calcium salts are contraindicated in hypercalcaemia
 

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Calcium Chloride BP Sterile Solution (UCB Pharma Limited)


1. Name Of The Medicinal Product

Calcium Chloride BP Sterile Solution

2. Qualitative And Quantitative Composition

Calcium Chloride Dihydrate BP 13.4% w/v

'For excipients, see 6.1'

3. Pharmaceutical Form

Sterile solution for slow intravenous injection.

4. Clinical Particulars 4.1 Therapeutic Indications

Calcium Chloride Sterile Solution is indicated for the treatment of acute hypocalcaemia where there is a requirement for the rapid replacement of calcium, e.g. severe hypocalcaemic tetany or hypoparathyroidism, or where the oral route is inappropriate due to malabsorption.

4.2 Posology And Method Of Administration

Route of Administration: Slow intravenous injection.

Adults

A typical dose is 2.25 to 4.5 mmol of calcium given by slow intravenous injection not exceeding 1 ml per minute and repeated as necessary.

Children

The cause of the hypocalcaemia must be fully assessed before starting therapy including dietary review, measurement of vitamin D and PTH, together with regular serum calcium and phosphate levels. For children with hypocalcaemic tetany a dosage of 0.25 to 0.35 mmol/kg of calcium given by slow intravenous injection may be given, repeated every six to eight hours until a response is seen. For other hypocalcaemia conditions initial doses of 0.5 to 3.5 mmol of calcium may be given to elevate serum calcium concentrations.

Infants

Calcium chloride has been given to infants at doses of under 0.5 mmol of calcium, but calcium gluconate is usually preferred due to the irritancy of calcium chloride.

4.3 Contraindications

Parenteral calcium therapy is contraindicated in patients receiving cardiac glycosides. Unsuitable for the treatment of hypocalcaemia caused by renal insufficiencies.

In cardiac resuscitation, the use of calcium is contraindicated in the presence of ventricular fibrillation.

Ceftriaxone is contraindicated in premature newborns up to a corrected age of 41 weeks (weeks of gestation + weeks of life) and full-term newborns (up to 28 days of age) if they require (or are expected to require) IV calcium treatment, or calcium-containing infusions because of the risk of precipitation of ceftriaxone-calcium (see sections 4.4 and 4.5).

The treatment of asystole and electromechanical dissociation.

Hypersensitivity to any component.

4.4 Special Warnings And Precautions For Use

Calcium chloride can cause gastro-intestinal irritation due to the stimulatory effects of calcium on gastric acid production. However, the effect would be most likely with oral administration.

Close monitoring of serum calcium levels is essential following IV administration of calcium.

Calcium salts should be used with caution in patients with impaired renal function, cardiac disease or sarcoidosis.

Because it is acidifying, calcium chloride should be used cautiously in patients with respiratory acidosis or respiratory failure.

Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and full-term newborns aged less than 1 month have been described. At least one of them had received ceftriaxone and calcium at different times and through different intravenous lines. In the available scientific data, there are no reports of confirmed intravascular precipitations in patients, other than newborns, treated with ceftriaxone and calcium-containing solutions or any other calcium-containing products.

In patients of any age ceftriaxone must not be mixed or administered simultaneously with any calcium-containing IV solutions, even via different infusion lines or at different infusion sites. However, in patients older than 28 days of age ceftriaxone and calcium-containing solutions may be administered sequentially one after another if infusion lines at different sites are used, or if the infusion lines are replaced or thoroughly flushed between infusions with physiological salt-solution to avoid precipitation. In patients requiring continuous infusion with calcium-containing TPN solutions, healthcare professionals may wish to consider the use of alternative antibacterial treatments which do not carry a similar risk of precipitation. If use of ceftriaxone is considered necessary in patients requiring continuous nutrition, TPN solutions and ceftriaxone can be administered simultaneously, albeit via different infusion lines at different sites. Alternatively, infusion of TPN solution could be stopped for the period of ceftriaxone infusion, considering the advice to flush infusion lines between solutions.

Calcium chloride injection is irritating to veins and must not be injected into tissues, since severe necrosis and sloughing may occur. Great care should be taken to avoid extravasation or accidental injection into perivascular tissues. Should perivascular infiltration occur, IV administration at that site should be discontinued at once. Local infiltration of the affected area with 1 % procaine hydrochloride, to which hyaluronidase may be added, will often reduce venospasm and dilute the calcium remaining in the tissues locally. Local application of heat may also be helpful.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

For interaction between calcium containing products and ceftriaxone, please see sections 4.3 and 4.4 above.

Calcium-containing products may decrease the effectiveness of calcium channel blockers.

Calcium salts reduce the absorption of a number of drugs such as bisphosphonates, fluoride, some fluoroquinolones and tetracyclines; administration should be separated by at least 3 hours.

Calcium chloride infusion reduces the cardiotonic effects of dobutamine.

The effects of digitalis can be increased by increases in blood calcium levels, and the administration of intravenous calcium may result in the development of potentially life-threatening digitalis induced heart arrhythmias.

Thiazide diuretics decrease urinary calcium excretion, and caution is required if such drugs are administered with both calcium chloride and other calcium-containing preparations.

4.6 Pregnancy And Lactation

Calcium chloride has no known effects on the foetus or infant, but as with all drugs it should not be administered during pregnancy or breast feeding unless considered essential.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Rapid intravenous injection may cause vasodilation, decreased blood pressure, bradycardia and arrhythmias.

The patient may complain of tingling sensations, a chalky 'calcium' taste and a sense of oppression or 'heat wave'.

Irritation can occur after intravenous injection. Extravasation can cause burning, necrosis and sloughing of tissue, cellulitis and soft tissue calcification.

Hypertension

Venous thrombosis

Hypercalcemia

4.9 Overdose

Excessive administration of calcium salts leads to hypercalcaemia. Too rapid injection of calcium salts may also lead to many of the symptoms of hypercalcaemia as well as chalky taste, hot flushes and peripheral vasodilation. Treatment of hypercalcaemia is by the administration of sodium chloride by intravenous infusion. Cardiac arrhythmia and cardiac arrest may occur.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC code:A12 A07

Calcium is an essential electrolyte involved in the function of nervous, muscular and skeletal systems, cell membrane and capillary permeability. The cation is also an important activator in many enzymatic reactions and plays a regulatory role in the release and storage of neurotransmitters and hormones.

5.2 Pharmacokinetic Properties

Intravenously administered calcium will be absorbed directly into the blood system. Serum calcium levels will increase immediately and may return to normal values in thirty minutes to two hours depending on the rate of renal clearance.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium hydroxide

Hydrochloric acid

Water for injections

6.2 Incompatibilities

Calcium salts are incompatible with oxidising agents, citrates, soluble carbonates, bicarbonates, phosphates, tartrates and sulphates.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

10ml neutral Type 1 glass ampoules in packs of 10.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

UCB Pharma Limited

208 Bath Road

Slough

Berkshire

SL1 3 WE

UK

8. Marketing Authorisation Number(S)

PL 00039/5888R

9. Date Of First Authorisation/Renewal Of The Authorisation

18 February 1993, 17 February 2003

10. Date Of Revision Of The Text

January 2010


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Adcal 1500mg chewable tablets


1. Name Of The Medicinal Product

Adcal 1500mg Chewable Tablets

2. Qualitative And Quantitative Composition

Per tablet:

Calcium carbonate: 1500mg

equivalent to 600mg of elemental calcium

3. Pharmaceutical Form

Chewable Tablet

4. Clinical Particulars 4.1 Therapeutic Indications

Adcal is a chewable tablet recommended as a supplementary source of calcium when normal requirements are high and in the correction of calcium deficiency in the diet. They can be used in osteoporosis therapy as an adjunct to more specific conventional treatments. Adcal chewable tablets can be used as a phosphate binding agent in the management of renal failure.

4.2 Posology And Method Of Administration

Oral.

Adults, elderly and children

Dietary deficiency and as an adjunct in osteoporosis therapy; 2 chewable tablets per day, preferably one tablet each morning and evening.

For use in binding phosphate in the management of renal failure in patients on renal dialysis, the dose should be adjusted for the individual patient and is dependent on the serum phosphate level.

The tablets should be chewed, not swallowed whole and taken just prior to, during or immediately following a meal.

4.3 Contraindications

Absolute contra-indications are hypercalcaemia resulting for example from myeloma, bone metastases or other malignant bone disease, sarcoidosis; primary hyperparathyroidism and vitamin D overdosage. Severe renal failure untreated by renal dialysis. Hypersensitivity to any of the tablet ingredients.

Relative contra-indications are osteoporosis due to prolonged immobilisation, renal stones, severe hypercalciuria.

4.4 Special Warnings And Precautions For Use

Patients with mild to moderate renal failure or mild hypercalciuria should be supervised carefully. Periodic checks of plasma calcium levels and urinary calcium excretion should be made in patients with mild to moderate renal failure or mild hypercalciuria.

Urinary calcium excretion should also be measured. In patients with a history of renal stones urinary calcium excretion should be measured to exclude hypercalciuria.

With long-term treatment it is advisable to monitor serum and urinary calcium levels and kidney function, and reduce or stop treatment temporarily if urinary calcium exceeds 7.5mmol/24 hours.

Allowances should be made for calcium and vitamin D supplements from other sources.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The risk of hypercalcaemia should be considered in patients taking thiazide diuretics since these drugs can reduce urinary calcium excretion. Hypercalcaemia must be avoided in digitalised patients.

The effects of digitalis and other cardiac glycosides may be accentuated with the oral administration of calcium combined with Vitamin D. Strict medical supervision is needed and, if necessary monitoring of ECG and calcium.

Certain foods (e.g. those containing oxalic acid, phosphate or phytinic acid) may reduce the absorption of calcium

Calcium salts may reduce the absorption of thyroxine, bisphosphonates, sodium fluoride, quinolone and tetracycline antibiotics or iron. It is advisable to allow a minimum period of four hours before taking the calcium.

Calcium absorption is reduced in patients receiving systemic corticosteroid therapy. This should be taken in to account when patients are receiving concomitant therapy.

4.6 Pregnancy And Lactation

During pregnancy and lactation treatment with Adcal should be under the direction of a physician. During pregnancy and lactation, requirements for calcium are increased but in deciding on the required supplementation allowances should be made for availability of these agents from other sources. If Adcal and iron supplements are both required to be administered to the patient, they should be taken at different times (see Section 4.5).

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

The use of calcium supplements has, rarely, given rise to mild gastro-intestinal disturbances, such as constipation, flatulence, nausea, gastric pain, diarrhoea.

4.9 Overdose

Overdosage may cause gastro-intestinal disturbances but would not be expected to cause hypercalcaemia except in patients treated with excessive doses of vitamin D. Treatment should be aimed at lowering serum calcium levels through a high fluid intake and low calcium diet. In severe cases treatments with corticosteroid and other specialist treatment may be necessary. Alkalosis is a potential but rare risk.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Calcium carbonate is a well established medicinal material and is used extensively for supplementation in deficiency states. Calcium carbonate is also widely used as an antacid.

5.2 Pharmacokinetic Properties

The pharmacokinetic profiles of calcium and its salts are well known. Calcium carbonate is converted to calcium chloride by gastric acid. Calcium is absorbed to the extent of about 15-25% from the gastro-intestinal tract while the remainder reverts to insoluble calcium carbonate and calcium stearate, and is excreted in the faeces.

5.3 Preclinical Safety Data

Calcium carbonate is a well known and widely used material and has been used in clinical practice for many years. As such toxicity is only likely to occur in chronic overdosage where hypercalcaemia could result.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Xylitol, polydextrose, pre-gelatinised starch, sodium saccharin, magnesium stearate, fruit flavour (contains propylene glycol and maltodextrin).

6.2 Incompatibilities

Not applicable, oral preparation.

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Do not store above 25°C.

Store in the original package. Keep container in the outer carton.

6.5 Nature And Contents Of Container

PVC/PVdC aluminium foil blister packs of 10 (Physicians sample), or 100 tablets in a cardboard carton.

6.6 Special Precautions For Disposal And Other Handling

No special conditions

7. Marketing Authorisation Holder

ProStrakan Ltd.

Galabank Business Park

Galashiels

Scotland

TD1 1QH

8. Marketing Authorisation Number(S)

PL16508/0005

9. Date Of First Authorisation/Renewal Of The Authorisation

04/10/2005

10. Date Of Revision Of The Text

November 2008

11 LEGAL CATEGORY

P


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Remegel Summer Fruit


1. Name Of The Medicinal Product

Remegel Summer Fruit.

2. Qualitative And Quantitative Composition

Each tablet contains 800mg Calcium Carbonate USP.

3. Pharmaceutical Form

Soft, pink, raspberry-flavoured, chewable square tablets.

4. Clinical Particulars 4.1 Therapeutic Indications

Remegel Summer Fruit are indicated for the relief of acid indigestion, heartburn and associated stomach upsets (dyspepsia).

4.2 Posology And Method Of Administration

Route of administration: oral

Adults and children 12 years and over: One or two tablets of Remegel Summer Fruit to be chewed as symptoms occur. Repeat hourly as necessary. Maximum dose: 12 tablets in 24 hours.

