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Indicated for the treatment of osteoarthritis of knee, hip, spine, hand, and other locations as a dietary supplement. It is also beneficial in rheumatoid arthritis, sport injuries, migraine, different skin problems (e.g., psoriasis), vascular complications (e. g., atherosclerosis), kidney stones, and inflammatory bowel disease (e.g., ulcerative colitis, leaky gut syndrome).

Stimulation of Cartilage formation

Glucosamine is a natural amino-sugar, produced by the body and found in certain foods. It is the most fundamental building block required for biosynthesis of glycosaminoglycans (GAGs) like Hyaluronic Acid, Keratan Sulfate, and Chondroitin Sulfate. GAGs binds with protein and form proteoglycans, the essential building block of articular cartilage. When cartilage in a joint deteriorates,Osteoarthritis develops. It also helps to form ligaments, tendon, nails, and various other connective tissues.When we take artificially synthesized Glucosamine Sulfate supplement, it increases Glucosamine level in the body, thus facilitates production and repair of cartilage. Glucosamine also activates chondrocytes in the cartilage which help produce GAGs and proteoglycans.

Chondroitin Sulfate is a glycosaminoglycan (acid muco polysaccharide) found in connective tissue, especially in the articular cartilage of all mammals. Chondroitin Sulfate supplement acts similarly as Glucosamine Sulfate, since it also provide substrate for proteoglycans. Chondroitin also protects existing healthy cartilage from premature decline by preventing the MMP (Matrix metalloproteinase) enzyme that breakdowns the proteoglycans.

Combining Glucosamine with Chondroitin Sulfate shows synergistic effect. Data supports that this combination has been shown to be very much effective in severe cases of Osteoarthritis that treats both sign and symptoms of Osteoarthritis & modifies disease progression. It prevents Osteoarthritis in case of normal adults. In Osteoarthritic pain it is as effective as NSAIDs with significantly better tolerability and clinical compliance. It is also helpful during the repair phase of musculo-skeletal soft tissue injuries such as tendon or ligament strains

250/200 mg tablet: 1 to 2 tablets, three times daily. Dose may be adjusted according to the response of the drug and body weight. Doses can be tapered after 60 days as per requirement of the individual and for cost convenience. Typical dosage recommendation, based on body weight is as follows-

• Under 54 Kg: 1000 mg Glucosamine Sulfate & 800 mg Chondroitin Sulfate per day
• 54 Kg to 91 Kg: 1500 mg Glucosamine Sulfate & 1200 mg Chondroitin Sulfate per day
• Over 91 Kg: 2000 mg Glucosamine Sulfate & 1600 mg Chondroitin Sulfate per day.

750/600 mg tablet: 1 tablet two times daily or as directed by the physician.

Safety studies with Glucosamine Sulfate & Chondroitin Sulfate show no demonstrable side effects. Rarely occurring side effects (such as, mild & reversible intestinal flatulence) are almost like placebo.

There are no known contraindications for Glucosamine and Chondroitin. But proven hypersensitivity (e. g. allergic to shellfish or sulfur) to Glucosamine and Chondroitin is a contraindication.

Patients with Diabetes Mellitus are advised to monitor blood glucose levels regularly when taking Glucosamine. No special studies were formed in patients with renal or hepatic insufficiency. The toxicological and pharmacokinetic profile of Glucosamine and Chondroitin does not indicate limitations for these patients. However, administration to patients with severe hepatic or renal insufficiency should be under appropriate medical supervision. Children should not be supplemented with Glucosamine and Chondroitin.

There have been no reports of significant drug interactions of Glucosamine and Chondroitin with Antibiotics/ Antidepressants/ Antihypertensives/ Nitrates/ Antiarrythmics/ Anxiolytics/ Hypoglycemic agents/ Antisecretives/ Antiasthmatics. Chondroitin may enhance the blood thinning effects of anticoagulants like Warfarin, Heparin.

Women who are pregnant or who could become pregnant should not supplement with Glucosamine Sulfate or Chondroitin Sulfate. Glucosamine and Chondroitin has not been studied enough to determine their effects on a developing fetus. No studies have evaluated the use of Glucosamine and Chondroitin during pregnancy or lactation. It should be taken with caution and medical advice during pregnancy and lactation.

Store in a cool and dry place, protected from light.

This is indicated for the fast relief of pain, discomfort and inflammation caused by Mouth ulcer/Aphthous ulcer/Canker sore, Cold sore/Fever blister, Denture sore, Irritation from braces, Gum swelling, and sore spots due to orthodontic device.

Non-steroidal Anti-inflammatory Drugs (NSAIDs), Preparations for Oral Ulceration & Inflammation

Choline salicylate has an analgesic & anti-inflammatory effect. Like salicylic acid Choline salicylate has no antithrombotic activity. The pharmacological actions of choline salicylate are thought to be primarily mediated through inhibition of prostaglandin production. Cetalkonium chloride is an antiseptic, being bactericidal towards both Gram-positive and Gram-negative organisms.

Absorption: Choline salicylate is absorbed from the gut
Distribution: Throughout extracellular water and most tissues
Plasma Half-life: 2-4 hours
Excretion: Mainly in the Urine
Protein binding: 80-90%

Adult: Wash hands, apply ½ inch of gel on to the sore area. This can be repeated after every 3 hours.

Salicylates may produce bronchospasm and induce asthma attacks in susceptible patients.

Not to be used in:

• If allergic to salicylates, e.g. Aspirin
• If have an active peptic ulcer

Do not exceed the recommended dose.

Salicylates may enhance the effect of anticoagulants and inhibit the action of uricosurics.

There is clinical evidence of the safety of salicylates in pregnancy. This medicine may pass into breast milk in very small amounts but is unlikely to have any adverse effects on a nursing infant.

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

Specific mineral & vitamin combined preparations

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.

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.

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.

It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.

If there is any pre-existing heart disease or kidney disease, precautions should be taken.

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.

This combination should be used as directed by physician during pregnancy or while breast-feeding.

Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache, constipation.

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

Minerals in bone formation, Specific mineral preparations

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.

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.

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.

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.

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).

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.

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.

Keep out of the reach of children. Keep in a cool & dry place. Protect from light.

