Metomide may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Metoclopramide hydrochloride (a derivative of Metoclopramide) is reported as an ingredient of Metomide in the following countries:
International Drug Name Search
Bleomicina Dosa may be available in the countries listed below.
Bleomycin is reported as an ingredient of Bleomicina Dosa in the following countries:
International Drug Name Search
OpticromTM Aqueous Eye Drops
Sodium cromoglicate 2.0% w/v.
A clear colourless to pale yellow solution for administration to the eye.
For the prophylaxis and symptomatic treatment of acute allergic conjunctivitis, chronic allergic conjunctivitis and vernal kerato conjunctivitis.
Adults and children: one or two drops into each eye four times daily or as indicated by the doctor.
Elderly: no current evidence for alteration of the dose.
Route of administration: topical ophthalmic.
The product is contraindicated in patients who have shown hypersensitivity to Sodium cromoglicate, Benzalkonium chloride or Disodium edetate.
Discard any remaining contents four weeks after opening the bottle.
As with other ophthalmic solutions containing Benzalkonium chloride, soft contact lenses should not be worn during treatment period.
None known.
As with all medication, caution should be exercised especially during the first trimester of pregnancy. Cumulative experience with Sodium cromoglicate suggests that it has no adverse effects on foetal development. It should be used in pregnancy only where there is a clear clinical need.
It is not known whether Sodium cromoglicate is excreted in human breast milk but, on the basis of its physicochemical properties, this is considered unlikely. There is no information to suggest the use of Sodium cromoglicate has any undesirable effects on the baby.
As with all eye drops, instillation of Opticrom may cause a transient blurring of vision.
Transient stinging and burning may occur after instillation. Other symptoms of local irritation have been reported rarely.
No action other than medical observation should be necessary.
In vitro and in vivo animal studies have shown that Sodium cromoglicate inhibits the degranulation of sensitised mast cells which occurs after exposure to specific antigens. Sodium cromoglicate acts by inhibiting the release of histamine and various membrane derived mediators from the mast cell.
Sodium cromoglicate has demonstrated the activity in vitro to inhibit the degranulation of non-sensitised rat mast cells by phospholipase A and subsequent release of chemical mediators. Sodium cromoglicate did not inhibit the enzymatic activity of released phospholipase A on its specific substrate.
Sodium cromoglicate has no intrinsic vasoconstrictor or antihistamine activity.
Sodium cromoglicate is poorly absorbed. When multiple doses of Sodium cromoglicate ophthalmic solution are instilled into normal rabbit eyes, less than 0.07% of the administered dose of Sodium cromoglicate is absorbed into the systemic circulation (presumably by way of the eye, nasal passages, buccal cavity and gastrointestinal tract). Trace amounts (less than 0.01%) of the sodium cromoglicate does penetrate into the aqueous humour and clearance from this chamber is virtually complete within 24 hours after treatment is stopped.
In normal volunteers, analysis of drug excretion indicates that approximately 0.03% of Sodium cromoglicate is absorbed following administration to the eye.
None stated.
Benzalkonium chloride, Disodium edetate, Purified water.
None known.
3 years.
The eye drops should be used within 4 weeks of opening the container. Any remaining after this time should be discarded.
Store below 30oC.
Protect from direct sunlight.
Low density polyethylene bottle and plug with a polypropylene cap with a shrink type security seat containing 13.5 ml.
None.
Sanofi-aventis
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
PL 04425/0324
28 February 2003
December 2006
POM
Broomhexine may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Bromhexine hydrochloride (a derivative of Bromhexine) is reported as an ingredient of Broomhexine in the following countries:
International Drug Name Search
Treating nausea and vomiting caused by cancer and chemotherapy in certain patients. It is also used to treat loss of appetite resulting in weight loss in patients who have AIDS. It may also be used for other conditions as determined by your doctor.
Dronabinol is a cannabinoid. It works by affecting the action of certain chemicals in the brain.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Dronabinol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Dronabinol. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Dronabinol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Dronabinol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Dronabinol.
