ADOL 250mg Rectal Suppositories

What is ADOL 250mg

• Pharmaceutical identity & presentation : ADOL 250 mg is a rectal suppository containing 250 mg of the active ingredient paracetamol (acetaminophen), an analgesic–antipyretic of the para-aminophenol class. Each white, torpedo-shaped unit is moulded in cocoa-butter-based excipients, packed five suppositories per PVC/PVDC blister, with 20 blisters (100 units) per carton for institutional or household stock.

• Therapeutic class & indications : Paracetamol is classified as a non-opioid, non-salicylate analgesic and antipyretic. ADOL suppositories are used for the short-term relief of mild-to-moderate pain (e.g., tension headache, post-vaccination discomfort, musculoskeletal aches, otalgia, toothache) and for the reduction of fever ≥38 °C when oral administration is impractical—such as in vomiting, peri-operative settings, or when nil-per-os status is required.

• Patient groups : The 250 mg strength is most commonly employed in paediatric patients 1–5 years (≈ 10–20 kg), older children with low body weight, or adults requiring fractional dosing. Rectal delivery circumvents first-pass gastric exposure, a benefit in gastritis or chemotherapy-induced nausea, but exhibits slower and more variable absorption than oral or IV forms.

• Clinical value : Compared with NSAIDs, paracetamol offers minimal gastrointestinal irritation and no platelet inhibition, making it suitable in dengue, varicella, or peri-operative haemostatic contexts. It is also a preferred antipyretic in infants, pregnancy (all trimesters, category B), and lactation when used at recommended doses.

• Regulatory & safety status : Listed on the WHO Essential Medicines List, paracetamol carries a favourable benefit-risk profile; however, dose-dependent hepatotoxicity remains the principal hazard, especially with unintentional cumulative exposure to multi-ingredient “cold & flu” products.

How to use ADOL 250mg

• Preparation : Ensure hands are washed or gloved. Warm the suppository for a few seconds between fingers or immerse the sealed blister in lukewarm water to soften the surface—this minimizes mucosal trauma.

• Positioning : The patient should lie on the left lateral side with the upper knee flexed (“Sims’ position”), or a child may be placed prone across the caregiver’s lap. Calm reassurance reduces anal sphincter tightening.

• Insertion technique : Tear one unit from the blister, peel back the foil, and gently insert the narrow (tapered) end into the rectum, pushing it just past the anal sphincter. Use water-based lubricant if needed. Ask the patient to remain supine or lateral for 5–10 minutes to prevent expulsion.

• Dosing frequency : Use 10–15 mg/kg per dose every 4–6 hours as required, not exceeding 60 mg/kg/day in children or 4 g daily in adults. In neonates <28 days, space doses at ≥6 h (immature glucuronidation).

• Missed dose : If fever or pain persists, administer when remembered provided ≥4 h have elapsed since the last dose. Do not double-dose.

• Duration of self-care : Seek medical review if fever lasts >3 days, pain surpasses 5 days, or new symptoms (rash, stiff neck) develop.

• Special populations : In hepatic impairment (Child-Pugh B/C) reduce total daily dose by ≥50 %. In chronic alcoholism (>3 drinks/day), limit to 2 g daily. Rectal route is valuable post-tonsillectomy or during intractable emesis.

Mode of Action ADOL 250mg

• Centrally acting COX inhibition : Paracetamol selectively inhibits prostaglandin H2 synthase activity within the CNS, particularly in the hypothalamic thermoregulatory centre. Unlike NSAIDs, it exerts negligible peripheral cyclo-oxygenase blockade, sparing gastric mucosa and platelet function.

• N-arachidonoyl-phenolamine (AM404) pathway : A hepatic metabolite of paracetamol is conjugated with arachidonic acid in the brain to form AM404, which modulates TRPV1 receptors and cannabinoid CB1 pathways, contributing to analgesia and blunted nociceptive transmission in the dorsal horn.

• Antipyretic effect : By lowering hypothalamic set-point prostaglandin E2 concentrations, paracetamol enhances heat dissipation via vasodilatation and sweating, reversing fever without affecting basal body temperature in normothermic patients.

• Pharmacokinetics (rectal) : Suppositories melt at body temperature; absorption occurs across the rectal venous plexus, partially bypassing first-pass hepatic metabolism. Peak plasma levels arise in 90–120 minutes (vs 30–60 min orally), with bioavailability ~60–70 % but inter-individual variability up to 50 % depending on insertion depth, stool presence, and perfusion.

• Metabolic fate : About 90 % undergoes hepatic conjugation (glucuronidation & sulfation) to inactive metabolites excreted in urine; <5 % is oxidised by CYP2E1 to N-acetyl-p-benzoquinone imine (NAPQI), detoxified by glutathione. Overdose saturates conjugation, permitting NAPQI accumulation and hepatocellular necrosis.