Specific mineral & vitamin combined preparations

This is combination of Calcium (Algae Source) & Vitamin D3. Calcium (Algae Source) is an essential element and plays vital role in the body. It makes body's framework stronger by building bones. Clinical evidence suggests that calcium is useful for prevention and treatment of osteoporosis and associated fractures. Vitamin D3 is also essential for healthy bones as it aids in calcium absorption from the Gl tract. In addition to this it stimulates bone formation. Controlled clinical studies show that Calcium and Vitamin D3 have synergistic effects on bone growth as well as in osteoporosis and fracture prevention.

Usual adult dose: 1 tablet in the morning and 1 tablet at night. Tablet should be taken orally.

Common side effects of Calcium and Vitamin D3 may include an irregular heartbeat, nausea, dry mouth, weakness, headache, a metallic taste in mouth, muscle or bone pain and drowsiness. Rare side effects are high amount of Calcium in blood, constipation, diarrhoea, loss of appetite.

Caution should be taken in patients with renal impairment, sarcoidosis, hypercalcemia and hypercalciuria.

With medicine:

• Calcium salts reduce absorption of bisphosphonates, ciprofloxacin, fluorides, iron, levothyroxine, tetracycline and zinc
• Absorption of calcium salts is reduced by corticosteroids
• Increased risk of hypercalcemia when Calcium and Vitamin D3 given with thiazides and related diuretics

With food and others: No clinically significant food drug interaction have been reported.

During pregnancy & lactation: Calcium and Vitamin D3 should be used considering the risk-benefit ratio.

Not recommended for children under 12 years.

At high doses it may result in nausea, vomiting, dizziness, anorexia, abdominal cramps, headache, constipation etc. Treatment includes cessation of therapy & adequate rehydration.

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

Specific mineral & vitamin combined preparations

This is combination of Calcium (Algae Source) & Vitamin D3. Calcium (Algae Source) is an essential element and plays vital role in the body. It makes body's framework stronger by building bones. Clinical evidence suggests that calcium is useful for prevention and treatment of osteoporosis and associated fractures. Vitamin D3 is also essential for healthy bones as it aids in calcium absorption from the Gl tract. In addition to this it stimulates bone formation. Controlled clinical studies show that Calcium and Vitamin D3 have synergistic effects on bone growth as well as in osteoporosis and fracture prevention.

Usual adult dose: 1 tablet in the morning and 1 tablet at night. Tablet should be taken orally.

Common side effects of Calcium and Vitamin D3 may include an irregular heartbeat, nausea, dry mouth, weakness, headache, a metallic taste in mouth, muscle or bone pain and drowsiness. Rare side effects are high amount of Calcium in blood, constipation, diarrhoea, loss of appetite.

Caution should be taken in patients with renal impairment, sarcoidosis, hypercalcemia and hypercalciuria.

With medicine:

• Calcium salts reduce absorption of bisphosphonates, ciprofloxacin, fluorides, iron, levothyroxine, tetracycline and zinc
• Absorption of calcium salts is reduced by corticosteroids
• Increased risk of hypercalcemia when Calcium and Vitamin D3 given with thiazides and related diuretics

With food and others: No clinically significant food drug interaction have been reported.

During pregnancy & lactation: Calcium and Vitamin D3 should be used considering the risk-benefit ratio.

Not recommended for children under 12 years.

At high doses it may result in nausea, vomiting, dizziness, anorexia, abdominal cramps, headache, constipation etc. Treatment includes cessation of therapy & adequate rehydration.

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

Specific mineral & vitamin combined preparations

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.

2 tablets per day, preferably 1 tablet in the morning and 1 tablet in the evening.

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.

It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.

If there is any pre-existing heart disease or kidney disease, precautions should be taken.

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.

This combination should be used as directed by physician during pregnancy or while breast-feeding.

Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache & constipation.

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

Bisphosphonate preparations

Zoledronic acid belongs to the class of nitrogen-containing bisphosphonates and acts primarily on bone. It is an inhibitor of osteoclast-mediated bone resorption. The action of bisphosphonates on bone is based on their high affinity for mineralized bone. Intravenously administered Zoledronic acid is rapidly distributed to bone. The main molecular target of Zoledronic acid in the osteoclast is the enzyme farnesyl pyrophosphate synthase, but this does not exclude other mechanisms. There was no accumulation of the active substance in plasma after multiple doses given every 28 days. Zoledronic acid is not metabolized and is excreted unchanged via the kidney.

Treatment of postmenopausal osteoporosis: Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year. Adequate supplemental Calcium and Vitamin-D intake is important in women with osteoporosis if dietary intake is inadequate. 

Prevention of clinical fractures after a hip fracture: Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year. In patients with a recent low-trauma hip fracture, it is recommended to give the first Zoledronic Acid solution for infusion two or more weeks after hip fracture repairs. It is also recommended to have a loading dose of 50,000 to 125,000 IU of Vitamin-D given orally or via intramuscular route prior to the first administration of Zoledronic Acid solution for infusion. Supplemental Calcium and Vitamin-D intake is recommended for patients treated to prevent clinical fractures after a hip fracture.

Treatment of osteoporosis in men: Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year. Adequate supplemental Calcium and Vitamin-D intake is important in men with osteoporosis if dietary intake is inadequate. 

Treatment and prevention of glucocorticoid-induced osteoporosis: Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year. Adequate supplemental Calcium and Vitamin-D intake is important in patients with osteoporosis if dietary intake is inadequate.

Treatment of paget's disease of bone: Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid. Re-treatment with Zoledronic Acid may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase, in patients who failed to achieve normalization of serum alkaline phosphatase, or in patients with symptoms, as dictated by medical practice 12 months after the initial dose.

In patients with paget's disease, adequate Vitamin-D intake is recommended in association with Zoledronic Acid administration. In addition, it is strongly advised that adequate supplemental Calcium corresponding to at least 500 mg elemental Calcium twice daily is ensured in patients with paget's disease for at least 10 days following Zoledronic Acid administration.

The dose of 5 mg Zoledronic acid must be administered over at least 15 minutes. Zoledronic Acid should be administered intravenously via a infusion line, given at a constant infusion rate. The infusion time must not be less than 15 minutes.

