprofen deplete calcium. Corticosteroids deplete calcium.
Pregnancy & lactationView
Women who are pregnant and breast-feeding need more calcium. Pregnancy related high blood pressure is a common and serious risk for women and their babies, and taking supplemental forms of Calcium Orotate can help to reduce this risk.
StorageView
Keep out of the reach of children. Keep in a cool & dry place. Protect from light.
Protec
Metronidazole
Protec
Metronidazole
Indications
Vaginal trichomoniasis
Indication detailsView
Metronidazole is indicated in the treatment of following diseases:
- The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
- The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
- In the treatment of urogenital trichomoniasis.
- Bacterial vaginosis (also known as non-specific vaginitis).
- All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
- Giardiasis.
- Acute ulcerative gingivitis.
- Anaerobically infected leg ulcers and pressure sores.
- Acute dental infections due to anaerobic organisms.
- Antibiotic associated pseudomembranus colitis.
Therapeutic classView
Amoebicides, Anti-diarrhoeal Antiprotozoal
PharmacologyView
Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.
DosageView
Tablet and Suspension:
Trichomoniasis (Adults & Children over 10 yrs)-- 200 mg tid or 400 mg bid for 7 days
- 800 mg in the morning and 1-2 gm at night for 2 days
- 2 gm as a single dose for 1 days
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 800 mg tid for 5 days
- Children 7-10 yrs: 400 mg tid
- Children 3-7 yrs: 200 mg qid
- Children 1-3 yrs: 200 mg tid
- 400-800 mg tid for 5-10 days
- Children 7-10 yrs: 200-400 mg tid
- Children 3-7 yrs: 100-200 mg qid
- Children 1-3 yrs: 100-200 mg tid
- 2 gm once daily for 3 days
- Children 7-10 yrs: 1 gm once daily
- Children 3-7 yrs: 600-800 mg once daily
- Children 1-3 yrs: 500 mg once daily
- 200 mg tid for 3 days
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 200 mg tid for 3-7 days
- 400 mg bid for 7 days
- 2 gm as a single dose for 1 days
- 400 mg tid for 7 days
- 800 mg initially and then 400 mg tid for 7 days
- Children 1-10 yrs: 7.5 mg/kg tid
- 400 mg tid started 24 hours before surgery for 1 days
- Children 1-10 yrs: 7.5 mg/kg tid
Vaginal Gel:
The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.
Suppository:
Anaerobic Infections-- Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
- Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.
- Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
- Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.
IV Infusion:
Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.- Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
- Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.
Side effectsView
Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.
ContraindicationsView
Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.
PrecautionsView
- If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
- Metronidazole should be administered with caution to patients with hepatic encephalopathy.
- Patients should be warned that metronidazole may darken urine.
InteractionsView
- Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
- Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
- Lithium: Plasma levels of lithium may be increased by metronidazole.
- Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
- Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
- 5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
- Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.
Pregnancy & lactationView
US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.
Pediatric usageView
Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.
Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
Overdose effectsView
Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.
StorageView
Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.
Protec R
Ranitidine Hydrochloride
Protec R
Ranitidine Hydrochloride
Indications
Zollinger-Ellison syndrome
Indication detailsView
Ranitidine is indicated in:
- Treatment of active duodenal ulcer
- Benign gastric ulcer
- Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
- Post operative stress ulcer.
- Zollinger-Ellison Syndrome.
- Gastroesophageal reflux disease (GERD).
- Gastro-intestinal haemorrhage from stress ulcer in seriously ill patient.
- Recurrent haemorrhage in patients with bleeding peptic ulcer.
- Before general anesthesia in patient considered to be at risk of acid aspiration particulary obstetric patients.
Therapeutic classView
H2 receptor antagonist
PharmacologyView
Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.
DosageView
Ranitidine Tablet & Syrup:
Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.
Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.
Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.
Maintenance: 150 mg at night for preventing recurrences.
Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.
Ranitidine IV injection & IV Infusion:
Ranitidine injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Ranitidine injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.
Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day. Safety and effectiveness of Ranitidine injection have not been established in case of children.
Side effectsView
Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.
ContraindicationsView
Patients hypersensitive to Ranitidine
PrecautionsView
Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.
InteractionsView
Delayed absorption and increased peak serum concentration with propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.
Pregnancy & lactationView
Pregnancy: Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.
Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Pediatric usageView
Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.
Overdose effectsView
Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.
ReconstitutionView
Slow IV inj: Ranitidine 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln.
Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
StorageView
Store in a cool and dry place. protect from light.
Protecor
Vitamin C + Vitamin E
Protecor
Vitamin C + Vitamin E
Indications
Vitamin C deficiency
Indication detailsView
Keratosis, Rough skin,Wrinkles associated with aging, Alzheimer's disease, Cancer Prevention, dementia, degenerative diseases, coronary heart diseases, end stage renal disease, growth and repair of body tissue, bone, skin, teeth and hair.
Therapeutic classView
Anti-oxidant Multivitamin preparations, Specific combined vitamin preparations
PharmacologyView
Vitamin C: 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 E plays a role in protecting red blood cells against hemolysis; has protective effects against free radicals on polyunsaturated fatty acids found in cell membranes; plays a role in preventing oxidation of vitamin A and C.
Vitamin E plays a role in protecting red blood cells against hemolysis; has protective effects against free radicals on polyunsaturated fatty acids found in cell membranes; plays a role in preventing oxidation of vitamin A and C.
DosageView
One tablet or capsule daily or as directed by a physician.
Side effectsView
Generally, this preparation is well-tolerated. Diarrhea may occasionally occur during treatment with beta carotene and the skin may assume a slightly yellow discoloration. The side-effects of vitamin A are reversible. Vitamin C and vitamin E may cause diarrhea and other gastrointestinal disturbances.
ContraindicationsView
Patients with a known hypersensitivity to any of the ingredients.
PrecautionsView
Hypervitaminosis. Avoid use in early pregnancy. Patients on anti coagulant therapy should not use ascorbic acid prolonged period of time.
InteractionsView
Vitamin C: Deferroxamine, hormonal contraceptives, flufenazine, warfarin, elemental iron, salicylates, warfarin, fluphenazine, disulfiram, mexiletine, vitamin B12.
Vitamin E: Colestyramine, colestipol, and orlistat may interfere with vitamin E absorption. High doses of vitamin E potentiates the anticoagulant action of warfarin. Large doses of vitamin E may impair response to iron supplementation.
Vitamin E: Colestyramine, colestipol, and orlistat may interfere with vitamin E absorption. High doses of vitamin E potentiates the anticoagulant action of warfarin. Large doses of vitamin E may impair response to iron supplementation.
Pregnancy & lactationView
Pregnancy Category A. Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
Protecto
Sucralfate
Protecto
Sucralfate
Indications
Peptic ulcer disease
Indication detailsView
Sucralfate is indicated in adults and adolescents over 14 years old for treatment of-
- Duodenal ulcer
- Gastric ulcer
- Chronic gastritis
- The prophylaxis of gastrointestinal hemorrhage from stress ulceration in seriously ill patients.
Therapeutic classView
Chelating complex
PharmacologyView
Sucralfate is non-systemic as the drug is only minimally absorbed from the gastrointestinal tract. The minute amount which absorbed primarily excretes in the urine. Sucralfate promotes the healing of gastric and duodenal ulcers by the formation of a chemical complex that binds to the ulcer site to establish a protective barrier. Besides, Sucralfate inhibits the action of pepsin and bile.
DosageView
Duodenal ulcer, gastric ulcer, chronic gastritis-
- Adults: The usual dose is Sucralfate 2 gm twice daily to be taken on rising and at bedtime or Sucralfate 1 gm four times a day to be taken 1 hour before meals and at bedtime. Maximum daily dose is 8 gm but up to twelve weeks may be necessary in resistant cases.
- Pediatric population: The safety and efficacy of Sucralfate in children under 14 years of age has not been established.
- Elderly: There are no special dosage requirements for elderly patients but as with all medicines the lowest effective dose should be used.
- Adults: The usual dose is Sucralfate 1 gm orally or via a nasogastric tube 4 to 6 times a day. To prevent clogging of the nasogastric tube flush with 10 ml of water following each administration. The duration of treatment for prophylaxis of stress ulceration must be individually determined. Treatment should be continued for as long as one or more of the risk factors for stress ulceration is present but normally not for more than 14 days.
AdministrationView
Sucralfate should be taken on an empty stomach. Antacid should not be administered within 30 minutes of Sucralfate.
