Syndol Plus
Generic Name
Paracetamol + Codeine Phosphate + Doxylamine Succinate + Caffeine
Manufacturer
GlaxoSmithKline
Country
United Kingdom
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| syndol plus 325 mg tablet | ৳ 8.00 | ৳ 80.00 |
Description
Overview of the medicine
Syndol Plus 325 mg Tablet is a combination analgesic used for the relief of moderate to severe pain. It contains Paracetamol to reduce pain and fever, Codeine Phosphate for stronger pain relief, Doxylamine Succinate for its sedative/antihistamine effect, and Caffeine as an adjuvant to enhance the analgesic effect.
Uses & Indications
Dosage
Adults
1-2 tablets every 4-6 hours as needed, not exceeding 8 tablets in 24 hours.
Elderly
May require lower doses due to reduced renal or hepatic function. Close monitoring is advised.
Renal_impairment
Dose adjustment and increased dosing interval may be necessary based on creatinine clearance.
How to Take
Take orally with water, with or without food. Do not chew or crush the tablet.
Mechanism of Action
Paracetamol inhibits prostaglandin synthesis in the central nervous system (CNS). Codeine acts as an opioid agonist, binding to mu-opioid receptors. Doxylamine is an H1-receptor antagonist with sedative properties. Caffeine acts as a CNS stimulant, inhibiting phosphodiesterase and enhancing the analgesic effect of other components.
Pharmacokinetics
Onset
Analgesic effects typically begin within 30-60 minutes.
Excretion
Mainly renal excretion of unchanged drug and metabolites.
Half life
Paracetamol 1-4 hours, Codeine 2.5-4 hours, Doxylamine 10-12 hours, Caffeine 3-7 hours.
Absorption
All active components are well absorbed orally. Paracetamol peak plasma concentrations are reached in 30-60 minutes, Codeine in about 60 minutes, Doxylamine in 2-3 hours, and Caffeine in 30-60 minutes.
Metabolism
Primarily hepatic. Paracetamol undergoes glucuronidation and sulfation. Codeine is metabolized to morphine via CYP2D6. Doxylamine and Caffeine are also metabolized in the liver (Caffeine via CYP1A2).
Side Effects
Contraindications
- Hypersensitivity to any of the active ingredients or excipients
- Acute respiratory depression
- Children under 12 years (due to codeine)
- Severe liver disease
- Concurrent use with MAOIs (Monoamine Oxidase Inhibitors) or within 14 days of stopping them
- Alcohol intoxication
- Head injury or increased intracranial pressure
Drug Interactions
MAOIs
Concurrent use may lead to serotonin syndrome.
Alcohol
Increased CNS depression, increased risk of hepatotoxicity (with paracetamol).
Anticoagulants (e.g., Warfarin)
Paracetamol may enhance the anticoagulant effect of warfarin with prolonged use.
CYP2D6 Inhibitors (e.g., quinidine, fluoxetine)
May reduce the efficacy of codeine by inhibiting its conversion to morphine.
Antihistamines (e.g., other sedating antihistamines)
Increased sedative effects due to doxylamine.
Other CNS Depressants (e.g., benzodiazepines, other opioids, sedatives)
Increased sedation, respiratory depression, hypotension, and profound sleep.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include severe drowsiness, respiratory depression, pinpoint pupils, cold and clammy skin, profound weakness, liver damage (from paracetamol), tachycardia (from caffeine), anticholinergic effects (from doxylamine). Management involves gastric lavage, activated charcoal, N-acetylcysteine for paracetamol toxicity, and naloxone for opioid effects. Supportive care is essential.
Pregnancy & Lactation
Not recommended during pregnancy, especially in the third trimester, due to the presence of codeine (risk of neonatal withdrawal syndrome) and doxylamine (sedation). Consult a doctor before use during lactation as all active ingredients pass into breast milk.
Side Effects
Contraindications
- Hypersensitivity to any of the active ingredients or excipients
- Acute respiratory depression
- Children under 12 years (due to codeine)
- Severe liver disease
- Concurrent use with MAOIs (Monoamine Oxidase Inhibitors) or within 14 days of stopping them
- Alcohol intoxication
- Head injury or increased intracranial pressure
Drug Interactions
MAOIs
Concurrent use may lead to serotonin syndrome.
Alcohol
Increased CNS depression, increased risk of hepatotoxicity (with paracetamol).
Anticoagulants (e.g., Warfarin)
Paracetamol may enhance the anticoagulant effect of warfarin with prolonged use.
CYP2D6 Inhibitors (e.g., quinidine, fluoxetine)
May reduce the efficacy of codeine by inhibiting its conversion to morphine.
Antihistamines (e.g., other sedating antihistamines)
Increased sedative effects due to doxylamine.
Other CNS Depressants (e.g., benzodiazepines, other opioids, sedatives)
Increased sedation, respiratory depression, hypotension, and profound sleep.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include severe drowsiness, respiratory depression, pinpoint pupils, cold and clammy skin, profound weakness, liver damage (from paracetamol), tachycardia (from caffeine), anticholinergic effects (from doxylamine). Management involves gastric lavage, activated charcoal, N-acetylcysteine for paracetamol toxicity, and naloxone for opioid effects. Supportive care is essential.
Pregnancy & Lactation
Not recommended during pregnancy, especially in the third trimester, due to the presence of codeine (risk of neonatal withdrawal syndrome) and doxylamine (sedation). Consult a doctor before use during lactation as all active ingredients pass into breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from manufacturing date
Availability
Pharmacies and Hospitals
Approval Status
Approved
Patent Status
Generic available, original patent expired
Clinical Trials
Studies on opioid-containing analgesic combinations continue to evaluate efficacy in various pain conditions, long-term safety, and abuse potential. Pharmacovigilance studies monitor real-world adverse effects.
Lab Monitoring
- Liver function tests (LFTs) if used long-term or in patients with hepatic impairment.
- Renal function tests if used long-term or in patients with renal impairment.
Doctor Notes
- Emphasize patient education on the risk of dependence, CNS depressant effects, and the importance of not exceeding recommended doses due to paracetamol toxicity.
- Advise patients against self-medication for extended periods.
- Caution about combining with alcohol or other sedatives.
Patient Guidelines
- Do not exceed the recommended dose to avoid serious side effects, including liver damage and respiratory depression.
- Avoid alcohol consumption while taking this medicine.
- Do not drive or operate heavy machinery if you experience drowsiness, dizziness, or blurred vision.
- Not for prolonged use without medical advice due to the risk of addiction and other adverse effects.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten one.
Driving Precautions
This medicine can cause drowsiness, dizziness, and blurred vision, which may impair your ability to drive or operate machinery. Do not drive or engage in such activities until you know how Syndol Plus affects you.
Lifestyle Advice
- Maintain adequate hydration to help manage constipation, a common side effect of codeine.
- Ensure sufficient rest, especially if experiencing drowsiness.
- Avoid activities requiring mental alertness if sedated.
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