Ticlopidine Sandoz may be available in the countries listed below.
Ticlopidine hydrochloride (a derivative of Ticlopidine) is reported as an ingredient of Ticlopidine Sandoz in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
USP
0000077-27-0
C12-H18-N2-O2-S
254
Anesthetic, injectable
5-Allyl-5-(1-methylbutyl)-2-thiobarbituric acid (USAN)
5-Allyl-5-(1-methylbutyl)-2-thiobarbitursäure (IUPAC)
5-Allyl-5-(1-methylbutyl)-2-thioxohexahydro-pyrimidine-4,6-dione
Dihydro-5-(1-methylbutyl)-5-(2-propenyl)-2-thioxo-4,6-(1H,5H)-pyrimidine-dione (USAN)
International Drug Name Search
Glossary
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| USAN | United States Adopted Name |
| USP | Pharmacopoeia of the United States |
Relieving runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.
Brompheniramine/Guaifenesin/Hydrocodone Liquid is an antihistamine, cough suppressant, and expectorant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex, which reduces a dry cough. The expectorant works by thinning mucus (phlegm) in the lungs and making it less sticky and easier to cough up. This reduces chest congestion by making coughs more productive.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Brompheniramine/Guaifenesin/Hydrocodone Liquid. 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 Brompheniramine/Guaifenesin/Hydrocodone Liquid. 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 Brompheniramine/Guaifenesin/Hydrocodone Liquid 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 Brompheniramine/Guaifenesin/Hydrocodone Liquid 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 Brompheniramine/Guaifenesin/Hydrocodone Liquid.
When used for long periods of time or at high doses, Brompheniramine/Guaifenesin/Hydrocodone Liquid may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Brompheniramine/Guaifenesin/Hydrocodone Liquid stops working well. Do not take more than prescribed.
When used for long periods of time or at high doses, some people develop a need to continue taking Brompheniramine/Guaifenesin/Hydrocodone Liquid. This is known as DEPENDENCE or addiction.
If you suddenly stop taking Brompheniramine/Guaifenesin/Hydrocodone Liquid, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; trouble sleeping.
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:
Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; trouble sleeping; 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: Brompheniramine/Guaifenesin/Hydrocodone 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.
Store Brompheniramine/Guaifenesin/Hydrocodone Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Brompheniramine/Guaifenesin/Hydrocodone Liquid out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Brompheniramine/Guaifenesin/Hydrocodone Liquid. 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.
Nifedipine is reported as an ingredient of Nifedical in the following countries:
International Drug Name Search
Ryzolt is a brand name of tramadol, approved by the FDA in the following formulation(s):
A generic version of Ryzolt has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Ryzolt and have been approved by the FDA:
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ryzolt. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Generic Name: Pimozide
Class: Antipsychotics, Miscellaneous
VA Class: CN709
Chemical Name: 1-(1-(4,4-bis(4-fluorophenyl)butyl)-4-piperidinyl)-1,3-dihydro-2H-benzimidazole-2-one
Molecular Formula: C28H29F2N3O
CAS Number: 2062-78-4
Special Alerts:
[Posted 02/22/2011] ISSUE: FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.
The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.
BACKGROUND: Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.
RECOMMENDATION: Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment. For more information visit the FDA website at: and .
[Posted 06/16/2008] FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNINGS section. For more information visit the FDA website at: , and .
Antipsychotic agent; diphenylbutylpiperidine-derivative.1 2 3 4 5
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Suppression of motor and vocal tics of Tourette’s syndrome (Gilles de la Tourette’s syndrome) in adults and children who have failed to respond adequately to, or who do not tolerate, conventional therapy (e.g., haloperidol).1 2 8 48 49 50 51 52 53 54 57 159 172 (See Pediatric Use under Cautions.)