Side effectsView
The most common adverse event was headache (3.4%) followed by nausea (2.3%), abdominal pain (2.3%), constipation (1.1%), diarrhea (1.1%), and urticaria (1.1%). The majority of patients who reported bezoars, had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings. Episodes of hyperglycemia have been reported in diabetic patient.
ContraindicationsView
Sucralfate tablet and suspension are contraindicated in patients with hypersensitivity to sucralfate.
PrecautionsView
Sucralfate should only be used with caution in patients with renal dysfunction, due to the possibility of increased aluminium absorption. Sucralfate is not recommended for use in individuals on dialysis. In patients with severe or chronic renal impairment, Sucralfate should be used with extreme caution and only for short-term treatment. Small amounts of aluminium are absorbed through the gastrointestinal tract and aluminium may accumulate. Aluminium osteodystrophy, osteomalacia, encephalopathy and anaemia have been reported in patients with chronic renal impairment. For patients with impairment of renal function, laboratory testing such as aluminium, phosphate, calcium and alkaline phosphatase is recommended to be periodically performed due to excretion impairment. The concomitant use of other aluminium containing medications is not recommended in view of the enhanced potential for aluminium absorption and toxicity. Bezoars have been reported after administration of sucralfate mainly to severely ill patients in intensive care units. The majority of these patients (including neonates in whom sucralfate is not recommended) had underlying conditions that may predispose to bezoar formation (such as delayed gastric emptying due to surgery, drug therapy or diseases that reduce motility) or were receiving concomitant enteral tube feeding.
InteractionsView
Concomitant administration of Sucralfate may reduce the bioavailability of certain drugs including Fluoroquinolones such as Ciprofloxacin and Norfloxacin, Tetracycline, Ketoconazole, Sulpiride, Digoxin, Warfarin, Phenytoin, Theophylline, Levothyroxine, Quinidine, and H2 antagonists. The bioavailability of these agents may be restored by separating the administration of these agents from Sucralfate by two hours. This interaction appears to be non-systemic in origin presumably resulting from these agents being bound by Sucralfate in the gastrointestinal tract. Because of the potential of Sucralfate to alter the absorption of some drugs from the gastrointestinal tract, the separate administration of Sucralfate from that of other agents should be considered when alterations in bioavailability are felt to be critical for concomitantly administered drugs. Sucralfate should not be co-administered with citrate preparations. Co-administration citrate preparations with sucralfate may increase the blood concentrations of aluminium. The mechanism may be due to the chelation of aluminium which is assumed to increase its absorption. The administration of Sucralfate 1 g and enteral feeds by nasogastric tube should be separated by one hour in patients receiving Sucralfate 1 g for the prophylaxis of stress ulceration. In rare cases, bezoar formation has been reported when Sucralfate and enteral feeds have been given too closely together.
Pregnancy & lactationView
Safety in pregnant women has not been established and Sucralfate should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Caution should be exercised when Sucralfate is administered to breast-feeding women.
Pediatric usageView
Pediatric Population: Sucralfate is not recommended for use in children under 14 years of age due to insufficient data on safety and efficacy.
In elderly patients: Dose adjustments are not necessary.
Renal Impairment: Sucralfate should be used with caution in renal insufficiency patients.
Effects on ability to drive and use machines: Patients should not be drive if feel dizzy or drowsy.
In elderly patients: Dose adjustments are not necessary.
Renal Impairment: Sucralfate should be used with caution in renal insufficiency patients.
Effects on ability to drive and use machines: Patients should not be drive if feel dizzy or drowsy.
Overdose effectsView
In a clinical trial on healthy men of overdose with Sucralfate, most cases remained asymptomatic but symptoms of abdominal pain, nausea, and vomiting were reported in a few cases. Acute oral toxicity studies in animals using doses up to 12 gm/kg body weight could not find a lethal dose. Risks associated with overdose should therefore be minimal.
StorageView
Store in a cool and dry place, protected from light.
Protecto
Sucralfate
Protecto
Sucralfate
Indications
Peptic ulcer disease
Indication detailsView
Sucralfate is indicated in adults and adolescents over 14 years old for treatment of-
- Duodenal ulcer
- Gastric ulcer
- Chronic gastritis
- The prophylaxis of gastrointestinal hemorrhage from stress ulceration in seriously ill patients.
Therapeutic classView
Chelating complex
PharmacologyView
Sucralfate is non-systemic as the drug is only minimally absorbed from the gastrointestinal tract. The minute amount which absorbed primarily excretes in the urine. Sucralfate promotes the healing of gastric and duodenal ulcers by the formation of a chemical complex that binds to the ulcer site to establish a protective barrier. Besides, Sucralfate inhibits the action of pepsin and bile.
DosageView
Duodenal ulcer, gastric ulcer, chronic gastritis-
- Adults: The usual dose is Sucralfate 2 gm twice daily to be taken on rising and at bedtime or Sucralfate 1 gm four times a day to be taken 1 hour before meals and at bedtime. Maximum daily dose is 8 gm but up to twelve weeks may be necessary in resistant cases.
- Pediatric population: The safety and efficacy of Sucralfate in children under 14 years of age has not been established.
- Elderly: There are no special dosage requirements for elderly patients but as with all medicines the lowest effective dose should be used.
- Adults: The usual dose is Sucralfate 1 gm orally or via a nasogastric tube 4 to 6 times a day. To prevent clogging of the nasogastric tube flush with 10 ml of water following each administration. The duration of treatment for prophylaxis of stress ulceration must be individually determined. Treatment should be continued for as long as one or more of the risk factors for stress ulceration is present but normally not for more than 14 days.
AdministrationView
Sucralfate should be taken on an empty stomach. Antacid should not be administered within 30 minutes of Sucralfate.
Side effectsView
The most common adverse event was headache (3.4%) followed by nausea (2.3%), abdominal pain (2.3%), constipation (1.1%), diarrhea (1.1%), and urticaria (1.1%). The majority of patients who reported bezoars, had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings. Episodes of hyperglycemia have been reported in diabetic patient.
ContraindicationsView
Sucralfate tablet and suspension are contraindicated in patients with hypersensitivity to sucralfate.
PrecautionsView
Sucralfate should only be used with caution in patients with renal dysfunction, due to the possibility of increased aluminium absorption. Sucralfate is not recommended for use in individuals on dialysis. In patients with severe or chronic renal impairment, Sucralfate should be used with extreme caution and only for short-term treatment. Small amounts of aluminium are absorbed through the gastrointestinal tract and aluminium may accumulate. Aluminium osteodystrophy, osteomalacia, encephalopathy and anaemia have been reported in patients with chronic renal impairment. For patients with impairment of renal function, laboratory testing such as aluminium, phosphate, calcium and alkaline phosphatase is recommended to be periodically performed due to excretion impairment. The concomitant use of other aluminium containing medications is not recommended in view of the enhanced potential for aluminium absorption and toxicity. Bezoars have been reported after administration of sucralfate mainly to severely ill patients in intensive care units. The majority of these patients (including neonates in whom sucralfate is not recommended) had underlying conditions that may predispose to bezoar formation (such as delayed gastric emptying due to surgery, drug therapy or diseases that reduce motility) or were receiving concomitant enteral tube feeding.
InteractionsView
Concomitant administration of Sucralfate may reduce the bioavailability of certain drugs including Fluoroquinolones such as Ciprofloxacin and Norfloxacin, Tetracycline, Ketoconazole, Sulpiride, Digoxin, Warfarin, Phenytoin, Theophylline, Levothyroxine, Quinidine, and H2 antagonists. The bioavailability of these agents may be restored by separating the administration of these agents from Sucralfate by two hours. This interaction appears to be non-systemic in origin presumably resulting from these agents being bound by Sucralfate in the gastrointestinal tract. Because of the potential of Sucralfate to alter the absorption of some drugs from the gastrointestinal tract, the separate administration of Sucralfate from that of other agents should be considered when alterations in bioavailability are felt to be critical for concomitantly administered drugs. Sucralfate should not be co-administered with citrate preparations. Co-administration citrate preparations with sucralfate may increase the blood concentrations of aluminium. The mechanism may be due to the chelation of aluminium which is assumed to increase its absorption. The administration of Sucralfate 1 g and enteral feeds by nasogastric tube should be separated by one hour in patients receiving Sucralfate 1 g for the prophylaxis of stress ulceration. In rare cases, bezoar formation has been reported when Sucralfate and enteral feeds have been given too closely together.
Pregnancy & lactationView
Safety in pregnant women has not been established and Sucralfate should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Caution should be exercised when Sucralfate is administered to breast-feeding women.