Some people who use Dronabinol for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Dronabinol suddenly, you may have WITHDRAWAL symptoms. These may include hiccups, "hot flashes," loose stools, loss of appetite, runny nose, and sweating.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Confusion; decreased coordination; dizziness; drowsiness; elevated or relaxed mood; headache; nausea; stomach pain; trouble concentrating; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; behavioral changes; fast or irregular heartbeat; hallucinations; memory problems; mental or mood changes (eg, feelings of anxiety, depression, detachment, panic, paranoia); seizures; severe or persistent dizziness; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Dronabinol side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased bowel movements; decreased coordination; difficulty urinating; distorted sense of time; dizziness; drowsiness; dry mouth; fainting; fast heartbeat; lightheadedness; memory changes; mental or mood changes; panic; reddened eyes; seizures; sluggishness; slurred speech.
Store Dronabinol in a cool place between 46 and 59 degrees F (8 and 15 degrees C). Dronabinol may also be stored in a refrigerator. DO NOT FREEZE. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dronabinol out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Dronabinol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Ondemet 4mg Tablets
Ondemet 4 mg
Each film-coated tablet contains 4 mg ondansetron (as hydrochloride dihydrate).
Excipients:
Each film-coated tablet contains 84.50 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
Film coated tablet
4 mg: pale yellow, round biconvex, film-coated tablet embossed with 41 on one side, diameter 7.2 mm.
Ondansetron is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention of post-operative nausea and vomiting (PONV).
Oral use
For the different dosage regimens appropriate strengths and formulations are available.
Chemotherapy and radiotherapy induced nausea and vomiting
Adults
The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The route of administration and dose of Ondansetron should be flexible and selected as shown below.
Emetogenic chemotherapy and radiotherapy
For patients receiving emetogenic chemotherapy or radiotherapy ondansetron can be given either by oral or intravenous administration.
For most patients receiving emetogenic chemotherapy or radiotherapy, ondansetron should initially be administered intravenously immediately before treatment, followed by 8 mg orally twelve hourly.
For oral administration: 8 mg 1-2 hours before treatment, followed by 8 mg 12 hours later.
To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with ondansetron should be continued for up to 5 days after a course of treatment. The recommended dose for oral administration is 8 mg twice daily.
Highly emetogenic chemotherapy
For patients receiving highly emetogenic chemotherapy, e.g. high-dose cisplatin, ondansetron can be given by intravenous administration.
To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with ondansetron should be continued for up to 5 days after a course of treatment. The recommended dose for oral administration is 8 mg twice daily.
Children (aged 2 years and over) and adolescents (< 18 years)
Experience in paediatric patients is limited. In children older than two years, ondansetron may be administered as a single intravenous dose of 5 mg/m2 over 15 minutes immediately before chemotherapy, followed by 4 mg orally twelve hours later. Oral treatment with a dose according to the body area should be continued for up to 5 days after a course of treatment. Children with a total body area between 0.6 and 1.2 m2 should receive a dosage schedule of 4 mg 3 times a day, while children with a body area above 1.2 m2 should receive 8 mg 3 times a day.
There is no experience in children younger than 2 years old.
Ondansetron film-coated tablets cannot be used in children with a total body surface below 0.6 m2.
Elderly
Ondansetron is well tolerated by patients over 65 years and no alteration of dosage, dosing frequency or route of administration are required.
Please refer also to ”Special populations”.
Post-operative nausea and vomiting (PONV)
Adults
Prevention of PONV
For the prevention of PONV ondansetron can be administered orally or by intravenous injection.
For oral administration:
16 mg one hour prior to anaesthesia.
Alternatively, 8 mg one hour prior to anaesthesia followed by two further doses of 8 mg at eight hourly intervals.
Treatment of established PONV
For the treatment of established PONV intravenous administration is recommended.
Children (aged 2 years and over) and adolescents (< 18 years)
For the prevention and treatment of PONV slow intravenous injection is recommended.
Elderly
There is limited experience in the use of ondansetron in the prevention and treatment of post-operative nausea and vomiting (PONV) in the elderly, however ondansetron is well tolerated in patients over 65 years receiving chemotherapy.
Please refer also to ”Special populations”.
Special populations
Patients with renal impairment
No alteration of daily dosage or frequency of dosing, or route of administration are required.
Patients with hepatic impairment
Clearance of Ondansetron is significantly reduced and serum half life significantly prolonged in subjects with moderate or severe impairment of hepatic function. In such patients a total daily dose of 8 mg should not be exceeded.