Children under 12 years of age: Not recommended

The elderly: As for adults, see above

Hepatic Dysfunction: There is no specific information relating to the use of Remegel Summer Fruit in hepatic impairment. Normal adult dosage is appropriate.

Renal Dysfunction: Remegel Summer Fruit should be used with caution in subjects with moderate to severe renal impairment. Current use of calcium carbonate as a phosphate binder should be taken into account to prevent hypercalcaemia.

4.3 Contraindications

Hypersensitivity to any of the components. Hypercalcaemia.

4.4 Special Warnings And Precautions For Use

This product should be taken with care by subjects on a low phosphate diet (e.g. the malnourished), as it may lead to a phosphate depletion syndrome, (see Undesirable Effects).

This product should be used with caution in renal dysfunction, (see Posology and Method of Administration).

This product contains sucrose and glucose syrup and as such, care is required in patients with diabetes mellitus.

If symptoms persist, a pharmacist or doctor should be consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In common with other antacids, calcium carbonate may form complexes with certain drugs such as tetracyclines and digoxin, leading to their reduced absorption. This should be taken into account when concomitant administration is considered.

4.6 Pregnancy And Lactation

There is no information relating to the use of Remegel Summer Fruit in pregnancy.

Calcium carbonate antacids have been used during pregnancy for many years without apparent ill consequence, although as with other antacids, this product should be administered with care in the first trimester.

There is no information relating to the excretion of Remegel Summer Fruit in breast milk. However, no problems would be anticipated from the use of this product during lactation.

4.7 Effects On Ability To Drive And Use Machines

No special comment – unlikely to produce an effect.

4.8 Undesirable Effects

Calcium carbonate may cause constipation. Eructation (due to carbon dioxide production in the stomach) may occur in come patients.

4.9 Overdose

Excessive ingestion of calcium carbonate can lead to hypercalcaemia (characterised by gastro-intestinal pain, nausea and vomiting), metabolic alkalosis and reversible renal failure, sometimes presenting as the milk-alkali syndrome. Treatment should be symptomatic and supportive. Haemodialysis and other therapeutic measures, such as saline diuresis, have been used to successfully treat excessive ingestion of calcium carbonate antacid.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Calcium carbonate is a potent antacid, neutralising gastric acid when taken orally.

Calcium carbonate neutralises gastric acid to provide fast relief from indigestion and heartburn.

5.2 Pharmacokinetic Properties

Absorption: Calcium carbonate is converted to calcium chloride by gastric acid (hydrochloric acid) in the stomach, with the resulting formation of carbon dioxide and water. Some of the calcium is absorbed from the intestines but the majority is reconverted into insoluble calcium salts such as carbonate and stearate, which is excreted in the faeces.

Distribution, Metabolism and Elimination: Once absorbed from the stomach, physiological concentrations of calcium are tightly controlled, principally through the effects of parathyroid hormone, vitamin D and its metabolites, and calcitonin. These control mechanisms are well documented in standard texts.

5.3 Preclinical Safety Data

Pre-clinical safety data does not add anything of further significance to the prescriber.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sugar solution; Glucose syrup (41o baume); Purified water; Hyfoama DS (hydrolysed milk protein); Gelatin 200 Bloom; Cornflour Starch; Sorbitol (crystalline); Glycerol; Titanium dioxide (E171); Allure Red (E129); Paramount C (hydrogenated vegetable fat); Amerfond Fondant Sugar; Raspberry flavour; Butylated hydroxyanisole; Talc

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25oC.

6.5 Nature And Contents Of Container

Each tablet in stickpacks is wrapped in printed silicone paper and overwrapped in hermetically sealed aluminium foil stickpack. 8 piece stickpack

6.6 Special Precautions For Disposal And Other Handling

None applicable.

7. Marketing Authorisation Holder

Seton Products Limited, Tubiton House, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 11314/0131.

9. Date Of First Authorisation/Renewal Of The Authorisation

03/01/2006

10. Date Of Revision Of The Text

03/01/2006


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Boots Epsom Salts B.P.


1. Name Of The Medicinal Product

Epsom Salts (Magnesium Sulphate BP)

Boots Epsom Salts B.P.

2. Qualitative And Quantitative Composition

Magnesium Sulphate 100%

3. Pharmaceutical Form

Powder for oral solution

4. Clinical Particulars 4.1 Therapeutic Indications

For the symptomatic relief of occasional constipation.

4.2 Posology And Method Of Administration

Adults and children over 12 years: 1 to 4g to be taken in warm water, once daily.

Children under 12 years. Not recommended.

4.3 Contraindications

Intestinal obstruction.

4.4 Special Warnings And Precautions For Use

To be used with caution in elderly or debilitated patients and in those with renal insufficiency.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

This product may interact with tetracyclines, digoxin, vitamins and iron and may potentiate tubocurarine during anaesthesia.

4.6 Pregnancy And Lactation

The use of magnesium containing salts in the first trimester of pregnancy should be avoided.

They should only be used after medical advice if the benefits exceed potentially unknown risks of foetal exposure to magnesium. No adverse effects are anticipated in breast fed infants.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Prolonged excessive use of this product may cause alkalosis and hypermagnesaemia.

4.9 Overdose

Excessive amounts of this medicine may cause diarrhoea and dehydration. Hypermagnesaemia and hypercalcaemia may also occur, particularly if there is impaired renal function. Treatment consists of supportive and symptomatic measures with appropriate correction of fluid and electrolyte balance.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Not applicable.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Never undertaken by Abdine Limited. This product was granted a 'Licence as of Right' some 25 years ago.

6. Pharmaceutical Particulars 6.1 List Of Excipients

None.

6.2 Incompatibilities

None are recognised.

6.3 Shelf Life

As packaged for sale: Three years

As reconstituted for use: One day

After first opening the container: One month

6.4 Special Precautions For Storage

Do not store above 25°C

6.5 Nature And Contents Of Container

A spirally wound, varnished, cardboard tub with a press-fit lid or polypropylene jar and cap containing 100g, 150g, 200g, 250g, 300g or 500g.

6.6 Special Precautions For Disposal And Other Handling

Take from 1 to 4g in warm water.

7. Marketing Authorisation Holder

Bell Sons & Co (Druggists) Ltd

Gifford House

Slaidburn Crescent

Southport

Merseyside PR9 9AL

8. Marketing Authorisation Number(S)

PL 03105/0068

9. Date Of First Authorisation/Renewal Of The Authorisation

12 February 1999

10. Date Of Revision Of The Text

29th November 2010

11 DOSIMETRY

(IF APPLICABLE)

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

(IF APPLICABLE)


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Calcichew Forte Chewable Tablets


1. Name Of The Medicinal Product

Calcichew Forte Chewable Tablets

2. Qualitative And Quantitative Composition

Per tablet: Calcium carbonate 2500mg equivalent to 1g of elemental calcium.

Contains sorbitol, 780mg; isomalt, 124mg; and aspartame, 2mg.

For a full list of excipients see Section 6.1.

3. Pharmaceutical Form

Chewable tablet.

Round, white, uncoated and convex tablets. May have small specks.

4. Clinical Particulars 4.1 Therapeutic Indications

Calcichew Forte Chewable Tablets are to be chewed as a supplemental source of calcium in the correction of dietary deficiencies or when normal requirements are high.

Calcichew Forte Chewable Tablets may be used as an adjunct to conventional therapy in the prevention and treatment of osteoporosis. They may be used as a phosphate binding agent in the management of renal failure in patients on renal dialysis.

4.2 Posology And Method Of Administration

Oral.

Adults and elderly:

Adjunct to osteoporosis therapy

One tablet to be chewed daily.

Dietary deficiency

One tablet to be chewed daily.

Osteomalacia

1-3 tablets daily is recommended.

Children:

Dietary deficiency

One tablet to be chewed daily.

Phosphate Binder:

 

Adults, children and elderly:

Dose as required by the individual patient depending on serum phosphate level.

The tablets should be taken just before, during or just after each meal.

The tablets may be chewed or sucked.

Dosage in hepatic impairment:

No dose adjustment is required.

Dosage in renal impairment:

In patients with severe renal failure having a creatinine clearance of less than 25 ml/minute, dosage adjustments may be necessary dependent on serum calcium levels. See section 4.4.

4.3 Contraindications

• Severe hypercalcaemia and hypercalciuria, for example in hyperparathyroidism, vitamin D overdosage, decalcifying tumours such as plasmacytoma and skeletal metastases, in severe renal failure untreated by renal dialysis and in osteoporosis due to immobilisation.

• Nephrolithiasis

• Hypersensitivity to the active substance or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Calcichew Forte chewable tablets contain aspartame (a source of phenylalanine) and should be avoided by patients with phenylketonuria.

Calcichew 500 mg Chewable Tablets contain sorbitol (E420) and isomalt (E953). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

In renal insufficiency the tablets should be given only under controlled conditions for hyperphosphataemia. Caution should be exercised in patients with a history of renal calculi.

During high dose therapy and especially during concomitant treatment with vitamin D or nutrients (such as milk), there is a risk of hypercalcaemia with subsequent kidney function impairment and milk-alkali syndrome. In these patients, serum calcium levels should be followed and renal function should be monitored.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Thiazide diuretics reduce the urinary excretion of calcium. Due to increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.

Systemic corticosteroids reduce calcium absorption. During concomitant use, it may be necessary to increase the dose of Calcichew Forte Chewable Tablets.

Calcium carbonate may interfere with the absorption of concomitantly administered tetracycline preparations. For this reason, tetracycline preparations should be administered at least two hours before, or four to six hours after, oral intake of calcium.

Hypercalcaemia may increase the toxicity of cardiac glycosides during treatment with calcium. Patients should be monitored with regard to electrocardiogram (ECG) and serum calcium levels.

The efficacy of levothyroxine can be reduced by the concurrent use of calcium, due to decreased levothyroxine absorption. Administration of calcium and levothyroxine should be separated by at least four hours.

The absorption of quinolone antibiotics may be impaired if administered concomitantly with calcium. Quinolone antibiotics should be taken two hours before or after intake of calcium.

If a bisphosphonate or sodium fluoride is used concomitantly, this preparation should be administered at least three hours before the intake of Calcichew Forte Chewable Tablets since gastrointestinal absorption may be reduced.

Oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals) may inhibit calcium absorption through formation of insoluble calcium salts. The patient should not take calcium products within two hours of eating foods high in oxalic acid and phytic acid.

4.6 Pregnancy And Lactation

The adequate daily intake (including food and supplementation) for normal pregnant and lactating women is 1000-1300 mg calcium. During pregnancy, the daily intake of calcium should not exceed 1500 mg. Significant amounts of calcium are secreted in milk during lactation. Calcichew Forte Chewable Tablets can be used during pregnancy in case of a calcium deficiency.

4.7 Effects On Ability To Drive And Use Machines

There are no data about the effect of this product on driving capacity. An effect is, however, unlikely.

4.8 Undesirable Effects

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (

Metabolism and nutrition disorders

Uncommon: Hypercalcaemia and hypercalciuria.

Very rare: Seen usually only in overdose, see 4.9: Milk-alkali syndrome

Gastrointestinal disorders

Rare: Constipation, dyspepsia, flatulence, nausea, abdominal pain and diarrhoea.

Skin and subcutaneous disorders

Rare: Pruritus, rash and urticaria.

4.9 Overdose

Overdose can lead to hypercalcaemia. Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, bone pain, nephrocalcinosis, nephrolithiasis and in severe cases, cardiac arrhythmias. Extreme hypercalcaemia may result in coma and death. Persistently high calcium levels may lead to irreversible renal damage and soft tissue calcification.

Milk-alkali syndrome (frequent urge to urinate; continuing headache; continuing loss of appetite; nausea or vomiting; unusual tiredness or weakness; hypercalcaemia, alkalosis and renal impairment). The milk-alkali syndrome of hypercalcaemia, alkalosis and renal impairment still occur in patients who ingest large amounts of calcium and absorbable alkali; it is not uncommon as a cause of hypercalcaemia requiring hospitalisation. The syndrome has also been reported in a patient taking recommended doses of antacids containing calcium carbonate for chronic epigastric discomfort, and in a pregnant woman taking high, but not grossly excessive, doses of calcium (about 3 g of elemental calcium daily). Metastatic calcification can develop.

Treatment of hypercalcaemia: The treatment with calcium must be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, vitamin D and cardiac glycosides must also be discontinued. Treatment: rehydration, and, according to severity of hypercalcaemia, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids should be considered. Serum electrolytes, renal function and diuresis must be monitored. In severe cases, ECG and CVP should be followed.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Calcium

ATC-code: A12A A04

An adequate intake of calcium is of importance during growth, pregnancy and breastfeeding.

5.2 Pharmacokinetic Properties

Absorption: The amount of calcium absorbed through the gastrointestinal tract is approximately 30% of the swallowed dose.

Distribution and metabolism: 99% of the calcium in the body is concentrated in the hard structure of bones and teeth. The remaining 1% is present in the intra- and extracellular fluids. About 50% of the total blood-calcium content is in the physiologically active ionised form with approximately 10% being complexed to citrate, phosphate or other anions, the remaining 40% being bound to proteins, principally albumin.

