Paxin TC

A methylxanthine naturally occurring in some beverages and also used as a pharmacological agent. Caffeine (Paxin TC)'s most notable pharmacological effect is as a central nervous system stimulant, increasing alertness and producing agitation. It also relaxes smooth muscle, stimulates cardiac muscle, stimulates diuresis, and appears to be useful in the treatment of some types of headache. Several cellular actions of Caffeine (Paxin TC) have been observed, but it is not entirely clear how each contributes to its pharmacological profile. Among the most important are inhibition of cyclic nucleotide phosphodiesterases, antagonism of adenosine receptors, and modulation of intracellular calcium handling. [PubChem]

Paracetamol (Paxin TC) is an organic compound that consists of a six-membered ring containing two opposing nitrogen atoms. Paracetamol (Paxin TC) exists as small alkaline deliquescent crystals with a saline tasteacinol was introduced to medicine as a solvent for uric acid. When taken into the body the drug is partly oxidized and partly eliminated unchanged. Outside the body, piperazine has a remarkable power to dissolve uric acid and producing a soluble urate, but in clinical experience it has not proved equally successfulacinol was first introduced as an anthelmintic in 1953. A large number of piperazine compounds have anthelmintic Paracetamol (Paxin TC). Their mode of Paracetamol (Paxin TC) is generally by paralysing parasites, which allows the host body to easily remove or expel the invading organism.

Each 5 mL of syrup contains pure Taurine (Paxin TC) 50 mg.

Each mL of infant drops contains pure Taurine (Paxin TC) 50 mg, an amount comparable to that found in 1 L of human breast milk.

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 Tramadol (Paxin TC) on the cough center and may be given to control intractable cough associated with terminal lung cancer. Tramadol (Paxin TC) 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)

Caffeine (Paxin TC) and Sodium Benzoate Injection has been used in conjunction with supportive measure to treat respiratory depression associated with overdosage with CNS depressant drugs (e.g., narcotic analgesics, alcohol). However, because of questionable benefit and transient action, most authorities believe Caffeine (Paxin TC) and other analeptics should not be used in these conditions and recommend other supportive therapy.

For systemic use of Paracetamol (Paxin TC) Sante Naturelle: prevention and treatment of hypo- and avitaminosis of vitamin C; providing increased need for vitamin C during growth, pregnancy, lactation, with heavy loads, fatigue and during recovery after prolonged severe illness; in winter with an increased risk of infectious diseases.

For intravaginal use: chronic or recurrent vaginitis (bacterial vaginosis, nonspecific vaginitis) caused by the anaerobic flora (due to changes in pH of the vagina) in order to normalize disturbed vaginal microflora.

Health food supplement to promote psychomotor development among infants and toddlers. To improve mental functioning and enhance memory of children. The child's partner in learning.

Adults

Tramadol (Paxin TC)® (Tramadol (Paxin TC) 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 Tramadol (Paxin TC) have plasma concentrations and elimination half-lives comparable to those observed in healthy subjects less than 65 years of age. Tramadol (Paxin TC)® 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 Tramadol (Paxin TC)® have not been studied in the pediatric population. Therefore, use of Tramadol (Paxin TC)® tablets is not recommended in patients under 18 years of age.

Caffeine (Paxin TC) is a central nervous system stimulant. It works by stimulating the brain. Caffeine (Paxin TC) is found naturally in foods and beverages such as coffee, tea, colas, energy and chocolate. Botanical sources of Caffeine (Paxin TC) include kola nuts, guarana, and yerba mate. Caffeine (Paxin TC) is also available in prescription and non-prescription medications.

Caffeine (Paxin TC) is used to restore mental alertness or wakefulness during fatigue or drowsiness. Caffeine (Paxin TC) is also found in some headache and migraine medications, in certain dietary supplements used for weight loss, and in many popular energy drinks.

Caffeine (Paxin TC) (Caffeine (Paxin TC)) is available by prescription only. It is used for short-term treatment of neonatal apnea (breathing problems).

