EPSOM SALTS (MAGNESIUM SULPHATE) B.P.

Active substance: MAGNESIUM SULPHATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Epsom Salts (Magnesium Sulphate) B.P.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Actives: Magnesium Sulphate B.P. 100%

3

PHARMACEUTICAL FORM
Powder

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Used as a laxative.

4.2

Posology and method of administration
Dose: To be taken orally.
Adults (including the elderly) and children over 12 years:
5 to 15g dissolved in 250-m1 water.
Children 6 to 12 years:
5 to l0g dissolved in 250m1 water.
Children 2 to 5 years:
5g dissolved in 250m1 water.

4.3

Contraindications

In patients with impaired renal function and children with intestinal parasitic
diseases. Also contra-indicated in intestinal obstruction.
Hypersensitivity to the active.

4.4

Special warnings and precautions for use
For occasional use only. Use with caution in the elderly and in patients with
renal impairment. Use with caution in those receiving Digitalis Glycosides.

4.5

Interaction with other medicinal products and other forms of interaction
None known

4.6

Fertility, pregnancy and lactation
Not recommended for use in the first trimester of pregnancy. Use with caution
during the rest of pregnancy and in lactation.

4.7

Effects on ability to drive and use machines
None

4.8

Undesirable effects
Hypermagnesaemia has occurred after the excessive use of Magnesium
Sulphate as a purgative and especially in renal insufficiency. Symptoms of
hypermagnesaemia which may begin to appear when the plasma magnesium
concentration exceeds 2mmol per litre, including flushing of the skin, thirst,
hypotension due to vaso-dilation, drowsiness, loss of tendon reflexes due to
neuromuscular blockade, weakness, respiratory depression, cardiac
arrhythmias, coma and cardiac arrest. Colic may also occur. Though
Magnesium is poorly absorbed following oral administration, there may be
sufficient accumulation to produce toxic effects if given to a patient with
impaired renal function.

4.9

Overdose
Symptoms of hypermagnesaemia include flushing of the skin, thirst,
hypotension due to vasodilatation, drowsiness, loss of tendon reflexes due to
neuromuscular blockade, weakness, respiratory depression, cardiac
arrhythmias, coma and cardiac arrest.
Hypermagnesaemia may be corrected by the intravenous injection of 10 to
20ml of 10% Calcium Gluconate injection. Dialysis and correction of fluid
deficit may be of value.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Magnesium Sulphate acts as a saline purgative. It is not readily absorbed from
the intestine. When taken by mouth in dilute solution it reduces the normal
absorption of water with the result that the bulky fluid contents distend the
bowel, active reflex peristalsis is excited and evacuation follows. With higher
concentrations water is withdrawn from the tissues.
Magnesium may also cause purgation.

5.2

Pharmacokinetic properties
The Magnesium Sulphate travels through the body with only a small quantity
being absorbed. The vast majority is excreted when evacuation occurs.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
None.

6.2

Incompatibilities
Incompatible with Polymyxin B Sulphate, concentrated solutions of Sodium
Iodide, Sodium and Potassium Tartrates, with soluble Phosphates and
Arsenates and with Alkali Carbonates and Bicarbonates unless in dilute
solutions; with Potassium or Ammonium Bromide, concentrated solutions
give a precipitate of the double Sulphate. There was loss of clarity when
intravenous solutions of Magnesium Sulphate were mixed with those of
Calcium Gluconate, Novobiocin Sodium, Procaine Hydrochloride or Sodium
Bicarbonate.

6.3

Shelf life
3 years

6.4

Special precautions for storage
None.

6.5

Nature and contents of container
NATURE:
A. Plastic container and lid. or
B. Cardboard container with plastic lid. or
C. Carton with a paper liner.
CONTENTS:
100gm, 200gm or 500gm.

6.6

Special precautions for disposal
None stated.

7

MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd Floor,
P.C. 1060

Nicosia.
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 28444/0088

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
23/02/2011

10

DATE OF REVISION OF THE TEXT
16/11/2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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