ADOL SINUS Tablets (Caplets)

What is ADOL SINUS

ADOL SINUS® caplets combine two well-established active ingredients—Paracetamol 500 mg, a centrally acting analgesic–antipyretic, and Pseudoephedrine HCl 30 mg, a sympathomimetic nasal decongestant—to provide dual relief from the discomfort of upper-respiratory tract infections. Each caplet is film-coated for easy swallowing and packaged in tamper-evident blisters (12 caplets × 2, total 24). The formulation is designed for short-term self-medication of symptoms such as sinus pressure, headache, facial pain, fever, and rhinorrhea associated with the common cold, influenza, allergic rhinitis, or acute sinusitis. Paracetamol reduces fever by acting on the hypothalamic heat-regulation center and alleviates pain through inhibition of central prostaglandin synthesis. Pseudoephedrine exerts selective α-adrenergic agonist activity on nasal mucosal blood vessels, shrinking swollen turbinates and improving airflow without significant sedative effect.

• Therapeutic class: Non-opioid analgesic & systemic decongestant combination.
• Intended population: Adults and adolescents > 12 years; not recommended for children under 12 years.
• Regulatory status (most markets): Over-the-counter (Pharmacy-only); pack size limited to reduce diversion for illicit purposes.
• Key benefits: Fast onset (≈ 30 min), convenient every-4-to-6-hour dosing, sugar-free & caffeine-free.
• Limitations: Symptomatic treatment only; does not shorten viral illness duration, and inappropriate prolonged use may mask serious conditions.

How to use ADOL SINUS

Optimal benefit and safety depend on correct, time-limited use. Patients should read the patient information leaflet thoroughly before starting therapy and consult a healthcare professional if symptoms persist beyond 5–7 days.

1. Dosage schedule
   • Adults & adolescents > 12 y: 1–2 caplets every 4–6 h as needed.
   • Do not exceed 8 caplets (4 g paracetamol; 240 mg pseudoephedrine) in 24 h.
2. Administration tips
   • Swallow whole with a full glass of water; do not crush or chew.
   • Avoid taking with other paracetamol-containing products to prevent accidental overdose.
   • Evening doses should be taken several hours before bedtime if insomnia occurs.
3. Duration of therapy
   • Self-care: ≤ 5 consecutive days for pain, ≤ 3 consecutive days for fever.
   • Seek medical review if symptoms worsen, new symptoms emerge, or fever > 38 °C persists > 3 days.
4. Special situations
   • Older adults (≥ 65 y): Start at 1 caplet per dose; monitor blood pressure.
   • Renal impairment: Extend interval to 6 h (CrCl 30–59 mL/min) or 8 h (CrCl < 30 mL/min).
   • Hepatic impairment/Alcohol use: Maximum 2 g paracetamol per day; specialist advice required.

Mode of Action ADOL SINUS

The therapeutic synergy in ADOL SINUS rests on complementary pharmacodynamics:

• Paracetamol (Acetaminophen)
  • Acts predominantly in the CNS, where it raises the pain threshold by inhibiting cyclooxygenase-2–mediated PGE₂ synthesis.
  • Antipyretic effect arises from direct modulation of the hypothalamic thermoregulatory center, promoting peripheral vasodilation and heat dissipation.
  • Lacks significant peripheral anti-inflammatory activity, preserving gastric mucosal integrity.
• Pseudoephedrine HCl
  • Selective α₁-adrenergic agonist; causes vasoconstriction of engorged nasal/sinus mucosa, reducing edema and mucus production.
  • Indirectly stimulates β-adrenergic receptors via norepinephrine release, aiding mucociliary clearance while sparing bronchial smooth muscle.
  • Minimal central penetration compared with ephedrine, so stimulant effects are milder, though insomnia and nervousness remain possible.

By tackling both pain/fever and congestion pathways, the combination provides rapid multi-symptom relief, improving patient comfort and functional capacity during upper-respiratory infections.

ADOL SINUS Interactions ADOL SINUS

Concurrent medications can potentiate toxicity or blunt efficacy. A structured medication review reduces adverse outcomes:

• Monoamine oxidase inhibitors (MAOIs)—hypertensive crisis may occur; contraindicated within 14 days of MAOI discontinuation.
• Other sympathomimetics or decongestants (e.g., phenylephrine, chlorphenamine combos)—additive pressor effects, insomnia, tachycardia.
• Antihypertensives (β-blockers, methyldopa)—pseudoephedrine may diminish antihypertensive response; monitor BP.
• Selective serotonin re-uptake inhibitors (SSRIs)/SNRIs—risk of serotonin syndrome when combined with high doses of paracetamol (weak serotonergic effect) and sympathomimetics.
• Warfarin & other Vitamin K antagonists—chronic high-dose paracetamol can enhance INR via hepatic enzyme interference; sporadic short use is generally safe.
• Alcohol & hepatotoxic drugs (e.g., isoniazid, high-dose rifampicin)—increase risk of paracetamol-induced hepatotoxicity; advise limitation of alcohol (< 3 drinks/day).
• CYP2D6 inhibitors (paroxetine, fluoxetine)—may raise pseudoephedrine exposure but clinical impact usually minimal.
• Digoxin—sympathomimetic-induced arrhythmias can potentiate digoxin toxicity; ECG monitoring recommended in cardiac patients.

