Ethylpapaverine may be available in the countries listed below.
Ethaverine hydrochloride (a derivative of Ethaverine) is reported as an ingredient of Ethylpapaverine in the following countries:
International Drug Name Search
Uropan may be available in the countries listed below.
Oxybutynin hydrochloride (a derivative of Oxybutynin) is reported as an ingredient of Uropan in the following countries:
International Drug Name Search
Carbamazépine Mylan LP may be available in the countries listed below.
Carbamazepine is reported as an ingredient of Carbamazépine Mylan LP in the following countries:
International Drug Name Search
Salofalk 1g Suppositories
Each suppository contains 1 g mesalazine.
For a full list of excipients, see section 6.1
Suppositories
Appearance: light beige coloured, torpedo-shaped suppositories
Treatment of acute mild to moderate ulcerative colitis that is limited to the rectum (ulcerative proctitis).
Adults and elderly:
One Salofalk 1g Suppository once daily (equivalent to 1g mesalazine daily) inserted into the rectum.
Children
There is little experience and only limited documentation for an effect in children.
General instructions for use:
Salofalk 1g Suppositories should be administered preferably at bedtime.
Treatment with Salofalk 1g Suppositories must be administered regularly and consistently, because only in this way can healing be successfully achieved.
The duration of use is determined by the physician.
Salofalk 1g Suppositories are contraindicated in patients with:
- known hypersensitivity to salicylates or the excipient
- severe impairment of hepatic or renal function
Blood tests (differential blood count; liver function tests such as ALT or AST; serum creatinine) and dip-stick urinalysis should be determined prior to and during treatment, at the discretion of the treating physician. As a guideline, further testing is recommended 14 days after commencement of treatment, then a further two to three times at intervals of 4 weeks.
If the findings are normal, further testing should be carried out every 3 months. If additional symptoms occur, tests should be performed immediately.
Caution is recommended in patients with impaired hepatic function.
Salofalk 1g Suppositories are not recommended in patients with impaired renal function. Mesalazine-induced renal toxicity should be considered if renal function deteriorates during treatment.
Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment with Salofalk 1g Suppositories.
Patients with a history of adverse drug reactions to preparations containing sulphasalazine should be kept under close medical surveillance on commencement of a course of treatment with Salofalk 1g Suppositories. Should Salofalk 1g Suppositories cause acute intolerability reactions such as cramps, acute abdominal pain, fever, severe headache and rash, therapy should be discontinued immediately.
Specific interaction studies have not been performed.
Interactions may occur during treatment with Salofalk 1g Suppositories and concomitant administration of the following medicinal products. Most of these possible interactions are based on theoretical reasons:
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In patients who are concomitantly treated with azathioprine or 6-mercaptopurine, possible enhanced myelosuppressive effects of azathioprine or 6-mercaptopurine should be taken into account.
There are no adequate data from the use of Salofalk 1g Suppositories in pregnant women. However, data on a limited number of exposed pregnancies indicate no adverse effect of mesalazine on pregnancy or on the health of the fetus/newborn child. To date no other relevant epidemiologic data are available. In one single case after long-term use of a high dose mesalazine (2-4 g, orally) during pregnancy, renal failure in a neonate was reported.
Animal studies on oral mesalazine do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.
Salofalk 1g Suppositories should only be used during pregnancy if the potential benefit outweighs the possible risk.
N-acetyl-5-aminosalicylic acid and to a lesser degree mesalazine are excreted in breast milk. Only limited experience during lactation in women is available to date. Hypersensitivity reactions like diarrhea can not be excluded. Therefore, Salofalk 1g Suppositories should only be used during breast-feeding if the potential benefit outweighs the possible risk. If the suckling neonate develops diarrhea, the breast-feeding should be discontinued.