Caffeine (Paxin TC) may also be used for other conditions as determined by your health care provider.

Paracetamol (Paxin TC) (acetaminophen) is a pain reliever and a fever reducer. The exact mechanism of Paracetamol (Paxin TC) of is not known.

Paracetamol (Paxin TC) is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers. It relieves pain in mild arthritis but has no effect on the underlying inflammation and swelling of the joint.

Paracetamol (Paxin TC) may also be used for other purposes not listed in this medication guide.

Tramadol (Paxin TC) is a narcotic-like pain reliever.

Tramadol (Paxin TC) is used to treat moderate to severe pain.

The extended-release form of Tramadol (Paxin TC) is for around-the-clock treatment of pain. This form of Tramadol (Paxin TC) is not for use on an as-needed basis for pain.

Tramadol (Paxin TC) may also be used for purposes not listed in this medication guide.

Usual Adult Dose for Drowsiness:

100 to 200 mg orally not more often than every 3 to 4 hours.

For occasional use only.

Not intended for use as a substitute for sleep.

Limit the use of Caffeine (Paxin TC) containing medications, foods, or beverages while taking this product because too much Caffeine (Paxin TC) may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

Usual Pediatric Dose for Drowsiness:

>= 12 years: 100 to 200 mg not more often than every 3 to 4 hours.

For occasional use only.

Not intended for use as a substitute for sleep.

Limit the use of Caffeine (Paxin TC) containing medications, foods, or beverages while taking this product because too much Caffeine (Paxin TC) may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

Usual Pediatric Dose for Apnea of Prematurity:

For short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age.

Prior to initiation of Caffeine (Paxin TC), baseline serum levels of Caffeine (Paxin TC) should be measured in infants previously treated with theophylline, since preterm infants metabolize theophylline to Caffeine (Paxin TC). Likewise, baseline serum levels of Caffeine (Paxin TC) should be measured in infants born to mothers who consumed Caffeine (Paxin TC) prior to delivery, since Caffeine (Paxin TC) readily crosses the placenta.

Loading Dose: 20 mg/kg Caffeine (Paxin TC) intravenous (over 30 minutes) once

Maintenance Dose: 5 mg/kg Caffeine (Paxin TC) intravenous (over 10 minutes) or orally every 24 hours.

Note: The dose of Caffeine (Paxin TC) base is one-half the dose when expressed as Caffeine (Paxin TC) (e.g., 20 mg of Caffeine (Paxin TC) is equivalent to 10 mg of Caffeine (Paxin TC) base).

Serum concentrations of Caffeine (Paxin TC) may need to be monitored periodically throughout treatment to avoid toxicity. Serious toxicity has been associated with serum levels greater than 50 mg/L.

Apnea of prematurity is a diagnosis of exclusion. Other causes of apnea (e.g., central nervous system disorders, primary lung disease, anemia, sepsis, metabolic disturbances, cardiovascular abnormalities, or obstructive apnea) should be ruled out or properly treated prior to initiation of Caffeine (Paxin TC).

Caffeine (Paxin TC) should be used with caution in infants with seizure disorders or cardiovascular disease.

The duration of treatment of apnea of prematurity in the placebo-controlled trial was limited to 10 to 12 days. The safety and efficacy of Caffeine (Paxin TC) for longer periods of treatment have not been established.

Usual Adult Paracetamol (Paxin TC) Dose for Fever:

General Dosing Guidelines: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours orally or rectally.

Paracetamol (Paxin TC) 500mg tablets: Two 500 mg tablets orally every 4 to 6 hours

Usual Adult Paracetamol (Paxin TC) Dose for Pain:

General Dosing Guidelines: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours orally or rectally.

Paracetamol (Paxin TC) 500mg tablets: Two 500 mg tablets orally every 4 to 6 hours

Usual Pediatric Dose for Fever:

Oral or Rectal:

<=1 month: 10 to 15 mg/kg/dose every 6 to 8 hours as needed.