ADOL 250mg Interactions ADOL 250mg

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Dosage of ADOL 250mg

• Paediatric dosing (standard) : 10–15 mg/kg per dose rectally every 4–6 hours. A single 250 mg suppository suits children 16–25 kg. Do not exceed 5 doses (75 mg/kg) in 24 h.

• Adult dosing : 500–1000 mg rectally every 4–6 hours; adults may insert one or two 250 mg units to achieve desired strength. Maximum 4 g/24 h. In low-body-weight adults (<50 kg), limit to 60 mg/kg/day.

• Neonates & infants : 10–12.5 mg/kg every 6–8 h; pharmacokinetics are prolonged (half-life ~3–4 h), necessitating wider intervals.

• Hepatic impairment : Reduce total daily dose by 50 % and extend dosing interval to 6–8 h. Close monitoring of ALT/AST is recommended for courses >48 h.

• Renal impairment : For eGFR <30 mL/min/1.73 m², maintain usual single doses but extend interval to 6 h; paracetamol metabolites accumulate yet are dialyzable.

• Elderly : No intrinsic adjustment needed; consider lower starting dose (250–500 mg) owing to frailty, low glutathione reserves, or polypharmacy.

• Peri-operative & procedural use : 20 mg/kg rectally (max 1 g) may be given 30–60 min pre-incision for opioid-sparing analgesia.

Possible side effects of ADOL 250mg

• Common (<10 %) : mild, self-limiting anorectal discomfort (burning, tenesmus) during insertion, transient flushing or hypotension (due to vagal reflex), and nausea if swallowed after partial expulsion.

• Uncommon (1–9 / 1,000) : pruritic anal rash, urticaria, rhinitis, or bronchospasm (particularly in aspirin-sensitive asthma) reflecting IgE-mediated hypersensitivity.

• Rare (<1 / 10,000) : thrombocytopenia, agranulocytosis, or pancytopenia—advise prompt medical review if unexplained bruising or infection signs appear.

• Very rare : Acute generalized exanthematous pustulosis (AGEP), Stevens–Johnson syndrome, toxic epidermal necrolysis; discontinue permanently if mucocutaneous lesions emerge.

• Hepatotoxicity (dose-dependent) : Typically manifests 24–72 h post-overdose with right-upper-quadrant pain, ALT >1000 IU/L, prolonged INR. Early intravenous N-acetylcysteine (NAC) remains life-saving.

• Renal tubular necrosis may accompany massive overdose or chronic high-dose misuse, especially with dehydration or NSAID co-use.

• Post-marketing paediatric observations : Rectal bleeding or prolapse is exceedingly rare, usually linked to forcible insertion or underlying prolapsing haemorrhoids.

ADOL 250mg Contraindications ADOL 250mg

• Absolute : Known hypersensitivity to paracetamol or any suppository excipients (e.g., hydrogenated vegetable oil, semi-synthetic glycerides).

• Severe hepatic insufficiency : Child-Pugh C cirrhosis or active fulminant hepatitis where baseline ALT/AST >3× ULN.

• Severe acute malnutrition or chronic cachexia (e.g., anorexia nervosa) impairing glutathione synthesis, heightening NAPQI toxicity risk.

• Chronic alcoholism with ongoing ethanol intake >3 drinks/day.

• Rectal pathology—active proctitis, bleeding haemorrhoids, anal fissures, or recent anorectal surgery where insertion may exacerbate trauma.

• G6PD deficiency with haemolytic crises has anecdotal links to paracetamol-induced oxidative stress; caution advised although not universally contraindicated.

Storage of ADOL 250mg

• Temperature : Store below 25 °C (77 °F). Suppositories soften above this; refrigeration (2–8 °C) is permissible to preserve firmness but bring to room temperature before use to avoid brittle fracture.

• Packaging integrity : Keep each unit in its individual blister cavity until needed. Foil and PVC layers safeguard against ambient humidity and oxidative degradation.

• Light & moisture protection : Paracetamol is photosensitive in solution but stable in solid fat matrices. Nevertheless, store in a closed carton away from direct sunlight, bathroom steam, or kitchen heat.

• Child safety : Due to palatable cocoa-butter odour, treat as a medicine not confectionery; employ locked cabinet storage above counter height.

• Shelf-life : Typically 36 months from manufacture. Check EXP date on carton; do not use if the suppository shows cracking, discoloration, or oil seepage.

• Disposal : Unused or expired units should be returned to a pharmacy take-back program or disposed of in accordance with local regulations—do not flush or burn.