Pediatric usageView
Pediatric Population: Sucralfate is not recommended for use in children under 14 years of age due to insufficient data on safety and efficacy.
In elderly patients: Dose adjustments are not necessary.
Renal Impairment: Sucralfate should be used with caution in renal insufficiency patients.
Effects on ability to drive and use machines: Patients should not be drive if feel dizzy or drowsy.
In elderly patients: Dose adjustments are not necessary.
Renal Impairment: Sucralfate should be used with caution in renal insufficiency patients.
Effects on ability to drive and use machines: Patients should not be drive if feel dizzy or drowsy.
Overdose effectsView
In a clinical trial on healthy men of overdose with Sucralfate, most cases remained asymptomatic but symptoms of abdominal pain, nausea, and vomiting were reported in a few cases. Acute oral toxicity studies in animals using doses up to 12 gm/kg body weight could not find a lethal dose. Risks associated with overdose should therefore be minimal.
StorageView
Store in a cool and dry place, protected from light.
Protemin
Amino Acid + D-Sorbitol + Electrolytes
Protemin
Amino Acid + D-Sorbitol + Electrolytes
Indications
Protein supply for peritoneal nutrition
Indication detailsView
Amino acid is indicated as a source of amino acids for protein synthesis in patients needing intravenous nutrition. Amino acid is particularly suitable for patients with basal amino acid requirements. Amino acid is also indicated in faster recovery in surgery, burns, renal insufficiency, hepatic insufficiency and effective management of cancer.
Therapeutic classView
Parenteral nutritional preparations
PharmacologyView
This IV solution is a sterile aqueous solution of crystalline Amino Acid and D-Sorbitol with electrolytes, which are necessary as the nitrogen source for parenteral nutrition. Nitrogen provided in the form of essential and non-essential amino acids. This IV solution contains all 18 essential and non-essential amino acids needed for protein synthesis. The amino acid composition is such that positive nitrogen balance can be achieved in the postoperative period and during extended periods of intravenous nutrition. The solution is clear, colorless to pale yellow colored, having a p H lying in the range of 5.0 to 7.0.
DosageView
The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress).
In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml Amino acids IV may be infused intravenously per 24 hours. Amino acids IV should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.
In children and infants: The rate of infusion is 28-35 ml/kg body weight per day is recommended, with a step-wise increase in the rate of administration during the frst week.
- No or minor metabolic stress and normal nutritional state: 0.10-0.15 g nitrogen/kg/day,
- Moderate metabolic stress with or without malnutrition: 0.15-0.20 g nitrogen/kg/day,
- Severe catabolism as in burns, sepsis and trauma: up to 0.20-0.25 g nitrogen/kg/day.
In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml Amino acids IV may be infused intravenously per 24 hours. Amino acids IV should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.
In children and infants: The rate of infusion is 28-35 ml/kg body weight per day is recommended, with a step-wise increase in the rate of administration during the frst week.
Side effectsView
This preparation is usually well tolerated. Nausea occurs rarely. Vomiting, flushing and sweating have been observed during infusion of Amino acid at rates exceeding the recommended maximal rate. Transient increases liver test during intravenous nutrition have been reported. The reasons are at present unclear. Hypersensitivity reactions have been reported. As with all hypertonic infusion solutions, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of 10% fat emulsion. If given to severely ill, premature infants, hyperphenylalaninemia may occur.
ContraindicationsView
This is contraindicated in patients with inborn errors of amino acids metabolism, severe liver dysfunction and in severe uremia when dialysis facilities are not available. Due to the content of glucose, Amino Acids IV infusion and 10% Glucose with Electrolytes is contraindicated in patients with hyperosmolar nonketotic diabetic coma.
PrecautionsView
IV infusion of amino acids is accompanied by increased urinary excretion of the trace elements copper and in particular zinc, which should be taken into account in the dosing of trace elements, particularly during long-term IV nutrition. Hyperphenylalaninemia may occur in severely ill, premature infants. In these patients, monitoring of the phenylalanine level is recommended and the infusion rate adjusted as needed. Amino Acids IV infusion and 10% Glucose with Electrolytes should be used with caution in patients with diabetes mellitus, severe heart failure or with renal function in combination with fluid restrictions or oliguria/anuria of another origin. In patients with hyperglycemia, administration of exogenous insulin might be necessary. In severely malnourished patients refeeding carbohydrates can trigger thiamine (vitamin B1 ) deficiency syndrome. Those at high risk are patients with a history of alcohol abuse, anorexia nervosa, prolonged fasting or starvation and pregnant women with hyperemesis gravidarum. In this kind of patients, parenteral nutrition containing glucose should be given with caution and parenteral administration of thiamine should be considered before and during the administration of glucose. Monitoring of serum potassium and blood glucose is recommended if Amino Acids IV infusion and 10% Glucose with electrolytes is infused rapidly or in a large quantity. For patients with hypophosphatemia, an additional supply of phosphate is recommended.
InteractionsView
At the recommended dosage the amino acid have no pharmacological effects and is not expected to interact with other medicaments.
Pregnancy & lactationView
Successful and safe administration of amino acid solutions during pregnancy in the human has been reported. Animal reproduction studies have not been carried out with Amino acid.
Overdose effectsView
If Amino Acids IV infusion and 10% Glucose with Electrolytes is administered at a higher rate than recommended, there is an augmented risk for nausea, vomiting and sweating. When peripheral veins are used thrombophlebitis may occur. Osmotic diuresis with dehydration may occur if the dosage recommendations are exceeded. There is also a risk of symptoms related to hyperglycemia with Amino Acids IV infusion and 10% Glucose with Electrolytes. In case of symptoms due to overdose, the infusion should be slowed down or discontinued.
StorageView
Protect from light and store between 15°C to 25°C temperature. Avoid freezing. Keep out of reach of children.
Protet-IG
Human Tetanus Immunoglobulin
Protet-IG
Human Tetanus Immunoglobulin
Indications
Tetanus
Indication detailsView
Indications and uses Human Tetanus Immunoglobulin is indicated for -
- Prophylaxis of tetanus following injury in patients whose immunization is incomplete or uncertain.
- Therapeutically in the treatment of tetanus.
Therapeutic classView
Vaccines, Anti-sera & Immunoglobulin
PharmacologyView
Human clostridium tetani toxoid immune globulin prevents tetanus toxoid from damaging tissue and producing the symptoms associated with tetanus. The immune globulin binds to tetanus toxiod, interfering with the normal interaction of the toxoid with human tissue. This prevents the toxoid from invading the nervous system and producing painful muscle spasms as well as autonomic dysfunction. The Clostridium tetani bacterium is killed either via antibiotic treatment of the host's immune system and immune globulin-bound toxoid is likely broken down by phagocytic immune cells.
DosageView
Post-exposure prophylaxis of tetanus:
At the same time, 0.5 ml of tetanus vaccine in a different extremity with a separate syringe and complete immunization schedule is required to be administered.
Therapy of clinically manifest tetanus: For adults and children single doses of 3,000 to 6,000 IU (in combination with other appropriate clinical procedures).
- For adults and children single dose of 250 IU should be given. The dose may be increased to 500 IU in case of:
- Infected wounds where surgically appropriate treatment cannot be achieved within 24 hours
- Deep or contaminated wounds with tissue damage and reduced oxygen supply, as well as foreign body injury (e.g., bites, stings or shots)
- Burns, congelations
- Tissue necrosis
- Septicaemic abortion
- Adults weighing more than the average
At the same time, 0.5 ml of tetanus vaccine in a different extremity with a separate syringe and complete immunization schedule is required to be administered.
Therapy of clinically manifest tetanus: For adults and children single doses of 3,000 to 6,000 IU (in combination with other appropriate clinical procedures).
AdministrationView
Administrations: Human Tetanus Immunoglobulin should only be administered by intramuscular injection. Human tetanus immunoglobulin should not be administered by intravenously.
Do not use solutions which are cloudy or contain residues (deposits/particles)
Human tetanus immunoglobulin is a ready for use solution and should be administered at body temperature. If comparatively large total volumes are required, it is advisable to administer them in divided doses at different sites
In the presence of a severe coagulation disorder where intramuscular injections are contraindicated, human tetanus immunoglobulin may be given subcutaneously (under the skin) for prophylaxis. Afterwards the injection site should be compressed with a swab. However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route
Co-administration: Immunoglobulin administration may impair the efficacy of live, attenuated virus vaccines such as measles, rubella, mumps and varicella vaccines for a period of up to three months.
