Product Summary

1.    Trade Name of the Medicinal Product Calcium Chloride Injection BP 10 millimoles in 10 ml

2.    Qualitative and Quantitative Composition

Calcium Chloride, Dihydrate BP 14.7% w/v

3.    Pharmaceutical Form

Injection

Clinical Particulars

4.1. Therap euti c Indi cati ons Hypocalcaemia or electrolyte imbalance

4.2. Posology and Method of Administration

For slow intravenous injection or, after dilution with at least 4 times its volume of Sodium Chloride Intravenous Infusion BP (0.9% w/v), by intravenous infusion.

Adults and the elderly

The precise dosage is determined by the requirements of the patient. Plasma Calcium must be monitored. An initial injection or infusion of up to 10 millimoles (at a rate not exceeding 1 millimole per minute) may be given. This may be continued by infusion of up to 10 millimoles per day.

Children

The precise dosage is determined by a paediatrician and is dependent on the requirements of the patient. Plasma calcium must be monitored.

Age 2 to 12 years 0.5 millimoles to 3.5 millimoles by intravenous infusion after dilution with at least 4 times its volume of Sodium Chloride Intravenous Infusion BP (0.9% w/v). The dose may be repeated every one to three days.

Age: under 2 years

Less than 0.5 millimoles by intravenous infusion after dilution with at least 4 times its volume of Sodium Chloride Intravenous Infusion BP (0.9% w/v). The dose may be repeated every one to three days.

4.3. Contraindications

Hypercalcaemia, hypercalciurea, renal calculi, chronic renal impairment, heart disease, digitalis toxicity, respiratory acidosis or failure. Not to be given to patients with a history of hypersensitivity or idiosyncratic response to the drug or any of it’s constituents.

4.4. Special Warnings and Precautions for Use

Injections of calcium chloride are extremely irritant, and so dilution is recommended. Only the intravenous route may be employed. Patients treated for hypocalcaemia should be adequately monitored, including serum calcium. It should be given with caution to patients with cardiac disease or sarcoidosis.

4.5. Interactions with other Medicaments and other forms of Interaction

With digitalis or potassium there is an increased risk of arrhythmias. Thiazide diuretics can reduce the excretion of calcium leading to elevated plasma levels. The effect of administered magnesium may be neutralised by calcium. The absorption of tetracyclines is reduced by calcium.

4.6. Pregnancy and Lactation

There is no evidence of safety of the drug in human pregnancy, but it has been in use for many years without ill consequence. If it is needed in pregnancy, the use of this drug is acceptable.

Parenteral calcium can cause dizziness and drowsiness, if affected, patients should not drive or operate machinery.

4.8. Undesirable Effects

Parenteral calcium may cause hypotension, drowsiness, flushing, irregular heartbeat, nausea, sweating and tingling sensations. Also mild gastrointestinal disturbances and irritation can occur following intravenous injection.

4.9. Overdose

Symptoms:

The early signs of overdose include severe constipation, drowsiness, continuous headache, loss of appetite, metallic taste, dry mouth, tiredness and weakness. Later signs include confusion, hypertension, increased light sensitivity, thirst, muscle or bone pain, nausea, vomiting and polyuria.

Treatment:

A diuretic such as bumetanide, ethacrynic acid or frusemide will assist in the excretion of excessive calcium, but in very severe cases, EDTA may be necessary.

Pharmacological Properties

5.1. Pharmacodynamic Properties

Calcium is essential to the function of the nervous, muscular and skeletal systems. It also plays a part in cardiac function, renal function, respiration and blood coagulation.

5.2. Pharmacokinetic Properties

Calcium is distributed throughout the body, but is in large amounts in the skeleton as the hydroxyapatite complex.Ca²+ is 45% plasma protein bound. Elimination is mainly faecal, with small amounts excreted in the urine.

5.3. Preclinical Safety Data

None stated.

Pharmaceutical Particulars

6.1.    List of Excipients

Water for Injections BP. pH may be adjusted with Hydrochloric Acid BP.

6.2.    Incompatibilities

Carbonates, bicarbonates, phosphates, sulphates and tartrates.

6.3.    Shelf Life

36 months.

6.4.    Special Precautions for Storage

None stated.

6.5.    Nature and Contents of Container

5 or 10 ml in Type 1 colourless neutral glass ampoules. Fusion sealed. Packed in cartons of 10 ampoules

6.6.    Instruction for Use/Handling

None stated.

Administrative Data

7. Marketing Authorisation Holder

Macarthys Laboratories

t/a Martindale Pharmaceuticals,

Bampton Road,

Harold Hill,

Romford RM3 8UG

8.    Marketing Authorisation Number

PL 1883/6174R

9.    Date of First Authorisation/Renewal of Authorisation

Renewal: 30.01.96

10.    Date of (Partial) Revision of the Text

January 2001