Patients with poor sparteine/debrisoquine metabolism
The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers of sparteine and debrisoquine. Consequently in such patients, repeat dosing will give medicinal product exposure levels no different from those of the general population. No alteration of daily dosage or frequency of dosing are required.
Hypersensitivity to ondansetron or to other selective 5-HT3-receptor antagonists (e.g. granisetron, dolasetron) or to any of the excipients.
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.
Very rarely and predominantly with intravenous ondansetron, transient ECG changes including QT interval prolongation have been reported. Therefore caution should be exercised in patients with cardiac rhythm or conduction disturbances, in patients treated with anti-arrhythmic agents or beta-adrenergic blocking agents and in patients with significant electrolyte disturbances.
As ondansetron is known to increase large bowel transit time, patients with signs of subacute intestinal obstruction should be monitored following administration.
In patients with adenotonsillar surgery prevention of nausea and vomiting with ondansetron may mask occult bleeding. Therefore, such patients should be followed carefully after ondansetron.
Since there is little experience to date of the use of ondansetron in cardiac patients, caution should be exercised if ondansetron is coadministered with anaesthetics to patients with arrhythmias or cardiac conduction disorders or to patients who are being treated with antiarrhythmic agents or beta-blockers.
Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Ondansetron film-coated tablets should not be used in children with a total body surface below 0.6 m2.
The medicinal product should not be used for children younger than two years, as for these patients the experience is limited.
There is no evidence that ondansetron either induces or inhibits the metabolism of other medicinal products commonly coadministered with it. Specific studies have shown that ondansetron does not interact with alcohol, temazepam, furosemide, alfentanil, propofol and thiopental.
Ondansetron is metabolised by multiple hepatic cytochrome P-450 enzymes: CYP3A4, CYP2D6 and CYP1A2. Due to the multiplicity of metabolic enzymes capable of metabolising ondansetron, enzyme inhibition or reduced activity of one enzyme (e.g. CYP2D6 genetic deficiency) is normally compensated by other enzymes and should result in little or no significant change in overall ondansetron clearance or dose requirement.
Phenytoin, Carbamazepine and Rifampicin: In patients treated with potent inducers of CYP3A4 (i.e. phenytoin, carbamazepine, and rifampicin), the oral clearance of ondansetron was increased and ondansetron blood concentrations were decreased.
Tramadol: Data from small studies indicate that ondansetron may reduce the analgesic effect of tramadol.
Pregnancy
Use in pregnancy has not been established and is not recommended.
To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. If it is absolutely necessary that Ondansetron be given caution should be exercised when prescribing to pregnant women especially in the first trimester. A careful risk/benefit assessment should be performed.
Lactation
Tests have shown that ondansetron passes into the milk of lactating animals (see section 5.3). It is therefore recommended that mothers receiving ondansetron should not breast-feed their babies.
Ondansetron has no or negligible influence on the ability to drive and use machines.
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (
The following frequencies are estimated at the standard recommended doses of ondansetron according to indication and formulation.
Immune system disorders
Rare: Immediate hypersensitivity reactions sometimes severe, including anaphylaxis.
Nervous system disorders
Very common: Headache.
Uncommon: Extrapyramidal reactions (such as oculogyric crisis/dystonic reactions) have been observed without definitive evidence of persistent clinical sequelae; seizures.
Eye disorders
Rare: Transient visual disturbances (eg. blurred vision) predominantly during rapid intravenous administration.
Very rare: transient blindness predominantly during intravenous administration.
The majority of the blindness cases reported resolved within 20 minutes. Most patients had received chemotherapeutic agents, which included cisplatin. Some cases of transient blindness were reported as cortical in origin.
Cardiac disorders
Uncommon: Arrhythmias, chest pain with or without ST segment depression, bradycardia.
Very rare: Transient ECG changes including QT interval prolongation.
Vascular disorders
Common: Sensation of warmth or flushing.
Uncommon: Hypotension.
Respiratory, thoracic and mediastinal disorders
Uncommon: Hiccups.
Gastrointestinal disorders
Common: Constipation. Local burning sensation following insertion of suppositories.
Hepatobiliary disorders
Uncommon: Asymptomatic increases in liver function tests.
These events were observed commonly in patients receiving chemotherapy with cisplatin.
