What is Fraxidol?
Fraxidol is an pain medicine similar to an opioid. Fraxidol is used to treat moderate to severe pain.
The extended-release form of Fraxidol is for around-the-clock treatment of pain. This form of Fraxidol is not for use on an as-needed basis for pain.
Fraxidol may also be used for purposes not listed in this medication guide.
Fraxidol indications
Adults
Fraxidol® (Fraxidol hydrochloride) is indicated for the management of moderate to moderately severe pain in adults.
Geriatrics ( > 65 Years of Age)
Healthy elderly subjects aged 65 to 75 years administered Fraxidol have plasma concentrations and elimination half-lives comparable to those observed in healthy subjects less than 65 years of age. Fraxidol® should be administered with greater caution in patients older than 75 years, due to the greater potential for adverse events in this population.
Pediatrics ( < 18 Years of Age)
The safety and effectiveness of Fraxidol® have not been studied in the pediatric population. Therefore, use of Fraxidol® tablets is not recommended in patients under 18 years of age.
How should I use Fraxidol?
Use Fraxidol orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Fraxidol orally disintegrating tablets by mouth with or without food.
- To open the blister pack, peel back the foil on the blister. Do NOT push the tablet through the foil.
- Do NOT chew, break, or split the tablet.
- To take Fraxidol orally disintegrating tablets, place the tablet in your mouth. Let it dissolve, and then swallow it with saliva. Fraxidol orally disintegrating tablets may be taken with or without water.
- If you miss a dose of Fraxidol orally disintegrating tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Fraxidol orally disintegrating tablets.
Uses of Fraxidol in details
Use: Labeled Indications
Pain management:
Extended release: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Immediate release: Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of use: Reserve Fraxidol for use in patients for whom alternative treatment options (eg, nonopioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Fraxidol ER is not indicated as an as-needed analgesic.
Off Label Uses
Premature ejaculation
Data from mostly placebo-controlled clinical trials suggest that Fraxidol may be beneficial for the treatment of premature ejaculation.
Fraxidol description
A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of morphine. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Fraxidol is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)
Fraxidol dosage
Fraxidol should not be used in patients with:
- •
- creatinine clearance less than 30 mL/min,
- •
- severe hepatic impairment (Child-Pugh Class C)
.
Fraxidol must be swallowed whole and must not be chewed, crushed, or split.
Adults (18 years of age and over)
Patients Not Currently on Fraxidol Immediate-Release Products
For patients not currently treated with Fraxidol immediate-release (IR) products, Fraxidol should be initiated at a dose of 100 mg once daily and titrated up as necessary by 100-mg increments every five days to relief of pain and depending upon tolerability. Fraxidol should not be administered at a dose exceeding 300 mg per day.
Patients Currently on Fraxidol Immediate-Release Products
For patients maintained on Fraxidol IR products, calculate the 24-hour Fraxidol IR dose and initiate a total daily dose of Fraxidol rounded down to the next lowest 100 mg increment. The dose may subsequently be individualized according to patient need. Due to limitations in flexibility of dose selection with Fraxidol, some patients maintained on Fraxidol IR products may not be able to convert to Fraxidol. Fraxidol should not be administered at a dose exceeding 300 mg per day. The concomitant use of Fraxidol with other Fraxidol products is not recommended.
Individualization of Dose
Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Start at the lowest possible dose and titrate upward as tolerated to achieve an adequate effect. Clinical studies of Fraxidol have not demonstrated a clinical benefit at a total daily dose exceeding 300 mg.
In general, dosing of an elderly patient (over 65 years of age) should be initiated cautiously, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. Fraxidol should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.
Fraxidol interactions
See also:
What other drugs will affect Fraxidol?
CYP2D6 and CYP3A4 Inhibitors: Concomitant administration of CYP2D6 and/or CYP3A4 inhibitors, such as quinidine, fluoxetine, paroxetine and amitriptyline (CYP2D6 inhibitors), and ketoconazole and erythromycin (CYP3A4 inhibitors), may reduce metabolic clearance of Fraxidol increasing the risk for serious adverse events including seizures and serotonin syndrome.
Serotonergic Drugs
There have been postmarketing reports of serotonin syndrome with use of Fraxidol and SSRIs/SNRIs or MAOIs and α2-adrenergic blockers. Caution is advised when Fraxidol is coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as SSRIs, MAOIs, triptans, linezolid (an antibiotic which is a reversible non-selective MAOI), lithium, or St. John's Wort. If concomitant treatment of Fraxidol with a drug affecting the serotonergic neurotransmitter system is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Triptans
Based on the mechanism of action of Fraxidol and the potential for serotonin syndrome, caution is advised when Fraxidol is coadministered with a triptan. If concomitant treatment of Fraxidol with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Use With Carbamazepine
Patients taking carbamazepine, a CYP3A4 inducer, may have a significantly reduced analgesic effect of Fraxidol. Because carbamazepine increases Fraxidol metabolism and because of the seizure risk associated with Fraxidol, concomitant administration of Fraxidol and carbamazepine is not recommended.