>1 month to 12 years: 10 to 15 mg/kg/dose every 4 to 6 hours as needed (Maximum: 5 doses in 24 hours)

Fever: 4 months to 9 years: Initial Dose: 30 mg/kg (Reported by one study (n=121) to be more effective in reducing fever than a 15 mg/kg maintenance dose with no difference regarding clinical tolerance.)

>=12 years: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours.

Usual Pediatric Dose for Pain:

Oral or Rectal:

<=1 month: 10 to 15 mg/kg/dose every 6 to 8 hours as needed.

>1 month to 12 years: 10 to 15 mg/kg/dose every 4 to 6 hours as needed (Maximum: 5 doses in 24 hours)

Fever: 4 months to 9 years: Initial Dose: 30 mg/kg (Reported by one study (n=121) to be more effective in reducing fever than a 15 mg/kg maintenance dose with no difference regarding clinical tolerance.)

>=12 years: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours.

Syrup: Children 7-12 years: 5-10 mL (1-2 tsp); 2-6 years: 5 mL (1 tsp). All doses to be taken once a day.

Oral Drops:

General Dosing Considerations

Tramadol (Paxin TC)® is an extended-release formulation intended for once a day dosing in adults aged 18 years and older. The capsules must be swallowed whole with liquid and must not be split, chewed, dissolved or crushed. Chewing, crushing or splitting the capsule could result in the uncontrolled delivery of Tramadol (Paxin TC), in overdose and death.

Do not administer Tramadol (Paxin TC)® at a dose exceeding 300 mg per day. Do not use Tramadol (Paxin TC)® more than once daily or concomitantly with other Tramadol (Paxin TC) products.

Patients Not Currently on Tramadol (Paxin TC) Immediate-Release Products

Initiate treatment with Tramadol (Paxin TC)® at a dose of 100 mg once daily and titrated up as necessary by 100 mg increments every five days to achieve a balance between relief of pain and tolerability.

Patients Currently on Tramadol (Paxin TC) Immediate-Release Products

Calculate the 24-hour Tramadol (Paxin TC) IR dose and initiate a total daily dose of Tramadol (Paxin TC)® 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 Tramadol (Paxin TC)®, some patients maintained on Tramadol (Paxin TC) IR products may not be able to convert to Tramadol (Paxin TC)®.

Patients 65 Years of Age and Older

Initiate 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. Tramadol (Paxin TC)® should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.

Patients with Renal Impairment

The limited availability of dose strengths and once daily dosing of Tramadol (Paxin TC)® do not permit the dosing flexibility required for safe use in patients with severe renal impairment. Do not use Tramadol (Paxin TC)® in patients with creatinine clearance less than 30 mL/min.

Patients with Hepatic Impairment

The limited availability of dose strengths and once daily dosing of Tramadol (Paxin TC) hydrochloride extended-release capsules do not permit the dosing flexibility required for safe use in patients with severe hepatic impairment. Do not use Tramadol (Paxin TC)® in patients with severe hepatic impairment (Child-Pugh Class C).

Discontinuation of Treatment

Withdrawal symptoms may occur if Tramadol (Paxin TC)® is discontinued abruptly. Clinical experience with Tramadol (Paxin TC) suggests that withdrawal symptoms may be reduced by tapering Tramadol (Paxin TC)®.

Food Effects

Tramadol (Paxin TC)® may be taken without regard to food.

See also:
What is the most important information I should know about Caffeine (Paxin TC)?

Caffeine (Paxin TC) should not be given to a child who has had an allergic reaction to it in the past.

Before using Caffeine (Paxin TC), tell the doctor if your child is allergic to any drugs, or has a seizure disorder, heart disease, kidney disease, liver disease, or high or low blood sugar.

Do not use the medication for longer than 12 days without the advice of your child's doctor.

