Vendexine Syrup (Dexamethasone & Chlorpheniramine): Uses, Dosage, Safety & EDA Clarification

Vendexine Syrup 125 mL — Updated, Evidence-Checked Drug Comment

1. Disclaimer:-

This information is provided for educational and reference purposes and is not a substitute for the official Egyptian package leaflet, a physician’s assessment, or a pharmacist’s advice. Because Vendexine contains a systemic corticosteroid, its use, dose, and duration should be individualized, particularly in children, pregnancy, chronic diseases, infections, and prolonged or repeated courses.

We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.

2. Summary

Vendexine Syrup is a combined oral formulation containing dexamethasone, a potent systemic glucocorticoid, and chlorpheniramine maleate, a first-generation H1 antihistamine with sedating and anticholinergic properties. Current Egyptian pharmacy listings continue to show the product as a 125 mL syrup containing dexamethasone 0.5 mg/5 mL plus chlorpheniramine maleate 2 mg/5 mL and manufactured by EVA Pharma.

3. Brand Name

Vendexine Syrup 125 mL
Manufacturer/brand: EVA Pharma, Egypt.

4. Category

Combined antihistamine + systemic glucocorticoid preparation; pharmacologically, chlorpheniramine is an H1-receptor antagonist and dexamethasone is a potent glucocorticoid.

5. Active Ingredient

Each 5 mL contains:

• Dexamethasone 0.5 mg
• Chlorpheniramine maleate 2 mg

The same strengths are identified in EVA Pharma product information and current Egyptian retail listings.

6. Pharmaceutical Form & Strength

Pharmaceutical form: Oral syrup.
Strength per 5 mL: Dexamethasone 0.5 mg + chlorpheniramine maleate 2 mg.
Pack size: 125 mL.
Current product images/listings also describe the marketed preparation as alcohol-free and sugar-free. (Lotus Pharmacies)

7. Manufacturer & Marketing Authorization Holder

Manufacturer/brand: EVA Pharma, Egypt. EVA Pharma’s product portfolio lists Vendexine as a syrup containing dexamethasone and chlorpheniramine maleate and identifies it under the company’s systemic-hormone portfolio.
A separately documented current Egyptian entry explicitly identifying a distinct legal Marketing Authorization Holder (MAH) was not independently verified in the publicly accessible sources reviewed; therefore, no separate MAH is stated here as a fact.

8. Mechanism of Action

Dexamethasone: binds intracellular glucocorticoid receptors and modifies gene transcription, producing potent anti-inflammatory and immunosuppressive effects. Its effects include suppression of inflammatory mediators, reduction of inflammatory cell activity, and decreased vascular permeability and tissue edema. (Medicines.org.uk)

Chlorpheniramine: competitively and reversibly blocks histamine H1 receptors, reducing histamine-mediated effects such as itching, wheal formation, mucosal symptoms, and increased capillary permeability. It also has anticholinergic activity and can cause central nervous system sedation. (Medicines.org.uk)

9. Spectrum of Activity

Vendexine is not an antimicrobial drug and does not directly treat bacterial, viral, fungal, or other infections. Its pharmacological activity is directed at allergic symptoms and inflammatory processes through antihistaminic and glucocorticoid mechanisms. Dexamethasone can suppress manifestations of infection and may mask or worsen some infections; therefore, unexplained infectious symptoms require medical assessment. (Medicines.org.uk)

10. Pharmacokinetics

Dexamethasone: is rapidly and well absorbed orally; available SmPC data report peak plasma concentrations generally within about 1–2 hours. It is extensively protein-bound, metabolized mainly in the liver, and excreted predominantly in urine. Its plasma half-life is approximately 3–4.5 hours, while its biological effect lasts substantially longer, with a biological half-life of approximately 36–54 hours. (Medicines.org.uk)

Chlorpheniramine: is well absorbed orally; effects may begin within approximately 30 minutes, with maximum effects around 1–2 hours and clinical effects lasting about 4–6 hours. Its plasma half-life is commonly estimated at 12–15 hours. It is metabolized in the liver, including formation of desmethyl metabolites, and is eliminated mainly through the urine. (Medicines.org.uk)

11. Indications

Available Egyptian product information historically lists Vendexine for hay fever, urticaria, bronchial asthma, and rheumatic arthritis. (DrugPamphlet)

The individual active ingredients have broader approved uses in different products, including allergic conditions for chlorpheniramine and a wide range of corticosteroid-responsive inflammatory/allergic disorders for dexamethasone. However, indications approved for the individual ingredients should not automatically be interpreted as indications approved specifically for the fixed-dose Vendexine combination. (Medicines.org.uk)

Vendexine should therefore be used only for an indication judged appropriate by the treating clinician, particularly because it contains systemic dexamethasone.