The post-dose side-effects are fever, myalgia, flu-like symptoms, arthralgia and headache, the majority of which occur within the first 3 days following Zoledronic Acid administration. The majority of these symptoms were mild to moderate in nature and resolved within 3 days of the event onset. The incidence of these symptoms occurring within the first 3 days after administration of Zoledronic Acid, can be reduced with the administration of Paracetamol or Ibuprofen shortly following Zoledronic Acid administration. Severe and occasionally incapacitating bone, joint, and/or muscle pain have been infrequently reported in patients taking Zoledronic Acid.

The drug is contraindicated if patients have hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates, hypocalcaemia, renal impairment (creatinine clearance <35 mL/min), current or recent uveitis, or a history of bisphosphonate-associated uveitis, pregnancy and lactation.

Patients must be appropriately hydrated prior to administration of Zoledronic Acid. This is especially important in the elderly and for patients receiving diuretic therapy. Adequate hydration can be achieved by the patient drinking two glasses of fluid (such as water) before and after the infusion. Pre-existing hypocalcaemia must be treated by adequate intake of Calcium and Vitamin-D before initiating therapy with Zoledronic Acid. Other disturbances of mineral metabolism must also be effectively treated (e.g. diminished parathyroid reserve, thyroid surgery, parathyroid surgery, intestinal Calcium malabsorption). Physicians should consider clinical monitoring for these patients.

Specific drug-drug interaction studies have not been conducted with Zoledronic acid. Zoledronic acid is eliminated by renal excretion. Caution is indicated when Zoledronic Acid is administered in conjunction with drugs that can significantly impact renal function (e.g. aminoglycosides or diuretics that may cause dehydration).

Zoledronic Acid is contraindicated during pregnancy and in breast-feeding women. It is also not recommended for use in children and adolescents below 18 years of age.

Patients with renal impairment: The use of Zoledronic Acid in patients with creatinine clearance <35 mL/min is not recommended due to limited clinical safety data in such patients. No dose adjustment is necessary in patients with creatinine clearance >35 mL/min.

Patients with hepatic impairment: No dose adjustment is required for patients with hepatic impairment.

Elderly patients: No dose adjustment is required. However, because decreased renal function occurs more commonly in the elderly, special care should be taken to monitor renal function.

Zoledronic Acid must not be mixed or given intravenously with any other medication and must be given through a separate infusion line at a constant infusion rate. If refrigerated, allow the refrigerated solution to reach room temperature before administration. Aseptic techniques must be followed during the preparation of the infusion. Any unused solution should be discarded. Only clear solution free from particles and discoloration should be used.

After opening, the solution is chemically and physically stable for at least 24 hours at 2°C to 8°C. From a microbiological point of view, the product should be used immediately. Zoledronic Acid solution for infusion must not be allowed to come into contact with any Calcium or other divalent cation-containing solutions.

Clinical experience with acute over dosage is limited. Patients who have received doses higher than those recommended should be carefully monitored. In the event of overdose leading to clinically significant hypocalcaemia, reversal may be achieved with supplemental oral Calcium and/or an infusion of Calcium.

Store below 30° C prior to opening. Protect from moisture and light. Zoledronic Acid must be kept out of the reach and sight of children.

Ibandronic acid is indicated for the treatment of postmenopausal osteoporosis, to reduce the risk of fractures.

Treatment of Osteoporosis: Osteoporosis may be confirmed by the finding of low bone mass (T-score <-2.0 SD) and the presence or history of osteoporotic fracture, or a low bone mass (T-score <-2.5 SD) in the absence of documented pre-existing osteoporotic fracture.

Bisphosphonate preparations

The pharmacodynamic action of ibandronic acid is inhibition of bone resorption. In vivo, ibandronic acid prevents experimentally induced bone destruction caused by cessation of gonadal function, retinoids, tumors or tumor extracts. In young (fast growing) rats, the endogenous bone resorption is also inhibited, leading to increased bone mass compared with untreated animals. Animal models confirm that ibandronic acid is a highly potent inhibitor of osteoclastic activity. In growing rats, there was no evidence of impaired mineralization even at doses greater than 5,000 times the dose required for osteoporosis treatment. The high potency and therapeutic margin of ibandronic acid allows for more flexible dosing regimens and intermittent treatment with long drug-free intervals at comparatively low doses.

Ibandronic acid is a highly potent bisphosphonate belonging to the nitrogen-containing group of bisphosphonates, which act on bone tissue and specifically inhibit osteoclast activity, It does not interfere with osteoclast recruitment. The selective action of ibandronic acid on bone tissue is based on the high affinity of this compound for hydroxyapatite, which represents the mineral matrix of the bone. Ibandronic acid reduces bone resorption, with no direct effect on bone formation. In postmenopausal women, it reduces the elevated rate of bone turnover towards premenopausal levels, leading to a progressive net gain in bone mass. Daily or intermittent administration of ibandronic acid results in reduced bone resorption as reflected in reduced levels of serum and urinary biochemical markers of bone turnover, increased BMD and a decreased incidence of fractures.

The recommended dose of Ibandronic acid for treatment is one 150 mg film-coated tablet once a month. The tablet should preferably be taken on the same date each month. Ibandronic acid should be taken 60 minutes before the first food or drink (other than water) of the day or any other oral medication or supplementation (including calcium):

• Tablets should be swallowed whole with a full glass of plain water (180 to 240 ml) while the patient is sitting or standing in an upright position. Patients should not lie down for 60 minutes after taking Ibandronic acid.
• Plain water is the only drink that should be taken with Ibandronic acid. Please note that some mineral waters may have a higher concentration of calcium and therefore should not be used.
• Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration. Patients should receive supplemental calcium or vitamin D if dietary intake is inadequate. In case a once-monthly dose is missed, patients should be instructed to take one Ibandronic Acid 150 mg tablet the morning after the tablet is remembered unless the time to the next scheduled dose is within 7 days. Patients should then return to taking their dose once a month on their originally scheduled date. If the next scheduled dose is within 7 days, patients should wait until their next dose and then continue taking one tablet once a month as originally scheduled. Patients should not take two 150 mg tablets within the same week.

