Each tablet contains: Dihydrocodeine Tartrate 30 mg.
Pharmacology: Pharmacodynamics: The action of dihydrocodeine tartrate is almost purely analgesic. It is virtually free from sedative or hypnotic effects.
30mg given parenterally has been shown to have an analgesic potency equivalent to that of 10mg of morphine; in a study of oral analgesics for the relief of chronic pain, the same dose was found to be equivalent to 100mg of pethidine. In both trials, dihydrocodeine was found to have a lower incidence of side effects than either morphine or pethidine. It is fully active when administered orally and in the recommended doses, causes little or no respiratory depression; in addition to being a potent analgesic, the compound also exhibits well-defined antitussive activity.
Pharmacokinetics: The pharmacokinetics of dihydrocodeine may be similar to those of codeine.
There have been few pharmacokinetic studies of dihydrocodeine. In one study peak plasma concentrations of dihydrocodeine were achieved 1.6 to 1.8 hours after an oral dose of 30 and 60mg, respectively; elimination half-lives varied between about 3.5 and 4.5 hours. The rate of absorption was independent of dose and oral bioavailability was only about 20%, possibly because of substantial first-pass metabolism in the gut wall or liver.
For the relief of moderate to severe pain.
Oral administration with or after food.
Adults: 1 tablet (30mg) every 4-6 hours or at the discretion of the physician.
Children 4-12 years: 0.5-1 mg/kg body weight every 4-6 hours.
It is not recommended for administration to children below 4 years.
Toxicity from dihydrocodeine is typical of opiates and includes pinpoint pupils, respiratory depression, and loss of consciousness. Convulsions, cardiovascular collapse and death may occur.
Conservative management is recommended; gastric lavage should be carried out. Severe respiratory depression can be treated with naloxone HCl 0.4 - 2mg subcutaneously, repeated as required at 2 or 3 min intervals.
Respiratory depression; obstructive airways disease.
As dihydrocodeine may bring about histamine-release effects, it should not be given during an attack of asthma and it should be administered with due care to patient liable to such attacks.
Dosage should be reduced in elderly, in hypothyroidism, in chronic hepatic disease and in renal insufficiency. Alcohol should be avoided whilst under treatment with dihydrocodeine. There is no or inadequate evidence of safety in human pregnancy but dihydrocodeine has been used for many years without apparent ill consequence.
Dihydrocodeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
Serotonin Syndrome with Concomitant Use of Serotonergic Drugs: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concurrent use of Suncodin Tablet with serotonergic drugs (See Interactions). This may occur within the recommended dosage range.
Serotonin syndrome symptoms may include mental-status changes (e.g. agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) and can be fatal (See Interactions). The onset of symptoms generally occurs within several hours to a few days of concomitant use, but may occur later than that. Discontinue Suncodin Tablet if serotonin syndrome is suspected.
Adrenal Insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, decreased appetite, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement dosing of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.
Sexual Function/Reproduction: Long term use of opioids may be associated with decreased sex hormone levels and symptoms such as low libido, erectile dysfunction, or infertility (See Postmarketing Experience under Adverse Reactions).
Risks from Concomitant Use with Benzodiazepines: Profound sedation, respiratory depression, coma, and death may result from the concomitant use of Suncodin Tablet with benzodiazepines. Observational studies have demonstrated that concomitant use of opioids and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
If the decision is made to newly prescribe a benzodiazepine and an opioid together, prescribe the lowest effective dosages and minimum durations of concomitant use.
If the decision is made to prescribe a benzodiazepine in a patient already receiving an opioid, prescribe a lower initial dose of the benzodiazepine than indicated in the absence of an opioid, and titrate based on clinical response.
If the decision is made to prescribe an opioid in a patient already taking a benzodiazepine, prescribe a lower initial dose of the opioid, and titrate based on clinical response.
Follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when Suncodin Tablet is used with benzodiazepines. Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of benzodiazepines (See Interactions).
Animal reproduction studies have not been conducted with dihydrocodeine. It is also not known whether dihydrocodeine can cause fetal harm when administered to pregnant women or can affect reproduction capacity in males and females.
Dihydrocodeine should be given to a pregnant woman only if clearly needed.
Because of the potential for serious adverse reactions in nursing infants from dihydrocodeine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Postmarketing Experience: Serotonin syndrome: (See Precautions).
Adrenal insufficiency: (See Precautions).
Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids. Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date. Patients presenting with symptoms of androgen deficiency should undergo laboratory evaluation.
Infertility: Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible.
Serotonergic Drugs: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Suncodin Tablet if serotonin syndrome is suspected. Examples of serotonergic drugs are selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g. mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) (See Precautions).
Benzodiazepines: Due to additive pharmacologic effect, the concomitant use of opioids with benzodiazepines increases the risk of respiratory depression, profound sedation, coma and death.
The concomitant use of opioids and benzodiazepines increases the risk of respiratory depression because of actions at different receptor sites in the central nervous system that control respiration. Opioids interact primarily at μ-receptors, and benzodiazepines interact at GABAA sites. When opioids and benzodiazepines are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists.
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate (see Precautions). Limit dosage and duration of concomitant use of benzodiazepines and opioids, and follow patients closely for respiratory depression and sedation.
Store below 30°C.
Shelf-Life: 3 years.
N02AA08 - dihydrocodeine ; Belongs to the class of natural opium alkaloids. Used to relieve pain.
Suncodin tab 30 mg
10 × 10's;100 × 10's;50 × 10's
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