Not intended as a treatment of first choice, nor is it intended for suppression of tics that are only annoying or cosmetically troublesome.1 2 8
Reserve for use in patients whose development and/or daily life function is severely compromised by the presence of motor and vocal tics.1 2
Has been used concomitantly with a stimulant in children with tic disorders (e.g., Tourette’s syndrome) and comorbid attention deficit hyperactivity disorder (ADHD)† in whom stimulants alone cannot control tics.171
Has been used for the symptomatic management of a variety of psychiatric illnesses†,58 59 60 61 62 63 64 65 66 67 68 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 principally schizophrenia†,58 59 60 61 62 63 64 65 66 67 68 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 but other agents generally are preferred.69 70
Perform ECG before initiation of therapy and periodically thereafter, particularly during periods of dosage adjustment.1 2 (See Cardiovascular Effects under Cautions.)
Administer orally,1 2 usually once daily;152 153 also may administer in divided doses, particularly if once-daily dosing is not well tolerated.1 152
Some clinicians recommend administration as a single dose at bedtime to minimize adverse effects.153
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Initiate therapy with low dosage and adjust dosage gradually.1 2 159
Children <12 years of age†: Reliable dose-response data for drug effects on tic manifestations not available.1 2
Children ≥12 years of age: Initially, 0.05 mg/kg daily, preferably at bedtime.1 May increase dosage every third day to a maximum of 0.2 mg/kg daily, not to exceed 10 mg daily.1 167
During prolonged maintenance therapy, use lowest possible effective dosage.1 2 Once adequate response is achieved, make periodic attempts (e.g., every 6–12 months) to reduce dosage to determine whether initial intensity and frequency of tics persist.1 2
In attempts to reduce dosage, consider possibility that observed increases of tic intensity and frequency may represent a transient, withdrawal-related phenomenon rather than return of the syndrome’s symptoms.1 2 Allow 1–2 weeks to elapse before concluding that an increase in tic manifestations is a function of the underlying disorder rather than a response to drug withdrawal.1 2
If therapy is to be discontinued, gradually reduce dosage.1 2
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Initially, 1–2 mg daily in divided doses.1 2 159 164 May increase dosage every other day according to patient’s tolerance and therapeutic response.1 2 165 Some clinicians suggest that dosage be increased at longer intervals (e.g., every 5–7 days) until manifestations decrease by ≥70%, adverse effects occur without symptomatic benefit, or symptomatic benefit and adverse effects occur simultaneously.153 164
If minimal adverse effects occur (e.g., not interfering with functioning) before adequate response is achieved, hold further dosage increase until adverse effects resolve.164 If adverse effects interfere with functioning but are not severe, can reduce dosage by 1-mg increments at weekly intervals until such effects resolve.164
If severe adverse effects occur, immediately reduce dosage by 50% or withhold drug.1 2 164 Once serious adverse effects resolve, can reinstitute with more gradual titration, increasing dosage at intervals ranging from 7–30 days.164
Most patients are adequately treated with dosages <0.2 mg/kg daily or 10 mg daily, whichever is less; higher dosages not recommended.1 2
During prolonged maintenance therapy, use lowest possible effective dosage.1 2 Once adequate response is achieved, make periodic attempts (e.g., every 6–12 months) to reduce dosage to determine whether initial intensity and frequency of tics persist.1 2
In attempts to reduce dosage, consider possibility that observed increases of tic intensity and frequency may represent a transient, withdrawal-related phenomenon rather than return of the syndrome’s symptoms.1 2 Allow 1–2 weeks to elapse before concluding that an increase in tic manifestations is a function of the underlying disorder rather than a response to drug withdrawal.1 2
If therapy is to be discontinued, gradually reduce dosage.1 2
Children ≥12 years of age: Maximum 0.2 mg/kg, not exceeding 10 mg daily.1
Dosages >0.2 mg/kg or 10 mg daily not recommended.1
Simple tics or tics other than those associated with Tourette’s syndrome.1
Concurrent therapy with drugs that cause motor and vocal tics (e.g., amphetamines, methylphenidate, pemoline [no longer commercially available in the US]) until such drugs have been withdrawn to determine whether tics were caused by the drug rather than Tourette’s syndrome.1
Congenital long QT syndrome, history of cardiac arrhythmias, concomitant therapy with other drugs that prolong QT interval, or known hypokalemia or hypomagnesemia.1 202 (See Cardiovascular Effects under Cautions.)