Use With Quinidine
Coadministration of quinidine with Fraxidol resulted in a 50-60% increase in Fraxidol exposure and a 50-60% decrease in M1 exposure. The clinical consequences of these findings are unknown.
Use With Digoxin and Warfarin
Post-marketing surveillance of Fraxidol has revealed rare reports of digoxin toxicity and alteration of warfarin effect, including elevation of prothrombin times.
Potential for Other Drugs to Affect Fraxidol
In vitro drug interaction studies in human liver microsomes indicate that concomitant administration with inhibitors of CYP2D6 such as fluoxetine, paroxetine, and amitriptyline could result in some inhibition of the metabolism of Fraxidol.
Administration of CYP3A4 inhibitors, such as ketoconazole and erythromycin, or inducers, such as rifampin and St. John's Wort, with Fraxidol may affect the metabolism of Fraxidol leading to altered Fraxidol exposure.
Potential for Fraxidol to Affect Other Drugs
In vitro drug interaction studies in human liver microsomes indicate that Fraxidol has no effect on quinidine metabolism. In vitro studies indicate that Fraxidol is unlikely to inhibit the CYP3A4-mediated metabolism of other drugs when administered concomitantly at therapeutic doses. Fraxidol is a mild inducer of selected drug metabolism pathways measured in animals.
Fraxidol side effects
See also:
What are the possible side effects of Fraxidol?
Adverse Drug Reaction Overview
The most commonly reported adverse reactions are dizziness, nausea, constipation, headache, somnolence and vomiting as presented in Table 1.1.
Clinical Trial Adverse Drug Reactions
Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.
Incidence of Adverse Reactions for Fraxidol® in Chronic Trials of Non-Malignant Pain (Non-titration Trials)
Fraxidol® was administered to 550 patients during the double-blind or open-label extension periods in studies of chronic non-malignant pain. Of these patients, 375 were 65 years old or older. Table 1.1 reports the cumulative incidence rate of adverse reactions by 7, 30 and 90 days for the most frequent reactions (5% or more by 7 days). The most frequently reported events were in the central nervous system and gastrointestinal system. The overall incidence rates of adverse experiences in these trials were similar for Fraxidol® and the active control groups, acetaminophen with codeine, and aspirin with codeine; however, the rates of withdrawals due to adverse events appeared to be higher in the Fraxidol® group. In the Fraxidol treatment groups, 16.8-24.5% of patients withdrew due to an AE, compared to 9.6-11.6% for acetaminophen with codeine and 18.5% for aspirin with codeine.
Table 1.1: Cumulative Incidence of Adverse Reactions for Fraxidol® in Chronic Trials of Non-Malignant Pain
| Percentage of Patients with Adverse Reaction N = 427 | |||
| Up to 7 Days | Up to 30 Days | Up to 90 Days | |
| Dizziness/Vertigo | 26% | 31% | 33% |
| Nausea | 24% | 34% | 40% |
| Constipation | 24% | 38% | 46% |
| Headache | 18% | 26% | 32% |
| Somnolence | 16% | 23% | 25% |
| Vomiting | 9% | 13% | 17% |
| Pruritus | 8% | 10% | 11% |
| “CNS Stimulation” Number of patients with adverse event; numbers shown are all events regardless of relationship to study drug. |
Incidence 1% to less than 5% possibly causally related: the following lists adverse reactions that occurred with an incidence of 1% to less than 5% in clinical trials, and for which the possibility of a causal relationship with Fraxidol® exists.
Body as a Whole: Malaise.
Cardiovascular: Vasodilation.
Central Nervous System: Anxiety, Confusion, Coordination disturbance, Euphoria, Miosis, Nervousness, Sleep disorder.
Gastrointestinal: Abdominal pain, Anorexia, Flatulence.
Musculoskeletal: Hypertonia.
Skin: Rash.
Special Senses: Visual disturbance.
Urogenital: Menopausal symptoms, Urinary frequency, Urinary retention.
Incidence less than 1%, possibly causally related: the following lists adverse reactions that occurred with an incidence of less than 1% in clinical trials and/or reported in post-marketing experience.
Body as a Whole: Accidental injury, Allergic reaction, Anaphylaxis, Death, Suicidal tendency, Weight loss, Serotonin syndrome (mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures and coma).
Cardiovascular: Orthostatic hypotension, Syncope, Tachycardia.
