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Analab Capsule (50 Mg)
 

Active ingredient: 
Tramadol Hydrochloride 
Dosage Form: 
Green, yellow hard gelatin capsule marked with Biolab logo
on the cap and 'BIOLAB' on the body.
Therapeutic category: 
Analgesic, Opioid
 
    

 


What is the medicine prescribed for? 

 
Adult Formulation:
Relief of moderate to moderately-severe pain

Medicines are sometimes prescribed for purposes other than those listed above. Use only for the condition for which it was prescribed. Do not give this medicine to other people even if they have the same symptoms you have, as it may not be right for them.

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How to take medication? 

 

The suitable dosage for each patient should be prescribed by a doctor.

Method of Administration:
May be taken without regard to meals.


Dietary Consideration:
Food: Immediate release: Does not affect the rate or extent of absorption.

Adult Dosage:
Dosage
Oral: Moderate-to-severe pain:
Children ≥17 years and Adults: Immediate release formulation: 50-100 mg every 4-6 hours (not to exceed 400 mg/day)

For patients not requiring rapid onset of effect, tolerability may be improved by starting dose at 25 mg/day and titrating dose by 25 mg every 3 days, until reaching 25 mg 4 times/day. The total daily dose may then be increased by 50 mg every 3 days as tolerated, to reach dose of 50 mg 4 times/day. After titration, 50-100 mg may be given every 4-6 hours as needed up to a maximum 400 mg/day.

Elderly >65 years: Use caution and initiate at the lower end of the dosing range
Immediate release: Elderly >75 years: Do not exceed 300 mg/day; see dosing adjustments for renal and hepatic impairment.

Dental Usual Dosing

Moderate-to-severe chronic pain: Oral:
Adults: Immediate release formulation: 50-100 mg every 4-6 hours (not to exceed 400 mg/day)

For patients not requiring rapid onset of effect, tolerability may be improved by starting dose at 25 mg/day and titrating dose by 25 mg every 3 days, until reaching 25 mg 4 times/day. The total daily dose may then be increased by 50 mg every 3 days as tolerated, to reach dose of 50 mg 4 times/day. After titration, 50-100 mg may be given every 4-6 hours as needed up to a maximum 400 mg/day.

Elderly >75 years:
Immediate release: 50 mg every 6 hours (not to exceed 300 mg/day); see dosing adjustments for renal and hepatic impairment.
 
Children Dosage:
Dosage
Oral: Moderate-to-severe pain:
Children 7-16 years (unlabeled use): 1-2 mg/kg/dose every 4-6 hours; maximum: 400 mg/day

How does it work? 


Amoxicillin:
Tramadol and its active metabolite (M1) binds to μ-opiate receptors in the CNS causing inhibition of ascending pain pathways, altering the perception of and response to pain; also inhibits the reuptake of norepinephrine and serotonin, which also modifies the ascending pain pathway
 
 

Contraindications

 
Hypersensitivity to tramadol, opioids, or any component of the formulation; opioid-dependent patients; acute intoxication with alcohol, hypnotics, centrally-acting analgesics, opioids, or psychotropic drugs

Canadian product labeling:
Tramadol is contraindicated during or within 14 days following MAO inhibitor therapy
 
This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
 
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
 
 

Important safety information 

Warnings/Precautions

Concerns related to adverse effects:
• Anaphylactoid reactions: Rare but serious anaphylactoid reactions (including fatalities) often following initial dosing have been reported. Pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis (TEN), and Stevens-Johnson syndrome also have been reported with use. Previous anaphylactoid reactions to opioids may increase risks for similar reactions to tramadol.
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
• Seizures: Even when taken within the recommended dosage seizures may occur; risk is increased in patients receiving serotonin reuptake inhibitors (SSRIs or anorectics), other opioids, tricyclic antidepressants or other cyclic compounds (including cyclobenzaprine, promethazine), neuroleptics, MAO inhibitors, drugs which may lower seizure threshold, or drugs which impair metabolism of tramadol (ie, CYP2D6 and 3A4 inhibitors). Patients with a history of seizures, or with a risk of seizures (head trauma, metabolic disorders, CNS infection, malignancy, or during alcohol/drug withdrawal) are also at increased risk.