Elimination: Calcium is eliminated through faeces, urine and sweat. Renal excretion depends on glomerular filtration and calcium tubular reabsorption.

5.3 Preclinical Safety Data

There is no information of relevance to the safety assessment in addition to what is stated in other parts of the SmPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sorbitol (E420)

Povidone

Magnesium stearate

Aspartame (E951)

Orange flavour:

Isomalt (E953)

Flavouring (orange)

Mono, di-fatty acid glycerides

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 30?C.

Keep the container tightly closed to protect from moisture.

6.5 Nature And Contents Of Container

WiMo Box of 28, 30, 56, 60, 90 and 100 tablets. Not all pack sizes may be marketed.

It is a high density polyethylene cylindrical bottle with high density polyethylene screw cap and medium density polyethylene tamper-evident liner.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Shire Pharmaceuticals Limited

Hampshire International Business Park

Chineham

Basingstoke

Hampshire RG24 8EP

United Kingdom

8. Marketing Authorisation Number(S)

PL 08557/0022

9. Date Of First Authorisation/Renewal Of The Authorisation

2 January 1992

10. Date Of Revision Of The Text

09-Jun-2010


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Renacet 950mg Tablets


1. Name Of The Medicinal Product

Renacet 950 mg, film-coated tablets

2. Qualitative And Quantitative Composition

Active substance: Calcium acetate

Each film-coated tablet contains:

950 mg calcium acetate (anhydrous) equivalent to 240.50 mg calcium.

Excipients: Contains sucrose, see section 4.4.

For a full list of excipients see section 6.1.

3. Pharmaceutical Form

Film-coated tablet

white, oval, convex film-coated tablets scored on both sides.

4. Clinical Particulars 4.1 Therapeutic Indications

Hyperphosphatemia associated with chronic renal insufficiency in patients undergoing dialysis.

4.2 Posology And Method Of Administration

The tablet can be divided into equal halves. Dosage should be effected individually. Unless a different dose has been prescribed, adults should take no more than 7 Renacet 950 mg film-coated tablets daily.

To achieve optimal efficacy, Renacet 950 mg should be taken during or immediately after meals.

The usual dose is:

with breakfast:

? to 1 film-coated tablet Renacet 950 mg,

with a snack:

? to 1 film-coated tablet Renacet 950 mg,

with a main meal:

1 to 3 film-coated tablets Renacet 950 mg,

with supper:

1 to 2 film-coated tablets Renacet 950 mg.

Renacet 950 mg film-coated tablets should be taken with some liquid during or immediately after meals and must not be chewed.

Experience with children is not available.

4.3 Contraindications

Renacet 950 mg must not be used in patients with:

Hypersensitivity to the active substance or to any of the excipients.

Hypophosphatemia, severe hypophosphatemia, hypercalcemia, hypercalciuria associated with calcium-containing kidney stones, decalcifying tumors and skeletal metastases; severe renal failure without dialysis treatment; constipation; known stenosis of the large intestine, osteoporosis due to immobilisation.

4.4 Special Warnings And Precautions For Use

Treatment with Renacet 950 mg film-coated tablets requires regular measurement of the serum calcium and serum phosphate levels. Under no circumstances should the calcium concentration multiplied by the phosphate concentration exceed 5.3 mmol/l since the frequency of extraosseous calcification increases if this value is exceeded.

To avoid an increase in serum calcium level beyond the normal range the intake of Renacet 950 mg film-coated tablets should be monitored regularly when patients are already on preparations which contain calcium.

Patients with the rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant intake of Renacet 950 mg film-coated tablets with other medicinal products may impair their absorption.

For numerous anionic medicinal agents, e.g. tetracyclines and doxycycline, quinolones (gyrase inhibitors), biphosphonates, fluorides and anticholinergics changes in absorption may occur. Interaction may also occur with vitamin D preparations.Therefore it is recommended that there should be an interval of 1-2 hours between the intake of Renacet 950 mg film-coated tablets and other medicinal products.

An increased effect may occur with cardiac glycosides, a reduced effect may occur with calcium antagonists.

Concomitant administration of thiazides results in an increased risk of hypercalcemia. If the calcium level is increased, use of adrenaline may lead to severe cardiac arrhythmia.

Intake of larger quantities of calcium salts may cause a precipitation of fatty or bile acids as calcium soaps. This may impair the absorption of ursodeoxycholic acid and chenodeoxycholic acid as well as fats and fat soluble vitamins.

4.6 Pregnancy And Lactation

Harmful effects on humans due to calcium taken during pregnancy and lactation have not been reported.

However, the likelihood of hypercalcaemia is increased in pregnant women in whom calcium and vitamin D are co-administered.

4.7 Effects On Ability To Drive And Use Machines

Renacet 950 mg has no effect on the ability to drive or use machines.

4.8 Undesirable Effects

The following definitions apply to the incidence of undesirable effects:

Very common (

Common (

Uncommon (

Rare (

Very rare (<1/10,000)

Not known (cannot be estimated from the available data)

General disorders:

 

Uncommon:

Soft tissue calcification (e.g in the fatty tissue under the skin) usually occurring only after many years of intake and frequently associated with increased blood calcium levels.

Cardiac/vascular disorders:

 

Uncommon:

Hypercalcemia, especially following overdosage.

Gastrointestinal disorders:

 

Rare:

Gastrointestinal disorders such as nausea and constipation, especially in case of too high dosages.

 

If gastrointestinal side effects occur, treatment should be changed to calcium carbonate as appropriate.

4.9 Overdose

Overdose would not be expected to cause gross hypercalcaemia except in patients taking excessive doses of vitamin D.

Measures in case of overdose: Discontinuation of the medicinal product and symptomatic treatment including lowering calcium levels e.g. administration of oral phosphates and non-saline laxatives such as lactulose.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group:

Drug for treatment of hyperphosphatemia

ATC-Code:

A12AA12

Calcium is an endogenous ion of the body essential for the maintenance of a number of physiologic processes. It participates as an integral factor in the maintenance of the functional integrity of the nervous system, in the contractile mechanisms of muscle tissue, in the clotting of blood, and in the formation of the major structural material of the skeleton.

A dynamic equilibrium occurs between blood calcium and skeletal calcium, homeostasis being mainly regulated by the parathyroid hormone, by calcitonin and by vitamin D.

Variations in the concentration of ionised calcium are responsible for the symptoms of hyper/hypocalcaemia. Soluble calcium salts are commonly used in the treatment of calcium deficiency.

5.2 Pharmacokinetic Properties

The pharmacokinetics of calcium and its salts are well known. Bioavailability of calcium acetate depends on the dissolution rate which is normally completed after 15 minutes. After 15 minutes the calcium acetate is released. The serum concentration of phosphate may decrease after interaction with calcium resulting in the formation of the less soluble calcium phosphate salts.

5.3 Preclinical Safety Data

Preclinical studies with calcium acetate are very limited and reveal no special additional risks to those already mentioned in other sections of the SPC. Preclinical effects were observed only at doses considered in excess of the maximum human dose.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Tablet core

Maize starch

Sucrose

Gelatin

Sodium starch glycolate (Type A)

Croscarmellose sodium

Magnesium stearate

Film coat

Hypromellose

Refined castor oil

Saccharin sodium

Talc

Orange flavour

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Do not store above 30 °C.

6.5 Nature And Contents Of Container

Pack sizes:

100 film-coated tablets

200 film-coated tablets

PVDC-coated PVC / aluminium foil blisters

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

RenaCare NephroMed GmbH

Werrastr. 1 a

35625 H?ttenberg

Germany

 

Phone:

Fax:

E-mail:

+49 (0) 64 03 9 21 60

+49 (0) 64 03 9 21 63

mail@renacare.com

8. Marketing Authorisation Number(S)

PL 36032/0002

9. Date Of First Authorisation/Renewal Of The Authorisation

30/06/2010

10. Date Of Revision Of The Text

30/06/2010


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One-Alpha Injection


1. Name Of The Medicinal Product

One-Alpha® Injection

2. Qualitative And Quantitative Composition

Alfacalcidol (1?-hydroxyvitamin D3) 2 micrograms/ml.

3. Pharmaceutical Form

Injection

4. Clinical Particulars 4.1 Therapeutic Indications

One-Alpha® is indicated in all conditions where there is a disturbance of calcium metabolism due to impaired 1 ?-hydroxylation such as when there is reduced renal function.

The main indications are:

a) Renal osteodystrophy

b) Hyperparathyroidism (with bone disease)

c) Hypoparathyroidism

d) Neonatal hypocalcaemia

e) Nutritional and malabsorptive rickets and osteomalacia

f) Pseudo - deficiency (D - dependent) rickets and osteomalacia

g) Hypophosphataemic vitamin D resistant rickets and osteomalacia

4.2 Posology And Method Of Administration

One-Alpha® Injection should be administered intravenously as a bolus over approximately 30 seconds. Shake the ampoule for a minimum of 5 seconds before use.

The dosage of One-Alpha® Injection is the same as for One-Alpha® in its oral presentations.

Initial dosage for all indications is:

Adults

1 microgram/day

Dosage in the elderly

0.5 microgram/day

Neonates and premature infants

0.05 - 0.1 microgram/kg/day

Children under 20 kg bodyweight

0.05 microgram/kg/day

Children over 20 kg bodyweight

1 microgram/day

The dose of One-Alpha® should be adjusted thereafter to avoid hypercalcaemia according to the biochemical response.

Indices of response include plasma levels of calcium (ideally corrected for protein binding), alkaline phosphatase, parathyroid hormone, as well as radiographic and histological investigations.

Maintenance doses are generally in the range of 0.25 - 1 microgram per day.

When administered as intravenous injection to patients undergoing haemodialysis the initial dosage for adults is 1 microgram per dialysis. The maximum dose recommended is 6 micrograms per dialysis and not more than 12 micrograms per week. The injection should be administered into the return line from the haemodialysis machine at the end of each dialysis.

(a) Renal bone disease:

Patients with relatively high initial plasma calcium levels may have autonomous hyperparathyroidism, often unresponsive to One-Alpha®. Other therapeutic measures may be indicated.

Before and during treatment with One-Alpha®, phosphate binding agents should be considered to prevent hyperphosphataemia. It is particularly important to make frequent plasma calcium measurements in patients with chronic renal failure because prolonged hypercalcaemia may aggravate the decline of renal function.

(b) Hyperparathyroidism:

In patients with primary or tertiary hyperparathyroidism about to undergo parathyroidectomy, pre-operative treatment with One-Alpha® for 2-3 weeks alleviates bone pain and myopathy without aggravating pre-operative hypercalcaemia. In order to decrease post-operative hypocalcaemia, One-Alpha® should be continued until plasma alkaline phosphatase levels fall to normal or hypercalcaemia occurs.

(c) Hypoparathyroidism:

In contrast to the response to parent vitamin D, low plasma calcium levels are restored to normal relatively quickly with One-Alpha®. Severe hypocalcaemia is corrected more rapidly with higher doses of One-Alpha® (eg 3-5 micrograms) together with calcium supplements.

(d) Neonatal hypocalcaemia:

Although the normal starting dose of One-Alpha® is 0.05-0.1 microgram/kg/day (followed by careful titration), in severe cases, doses of up to 2 microgram/kg/day may be required. Whilst ionised serum calcium levels may provide a guide to response, measurement of plasma alkaline phosphatase activity may be more useful. Levels of alkaline phosphatase approximately 7.5 times above the adult range indicates active disease.

(e) Nutritional and malabsorptive rickets and osteomalacia:

Nutritional rickets and osteomalacia can be cured rapidly with One-Alpha®. Malabsorptive osteomalacia (responding to large doses of IM or IV parent vitamin D) will respond to small doses of One-Alpha®.

(f) Pseudo-deficiency (D-dependent) rickets and osteomalacia:

Although large doses of parent vitamin D would be required, effective doses of One-Alpha® are similar to those required to heal nutritional Vitamin D deficiency rickets and osteomalacia.

(g) Hypophosphataemic vitamin D-resistant rickets and osteomalacia:

Neither large doses of parent vitamin D nor phosphate supplements are entirely satisfactory. Treatment with One-Alpha® at normal dosage rapidly relieves myopathy when present and increases calcium and phosphate retention. Phosphate supplements may also be required in some patients.

4.3 Contraindications

Hypercalcaemia, metastatic calcification.

Hypersensitivity to alfacalcidol or any of the other ingredients.

4.4 Special Warnings And Precautions For Use

One-Alpha® Injection should be avoided in patients with known sensitivity to injections containing propylene glycol.

One-Alpha® should be used with caution for:

• small premature infants

• patients being treated with cardioactive glycosides or digitalis as hypercalcaemia may lead to arrhythmia in such patients

• patients with nephrolithiasis

During treatment with One-Alpha® serum calcium and serum phosphate should be monitored regularly especially in children, patients with renal impairment and patients receiving high doses. To maintain serum phosphate at an acceptable level in patients with renal bone disease a phosphate binding agent may be used.