The main side effects of ibandronic acid are dyspepsia, nausea, diarrhea, abdominal pain, muscle aches, headaches, dizziness.

Ibandronic Acid is contraindicated in patients with known hypersensitivity to ibandronic acid or to any of the excipients. Ibandronic Acid is contraindicated in patients with uncorrected hypocalcemia. As with all bisphosphonates indicated in the treatment of osteoporosis, pre-existing hypocalcemia needs to be corrected before initiating therapy with Ibandronic Acid. As with several bisphosphonates, Ibandronic Acid is contraindicated in patients with abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia. Ibandronic Acid is contraindicated in patients who are unable to stand or sit upright for at least 60 minutes.

Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Ibandronic Acid therapy. Adequate intake of calcium and vitamin D is important in all patients. Orally administered bisphosphonates may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Ibandronic Acid is given to patients with active upper gastrointestinal problems (e.g. known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers). Adverse experiences such as esophagitis, esophageal ulcers and esophageal erosions, in some cases severe and requiring hospitalization, rarely with bleeding or followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. The risk of severe esophageal adverse experiences appears to be greater in patients who do not comply with the dosing instruction and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. Patients should pay particular attention and be able to comply with the dosing instructions.

Physicians should be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue Ibandronic Acid and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. While no increased risk was observed in controlled clinical trials there have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications. Since NSAIDs and bisphosphonates are both associated with gastrointestinal irritation, caution should be taken during concomitant medication with Ibandronic Acid. Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates. Most cases have been in cancer patients undergoing dental procedures, but some have occurred in patients with postmenopausal osteoporosis or other diagnoses. Known risk factors for osteonecrosis of the jaw include a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids), and co-morbid disorders (e.g., anemia, coagulopathy, infection, pre-existing dental disease). Most reported cases have been in patients treated with bisphosphonates intravenously but some have been in patients treated orally. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit-risk assessment.

It is likely that calcium supplements, antacids and some oral medications containing multivalent cations (such as aluminium, magnesium, iron) are likely to interfere with the absorption of Ibandronic Acid. Therefore, patients must wait 60 minutes after taking Ibandronic Acid before taking other oral medications. Pharmacokinetic interaction studies in postmenopausal women have demonstrated the absence of any interaction potential with tamoxifen or hormone replacement therapy (estrogen). No interaction was observed when co-administered with melphalan/prednisolone in patients with multiple myeloma. In healthy male volunteers and postmenopausal women, i.v. ranitidine caused an increase in ibandronic acid bioavailability of about 20 %, probably as a result of reduced gastric acidity. However, since this increase is within the normal range of the bioavailability of ibandronic acid, no dosage adjustment is required when Ibandronic Acid is administered with H2-antagonists or other drugs which increase gastric pH.

In relation to disposition, no drug interactions of clinical significance are considered likely, since ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and has been shown not to induce the hepatic cytochrome P450 system in rats. Furthermore, plasma protein binding is low at therapeutic concentrations and ibandronic acid is therefore unlikely to displace other drugs. Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation. The secretory pathway appears not to include known acidic or basic transport systems involved in the excretion of other drugs. In a one-year study in postmenopausal women with osteoporosis (BM16549). the incidence of upper gastrointestinal events in patients concomitantly taking aspirin or NSAIDs was similar in patients taking Ibandronic Acid 2.5 mg daily or 150mg once monthly. Of over 1500 patients enrolled in study BM 16549 comparing monthly with daily dosing regimens of ibandronic acid, 14% of patients used histamine (H2) blockers or proton pump inhibitors. Among these patients, the incidence of upper gastrointestinal events in the patients treated with Ibandronic Acid 150 mg once monthly was similar to that in patients treated with Ibandronic Acid 2.5 mg daily.

Pregnancy: Ibandronic Acid should not be used during pregnancy. There was no evidence for a direct fetal toxic or teratogenic effect of ibandronic acid in daily orally treated rats and rabbits and there were no adverse effects on the development in F1 offspring in rats. Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class. They include a decreased number of implantation sites, interference with natural delivery (dystocia), and an increase in visceral variations (renal pelvis ureter syndrome). Specific studies for the monthly regimen have not been performed. There is no clinical experience with Ibandronic Acid in pregnant women.

Nursing Mothers: Ibandronic Acid should not be used during lactation. In lactating rats treated with 0.08 mg/kg/day IV. ibandronic acid, the highest concentration of ibandronic acid in breast milk was 8.1 ng/ml and was seen in the first 2 hours after i.v. administration. After 24 hours, the concentration in milk and plasma was similar, and corresponded to about 5 % of the concentration measured after 2 hours.

No specific information is available on the treatment of overdosage with ibandronic acid. However, oral overdosage may result in upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer. Milk or antacids should be given to bind ibandronic acid. Owing to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright.

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

Specific mineral & vitamin combined preparations

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.

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.

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.

It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.

If there is any pre-existing heart disease or kidney disease, precautions should be taken.

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.

This combination should be used as directed by physician during pregnancy or while breast-feeding.

Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache, constipation.

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

Specific mineral & vitamin combined preparations

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.

2 tablets per day, preferably 1 tablet in the morning and 1 tablet in the evening.

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.

It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.

If there is any pre-existing heart disease or kidney disease, precautions should be taken.

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.

This combination should be used as directed by physician during pregnancy or while breast-feeding.

Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache & constipation.

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

Ibandronic acid is indicated for the treatment of postmenopausal osteoporosis, to reduce the risk of fractures.

Treatment of Osteoporosis: Osteoporosis may be confirmed by the finding of low bone mass (T-score <-2.0 SD) and the presence or history of osteoporotic fracture, or a low bone mass (T-score <-2.5 SD) in the absence of documented pre-existing osteoporotic fracture.

Bisphosphonate preparations

The pharmacodynamic action of ibandronic acid is inhibition of bone resorption. In vivo, ibandronic acid prevents experimentally induced bone destruction caused by cessation of gonadal function, retinoids, tumors or tumor extracts. In young (fast growing) rats, the endogenous bone resorption is also inhibited, leading to increased bone mass compared with untreated animals. Animal models confirm that ibandronic acid is a highly potent inhibitor of osteoclastic activity. In growing rats, there was no evidence of impaired mineralization even at doses greater than 5,000 times the dose required for osteoporosis treatment. The high potency and therapeutic margin of ibandronic acid allows for more flexible dosing regimens and intermittent treatment with long drug-free intervals at comparatively low doses.

