Product Packing: 100 ML
Product Composition: Dextromethorphan + Chlorpheneramine maleate + Phenylephrine HCL
Product Price: MRP : 107
EXOFEX-D is
an oral cough-and-cold syrup containing
Dextromethorphan, Chlorpheniramine Maleate and Phenylephrine HCl.
The combination provides antitussive, antihistamine and decongestant actions
for short-term symptomatic relief in selected patients where this combination
is approved and age-appropriate.
Dextromethorphan suppresses the cough reflex
centrally, Chlorpheniramine is a first-generation H1 antihistamine that helps
reduce allergy-related symptoms, and Phenylephrine is an alpha-adrenergic
decongestant that reduces nasal mucosal congestion. The supplied strengths are
preserved exactly, but because no per-volume basis was supplied, the exact
concentration per ml or measured dose must be verified from the approved
product label.
Each labelled dose contains:
·
Dextromethorphan - 10 mg | Chlorpheniramine
Maleate - 2 mg
·
Phenylephrine HCl - 5 mg
·
Syrup base / excipients - q.s. The supplied
brief gives ingredient strengths but does not state the measured volume to
which they apply; exact concentration per ml/measured dose must be verified
from the approved product label.
Dosage form: Oral Syrup
Uses of EXOFEX-D
EXOFEX-D may
be used for short-term symptomatic relief of selected cough-and-cold symptoms
where the combination is approved, clinically appropriate and age-appropriate.
·
Dextromethorphan helps suppress troublesome
dry or non-productive cough
·
Chlorpheniramine helps reduce allergy-related
symptoms such as sneezing and runny nose
·
Phenylephrine provides nasal decongestant
action by constricting swollen nasal mucosal blood vessels
·
The combination may provide multi-symptom
relief in selected patients when used according to the approved label
How
EXOFEX-D Works
EXOFEX-D combines
three cough-and-cold active ingredients with complementary actions:
Dextromethorphan: A centrally acting antitussive that
reduces the cough reflex. It can interact seriously with MAO inhibitors and
other serotonergic medicines.
Chlorpheniramine Maleate: A first-generation H1
antihistamine that reduces histamine-mediated symptoms but can cause
drowsiness, dry mouth, blurred vision and other anticholinergic effects.
The overall response and safety depend on the exact dose, age,
underlying condition, concurrent medicines and individual clinical status.
This
syrup provides symptomatic relief only and does not treat the underlying
cause of every cough or cold. Severe or persistent symptoms require
clinical assessment.
Dosage
and Direction for Use
Use EXOFEX-D strictly according to the approved product
label or healthcare professional's advice. The supplied brief lists
Dextromethorphan 10 mg, Chlorpheniramine Maleate 2 mg and Phenylephrine HCl 5
mg but does not state the volume containing these strengths, so no per-ml or
per-5-ml dose has been inferred.
Measure
the recommended quantity accurately with a calibrated measuring cup, spoon or
oral syringe as appropriate.
Pediatric cough-and-cold medicines require age-specific caution. Use in
children only when permitted by the current approved label and specifically
advised by an appropriate healthcare professional.
Possible
Side Effects
Possible
adverse effects may include:
·
Drowsiness, dizziness, impaired coordination, dry mouth, blurred vision
or constipation from Chlorpheniramine
·
Nausea, stomach discomfort, nervousness or dizziness
·
Phenylephrine may cause palpitations, increased blood pressure,
headache, restlessness or difficulty sleeping
·
Excess Dextromethorphan or interactions with serotonergic medicines can
cause serious neurologic effects, including serotonin syndrome
Any persistent or troublesome adverse effect should be discussed with a
healthcare professional.
Precautions
and Contraindications
·
Review the complete approved label before use, particularly in patients
with hypertension, cardiovascular disease, hyperthyroidism, diabetes, glaucoma,
urinary retention/prostatic problems or significant respiratory disease.
·
Avoid use in patients with known hypersensitivity to Dextromethorphan,
Chlorpheniramine, Phenylephrine or any formulation excipient.
·
Do not use Dextromethorphan with monoamine oxidase inhibitors (MAOIs) or
within the label-specified washout period because serious reactions, including
serotonin syndrome, can occur.
·
Use caution with SSRIs, SNRIs, tricyclic antidepressants and other
serotonergic medicines because Dextromethorphan can increase serotonin-syndrome
risk.
·
Chlorpheniramine can cause sedation and anticholinergic effects.
Alcohol, sedatives, opioids and other CNS depressants may increase impairment.
·
Phenylephrine requires caution in hypertension, cardiovascular disease,
hyperthyroidism and with other sympathomimetic/decongestant medicines.
Pregnancy and breastfeeding require professional review.
·
Check sweeteners, flavours, preservatives and potential allergens on the
final approved label.
·
Drug Interaction Considerations
·
Important interactions include MAOIs and serotonergic medicines with
Dextromethorphan; alcohol, sedatives and other CNS depressants with
Chlorpheniramine; and other sympathomimetics or medicines affecting blood
pressure/heart rate with Phenylephrine. Review the complete medication list
before use.
Business
Growth Opportunity with EXOFEX-D
EXOFEX-D offers
pharmaceutical distributors and healthcare entrepreneurs an opportunity to add
a Dextromethorphan + Chlorpheniramine Maleate + Phenylephrine HCl oral syrup
in a convenient 100 ml pack to their cough-and-cold portfolio.
Key Business Advantages
·
Triple-action cough-and-cold formulation
·
Dextromethorphan + Chlorpheniramine Maleate + Phenylephrine HCl
·
Antitussive + antihistamine + decongestant product concept
·
Convenient 100 ml oral syrup pack
·
Suitable addition to cough-and-cold portfolios subject to approved
formulation, age range and indications
PCD
Pharma Franchise Opportunity for EXOFEX-D
Ethics Medinova Private Limited offers PCD Pharma Franchise
opportunities for EXOFEX-D in selected territories across India, subject to availability,
applicable regulations and mutually agreed business terms.
Franchise Support May Include
·
Monopoly-based territory opportunities, subject to availability
·
Promotional materials and visual aids consistent with approved claims
·
Product information and marketing support
·
Reliable supply coordination
·
Access to a growing pharmaceutical product portfolio
·
Professional partner assistance
Third-Party
Manufacturing Support for Dextromethorphan + Chlorpheniramine Maleate +
Phenylephrine HCl Syrup
Ethics
Medinova also supports eligible businesses exploring third-party
manufacturing of formulations similar to EXOFEX-D under their own brand,
subject to applicable drug licensing, age-related, regulatory and manufacturing
requirements.
Our
third-party manufacturing support may include:
·
Customized approved strengths, flavour and pack requirements, subject to
regulatory feasibility
·
Private-label manufacturing opportunities
·
Customized packaging and branding support
·
Product label and pack configuration assistance
·
Manufacturing coordination through suitable licensed facilities
·
Support for documentation and applicable regulatory requirements
1. What is EXOFEX-D?
2. What does Dextromethorphan do?
3. What is the role of
Chlorpheniramine?
4. What does Phenylephrine do?
5. Can EXOFEX-D be combined with other cough-and-cold medicines?
6. How should EXOFEX-D be taken?
7. Is a PCD Pharma Franchise available
for EXOFEX-D?
8. Can this formulation be manufactured
under my own brand?
Disclaimer