Coldex

• Upper Respiratory Tract Infections (URTIs):
  Relief of symptoms associated with common cold, flu, sinusitis, allergic rhinitis, and other URTIs.
• Nasal Congestion:
  Reduction of nasal mucosal swelling and congestion due to allergies or infections.
• Productive Cough:
  Use of guaiphenesin as an expectorant to loosen mucus and facilitate productive cough.
• Allergic Symptoms:
  Triprolidine, an antihistamine, helps relieve sneezing, runny nose, and watery eyes associated with allergic rhinitis or hay fever.
• Off-label/Clinically accepted uses:
  Symptomatic treatment of sinus congestion and cough related to allergic or viral etiologies.

• Adults and Children ≥12 years:
• Typical dose: One tablet or 5 mL syrup every 4–6 hours as needed.
• Maximum: Do not exceed 4 doses (24 hours).
• Children 6–11 years:
• Half the adult dose or as per physician recommendation.
• Use caution; consult a pediatrician.
• Children under 6 years:
• Generally not recommended without medical advice.
• Administration:
• Oral route.
• Tablets with water; syrup measured with appropriate dosing device.
• Can be taken with or without food.
• Special Populations:
• Renal or hepatic impairment: Use with caution; no established dose adjustments.
• Elderly: Use lowest effective dose; monitor for adverse effects.

• Pseudoephedrine: A sympathomimetic amine acting as an alpha-adrenergic receptor agonist, causing vasoconstriction in nasal mucosa, thereby reducing swelling and nasal congestion.
• Guaiphenesin: An expectorant that increases respiratory tract fluid secretion, thinning mucus to facilitate easier clearance via coughing.
• Triprolidine: A first-generation H1-antihistamine that competitively blocks histamine H1 receptors, reducing allergic symptoms such as sneezing, itching, and rhinorrhea.

Together, this combination addresses nasal congestion, facilitates mucus clearance, and relieves allergic symptoms for comprehensive symptomatic relief in upper respiratory conditions.

• Pseudoephedrine:
• Absorbed rapidly from the GI tract with peak plasma levels in 1–2 hours.
• Bioavailability ~90%.
• Metabolized partially in liver; excreted mainly unchanged in urine.
• Half-life: 5–8 hours.
• Guaiphenesin:
• Rapidly absorbed orally with peak plasma concentrations in ~1 hour.
• Metabolized by liver; primarily excreted in urine as metabolites.
• Half-life: approximately 1 hour.
• Triprolidine:
• Rapid oral absorption; peak plasma levels in about 2 hours.
• Extensively metabolized in the liver.
• Half-life: 4–6 hours.

• Pregnancy:
• Pseudoephedrine is FDA Category C: risk cannot be ruled out; avoid in first trimester if possible.
• Guaiphenesin: limited data; use only if benefits justify risk.
• Triprolidine is Category B: animal studies show no harm; limited human data.
• Lactation:
• Pseudoephedrine and triprolidine are excreted in breast milk; may cause irritability or feeding difficulties in infants. Use with caution.
• Guaiphenesin excretion unknown; use only if clearly needed.

• Combination product comprising:
• Nasal decongestant (Pseudoephedrine)
• Expectorant (Guaiphenesin)
• First-generation antihistamine (Triprolidine)

• Known hypersensitivity to pseudoephedrine, guaiphenesin, triprolidine, or formulation excipients.
• Severe hypertension, severe coronary artery disease, or severe arteriosclerosis.
• Closed-angle glaucoma.
• Hyperthyroidism.
• Monoamine oxidase inhibitors (MAOIs) use within past 14 days.
• Severe hepatic or renal impairment (relative contraindication).
• Infants under 6 years (risk of serious adverse effects).

• Use cautiously in patients with:
• Cardiovascular disease (hypertension, arrhythmias).
• Diabetes mellitus (pseudoephedrine may elevate blood glucose).
• Prostatic hypertrophy (risk of urinary retention).
• Glaucoma (can worsen intraocular pressure).
• Seizure disorders (triprolidine may lower seizure threshold).
• Avoid driving or operating machinery due to possible sedation from triprolidine.
• Risk of serotonin syndrome if combined with other serotonergic drugs is low but possible.
• Monitor for signs of overdose: tachycardia, hypertension, hallucinations, seizures.

• Common:
• Nervous system: Drowsiness, dizziness, headache.
• Gastrointestinal: Nausea, dry mouth.
• Cardiovascular: Palpitations, increased heart rate, hypertension (pseudoephedrine).
• Respiratory: Thickening of bronchial secretions (guaiphenesin).
• Allergic: Rash, itching (rare).
• Serious (rare):
• Arrhythmias, hypertensive crisis, hallucinations, seizures.
• Urinary retention, especially in men with prostatic hypertrophy.
• Side effects often dose-dependent and may resolve with discontinuation.

• MAO inhibitors: Risk of hypertensive crisis with pseudoephedrine; contraindicated.
• Other sympathomimetics: Additive cardiovascular effects.
• CNS depressants (alcohol, benzodiazepines): Increased sedation from triprolidine.
• Anticholinergic drugs: Enhanced anticholinergic side effects.
• Antihypertensives: Pseudoephedrine may reduce efficacy.
• CYP450 enzymes: Triprolidine is metabolized by CYP450; inhibitors or inducers may alter levels.

• Recent cold and allergy management guidelines continue to recommend combination therapy for symptomatic relief in uncomplicated URTIs.
• Regulatory agencies emphasize caution in pediatric use due to risk of severe adverse effects.
• No new black box warnings; continued advisories on cardiovascular monitoring in high-risk patients.
• Updated labeling stresses avoidance in children under 6 years.

• Store at controlled room temperature: 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep bottle tightly closed.
• Syrups should be shaken well before use.
• Do not freeze.
• Keep out of reach of children.