Ibandronic acid is a highly potent bisphosphonate belonging to the nitrogen-containing group of bisphosphonates, which act on bone tissue and specifically inhibit osteoclast activity, It does not interfere with osteoclast recruitment. The selective action of ibandronic acid on bone tissue is based on the high affinity of this compound for hydroxyapatite, which represents the mineral matrix of the bone. Ibandronic acid reduces bone resorption, with no direct effect on bone formation. In postmenopausal women, it reduces the elevated rate of bone turnover towards premenopausal levels, leading to a progressive net gain in bone mass. Daily or intermittent administration of ibandronic acid results in reduced bone resorption as reflected in reduced levels of serum and urinary biochemical markers of bone turnover, increased BMD and a decreased incidence of fractures.

The recommended dose of Ibandronic acid for treatment is one 150 mg film-coated tablet once a month. The tablet should preferably be taken on the same date each month. Ibandronic acid should be taken 60 minutes before the first food or drink (other than water) of the day or any other oral medication or supplementation (including calcium):

• Tablets should be swallowed whole with a full glass of plain water (180 to 240 ml) while the patient is sitting or standing in an upright position. Patients should not lie down for 60 minutes after taking Ibandronic acid.
• Plain water is the only drink that should be taken with Ibandronic acid. Please note that some mineral waters may have a higher concentration of calcium and therefore should not be used.
• Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration. Patients should receive supplemental calcium or vitamin D if dietary intake is inadequate. In case a once-monthly dose is missed, patients should be instructed to take one Ibandronic Acid 150 mg tablet the morning after the tablet is remembered unless the time to the next scheduled dose is within 7 days. Patients should then return to taking their dose once a month on their originally scheduled date. If the next scheduled dose is within 7 days, patients should wait until their next dose and then continue taking one tablet once a month as originally scheduled. Patients should not take two 150 mg tablets within the same week.

The main side effects of ibandronic acid are dyspepsia, nausea, diarrhea, abdominal pain, muscle aches, headaches, dizziness.

Ibandronic Acid is contraindicated in patients with known hypersensitivity to ibandronic acid or to any of the excipients. Ibandronic Acid is contraindicated in patients with uncorrected hypocalcemia. As with all bisphosphonates indicated in the treatment of osteoporosis, pre-existing hypocalcemia needs to be corrected before initiating therapy with Ibandronic Acid. As with several bisphosphonates, Ibandronic Acid is contraindicated in patients with abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia. Ibandronic Acid is contraindicated in patients who are unable to stand or sit upright for at least 60 minutes.

Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Ibandronic Acid therapy. Adequate intake of calcium and vitamin D is important in all patients. Orally administered bisphosphonates may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Ibandronic Acid is given to patients with active upper gastrointestinal problems (e.g. known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers). Adverse experiences such as esophagitis, esophageal ulcers and esophageal erosions, in some cases severe and requiring hospitalization, rarely with bleeding or followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. The risk of severe esophageal adverse experiences appears to be greater in patients who do not comply with the dosing instruction and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. Patients should pay particular attention and be able to comply with the dosing instructions.

Physicians should be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue Ibandronic Acid and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. While no increased risk was observed in controlled clinical trials there have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications. Since NSAIDs and bisphosphonates are both associated with gastrointestinal irritation, caution should be taken during concomitant medication with Ibandronic Acid. Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates. Most cases have been in cancer patients undergoing dental procedures, but some have occurred in patients with postmenopausal osteoporosis or other diagnoses. Known risk factors for osteonecrosis of the jaw include a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids), and co-morbid disorders (e.g., anemia, coagulopathy, infection, pre-existing dental disease). Most reported cases have been in patients treated with bisphosphonates intravenously but some have been in patients treated orally. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit-risk assessment.

It is likely that calcium supplements, antacids and some oral medications containing multivalent cations (such as aluminium, magnesium, iron) are likely to interfere with the absorption of Ibandronic Acid. Therefore, patients must wait 60 minutes after taking Ibandronic Acid before taking other oral medications. Pharmacokinetic interaction studies in postmenopausal women have demonstrated the absence of any interaction potential with tamoxifen or hormone replacement therapy (estrogen). No interaction was observed when co-administered with melphalan/prednisolone in patients with multiple myeloma. In healthy male volunteers and postmenopausal women, i.v. ranitidine caused an increase in ibandronic acid bioavailability of about 20 %, probably as a result of reduced gastric acidity. However, since this increase is within the normal range of the bioavailability of ibandronic acid, no dosage adjustment is required when Ibandronic Acid is administered with H2-antagonists or other drugs which increase gastric pH.

In relation to disposition, no drug interactions of clinical significance are considered likely, since ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and has been shown not to induce the hepatic cytochrome P450 system in rats. Furthermore, plasma protein binding is low at therapeutic concentrations and ibandronic acid is therefore unlikely to displace other drugs. Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation. The secretory pathway appears not to include known acidic or basic transport systems involved in the excretion of other drugs. In a one-year study in postmenopausal women with osteoporosis (BM16549). the incidence of upper gastrointestinal events in patients concomitantly taking aspirin or NSAIDs was similar in patients taking Ibandronic Acid 2.5 mg daily or 150mg once monthly. Of over 1500 patients enrolled in study BM 16549 comparing monthly with daily dosing regimens of ibandronic acid, 14% of patients used histamine (H2) blockers or proton pump inhibitors. Among these patients, the incidence of upper gastrointestinal events in the patients treated with Ibandronic Acid 150 mg once monthly was similar to that in patients treated with Ibandronic Acid 2.5 mg daily.

Pregnancy: Ibandronic Acid should not be used during pregnancy. There was no evidence for a direct fetal toxic or teratogenic effect of ibandronic acid in daily orally treated rats and rabbits and there were no adverse effects on the development in F1 offspring in rats. Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class. They include a decreased number of implantation sites, interference with natural delivery (dystocia), and an increase in visceral variations (renal pelvis ureter syndrome). Specific studies for the monthly regimen have not been performed. There is no clinical experience with Ibandronic Acid in pregnant women.