Always cross-check OTC cold remedies, combination analgesics, and herbal stimulants (e.g., ginseng) before initiating ADOL SINUS.

Dosage of ADOL SINUS

The following dosing guidance applies to the marketed 24-caplet pack (Paracetamol 500 mg + Pseudoephedrine HCl 30 mg per caplet):

• Adults & adolescents (12–64 y): 1–2 caplets orally every 4–6 h.
• Maximum daily dose: 8 caplets within any 24-h period.
• Elderly (≥ 65 y): Start with 1 caplet; not more than 6 caplets/24 h unless medically supervised.
• Renal impairment:
  • CrCl 30–59 mL/min: 1 caplet every 6 h; max 6 caplets/day.
  • CrCl < 30 mL/min: 1 caplet every 8 h; max 4 caplets/day.
• Hepatic impairment, chronic alcoholism, malnutrition: Reduce paracetamol component to ≤ 2 g/day (max 4 caplets); extended dosing interval recommended.
• Not recommended in children < 12 y, pregnancy (especially 1st trimester) without medical advice, or breastfeeding due to pseudoephedrine secretion into milk.
• Missed dose: Take as soon as remembered if still needed, ensuring at least 4 h between doses; skip if next dose is imminent—do not double.

Exceeding the recommended limit risks acute liver failure (paracetamol) and severe hypertension or arrhythmia (pseudoephedrine).

Possible side effects of ADOL SINUS

Most adverse reactions are mild and self-limiting; serious events are uncommon when used at therapeutic dosages. Patients should discontinue and seek care if severe reactions occur.

• Very common (≥ 1/10)
  • Insomnia, restlessness, mild nervousness.
• Common (≥ 1/100 – < 1/10)
  • Dry mouth or throat, dizziness, mild tremor.
  • Gastrointestinal discomfort: nausea, epigastric pain.
  • Transient increase in blood pressure or heart rate.
• Uncommon (≥ 1/1 000 – < 1/100)
  • Palpitations, anxiety, urinary retention (especially in males with prostatic enlargement).
  • Skin rash, pruritus.
• Rare / Very rare
  • Severe cutaneous adverse reactions (SCARs): Stevens–Johnson syndrome, toxic epidermal necrolysis.
  • Agranulocytosis, thrombocytopenia, pancytopenia (idiosyncratic paracetamol reaction).
  • Acute hepatic failure with overdose or chronic heavy alcohol use.
  • Hypertensive crisis, ischemic chest pain, or hemorrhagic stroke in predisposed individuals.

Report adverse events to the national pharmacovigilance center. Prompt N-acetylcysteine therapy is life-saving in paracetamol overdose; pseudoephedrine toxicity is managed with benzodiazepines (for agitation) and intravenous antihypertensives.

ADOL SINUS Contraindications ADOL SINUS

• Known hypersensitivity to paracetamol, pseudoephedrine, or any excipient.
• Severe hypertension or significant cardiovascular disease (e.g., coronary artery disease, arrhythmia).
• Cerebrovascular disorders (history of hemorrhagic stroke).
• Hyperthyroidism, pheochromocytoma, or uncontrolled diabetes mellitus.
• Angle-closure glaucoma or severe urinary retention due to bladder neck obstruction.
• Concomitant or recent (≤ 14 days) use of MAOIs, linezolid, or reversible MAO-A inhibitors (e.g., moclobemide).
• Severe hepatic impairment or active liver disease.
• Children under 12 years.
• Pregnancy—especially first trimester—unless benefits outweigh risks; breastfeeding discouraged due to reduced milk production and irritability in the infant.

Storage of ADOL SINUS

• Store below 25 °C (77 °F) in a dry place, away from direct sunlight and heat sources.
• Keep blisters in the outer carton until use to protect from moisture and accidental damage.
• Do not refrigerate or freeze; condensation can compromise film-coating integrity.
• Keep out of the sight and reach of children; child-resistant outer packaging is recommended in households with young children.
• Check the expiry date printed on the carton and blister; dispose of any unused caplets safely after this date—community take-back programs or pharmacy return preferred.
• Do not use if blisters are torn, punctured, or show evidence of tampering.
• For emergency preparedness kits, rotate stock every 18 months to ensure potency.
• In regions with high humidity (> 80 % RH), silica-gel desiccant sachets may be placed in the secondary container when transferring partial strips.

Proper storage maintains therapeutic effectiveness and minimizes accidental ingestion or degradation products that could pose toxicity risks.