Hypercalcaemia may appear in patients treated with One-Alpha®, the early symptoms are as follows:

• polyurina

• polydipsia

• weakness, headache, nausea, constipation

• dry mouth

• muscle and bone pain

• metallic taste

Hypercalcaemia can be rapidly corrected by stopping treatment until plasma calcium levels return to normal (in about one week). One-Alpha® treatment may then be restarted at a reduced dose (half the previous dose).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Patients taking barbiturates or anticonvulsants may require larger doses of One-Alpha® to produce the desired effect due to the induction of hepatic detoxification enzymes.

Use with caution in patients being treated with thiazide diuretics as they may have an increased risk of developing hypercalcaemia.

4.6 Pregnancy And Lactation

There are no adequate data from the use of alfacalcidol in pregnant women. Animal studies are insufficient with respect to effects on pregnancy. The potential risks for humans are unknown. Caution should be taken when prescribing to pregnant women as hypercalcaemia during pregnancy may produce congenital disorders in the offspring.

Although it has not been established, it is likely that increased amounts of 1,25 dihydroxyvitamin D will be found in the milk of lactating mothers treated with One-Alpha®. This may influence calcium metabolism in the infant.

4.7 Effects On Ability To Drive And Use Machines

One-Alpha® has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable Effects

The most frequently reported undesirable effects are hypercalcaemia and various skin reactions. Hypercalcaemia can be rapidly corrected by stopping treatment until plasma calcium levels return to normal (about 1 week). One-Alpha® treatment may then be restarted at half the previous dose.

Based on data from post-market use the total undesirable effect 'reporting rate' is rare or very rare being approximately 1:10,000 patients treated.

Metabolism and Nutrition Disorders

Hypercalcaemia

Hyperphosphataemia

Skin and Subcutaneous Tissue Disorders

Pruritus

Rash

Urticaria

Renal and Urinary Disorders

Nephrocalcinosis

Renal impairment

4.9 Overdose

Hypercalcaemia is treated by suspending the administration of One-Alpha®.

In severe cases of hypercalcaemia general supportive measures should be undertaken. Keep the patient well hydrated by i.v. infusion of saline (force diuresis), measure electrolytes, calcium and renal function indices; assess electrocardiographic abnormalities, especially in patients on digitalis. More specifically, treatment with glucocorticosteroids, loop diuretics, bisphosphonates, calcitonin and eventually haemodialysis with low calcium content should be considered.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Alfacalcidol is converted rapidly in the liver to 1,25 dihydroxyvitamin D. This is the metabolite of vitamin D which acts as a regulator of calcium and phosphate metabolism. Since this conversion is rapid, the clinical effects of One-Alpha® and 1,25 dihydroxyvitamin D are very similar.

Impaired 1 ?-hydroxylation reduces 1,25 dihydroxyvitamin D production. This contributes to the disturbances in mineral metabolism found in several disorders, including renal bone disease, hypoparathyroidism, neonatal hypocalcaemia and vitamin D dependent rickets. These disorders, which require high doses of parent vitamin D for their correction, will respond to small doses of One-Alpha®.

The delay in response and high dosage required in treating these disorders with parent vitamin D makes dosage adjustment difficult. This can result in unpredictable hypercalcaemia which may take weeks or months to reverse. The major advantage of One-Alpha® is the more rapid onset of response, which allows a more accurate titration of dosage. Should inadvertent hypercalcaemia occur it can be reversed within days of stopping treatment.

5.2 Pharmacokinetic Properties

In patients on regular haemodialysis administration of doses between 1 - 4 micrograms of intravenous 1 ?-hydroxyvitamin D3 resulted in increased levels of 1,25 dihydroxyvitamin D. Formation of 1,25 dihydroxyvitamin D3 occurred within 1 hour after intravenous 1 ?-hydroxyvitamin D3 and peak concentrations were reached between 2 and 5 hours. Elimination half life of the formed 1,25 dihydroxyvitamin D was between 14 and 30 hours.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Citric acid, ethanol, sodium citrate, propylene glycol and water for injection.

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store at 2-8°C.

Keep the ampoule in the outer carton in order to protect it from light.

6.5 Nature And Contents Of Container

10 x 0.5ml amber glass ampoules.

10 x 1.0ml amber glass ampoules.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

LEO Laboratories Limited

Longwick Road

Princes Risborough

Bucks

HP27 9RR

8. Marketing Authorisation Number(S)

PL 0043/0183

9. Date Of First Authorisation/Renewal Of The Authorisation

11/11/2005

10. Date Of Revision Of The Text

May 2009


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Curatoderm Ointment


1. Name Of The Medicinal Product

Curatoderm Ointment 4?g/g

2. Qualitative And Quantitative Composition

Tacalcitol monohydrate 4.17 ?g/g

(tacalcitol 4 ?g/g)

3. Pharmaceutical Form

Ointment

4. Clinical Particulars 4.1 Therapeutic Indications

Psoriasis vulgaris.

4.2 Posology And Method Of Administration

Adults and the Elderly: Apply sparingly, once daily to the affected areas, preferably at bedtime. The amount applied should not exceed l0g of ointment/day. Normally duration of treatment depends on the severity of the lesions and should be decided by the physician. There is clinical trial experience with continuous and intermittent treatment in adults up to twelve months.

Curatoderm Ointment can be used on all areas of the body (including face, hairline, scalp, axilla and other flexures).

When used on the scalp the ointment can be shampooed out the next morning.

Children: Not recommended. There is limited clinical experience in children.

4.3 Contraindications

Hypersensitivity to constituents; in patients with hypercalcaemia or other known disorders of calcium metabolism.

4.4 Special Warnings And Precautions For Use

At the doctor's discretion, in patients at risk of hypercalcaemia, or patients taking high Vitamin D preparations (in excess of 500 IU vitamin D) albumin corrected serum calcium levels should be closely monitored. Treatment should be stopped if hypercalcaemia occurs. Serum calcium levels should also be monitored in patients with renal impairment.

Care should be exercised in patients with generalised pustular or erythrodermic exfoliative psoriasis as the risk of hypercalcaemia may be enhanced.

When applying to the face avoid contact with the eyes. Patients should be advised to wash their hands after applying the ointment to avoid inadvertent transfer to other parts of the body.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interactions are likely in patients using multivitamin preparations with up to 500 IU vitamin D.

UVB radiation can be combined with Curatoderm Ointment. This approach increases the efficacy of the treatment and shortens the radiation period. UV radiation should be given in the morning and Curatoderm Ointment at bedtime. There has been limited experience of the concomitant use of Curatoderm Ointment with topical corticosteroids, urea, emollients, dithranol cream and PUVA.

4.6 Pregnancy And Lactation

The safety of this medicinal product for use in human pregnancy has not been established. Evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to the development of the embryo or foetus, the course of gestation or peri- or postnatal development. Avoid use in pregnancy unless there are no safer alternatives. During lactation the breast area should not be treated. It is not known whether tacalcitol is excreted in human breast milk.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Local skin reactions (itching, erythema, burning, paraesthesia) have been reported. Other local reactions and in isolated cases contact dermatitis or a worsening of the skin condition may occur. In general, these local reactions are mild and transient.

4.9 Overdose

Overdosing by ingestion of an ointment is very unlikely. It cannot be excluded that topical application of excessive amounts may lead to hypercalcaemia. In this case Curatoderm treatment and other possible vitamin D or calcium supplement intakes must be stopped until serum calcium returns to normal.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: D05A X02.

Tacalcitol is a vitamin D3 derivative, which inhibits keratinocyte hyper-proliferation and induces differentiation of these cells. The normalisation of these mechanisms is the basis for the efficacy in the treatment of psoriasis. In biopsies from patients treated with tacalcitol specific indicators for inflammation were improved. Tacalcitol binds to the keratinocyte vitamin D receptor to the same extent as natural active vitamin D3.

5.2 Pharmacokinetic Properties

Single or repeated application of tacalcitol ointment in humans results in less than 0.5% of the drug being systemically absorbed through psoriatic skin. Tacalcitol is completely bound to plasma proteins (vitamin D binding protein) The main metabolite is 1 ?, 24, 25 (OH)3 vitamin D3, a metabolite shared with the natural active vitamin, with 5-10 times less vitamin D activity. Tacalcitol and metabolites are excreted mainly in the faeces in rat and dog studies with excretion in urine in man. It cannot therefore be excluded that if there is sufficient systemic absorption accumulation may occur in patients with renal failure.

5.3 Preclinical Safety Data

Tacalcitol is effective in very low concentrations. The no-effect-level following cutaneous application over 12 months in rat studies amounted to only 4 ng/kg daily. Toxicity is focused to the classic vitamin effects of calciferols. Teratogenicity studies in mice and rats showed no teratogenic effects of tacalcitol. The results of mutagenicity studies (Ames test, chromosomal aberration test and micronucleus test), indicate no genotoxic potential.

6. Pharmaceutical Particulars 6.1 List Of Excipients

White petrolatum, liquid paraffin, diisopropyl adipate.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months at up to 30°C. 6 months after first opening the tube.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Aluminium tubes with internal lacquer, membrane-sealed opening and plastic screw cap, containing 5g, 20g, 30g, 60g or 100g.

6.6 Special Precautions For Disposal And Other Handling

External use only.

7. Marketing Authorisation Holder

Almirall Hermal GmbH

Scholtzstrasse 3

D-21465,

Reinbek

Germany

8. Marketing Authorisation Number(S)

PL 33016/0012

9. Date Of First Authorisation/Renewal Of The Authorisation

13th July 2006

10. Date Of Revision Of The Text

31st July 2010


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Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets


Pronunciation: a-LOO-min-uhm/KAL-see-uhm/mag-NEE-zee-uhm/si-METH-i-kone
Generic Name: Aluminum/Calcium/Magnesium/Simethicone
Brand Name: Tempo
Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets are used for:

Treating acid indigestion, heartburn, gas, and sour stomach. It may also be used for other conditions as determined by your doctor.

Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets are an antacid and antiflatulent. It works by neutralizing acid in the stomach. It also helps to break up gas bubble in the stomach, allowing it to be passed through the system more comfortably.

Do NOT use Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets if: you are allergic to any ingredient in Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets you are also taking citrate salts (found in some calcium supplements, antacids, and laxatives) you have a history of high blood calcium levels

Contact your doctor or health care provider right away if any of these apply to you.

Before using Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets:

Some medical conditions may interact with Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have Alzheimer disease, kidney problems, appendicitis, diarrhea, a stomach blockage, or an ileostomy if you have recently had stomach bleeding

Some MEDICINES MAY INTERACT with Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Cation exchange resins (eg, sodium polystyrene sulfonate) and citrate salts (found in some calcium supplements, antacids, and laxatives) because they may increase the actions and the risk of Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets's side effects Anticoagulants (eg, warfarin), quinidine, or sulfonylureas (eg, glyburide) because their actions and the risk of their side effects may be increased by Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), bisphosphonates (eg, risedronate), cephalosporins (eg, cephalexin), corticosteroids (eg, hydrocortisone), cyclosporine, delavirdine, digoxin, imidazoles (eg, ketoconazole), mycophenolate, penicillamine, quinolones (eg, ciprofloxacin), tetracyclines (eg, doxycycline), thyroid hormones (eg, levothyroxine), or verapamil because their effectiveness may be decreased by Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets, especially when taken at the same time as Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets:

Use Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets by mouth with or without food. Chew thoroughly before swallowing. Drink a glass of water after swallowing. Do not use Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets within 2 hours before or after taking a beta-blocker (eg, propranolol), bisphosphonate (eg, risedronate), cephalosporin (eg, cephalexin), corticosteroid (eg, hydrocortisone), delavirdine, digoxin, imidazole (eg, ketoconazole), penicillamine, or sulfonylurea (eg, glyburide) because their effectiveness may be decreased by Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets. If you miss a dose of Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets.

Important safety information: Do NOT take more than the recommended dose or use the maximum dose for longer than 2 weeks without checking with your doctor. If your symptoms do not get better within 2 weeks or if they get worse, or if you experience black, tarry stools or vomit that looks like coffee grounds, check with your doctor. Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets has aluminum and magnesium in it. Before you start any new prescription or over-the-counter medicine, read the ingredients to see if it has aluminum or magnesium in it too. If it does or if you are not sure, check with your doctor or pharmacist. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets while you are pregnant. If you are or will be breast-feeding while you use Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); loss of appetite; muscle weakness; nausea; slow reflexes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets:

Store Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets out of the reach of children and away from pets.

General information: If you have any questions about Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider. Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Aluminum/Calcium/Magnesium/Simethicone Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Aluminum/Calcium/Magnesium/Simethicone resources Aluminum/Calcium/Magnesium/Simethicone Dosage Aluminum/Calcium/Magnesium/Simethicone Use in Pregnancy & Breastfeeding Aluminum/Calcium/Magnesium/Simethicone Drug Interactions Aluminum/Calcium/Magnesium/Simethicone Support Group 1 Review for Aluminum/Calcium/Magnesium/Simethicone - Add your own review/rating Compare Aluminum/Calcium/Magnesium/Simethicone with other medications Gas GERD Indigestion
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Calcium Citrate


Pronunciation: KAL-see-um SIT-rate with VYE-ta-min D
Generic Name: Calcium Citrate
Brand Name: Examples include Citracal+D and Citracal Petites/Vitamin D
Calcium Citrate is used for:

Treating or preventing calcium deficiency. It may also be used for other conditions as determined by your doctor.