Disease-related concerns:
• Abdominal conditions: May obscure diagnosis or clinical course of patients with acute abdominal conditions.
• Drug abuse: Use with caution in patients with a history of drug abuse or acute alcoholism; potential for drug dependency exists.
• Ethanol use: Use with caution in heavy alcohol users.
• Head trauma: Use with extreme caution in patients with head injury, intracranial lesions, or elevated intracranial pressure; exaggerated elevation of ICP may occur.
• Hepatic impairment: Use with caution and reduce dosage in patients with mild-to-moderate hepatic impairment; extended release formulations should not be used in severe hepatic impairment (Child-Pugh class C); Ryzolt™ (extended release tablet) should not be used in any degree of hepatic impairment.
• Renal impairment: Use with caution and reduce dosage in patients with mild-to-moderate renal impairment; extended release formulations should not be used in severe renal impairment Clcr <30 mL/minute.
• Respiratory disease: Patients with respiratory disorders (eg, significant chronic obstructive pulmonary disease (COPD), cor pulmonale, hypoxia, hypercapnia) may be at greater risk of respiratory depression.
• Suicide risk: Suicide risk: Avoid use in patients who are suicidal; use with caution in patients taking tranquilizers and/or antidepressants, or those with an emotional disturbance including depression.

Concurrent drug therapy issues:
• CNS depressants: Use with caution and reduce dosage when administering to patients receiving other CNS depressants; may cause CNS depression and/or respiratory depression.
• Serotonin syndrome: Avoid, if possible, use with serotonergic agents such as TCAs, MAO inhibitors (use with extreme caution; contraindicated in Canadian product labeling), triptans, venlafaxine, trazodone, lithium, sibutramine, meperidine, dextromethorphan, St John's wort, SNRIs, and SSRIs; use caution with drugs which impair metabolism of tramadol (ie, CYP2D6 and 3A4 inhibitors); concomitant use may increase the risk of serotonin syndrome.

Special populations:
• Debilitated patients: Use with caution in debilitated patients; there is a greater potential for critical respiratory depression, even at therapeutic dosages.
• Elderly: Extended-release formulation should be used with extreme caution in the elderly (particularly >75 years of age); may be more sensitive to adverse effects. Reduce initial dose.

Other warnings/precautions:
• Abuse/misuse/diversion: Healthcare provider should be alert to problems of abuse, misuse, and diversion.
• Withdrawal: Tolerance or drug dependence may result from extended use (withdrawal symptoms have been reported); abrupt discontinuation should be avoided. Tapering of dose at the time of discontinuation limits the risk of withdrawal symptoms.
 

If you miss a dose

 
Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at the same time.
 
 

Pregnancy and breastfeeding

 
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
 
Pregnancy considerations
 
Pregnancy Category C, Not recommended for use during labor and delivery.
 
Adverse events were observed in animal studies. Tramadol has been shown to cross the human placenta when administered during labor. Postmarketing reports following tramadol use during pregnancy include neonatal seizures, withdrawal syndrome, fetal death, and stillbirth. Not recommended for use during labor and delivery.
 
Breastfeeding considerations
 
Enters breast milk/not recommended
 
Sixteen hours following a single 100 mg I.V. dose, the amount of tramadol found in breast milk was 0.1% of the maternal dose. Use is not recommended by the manufacturer for postdelivery analgesia in nursing mothers.

Tramadol and its metabolites are found in small amounts in human breast milk. An infant could ingest 0.1% of the dose given to the mother. Tramadol 50mg/ml Solution for Injection should not be administered during breast-feeding.
 
