EPHEDRINE 1.0% Nasal drops (2015)
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Περιεχόμενα
Name of the medicinal product
Ephedrine Nasal Drops 1.0%.
Qualitative and quantitative composition
Ephedrine Hydrochloride BP 1.0% W/V.
Pharmaceutical form
Nasal Drops.
Therapeutic indications
For the relief of nasal congestion.
Posology and method of administration
Nasal, by application to the mucous membranes. Recommended dose Instil one or two drops into each nostril. Dosage schedule As required, but not more than 4 times a day. The above dose and schedule are ...
Contraindications
Ephedrine should not be given to patients who are being treated with monoamine oxidase inhibitors, or within two weeks of stopping such treatment (see section 4.5). Ephedrine should not be taken with beta-blockers ...
Special warnings and precautions for use
Store below 25°C. Do not allow to freeze. Keep all medicines away from children. Warning: asthmatics should consult their doctor before using this product. Ephedrine should be used with care in the elderly ...
Interaction with other medicinal products and other forms of interaction
Medicinal products, the use of which may be affected by ephedrine nasal drops MAOIs: Risk of hypertensive crisis. Sympathomimetics such as ephedrine should not be given with MAOIs or within 14 days of ...
Pregnancy and lactation
This product should not be used in pregnancy or whilst breast feeding unless recommended by a doctor. Ephedrine crosses the placenta and has been associated with an increase in foetal heart rate. Ephedrine ...
Effects on ability to drive and use machines
None known.
Undesirable effects
The following undesirable effects have been reported following use of ephedrine and may arise following use of ephedrine nasal drops. The frequency of adverse effects cannot be estimated from available ...
Overdose
The estimated minimal lethal dose of ephedrine in children up to 2 years of age is 200mg, and for adults 2g, but fatalities due to ephedrine overdose are rare and not likely to occur following administration ...
Pharmacodynamic properties
Ephedrine hydrochloride is applied locally to relieve congestion of mucous membranes in acute sinusitis and hay fever. It has a stimulant action on the respiratory centre. Ephedrine releases norepinephrine ...
Pharmacokinetic properties
Ephedrine is readily and completely absorbed from the gastro-intestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted unchanged in the urine, together with small amounts ...
Preclinical safety data
No data of relevance, which is additional to that included on other sections of the SPC.
List of excipients
Chlorobutanol BP Sodium chloride BP Purified water BP
Incompatibilities
None known.
Shelf life
<u>10 ml:</u> 18 months unopened, 2 months after first opening. <u>500 ml:</u> 18 months unopened.
Special precautions for storage
Store below 25°C.
Nature and contents of container
10 ml: amber glass, winchester bottle with 20mm R3 plastic wadded cap.
Special precautions for disposal and other handling
None.
Marketing authorization holder
Thornton & Ross Ltd, Linthwaite Laboratories, Huddersfield, HD7 5QH
Marketing authorization number(s)
PL 00240/5006R
Date of first authorization / renewal of the authorization
29.03.90 / 24.06.97
Date of revision of the text
09/03/2015
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