Calcium Citrate is a dietary supplement. It works by providing extra calcium to the body.

Do NOT use Calcium Citrate if: you are allergic to any ingredient in Calcium Citrate you have high blood calcium levels or high blood vitamin D levels you take aluminum salts (eg, aluminum chloride)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Calcium Citrate:

Some medical conditions may interact with Calcium Citrate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have high blood phosphate levels or high levels of calcium in the urine if you have dehydration, heart problems, hardening of the arteries, kidney problems, kidney stones, or sarcoidosis if you take digoxin

Some MEDICINES MAY INTERACT with Calcium Citrate. Tell your health care provider if you are taking any other medicines, especially any of the following:

Iron, quinolones (eg, ciprofloxacin), sodium polystyrene sulfonate, tetracyclines (eg, doxycycline), thyroid hormones, or verapamil because their effectiveness may be decreased by Calcium Citrate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Calcium Citrate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Calcium Citrate:

Use Calcium Citrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Calcium Citrate by mouth with or without food. Take Calcium Citrate with a full glass of water (8 oz/240 mL). Do not take an antacid that has aluminum in it within 1 hour before or 2 hours after you take Calcium Citrate. If you miss a dose of Calcium Citrate, take it as soon as you remember. Continue to take it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Calcium Citrate.

Important safety information: Do not take large doses of vitamins while you use Calcium Citrate unless your doctor tells you to. Tell your doctor or dentist that you take Calcium Citrate before you receive any medical or dental care, emergency care, or surgery. This product may contain tartrazine dye (FD&C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it. Lab tests, including serum calcium levels, may be performed while you use Calcium Citrate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Calcium Citrate should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Calcium Citrate while you are pregnant. It is not known if Calcium Citrate is found in breast milk. If you are or will be breast-feeding while you use Calcium Citrate, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Calcium Citrate:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; headache.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); loss of appetite; nausea; severe or persistent constipation; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; delirium; loss of consciousness; mood or mental changes.

Proper storage of Calcium Citrate:

Store Calcium Citrate at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Calcium Citrate out of the reach of children and away from pets.

General information: If you have any questions about Calcium Citrate, please talk with your doctor, pharmacist, or other health care provider. Calcium Citrate is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Calcium Citrate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Calcium Citrate resources Calcium Citrate Use in Pregnancy & BreastfeedingCalcium Citrate Drug InteractionsCalcium Citrate Support Group0 Reviews for Calcium Citrate - Add your own review/rating calcium citrate Concise Consumer Information (Cerner Multum) Citracal Liquitab Concise Consumer Information (Cerner Multum) Compare Calcium Citrate with other medications Dietary SupplementationOsteoporosis
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CX Powder (Ecolab)


1. Name Of The Medicinal Product

CX POWDER

2. Qualitative And Quantitative Composition

Chlorhexidine Acetate BP 1% w/w

3. Pharmaceutical Form

Powder

4. Clinical Particulars 4.1 Therapeutic Indications

General skin disinfection and antisepsis for topical application only.

4.2 Posology And Method Of Administration

Apply lightly to the affected area up to three times daily. The dosage schedule does not require adjustment for adults, children or the elderly. The dosage is as stated for both the clinical indications, vis skin disinfection and antisepsis.

4.3 Contraindications

Known hypersensitivity to chlorhexidine.

4.4 Special Warnings And Precautions For Use

Skin sensitivity to Chlorhexidine salts has occurred occasionally, Chlorhexidine salts are irritant to the conjunctiva and other sensitive tissue.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

No special precautions need to be taken when used in pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

None known

4.9 Overdose

Not applicable. Ingestion of Chlorhexidine salts should be treated symptomatically, unless gastric lavage is required from other clinical considerations.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Chlorhexidine Acetate is an antibacterial substance which is effective against a wide range of gram-positive and gram-negative bacteria. It has limited activity against some viruses and fungi. It is inactive against bacterial spores at room temperature and some strains of pseudomonas and proteus tend to be less susceptible than other bacteria.

Sterilisable Maize Starch BP is an absorbent powder.

5.2 Pharmacokinetic Properties

Not applicable. The product is for topical application and significant systematic absorption does not occur.

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sterilisable Maize Starch BP.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

Store below 25°C. Protect from light.

6.5 Nature And Contents Of Container

CX Powder is packed in LDPE bottles fitted with a nozzle plug and white plastic cap. Pack size 15g.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Ecolab Ltd, Lotherton Way, Garforth, Leeds, LS25 2JY.

8. Marketing Authorisation Number(S)

PL 04509/0011

9. Date Of First Authorisation/Renewal Of The Authorisation

05/12/2008

10. Date Of Revision Of The Text

05/12/2008


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Luborant


1. Name Of The Medicinal Product

Luborant.

2. Qualitative And Quantitative Composition

Each 0.8ml contains 0.003mg of Sodium Fluoride BP

Nipasept Sodium 1.600mg per 0.8 ml contains mixture of sodium hydroxybenzoates which is comprised of sodium p-hydroxybenzoate max. 0.064mg, Sodium Methyl 4-Hydroxybenzoate (E 219) 1.088mg to 1.216mg per 0.8 ml; Sodium Ethyl 4-hydroxybenzoate (E 215) 0.208mg to 0.288mg per 0.8 ml and Sodium Propyl 4-hydroxybenzoate (E 217) 0.128mg to 0.208mg.

3. Pharmaceutical Form

Oromucosal solution.

Pink viscous liquid with as odour of orange.

4. Clinical Particulars 4.1 Therapeutic Indications

Saliva deficiency. Luborant is a saliva substitute for the management of conditions involving dryness of the mouth. These include xerostomia following radiotherapy or during treatment with antidepressants or anxiolytics, and other conditions involving a decrease in production of saliva, such as Sjogren's disease.

4.2 Posology And Method Of Administration

Luborant is for oral use.

Adults, including the elderly: Two or three single applications orally up to four times daily or as directed by the physician. The average dose per application is 0.8ml of the product.

4.3 Contraindications

Hypersensitivity to sodium fluoride.

4.4 Special Warnings And Precautions For Use

Mottling of dental enamel has occurred in association with use of Sodium Fluoride in larger amounts than those contained in the dosage recommended for Luborant.

Do not exceed the stated dose.

The contents should be discarded if not used before a date one month after the date of opening.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is no known or perceived hazard for use in pregnancy or lactation at the dosage recommended.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

None stated

4.9 Overdose

There are no reports of overdose. Serious symptoms are unlikely following acute overdosage.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Potassium Chloride

]

Salts normally found in saliva Electrolyte concentration close to whole saliva. No precise pharmacological activity other than electrolyte replacement in oral cavity.

Magnesium Chloride

]

 

hexahydrate

 

 

Calcium Chloride dihydrate

]

 

Potassium Phosphate Dibasic

]

 

Potassium Phosphate Monobasic

]

 

Sodium fluoride: used for the prophylaxis of dental caries, it renders the dentine and enamel of the teeth more resistant to acid.

5.2 Pharmacokinetic Properties

Luborant is applied topically to the oral mucous membrane for its local effects within the oral cavity. Although the individual constituent salts may undergo gastro-intestinal absorption, their concentration in daily dosage recommended for Luborant represents only a small percentage pf the recommended daily human requirements of these salts and can not, therefore, be expected to influence normal fluid or electrolyte balance.

5.3 Preclinical Safety Data

No further relevant information other than that which is included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Potassium Chloride

Magnesium Chloride hexahydrate

Calcium Chloride dihydrate

Potassium Phosphate Dibasic

Potassium Phosphate Monobasic

Nipasept Sodium

Sorbitol solution 70% Non-crystallizing

Sodium carboxymethyl cellulose

Orange Flavour IFF VX 1997

Carmoisine Red CI 14720 E122

Hydrochloric Acid

Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf Life

Unopened : 2 years

Opened : 1 month

6.4 Special Precautions For Storage

Keep in outer carton.

Do not store above 25°C.

6.5 Nature And Contents Of Container

60ml, high density polyethylene bottle with a pump action applicator packed in cardboard cartons to contain 1 x 60ml and 6 x 60ml bottles.

6.6 Special Precautions For Disposal And Other Handling

Contents to be discarded if not used before a date one month after the date of opening.

7. Marketing Authorisation Holder

Goldshield Pharmaceuticals Limited,

NLA Tower, 12-16 Addiscombe road,

Croydon,

Surrey,

CR0 0XT,

United Kingdom

8. Marketing Authorisation Number(S)

PL 12762/0227

9. Date Of First Authorisation/Renewal Of The Authorisation

10th January 1990/24th February 1999

10. Date Of Revision Of The Text

December 2009


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Osteopenia Medications


Drugs associated with Osteopenia

The following drugs and medications are in some way related to, or used in the treatment of Osteopenia. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.


Drug List: Cal-Gest Calcarb Calci-Mix Calci-Chew Calcium-Concentrate Calcium-Liquid-Softgel Calcium-Oyster-Shell Caltrate Nephro-Calci Os-Cal-500 Oysco-500 Oyst-Cal-500 Oyster-Cal Oyster-Calcium Oyster-Shell Tums-Kids-Chewable-Tablets
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Inotropic agents


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Inotropic agents affect the contraction of the heart muscle. Positive inotropes stimulate and increase the strength of heart muscle contraction causing the heart rate to increase. Negative inotropic agents weaken the force of muscular contractions.

Inotropic state depends on the amount of calcium in the cytoplasm of the heart muscle wall, as contractility of the heart depends on control of intracellular calcium i.e. control of calcium entry into the cell membrane and calcium storage in the sarcoplasmic reticulum. The main factors controlling calcium entry are activity of voltage gated calcium channels and sodium ions, which affects calcium/sodium ion exchange.

Positive inotropes usually increase the level of intracellular calcium and negative inotropes decrease it.

See also

Medical conditions associated with inotropic agents:

Atrial Fibrillation Heart Failure Nonobstructive Oliguria Shock Drug List: Lanoxicaps Lanoxin Digitek Dobutrex Primacor Primacor-I-V
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Idracal


Idracal may be available in the countries listed below.

Ingredient matches for Idracal Calcium Carbonate

Calcium Carbonate is reported as an ingredient of Idracal in the following countries:

Italy

International Drug Name Search


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Boots Effervescent Health Salts


Boots Effervescent Health Salts

(Magnesium Sulphate, Sodium Bicarbonate, Citric acid)

Sparkling relief of upset stomach, heartburn, indigestion and occasional constipation

227 g

Read all of this label for full instructions.

Uses: An antacid and laxative for the relief of upset stomach, heartburn, indigestion, feeling sick and for the relief of occasional constipation.

Before you take this medicine Do not take: If you are allergic to any of the ingredients If you have severe stomach problems If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains sucrose) Talk to your pharmacist or doctor: If you have heart, kidney or liver problems If you have diabetes If you need to use a laxative every day If you have severe stomach pain If you are elderly, or feel very weak If you are on a controlled sodium diet (each level teaspoon of powder contains 185 mg sodium) If you are pregnant or breastfeeding How to take this medicine

Check the inner seal is not broken before first use. If it is, do not use the powder.

Use a dry spoon to measure. Mix the amount in the table with a glass of water and drink the solution, before it stops fizzing. Replace lid firmly after use.

Adults:

For upset stomach, heartburn, indigestion, feeling sick: One or two teaspoonfuls.

For constipation: Two teaspoonfuls before breakfast or at bedtime.

Children of 3 years and over: Reduce the amount above according to size and age.

Do not give to children under 3 years.

Do not take this medicine for long periods of time (generally more than a week).

Do not take more than the amount recommended.

If symptoms worsen talk to your doctor. If symptoms don’t go away talk to your doctor.

Possible side effects

Most people will not have problems, but some may get some of these:

Gripping pain in your stomach Diarrhoea, feeling sick, being sick

If you have taken the medicine for a long time you may get:

Light headedness, confusion Muscle weakness, cramps Numbness, tingling, breathing problems

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

Store in a dry place below 25°C and away from strong smells.

Keep all medicines out of the sight and reach of children.

Use by the date on the base of the tub. Throw away any powder left 3 months after opening.

Active ingredients: This effervescent powder contains Citric Acid 19.5% w/w, Magnesium Sulphate 17.4% w/w, Sodium Bicarbonate 22.6% w/w.

Also contains: sucrose.

PL12063/0039

Text prepared 4/08

Manufactured for

The Boots Company PLC Nottingham NG2 3AA

by the MA holder

Wrafton Laboratories Limited Braunton Devon EX33 2DL

If you need more advice ask your pharmacist.