Nursing Mothers: Ibandronic Acid should not be used during lactation. In lactating rats treated with 0.08 mg/kg/day IV. ibandronic acid, the highest concentration of ibandronic acid in breast milk was 8.1 ng/ml and was seen in the first 2 hours after i.v. administration. After 24 hours, the concentration in milk and plasma was similar, and corresponded to about 5 % of the concentration measured after 2 hours.

No specific information is available on the treatment of overdosage with ibandronic acid. However, oral overdosage may result in upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer. Milk or antacids should be given to bind ibandronic acid. Owing to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright.

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

This tablet is indicated in-

• Osteoarthritis
• Rheumatoid arthritis
• Bone and Joint injuries

Stimulation of Cartilage formation

Glucosamine: Glucosamine (2-amino-2-deoxy-alpha-D-glucose) is a natural amino sugar, produced by the body and found in certain foods. It is the most fundamental building block required for biosynthesis of glycosaminoglycans (GAGs) like Hyaluronic Acid, Keratan Sulfate and Chondroitin Sulfate. GAGs binds with protein and form proteoglycans, the essential building block of articular cartilage. When cartilage in a joint deteriorates, Osteoarthritis develops. It also helps to form ligaments, tendon, nails and various other connective tissues. When we take artificially synthesized Glucosamine Sulfate supplement, it increases Glucosamine level in the body, thus facilitates production and repair of cartilage. Glucosamine also activates chondrocytes in the cartilage which help produce GAGs and proteoglycans.

In humans, about 90 percent of glucosamine, administered as an oral dose of glucosamine sulfate, is absorbed from the digestive tract. Predominantly metabolized by liver & excreted through urine.

Diacerein: This is used for the treatment of Osteoarthritis. It has also analgesic, antipyretic and anti-inflammatory activity. It release in vitro and directly inhibits InterLeukin-1(IL-1) synthesis, which is the main cytokine involved in cartilage destruction. Due to specific mode of action, it have been shown to have disease-modifying effect in experimental models of osteoarthritis and in human subjects with finger joint and knee osteoarthritis.

Oral bioavailability of Diacerein 56%. Concurrent intake of food delays the time to peak concentration but associated with a 25% increase in absorption. Therefore, diacerein is best given with food. Mainly binds with protein albumin. Diacerein is metabolized extensively (100%) in liver following oral dosing. Urinary excretion of diacerein in the form of its metabolites has ranged between 35% and 60%.

Use in adults: One tablet twice daily with food.

Use in children and adolescents: The safety and effectiveness of children and adolescents under the age of 18 years have not been established.

No serious adverse effect has been reported. Nausea, vomiting, diarrhea, epigastria pain, headache, skin rashes & intense yellow coloring of urine may be occurred.

Contraindicated for those who shows hypersensitivity to Glucosamine or Diacerein.

Caution should be practised when administering this tablet in case of patients who are allergic to Glucosamine or Diacerein.

Decrease absorption of Diacerein with aluminium and/ or magnesium hydroxide antacids. Increase risk of diarrhea with laxatives or antibiotics.

This tablet is contraindicated during pregnancy and breastfeeding.

Store in cool & dry place below 30ºC, protect from light & moisture. Keep out of reach of children.

Specific mineral & vitamin combined preparations

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.

2 tablets per day, preferably 1 tablet in the morning and 1 tablet in the evening.

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.

It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.

If there is any pre-existing heart disease or kidney disease, precautions should be taken.

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.

This combination should be used as directed by physician during pregnancy or while breast-feeding.

Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache & constipation.

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

Specific mineral & vitamin combined preparations

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.

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.

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.

It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.

If there is any pre-existing heart disease or kidney disease, precautions should be taken.

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.

This combination should be used as directed by physician during pregnancy or while breast-feeding.

Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache, constipation.

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

Benzodiazepine sedatives

Bromazepam is a powerful psychotropic agent. In lower dosage, it selectively reduces tension and anxiety. In higher dosage, it shows sedative and muscle-relaxant properties. Bromazepam binds to the GABA-A receptor producing a conformational change and potentiating its inhibitory effects. Other neurotransmitters are not influenced.

Standard dosage: Average dosage for outpatient therapy is 1.5-3 mg up to three times daily. Treatment of outpatients should begin with low doses, gradually increasing to the optimum level.

In severe cases, especially in hospital: 6-12 mg 2 or 3 times daily. The overall treatment generally should not be more than 8-12 weeks. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should be taken with re-evaluation of the patient's status with special expertise.

Elderly and debilitated patients: Elderly patients and those with impaired hepatic functions require lower doses.

Children: Bromazepam is usually not indicated in children, but if the physician feels bromazepam treatment is appropriate, then the dose should be adjusted to their low bodyweight (about 0.1-0.3 mg/kg bodyweight)

Bromazepam tablets are for oral administration

Common side-effects include fatigue, drowsiness, muscle weakness, numbed muscle, reduced alertness, confusion, headache, ataxia etc. These phenomena occur predominantly at the start of therapy and usually disappear with prolonged administration. Anterograde amnesia may occur using therapeutic doses.

Bromazepam is contraindicated in patients with known hypersensitivity to bromazepam, severe respiratory insufficiency, severe hepatic insufficiency or sleep apnea syndrome.

The use of benzodiazepines and benzodiazepine like agents may lead to the development of physical and psychological dependence upon these products. This dependence depends on the dose and duration of treatment; it is also greater in predisposed patients with a history of alcohol. Once physical dependence has developed, termination of the treatment will be accompanied by withdrawal symptoms. These may consist of headache, muscle pain, extreme anxiety, tension, confusion and irritability. Since the risk of withdrawal phenomena and rebound phenomena is greater after abrupt discontinuation of the treatment, it is recommended that the dosage be decreased gradually. Bromazepam is not recommended for the primary treatment of sleeplessness caused by psychotic illness. Caution should be exercised while driving cars or using machineries.