Concomitant therapy with drugs that inhibit CYP3A4 or drugs that prolong the QT interval (e.g., azole antifungals, macrolide antibiotics, protease inhibitors, SSRIs [citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline], nefazodone, zileuton).1 200 205 206 207 208 209 210 211 (See Interactions.)
Severe toxic CNS depression or comatose states from any cause.1
Hypersensitivity to pimozide;1 use caution in patients who have demonstrated hypersensitivity to other antipsychotic drugs.1
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Tardive dyskinesia, a syndrome of potentially irreversible, involuntary, dyskinetic movements, may develop in patients receiving antipsychotic agents, including pimozide.1 2 3 71 92 94 96 Consider discontinuance.1
May occur during long-term administration or following discontinuance.1 2 3 71
Neuroleptic malignant syndrome (NMS), a potentially fatal syndrome requiring immediate discontinuance of the drug and intensive symptomatic treatment, has been reported with antipsychotic agents, including pimozide.1 2 146
Hyperpyrexia not associated with NMS also reported with antipsychotic agents.1
Sudden, unexpected deaths have occurred in some patients receiving high doses (>10 mg; in the range of 1 mg/kg) for conditions other than Tourette’s syndrome or in patients receiving concomitant pimozide and clarithromycin.1 168 170 Possibly due to QT interval prolongation, predisposing patients to ventricular arrhythmia.1 2
Various ECG changes (e.g., QT [including QTc] interval prolongation; flattening, notching, and inversion of the T wave; appearance of U waves) have occurred.1 2 164 165 202
Perform ECG evaluations before and periodically during therapy, especially during periods of dosage adjustment.1 2 202
Some clinicians recommend consultation with a cardiologist before therapy initiation in patients with a baseline QTc interval >440 ms.164
Consider stopping further dosage increases and dosage reduction for QTc interval prolongation >470 ms in children or 520 ms in adults or >25% beyond patient’s pretreatment value, or development of other T-wave abnormalities.1 2 164 Also consider dosage reduction if bradycardia (<50 bpm) occurs.164
Some clinicians recommend withholding drug if T-wave inversion, U waves, or cardiac arrhythmia occurs and reinstituting only after ECG findings are normal.164
Use with caution in patients with cardiovascular disorders.3 164 165
Because hypokalemia has been associated with ventricular arrhythmias, correct potassium insufficiency because of diuretics, diarrhea, or other causes before pimozide initiation; maintain normal serum potassium concentrations during therapy.1 2
Dose-related increase in benign pituitary tumors observed in female mice; clinical importance is not known.1 2 Carefully consider tumorigenic potential in decision to use drug, especially if patient is young and long-term therapy is anticipated.1 2
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Possible risk of seizures;1 2 3 140 141 167 may lower seizure threshold.1 Use with caution in patients with history of seizures or EEG abnormalities or in those receiving anticonvulsants.1 Maintain adequate anticonvulsant therapy.1
Possible impairment of ability to perform activities requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle), especially during first few days of therapy.1
Extrapyramidal symptoms occur frequently;1 2 3 9 40 50 52 58 59 60 68 71 73 78 81 85 87 88 90 92 93 94 96 97 99 100 102 104 122 145 especially during first few days of therapy.1 2 52 122 In most patients, reactions consist of parkinsonian symptoms1 2 4 68 71 78 81 92 94 99 100 102 159 that are mild to moderate in severity and usually reversible following discontinuance.1 2
Causes adverse anticholinergic effects; use with caution in individuals whose condition may be aggravated by such effects.1
Possible transient dyskinetic signs after abrupt withdrawal in some patients receiving maintenance therapy; in some cases, dyskinetic movements are indistinguishable from tardive dyskinesia except for duration.1 2 Not known whether gradual withdrawal will reduce occurrence; pending further evidence, withdraw gradually.1 2
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Category C.1
Not known whether pimozide is distributed into human milk; discontinue nursing or the drug.1
Onset of Tourette’s syndrome usually occurs between ages of 2 and 15 years, but data on use and efficacy in children <12 years of age are limited.1 2 Limited clinical evidence suggests that safety profile in children 2–12 years of age generally is comparable to that in older patients.1
Safety and efficacy for management of other conditions in children not evaluated; use in children for any condition other than Tourette’s syndrome not recommended.1 2
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Prevalence of tardive dyskinesia appears to be highest among geriatric patients, particularly geriatric women.1 2 3 59
Transient hypotension for several hours after administration has occurred in some geriatric or debilitated patients.3
Use with caution.1
Use with caution.1
Extrapyramidal reactions (e.g., pseudoparkinsonism, dystonia, dyskinesia, akathisia), dry mouth, drowsiness, sedation, adverse behavior effect, asthenia, somnolence.1
Metabolized by CYP3A41 and, to a lesser extent, by CYP1A2.1 168 170
Potential pharmacokinetic interaction (decreased metabolism) with inhibitors of CYP3A41 200 or CYP1A2.1
Prolongation of QT interval and, rarely, serious cardiovascular effects, including ventricular arrhythmias and death, reported in patients receiving CYP3A4 inhibitors and pimozide concomitantly;1 168 170 concomitant use contraindicated.1 (See Specific Drugs and Foods under Interactions.)