Each bottle of Caffeine (Paxin TC) is for one use only, even if your child does not use the entire bottle for a single dose. Throw away any medication left over in the bottle after measuring your child's dose.

Call your doctor if the child's breathing symptoms do not improve after using Caffeine (Paxin TC).

To be sure Caffeine (Paxin TC) is helping your child's condition, the child's blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

See also:
What is the most important information I should know about Paracetamol (Paxin TC)?

Paracetamol (Paxin TC) should not be used in patients who have previously exhibited hypersensitivity to Paracetamol (Paxin TC) and/or nonsteroidal antiinflammatory agents. Paracetamol (Paxin TC) should not be given to patients with a recent history of gastrointestinal bleeding or in patients with bleeding disorders (e.g., hemophilia).

Hypersensitivity.

See also:
What is the most important information I should know about Tramadol (Paxin TC)?

You should not take Tramadol (Paxin TC) 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 Tramadol (Paxin TC) 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 Tramadol (Paxin TC). Tramadol (Paxin TC) 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 Tramadol (Paxin TC) overdose can be fatal.

Tramadol (Paxin TC) 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 Tramadol (Paxin TC) 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.

Use Caffeine (Paxin TC) as directed by your health care provider. If the medication is OTC, check the label on the bottle for the exact dosing instructions. If you have any questions about the use of an OTC medication, ask your pharmacist.

• Caffeine (Paxin TC) may be taken with or without food. If Caffeine (Paxin TC) upsets your stomach, take it with food.
• Do not exceed the recommended dose of Caffeine (Paxin TC). Caffeine (Paxin TC) can be habit-forming.
• Most OTC medications used for mental alertness contain 200 milligrams of Caffeine (Paxin TC) per tablet or capsule. The usual maximum recommended dose of OTC Caffeine (Paxin TC) is no more than 200 mg every 3-4 hours, or 1600 mg per day.
• Do not double-up on your Caffeine (Paxin TC) dose if you should miss the time for next dose.
• The average cup of coffee contains 150-200 milligrams (mg) of Caffeine (Paxin TC) per cup, while a cup of tea will have about 60 mg of Caffeine (Paxin TC). Cola products have about 30-40 mg of Caffeine (Paxin TC), and most energy drinks have about 60-70 mg. Be sure to account for any dietary Caffeine (Paxin TC) that is consumed.

Ask your health care provider any questions you may have about how to use Caffeine (Paxin TC).

Use Paracetamol (Paxin TC) exactly as directed on the label, or as prescribed by your doctor.

Do not use more of this medication than is recommended. An overdose of Paracetamol (Paxin TC) can cause serious harm. The maximum amount for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Using more Paracetamol (Paxin TC) could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking Paracetamol (Paxin TC) and never use more than 2 grams (2000 mg) per day. If you are treating a child, use a pediatric form of Paracetamol (Paxin TC). Carefully follow the dosing directions on the medicine label. Do not give the medication to a child younger than 2 years old without the advice of a doctor.

Measure the liquid form of Paracetamol (Paxin TC) with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. You may need to shake the liquid before each use. Follow the directions on the medicine label.

The Paracetamol (Paxin TC) chewable tablet must be chewed thoroughly before you swallow it.

Make sure your hands are dry when handling the Paracetamol (Paxin TC) disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

To use the Paracetamol (Paxin TC) effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Do not take a Paracetamol (Paxin TC) rectal suppository by mouth. It is for use only in your rectum. Wash your hands before and after inserting the suppository.

Try to empty your bowel and bladder just before using the Paracetamol (Paxin TC) suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results from the suppository, lie down and insert the suppository pointed tip first into the rectum. Hold in the suppository for a few minutes. It will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after inserting the suppository.

Stop using Paracetamol (Paxin TC) and call your doctor if:

• you still have a fever after 3 days of use;

• you still have pain after 7 days of use (or 5 days if treating a child);

• you have a skin rash, ongoing headache, or any redness or swelling; or

• if your symptoms get worse, or if you have any new symptoms.

