Finlepsin may be available in the countries listed below.
Carbamazepine is reported as an ingredient of Finlepsin in the following countries:
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Fluracil may be available in the countries listed below.
Fluorouracil is reported as an ingredient of Fluracil in the following countries:
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Fluoxone may be available in the countries listed below.
Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Fluoxone in the following countries:
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Ufexil may be available in the countries listed below.
Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Ufexil in the following countries:
Ciprofloxacin lactate (a derivative of Ciprofloxacin) is reported as an ingredient of Ufexil in the following countries:
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Aprecap may be available in the countries listed below.
Aprepitant is reported as an ingredient of Aprecap in the following countries:
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Fluoxetina Kern Pharma may be available in the countries listed below.
Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Fluoxetina Kern Pharma in the following countries:
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Rec.INN
M01AX04
0013539-59-8
C16-H20-N4-O2
300
Analgesic, antipyretic and anti-inflammatory agent
Non-steroidal anti-inflammatory drug, NSAID
1H-Pyrazolo[1,2-a][1,2,4]benzotriazine-1,3(2H)-dione, 5-(dimethylamino)-9-methyl-2-propyl-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Tosufloxacin Tosilate may be available in the countries listed below.
Tosufloxacin Tosilate (JAN) is also known as Tosufloxacin (Rec.INN)
International Drug Name Search
Glossary
| JAN | Japanese Accepted Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Flogovital N.F. may be available in the countries listed below.
Nimesulide is reported as an ingredient of Flogovital N.F. in the following countries:
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Flurbiprofen Sodium may be available in the countries listed below.
Flurbiprofen Sodium (BANM) is known as Flurbiprofen in the US.
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Glossary
| BANM | British Approved Name (Modified) |
F-Din may be available in the countries listed below.
Mometasone 17-(2-furoate) (a derivative of Mometasone) is reported as an ingredient of F-Din in the following countries:
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Fenilefrina ALM may be available in the countries listed below.
Phenylephrine hydrochloride (a derivative of Phenylephrine) is reported as an ingredient of Fenilefrina ALM in the following countries:
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Debenal may be available in the countries listed below.
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Debenal in the following countries:
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Duclazide may be available in the countries listed below.
Gliclazide is reported as an ingredient of Duclazide in the following countries:
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DHC® Continus® prolonged release tablets 60 mg, 90 mg, 120 mg.
Dihydrocodeine tartrate 60 mg, 90 mg, 120 mg.
Prolonged release tablet.
White capsule shaped tablets, 60 mg are marked DHC 60, 90 mg are marked DHC 90 and 120 mg are marked DHC 120.
For the relief of severe pain in cancer and other chronic conditions.
Adults and children over 12 years: 60 mg - 120 mg every 12 hours.
Elderly: Dosage should be reduced.
Children 12 years or under: Not recommended.
Method of administration
Oral.
Hypersensitivity to dihydrocodeine or any of the tablet constituents; respiratory depression; obstructive airways disease; paralytic ileus; head injury; raised intracranial pressure; acute alcoholism. As dihydrocodeine may cause the release of histamine, it should not be given during an asthma attack and should be given with caution to asthmatics.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Dosage should be reduced in the elderly, in hypothyroidism, chronic hepatic disease and renal insufficiency.
Dihydrocodeine should be administered with caution to patients with a history of opioid abuse, biliary tract disorders, prostatic hypertrophy, pancreatitis, constipation, obstructive bowel disorder and severe cor pulmonale.
Dihydrocodeine has a recognised abuse and addiction profile similar to other opioids. Tolerance to analgesic effects may develop upon repeated administration.
The risk-benefit of continued use should be assessed regularly by the prescriber, and in particular the prescriber should take care to avoid any unnecessary increase in dosage especially where there is evidence of a previous history of drug dependence or abuse.
DHC Continus tablets must be swallowed whole, and not broken, chewed or crushed. The administration of broken, chewed or crushed tablets may lead to a rapid release and absorption of a potential overdose of dihydrocodeine (see Section 4.9).
Other central nervous system depressants, including sedatives or hypnotics, phenothiazines, other tranquillisers and alcohol, may result in respiratory depression or sedation. Dihydrocodeine should be used with caution in patients taking monoamine oxidase inhibitors or within two weeks of such therapy.
There is little published evidence on safety in human pregnancy but dihydrocodeine has been used for many years without apparent ill effects. Dihydrocodeine has not been reported to be excreted in breast milk. However, it is advisable that dihydrocodeine only be administered to breast-feeding mothers if considered essential.
Dihydrocodeine may cause drowsiness and, if affected, patients should not drive or operate machinery.
Common adverse drug reactions seen during therapy are constipation, nausea, vomiting, headache, somnolence, pruritus and rash.
Uncommon adverse reactions are urinary retention, ureteric or biliary spasm, dry mouth, mood changes, blurred vision, sweating, decreased libido, flushing, abdominal pain, hypotension, paraesthesia, confusion, dizziness, hallucinations, urticaria, paralytic ileus and respiratory depression.
Dependence may occur. Regular prolonged use of dihydrocodeine is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is stopped.