12. Administration

The archived product information for Vendexine states:

• Adults: 5 mL three times daily.
• Children 6–12 years: 2.5 mL three times daily.
• The dose should be adjusted by the physician according to the clinical condition. (DrugPamphlet)

The product should be measured accurately with an appropriate dosing device. Because it contains a systemic corticosteroid, the lowest effective dose for the shortest clinically appropriate duration should generally be used. (Medicines.org.uk)

The original statement that every course must automatically be tapered is too broad: abrupt withdrawal is particularly important to avoid after prolonged systemic corticosteroid therapy or in patients at risk of adrenal suppression. A short course of systemic dexamethasone does not universally require tapering; the decision depends on dose, duration, repeated previous courses, and the patient's clinical circumstances. (Medicines.org.uk)

13. Method of Preparation

Vendexine is supplied as a ready-to-use oral syrup; no reconstitution step is indicated for the marketed 125 mL presentation in the available product information. The dose should be measured accurately rather than estimated with an ordinary household teaspoon. Current retail information also advises closing the bottle tightly after use. (Lotus Pharmacies)

14. Contraindications

Important contraindications/avoidance situations include:

• Hypersensitivity to dexamethasone, chlorpheniramine, other antihistamines, or formulation components.
• Systemic fungal infection.
• Relevant acute infections in which systemic corticosteroid immunosuppression is inappropriate or inadequately treated.
• Certain parasitic infections.
• Recent MAOI therapy: chlorpheniramine's anticholinergic effects may be intensified; current chlorphenamine prescribing information considers use contraindicated within 14 days of MAOI treatment.
• Live vaccines when receiving immunosuppressive corticosteroid doses.
• Gastric/duodenal ulceration may constitute a corticosteroid contraindication depending on the applicable product labeling and clinical circumstances. (Medicines.org.uk)

Diabetes, osteoporosis, tuberculosis, and psychiatric disorders should not simply be presented as universal absolute contraindications. They are conditions requiring careful risk-benefit assessment and, where appropriate, medical monitoring. Corticosteroids can aggravate hyperglycemia, osteoporosis, infection risk, and psychiatric symptoms. (Medicines.org.uk)

15. Warnings & Precautions

Particular caution is warranted in patients with diabetes, hypertension, heart failure, osteoporosis, glaucoma, psychiatric disorders, renal or hepatic impairment, peptic ulcer disease, active or previous tuberculosis, and other infections. Systemic corticosteroids may suppress immune responses and mask clinical signs of infection. (Medicines.org.uk)

Chlorpheniramine requires caution in glaucoma, prostatic enlargement/urinary retention, epilepsy, severe cardiovascular disease or hypertension, asthma/bronchitic disorders, and hepatic or renal impairment. Children and older adults may be more susceptible to neurological or anticholinergic effects, including paradoxical excitation. (Medicines.org.uk)

Drowsiness, impaired attention, dizziness, and blurred vision may occur; patients should avoid driving or operating machinery until they know how the medicine affects them. Alcohol may increase sedation and should be avoided. (Medicines.org.uk)

Long-term or repeated systemic corticosteroid therapy carries risks including adrenal suppression, growth retardation in children, osteoporosis, hyperglycemia, hypertension, cataract/glaucoma, infection, psychiatric effects, and other metabolic complications. (Medicines.org.uk)

16. Drug Interactions

Clinically important interactions include:

• MAO inhibitors: may intensify chlorpheniramine's anticholinergic effects. (Medicines.org.uk)
• Alcohol, sedatives, hypnotics, anxiolytics and other CNS depressants: may increase sedation and psychomotor impairment. (Medicines.org.uk)
• Other antihistamine-containing medicines: may increase antihistaminic/anticholinergic adverse effects and should generally not be duplicated. (Medicines.org.uk)
• Phenytoin: chlorpheniramine can inhibit phenytoin metabolism and increase toxicity risk. (Medicines.org.uk)
• CYP3A4 inducers such as rifampicin/rifabutin, carbamazepine, phenytoin, phenobarbital and primidone may reduce dexamethasone exposure. CYP3A4 inhibitors, including some strong inhibitors or cobicistat-containing products, may increase systemic corticosteroid adverse effects. (Medicines.org.uk)
• Dexamethasone may reduce the effectiveness of antidiabetic medicines, some antihypertensives and diuretics. Potassium-depleting diuretics may increase hypokalemia risk. (Medicines.org.uk)
• Corticosteroids may alter the response to coumarin anticoagulants and can increase the gastrointestinal-ulcer risk when combined with NSAIDs. (Medicines.org.uk)

17. Side Effects

Potential adverse effects include drowsiness/somnolence, dizziness, impaired coordination or attention, headache, dry mouth, blurred vision, nausea, dyspepsia, vomiting, fatigue, urinary retention, palpitations/tachycardia, and hypersensitivity reactions from chlorpheniramine. (Medicines.org.uk)

Dexamethasone may cause mood or behavioral changes, insomnia, hyperglycemia, increased blood pressure, fluid retention, increased susceptibility to infection, gastrointestinal ulceration/bleeding, adrenal suppression, glaucoma/cataract, osteoporosis, muscle weakness, impaired growth in children, and other corticosteroid-related complications, particularly with higher doses or prolonged/repeated therapy. (Medicines.org.uk)

Urgent medical evaluation is warranted for severe allergic reactions, severe psychiatric symptoms, significant visual changes, gastrointestinal bleeding, severe infection, or other serious unexpected reactions.