Potential pharmacologic interaction (additive effect on QT interval prolongation; concomitant use contraindicated) when used with drugs that prolong QTc interval.1 200 207 208 209 (See Contraindications and Cardiovascular Effects under Cautions and also Specific Drugs and Foods under Interactions.)
Drug or Food | Interaction | Comments |
|---|---|---|
Antiarrhythmic agents (e.g., dofetilide, quinidine, sotalol, other class IA and III antiarrhythmics)1 | Additive effects on prolongation of QT interval1 | Concomitant use contraindicated1 |
Antidepressants, tricyclics | Additive effects on prolongation of QT interval1 | Concomitant use not recommended1 |
Antidepressants, SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) | Decreased pimozide metabolism; increased risk of prolongation of QT interval1 200 201 204 205 206 207 208 209 210 211 | Concomitant use contraindicated1 200 205 206 207 208 209 210 211 |
Antifungals, azole (e.g., itraconazole, ketoconazole, voriconazole) | Decreased pimozide metabolism; increased risk of prolongation of QT interval1 | Concomitant use contraindicated1 |
Aprepitant | Increased plasma pimozide concentrations; potential for serious or life-threatening reaction | Concomitant use contraindicated |
Arsenic trioxide | Additive effects on prolongation of QT interval1 | Concomitant use contraindicated1 |
CNS agents (e.g., opiates or other analgesics, barbiturates or other sedatives, anxiolytics, alcohol) | Additive CNS effects or potentiated action of CNS depressant1 2 4 146 151 | Use concomitantly with caution to avoid excessive CNS depression1 2 |
Delavirdine | Potential for serious or life-threatening reactions (e.g., cardiac arrhythmias) | Concomitant use contraindicated |
Dolasetron | Additive effects on prolongation of QT interval1 | Concomitant use contraindicated1 |
Droperidol | Additive effects on prolongation of QT interval1 | Concomitant use contraindicated1 |
Fluoroquinolones (e.g., gatifloxacin, moxifloxacin, sparfloxacin) | Additive effects on prolongation of QT interval1 | Concomitant use contraindicated1 |
Grapefruit juice | Decreased pimozide metabolism1 | Avoid grapefruit juice during therapy1 |
Halofantrine (licensed in the US but not commercially available) | Additive effects on prolongation of QT interval1 | Concomitant use contraindicated1 |
HIV protease inhibitors (e.g., amprenavir [no longer commercially available in the US], atazanavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir) | Decreased pimozide metabolism; increased risk of prolongation of QT interval1 | Concomitant use contraindicated1 |
Imatinib | Increased pimozide concentrations | Use with caution because pimozide has a narrow therapeutic window |
Levomethadyl acetate (no longer commercially available in the US) | Additive effects on prolongation of QT interval1 | Concomitant use contraindicated1 |
Macrolides (e.g., azithromycin, clarithromycin, dirithromycin, erythromycin, troleandomycin) | Decreased pimozide metabolism; increased risk of prolongation of QT interval and ventricular arrhythmias1 Sudden death reported in at least 2 patients when clarithromycin added to ongoing pimozide therapy1 | Concomitant use contraindicated1 |
Mefloquine | Additive effects on prolongation of QT interval1 | Concomitant use contraindicated1 |
Nefazodone | Decreased pimozide metabolism; increased risk of prolongation of QT interval1 | Concomitant use contraindicated1 |
Pentamidine | Additive effects on prolongation of QT interval1 | Concomitant use contraindicated1 |
Phenothiazines (e.g., chlorpromazine, mesoridazine [no longer commercially available in US], thioridazine1 ) | Additive effects on prolongation of QT interval1 | Concomitant use contraindicated1 |
Probucol (no longer commercially available in the US) | Additive effects on prolongation of QT interval1 | Concomitant use contraindicated1 |
Tacrolimus | Additive effects on prolongation of QT interval1 | Concomitant use contraindicated1 |