If bromazepam is combined with other centrally active drugs, its sedative effects may be enhanced. These drugs are antidepressants, hypnotics, narcotics, antipsychotics, sedatives, antiepileptic drugs, sedative antihistamines and anesthetics. Co-administration of cimetidine may prolong the eliminiation half-life of bromazepam. Concomitant intake of bromazepam with alcohol should be avoided, because the sedative effect of bromazepam may be intensified by alcohol.

The safety of bromazepam during pregnancy has not been established. As bromazepam is excreted in breast milk, use should be avoided during lactation.

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

Bortezomib is a proteasome inhibitor indicated for:

• Treatment of patients with multiple myeloma
• Treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy

Targeted Cancer Therapy

Bortezomib is a reversible inhibitor of the chymotrypsin-like activity of the 26S proteasome in mammalian cells. The 26S proteasome is a large protein complex that degrades ubiquitinated proteins. The ubiquitin-proteasome pathway plays an essential role in regulating the intracellular concentration of specific proteins, thereby maintaining homeostasis within cells. Inhibition of the 26S proteasome prevents this targeted proteolysis, which can affect multiple signaling cascades within the cell. This disruption of normal homeostatic mechanisms can lead to cell death. Experiments have demonstrated that bortezomib is cytotoxic to a variety of cancer cell types in vitro. Bortezomib causes a delay in tumor growth in vivo in nonclinical tumor models, including multiple myeloma.

The recommended dose of Bortezomib is 1.3 mg/m2 administered as a 3 to 5 second bolus intravenous injection. Dose adjustment may be used to manage adverse events that occur during treatment

Most commonly reported adverse reactions (incidence ≥30%) in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia and anemia. Other adverse reactions, including serious adverse reactions, have been reported

Bortezomib is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol

Women should avoid becoming pregnant while being treated with Bortezomib. Pregnant women should be apprised of the potential harm to the fetus

Peripheral neuropathy, including severe cases, may occur - manage with dose modification or discontinuation. Patients with preexisting severe neuropathy should be treated with Bortezomib only after careful risk-benefit assessment.

Hypotension can occur. Caution should be used when treating patients receiving antihypertensives, those with a history of syncope, and those who are dehydrated. 

Patients with risk factors for, or existing heart disease, should be closely monitored.

Acute diffuse infiltrative pulmonary disease has been reported.

Nausea, diarrhea, constipation, and vomiting have occurred and may require use of antiemetic and antidiarrheal medications or fluid replacement.

Thrombocytopenia or neutropenia can occur; complete blood counts should be regularly monitored throughout treatment.

Tumor Lysis Syndrome, Reversible Posterior Leukoencephalopathy Syndrome, and acute hepatic failure have been reported.

Ketoconazole: Co-administration of ketoconazole, a potent CYP3A inhibitor, increased the exposure of bortezomib. Therefore, patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir).

Melphalan-Prednisone: Co-administration of melphalan prednisone increased the exposure of bortezomib. However, this increase is unlikely to be clinically relevant.

Omeprazole: Co-administration of omeprazole, a potent inhibitor of CYP2C19, had no effect on the exposure of bortezomib.

Cytochrome P450: Patients who are concomitantly receiving Bortezomib and drugs that are inhibitors or inducers of cytochrome P450 3A4 should be closely monitored for either toxicities or reduced efficacy

Pregnancy Category D. Women of childbearing potential should avoid becoming pregnant while being treated with Bortezomib. Bortezomib administered to rabbits during organogenesis at a dose approximately 0.5 times the clinical dose of 1.3 mg/m2 based on body surface area caused post implantation loss and a decreased number of live fetuses.

Unopened vials may be stored at controlled room temperature 25º C

Bortezomib is a proteasome inhibitor indicated for:

• Treatment of patients with multiple myeloma
• Treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy

Targeted Cancer Therapy

Bortezomib is a reversible inhibitor of the chymotrypsin-like activity of the 26S proteasome in mammalian cells. The 26S proteasome is a large protein complex that degrades ubiquitinated proteins. The ubiquitin-proteasome pathway plays an essential role in regulating the intracellular concentration of specific proteins, thereby maintaining homeostasis within cells. Inhibition of the 26S proteasome prevents this targeted proteolysis, which can affect multiple signaling cascades within the cell. This disruption of normal homeostatic mechanisms can lead to cell death. Experiments have demonstrated that bortezomib is cytotoxic to a variety of cancer cell types in vitro. Bortezomib causes a delay in tumor growth in vivo in nonclinical tumor models, including multiple myeloma.

The recommended dose of Bortezomib is 1.3 mg/m2 administered as a 3 to 5 second bolus intravenous injection. Dose adjustment may be used to manage adverse events that occur during treatment

Most commonly reported adverse reactions (incidence ≥30%) in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia and anemia. Other adverse reactions, including serious adverse reactions, have been reported

Bortezomib is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol

Women should avoid becoming pregnant while being treated with Bortezomib. Pregnant women should be apprised of the potential harm to the fetus

Peripheral neuropathy, including severe cases, may occur - manage with dose modification or discontinuation. Patients with preexisting severe neuropathy should be treated with Bortezomib only after careful risk-benefit assessment.

Hypotension can occur. Caution should be used when treating patients receiving antihypertensives, those with a history of syncope, and those who are dehydrated. 

Patients with risk factors for, or existing heart disease, should be closely monitored.

Acute diffuse infiltrative pulmonary disease has been reported.

Nausea, diarrhea, constipation, and vomiting have occurred and may require use of antiemetic and antidiarrheal medications or fluid replacement.

Thrombocytopenia or neutropenia can occur; complete blood counts should be regularly monitored throughout treatment.

Tumor Lysis Syndrome, Reversible Posterior Leukoencephalopathy Syndrome, and acute hepatic failure have been reported.

Ketoconazole: Co-administration of ketoconazole, a potent CYP3A inhibitor, increased the exposure of bortezomib. Therefore, patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir).

Melphalan-Prednisone: Co-administration of melphalan prednisone increased the exposure of bortezomib. However, this increase is unlikely to be clinically relevant.

Omeprazole: Co-administration of omeprazole, a potent inhibitor of CYP2C19, had no effect on the exposure of bortezomib.