18. Use in Special Populations

Children: Available Vendexine product information specifies use in children aged 6–12 years, with 2.5 mL three times daily, and states that it should not be used below 6 years. Pediatric corticosteroid exposure should be carefully justified because systemic glucocorticoids can affect growth and adrenal function. (DrugPamphlet)

Older adults: Greater susceptibility to chlorpheniramine-related sedation, confusion, anticholinergic effects, and adverse corticosteroid effects warrants additional caution. (Medicines.org.uk)

Pregnancy: Dexamethasone crosses the placenta, and chlorpheniramine should be used during pregnancy only when the expected benefit justifies the potential risk. Use requires medical supervision. (Medicines.org.uk)

Breastfeeding: Both components require medical assessment; chlorpheniramine may affect lactation and may enter breast milk, while clinical information on dexamethasone exposure through milk is limited. (Medicines.org.uk)

Renal/Hepatic impairment: Caution may be required, especially because chlorpheniramine undergoes hepatic metabolism and renal elimination and its use warrants caution in renal and hepatic impairment. (Medicines.org.uk)

19. Storage Conditions

Available Egyptian product information states:

• Store at a temperature not exceeding 30°C.
• Keep the bottle tightly closed.
• Keep out of reach of children.

The exact shelf life should be taken from the expiry date printed on the current package, rather than inferred from information for another formulation.

20. Additional Sections

Current Egyptian market status: Current Egyptian pharmacy listings accessed in August 2026 continue to display Vendexine Syrup 125 mL by EVA Pharma, with the same stated concentrations of dexamethasone 0.5 mg/5 mL and chlorpheniramine maleate 2 mg/5 mL. (Bloom Pharmacy)

Important regulatory clarification: The Egyptian Drug Authority published a refusal concerning an oral fixed-dose combination of chlorpheniramine maleate 2 mg/mL + dexamethasone 0.5 mg/mL. Those concentrations are not the same as Vendexine's marketed concentrations of 2 mg/5 mL and 0.5 mg/5 mL. Therefore, that EDA refusal should not be interpreted as a refusal of Vendexine's formulation.

The EDA report specifically criticized the much higher submitted concentrations, the lack of clinical evidence for that fixed-dose formulation at those concentrations, dosing-error risk, and corticosteroid exposure.

21. Frequently Asked Questions (FAQ)

Is Vendexine only an antihistamine?
No. It combines a sedating H1 antihistamine, chlorpheniramine, with the systemic glucocorticoid dexamethasone.

Does Vendexine treat infection?
No. It is not an antibiotic or antifungal. Dexamethasone can suppress immune responses and may mask infection. (Medicines.org.uk)

Can Vendexine cause sleepiness?
Yes. Chlorpheniramine commonly causes sedation and may impair attention, coordination, and driving ability. (Medicines.org.uk)

Is diabetes an absolute contraindication?
Not universally. Diabetes is an important precaution because systemic corticosteroids can worsen glucose control; use should be based on an individualized medical risk-benefit assessment. (Medicines.org.uk)

Does every course have to be tapered?
No. Tapering is particularly relevant after prolonged systemic corticosteroid exposure or in patients at risk of adrenal suppression. Short courses do not automatically require tapering. (Medicines.org.uk)

Can it be used for ordinary cough or a common cold?
The presence of cough or nasal symptoms alone does not establish an indication for a systemic corticosteroid-containing combination. It should not be used routinely for uncomplicated viral respiratory illness without an appropriate clinical indication.

Is the EDA refusal for chlorpheniramine 2 mg/mL + dexamethasone 0.5 mg/mL the same product as Vendexine?
No. Vendexine is labeled at 2 mg/5 mL chlorpheniramine + 0.5 mg/5 mL dexamethasone, whereas the EDA-refused submission used concentrations expressed per 1 mL, which are five times higher.

22. References

1. Egyptian Drug Authority (EDA) — Refusal Public Assessment Report for Chlorpheniramine maleate 2 mg/mL + Dexamethasone 0.5 mg/mL oral dosage form.
2. Egyptian Drug Authority — Technical Committee decisions concerning the above high-concentration combination.
3. EVA Pharma Product Portfolio, 2024 — Vendexine syrup composition and therapeutic classification.
4. Current Egyptian pharmacy listings — Vendexine Syrup 125 mL, current marketed presentation and concentrations. (Bloom Pharmacy)
5. Medicines.org.uk (emc), current SmPCs — Dexamethasone oral solution: contraindications, warnings, interactions, pharmacokinetics and adverse effects. (Medicines.org.uk)
6. Medicines.org.uk (emc), Chlorphenamine SmPC — indications, contraindications, interactions, sedation, special populations and pharmacokinetics. (Medicines.org.uk)
7. Abdellatif et al., Ain-Shams Journal of Anaesthesiology (2016) — identifies Vendexine as a commercially available dexamethasone–chlorpheniramine syrup in Egypt and documents its composition/use in a clinical research setting. (ResearchGate)