After administration of human tetanus immunoglobulin an interval of at least three months should elapse before vaccination with live, attenuated virus vaccines. In the case of measles, this impairment may persist for up to five months. Therefore, patients receiving measles vaccine should have their antibody status checked.
Do not use solutions which are cloudy or contain residues (deposits/particles)
Human tetanus immunoglobulin is a ready for use solution and should be administered at body temperature. If comparatively large total volumes are required, it is advisable to administer them in divided doses at different sites
In the presence of a severe coagulation disorder where intramuscular injections are contraindicated, human tetanus immunoglobulin may be given subcutaneously (under the skin) for prophylaxis. Afterwards the injection site should be compressed with a swab. However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route
Co-administration: Immunoglobulin administration may impair the efficacy of live, attenuated virus vaccines such as measles, rubella, mumps and varicella vaccines for a period of up to three months.
After administration of human tetanus immunoglobulin an interval of at least three months should elapse before vaccination with live, attenuated virus vaccines. In the case of measles, this impairment may persist for up to five months. Therefore, patients receiving measles vaccine should have their antibody status checked.
Side effectsView
Adverse reaction following administration of human tetanus immunoglobulin is infrequent and mild, but severe local and systemic reactions have occurred rarely.
- Local reactions at the injection site: Local pain, tenderness or swelling.
- Immune system disorders: Allergic reactions including fall in blood pressure, dyspnoea, cutaneous reactions, in isolated cases reaching as far as anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration of immunoglobulins.
- Generalized reactions: Chills, fever, headache, malaise, nausea, vomiting, arthralgia and moderate back pain.
- Heart and vascular disorders: Cardiovascular reactions particularly if the product is inadvertently injected intravascularly.
ContraindicationsView
- Known hypersensitivity to any of the components of the product
- Known hypersensitivity to human immunoglobulins
- Like any other intramuscular injections, human tetanus immunoglobulin is not advocated for patients with bleeding disorders
- In patients with a history of immunoglobulin A (IgA) deficiency or severe anaphylactic reactions to plasma products, the risk-benefit ratio must be considered
PrecautionsView
Should not be administered intravenously
A separate sterile syringe must be used for each patient to prevent the possible transmission of hepatitis B and other infectious diseases.
Should be administered with caution to individuals who have exhibited systemic allergic reactions to immunoglobulin. Epinephrine (0.1~0.5ml, 1:1000) should be available for immediate treatment.
In patients who have severe thrombocytopenia or any coagulation disorder that would contra-indicated intramuscular injection, human tetanus immunoglobulin should be given only if the expected benefits out way the risks.
While administering human tetanus immunoglobulin care should be taken to drawback the plunger of the syringe before injection in order to be certain that the needle is not in blood vessel.
Human tetanus immunoglobulin is prepared from human plasma is pasteurized in its bulk condition to reduce the risk of viruses infections but freedom from the risk of unknown viruses (Parvovirus B-19, etc) cannot be assumed. The infused patient is continuously checked for long time after injection.
A separate sterile syringe must be used for each patient to prevent the possible transmission of hepatitis B and other infectious diseases.
Should be administered with caution to individuals who have exhibited systemic allergic reactions to immunoglobulin. Epinephrine (0.1~0.5ml, 1:1000) should be available for immediate treatment.
In patients who have severe thrombocytopenia or any coagulation disorder that would contra-indicated intramuscular injection, human tetanus immunoglobulin should be given only if the expected benefits out way the risks.
While administering human tetanus immunoglobulin care should be taken to drawback the plunger of the syringe before injection in order to be certain that the needle is not in blood vessel.
Human tetanus immunoglobulin is prepared from human plasma is pasteurized in its bulk condition to reduce the risk of viruses infections but freedom from the risk of unknown viruses (Parvovirus B-19, etc) cannot be assumed. The infused patient is continuously checked for long time after injection.
InteractionsView
May reduce the efficacy of live vaccines.
Pregnancy & lactationView
The safety for use of human tetanus immunoglobulin in human pregnancy has not been established in controlled clinical trials. Long lasting clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the fetus and the neonate are to be expected.
Overdose effectsView
Not applicable.
StorageView
Keep out of the reach and sight of children. Store at +2 °C to +8 °C. Transportation should also be in designed packs to maintain the product temperature +2 °C to +8 °C. Do not freeze. Discard vaccine if frozen. Protect from light
Protide
Salmeterol + Fluticasone Propionate
Protide
Salmeterol + Fluticasone Propionate
Indications
COPD
Indication detailsView
This is indicated in the regular treatment of asthma where use of a combination product (long-acting β2-agonist and inhaled corticosteroid) is appropriate:
- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting β2-agonist or
- patients already adequately controlled on both inhaled corticosteroid and long-acting β2-agonist.
Therapeutic classView
Long-acting selective β-adrenoceptor stimulants, Respiratory corticosteroids
PharmacologyView
Salmeterol Xinafoate is a selective, long acting beta-2 agonist used in the treatment of asthma and other forms of diffuse airways obstruction. Fluticasone Propionate is a corticosteroid with mainly glucocorticoid activity. Fluticasone Propionate is stated to exert a topical effect on the lungs without systematic effects at usual dose.
Salmeterol protects against symptoms, Fluticasone Propionate improves lung function and prevents exacerbations of the condition. This preparation can offer a more convenient regime for patients on concurrent β-agonist and inhaled corticosteroid therapy. The respective mechanisms of action of both drugs are discussed below:
Salmeterol: Salmeterol is a selective long-acting (12 hour) beta-2-adrenoceptor agonist with a long side chain which binds to the exo-site of the receptor.
Fluticasone Propionate: Fluticasone Propionate given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbaions of asthma, without the adverse effects observed when corticosteroids are administered systemically.
Salmeterol protects against symptoms, Fluticasone Propionate improves lung function and prevents exacerbations of the condition. This preparation can offer a more convenient regime for patients on concurrent β-agonist and inhaled corticosteroid therapy. The respective mechanisms of action of both drugs are discussed below:
Salmeterol: Salmeterol is a selective long-acting (12 hour) beta-2-adrenoceptor agonist with a long side chain which binds to the exo-site of the receptor.
Fluticasone Propionate: Fluticasone Propionate given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbaions of asthma, without the adverse effects observed when corticosteroids are administered systemically.
DosageView
Inhalation Aerosol:
Inhalation Powder in Maxhaler (For Asthma): This is a moulded plastic device containing a foil strip with 60 regularly placed blisters containing pre-dispensed inhalation powder. Patients should be made aware that Maxhaler must be used daily for optimum benefit, even when asymptomatic.
Adults and Adolescents (12 years and older)-
- Adults and adolescents 12 years and older: 2 puffs of 25 µg Salmeterol and 50 µg Fluticasone Propionate twice daily or 2 puffs of 25 µg Salmeterol and 125 µg Fluticasone Propionate twice daily or 2 puffs of 25 µg Salmeterol and 250 µg Fluticasone Propionate twice daily.
- Children (4-12 years): 2 puffs of 25 µg salmeterol and 50 µg Fluticasone Propionate twice daily.
- Adult and Adolescent (12 Years and Older): Salmeterol 50 µg & Fluticasone 100 µg or Salmeterol 50 µg & Fluticasone 250 µg twice daily (morning and evening, approximately 12 hours apart).
- The recommended starting dosages for Salmeterol 50 µg & Fluticasone 100 µg & Salmeterol 50 µg & Fluticasone 250 µg for patients aged 12 years and older are based upon patients asthma severity.
- The maximum recommended dosage is Salmeterol 50 µg & Fluticasone 500 µg twice daily.
- Pediatric Patients (4 to 11 Years): For patients with asthma who are not controlled on an inhaled corticosteroid, the dosage is Salmeterol 50 µg & Fluticasone 100 µg twice daily (morning and evening, approximately 12 hours apart).
Inhalation Powder in Maxhaler (For Asthma): This is a moulded plastic device containing a foil strip with 60 regularly placed blisters containing pre-dispensed inhalation powder. Patients should be made aware that Maxhaler must be used daily for optimum benefit, even when asymptomatic.
Adults and Adolescents (12 years and older)-
- 50/100 Maxhaler: One Inhalation twice daily
- 50/250 Maxhaler: One Inhalation twice daily
- 50/500 Maxhaler: One Inhalation twice daily
- 50/100 Maxhaler: One Inhalation twice daily. The maximum licensed dose of fluticasone propionate delivered by this Maxhaler in children is 100 ug twice daily. There are no data available for use of this Maxhaler in children aged under 4 years.
