In the pharmaceutical industry, CPM (Chlorpheniramine Maleate) is a first-generation Antihistamine used to treat allergic symptoms. As a pharmacist and manufacturer, I view this molecule as a highly effective but “sedating” therapy, meaning its administration must be timed carefully to balance relief with alertness.
At your WHO-GMP facility in Mumbai, where you likely produce the standard 4 mg tablet, it is critical to provide clear dosing intervals, as this drug has a relatively short half-life compared to second-generation antihistamines like Cetirizine.
Standard Dosage & Administration
The “Gold Standard” for CPM administration involves frequent, smaller doses to maintain consistent blood levels.
| Age Group | Usual Dosage (4 mg Tablet) | Maximum Daily Limit |
| Adults & Teens (12+ yrs) | 1 tablet every 4 to 6 hours. | 6 tablets (24 mg) |
| Children (6 to 12 yrs) | 1/2 tablet (2 mg) every 4 to 6 hours. | 3 tablets (12 mg) |
| Elderly / Frail Adults | 1/2 to 1 tablet every 6 to 8 hours. | 3 tablets (12 mg) |
Technical Note: CPM tablets are typically not recommended for children under 6 years of age unless specifically directed by a pediatrician, usually in liquid (syrup) form for precise measuring.
How to Take the Tablet
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Method: Swallow the tablet whole with a full glass of water. Do not chew or crush it, as the bitter taste of the API can be unpleasant and may affect the absorption rate.
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With or Without Food: CPM can be taken with or without food. However, if a patient experiences gastrointestinal upset (nausea), taking it with milk or a light snack can help buffer the stomach lining.
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The “Sedation” Window: Because drowsiness is the most common side effect (occurring in up to 50% of users), the best time for the first dose is often in the evening to see how it affects alertness before driving or operating machinery.
The Pharmacist’s “Technical Warning”
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Alcohol Interaction: Alcohol significantly potentiates (increases) the sedative effects of CPM. Advise patients to avoid all alcoholic beverages during treatment to prevent severe respiratory depression or excessive grogginess.
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Anticholinergic Effects: CPM can cause “drying” effects. Advise patients to drink plenty of water to manage dry mouth and to be cautious if they have a history of glaucoma or prostate enlargement, as it can increase eye pressure and make urination difficult.
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The “Paradoxical” Effect: In children, instead of making them sleepy, CPM can sometimes cause excitability or hyperactivity. Parents should be warned of this potential “switch.”
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The “Scored Tablet” USP: On your digital marketplace, highlight that your 4 mg tablets are scored (have a line down the middle). This is a vital technical feature for pediatric dosing (2 mg) and allows for easier “step-down” therapy.
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Stability for Export: Chlorpheniramine Maleate is stable but must be protected from light and moisture. For export to Zone IVb tropical regions, using Alu-Alu or high-grade PVDC blister packaging is essential to maintain a 36-month shelf life.
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Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international allergy and “Cold & Flu” combination drug tenders.