 
 

Possible side effects

 
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
 
Side effects may include:
 
Very common (≥10%) 
Cardiovascular: Flushing (8% to 16%)
Central nervous system: Dizziness (10% to 33%), headache (4% to 32%), somnolence (7% to 25%), insomnia (2% to 11%)
Dermatologic: Pruritus (5% to 12%)
Gastrointestinal: Constipation (10% to 46%), nausea (15% to 40%), vomiting (5% to 17%), dyspepsia (1% to 13%)
Neuromuscular & skeletal: Weakness (4% to 12%)
 
Common (1%-10%) 
Cardiovascular: Postural hypotension (2% to 5%), chest pain (1% to <5%), vasodilation (1% to <5%)
Central nervous system: Anxiety (1% to <5%), confusion (1% to <5%), coordination impaired (1% to <5%), depression (1% to <5%), euphoria (1% to <5%), hypoesthesia (1% to <5%), lethargy (1% to <5%), nervousness (1% to <5%), pain (1% to <5%), pyrexia (1% to <5%), restlessness (1% to <5%), malaise (<1% to <5%), fatigue (2%), vertigo (2%)
Dermatologic: Dermatitis (1% to <5%), rash (1% to <5%)
Endocrine & metabolic: Hot flashes (2% to 9%), menopausal symptoms (1% to <5%)
Gastrointestinal: Diarrhea (5% to 10%), xerostomia (3% to 10%), anorexia (1% to <6%), abdominal pain (1% to <5%), appetite decreased (1% to <5%), weight loss (1% to <5%), flatulence (<1% to <5%)
Genitourinary: Urinary tract infection (1% to <5%), urinary frequency (<1% to <5%), urinary retention (<1% to <5%)
Neuromuscular & skeletal: Arthralgia (1% to <5%), back pain (1% to <5%), hypertonia (1% to <5%), rigors (1% to <5%), paresthesia (1% to <5%), tremor (1% to <5%), creatine phosphokinase increased (1% to <5%)
Ocular: Blurred vision (1% to <5%), miosis (1% to <5%)
Respiratory: Bronchitis (1% to <5%), congestion (nasal/sinus) (1% to <5%), cough (1% to <5%), dyspnea (1% to <5%), nasopharyngitis (1% to <5%), rhinorrhea (1% to <5%), sinusitis (1% to <5%), sneezing (1% to <5%), sore throat (1% to <5%), upper respiratory infection (1% to <5%)
Miscellaneous: Diaphoresis (2% to 9%), flu-like syndrome (1% to < 5%), shivering (<1% to <5%)
 
Serious ADR (<1%) 
postmarketing, and/or case reports (limited to important or life-threatening): Abnormal ECG, abnormal gait, agitation, allergic reaction, amnesia, anaphylactoid reactions, anaphylaxis, anemia, angioedema, appendicitis, ALT increased/decreased, AST increased/decreased, bradycardia, bronchospasm, cataracts, cellulitis, cholecystitis, cholelithiasis, clamminess, cognitive dysfunction, concentration difficulty, creatinine increased, deafness, disorientation, diverticulitis, dreams abnormal, dysphagia, dysuria, ear infection, edema, fecal impaction, gastroenteritis, gastrointestinal bleeding, hallucination, hematuria, hemoglobin decreased, hepatitis, hyperglycemia, hyper-/hypotension, hypersensitivity, irritability, joint stiffness, libido decreased, liver enzymes increased, liver failure, menstrual disorder, MI, migraine, muscle cramps, muscle spasms, muscle twitching, myalgia, myocardial ischemia, night sweats, orthostatic hypotension, palpitation, pancreatitis, peripheral edema, peripheral ischemia, pneumonia, proteinuria, pulmonary edema, pulmonary embolism, sedation, seizure, serotonin syndrome, sleep disorder, speech disorder, Stevens-Johnson syndrome, stomatitis, suicidal tendency, syncope, taste perversion, tachycardia, thrombocytopenia, tinnitus, toxic epidermal necrolysis, urticaria, vesicles, visual disturbance

A withdrawal syndrome may occur with abrupt discontinuation; includes anxiety, diarrhea, hallucinations (rare), nausea, pain, piloerection, rigors, sweating, and tremor. Uncommon discontinuation symptoms may include severe anxiety, panic attacks, or paresthesia.
 
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
 
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
 
Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
 
 

Interaction with other medication 

 
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while having treatment with this one, to ensure that the combination is safe. 
 