No effects on ability to drive and use machines have been observed
In clinical studies involving 248 participants, approximately 3% experienced adverse reactions while receiving Salofalk 1g Suppositories. The most commonly reported ADRs were headache, in approximately 0.8%, and gastrointestinal side effects (constipation in approximately 0.8%; nausea, vomiting and abdominal pain in 0.4% each).
The following side effects have been reported with the use of mesalazine:
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No cases of intoxication have been reported to date and no specific antidotes are known.
If necessary, intravenous infusion of electrolytes (forced diuresis) should be considered in cases of overdose.
Pharmacotherapeutic group: Aminosalicylic acid and similar agents
ATC code: A07EC02
The mechanism of the anti-inflammatory action is unknown. The results of in vitro studies indicate that inhibition of lipoxygenase may play a role.
Effects on prostaglandin concentrations in the intestinal mucosa have also been demonstrated. Mesalazine (5-Aminosalicylic acid / 5-ASA) may also function as a radical scavenger of reactive oxygen compounds.
On reaching the intestinal lumen, rectally administered mesalazine has largely local effects on the intestinal mucosa and submucosal tissue.
Clinical efficacy and safety of Salofalk® 1 g suppositories was evaluated in a multicentre phase III study, which included 403 patients with endoscopically and histologically confirmed mild to moderately active ulcerative proctitis. The mean disease activity index (DAI) at base line was 6.2 ± 1.5 (range: 3 – 10). Patients were randomised to treatment with one Salofalk® 1 g suppository (1 g OD group) or 3 suppositories containing 0.5 g mesalazine (0.5 g TID group per day for 6 weeks. The primary efficacy variable was clinical remission defined as DAI < 4 at the final visit or withdrawal. At the final per protocol analysis, 87.9% of the patients in the 1 g OD group and 90.7% of the 0.5 g TID group were in clinical remission (Intention-to-treat analysis: 1 g OD group: 84.0%; 0.5 g TID group: 84.7%). The mean change in DAI from baseline was -4.7 in both treatment groups. No drug-related serious AEs occurred.
General considerations of mesalazine:
Absorption:
Mesalazine absorption is highest in proximal gut regions and lowest in distal gut areas.
Biotransformation:
Mesalazine is metabolised both pre-systemically by the intestinal mucosa and in the liver to the pharmacologically inactive N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA). The acetylation seems to be independent of the acetylator phenotype of the patient. Some acetylation also occurs through the action of colonic bacteria. Protein binding of mesalazine and N-Ac-5-ASA is 43% and 78%, respectively.
Elimination:
Mesalazine and its metabolite N-Ac-5-ASA are eliminated via the faeces (major part), renally (varies between 20 and 50 %, dependent on kind of application, pharmaceutical preparation and route of mesalazine release, respectively), and biliary (minor part). Renal excretion predominantly occurs as N-Ac-5-ASA. About 1 % of total orally administered mesalazine dose is excreted into the breast milk mainly as N-Ac-5-ASA.
Salofalk 1g suppositories specific:
Distribution:
Scintigraphic studies with a similar medicinal product, technetium-labelled mesalazine 500mg suppositories showed peak spread of the suppository that had melted due to body temperature after 2 – 3 hours. The spread was limited primarily to the rectum and rectosigmoid junction. It is assumed that Salofalk 1g suppositories act very similar and thus are particularly suitable for treating proctitis (ulcerative colitis of the rectum).
Absorption:
In healthy subjects mean peak plasma concentrations of 5-ASA after a single rectal dose of 1g mesalazine (Salofalk 1 g Suppository) were 192 ± 125 ng/ml (range 19 – 557 ng/ml), those of the main metabolite N-Ac-5-ASA were 402 ± 211 ng/ml (range 57 – 1070 ng/ml). Time to reach the peak plasma concentration of 5-ASA was 7.1 ± 4.9 h (range 0.3 – 24 h).
Elimination:
In healthy subjects, after a single rectal dose of 1g mesalazine (Salofalk 1g Suppository) approx. 14 % of the administered 5-ASA dose were recovered in the urine during 48 hours.
