Dihydrocodeine Tablets Bp 30mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dihydrocodeine Tablets BP 30 mg.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg Dihydrocodeine Tartrate BP.
For excipients, see 6.1.
3. PHARMACEUTICAL FORM
Tablet.
Round N/C 8.5 mm diameter tablet, marked “DH” breakline “30” on one side and “G” on the reverse.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Dihydrocodeine Tablets are indicated for the relief of moderate to severe pain.
4.2. Posology and Method of Administration
For oral administration.
Adults and Children over 12 years: 30 mg every 4-6 hours, with or after food, up to 60 mg may be given if necessary.
Dosage should be reduced in the elderly.
Children: 0.5-1.0 mg/kg bodyweight every 4-6 hours. This medicine should not be used for children under 4 years.
Contra-Indications
4.3
Respiratory depression; obstructive airways disease.
4.4 Special warnings and precautions for use
As Dihydrocodeine may bring about histamine-release, Dihydrocodeine should not be given during an attack of asthma and it should be administered with due care to persons liable to such attacks.
Dosage should be reduced in the elderly and debilitated patients, in chronic hepatic disease, renal insufficiency and hypothyroidism. Opioid analgesics should be avoided in patients with raised intra cranial pressure or head injury. Alcohol should be avoided whilst under treatment with Dihydrocodeine.
In patients already habituated to a drug such as Pethidine, the substitution of Dihydrocodeine in equi-analgesic doses has led to the appearance of abstinence symptoms. This suggests that low addiction potential. Nevertheless, when Dihydrocodeine is prescribed for chronic use the physician should take care to avoid any unnecessary increase in dosage especially where there is a previous history of drug dependence or abuse.
4.5 Interaction with other medicinal products and other forms of interaction
Metoclopramide - antagonism, opposite effects on gastro intestinal activity. Mexiletine - delayed absorption
Hypnotics and sedatives (includes alcohol) - potentiation Monoamine oxidase inhibitors - CNS excitation, hypertension
4.6. Pregnancy and Lactation
The administration of Dihydrocodeine during labour may give rise to respiratory depression in the neonate.
There is no, or inadequate evidence of safety in human pregnancy but the drug has been used for many years without apparent ill consequence. Dihydrocodeine should only be administered to nursing mothers if considered essential.
4.7. Effects on Ability to Drive and Use Machines
Although Dihydrocodeine is an opiate analgesic the occurrence of hypnotic or sedative effects are rare.
4.8. Undesirable Effects
Constipation, nausea, vomiting, headache, urinary retention and vertigo occur and are relatively more common when the dose is increased above 30 mg. Constipation may be treated with a gentle laxative.
4.9. Overdose
It is recommended that gastric lavage should be performed. Naloxone Hydrochloride 0.4 to 2 mg by injection or infusion can be used to treat severe respiratory depression and should be repeated as needed at 2-3 minute intervals, as recommended for treatment of opiates overdose in the naloxone hydrochloride injection data sheet.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Dihydrocodeine Tartrate is a narcotic analgesic.
5.2. Pharmacokinetic Properties
Despite its use as an analgesic for many years there is very little information about its pharmacokinetic parameters.
Dihydrocodeine Tartrate is readily soluble in water (1 in 4.5) and would not be expected to show problems in dissolution and absorption from a conventional release tablet.
Following oral administration it is reported to be rapidly absorbed from the gastrointestinal tract. Peak plasma concentrations occur 1.6 - 1.8 hours after dosing and it has a duration of action of 4 to 5 hours.
The metabolism of Dihydrocodeine is not yet fully determined, but it is believed to undergo similar biotranformation to codeine.
Studies in 7 healthy subjects indicated that the rate of absorption of Dihydrocodeine following oral administration was independent of dose. It was considered likely that the substantially reduced bioavailability observed was due to presystemic metabolism in the gut wall or liver.
The pharmacokinetics of Dihydrocodeine given by mouth differed between subjects with normal renal function and patients with chronic renal failure treated with haemodialysis. It was suggested that the kidney has an important role in the elimination of opioid analgesics.
5.3. Pre-clinical Safety Data
There are no preclinical safety data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Lactose
Microcrystalline Cellulose Sodium Starch Glycollate (Type A)
Magnesium Stearate
6.2. Incompatibilities
None stated.
6.3. Shelf Life
36 months.
6.4. Special Precautions for Storage
Store in a dry place below 25°C. Protect from light.
Nature and Contents of Container
6.5.
Dihydrocodeine Tablets are available in polypropylene containers with polyethylene caps (with optional polyethylene ullage filler), high density polyethylene (HDPE) containers with polyethylene snap closures or PVC aluminium foil blisters.
Pack Size:
Polypropylene containers and HDPE containers:
5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, 112, 120, 168, 180 and 500.
PVC Aluminium foil blisters:
5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, 112, 120, 168 and 180. Not all pack sizes may be marketed.
6.6. Instructions for Use, Handling and Disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Generics [UK] Limited T/A Mylan Station Close Potters Bar Hertfordshire EN6 1TL
8 MARKETING AUTHORISATION NUMBER(S)
PL 04569/0161
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Date MA granted: 20 March 1987 Last renewal granted:29 October 2002
10 DATE OF REVISION OF THE TEXT
25/01/2010