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Calcium Salts


Class: Replacement Preparations
VA Class: TN420
CAS Number: 543-90-8
Brands: Alka-Mints, Calcet, Calci-Chew, Calci-Mix, Calphosan, Caltrate, Caltrate + Vitamin D, Chooz, Citracal, Citracal + D, Healthy Woman, Liqui-Cal, Os-Cal, Os-Cal +D, PhosLo, Posture, Posture-D, Titralac, Tums, Viactiv

Pharmacy Bulk Packages

Pharmacy bulk packages are for preparation of IV mixtures only.g

Not for direct IV infusion.g

Introduction

Calcium salts are used as a source of calcium, an essential nutrient cation.b

Uses for Calcium Salts Dietary Requirements (oral therapy)

For maintaining an adequate intake of calcium to support the development and preservation of bone mass at a level sufficient to prevent fractures associated with osteopenia or osteoporosis in later life and of other calcified tissues (e.g., teeth).112 126 129

Although calcium can have beneficial effects on BP, 101 102 no current rationale to supplement calcium intake solely for BP reduction.114 120 121

Adequate intakes of calcium can be accomplished through changes in food consumption behaviors, consumption of nutrient-fortified foodstuffs, use of dietary supplements, or a combination of these.112

Use fortified foodstuffs to increase or maintain intakes without major changes in food habits and use supplements in certain individuals who are at increased risk.112 In the US and Canada, calcium principally is obtained from dairy products (almost 75% of total intake).112 Other principal sources include fruits and vegetables (about 9%) and grain products (about 5%).112 In addition, many healthy individuals take dietary supplements containing calcium.112

For specific information on currently recommended Adequate Intakes (AIs) of calcium for various life-stage and gender groups, see Dosage under Dosage and Administration.b

Supplemental Therapy for Pregnant, Postmenopausal, or Nursing Women (oral therapy)

Calcium salts are used as supplemental therapy for pregnant, postmenopausal, or nursing women.b

In general, any calcium salt may be used for chronic replacement therapy.b

Phosphate salts of calcium are efficacious in pregnant, nursing, or osteoporotic patients who usually require both calcium and phosphorus supplements, but they should not be used in hypocalcemic-hyperphosphatemic states (e.g., hypoparathyroidism, renal failure).b

Hypocalcemia (parenteral and oral therapy)

Calcium salts are used as a source of calcium cation for the treatment or prevention of calcium depletion when dietary measures are inadequate.b Conditions associated with calcium deficiency include hypoparathyroidism, achlorhydria, chronic diarrhea, vitamin D deficiency, steatorrhea, sprue, pregnancy and lactation, menopause, pancreatitis, renal failure, alkalosis, and hyperphosphatemia.b

IV calcium chloride is considered the calcium salt of choice to prevent hypocalcemia during transfusions with citrated blood.b In addition to being irritating, however, the chloride salt is acidifying and generally should not be used when acidosis coincides with hypocalcemia (e.g., renal failure).b

The calcium glycerophosphate and calcium lactate fixed-combination injection is used IM to increase serum calcium concentrations.142

Administration of certain drugs (e.g., some diuretics, anticonvulsants) may sometimes result in hypocalcemia, which may warrant calcium replacement therapy.b

Calcium is administered in long-term electrolyte replacement regimens.b

Use of calcium salts should not preclude the use of other measures intended to correct the underlying cause of calcium depletion.b

Vitamin D analogs may be administered concomitantly with oral calcium salts for the treatment of chronic hypocalcemia, especially when caused by vitamin D deficiency.b

Calcium salts may be used orally for the treatment of hypocalcemia secondary to the administration of anticonvulsant drugs.b

Hypocalcemic Tetany (IV therapy)

IV calcium gluconate is considered the salt of choice for the treatment of acute hypocalcemia.b

Calcium salts are used to treat acute hypocalcemic tetany secondary to renal failure, hypoparathyroidism, premature delivery, and/or maternal diabetes mellitus in infants, and poisoning with magnesium, oxalic acid, radiophosphorus, carbon tetrachloride, fluoride, phosphate, strontium, or radium.b

Hypoparathyroidism, Chronic (oral therapy)

Calcium salts may be used for treatment of chronic hypoparathyroidism.b

Latent Tetany (oral therapy)

Calcium salts may be used for the treatment of latent tetany.b

Osteoporosis Prevention (oral therapy)

For women whose dietary intake of calcium is limited, supplementation with oral calcium salts is recommended for the prevention of primary osteoporosis.100 126

Daily calcium requirement is about 1 g in premenopausal women and in women receiving estrogen therapy and about 1.5 g in postmenopausal women who are not receiving supplemental estrogen therapy.100 126

While not as effective as a regimen of estrogens and exercise, the addition of calcium to a regimen of exercise appears be more effective than exercise alone in preventing or slowing bone loss in postmenopausal women considered at risk for osteoporotic fracture because of low bone density, and generally appears to be better tolerated than the estrogen-exercise regimen.111 126

Intake of elemental calcium of 1–1.5 g daily, beginning well before the menopause, is believed by some clinicians to reduce the incidence of osteoporosis in postmenopausal women; increased calcium intake may also prevent or diminish age-related bone loss in men.100 126

Osteoporosis Treatment (oral therapy)

Calcium salts may be used for treatment of osteoporosis.b

Osteomalacia (oral therapy)

Calcium salts may be used for treatment of osteomalacia.b

Anticonvulsant-induced Hypocalcemia (oral therapy)

Calcium salts may be used for treatment of rickets, latent tetany, and hypocalcemia secondary to the administration of anticonvulsant drugs.b

Rickets (oral therapy)

Calcium salts may be used for treatment of rickets.b

Corticosteroid-induced Osteoporosis (oral therapy)

Corticosteroid-induced osteoporosis results in part from decreased GI absorption of calcium and increased urinary calcium excretion; attempts at normalizing calcium balance may limit the extent of bone loss during systemic corticosteroid therapy.119

Maintain an adequate calcium intake of about 1.5 g of elemental calcium daily in adults receiving chronic systemic corticosteroid therapy.119

Hyperphosphatemia in Chronic Renal Failure (oral therapy)

Calcium acetate and calcium carbonate are considered the salts of choice for chronic renal failure.113 126

In addition to providing a source of calcium, calcium acetate or carbonate sequesters phosphate in the intestine by forming insoluble phosphates that are excreted fecally, thus reducing serum phosphate concentrations and secondary hyperparathyroidism.b

Calcium carbonate partially corrects metabolic acidosis which may occur in chronic renal failure.b

Because of the risk of aluminum accumulation and resultant neurotoxic and osteomalacic effects, most clinicians no longer use aluminum hydroxide to inhibit phosphorus absorption; instead calcium acetate or carbonate and/or non-calcium-, non-aluminum-, non-magnesium-containing phosphate binders (e.g., lanthanum carbonate, sevelamer hydrochloride) currently are used.127 130 131 132

When taken with meals, calcium acetate or carbonate can contribute to controlling hyperphosphatemia in chronic renal failure by binding to and inhibiting absorption of phosphates in the GI tract.113 127

Exercise caution in patients undergoing chronic hemodialysis to prevent hypophosphatemia.b

Patients with end-stage renal failure may develop hypercalcemia when calcium is administered with meals; do not give calcium supplementation concomitantly when calcium salts are used to control hyperphosphatemia in such patients.113

Progressive hypercalcemia secondary to overdose of calcium salts can occur and may require emergency treatment measures.113

Chronic hypercalcemia also may lead to vascular and other soft-tissue calcification;113 126 periodic (e.g., twice weekly) monitoring of calcium concentrations is recommended during the initial dose adjustment.113 One manufacturer recommends that the serum calcium times phosphate (Ca ? P) product should not exceed 66.113 Radiographic evaluation of a suspected anatomical region for early soft-tissue calcification may be useful.113

Hyperkalemia with Secondary Cardiotoxicity (IV therapy)

Calcium salts are used with ECG monitoring to antagonize the cardiotoxicity of hyperkalemia when the ECG shows broad QRS complexes or absent P waves.134 b

Administer parenteral calcium salts cautiously, if at all, to patients receiving cardiac glycosides (especially during cardiac resuscitation or for the treatment of hyperkalemia) or if digoxin toxicity is suspected.134 b (See Digoxin under Drug Interactions.)

CPR (IV therapy)

Calcium has been administered IV or into the ventricular cavity during cardiac resuscitation when epinephrine or isoproterenol had failed to improve weak or ineffective myocardial contraction.b j However, because of the theoretical potential for detrimental effects resulting from high concentrations of calcium and the lack of demonstrated benefit, the guidelines on CPR and emergency cardiovascular care (ECC) currently state that calcium should not be used routinely to support circulation in the setting of cardiac arrest in ACLS in adults and pediatric advanced life support (PALS) in children, except when hyperkalemia, ionized hypocalcemia (e.g., after multiple blood transfusions), or calcium-channel blocking agent toxicity is present.109 134 b

Guidelines no longer include recommendations for the use of calcium in the acute phase of CPR in neonates.109 134 b

Calcium chloride is the calcium salt of choice for cardiac resuscitation, when calcium is indicated.134 b In addition to being irritating, however, the chloride salt is acidifying and generally should not be used when acidosis coincides with hypocalcemia (e.g., renal failure).b

Aminoglycoside Neuromuscular Blockade (IV therapy)

Calcium salts are used to antagonize neuromuscular blockade† resulting from the use of aminoglycoside antibiotics (e.g., gentamicin, kanamycin, neomycin) with or without agents possessing neuromuscular blocking properties (e.g., gallamine triethiodide).b

Magnesium Intoxication (IV therapy)

Calcium gluconate may be used in the treatment of magnesium sulfate overdosage.c

Calcium gluconate is considered treatment of choice for magnesium toxicity in pregnant women with eclampsia.134 b

Myasthenia Gravis (oral therapy)

Calcium salts are used as adjunctive treatment of myasthenia gravis.b

In general, any oral calcium salt may be used for chronic replacement therapy.b

Medullary Thyroid Carcinoma (IV therapy)

Calcium infusions (“calcium challenge”) are used in medullary thyroid carcinoma†.b

Acid Indigestion (oral therapy)

Calcium carbonate or phosphate may be used for self-medication for the relief of acid indigestion, heartburn, and sour stomach.d

Colic, Renal, Biliary, Intestinal, or Lead (IV and IM therapy)

Calcium salts have been used IM or IV as adjunctive therapy to reduce spasms in renal, biliary, intestinal, or lead colic.b

Zollinger-Ellison Syndrome, Diagnosis (IV therapy)

Calcium infusions (“calcium challenge”) are used to diagnose the Zollinger-Ellison syndrome†.b

Eaton-Lambert Syndrome (oral therapy)

Calcium salts are used as adjunctive treatment of the Eaton-Lambert syndrome.b

In general, any oral calcium salt may be used for chronic replacement therapy.b

Insect Bites and Other Sensitivity Reactions (IV therapy)

Calcium salts have been used IV as adjuncts to relieve muscle cramps in the treatment of insect bites or stings (e.g., black widow spider) or to decrease capillary permeability in sensitivity reactions characterized by urticaria or angioedema and in allergic conditions, including nonthrombocytopenic purpura, dermatitis herpetiformis, drug-induced pruritus, hay fever, and asthma.b

Preeclampsia (oral therapy)

Although some evidence suggested a beneficial effect of calcium supplementation on preeclampsia,117 118 125 a large, well-designed study did not confirm a beneficial effect of calcium supplementation in preventing preeclampsia during pregnancy.114 117 However, these findings do not obviate adequate dietary calcium intake during pregnancy nor do they address whether adequate or increased calcium intake can affect blood pressure favorably in pregnant women.105 118 125

?-Adrenergic or Calcium-channel Blocking Agent Overdosage (IV therapy)

Some experts state that calcium salts may be considered in the treatment of bradycardia or shock associated with calcium-channel blocking agent-induced toxicity.134 b

These experts state that there is insufficient evidence to recommend for or against the use of calcium in ?-adrenergic blocking agent toxicity, but that calcium salts may be considered in the treatment of bradycardia or shock.134 b

Diuresis (oral therapy)

Calcium chloride, an acid-forming salt, has been used to promote diuresis, however, because it is irritating and loses effectiveness after a few days, it is rarely used for this effect.b

Calcium Salts Dosage and Administration Administration

Administer calcium orally (as acetate, carbonate, citrate, gluconate, lactate, or phosphate salt) or IV (as chloride or gluconate salt).134 b j

The fixed combination of calcium glycerophosphate and calcium lactate is injected IM.142

In extreme cardiac emergencies, calcium chloride has been administered intracardially into the ventricular cavity.b j

For ACLS during CPR in pediatric patients, calcium chloride administration via central venous catheter is preferred because of the risk of sclerosis or infiltration with a peripheral venous line.134 b

For ACLS during CPR in pediatric patients, calcium chloride also may be administered by intraosseous injection†; onset of action and systemic concentrations are comparable to those achieved with central venous administration.134 b

Oral Administration

Administer acetate, carbonate, citrate, gluconate, lactate, and phosphate salts of calcium orally.b

Administer most oral calcium supplements 1–1.5 hours after meals or with a demulcent (e.g., milk).112 b However, calcium carbonate powder generally should be administered with meals, since mixing the powder with food for administration is recommended.b

Calcium salts used to bind dietary phosphate in patients with end-stage renal disease should be administered with meals (e.g., 10–15 minutes before, or during, the meal).130

IV Administration

Calcium chloride or gluconate may be administered IV.b j

Calcium gluconate usually is administered IV as a 10% solution and calcium chloride as a 2–10% solution.b j

When injected IV, administer calcium salts slowly through a small needle into a large vein to avoid too rapid an increase in serum calcium and extravasation of calcium solution into the surrounding tissue with resultant necrosis.b

Following IV injections, the patient should remain recumbent for a short time.b

Close monitoring of serum calcium concentrations is essential during IV administration of calcium.b

Children: Calcium salts should not be administered through scalp veins; oral administration of calcium supplements or calcium-rich foods should replace IV calcium therapy as soon as possible.b

Dilution

Usually, administer IV undiluted.a b c

Parenteral calcium salts also may be administered in a compatible large-volume IV infusion fluid.b (See Solution Compatibility under Compatibility.)