Cytochrome P450: Patients who are concomitantly receiving Bortezomib and drugs that are inhibitors or inducers of cytochrome P450 3A4 should be closely monitored for either toxicities or reduced efficacy

Pregnancy Category D. Women of childbearing potential should avoid becoming pregnant while being treated with Bortezomib. Bortezomib administered to rabbits during organogenesis at a dose approximately 0.5 times the clinical dose of 1.3 mg/m2 based on body surface area caused post implantation loss and a decreased number of live fetuses.

Unopened vials may be stored at controlled room temperature 25º C

Vitamin B1, B6 & B12 is indicated for the treatment of vitamin B1, B6 & B12 deficiency syndrome. It is also indicated for the supportive treatment of neuritis & non-inflammatory diseases of the nerves, e.g.- Diabetic neuropathy, Peripheral neuralgin, Lumbago, Myalgia, Optic neuritis, Sciatica, Facial neuralgia, Intercostal neuralgia, Spinal pain.

Specific combined vitamin preparations

Vitamin B1 converts carbohydrates, fatty acids and amino acids into energy, promotes healthy nerves, improves mood, strengthens the heart. Vitamin B6 forms RBCs, helps cells to make proteins, manufactures neurotransmitters e.g. serotonin and releases stored forms of energy, helps to prevent CVS diseases and stroke, helps to lift depression and eases insomnia. Vitamin B12 is essential for cell replication and important for RBC production, prevents anemia, helps to prevent depression, reduces nerve pain, numbness, tingling and lowers the risk of heart diseases.

The vitamin ingredients are absorbed well in per oral reception. It is widely distributed to most tissues and appears in breast milk. Within the cell, thiamine is mostly present as diphosphate. Thiamine is not stored to any appreciable extent in the body and amounts in excess of the body’s requirements are excreted in the urine as unchanged thiamine or as metabolites. Pyridoxine, pyridoxal and pyridoxamine are readily absorbed from the GIT following oral administration and are converted to the active forms of pyridoxal phosphate an pyridoxamine phosphate. They are stored mainly in liver where there is oxidation to 4-pyridoxic acid and other inactive metabolites, which are excreted in urine. As the dose increases, proportionally greater amounts are excreted unchanged in the urine.

Tablet: 1-3 Tablets per day or as advised by the physician.

Injection:

• In severe (acute) cases: 1 injection daily until the acute symptoms subside or taken as advised by the physician.
• In mild cases: 1 injection 2-3 times per week. Ampoules are preferably injected intramuscularly.

Use in children: There is no information on the use of this drug in children.

Generally well tolerated but allergic reactions may be observed in few cases.

Vitamin B1, Vitamin B6 and Vitamin B12 is contraindicated in patients on levodopa therapy, and in patients with hypersensitivity to any of the ingredients of the preparation.

Cyanocobalamin should not be given in patients with subacute degeneration of the spinal cord. Cyanocobalamin is not suitable form of vitamin B12 for the treatment of optic neuropathies associated with raised plasma concentrations of cyanocobalamin.

No drug interaction has been reported yet.

Oral tablet form is recommended but due to the presence of benzyl alcohol, injection is not recommended during pregnancy & lactation.

No overdosage symptoms are to be expected in the recommended dosage. If there is known overdose then treatment is symptomatic & supportive.

Keep out of reach of children. Store in a cool (below 25°C temperature) and dry place, protected from light.

Vitamin B1, B6 & B12 is indicated for the treatment of vitamin B1, B6 & B12 deficiency syndrome. It is also indicated for the supportive treatment of neuritis & non-inflammatory diseases of the nerves, e.g.- Diabetic neuropathy, Peripheral neuralgin, Lumbago, Myalgia, Optic neuritis, Sciatica, Facial neuralgia, Intercostal neuralgia, Spinal pain.

Specific combined vitamin preparations

Vitamin B1 converts carbohydrates, fatty acids and amino acids into energy, promotes healthy nerves, improves mood, strengthens the heart. Vitamin B6 forms RBCs, helps cells to make proteins, manufactures neurotransmitters e.g. serotonin and releases stored forms of energy, helps to prevent CVS diseases and stroke, helps to lift depression and eases insomnia. Vitamin B12 is essential for cell replication and important for RBC production, prevents anemia, helps to prevent depression, reduces nerve pain, numbness, tingling and lowers the risk of heart diseases.

The vitamin ingredients are absorbed well in per oral reception. It is widely distributed to most tissues and appears in breast milk. Within the cell, thiamine is mostly present as diphosphate. Thiamine is not stored to any appreciable extent in the body and amounts in excess of the body’s requirements are excreted in the urine as unchanged thiamine or as metabolites. Pyridoxine, pyridoxal and pyridoxamine are readily absorbed from the GIT following oral administration and are converted to the active forms of pyridoxal phosphate an pyridoxamine phosphate. They are stored mainly in liver where there is oxidation to 4-pyridoxic acid and other inactive metabolites, which are excreted in urine. As the dose increases, proportionally greater amounts are excreted unchanged in the urine.

Tablet: 1-3 Tablets per day or as advised by the physician.

Injection:

• In severe (acute) cases: 1 injection daily until the acute symptoms subside or taken as advised by the physician.
• In mild cases: 1 injection 2-3 times per week. Ampoules are preferably injected intramuscularly.

Use in children: There is no information on the use of this drug in children.

Generally well tolerated but allergic reactions may be observed in few cases.

Vitamin B1, Vitamin B6 and Vitamin B12 is contraindicated in patients on levodopa therapy, and in patients with hypersensitivity to any of the ingredients of the preparation.

Cyanocobalamin should not be given in patients with subacute degeneration of the spinal cord. Cyanocobalamin is not suitable form of vitamin B12 for the treatment of optic neuropathies associated with raised plasma concentrations of cyanocobalamin.

No drug interaction has been reported yet.

Oral tablet form is recommended but due to the presence of benzyl alcohol, injection is not recommended during pregnancy & lactation.

No overdosage symptoms are to be expected in the recommended dosage. If there is known overdose then treatment is symptomatic & supportive.

Keep out of reach of children. Store in a cool (below 25°C temperature) and dry place, protected from light.