Prolonged use of a painkiller for headaches can make them worse.
Acute overdosage with dihydrocodeine can be manifested by somnolence progressing to stupor or coma, miotic pupils, rhabdomyolysis, non-cardiac pulmonary oedema, bradycardia, hypotension and respiratory depression or apnoea.
Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation.
In the case of massive overdosage, administer naloxone intravenously (0.4 to 2 mg for an adult and 0.01 mg/kg body weight for children) if the patient is in a coma or respiratory depression is present. Repeat the dose at 2 minute intervals if there is no response, or by an infusion. An infusion of 60% of the initial dose per hour is a useful starting point. A solution of 10 mg made up in 50 ml dextrose will produce 200 micrograms/ml for infusion using an IV pump (dose adjusted to the clinical response). Infusions are not a substitute for frequent review of the patient's clinical state. Intramuscular naloxone is an alternative in the event that IV access is not possible.
As the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established. Naloxone is a competitive antagonist and large doses (4 mg) may be required in seriously poisoned patients. For less severe overdosage, administer naloxone 0.2 mg intravenously followed by increments of 0.1 mg every 2 minutes if required.
Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to dihydrocodeine overdosage. Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on dihydrocodeine. In such cases, an abrupt or complete reversal of opioid effects may precipitate pain and an acute withdrawal syndrome.
Additional/other considerations:
• Consider activated charcoal (50 g for adults, 10-15 g for children), if a substantial amount has been ingested within 1 hour, provided the airway can be protected. It may be reasonable to assume that late administration of activated charcoal may be beneficial for prolonged release preparations but there is no evidence to support this.
•DHC Continus tablets will continue to release and add to the dihydrocodeine load for up to 12 hours after administration and the management of overdosage should be modified accordingly. Gastric contents may therefore need to be emptied, as this can be useful in removing unabsorbed drug, particularly when a prolonged release formulation has been taken.
Dihydrocodeine is a semisynthetic narcotic analgesic with a potency between morphine and codeine. It acts on opioid receptors in the brain to reduce the patient's perception of pain and improve the psychological reaction to pain by reducing the associated anxiety.
Dihydrocodeine is well absorbed from the gastrointestinal tract following administration of DHC Continus tablets and plasma levels are maintained throughout the twelve hour dosing interval.
Like other phenanthrene derivatives, dihydrocodeine is mainly metabolised in the liver with the resultant metabolites being excreted mainly in the urine. Metabolism of dihydrocodeine includes o-demethylation, n-demethylation and 6-keto reduction.
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
Lactose (anhydrous)
Hydroxyethylcellulose
Cetostearyl alcohol
Magnesium stearate
Purified talc
Purified water
None known.
Three years.
Do not store above 25°C.
Polypropylene containers with polyethylene lids (56 tablets)
None stated.
Napp Pharmaceuticals Limited
Cambridge Science Park
Milton Road
Cambridge
CB4 0GW
PL 16950/0019 - 0021
|
|
|
|
February 2007
POM
® The Napp device, DHC and DHC CONTINUS are Registered Trade Marks
© Napp Pharmaceuticals Ltd 2007.
Fluvoxaminemaleaat PCH may be available in the countries listed below.
Fluvoxamine maleate (a derivative of Fluvoxamine) is reported as an ingredient of Fluvoxaminemaleaat PCH in the following countries:
International Drug Name Search
Lorazepam MK may be available in the countries listed below.
Lorazepam is reported as an ingredient of Lorazepam MK in the following countries:
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Ketoplus may be available in the countries listed below.
Ketoprofen is reported as an ingredient of Ketoplus in the following countries:
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Perioxidin may be available in the countries listed below.
Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Perioxidin in the following countries:
International Drug Name Search
Generic Name: benzocaine (Oral route, Oromucosal route)
BEN-zoe-kane
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Anesthetic, Local
Chemical Class: Amino Ester
Benzocaine lozenges are used to relieve pain and irritation caused by sore throat, sore mouth, or canker sores.
This medicine is available without a prescription; however, your doctor may have special instructions on the proper use and dose for your medical problem.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
No information is available on the relationship of age to the effects of benzocaine lozenges in the pediatric population. Safety and efficacy have not been established in children below 5 years of age.
No information is available on the relationship of age to the effects of benzocaine in geriatric patients.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain benzocaine. It may not be specific to Baby Orajel. Please read with care.
Use this medicine exactly as directed by your doctor. Do not use more of this medicine, do not use it more often, and do not use it for a longer time than directed. To do so may increase the chance of absorption into the body and the risk of side effects.
This medicine should be used only for problems being treated by your doctor or conditions listed in the package directions. Check with your doctor before using it for other problems, especially if you think that an infection may be present.
Do not use this medicine for more than 2 days without checking first with your doctor.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
If your condition does not improve within 7 days, or if it becomes worse, check with your doctor.
Call your doctor right away if you start to have a severe sore throat or sore throat that occurs with a high fever, headache, nausea, or vomiting. These maybe signs of an infection.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Baby Orajel side effects (in more detail)
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