Pharmacy bulk packages are for preparing IV admixtures only.g

Rate of Administration

Administer IV calcium injections slowly at a rate not exceeding 0.7–1.8 mEq/minute.b

Stop the injection if the patient complains of discomfort.b

Pharmacy bulk packages must not be infused IV directly.g

Administer pediatric dose for CPR by slow IV injection over 10–20 seconds.b

IM or Sub-Q Injection

Calcium chloride should not be injected IM or into subcutaneous or perivascular tissue, since severe necrosis and sloughing may occur.b

Although other calcium salts may cause mild to severe local reactions, they generally are less irritating than calcium chloride.b (See Cautions.)

Although some manufacturers previously stated that calcium gluconate could be injected IM when IV administration was not possible,b manufacturers of calcium gluconate currently state that the drug should not be injected IM or into subcutaneous tissue because of the potential for severe local reactions.140 141

The fixed-combination of calcium glycerophosphate and calcium lactate is injected IM.142

Intracardiac Injection

Limit intracardiac injection to personnel well trained in the technique and generally use only during open cardiac massage or when other routes of administration are persistently inaccessible.109

Inject into the left ventricular chamber.109

Follow intracardiac administration by external cardiac massage to ensure entry of the drug into the coronary circulation.

Administration Risks

Hazards include coronary artery laceration, cardiac tamponade, pneumothorax, and the need to interrupt external chest compressions and ventilation during the period of administration.109

Dosage

Dosage of the oral calcium supplements usually is expressed in g or mg of elemental calcium and depends on the requirements of the individual patient.b

Dosage of parenteral calcium replacements usually is expressed as mEq of calcium and depends on individual patient requirements.b

One mEq of elemental calcium is equivalent to 20 mg.b

The calcium content of the various calcium salts is approximately:b

Calcium Salt

Calcium Content

calcium acetate

253 mg (12.7 mEq) per g

calcium carbonate

400 mg (20 mEq) per g

calcium chloride

270 mg (13.5 mEq) per g

calcium citrate

211 mg (10.6 mEq) per g

calcium gluceptate

82 mg (4.1 mEq) per g

calcium gluconate

90 mg (4.5 mEq) per g

calcium glycerophosphate

191 mg (9.6 mEq) per g

calcium lactate

130 mg (6.5 mEq) per g

calcium phosphate dibasic anhydrous

290 mg (14.5 mEq) per g

calcium phosphate dibasic dihydrate

230 mg (11.5 mEq) per g

calcium phosphate tribasic

400 mg (20 mEq) per g

Oral calcium supplements usually are administered in 3 or 4 divided doses daily.b

Optimum calcium absorption may require supplemental vitamin D in individuals with inadequate vitamin D intake, those with impaired renal activation of the vitamin, or those not receiving adequate exposure to sunlight.112 116

Pediatric Patients Dietary Requirements Oral

Because hypocalcemia is relatively common in neonates, special evaluation of calcium requirements may be needed for some neonates.112

Adequate Intake (AI) of elemental calcium currently recommended by the National Academy of Sciences (NAS) in healthy children:112

Infants <6 Months of Age:

210 mg daily when the source is human milk (i.e., for breast-fed infants); 315 mg daily for infants receiving cow milk-based formula.112

Infants 6–12 Months of Age:

270 mg daily when the source is human milk and solid foods; 335 mg daily for infants receiving cow milk-based formula.112

Children 1–3 Years of Age:

500 mg daily.b

Children 4–8 Years of Age:

800 mg daily.b

Children 9–18 Years of Age:

1.3 g daily.112

Infants fed with various specialty formulas, including soy protein-based and protein hydrolysate formulas, should receive an additional 20% increase in calcium intake compared with infants receiving cow milk-based formulas due to lower calcium bioavailability associated with various specialty formulas.112

Give special consideration for different calcium requirements in children with chronic illnesses such as juvenile rheumatologic conditions, renal disease, liver failure, and certain endocrine disorders, including type 1 (insulin-dependent) diabetes mellitus.112

Hypocalcemia

Calcium gluconate usually is administered IV as a 10% solution and calcium chloride as a 2–10% solution.b j

Calcium replacement requirements can be estimated by clinical condition and/or serum calcium determinations.b

Prevention Oral

Neonates: Usually, 50–150 mg/kg of elemental calcium daily; do not exceed 1 g daily.b

Children: Usually, 45–65 mg/kg of elemental calcium daily.b

Treatment When Prompt Elevation of Serum Calcium Is Required IV

Infants: <0.93 mEq of calcium; may be repeated every 1–3 days depending on the patient’s response.140 141 b

Children: Usually, initial dose of 0.93–2.3 mEq of calcium; may be repeated every 1–3 days depending on the patient’s response.140 141 b

Alternatively, one manufacturer recommends a pediatric IV calcium dose of 0.272 mEq/kg, up to a maximum total daily dosage of 1.36–13.6 mEq, in the treatment of hypocalcemic disorders.138

Hypocalcemic Tetany IV

Neonates: May be treated with divided doses of calcium totaling about 2.4 mEq/kg daily.b

Children: Usually, calcium dose of 0.5–0.7 mEq/kg administered IV 3 or 4 times daily or until tetany is controlled.b

Exchange Transfusions of Citrated Blood IV

Neonates: 0.45 mEq of calcium concurrently with each 100 mL of citrated blood.b

CPR

In critically ill children, calcium chloride may provide greater bioavailability of calcium than calcium gluconate.134 b Administer appropriate dose by slow IV or intraosseous† injection.134 b

IV

Children, per PALS guidelines: 0.272 mEq/kg of calcium 128 134 as calcium chloride (0.2 mL/kg of 10% calcium chloride); this dose of 10% calcium chloride will provide 20 mg/kg of the salt and 5.4 mg/kg of elemental calcium.128 134

Calcium-channel Blocking Agent Overdosage IV

For cardiovascular emergencies in pediatric patients: 0.272 mEq/kg of calcium as 10% calcium chloride (0.2 mL/kg) may be given over 5–10 minutes; if a beneficial effect is observed, an IV calcium infusion of 0.27–0.68 mEq/kg per hour using calcium chloride may be given.134 b Monitor ionized calcium concentrations to prevent hypercalcemia.134 b

Adults Dietary Requirements Oral

Calcium replacement requirements can be estimated by clinical condition and/or serum calcium determinations.b

Prophylactic administration of calcium supplements may be necessary in some patients in order to maintain serum calcium >9 mg/dL.b

The AI of elemental calcium for healthy adults are:

Adults 19–50 Years of Age:

1 g daily.112

Adults ? 51 Years of Age:

1.2 g daily.112

Pregnant or Lactating Women:

Generally, the usual AI of calcium appropriate for their age.112

Hypocalcemia

Calcium gluconate usually is administered IV as a 10% solution and calcium chloride as a 2–10% solution.b j

Calcium replacement requirements can be estimated by clinical condition and/or serum calcium determinations.b

Prevention Oral

Usually, about 1 g of elemental calcium daily.b

Treatment Oral

Usually, 1–2 g or more of elemental calcium daily.b

IM

Usually, 0.8 mEq of calcium as the calcium glycerophosphate and calcium lactate fixed-combination preparation 1–4 times weekly or as directed by a clinician.142

Treatment When Prompt Elevation of Serum Calcium Is Required

Calcium gluconate usually is administered IV as a 10% solution and calcium chloride as a 2–10% solution.134 b j

IV

Usual initial dose of 2.3–14 mEq of calcium; doses may be repeated every 1–3 days depending on the patient’s response.136 137 138 139 140 141 b

Acute, symptomatic hypocalcemia: 4.65–9.3 mEq of calcium as 10% calcium gluconate (10–20 mL) over 10 minutes, followed by IV infusion of 27–36 mEq of calcium (58–77 mL of 10% calcium gluconate in 0.5–1 L of 5% dextrose injection).134 b Alternatively, 6.8 mEq of calcium as 10% calcium chloride (5 mL) over 10 minutes, followed by IV infusion of 50 mEq of calcium (36.6 mL of 10% calcium chloride) over 6–12 hours.134 b Measure serum calcium concentrations every 4–6 hours and maintain total serum calcium concentrations at 7–9 mg/dL.134 b

Hypocalcemic Tetany

Calcium gluconate usually is administered IV as a 10% solution and calcium chloride as a 2–10% solution.134 b j

IV

4.5–16 mEq doses of calcium, administered until therapeutic response occurs.b

Exchange Transfusions of Citrated Blood IV

About 1.35 mEq of calcium concurrently with each 100 mL of citrated blood.b

CPR IV

Per ACLS guidelines, 0.109–0.218 mEq/kg of calcium as calcium chloride; may repeat dose as necessary.109 134 b

Alternatively, 7–14 mEq of calcium as calcium chloride has been given.b

Intracardiac Injection

Usually, 2.7–5.4 mEq of calcium as calcium chloride into the ventricular cavity during cardiac resuscitation.b j

Hyperkalemia with Secondary Cardiotoxicity IV

Usually, 2.25–14 mEq of calcium while monitoring the ECG; may repeat dosage after 1–2 minutes if necessary.b

Alternatively, for hyperkalemia associated with severe potassium elevation (>7 mEq/L with toxic ECG changes), 6.8–13.6 mEq of calcium as 10% calcium chloride (5–10 mL) has been administered over 2–5 minutes to reduce the effects of potassium at the myocardial cell membrane (e.g., reduce the risk of ventricular fibrillation).134 b

Hyperphosphatemia in Chronic Renal Failure Oral

Usual initial dose of 1.334 g of calcium acetate (338 mg of calcium) with each meal;113 increase dosage gradually according to serum phosphate concentrations, provided hypercalcemia does not occur.113

Manufacturer states that most patients require about 2–2.67 g (about 500–680 mg of calcium) with each meal.113 However, some experts recommend limiting dosage of calcium provided by phosphate binders to ?1.5 g daily and limiting total calcium intake (including dietary calcium) to ?2 g daily; dialysis patients who remain hyperphosphatemic despite such therapy should receive a calcium-containing phosphate binder in combination with a non-calcium-, non-aluminum-, non-magnesium-containing phosphate binder.130

Monitor serum calcium concentrations twice weekly during initiation of therapy and subsequent dosage adjustment; also monitor serum phosphorus concentrations periodically.113

If hypercalcemia occurs, reduce dosage or withhold the salt.113 If severe hypercalcemia occurs, specific measures (e.g., hemodialysis) for the management of overdosage may be necessary.113

Zollinger-Ellison Syndrome, Diagnosis IV

Usually, 0.25 mEq/kg of calcium per hour for a 3-hour period; serum gastrin concentrations are determined 30 minutes before the infusion, at the start of the infusion, and at 30-minute intervals thereafter for 4 hours.b

In most patients with Zollinger-Ellison syndrome, preinfusion serum gastrin concentrations increase by more than 50% or by greater than 500 pg/mL during the infusion.b

Magnesium Intoxication IV

Initially, 7 mEq of calcium; adjust subsequent doses according to patient response.b

Alternatively, 6.8–13.6 mEq of calcium as 10% calcium chloride (5–10 mL) has been administered and repeated as necessary.134 b

Medullary Thyroid Carcinoma, Diagnosis IV

Usually, about 7 mEq of calcium over 5–10 minutes; in patients with medullary thyroid carcinoma, plasma calcitonin concentrations are elevated above normal basal concentrations.b

Osteoporosis Primary Prevention in Women Oral

Usually, 1–1.5 g daily of elemental calcium; 1 g daily in premenopausal women and 1.5 g daily in postmenopausal women not receiving estrogen replacement.100 126

Corticosteroid-induced Osteoporosis

To limit the extent of corticosteroid-induced osteoporosis, adults receiving chronic systemic corticosteroid therapy should maintain an adequate calcium intake.119

Oral

About 1.5 g of elemental calcium daily.119

Special Populations Hepatic Impairment

No specific dosage recommendations for hepatic impairment.a b c

Renal Impairment

No specific dosage recommendations for renal impairment.a b c

Geriatric Patients

No specific geriatric dosage recommendations.a

Cautions for Calcium Salts Contraindications

Ventricular fibrillation.b

Hypercalcemia.b

Hypophosphatemia.b

Renal calculi.b

IV administration contraindicated when serum calcium concentrations are above normal.b

Warnings/Precautions Warnings

Use calcium salts cautiously, if at all, in sarcoidosis,b renal or cardiac disease,b or patients receiving cardiac glycosides (see Digoxin under Interactions).b

Because it is acidifying, use calcium chloride cautiously in cor pulmonale,b respiratory acidosis,b renal disease,b or respiratory failure.b

Non-lipid-soluble drugs (e.g., calcium) may injure the airway; avoid endotracheal administration.134

Calcium Monitoring

Frequently perform determinations of serum calcium concentrations.b

Maintain serum calcium concentrations at 9–10.4 mg/dL (4.5–5.2 mEq/L).b Some clinicians prefer to maintain serum calcium at slightly lower concentrations.b

Usually, do not allow serum calcium concentrations to exceed 12 mg/dL.b

Determinations of urine calcium are generally unreliable and hypercalciuria can occur in the presence of hypocalcemia.b Forcing fluids may produce increased urine volume and thus prevent the formation of renal stones in patients with hypercalciuria.b

For treatment of acute, symptomatic hypocalcemia, measure serum calcium concentrations every 4–6 hours.134 Total serum calcium concentrations should be maintained at 7–9 mg/dL 134

For ACLS during CPR, measure ionized calcium concentrations because total calcium concentration does not correlate well with ionized concentration in critically ill patients.134 b

Citrated Blood Transfusion

Administration of calcium in patients who have received transfusions of citrated blood may result in higher than normal total serum calcium concentrations.b In these patients, however, most of the excess calcium is bound to citrate and is inactive; therefore, serious toxicity usually does not result.b

Discontinuing calcium when hypercalcemia occurs usually is sufficient to return serum calcium concentrations to normal.b

Local Effects

Calcium salts are irritating to tissue when administered by IM or sub-Q injection and cause mild to severe local reactions including burning, necrosis and sloughing of tissue, cellulitis, and soft tissue calcification; venous irritation may occur with IV administration.b (See IV Administration and also see IM or Sub-Q Injection, under Dosage and Administration.)

