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