With the exception of a local tolerance study in dogs, which demonstrated good rectal tolerance, no preclinical studies have been performed with Salofalk 1g Suppositories.
Preclinical data on mesalazine reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, carcinogenicity (rat) or toxicity to reproduction.
Kidney toxicity (renal papillary necrosis and epithelial damage in the proximal convoluted tubule or the whole nephron) has been seen in repeat-dose toxicity studies with high oral doses of mesalazine. The clinical relevance of this finding is unknown.
Hard fat
Not applicable.
3 years
Store in the original container in order to protect contents from light.
Do not store above 25°C.
Container (strip): PVC/polyethylene film
Package sizes: 10, 12, 15, 20, 30, 60, 90
Not all package sizes may be marketed.
Any unused product or waste material should be disposed of in accordance with local requirements.
Dr. Falk Pharma GmbH
Leinenweberstr. 5
79108 Freiburg
Germany
Tel: +49 (0)761 1514-0
PL 08637/0018; PA573/4/4
17 May 2010
17 May 2010
In some countries, this medicine may only be approved for veterinary use.
Rec.INN
0481658-94-0
C40-H33-F3-N4-O3
674
Antiobesity agent
N-{(1S)-2-[Benzyl(methyl)amino]-2-oxo-1-phenylethyl}-1-methyl-5-[4'-(trifluoromethyl)biphenyl-2-carboxamido]-1H-indol-2-carboxamide (WHO)
1H-Indole-2-carboxamide, 1-methyl-N-[(1S)-2-[methyl(phenylmethyl)amino]-2-oxo-1-phenylethyl]-5-[[[4'-(trifluoromethyl)[1,1'-biphenyl]-2-yl]carbonyl]amino]- (USAN)
1-Methyl-5-[(4'-trifluormethylbiphenyl-2-carbonyl)amino]-1H-indol-2-carbonsäure-[(S)-(benzylmethylcarbamoyl)phenylmethyl]amid (IUPAC)
5-[4'-(Trifluoromethylbiphenyl-2-carbonyl)amino]-1H-indole-2-carboxylic acid benzylmethyl carbamoylamide
International Drug Name Search
Glossary
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
| WHO | World Health Organization |
Salicylic Acid Ointment BP
Salicylic acid BP 2.0% w/w
Ointment.
For the treatment of hyperkeratotic and scaling conditions such as psoriasis.
Topical.
Recommended dose and dosage schedule
Adults, children and the elderly: apply twice daily to the affected area.
Contraindicated in patients displaying salicylate hypersensitivity, or sensitivity to any other ingredient in the preparation.
For external use only.
Avoid contact with broken or inflamed skin.
Salicylate toxicity may occur if applied to large areas of skin or to the skin of neonates.
There are no known interactions when used as indicated. However, topical salicylic acid may increase the absorption of other topically applied medicines. Concomitant use of Salicylic Acid Ointment BP and other topical medicines on the same area of skin should therefore be avoided.
Whilst there are no known contra-indications to the use of Salicylic Acid Ointment BP during pregnancy and lactation, the safety has not been established. Salicylic Acid Ointment BP should therefore be used with caution or following professional advice.
None likely.
Possible sensitivity reactions, drying and irritation.
Symptoms of systemic salicylate poisoning (tinnitus, dizziness and deafness) have been reported after the application of salicylic acid to large areas of skin and for prolonged periods. Salicylism may also occur in the unlikely event of large quantities being ingested. Salicylism is unlikely to occur if Salicylic Acid Ointment BP is used as indicated.
Salicylate poisoning is usually associated with plasma concentrations >350mg/L (2.5mmol/L). Most adult deaths occur in patients whose concentrations exceed 700mg/L (5.1mmol/L). Single doses less than 100mg/kg are unlikely to cause serious poisoning.
Symptoms
Common features include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree of acid-base disturbance is present in most cases.