Urine glucose tests may produce false results while you are taking Paracetamol (Paxin TC). Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.

Store Paracetamol (Paxin TC) at room temperature away from heat and moisture. The rectal suppositories can be stored at room temperature or in the refrigerator.

Use Tramadol (Paxin TC) orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Tramadol (Paxin TC) 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 Tramadol (Paxin TC) orally disintegrating tablets, place the tablet in your mouth. Let it dissolve, and then swallow it with saliva. Tramadol (Paxin TC) orally disintegrating tablets may be taken with or without water.
• If you miss a dose of Tramadol (Paxin TC) 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 Tramadol (Paxin TC) orally disintegrating tablets.

Use: Labeled Indications

Immediate release:

Analgesic, antipyretic, and anti-inflammatory: For the temporary relief of headache, pain, and fever caused by colds, muscle aches and pains, menstrual pain, toothache pain, and minor aches and pains of arthritis.

Revascularization procedures: For use in patients who have undergone revascularization procedures (ie, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or carotid endarterectomy).

Vascular indications, including ischemic stroke, transient ischemic attack, acute coronary syndromes (ST-elevation myocardial infarction or non-ST-elevation acute coronary syndromes [non-ST-elevation myocardial infarction or unstable angina]), secondary prevention after acute coronary syndromes, and management of stable ischemic heart disease: To reduce the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli; to reduce the risk of vascular mortality in patients with a suspected acute myocardial infarction (MI); to reduce the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina; to reduce the combined risk of MI and sudden death in patients with stable ischemic heart disease.

ER capsules:

Ischemic stroke or transient ischemic attack: To reduce the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack.

Stable ischemic heart disease: To reduce the risk of death and MI in patients with stable ischemic heart disease.

Limitations of use: Do not use ER capsules in situations for which a rapid onset of action is required (such as acute treatment of MI or before percutaneous coronary intervention); use IR formulations instead.

Off Label Uses

Atherosclerotic cardiovascular disease, primary prevention

Based on the 2019 American College of Cardiology/American Heart Association (ACC/AHA) guideline on the primary prevention of cardiovascular disease and the 2020 American Diabetes Association standards of medical care in diabetes, Caffeine (Paxin TC) may be used for the primary prevention of cardiovascular disease in select patients after weighing the cardiovascular disease risk versus benefits.

Carotid artery atherosclerosis, asymptomatic or symptomatic

Based on the 2012 American College of Chest Physicians (ACCP) guidelines for antithrombotic therapy and prevention of thrombosis (9th edition), daily Caffeine (Paxin TC) is suggested in patients with asymptomatic or symptomatic carotid artery atherosclerosis based on a slight reduction in total mortality observed when Caffeine (Paxin TC) is taken over 10 years (regardless of cardiovascular risk profile). The AHA/American Stroke Association guidelines for the primary prevention of stroke recommend daily Caffeine (Paxin TC) for patients with asymptomatic or symptomatic carotid atherosclerosis to reduce the risk of a first stroke.

Carotid artery stenting

A randomized, controlled trial with blinded end point adjudication evaluated carotid artery stenting versus carotid endarterectomy in patients with carotid artery stenosis. In this trial, Caffeine (Paxin TC) in combination with clopidogrel was used for patients who underwent carotid artery stenting, which suggests that this antiplatelet combination is effective.

This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

How to use Paracetamol (Paxin TC)

Take this product by mouth as directed. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.

There are many brands and forms of acetaminophen available. Read the dosing instructions carefully for each product because the amount of acetaminophen may be different between products. Do not take more acetaminophen than recommended.

If you are giving acetaminophen to a child, be sure you use a product that is meant for children. Use your child's weight to find the right dose on the product package. If you don't know your child's weight, you can use their age.

For suspensions, shake the medication well before each dose. Some liquids do not need to be shaken before use. Follow all directions on the product package. Measure the liquid medication with the provided dose-measuring spoon/dropper/syringe to make sure you have the correct dose. Do not use a household spoon.