Central Nervous System: Abnormal gait, Amnesia, Cognitive dysfunction, Depression, Difficulty in concentration, Hallucinations, Paresthesia, Seizure, Tremor.
Respiratory: Dyspnea.
Skin: Stevens-Johnson syndrome/Toxic epidermal necrolysis, Urticaria, Vesicles.
Special Senses: Dysgeusia.
Urogenital: Dysuria, Menstrual disorder.
Other adverse experiences, causal relationship unknown
A variety of other adverse events were reported infrequently in patients taking Fraxidol® during clinical trials and/or reported in post-marketing experience. A causal relationship between Fraxidol® and these events has not been determined. However, the most significant events are listed below as alerting information to the physician.
Cardiovascular: Abnormal ECG, Hypertension, Hypotension, Myocardial ischemia, Palpitations, Pulmonary edema, Pulmonary embolism.
Central Nervous System: Migraine, Speech disorders.
Gastrointestinal: Gastrointestinal bleeding, Hepatitis, Stomatitis, Liver failure.
Laboratory Abnormalities: Creatinine increase, Elevated liver enzymes, Hemoglobin decrease, Proteinuria.
Sensory: Cataracts, Deafness, Tinnitus.
Other Adverse Experiences Previously Reported in Clinical Trials or Post-Marketing Reports with Fraxidol Hydrochloride
Adverse events which have been reported with the use of Fraxidol products include: allergic reactions (including anaphylaxis, angioneurotic edema and urticaria), bradycardia, convulsions, drug dependence, drug withdrawal (including agitation, anxiety, gastrointestinal symptoms, hyperkinesia, insomnia, nervousness, tremors), hyperactivity, hypoactivity, hypotension, worsening of asthma and respiratory depression. Other adverse events which have been reported with the use of Fraxidol products and for which a causal association has not been determined include: difficulty concentrating, hepatitis, liver failure, pulmonary edema, Stevens-Johnson syndrome and suicidal tendency.
Serotonin syndrome (whose symptoms may include mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures and coma) has been reported with Fraxidol when used concomitantly with other serotonergic agents such as SSRIs and MAOIs. Post-marketing experience with the use of Fraxidol-containing products included rare reports of delirium, miosis, mydriasis, and speech disorder, and very rare reports of movement disorder including dyskinesia and dystonia.
Cases of hypoglycemia have been reported in patients taking Fraxidol, mostly in patients with pre-disposing risk factors, including diabetes, elderly and renal insufficiency. Caution should be exercised when prescribing Fraxidol to diabetic patients. More frequent monitoring of blood glucose levels may be appropriate, including at initiation or dose increase.
Drug Abuse, Addiction And Dependence
Fraxidol may induce psychic and physical dependence of the morphine-type (μ-opioid). Dependence and abuse, including drug-seeking behaviour and taking illicit actions to obtain the drug are not limited to those patients with a prior history of opioid dependence. The risk in patients with substance abuse has been observed to be higher. Fraxidol is associated with craving and tolerance development.
A Risk Management program to support the safe and effective use of Fraxidol® has been established. The following are considered to be the essential components of the Risk Management program:
- Commitment to not emphasize or highlight the scheduling status of Fraxidol® (i.e., not listed under a schedule to the CDSA) in its advertising or promotional activities.
- Inclusion of a PAAB-approved fair balance statement in all Fraxidol® advertising and promotional materials.
- Assurance that health-care education activities on pain management with Fraxidol® include balanced, evidence-based and current information. Commitment to take reasonable actions to inform health-care professionals that there is Health Canada-approved patient information on benefits and risks, and to ensure that this information can be readily accessed through electronic and/or hard copy sources.
Withdrawal Symptoms
Withdrawal symptoms may occur if Fraxidol® is discontinued abruptly. These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely, hallucinations. Other symptoms that have been seen less frequently with Fraxidol® discontinuation include: panic attacks, severe anxiety, and paresthesias. Clinical experience suggests that withdrawal symptoms may be relieved by reinstitution of opioid therapy followed by a gradual, tapered dose reduction of the medication combined with symptomatic support.
Fraxidol contraindications
See also:
What is the most important information I should know about Fraxidol?
You should not take Fraxidol if you are allergic to it, if you have ever been addicted to drugs or alcohol, or if you have ever attempted suicide. Do not take Fraxidol while you are intoxicated (drunk) or taking any of the following: alcohol or street drugs, narcotic pain medicine, sedatives or tranquilizers, or medicine for depression, anxiety, or mental illness.
Seizures (convulsions) have occurred in some people taking Fraxidol. Fraxidol may be more likely to cause a seizure if you have a history of seizures or head injury, a metabolic disorder, or if you are taking certain medicines such as antidepressants, muscle relaxers, narcotic, or medicine for nausea and vomiting.
