Maxtra S Nasal Spray

Saline Nasal Solution IP

Sodium Chloride IP 0.65% w/v

In an Aqueous Isotonic Solution

using Purified Water IP

Excipients q.s.

Benzalkonium Chloride IP 0.01% w/v

(As a preservative)

Nasal Spray

Sodium Chloride (0.65%w/v)

4.1 Therapeutic Indication

Naturally provides instant, soothing relief for dry, irritated nasal passages caused by colds, allergies, dry air, pollution, smoke, air travel, and the use of decongestants or steroidal sprays.

4.2 Posology and method of administration

Method of administration: Nasal use

• Clean nose by blowing.
• For children and adults: In erect posture, insert nozzle into nostril, squeeze bottle once & inhale spray.
• For infants/babies: tilt head far back while lying down or sitting. Turn bottle upside down. Allow 2-3 drops into nostril & spread.
• Repeat for other nostril

4.3 Contraindications

Maxtra-S Nasal Spray should not be used in the following conditions:

In case of hypersensitivity to the active substance or to any of the excipients listed in the formulation.

4.4 Special warnings and precautions for use

• The use of this Maxtra®-S Nasal Spray by more than one person may spread infection.
• Avoid if you are allergic to any of the ingredients in the formulation.
• 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 severe nasal irritation.
• The product contains benzalkonium chloride 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.
• Ensure that the container is undamaged and the contents clear in appearance before use. After use, discard any remaining solution.

4.5 Drugs interactions

None.

4.6 Use in special populations

Safe to use during pregnancy and lactation.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable 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 authorisation 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 via email to: medico@zuventus.com

Website: https://www.zuventus.co.in/drug-safety-reporting

By reporting side effects, you can help provide more information on the safety of this medicine.

4.9 Overdose

None

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Decongestants and other nasal preparations, sodium chloride nasal spray

ATC code: R01AX10

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.

5.2 Pharmacokinetic properties

Absorption

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.

No further information other than that which is included in the Summary of Product Characteristics.

6.1 Animal Toxicology or Pharmacology

No information provided.

Sodium chloride, also known as salt, common salt, table salt or halite, is an ionic compound with the chemical formula NaCl, representing a 1:1 ratio of sodium and chloride ions. It is listed on the World Health Organization Model List of Essential Medicine.

Molecular Weight : 58.44 g/mol.

8.1 Incompatibilities

None known.

8.2 Shelf-life

Refer on the pack.

8.3 Packaging information

A bottle of 20 ml.

8.4 Storage and handing instructions

Store at temperature not exceeding 30°C. Protect from light and moisture. Keep out of reach of children. Shake well before each use.

Do not accept the pack if cap seal is broken on the bottle.

Close the cap tightly after use.

Preserve in tight container.

Alcohol Free Safe for Children Safe for repeated daily use

18-09-2024