- Maxhaler: One Inhalation twice daily
- Special patient groups: There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available for use of this in patients with hepatic impairment.
- Using the Maxhaler: This is a patient friendly, ready to use and easy to grip device. Use as per instructions for use.
AdministrationView
Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.
Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):
Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):
- Take off the cap.
- Shake the inhaler (at least six times) vigorously before each use.
- If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
- Breathe out as full as comfortably possible & hold the inhaler upright.
- Place the actuator into mouth between the teeth and close lips around the mouthpiece.
- While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
- Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
- If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
- After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
- Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.
Side effectsView
As this preparation contains Salmeterol and Fluticasone Propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds. Adverse events, which have been associated with Salmeterol or Fluticasone Propionate, are given below.
Salmeterol: The pharmacological side effects of beta-2-agonist treatment, such as tremor, subjective palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. Cardiac arrhythmia (including atrial fibrillation, supraventricular tachycardia and extra systoles) may occur, usually in susceptible patients. There have been reports of arthralgia and hypersensitivity reactions, including rash, oedema and angioedema. There have been reports of oropharyngeal irritation. There have been rare reports of muscle cramps.
Fluticasone propionate: Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported. Rare cases of facial and oropharyngeal oedema have been reported. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of Salmeterol/ Fluticasone Propionate Inhaler.
Salmeterol: The pharmacological side effects of beta-2-agonist treatment, such as tremor, subjective palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. Cardiac arrhythmia (including atrial fibrillation, supraventricular tachycardia and extra systoles) may occur, usually in susceptible patients. There have been reports of arthralgia and hypersensitivity reactions, including rash, oedema and angioedema. There have been reports of oropharyngeal irritation. There have been rare reports of muscle cramps.
Fluticasone propionate: Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported. Rare cases of facial and oropharyngeal oedema have been reported. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of Salmeterol/ Fluticasone Propionate Inhaler.
ContraindicationsView
This is contraindicated in patients with a history of hypersensitivity to any of the ingredients.
PrecautionsView
Consideration should be given to additional corticosteroid therapies, and to including administration of antibiotics if an infection is present. As with all inhaled medication containing corticosteroids, this preparation should be administered with caution in patients with active or quiescent pulmonary tuberculosis. This preparation should be administered with caution in patients with thyrotoxicosis.
InteractionsView
Both non-selective and selective β-blockers should be avoided in patients with asthma, unless there are compelling reasons for their use. Due to the very low plasma concentrations achieved after inhaled dosing clinically significant drug interactions are unlikely. Care should be taken when co-administering known strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir), as there is potential for increased systemic exposure to Fluticasone Propionate.
Pregnancy & lactationView
Administration of drugs during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus or child. There is insufficient experience of the use of Salmeterol Xinafoate and Fluticasone Propionate in human pregnancy and lactation. There are no data available for human breast milk.
Pediatric usageView
Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to paediatric patients. The long-term effects of this reduction including the impact of final adult height are unknown.
StorageView
Pressurised canister, do not puncture, break or incinerate even when apparently empty. Avoid storage in direct sunlight or heat. Store below 30°C. Keep away from eyes. Keep away from children.
Protide
Salmeterol + Fluticasone Propionate
Protide
Salmeterol + Fluticasone Propionate
Indications
COPD
Indication detailsView
This is indicated in the regular treatment of asthma where use of a combination product (long-acting β2-agonist and inhaled corticosteroid) is appropriate:
- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting β2-agonist or
- patients already adequately controlled on both inhaled corticosteroid and long-acting β2-agonist.
Therapeutic classView
Long-acting selective β-adrenoceptor stimulants, Respiratory corticosteroids
PharmacologyView
Salmeterol Xinafoate is a selective, long acting beta-2 agonist used in the treatment of asthma and other forms of diffuse airways obstruction. Fluticasone Propionate is a corticosteroid with mainly glucocorticoid activity. Fluticasone Propionate is stated to exert a topical effect on the lungs without systematic effects at usual dose.
Salmeterol protects against symptoms, Fluticasone Propionate improves lung function and prevents exacerbations of the condition. This preparation can offer a more convenient regime for patients on concurrent β-agonist and inhaled corticosteroid therapy. The respective mechanisms of action of both drugs are discussed below:
Salmeterol: Salmeterol is a selective long-acting (12 hour) beta-2-adrenoceptor agonist with a long side chain which binds to the exo-site of the receptor.
Fluticasone Propionate: Fluticasone Propionate given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbaions of asthma, without the adverse effects observed when corticosteroids are administered systemically.
Salmeterol protects against symptoms, Fluticasone Propionate improves lung function and prevents exacerbations of the condition. This preparation can offer a more convenient regime for patients on concurrent β-agonist and inhaled corticosteroid therapy. The respective mechanisms of action of both drugs are discussed below:
Salmeterol: Salmeterol is a selective long-acting (12 hour) beta-2-adrenoceptor agonist with a long side chain which binds to the exo-site of the receptor.
Fluticasone Propionate: Fluticasone Propionate given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbaions of asthma, without the adverse effects observed when corticosteroids are administered systemically.
DosageView
Inhalation Aerosol:
Inhalation Powder in Maxhaler (For Asthma): This is a moulded plastic device containing a foil strip with 60 regularly placed blisters containing pre-dispensed inhalation powder. Patients should be made aware that Maxhaler must be used daily for optimum benefit, even when asymptomatic.
Adults and Adolescents (12 years and older)-
- Adults and adolescents 12 years and older: 2 puffs of 25 µg Salmeterol and 50 µg Fluticasone Propionate twice daily or 2 puffs of 25 µg Salmeterol and 125 µg Fluticasone Propionate twice daily or 2 puffs of 25 µg Salmeterol and 250 µg Fluticasone Propionate twice daily.
- Children (4-12 years): 2 puffs of 25 µg salmeterol and 50 µg Fluticasone Propionate twice daily.
- Adult and Adolescent (12 Years and Older): Salmeterol 50 µg & Fluticasone 100 µg or Salmeterol 50 µg & Fluticasone 250 µg twice daily (morning and evening, approximately 12 hours apart).
- The recommended starting dosages for Salmeterol 50 µg & Fluticasone 100 µg & Salmeterol 50 µg & Fluticasone 250 µg for patients aged 12 years and older are based upon patients asthma severity.
- The maximum recommended dosage is Salmeterol 50 µg & Fluticasone 500 µg twice daily.
- Pediatric Patients (4 to 11 Years): For patients with asthma who are not controlled on an inhaled corticosteroid, the dosage is Salmeterol 50 µg & Fluticasone 100 µg twice daily (morning and evening, approximately 12 hours apart).
Inhalation Powder in Maxhaler (For Asthma): This is a moulded plastic device containing a foil strip with 60 regularly placed blisters containing pre-dispensed inhalation powder. Patients should be made aware that Maxhaler must be used daily for optimum benefit, even when asymptomatic.
Adults and Adolescents (12 years and older)-
- 50/100 Maxhaler: One Inhalation twice daily
- 50/250 Maxhaler: One Inhalation twice daily
- 50/500 Maxhaler: One Inhalation twice daily
- 50/100 Maxhaler: One Inhalation twice daily. The maximum licensed dose of fluticasone propionate delivered by this Maxhaler in children is 100 ug twice daily. There are no data available for use of this Maxhaler in children aged under 4 years.
- Maxhaler: One Inhalation twice daily
- Special patient groups: There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available for use of this in patients with hepatic impairment.
- Using the Maxhaler: This is a patient friendly, ready to use and easy to grip device. Use as per instructions for use.
AdministrationView
Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.
Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):
Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):
- Take off the cap.
- Shake the inhaler (at least six times) vigorously before each use.
- If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
- Breathe out as full as comfortably possible & hold the inhaler upright.
- Place the actuator into mouth between the teeth and close lips around the mouthpiece.
- While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
- Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
- If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
- After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
- Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.
Side effectsView
As this preparation contains Salmeterol and Fluticasone Propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds. Adverse events, which have been associated with Salmeterol or Fluticasone Propionate, are given below.
Salmeterol: The pharmacological side effects of beta-2-agonist treatment, such as tremor, subjective palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. Cardiac arrhythmia (including atrial fibrillation, supraventricular tachycardia and extra systoles) may occur, usually in susceptible patients. There have been reports of arthralgia and hypersensitivity reactions, including rash, oedema and angioedema. There have been reports of oropharyngeal irritation. There have been rare reports of muscle cramps.
Fluticasone propionate: Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported. Rare cases of facial and oropharyngeal oedema have been reported. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of Salmeterol/ Fluticasone Propionate Inhaler.