Zileuton | Decreased pimozide metabolism; increased risk of prolongation of QT interval1 | Concomitant use contraindicated1 |
Ziprasidone | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Slowly1 2 4 39 40 and variably absorbed1 2 4 39 after oral administration, with peak plasma concentrations of the drug1 2 4 39 40 and its metabolites39 attained within 6–8 hours (range: 4–12 hours).1 2 4 39 40
Appears to be at least 40–50% absorbed.1 2 4 39
Effects of food on pharmacokinetics are not known.1
Effects of disease on pharmacokinetics are not known.1
Distribution into human body tissues and fluids not well characterized.152 153 In animals, widely distributed after sub-Q administration, with highest concentrations attained in the liver,2 4 43 44 lungs,43 44 kidneys,43 44 and heart;43 44 also distributed into the brain,2 4 42 43 44 45 thymus,43 adrenals,43 thyroid,43 uterus,43 ovaries,43 and bile.46
Not known whether crosses placenta or is distributed into milk.1 2
Extent of binding to plasma proteins is not known.152
Appears to undergo extensive first-pass metabolism.1 39
Metabolized principally via oxidative N-dealkylation in the liver, catalyzed by CYP3A4 and, to a lesser extent, by CYP1A2.1 168 170 Pharmacologic activity of metabolites not determined,1 2 4 but results of animal studies suggest metabolites are inactive.4 37 45
Excreted principally in urine1 2 4 39 (about 40%39 ) almost completely as metabolites,4 39 and, to a lesser extent, in feces (about 15%) mainly as unchanged drug.39
Not known if drug and/or its metabolites are removed by hemodialysis or peritoneal dialysis.152
Approximately 55 hours after multiple oral doses in patients with chronic schizophrenic disorder.1 2 40
In patients with hepatic impairment, metabolism may be impaired.1
In patients with renal impairment, elimination may be decreased.1
Tight, light-resistant containers1 2 at 25°C (may be exposed to 15–30°C).1
Principal pharmacologic effects are similar to those of haloperidol2 4 6 and, to a lesser extent, those of phenothiazines.1 2 4 6 10
Precise mechanism(s) of action in suppressing motor and vocal tics in patients with Tourette’s syndrome1 2 10 11 and its antipsychotic action4 15 17 19 20 not determined, but may be related principally to antidopaminergic effects.1 2 4 10 11 12 15 17 19 20 Appears to be a selective dopamine-2 (D2) receptor antagonist.10 21 156
Appears to have little effect on catecholamines other than dopamine,2 13 24 although turnover of brain norepinephrine may be increased at high doses.3 13
Like other antipsychotic agents, has various effects on CNS receptor systems (e.g., γ-aminobutyric acid [GABA]),42 which are not fully characterized.1 42
Exhibits some anticholinergic activity,1 2 3 4 9 50 62 78 93 136 although generally considered to be relatively weak compared with most other antipsychotic agents.4
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Importance of taking medication exactly as prescribed by the clinician;1 necessity of ECG monitoring before and during therapy.1
Importance of avoiding driving, operating machinery, or performing hazardous tasks until gain experience with the drug’s effects.1
Importance of clinicians informing patients in whom chronic use is contemplated of risk of tardive dyskinesia, taking into account clinical circumstances and competency of patient to understand information provided.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription or OTC drugs, dietary supplements, and herbal products, as well as any concomitant illnesses (e.g., cardiovascular).1 Importance of avoiding grapefruit juice.1 170
Importance of avoiding alcohol during therapy.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 1 mg | Orap (scored) | Gate |
2 mg | Orap (scored) | Gate |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Orap 1MG Tablets (GATE): 60/$75.99 or 180/$209.97
Orap 2MG Tablets (GATE): 60/$99.99 or 180/$269.97
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 15, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
Panoral may be available in the countries listed below.