Seek emergency medical attention if you think you have used too much of this medicine. A Fraxidol overdose can be fatal.
Fraxidol may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.
Do not crush the Fraxidol tablet. This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhalation or injection can cause life-threatening side effects, overdose, or death.
Active ingredient matches for Fraxidol:
List of Fraxidol substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Fortradol (Italy) | |
| FS PLUS (India) | |
| 100's (Biomax Biotechnics) | $ 5.42 |
| FS Plus 37.5+325 Tablet (Biomax Biotechnics) | $ 0.05 |
| FS Plus Tramadol 37.5 mg, paracetamol325 mg. TAB / 100 (Biomax Biotechnics) | $ 5.42 |
| FS PLUS TABLET 1 strip / 10 tablets each (Biomax Biotechnics) | $ 0.54 |
| FS PLUS tab 10's (Biomax Biotechnics) | $ 0.54 |
| FS Plus Tramadol 37.5 mg, paracetamol325 mg. TAB / 100 (Biomax Biotechnics) | $ 5.42 |
| FS Plus Tablet (Biomax Biotechnics) | $ 0.05 |
| FS-D (India) | |
| 100's (Biomax) | $ 5.54 |
| FS-D Tramadol 37.5 mg, paracetamol325 mg, domperidone 10 mg. TAB / 100 (Biomax) | $ 5.54 |
| FS-D tab 10's (Biomax) | $ 0.55 |
| FusePaq Synapryn | |
| GA Tramadol (Australia) | |
| Gelotradol (Spain) | |
| Gelotralib (Portugal) | |
| Gemadol Retard (Denmark) | |
| GenRX Tramadol | |
| Capsule; Oral; Tramadol 50 mg | |
| Capsules; Oral; Tramadol 50 mg | |
| Gesidol (Chile, Philippines) | |
| Gesidol 50 mg x 100's | |
| Gesitram (Philippines) | |
| Getpar | |
| Getpar 50+500 Tablet (Geneka Healthcare) | $ 0.07 |
| Gudril | |
| Gudril 50+500 Tablet (Intas Pharmaceuticals Ltd.) | $ 0.07 |
| GUDRIL 500 MG/50 MG TABLET 1 strip / 10 tablets each (Intas Pharmaceuticals Ltd.) | $ 0.81 |
| Gudril 500 mg/50 mg Tablet (Intas Pharmaceuticals Ltd.) | $ 0.09 |
| Haldotram | |
| Haldotram 50mg/ml INJ / 1ml (Hallmark Formulations Pharmaceuticals) | $ 0.18 |
| Haldotram 50mg/ml INJ / 2ml (Hallmark Formulations Pharmaceuticals) | $ 0.35 |
| Haldotram 100 mg Injection (Hallmark Formulations Pharmaceuticals) | $ 0.17 |
| Haldotram 50 mg Injection (Hallmark Formulations Pharmaceuticals) | $ 0.17 |
| HALEDOL-P (India) | |
| 10's (Haledew) | $ 0.48 |
| Haledol-P Tramadol 37.5 mg, paracetamol325 mg. TAB / 10 (Haledew) | $ 0.48 |
| HALEDOL-P tab 10's (Haledew) | $ 0.48 |
| Haledol-P Tramadol 37.5 mg, paracetamol325 mg. TAB / 10 (Haledew) | $ 0.48 |
| HALEDOL-SP (India) | |
| 10's (Haledew) | $ 0.83 |
| Haledol-SP Tramadol 37.5 mg, paracetamol325 mg, serratiopeptidase 15mg. FC-TAB / 10 (Haledew) | $ 0.83 |
| HALEDOL-SP film-coated tab 10's (Haledew) | $ 0.83 |
| Haledol-SP Tramadol 37.5 mg, paracetamol325 mg, serratiopeptidase 15mg. FC-TAB / 10 (Haledew) | $ 0.83 |
| Hetradol (India) | |
| Hetradol 50mg INJ / 2ml (Hecures) | |
| 50 mg x 2ml (Hecures) | |
| HETRADOL inj 50 mg x 2ml (Hecures) | |
| HIMADOL INJ (India) | |
| HIMADOL INJ inj 50 mg x 1 mL x 2ml (Jainik) | |
| Hua Jie Wei (China) | |
| Hua Qu (China) | |
See 3515 substitutes for Fraxidol | |
References
- PubChem. "Tramadol". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "Tramadol". http://www.drugbank.ca/drugs/DB00193 (accessed September 17, 2018).
- MeSH. "Narcotics". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Fraxidol are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Fraxidol. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
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Information checked by Dr. Sachin Kumar, MD Pharmacology