Salmeterol: The pharmacological side effects of beta-2-agonist treatment, such as tremor, subjective palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. Cardiac arrhythmia (including atrial fibrillation, supraventricular tachycardia and extra systoles) may occur, usually in susceptible patients. There have been reports of arthralgia and hypersensitivity reactions, including rash, oedema and angioedema. There have been reports of oropharyngeal irritation. There have been rare reports of muscle cramps.
Fluticasone propionate: Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported. Rare cases of facial and oropharyngeal oedema have been reported. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of Salmeterol/ Fluticasone Propionate Inhaler.
ContraindicationsView
This is contraindicated in patients with a history of hypersensitivity to any of the ingredients.
PrecautionsView
Consideration should be given to additional corticosteroid therapies, and to including administration of antibiotics if an infection is present. As with all inhaled medication containing corticosteroids, this preparation should be administered with caution in patients with active or quiescent pulmonary tuberculosis. This preparation should be administered with caution in patients with thyrotoxicosis.
InteractionsView
Both non-selective and selective β-blockers should be avoided in patients with asthma, unless there are compelling reasons for their use. Due to the very low plasma concentrations achieved after inhaled dosing clinically significant drug interactions are unlikely. Care should be taken when co-administering known strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir), as there is potential for increased systemic exposure to Fluticasone Propionate.
Pregnancy & lactationView
Administration of drugs during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus or child. There is insufficient experience of the use of Salmeterol Xinafoate and Fluticasone Propionate in human pregnancy and lactation. There are no data available for human breast milk.
Pediatric usageView
Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to paediatric patients. The long-term effects of this reduction including the impact of final adult height are unknown.
StorageView
Pressurised canister, do not puncture, break or incinerate even when apparently empty. Avoid storage in direct sunlight or heat. Store below 30°C. Keep away from eyes. Keep away from children.
Protide
Salmeterol + Fluticasone Propionate
Protide
Salmeterol + Fluticasone Propionate
Indications
COPD
Indication detailsView
This is indicated in the regular treatment of asthma where use of a combination product (long-acting β2-agonist and inhaled corticosteroid) is appropriate:
- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting β2-agonist or
- patients already adequately controlled on both inhaled corticosteroid and long-acting β2-agonist.
Therapeutic classView
Long-acting selective β-adrenoceptor stimulants, Respiratory corticosteroids
PharmacologyView
Salmeterol Xinafoate is a selective, long acting beta-2 agonist used in the treatment of asthma and other forms of diffuse airways obstruction. Fluticasone Propionate is a corticosteroid with mainly glucocorticoid activity. Fluticasone Propionate is stated to exert a topical effect on the lungs without systematic effects at usual dose.
Salmeterol protects against symptoms, Fluticasone Propionate improves lung function and prevents exacerbations of the condition. This preparation can offer a more convenient regime for patients on concurrent β-agonist and inhaled corticosteroid therapy. The respective mechanisms of action of both drugs are discussed below:
Salmeterol: Salmeterol is a selective long-acting (12 hour) beta-2-adrenoceptor agonist with a long side chain which binds to the exo-site of the receptor.
Fluticasone Propionate: Fluticasone Propionate given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbaions of asthma, without the adverse effects observed when corticosteroids are administered systemically.
Salmeterol protects against symptoms, Fluticasone Propionate improves lung function and prevents exacerbations of the condition. This preparation can offer a more convenient regime for patients on concurrent β-agonist and inhaled corticosteroid therapy. The respective mechanisms of action of both drugs are discussed below:
Salmeterol: Salmeterol is a selective long-acting (12 hour) beta-2-adrenoceptor agonist with a long side chain which binds to the exo-site of the receptor.
Fluticasone Propionate: Fluticasone Propionate given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbaions of asthma, without the adverse effects observed when corticosteroids are administered systemically.
DosageView
Inhalation Aerosol:
Inhalation Powder in Maxhaler (For Asthma): This is a moulded plastic device containing a foil strip with 60 regularly placed blisters containing pre-dispensed inhalation powder. Patients should be made aware that Maxhaler must be used daily for optimum benefit, even when asymptomatic.
Adults and Adolescents (12 years and older)-
- Adults and adolescents 12 years and older: 2 puffs of 25 µg Salmeterol and 50 µg Fluticasone Propionate twice daily or 2 puffs of 25 µg Salmeterol and 125 µg Fluticasone Propionate twice daily or 2 puffs of 25 µg Salmeterol and 250 µg Fluticasone Propionate twice daily.
- Children (4-12 years): 2 puffs of 25 µg salmeterol and 50 µg Fluticasone Propionate twice daily.
- Adult and Adolescent (12 Years and Older): Salmeterol 50 µg & Fluticasone 100 µg or Salmeterol 50 µg & Fluticasone 250 µg twice daily (morning and evening, approximately 12 hours apart).
- The recommended starting dosages for Salmeterol 50 µg & Fluticasone 100 µg & Salmeterol 50 µg & Fluticasone 250 µg for patients aged 12 years and older are based upon patients asthma severity.
- The maximum recommended dosage is Salmeterol 50 µg & Fluticasone 500 µg twice daily.
- Pediatric Patients (4 to 11 Years): For patients with asthma who are not controlled on an inhaled corticosteroid, the dosage is Salmeterol 50 µg & Fluticasone 100 µg twice daily (morning and evening, approximately 12 hours apart).
Inhalation Powder in Maxhaler (For Asthma): This is a moulded plastic device containing a foil strip with 60 regularly placed blisters containing pre-dispensed inhalation powder. Patients should be made aware that Maxhaler must be used daily for optimum benefit, even when asymptomatic.
Adults and Adolescents (12 years and older)-
- 50/100 Maxhaler: One Inhalation twice daily
- 50/250 Maxhaler: One Inhalation twice daily
- 50/500 Maxhaler: One Inhalation twice daily
- 50/100 Maxhaler: One Inhalation twice daily. The maximum licensed dose of fluticasone propionate delivered by this Maxhaler in children is 100 ug twice daily. There are no data available for use of this Maxhaler in children aged under 4 years.
- Maxhaler: One Inhalation twice daily
- Special patient groups: There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available for use of this in patients with hepatic impairment.
- Using the Maxhaler: This is a patient friendly, ready to use and easy to grip device. Use as per instructions for use.
AdministrationView
Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.
Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):
Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):
- Take off the cap.
- Shake the inhaler (at least six times) vigorously before each use.
- If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
- Breathe out as full as comfortably possible & hold the inhaler upright.
- Place the actuator into mouth between the teeth and close lips around the mouthpiece.
- While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
- Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
- If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
- After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
- Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.
Side effectsView
As this preparation contains Salmeterol and Fluticasone Propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds. Adverse events, which have been associated with Salmeterol or Fluticasone Propionate, are given below.
Salmeterol: The pharmacological side effects of beta-2-agonist treatment, such as tremor, subjective palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. Cardiac arrhythmia (including atrial fibrillation, supraventricular tachycardia and extra systoles) may occur, usually in susceptible patients. There have been reports of arthralgia and hypersensitivity reactions, including rash, oedema and angioedema. There have been reports of oropharyngeal irritation. There have been rare reports of muscle cramps.
Fluticasone propionate: Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported. Rare cases of facial and oropharyngeal oedema have been reported. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of Salmeterol/ Fluticasone Propionate Inhaler.
Salmeterol: The pharmacological side effects of beta-2-agonist treatment, such as tremor, subjective palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. Cardiac arrhythmia (including atrial fibrillation, supraventricular tachycardia and extra systoles) may occur, usually in susceptible patients. There have been reports of arthralgia and hypersensitivity reactions, including rash, oedema and angioedema. There have been reports of oropharyngeal irritation. There have been rare reports of muscle cramps.
Fluticasone propionate: Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported. Rare cases of facial and oropharyngeal oedema have been reported. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of Salmeterol/ Fluticasone Propionate Inhaler.
ContraindicationsView
This is contraindicated in patients with a history of hypersensitivity to any of the ingredients.
PrecautionsView
Consideration should be given to additional corticosteroid therapies, and to including administration of antibiotics if an infection is present. As with all inhaled medication containing corticosteroids, this preparation should be administered with caution in patients with active or quiescent pulmonary tuberculosis. This preparation should be administered with caution in patients with thyrotoxicosis.