Cefaclor monohydrate (a derivative of Cefaclor) is reported as an ingredient of Panoral in the following countries:
International Drug Name Search
Bersol may be available in the countries listed below.
Clobetasol 17α-propionate (a derivative of Clobetasol) is reported as an ingredient of Bersol in the following countries:
International Drug Name Search
Toraseptol may be available in the countries listed below.
Azithromycin dihydrate (a derivative of Azithromycin) is reported as an ingredient of Toraseptol in the following countries:
International Drug Name Search
In the US, Neurontin (gabapentin systemic) is a member of the drug class gamma-aminobutyric acid analogs and is used to treat Alcohol Withdrawal, Anxiety, Benign Essential Tremor, Bipolar Disorder, Burning Mouth Syndrome, Diabetic Nerve Damage, Epilepsy, Fibromyalgia, Hiccups, Hot Flashes, Hyperhidrosis, Insomnia, Migraine, Nausea/Vomiting - Chemotherapy Induced, Pain, Periodic Limb Movement Disorder, Peripheral Neuropathy, Persisting Pain - Shingles, Postmenopausal Symptoms, Pruritus, Reflex Sympathetic Dystrophy Syndrome, Restless Legs Syndrome, Trigeminal Neuralgia and Vulvodynia.
US matches:
UK matches:
Gabapentin is reported as an ingredient of Neurontin in the following countries:
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Treating swelling, itching, redness, and irritation of the eyes and eyelids. It may also be used in the ear canal to treat inflammation of the outer ear. It may also be used to treat other conditions as determined by your doctor.
Dexasol Drops are a corticosteroid. It works by decreasing inflammation, which helps to relieve symptoms such as redness, swelling, itching, warmth, and pain.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Dexasol Drops. 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 Dexasol Drops. Because little, if any, of Dexasol Drops are absorbed into the blood, the risk of it interacting with another medicine is low.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Dexasol Drops 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 Dexasol Drops 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 Dexasol Drops.
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:
Blurring of vision; increased pressure in the eye.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); cataracts; changes in vision; continued or worsening itching or swelling; continuing blurred vision; discharge from eyes; eye pain; glaucoma; vision problems.
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: Dexasol 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. Dexasol Drops may be harmful if swallowed.
Store Dexasol Drops tightly closed at room temperature between 59 and 86 degrees F (15 and 30 degrees C) away from heat, moisture, and light. Do not store in the bathroom. Keep Dexasol Drops out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Dexasol Drops. 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.
Skinderm A may be available in the countries listed below.
Retinol is reported as an ingredient of Skinderm A in the following countries:
International Drug Name Search
Myoplège may be available in the countries listed below.
Thiocolchicoside is reported as an ingredient of Myoplège in the following countries:
International Drug Name Search
Tocopherol Acetate may be available in the countries listed below.
Tocopherol Acetate (JAN) is also known as Tocopherol, α- (Ph. Eur.)
International Drug Name Search
Glossary
| JAN | Japanese Accepted Name |
| Ph. Eur. | European Pharmacopoeia |
Maxius may be available in the countries listed below.
Tibezonium Iodide is reported as an ingredient of Maxius in the following countries:
International Drug Name Search
Fluoxemed may be available in the countries listed below.
Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Fluoxemed in the following countries:
International Drug Name Search
Amlomark may be available in the countries listed below.
Amlodipine is reported as an ingredient of Amlomark in the following countries:
International Drug Name Search
