Valid Ghana · FDA Ghana

DIHYDROCODEINE TABLETS

Dihydrocodeine Tartrate

FDA/GD.245-040077 Dihydrocodeine Tartrate 30MG nervous system INN generic

What it does

Dihydrocodeine is a strong pain relief medicine that belongs to the opioid class.

Commonly used for: severe pain, chronic pain

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Registration & product details

Registration no.
FDA/GD.245-040077
Registration date
2024-04-19
Expiry date
2029-05-01
Status
Valid
Active ingredient
Dihydrocodeine Tartrate
Strength
30MG
Pack size
-
Therapeutic class
-
ATC class (WHO)
N02AA - Natural opium alkaloids
Drug group
NERVOUS SYSTEM
RxNorm RxCUI
23088
Manufacturer / MAH
Bristol Laboratories
Country of origin
-
Manufacturer location
5 Traynor Way, Peterlee SR8 2RU, UK

Source: Food and Drugs Authority · fetched 2026-04-18 08:33:08 · updated 2026-09-18 04:00:13

Drug Interactions

60
Check interactions

Pharmacodynamic Warnings

Dihydrocodeine appears in TABLE 11: Drugs with CNS depressant effects

Severe (6)

Opioids - decreases concentration

Brigatinib potentially decreases the concentration of opioids (alfentanil, fentanyl). Avoid. Also see TABLE 6 p. 1518

Severe Theoretical

Opioids - increases exposure

Ceritinib is predicted to increase the exposure to opioids (alfentanil, fentanyl). Avoid. Theoretical → Also see TABLE 6 p. 1518

Severe Theoretical

Opioids - increases risk of cnstoxicity

Ritonavir increases the risk of CNS toxicity when given with opioids (pethidine). Avoid.

Severe Study

Opioids - decreases exposure

Lorlatinib is predicted to decrease the exposure to opioids (alfentanil, fentanyl). Avoid.

Severe Theoretical

Opioids - increases risk of adverse effects

Selegiline increases the risk of adverse effects when given with opioids (pethidine). Avoid. Also see TABLE 13 p. 1520

Severe Anecdotal

Opioids - increases exposure

Selpercatinib is predicted to increase the exposure to opioids (alfentanil, buprenorphine). Avoid.

Severe Study

Moderate (31)

Opioids - increases exposure

Dronedaroneispredictedtoincreasetheexposuretoopioids (alfentanil,buprenorphine,fentanyl,oxycodone).Monitorand adjustdose.oStudy →AlsoseeTABLE6p.1518

Moderate Study

Opioids - increases concentration

Amiodarone is predicted to increase the concentration of opioids (fentanyl). Monitor and adjust dose. Also see TABLE 6 p. 1518.

Moderate Theoretical

Opioids - decreases concentration

Carbamazepine decreases the concentration of opioids (tramadol). Adjust dose.

Moderate Study

Opioids - increases exposure

Miconazole is predicted to increase the exposure to opioids (alfentanil). Use with caution and adjust dose.

Moderate Theoretical

Opioids - increases exposure

Antifungals, azoles (fluconazole, isavuconazole, posaconazole) are predicted to increase the exposure to opioids (alfentanil, buprenorphine, fentanyl, oxycodone). Monitor and adjust dose.

Moderate Study

Unknown (23)

Drugs That Cause Serotonin Syndrome - increases risk of serotonin syndrome

Opioids (tapentadol) are predicted to increase the risk of serotonin syndrome when given with drugs that cause serotonin syndrome (see TABLE 13 p. 1520). Theoretical drugs that reduce serum potassium.

Unknown Theoretical

Opioids - additive effect

Clozapine can cause constipation, as can opioids; concurrent use might increase the risk of developing intestinal obstruction. Also see TABLE 11 p. 1519

Unknown Anecdotal

Opioids - increases exposure

Asciminibispredictedtoincreasetheexposuretoopioids (alfentanil).rTheoretical

Unknown Theoretical

Opioids - increases exposure

Bictegravirispredictedtoincreasetheexposuretoopioids (methadone).oTheoretical

Unknown Theoretical

Opioids - increases exposure

Bulevirtideispredictedtoincreasetheexposuretoopioids (alfentanil).oTheoretical

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: class

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Dihydrocodeine is a strong pain relief medicine that belongs to the opioid class.

What it treats

  • severe pain
  • chronic pain

How it works

It works by blocking pain signals in the brain and changing how the body feels and responds to pain.

Who it's for

This medicine is for adults and children aged 12 years and older who need relief from severe pain.

Drug class

Opioids

Cautions

  • • Be careful if you are taking other medicines that can make you sleepy or relaxed.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: dihydrocodeine

BNF-referenced

Dihydrocodeine is an opioid analgesic used for the relief of moderate to severe pain. As a member of the opioid class, it exerts its effects primarily through interaction with the central nervous system. Dihydrocodeine is often utilized in cases where other analgesics are inadequate, providing effective pain management.

Indications

  • Moderate to severe pain management
  • Pain relief in palliative care

Dosage

Children: Refer to the BNF for Children for appropriate dosing based on age and weight.

Adults: Refer to the BNF for specific dosing recommendations based on the clinical scenario.

Mechanism of action

Dihydrocodeine is metabolized to dihydromorphine, a potent active metabolite that demonstrates a high affinity for mu opioid receptors. This interaction leads to the modulation of pain perception and provides analgesic effects.

Pharmacodynamics

The pharmacodynamics of dihydrocodeine include its potential to cause various opioid-related side effects such as drowsiness, nausea, headache, dry mouth, constipation, difficulty passing urine, and mild euphoria. These effects result from its action on the central nervous system, where it alters the perception of pain and emotional response to discomfort.