InteractionsView
Both non-selective and selective β-blockers should be avoided in patients with asthma, unless there are compelling reasons for their use. Due to the very low plasma concentrations achieved after inhaled dosing clinically significant drug interactions are unlikely. Care should be taken when co-administering known strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir), as there is potential for increased systemic exposure to Fluticasone Propionate.
Pregnancy & lactationView
Administration of drugs during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus or child. There is insufficient experience of the use of Salmeterol Xinafoate and Fluticasone Propionate in human pregnancy and lactation. There are no data available for human breast milk.
Pediatric usageView
Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to paediatric patients. The long-term effects of this reduction including the impact of final adult height are unknown.
StorageView
Pressurised canister, do not puncture, break or incinerate even when apparently empty. Avoid storage in direct sunlight or heat. Store below 30°C. Keep away from eyes. Keep away from children.
Protide
Salmeterol + Fluticasone Propionate
Protide
Salmeterol + Fluticasone Propionate
Indications
COPD
Indication detailsView
This is indicated in the regular treatment of asthma where use of a combination product (long-acting β2-agonist and inhaled corticosteroid) is appropriate:
- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting β2-agonist or
- patients already adequately controlled on both inhaled corticosteroid and long-acting β2-agonist.
Therapeutic classView
Long-acting selective β-adrenoceptor stimulants, Respiratory corticosteroids
PharmacologyView
Salmeterol Xinafoate is a selective, long acting beta-2 agonist used in the treatment of asthma and other forms of diffuse airways obstruction. Fluticasone Propionate is a corticosteroid with mainly glucocorticoid activity. Fluticasone Propionate is stated to exert a topical effect on the lungs without systematic effects at usual dose.
Salmeterol protects against symptoms, Fluticasone Propionate improves lung function and prevents exacerbations of the condition. This preparation can offer a more convenient regime for patients on concurrent β-agonist and inhaled corticosteroid therapy. The respective mechanisms of action of both drugs are discussed below:
Salmeterol: Salmeterol is a selective long-acting (12 hour) beta-2-adrenoceptor agonist with a long side chain which binds to the exo-site of the receptor.
Fluticasone Propionate: Fluticasone Propionate given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbaions of asthma, without the adverse effects observed when corticosteroids are administered systemically.
Salmeterol protects against symptoms, Fluticasone Propionate improves lung function and prevents exacerbations of the condition. This preparation can offer a more convenient regime for patients on concurrent β-agonist and inhaled corticosteroid therapy. The respective mechanisms of action of both drugs are discussed below:
Salmeterol: Salmeterol is a selective long-acting (12 hour) beta-2-adrenoceptor agonist with a long side chain which binds to the exo-site of the receptor.
Fluticasone Propionate: Fluticasone Propionate given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbaions of asthma, without the adverse effects observed when corticosteroids are administered systemically.
DosageView
Inhalation Aerosol:
Inhalation Powder in Maxhaler (For Asthma): This is a moulded plastic device containing a foil strip with 60 regularly placed blisters containing pre-dispensed inhalation powder. Patients should be made aware that Maxhaler must be used daily for optimum benefit, even when asymptomatic.
Adults and Adolescents (12 years and older)-
- Adults and adolescents 12 years and older: 2 puffs of 25 µg Salmeterol and 50 µg Fluticasone Propionate twice daily or 2 puffs of 25 µg Salmeterol and 125 µg Fluticasone Propionate twice daily or 2 puffs of 25 µg Salmeterol and 250 µg Fluticasone Propionate twice daily.
- Children (4-12 years): 2 puffs of 25 µg salmeterol and 50 µg Fluticasone Propionate twice daily.
- Adult and Adolescent (12 Years and Older): Salmeterol 50 µg & Fluticasone 100 µg or Salmeterol 50 µg & Fluticasone 250 µg twice daily (morning and evening, approximately 12 hours apart).
- The recommended starting dosages for Salmeterol 50 µg & Fluticasone 100 µg & Salmeterol 50 µg & Fluticasone 250 µg for patients aged 12 years and older are based upon patients asthma severity.
- The maximum recommended dosage is Salmeterol 50 µg & Fluticasone 500 µg twice daily.
- Pediatric Patients (4 to 11 Years): For patients with asthma who are not controlled on an inhaled corticosteroid, the dosage is Salmeterol 50 µg & Fluticasone 100 µg twice daily (morning and evening, approximately 12 hours apart).
Inhalation Powder in Maxhaler (For Asthma): This is a moulded plastic device containing a foil strip with 60 regularly placed blisters containing pre-dispensed inhalation powder. Patients should be made aware that Maxhaler must be used daily for optimum benefit, even when asymptomatic.
Adults and Adolescents (12 years and older)-
- 50/100 Maxhaler: One Inhalation twice daily
- 50/250 Maxhaler: One Inhalation twice daily
- 50/500 Maxhaler: One Inhalation twice daily
- 50/100 Maxhaler: One Inhalation twice daily. The maximum licensed dose of fluticasone propionate delivered by this Maxhaler in children is 100 ug twice daily. There are no data available for use of this Maxhaler in children aged under 4 years.
- Maxhaler: One Inhalation twice daily
- Special patient groups: There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available for use of this in patients with hepatic impairment.
- Using the Maxhaler: This is a patient friendly, ready to use and easy to grip device. Use as per instructions for use.
AdministrationView
Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.
Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):
Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):
- Take off the cap.
- Shake the inhaler (at least six times) vigorously before each use.
- If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
- Breathe out as full as comfortably possible & hold the inhaler upright.
- Place the actuator into mouth between the teeth and close lips around the mouthpiece.
- While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
- Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
- If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
- After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
- Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.
Side effectsView
As this preparation contains Salmeterol and Fluticasone Propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds. Adverse events, which have been associated with Salmeterol or Fluticasone Propionate, are given below.
Salmeterol: The pharmacological side effects of beta-2-agonist treatment, such as tremor, subjective palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. Cardiac arrhythmia (including atrial fibrillation, supraventricular tachycardia and extra systoles) may occur, usually in susceptible patients. There have been reports of arthralgia and hypersensitivity reactions, including rash, oedema and angioedema. There have been reports of oropharyngeal irritation. There have been rare reports of muscle cramps.
Fluticasone propionate: Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported. Rare cases of facial and oropharyngeal oedema have been reported. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of Salmeterol/ Fluticasone Propionate Inhaler.
Salmeterol: The pharmacological side effects of beta-2-agonist treatment, such as tremor, subjective palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. Cardiac arrhythmia (including atrial fibrillation, supraventricular tachycardia and extra systoles) may occur, usually in susceptible patients. There have been reports of arthralgia and hypersensitivity reactions, including rash, oedema and angioedema. There have been reports of oropharyngeal irritation. There have been rare reports of muscle cramps.
Fluticasone propionate: Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported. Rare cases of facial and oropharyngeal oedema have been reported. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of Salmeterol/ Fluticasone Propionate Inhaler.
ContraindicationsView
This is contraindicated in patients with a history of hypersensitivity to any of the ingredients.
PrecautionsView
Consideration should be given to additional corticosteroid therapies, and to including administration of antibiotics if an infection is present. As with all inhaled medication containing corticosteroids, this preparation should be administered with caution in patients with active or quiescent pulmonary tuberculosis. This preparation should be administered with caution in patients with thyrotoxicosis.
InteractionsView
Both non-selective and selective β-blockers should be avoided in patients with asthma, unless there are compelling reasons for their use. Due to the very low plasma concentrations achieved after inhaled dosing clinically significant drug interactions are unlikely. Care should be taken when co-administering known strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir), as there is potential for increased systemic exposure to Fluticasone Propionate.
Pregnancy & lactationView
Administration of drugs during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus or child. There is insufficient experience of the use of Salmeterol Xinafoate and Fluticasone Propionate in human pregnancy and lactation. There are no data available for human breast milk.
Pediatric usageView
Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to paediatric patients. The long-term effects of this reduction including the impact of final adult height are unknown.
StorageView
Pressurised canister, do not puncture, break or incinerate even when apparently empty. Avoid storage in direct sunlight or heat. Store below 30°C. Keep away from eyes. Keep away from children.
Protide
Salmeterol + Fluticasone Propionate
Protide
Salmeterol + Fluticasone Propionate
Indications
COPD
Indication detailsView
This is indicated in the regular treatment of asthma where use of a combination product (long-acting β2-agonist and inhaled corticosteroid) is appropriate:
- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting β2-agonist or
- patients already adequately controlled on both inhaled corticosteroid and long-acting β2-agonist.