IV Injection Effects

Extravasation of calcium solution into surrounding tissues during IV injection can cause necrosis.b

Patients may complain of tingling sensations, a sense of oppression or heat waves, and a calcium or chalky taste following IV administration of calcium salts.b

Cardiovascular Effects

Rapid IV injection of calcium salts may cause vasodilation, decreased BP, bradycardia, cardiac arrhythmias, syncope, and cardiac arrest.b

Inadvertent injection of calcium into the myocardium during attempted intracardiac injection into the ventricular cavity can result in lacerated coronary arteries, cardiac tamponade or pneumothorax, and intractable ventricular fibrillation may result.b

GI Effects

Orally administered calcium salts may be irritating to the GI tract.b

Calcium salts are constipating.b

Calcium chloride, by any route of administration, produces more irritation than the other calcium salts and has been reported to cause GI hemorrhage when taken orally.b

Hypercalcemia

Hypercalcemia is rarely produced by administration of calcium alone, but may occur with large doses in patients with chronic renal failure.b

Avoid overtreatment of hypocalcemia since hypercalcemia may be more dangerous than hypocalcemia.b

Mild hypercalcemia may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting, with mental changes such as confusion, delirium, stupor, and coma becoming evident as the degree of hypercalcemia increases.113

Mild hypercalcemia usually is readily controlled by reducing calcium intake (e.g., decreasing the dose of or avoiding supplemental calcium); more severe hypercalcemia may require specific management (e.g., hemodialysis).113

Dialysis patients with chronic renal failure receiving calcium salts may require adjustments in calcium concentrations in the dialysate to reduce the risk of hypercalcemia.113 126

Long-term effects of chronic calcium administration (e.g., for hyperphosphatemia in chronic renal failure) on progression of vascular or soft-tissue calcification is unknown.113 127

Renal Calculi

High dietary intake of calcium has long been suspected as contributing to the risk of renal calculi, and restriction of calcium intake (i.e., low-calcium diets) had long been considered a reasonable measure in an attempt to prevent calculi formation in patients with idiopathic hypocalciuria.122 123 124

Recent evidence indicates that high dietary intake of calcium actually decreases the risk of symptomatic renal calculi, while intake of supplemental calcium may increase the risk of symptomatic stones.122 123 124

General Precautions Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations Pregnancy

Category C.c i

Lactation

Manufacturers state that it is not known whether calcium salts are distributed into milk,a c and to observe caution with parenteral therapy.c

Calcium is an important component of human milk in women not receiving supplemental calcium salts,112 and maternal calcium supplementation does not substantially affect milk calcium concentrations since the principal source is from maternal bone resorption.112

Pediatric Use

Give calcium cautiously to children by IV route.PDH

Geriatric Use

Calcium absorption (after oral administration) may be decreased in geriatric patients.PDH

Common Adverse Effects

Constipation, nausea, vein irritation.PDH

Interactions for Calcium Salts

Consider the possibility that other drug interactions reported with antacids could occur.k

Specific Drugs and Laboratory Tests

Drug or Test

Interaction

Comments

Bisphosphonates, oral (e.g., alendronate, etidronate, ibandronate, risedronate)

Concomitant administration may result in reduced bisphosphonate absorption144 145 146 147 148 150

Administer calcium salts ?30 minutes after alendronate or risedronate, ?60 minutes after ibandronate, and not within 2 hours of etidronate administration144 145 146 147 148

Digoxin

Inotropic and toxic effects are synergistic and arrhythmias may occur (particularly when calcium is given IV)b

Avoid IV administration of calcium in patients receiving digoxin, particularly if digoxin toxicity is suspected; if necessary, calcium should be given slowly in small amounts134 b

Iron


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Meglitinides


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Meglinitides work by stimulating the pancreas to release insulin in response to a meal. It closes ATP-dependent potassium channels in functioning pancreatic beta cells. This blockade of potassium channels depolarizes the beta cells, which leads to opening of calcium channels resulting in influx of calcium. Increased intracellular calcium induces insulin secretion.

Meglitinides are used in the treatment of Type 2 diabetes.

See also

Medical conditions associated with meglitinides:

Diabetes, Type 2 Drug List: Prandin Starlix
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Tums Plus Chewable Tablets


Pronunciation: KAL-see-uhm/si-METH-i-kone
Generic Name: Calcium/Simethicone
Brand Name: Examples include Titralac Plus and Tums Plus
Tums Plus Chewable Tablets are used for:

Treating acid indigestion, heartburn, gas, and sour stomach. It may also be used for other conditions as determined by your doctor.

Tums Plus Chewable Tablets are an antacid and antiflatulent. It works by neutralizing acid in the stomach. It also helps to break up gas bubbles in the stomach, allowing it to be passed through the system more comfortably.

Do NOT use Tums Plus Chewable Tablets if: you are allergic to any ingredient in Tums Plus Chewable Tablets you are also taking citrate salts (found in some calcium supplements, antacids, and laxatives) you have a history of high blood calcium levels

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tums Plus Chewable Tablets:

Some medical conditions may interact with Tums Plus Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have Alzheimer disease, kidney problems, appendicitis, diarrhea, a stomach blockage, or an ileostomy if you have recently had stomach bleeding

Some MEDICINES MAY INTERACT with Tums Plus Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Cation exchange resins (eg, sodium polystyrene sulfonate) and citrate salts (found in some calcium supplements, antacids, and laxatives) because the actions and side effects of Tums Plus Chewable Tablets may be increased Anticoagulants (eg, warfarin), quinidine, or sulfonylureas (eg, glyburide) because the actions and side effects of these medicines may be increased Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), bisphosphonates (eg, risedronate), cephalosporins (eg, cephalexin), corticosteroids (eg, hydrocortisone), cyclosporine, delavirdine, digoxin, imidazoles (eg, ketoconazole), mycophenolate, penicillamine, quinolones (eg, ciprofloxacin), tetracyclines (eg, doxycycline), thyroid hormones (eg, levothyroxine), or verapamil because the effectiveness of these medicines may be decreased, especially when taken at the same time as Tums Plus Chewable Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tums Plus Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tums Plus Chewable Tablets:

Use Tums Plus Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Tums Plus Chewable Tablets may be taken with or without food. Chew thoroughly before swallowing. Drink a glass of water after swallowing. Do not use Tums Plus Chewable Tablets within 2 hours before or after taking a beta-blocker (eg, propranolol), bisphosphonate (eg, risedronate), cephalosporin (eg, cephalexin), corticosteroid (eg, hydrocortisone), delavirdine, digoxin, imidazole (eg, ketoconazole), penicillamine, or sulfonylurea (eg, glyburide) because Tums Plus Chewable Tablets may decrease the effectiveness of these medicines. If you miss a dose of Tums Plus Chewable Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tums Plus Chewable Tablets.

Important safety information: Do not exceed the recommended dose or use the maximum dose for more than 2 weeks without checking with your doctor. If your symptoms do not improve within 2 weeks or if they become worse, or if you experience black, tarry stools or vomit that looks like coffee grounds, check with your doctor. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Tums Plus Chewable Tablets, discuss with your doctor the benefits and risks of using Tums Plus Chewable Tablets during pregnancy. If you are or will be breast-feeding while you are using Tums Plus Chewable Tablets, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Tums Plus Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); loss of appetite; muscle weakness; nausea; slow reflexes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Tums Plus side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Tums Plus Chewable Tablets:

Store Tums Plus Chewable Tablets in a tightly closed container at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tums Plus Chewable Tablets out of the reach of children and away from pets.

General information: If you have any questions about Tums Plus Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider. Tums Plus Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Tums Plus Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Tums Plus resources Tums Plus Side Effects (in more detail)Tums Plus Use in Pregnancy & BreastfeedingTums Plus Drug InteractionsTums Plus Support Group0 Reviews for Tums Plus - Add your own review/rating Compare Tums Plus with other medications GERD
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Tempo Chewable Tablets


Pronunciation: a-LOO-min-uhm/KAL-see-uhm/mag-NEE-zee-uhm/si-METH-i-kone
Generic Name: Aluminum/Calcium/Magnesium/Simethicone
Brand Name: Tempo
Tempo Chewable Tablets are used for:

Treating acid indigestion, heartburn, gas, and sour stomach. It may also be used for other conditions as determined by your doctor.

Tempo Chewable Tablets are an antacid and antiflatulent. It works by neutralizing acid in the stomach. It also helps to break up gas bubble in the stomach, allowing it to be passed through the system more comfortably.

Do NOT use Tempo Chewable Tablets if: you are allergic to any ingredient in Tempo Chewable Tablets you are also taking citrate salts (found in some calcium supplements, antacids, and laxatives) you have a history of high blood calcium levels

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tempo Chewable Tablets:

Some medical conditions may interact with Tempo Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have Alzheimer disease, kidney problems, appendicitis, diarrhea, a stomach blockage, or an ileostomy if you have recently had stomach bleeding

Some MEDICINES MAY INTERACT with Tempo Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Cation exchange resins (eg, sodium polystyrene sulfonate) and citrate salts (found in some calcium supplements, antacids, and laxatives) because they may increase the actions and the risk of Tempo Chewable Tablets's side effects Anticoagulants (eg, warfarin), quinidine, or sulfonylureas (eg, glyburide) because their actions and the risk of their side effects may be increased by Tempo Chewable Tablets Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), bisphosphonates (eg, risedronate), cephalosporins (eg, cephalexin), corticosteroids (eg, hydrocortisone), cyclosporine, delavirdine, digoxin, imidazoles (eg, ketoconazole), mycophenolate, penicillamine, quinolones (eg, ciprofloxacin), tetracyclines (eg, doxycycline), thyroid hormones (eg, levothyroxine), or verapamil because their effectiveness may be decreased by Tempo Chewable Tablets, especially when taken at the same time as Tempo Chewable Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tempo Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tempo Chewable Tablets:

Use Tempo Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Tempo Chewable Tablets by mouth with or without food. Chew thoroughly before swallowing. Drink a glass of water after swallowing. Do not use Tempo Chewable Tablets within 2 hours before or after taking a beta-blocker (eg, propranolol), bisphosphonate (eg, risedronate), cephalosporin (eg, cephalexin), corticosteroid (eg, hydrocortisone), delavirdine, digoxin, imidazole (eg, ketoconazole), penicillamine, or sulfonylurea (eg, glyburide) because their effectiveness may be decreased by Tempo Chewable Tablets. If you miss a dose of Tempo Chewable Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tempo Chewable Tablets.

Important safety information: Do NOT take more than the recommended dose or use the maximum dose for longer than 2 weeks without checking with your doctor. If your symptoms do not get better within 2 weeks or if they get worse, or if you experience black, tarry stools or vomit that looks like coffee grounds, check with your doctor. Tempo Chewable Tablets has aluminum and magnesium in it. Before you start any new prescription or over-the-counter medicine, read the ingredients to see if it has aluminum or magnesium in it too. If it does or if you are not sure, check with your doctor or pharmacist. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tempo Chewable Tablets while you are pregnant. If you are or will be breast-feeding while you use Tempo Chewable Tablets, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Tempo Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); loss of appetite; muscle weakness; nausea; slow reflexes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Tempo side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Tempo Chewable Tablets:

Store Tempo Chewable Tablets between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tempo Chewable Tablets out of the reach of children and away from pets.

General information: If you have any questions about Tempo Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider. Tempo Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Tempo Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Tempo resources Tempo Side Effects (in more detail)Tempo Use in Pregnancy & BreastfeedingTempo Drug InteractionsTempo Support Group0 Reviews for Tempo - Add your own review/rating Compare Tempo with other medications GasGERDIndigestion
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