Little is known at present about overdosage with ondansetron, however, a limited number of patients received overdoses. Manifestations that have been reported include visual disturbances, severe constipation, hypotension and a vasovagal episode with transient second degree AV block. In all instances, the events resolved completely. There is no specific antidote for ondansetron, therefore in all cases of suspected overdose, symptomatic and supportive therapy should be given as appropriate.
Pharmacotherapeutic group: Antiemetics and antinauseants, Serotonin (5-HT3) antagonists
ATC Code: A04AA01
Ondansetron is a potent, highly selective 5-HT3 receptor-antagonist.
Its precise antiemetic and antinauseal mechanism of action is not known. Chemotherapeutic agents and radiotherapy may cause release of 5-HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5-HT3 receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5-HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5-HT3 receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.
In a pharmaco-psychological study in volunteers ondansetron has not shown a sedative effect.
Ondansetron does not alter plasma prolactin concentrations.
The role of ondansetron in opiate-induced emesis is not yet established.
Following oral administration, ondansetron is passively and completely absorbed from the gastrointestinal tract and undergoes first pass metabolism (bioavailability is about 60%). Peak plasma concentrations of about 30 ng/ml are attained approximately 1.5 hours after an 8 mg dose. For doses above 8 mg the increase in ondansetron systemic exposure with dose is greater than proportional; this may reflect some reduction in first pass metabolism at higher oral doses. Bioavailability, following oral administration, is slightly enhanced by the presence of food but unaffected by antacids. Studies in healthy elderly volunteers have shown slight, but clinically insignificant, age-related increases in both oral bioavailability (65%) and half-life (5 hours) of ondansetron. Gender differences were shown in the disposition of ondansetron, with females having a greater rate and extent of absorption following an oral dose and reduced systemic clearance and volume of distribution (adjusted for weight).
The disposition of ondansetron following oral, intramuscular(IM) and intravenous(IV) dosing is similar with a terminal half life of about 3 hours and steady state volume of distribution of about 140 L. Equivalent systemic exposure is achieved after IM and IV administration of ondansetron.
The protein binding of ondansetron is 70-76%. A direct effect of plasma concentration and anti-emetic effect has not been established. Ondansetron is cleared from the systemic circulation predominantly by hepatic metabolism through multiple enzymatic pathways. Less than 5% of the absorbed dose is excreted unchanged in the urine. The absence of the enzyme CYP2D6 has no effect on ondansetron's pharmacokinetics. The pharmacokinetic properties of ondansetron are unchanged on repeat dosing.
Following oral, intravenous or intramuscular dosing in patients with severe hepatic impairment, ondansetron's systemic clearance is markedly reduced with prolonged elimination half-lives (15-32 h) and an oral bioavailability approaching 100% due to reduced pre-systemic metabolism.
Preclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Ondansetron and its metabolites accumulate in the milk of rats, milk/plasma-ratio was 5.2.1.
A study in cloned human cardiac ion channels has shown ondansetron has the potential to affect cardiac repolarisation via blockade of HERG potassium channels. The clinical relevance of this finding is uncertain.
Tablet core:
Cellulose, microcrystalline
Lactose monohydrate
Starch, pregelatinised (maize)
Magnesium stearate
Film coating:
Hypromellose
Hydroxypropylcellulose
Propylene glycol
Sorbitan oleate
Sorbic acid
Vanillin
Titanium dioxide (E171)
Quinoline yellow (E 104).
Not applicable.
3 years.
This medicinal product does not require any special storage precautions.
Blister (PVC/Al)
4 mg: 6, 10, 30, 50 and 100 film coated tablets.
Not all pack sizes may be marketed.
No special requirements.
Beacon Pharmaceuticals Ltd
The Regent
The Broadway
Crowborough
East Sussex
TN6 1DA
UK
PL 18157/0016
08/06/2009
08/06/2009
In the US, Anusol (hydrocortisone topical) is a member of the drug class anorectal preparations and is used to treat Hemorrhoids.
US matches:
Bismuth Subgallate is reported as an ingredient of Anusol in the following countries:
Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Anusol in the following countries:
Zinc Oxide is reported as an ingredient of Anusol in the following countries:
Zinc Sulfate is reported as an ingredient of Anusol in the following countries:
International Drug Name Search