Drug
Metabolism/Transport Effects
Substrate of CYP2D6 (major), 3A4 (major)

Drug Interactions

Alvimopan: Analgesics (Opioid) may enhance the adverse/toxic effect of Alvimopan. This is most notable for patients receiving long-term (i.e., more than 7 days) opiates prior to alvimopan initiation. Management: Alvimopan is contraindicated in patients receiving therapeutic doses of opioids for more than 7 consecutive days immediately prior to alvimopan initiation. Risk D: Consider therapy modification
Ammonium Chloride: May increase the excretion of Analgesics (Opioid). Risk C: Monitor therapy
Amphetamines: May enhance the analgesic effect of Analgesics (Opioid). Risk C: Monitor therapy
Antipsychotic Agents (Phenothiazines): May enhance the hypotensive effect of Analgesics (Opioid). Risk C: Monitor therapy

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Exceptions: Levocabastine (Nasal). Risk C: Monitor therapy
Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Risk X: Avoid combination
CYP2D6 Inhibitors (Moderate): May diminish the therapeutic effect of TraMADol. These CYP2D6 inhibitors may prevent the metabolic conversion of tramadol to its active metabolite that accounts for much of its opioid-like effects. Risk C: Monitor therapy
CYP2D6 Inhibitors (Strong): May diminish the therapeutic effect of TraMADol. These CYP2D6 inhibitors may prevent the metabolic conversion of tramadol to its active metabolite that accounts for much of its opioid-like effects. Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates. Risk D: Consider therapy modification

Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Desmopressin: Analgesics (Opioid) may enhance the adverse/toxic effect of Desmopressin. Risk C: Monitor therapy
Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e.g., opioids, barbiturates) with concomitant use. Risk D: Consider therapy modification

HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

MAO Inhibitors: TraMADol may enhance the neuroexcitatory and/or seizure-potentiating effect of MAO Inhibitors. TraMADol may enhance the serotonergic effect of MAO Inhibitors. Management: Consider alternatives to combined treatment with tramadol and monoamine oxidase inhibitors due to an increased risk of serotonin syndrome and seizures. Avoid transdermal selegiline. Risk D: Consider therapy modification
Mixed Agonist / Antagonist Opioids: May diminish the analgesic effect of Analgesics (Opioid). Management: Seek alternatives to mixed agonist/antagonist opioids in patients receiving pure opioid agonists, and monitor for symptoms of therapeutic failure/high dose requirements (or withdrawal in opioid-dependent patients) if patients receive these combinations. Risk D: Consider therapy modification

Pegvisomant: Analgesics (Opioid) may diminish the therapeutic effect of Pegvisomant. Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the neuroexcitatory and/or seizure-potentiating effect of TraMADol. TraMADol may enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors. This may cause serotonin syndrome. Risk D: Consider therapy modification
Selective Serotonin Reuptake Inhibitors: Analgesics (Opioid) may enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors. This may cause serotonin syndrome. Risk C: Monitor therapy
Serotonin Modulators: May enhance the adverse/toxic effect of other Serotonin Modulators. The development of serotonin syndrome may occur. Risk D: Consider therapy modification
Sibutramine: May enhance the serotonergic effect of Serotonin Modulators. This may cause serotonin syndrome. Risk X: Avoid combination
Succinylcholine: May enhance the bradycardic effect of Analgesics (Opioid). Risk C: Monitor therapy

Thiazide Diuretics: Analgesics (Opioid) may enhance the orthostatic hypotensive effect of Thiazide Diuretics. Risk C: Monitor therapy
 
Ethanol/ Nutraceutical/ Herb
Herb/Nutraceutical: Avoid valerian, St John's wort, kava kava, gotu kola (may increase CNS depression).
Ethanol: May increase CNS depression; monitor for increased effects with coadministration. Caution patients about effects.
 
Laboratory Test
May interfere with urine detection of PCP (false-positive).
 

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
 
 

This information is a merely a general guideline and is not a substitute for a consultation with your doctor. 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.
 
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