Pharmacokinetics

Dihydrocodeine is absorbed following oral administration, with its effects typically observed within a short time frame. It undergoes hepatic metabolism, primarily converting to its active metabolite, dihydromorphine. The drug's elimination half-life is variable, influenced by individual metabolic rates and hepatic function.

Contra-indications

  • Hypersensitivity to dihydrocodeine or any of its components
  • Severe respiratory depression
  • Acute or severe bronchial asthma
  • Increased intracranial pressure
  • Convulsive disorders
  • Concurrent use of monoamine oxidase inhibitors

Adverse effects

  • Drowsiness
  • Nausea
  • Headache
  • Dry mouth
  • Constipation
  • Difficulty passing urine
  • Mild euphoria

Interactions

  • Caution with other CNS depressants such as benzodiazepines, alcohol, and other opioids due to additive effects
  • May enhance the effects of anticholinergic drugs, leading to increased risk of constipation and urinary retention
  • Potential interaction with CYP3A4 inhibitors or inducers affecting metabolism

Precautions

  • Use with caution in patients with a history of substance use disorder
  • Monitor for signs of respiratory depression, especially in the elderly or those with lung disease
  • Consider dosage adjustment in patients with renal or hepatic impairment

Pregnancy

Dihydrocodeine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. It is classified as a category C drug.

Breast-feeding

Dihydrocodeine is excreted in breast milk and may cause sedation or respiratory depression in a nursing infant. Caution is advised.

Storage

Store in a cool, dry place at room temperature away from direct sunlight. Keep out of reach of children.

Formulations

  • Tablets
  • Oral solution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: Dihydrocodeinetartrate

BNF-referenced

Dihydrocodeine tartrate is an opioid analgesic used for the management of moderate to severe pain. It acts on the central nervous system to alter the perception of pain and can also produce sedation. Dihydrocodeine is derived from codeine and has a stronger analgesic effect due to its higher potency.

Indications

  • Moderate to severe pain
  • Acute pain
  • Chronic severe pain
  • Chronic pain not currently treated with a strong opioid
  • Acute pulmonary edema

Dosage

Children: Child 1-3 years: 500 micrograms/kg every 4-6 hours (maximum per dose 30 mg). Child 4-11 years: 0.5-1 mg/kg every 4-6 hours (maximum per dose 30 mg). Child 12-17 years: 30 mg every

Adults: 5 mg every 4 hours if required, or 2.5-5 mg every 4 hours initially, adjusted according to response. Maximum dose may be up to 50 mg every 4-6 hours for severe pain.

Mechanism of action

Dihydrocodeine acts primarily as an agonist at the mu-opioid receptors in the brain and spinal cord, leading to increased pain threshold and altered pain perception. It also inhibits the release of neurotransmitters involved in pain signaling pathways, which contributes to its analgesic effects.

Pharmacodynamics

As an opioid, dihydrocodeine induces analgesia through its action on the mu-opioid receptors. This results in decreased sensitivity to pain and an increased pain tolerance. The drug may also produce euphoria, sedation, and respiratory depression, which are common side effects associated with opioid use. It can lead to physical dependence and tolerance with prolonged use.

Pharmacokinetics

Dihydrocodeine is well absorbed from the gastrointestinal tract, with peak plasma concentrations occurring about 1 to 1.5 hours after oral administration. It undergoes extensive hepatic metabolism, primarily via CYP3A4 and CYP2D6, to form active metabolites. The elimination half-life is approximately 3 to 4 hours. It is primarily excreted in the urine, both as unchanged drug and metabolites. Dose adjustments may be required in patients with hepatic or renal impairment.

Contra-indications

  • Severe respiratory depression
  • Acute or severe bronchial asthma
  • Known or suspected gastrointestinal obstruction
  • Hypersensitivity to dihydrocodeine or any of its components
  • Concurrent use of monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs

Adverse effects

  • Biliary spasm
  • Circulatory depression
  • Increased intracranial pressure
  • Mood alteration
  • Postural hypotension
  • Constipation
  • Nausea and vomiting
  • Dizziness
  • Sedation
  • Dependence and withdrawal symptoms

Interactions

  • Increased risk of respiratory depression with other central nervous system depressants (e.g., benzodiazepines, alcohol)
  • Increased sedation when combined with sedative antihistamines
  • Potentially increased effects when used with other opioids
  • Caution advised when used with other medications that can cause hypotension

Precautions

  • Use with caution in patients with hepatic impairment
  • Use with caution in patients with renal impairment
  • Monitor for signs of respiratory depression, especially in opioid-naïve patients
  • Caution in elderly patients or those with debilitation
  • Assess risk of abuse and dependence

Pregnancy

Dihydrocodeine should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Chronic use during pregnancy may lead to neonatal withdrawal syndrome.

Breast-feeding

Therapeutic doses are unlikely to affect the infant; however, there is a risk of withdrawal symptoms in infants of dependent mothers. Breastfeeding is not the best method of treating dependence in offspring.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Oral suspension
  • Oral solution
  • Tablets
  • Powder for solution for injection
BNF 85 (British National Formulary) p.513 BNF for Children 2019-2020 p.307 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: dihydrocodeine

PubChem CID 5284543

Molecular formula: C18H23NO3

Mechanism of action

Dihydrocodeine is metabolized to dihydromorphine -- a highly active metabolite with a high affinity for mu opioid receptors. [3]

Pharmacodynamics

Possible opioid related side effects include, but are not limited to, drowsiness, nausea, headache, dry mouth, constipation, difficulty passing urine, and mild euphoria.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.