Maxtra O Nasal Spray

Oxymetazoline Hydrochloride Nasal Spray

Oxymetazoline Hydrochloride IP 0.05% w/v

Benzalkonium Chloride IP 0.02% w/v

(As preservative)

In buffered aqueous solution q.s

Nasal Spray

Oxymetazoline (0.05%w/v)

4.1 Therapeutic Indication

For the relief of stuffy, running nose associated with cold and influenza, also post nasal drip, sinusitis.

4.2 Posology and method of administration

Adults and children over 12 years: 1 – 2 sprays up each nostril maximum 2 – 3 times daily. The preparation should not be used for more than 5 – 7 days in a row. Method of administration: Nasal use

4.3 Contraindications

Maxtra-O 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.

Patients taking monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs in the previous two weeks.

In patients with narrow-angle glaucoma. Maxtra-O nasal spray should not be used by patients after trans-sphenoidal hypophysectomy.

Children under 12 years of age.

Inflammation of the skin and mucosa of the nasal vestibule and encrustation (rhinitis sicca).

Patients with acute coronary disease or cardiac asthma.

4.4 Special warnings and precautions for use

• Caution should be exercised in case of hypertension, cardiac diseases including angina, hyperthyroidism, diabetes mellitus and prostatic hypertrophy.
• Do not exceed the recommended dose.
• If symptoms worsen or do not improve after 3 days, physician should re-evaluate clinical situation.
• Maxtra-0 Nasal Spray should be used for a maximum of 7 consecutive days to avoid rebound-effect and drug induced rhinitis.
• The preservative (benzalkonium chloride) contained Maxtra-0 Nasal Spray can cause swelling of the nasal mucosa, especially during long-term use. If such a reaction (persistent nasal congestion) is suspected, a product for nasal administration which contains no preservative should be used if possible. If such products for nasal administration are not available without preservative, the use of another dosage form should be considered.

4.5 Drugs interactions

• This product should not be used in combination with MAOIs, or for up to 2 weeks after taking MAOIs as there is a risk of interactions leading to hypertension.
• This product is known to interact with tricyclic antidepressants with a possible increased risk of hypertension and arrhythmias.
• The effects of beta-blockers or other antihypertensive drugs e.g. methyl dopa, bethanidine, debrisoquine and guanethidine may be antagonised.
• Possible additive cardiovascular toxicity may occur when sympathomimetics are given with anti-parkinsonian drugs such as bromocriptine.

4.6 Use in special populations

Pregnancy

For oxymetazoline no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.

Breast Feeding

It is unknown whether oxymetazoline hydrochloride is excreted into breast milk. The recommended dose should not be exceeded because overdosing can decrease placental blood flow and reduce milk production. Caution should be exercised during pregnancy and lactation as oxymetazoline may be systemically absorbed

4.7 Effects on ability to drive and use machines

Maxtra-0 Nasal Spray has no influence on the ability to drive and use machines.

4.8 Undesirable effects

Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories, very common (≥1/10); common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

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

Symptoms of Overdose

Symptoms of moderate or severe overdose can be mydriasis, nausea, cyanosis, fever, spasms, tachycardia, cardiac arrhythmia, cardiac arrest, hypertension, oedema of the lungs, dyspnoea, psychic disturbance. The inhibition of functions of the central nervous system such as somnolence, lowering of the body temperature, bradycardia, shock like hypotension, apnoea and loss of consciousness is also possible.

Treatment of overdose

Symptomatic treatment of overdose is required. A nonselective alpha-lytic such as phentolamine may be administered to depress the increased blood pressure, Intubation and artificial respiration may be necessary in serious cases. In the case of moderate or severe inadvertent oral consumption, the administration of activated carbon (adsorbent) and sodium sulphate (laxative) or perhaps gastro-lavage in the case of large amounts should be undertaken. Further treatment is supportive and symptomatic. Vasopressor drugs are contraindicated.

5.1 Pharmacodynamic properties

Oxymetazoline is a direct-acting sympathomimetic amine. It acts on alpha-adrenergic receptors in the blood vessels of the nasal mucosa producing vasoconstriction and decongestion. Onset of action is within minutes and lasts up to 12 hours.

5.2 Pharmacokinetic properties

Absorption

With local use on the nasal mucosa, there is no clinically relevant absorption of oxymetazoline hydrochloride

6.1 Animal Toxicology or Pharmacology

Preclinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity or toxicity to reproduction. Oxymetazoline Hydrochloride Nasal Spray has not been tested for genotoxicity or carcinogenicity. Preclinical data suggest that benzalkonium chloride can produce a concentration- and time-dependant toxic effect on cilia, including irreversible immobility, and can induce histopathological changes in the nasal mucosa.

Oxymetazoline is a member of the class of phenols that is 2,4-dimethylphenol which is substituted at positions 3 and 6 by 4,5-dihydro-1H-imidazol-2-ylmethyl and tert-butyl groups, respectively. A direct-acting sympathomimetic with marked alpha-adrenergic activity, it is a vasoconstrictor that is used (generally as the hydrochloride salt) to relieve nasal congestion. It has a role as an alpha-adrenergic agonist, a sympathomimetic agent, a nasal decongestant and a vasoconstrictor agent.

Oxymetazoline

Chemical Name: 6-tert-butyl-3-(4,5-dihydro-1H-imidazol-2-ylmethyl)-2,4-dimethylphenol. Molecular formula: C₁₆H₂₄N₂O Molecular weight: 260.37 g/mol Structural formula:

8.1 Incompatibilities

None

8.2 Shelf-life

Refer on the pack

8.3 Packaging information

A bottle of 10 ml.

8.4 Storage and handing instructions

Preserve in tight container at a temperature not exceeding 30°C.

Keep out of reach of children.

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

Close the cap tightly after use.

Zuventus healthcare Ltd.

Plot Y2, CTS No: 358/A2, Near

Nahur Railway Station, Nahur

(West), Mumbai - 400 078, India