SALINE NASAL SOLUTION IP 0.65% w/v
COMPOSITION
Each ml contains:
Sodium Chloride IP 0.65% w/v
Benzalkonium Chloride BP 0.03% w/v (as preservative)
Water for Injections BP q.s.
DESCRIPTION
A clear, colorless to almost colorless solution.
PHARMACODYNAMIC
Pharmacotherapeutic group: Decongestants and other nasal preparations, sodium chloride nasal drops.
The exact mechanism of action of saline nasal irrigation is unknown. One possibility is that the breakdown of the protective function of the nasal mucosa plays a role in upper respiratory conditions. Saline nasal irrigation may improve nasal mucosa function through several physiologic effects, including direct cleansing, removal of inflammatory mediators and improved mucociliary function, as suggested by increasing ciliary beat frequency.
ATC code: R01AX10
PHARMACOKINETICS
Sodium chloride distributes primarily to extracellular compartments, including plasma and interstitial fluid; sodium is maintained outside the cell via the Na+/K+-ATPase pump, which exchanges intracellular sodium for extracellular potassium. Penetration across the blood-brain barrier is low. Sodium chloride is excreted primarily in the urine, but it is also excreted in sweat and stool. In healthy patients at steady state with minimal sweat losses, sodium excreted in urine is roughly the same as dietary intake. Sweat sodium concentration is increased in children with cystic fibrosis, aldosterone deficiency, or pseudohypoaldosteronism.
THERAPEUTIC INDICATION
For relieving nasal congestion by dissolving and softening thick and crusty mucus in the nose.
DOSAGE AND ADMINISTRATION
Saline solution is recommended for children and adults.
Apply one or two drops in each nostril as needed or directed by the physician.
Method of administration
For nasal use only. Shake well before use.
Turn your head to the left in the extended position. Gently introduce the tip at the entrance of the right nostril. Press the vial. Turn the head on the other side and repeat the same operation with the other nostril.
Overdose
None
CONTRAINDICATION
There are no absolute contraindications to use NAZAL-S.
WARNING AND PRECAUTIONS
Before use, tell the doctor or pharmacist if you are allergic to any of the ingredients.
Signs of an allergic reaction may include: rash, hives, itching, red-swollen-blistered or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, unusual hoarseness or swelling of the mouth, face, lips, tongue or throat. Very bad nose irritation.
The product contains benzalkonium chloride solution which may cause irritation or swelling inside the nose, especially if used for a long time. Long term use may cause oedema of the nasal mucosa.
Before use, ensure that the container is undamaged and the contents clear in appearance.
PREGNANCY, LACTATION
Safe to use during pregnancy and lactation.
SIDE EFFECTS
Usually do not occur, however rarely occurring side effects may include:
-if the inside of the nose is very dry and irritated, stinging may occur
-allergic reactions
-sneezing
-cough
-nose irritation
-abnormal taste
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.
PRESENTATION
NAZAL-S nasal solution/drops are supplied in Low density polyethylene (LDPE) white bottles with a white screw cap in pack size 10 ml.
STORAGE AND OTHER INFORMATION
Store at temperature below 30 °C.
Protect from light.
Keep this medicine out of the sight and reach of children.
Do not touch the container tip to any surface since this may contaminate the solution.