A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of four years. In children aged four years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Acidosis may increase salicylate transfer across the blood brain barrier.
Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopaenia, increased INR/PTR, intravascular coagulation, renal failure and non-cardiac pulmonary oedema.
Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children.
Management
Give activated charcoal if an adult presents within one hour of ingestion of more than 250 mg/kg. The plasma salicylate concentration should be measured, although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. Elimination is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate. The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema.
Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations >700 mg/L (5.1 mmol/L), or lower concentrations associated with severe clinical or metabolic features. Patients under ten years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.
Salicylic acid has a keratolytic action.
Salicylic acid may be percutaneously absorbed. However, there is no evidence of any systemic absorption from the use of Salicylic Acid Ointment BP.
No other information relevant to the prescriber other than that already stated in other sections of the SPC.
White petroleum jelly BP, hard paraffin BP, wool alcohols BP, liquid paraffin BP.
None known.
36 months unopened.
Store below 25°C.
700ml securitub polypropylene white with cap.
No special requirements.
Thornton & Ross Ltd.
Huddersfield
HD7 5QH
England.
PL 00240/6616R
22/11/85 / 30/01/2004
20/01/2011
Generic Name: carbinoxamine, dextromethorphan, and pseudoephedrine (kar bi NOX a meen/dex troe meh THOR fan/soo doe eh FEH drin)
Brand Names: Andehist DM NR, Carb PSE 12 DM, Carbaxef-DM, Carbodex DM, Carbofed DM Drops, Cordron-12 DM, Cordron-DM NR, Mintex DM, Pediatex 12 DM, Pediatex-DM, PSE Allergy DM, PSE Carb DM Drops, PSE Carbinoxamine DM, Pseudo Carb DM
Carbinoxamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Dextromethorphan is a cough suppressant. It suppresses an area in the brain that causes coughing.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of carbinoxamine, dextromethorphan, and pseudoephedrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.
Carbinoxamine, dextromethorphan, and pseudoephedrine may also be used for other purposes not listed in this medication guide.
Call your doctor if you have a fever, or if your symptoms get worse or do not improve after taking this medicine for 7 days.
Do not take this product for cough caused by smoking, asthma, or emphysema. Do not take this medicine if your cough produces a lot of mucus, unless your doctor has told you to.
Before taking this medication, tell your doctor if you are allergic to carbinoxamine, dextromethorphan, or pseudoephedrine, or if you have:
diabetes;
glaucoma;
heart disease or high blood pressure;
thyroid disease;
a stomach ulcer or a stomach obstruction,
emphysema or chronic bronchitis; or
an enlarged prostate or urination problems.
If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.
Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Cold medicine is usually taken only for a short time until your symptoms clear up.
Measure the liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.
Call your doctor if you have a fever, or if your symptoms get worse or do not improve after taking this medicine for 7 days.
Since cough and cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include extreme drowsiness, confusion, feeling restless or nervous, blurred vision, dry mouth, nausea, vomiting, restlessness, hallucinations, fainting, and seizure (convulsions).
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.
feeling light-headed, fainting;
urinating less than usual or not at all;
wheezing, tightness in your chest;
severe dizziness, anxiety, restless feeling, or nervousness;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).
Less serious side effects may include:
drowsiness, dizziness;
lack of coordination;
upset stomach;
stuffy nose, chest congestion;
sleep problems (insomnia);
feeling restless or excited (especially in children);
dry mouth or nose; or
blurred vision.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
Before taking carbinoxamine, dextromethorphan, and pseudoephedrine, tell your doctor if you are using any of the following drugs:
a diuretic (water pill), or blood pressure medicine;
medication to treat irritable bowel syndrome;
bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);
aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);
a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or
antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.
This list is not complete and there may be other drugs that can interact with carbinoxamine, dextromethorphan, and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
See also: Pediatex-DM side effects (in more detail)