Therapeutic classView
Long-acting selective β-adrenoceptor stimulants, Respiratory corticosteroids
PharmacologyView
Salmeterol Xinafoate is a selective, long acting beta-2 agonist used in the treatment of asthma and other forms of diffuse airways obstruction. Fluticasone Propionate is a corticosteroid with mainly glucocorticoid activity. Fluticasone Propionate is stated to exert a topical effect on the lungs without systematic effects at usual dose.
Salmeterol protects against symptoms, Fluticasone Propionate improves lung function and prevents exacerbations of the condition. This preparation can offer a more convenient regime for patients on concurrent β-agonist and inhaled corticosteroid therapy. The respective mechanisms of action of both drugs are discussed below:
Salmeterol: Salmeterol is a selective long-acting (12 hour) beta-2-adrenoceptor agonist with a long side chain which binds to the exo-site of the receptor.
Fluticasone Propionate: Fluticasone Propionate given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbaions of asthma, without the adverse effects observed when corticosteroids are administered systemically.
Salmeterol protects against symptoms, Fluticasone Propionate improves lung function and prevents exacerbations of the condition. This preparation can offer a more convenient regime for patients on concurrent β-agonist and inhaled corticosteroid therapy. The respective mechanisms of action of both drugs are discussed below:
Salmeterol: Salmeterol is a selective long-acting (12 hour) beta-2-adrenoceptor agonist with a long side chain which binds to the exo-site of the receptor.
Fluticasone Propionate: Fluticasone Propionate given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbaions of asthma, without the adverse effects observed when corticosteroids are administered systemically.
DosageView
Inhalation Aerosol:
Inhalation Powder in Maxhaler (For Asthma): This is a moulded plastic device containing a foil strip with 60 regularly placed blisters containing pre-dispensed inhalation powder. Patients should be made aware that Maxhaler must be used daily for optimum benefit, even when asymptomatic.
Adults and Adolescents (12 years and older)-
- Adults and adolescents 12 years and older: 2 puffs of 25 µg Salmeterol and 50 µg Fluticasone Propionate twice daily or 2 puffs of 25 µg Salmeterol and 125 µg Fluticasone Propionate twice daily or 2 puffs of 25 µg Salmeterol and 250 µg Fluticasone Propionate twice daily.
- Children (4-12 years): 2 puffs of 25 µg salmeterol and 50 µg Fluticasone Propionate twice daily.
- Adult and Adolescent (12 Years and Older): Salmeterol 50 µg & Fluticasone 100 µg or Salmeterol 50 µg & Fluticasone 250 µg twice daily (morning and evening, approximately 12 hours apart).
- The recommended starting dosages for Salmeterol 50 µg & Fluticasone 100 µg & Salmeterol 50 µg & Fluticasone 250 µg for patients aged 12 years and older are based upon patients asthma severity.
- The maximum recommended dosage is Salmeterol 50 µg & Fluticasone 500 µg twice daily.
- Pediatric Patients (4 to 11 Years): For patients with asthma who are not controlled on an inhaled corticosteroid, the dosage is Salmeterol 50 µg & Fluticasone 100 µg twice daily (morning and evening, approximately 12 hours apart).
Inhalation Powder in Maxhaler (For Asthma): This is a moulded plastic device containing a foil strip with 60 regularly placed blisters containing pre-dispensed inhalation powder. Patients should be made aware that Maxhaler must be used daily for optimum benefit, even when asymptomatic.
Adults and Adolescents (12 years and older)-
- 50/100 Maxhaler: One Inhalation twice daily
- 50/250 Maxhaler: One Inhalation twice daily
- 50/500 Maxhaler: One Inhalation twice daily
- 50/100 Maxhaler: One Inhalation twice daily. The maximum licensed dose of fluticasone propionate delivered by this Maxhaler in children is 100 ug twice daily. There are no data available for use of this Maxhaler in children aged under 4 years.
- Maxhaler: One Inhalation twice daily
- Special patient groups: There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available for use of this in patients with hepatic impairment.
- Using the Maxhaler: This is a patient friendly, ready to use and easy to grip device. Use as per instructions for use.
AdministrationView
Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.
Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):
Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):
- Take off the cap.
- Shake the inhaler (at least six times) vigorously before each use.
- If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
- Breathe out as full as comfortably possible & hold the inhaler upright.
- Place the actuator into mouth between the teeth and close lips around the mouthpiece.
- While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
- Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
- If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
- After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
- Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.
Side effectsView
As this preparation contains Salmeterol and Fluticasone Propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds. Adverse events, which have been associated with Salmeterol or Fluticasone Propionate, are given below.
Salmeterol: The pharmacological side effects of beta-2-agonist treatment, such as tremor, subjective palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. Cardiac arrhythmia (including atrial fibrillation, supraventricular tachycardia and extra systoles) may occur, usually in susceptible patients. There have been reports of arthralgia and hypersensitivity reactions, including rash, oedema and angioedema. There have been reports of oropharyngeal irritation. There have been rare reports of muscle cramps.
Fluticasone propionate: Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported. Rare cases of facial and oropharyngeal oedema have been reported. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of Salmeterol/ Fluticasone Propionate Inhaler.
Salmeterol: The pharmacological side effects of beta-2-agonist treatment, such as tremor, subjective palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. Cardiac arrhythmia (including atrial fibrillation, supraventricular tachycardia and extra systoles) may occur, usually in susceptible patients. There have been reports of arthralgia and hypersensitivity reactions, including rash, oedema and angioedema. There have been reports of oropharyngeal irritation. There have been rare reports of muscle cramps.
Fluticasone propionate: Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported. Rare cases of facial and oropharyngeal oedema have been reported. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of Salmeterol/ Fluticasone Propionate Inhaler.
ContraindicationsView
This is contraindicated in patients with a history of hypersensitivity to any of the ingredients.
PrecautionsView
Consideration should be given to additional corticosteroid therapies, and to including administration of antibiotics if an infection is present. As with all inhaled medication containing corticosteroids, this preparation should be administered with caution in patients with active or quiescent pulmonary tuberculosis. This preparation should be administered with caution in patients with thyrotoxicosis.
InteractionsView
Both non-selective and selective β-blockers should be avoided in patients with asthma, unless there are compelling reasons for their use. Due to the very low plasma concentrations achieved after inhaled dosing clinically significant drug interactions are unlikely. Care should be taken when co-administering known strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir), as there is potential for increased systemic exposure to Fluticasone Propionate.
Pregnancy & lactationView
Administration of drugs during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus or child. There is insufficient experience of the use of Salmeterol Xinafoate and Fluticasone Propionate in human pregnancy and lactation. There are no data available for human breast milk.
Pediatric usageView
Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to paediatric patients. The long-term effects of this reduction including the impact of final adult height are unknown.
StorageView
Pressurised canister, do not puncture, break or incinerate even when apparently empty. Avoid storage in direct sunlight or heat. Store below 30°C. Keep away from eyes. Keep away from children.
Protilez
Aceclofenac
Protilez
Aceclofenac
Indications
Spondylitis
Indication detailsView
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma and lumbago.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
DosageView
Extended release tablet: The recommended dose in adults is one 200 mg Aceclofenac tablet daily or as prescribed by the physician.
Film coated tablet: The recommended dose in adults is 100 mg, twice daily.
Side effectsView
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
ContraindicationsView
Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.
PrecautionsView
Caution should be exercised to patients with active or suspected peptic ulcer or gastro-intestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.
InteractionsView
No significant drug interactions has not been observed but close monitoring of patients is required when it is used with:
- Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
- Diuretics: may interact the activity of diuretics.
- Anticoagulants: may enhance the activity of anticoagulant.
- Methotrexate: may increase the plasma level of methotrexate.
Pregnancy & lactationView
The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Pediatric usageView
There are no clinical data on the use of Aceclofenac in children.
StorageView
keep in a dry place away from light and heat. Keep out of the reach of children.
Protinavit
Spirulina
Protinavit
Spirulina
Indications
Runny nose
Indication detailsView
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.
Therapeutic classView
Herbal and Nutraceuticals
PharmacologyView
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-
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.
DosageView
2 to 4 capsules daily or as advised by the physician.
Side effectsView
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.
ContraindicationsView
Spirulina is contraindicated in those who are hypersensitive to any component of this product.
PrecautionsView
Before taking spirulina pregnant or breast-feeding women should talk to the physician.
InteractionsView
There are no reports suggesting that spirulina interacts with any conventional medication.
Pregnancy & lactationView
Before taking spirulina pregnant or breast-feeding women should talk to the physician.
StorageView
Store in a cool and dry place. Keep away from direct sunlight. Keep out of reach of the children.