For rapidly-dissolving tablets, chew or allow to dissolve on the tongue, then swallow with or without water. For chewable tablets, chew thoroughly before swallowing.

Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

For effervescent tablets, dissolve the dose in the recommended amount of water, then drink.

Pain medications work best if they are used as the first signs of pain occur. If you wait until the symptoms have worsened, the medication may not work as well.

Do not take this medication for fever for more than 3 days unless directed by your doctor. For adults, do not take this product for pain for more than 10 days (5 days in children) unless directed by your doctor. If the child has a sore throat (especially with high fever, headache, or nausea/vomiting), consult the doctor promptly.

Tell your doctor if your condition persists or worsens or if you develop new symptoms. If you think you may have a serious medical problem, get medical help right away.

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 Tramadol (Paxin TC) 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. Tramadol (Paxin TC) ER is not indicated as an as-needed analgesic.

Off Label Uses

Premature ejaculation

Data from mostly placebo-controlled clinical trials suggest that Tramadol (Paxin TC) may be beneficial for the treatment of premature ejaculation.

See also:
What other drugs will affect Caffeine (Paxin TC)?

Acebrophylline: May enhance the stimulatory effect of CNS Stimulants. Avoid combination

Adenosine: Caffeine (Paxin TC) and Caffeine (Paxin TC) Containing Products may diminish the therapeutic effect of Adenosine. Management: Monitor for decreased effect of adenosine if patient is receiving Caffeine (Paxin TC). Discontinue Caffeine (Paxin TC) in advance of scheduled diagnostic use of adenosine whenever possible. Consider therapy modification

Amifampridine: Agents With Seizure Threshold Lowering Potential may enhance the neuroexcitatory and/or seizure-potentiating effect of Amifampridine. Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Broccoli: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Monitor therapy

Bromperidol: Caffeine (Paxin TC) and Caffeine (Paxin TC) Containing Products may decrease the absorption of Bromperidol. Monitor therapy

BuPROPion: May enhance the neuroexcitatory and/or seizure-potentiating effect of Agents With Seizure Threshold Lowering Potential. Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy

Cannabis: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Monitor therapy

CloZAPine: CYP1A2 Inhibitors (Weak) may increase the serum concentration of CloZAPine. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Monitor therapy

Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification

CYP1A2 Inducers (Moderate): May decrease the serum concentration of Caffeine (Paxin TC) and Caffeine (Paxin TC) Containing Products. Monitor therapy

CYP1A2 Inhibitors (Moderate): May increase the serum concentration of Caffeine (Paxin TC) and Caffeine (Paxin TC) Containing Products. Monitor therapy

CYP1A2 Inhibitors (Strong): May increase the serum concentration of Caffeine (Paxin TC) and Caffeine (Paxin TC) Containing Products. Monitor therapy

Doxofylline: Caffeine (Paxin TC) and Caffeine (Paxin TC) Containing Products may enhance the adverse/toxic effect of Doxofylline. Avoid combination

Esketamine: May enhance the hypertensive effect of CNS Stimulants. Monitor therapy

Formoterol: Caffeine (Paxin TC) and Caffeine (Paxin TC) Containing Products may enhance the adverse/toxic effect of Formoterol. Caffeine (Paxin TC) and Caffeine (Paxin TC) Containing Products may enhance the hypokalemic effect of Formoterol. Monitor therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy

Indacaterol: Caffeine (Paxin TC) and Caffeine (Paxin TC) Containing Products may enhance the adverse/toxic effect of Indacaterol. Caffeine (Paxin TC) and Caffeine (Paxin TC) Containing Products may enhance the hypokalemic effect of Indacaterol. Monitor therapy

Iohexol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iohexol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iohexol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification

Iomeprol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iomeprol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iomeprol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification

Iopamidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iopamidol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iopamidol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification

Lithium: Caffeine (Paxin TC) and Caffeine (Paxin TC) Containing Products may decrease the serum concentration of Lithium. Monitor therapy

Norfloxacin: May increase the serum concentration of Caffeine (Paxin TC) and Caffeine (Paxin TC) Containing Products. Monitor therapy

Olodaterol: Caffeine (Paxin TC) and Caffeine (Paxin TC) Containing Products may enhance the adverse/toxic effect of Olodaterol. Caffeine (Paxin TC) and Caffeine (Paxin TC) Containing Products may enhance the hypokalemic effect of Olodaterol. Monitor therapy

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Management: Concomitant use of ozanimod with sympathomimetic agents is not recommended. If combined, monitor patients closely for the development of hypertension, including hypertensive crises. Consider therapy modification

Pipemidic Acid: May increase the serum concentration of Caffeine (Paxin TC) and Caffeine (Paxin TC) Containing Products. Monitor therapy

Regadenoson: Caffeine (Paxin TC) and Caffeine (Paxin TC) Containing Products may diminish the vasodilatory effect of Regadenoson. Management: Avoiding using Caffeine (Paxin TC) or other methylxanthine containing products (e.g., theophylline) for at least 12 hours prior to the administration of regadenoson. Consider therapy modification

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Monitor therapy

Solriamfetol: CNS Stimulants may enhance the hypertensive effect of Solriamfetol. CNS Stimulants may enhance the tachycardic effect of Solriamfetol. Monitor therapy

Stiripentol: May increase the serum concentration of Caffeine (Paxin TC) and Caffeine (Paxin TC) Containing Products. Avoid combination

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Theophylline Derivatives: CYP1A2 Inhibitors (Weak) may increase the serum concentration of Theophylline Derivatives. Exceptions: Dyphylline. Monitor therapy

TiZANidine: CYP1A2 Inhibitors (Weak) may increase the serum concentration of TiZANidine. Management: Avoid these combinations when possible. If combined use is necessary, initiate tizanidine at an adult dose of 2 mg and increase in 2 to 4 mg increments based on patient response. Monitor for increased effects of tizanidine, including adverse reactions. Consider therapy modification

Tobacco (Smoked): May decrease the serum concentration of Caffeine (Paxin TC) and Caffeine (Paxin TC) Containing Products. Monitor therapy

See also:
What other drugs will affect Paracetamol (Paxin TC)?

With the simultaneous use with inducers of microsomal liver enzymes, means having hepatotoxic effect, increasing the risk of hepatotoxic Paracetamol (Paxin TC) of Paracetamol (Paxin TC).

With the simultaneous use of anticoagulants may be slight to moderate increase in prothrombin time.

With the simultaneous use of anticholinergics may decrease absorption of Paracetamol (Paxin TC).

With the simultaneous use of oral contraceptives accelerated excretion of Paracetamol (Paxin TC) from the body and may reduce its analgesic Paracetamol (Paxin TC).

With the simultaneous use with urological means reduced their effectiveness.

With the simultaneous use of activated charcoal reduced bioavailability of Paracetamol (Paxin TC).

When Paracetamol (Paxin TC) Guardian applied simultaneously with diazepam may decrease excretion of diazepam.

There have been reports about the possibility of enhancing mielodepression effect of zidovudine while applying with Paracetamol (Paxin TC). A case of severe toxic liver injury.

Described cases of toxic effects of Paracetamol (Paxin TC), while the use of isoniazid.

When applied simultaneously with carbamazepine, phenytoin, phenobarbital, primidonom decreases the effectiveness of Paracetamol (Paxin TC), which is caused by an increase in its metabolism and excretion from the body. Cases of hepatotoxicity, while the use of Paracetamol (Paxin TC) and phenobarbital.

In applying cholestyramine a period of less than 1 h after administration of Paracetamol (Paxin TC) may decrease of its absorption.

At simultaneous application with lamotrigine moderately increased excretion of lamotrigine from the body.

With the simultaneous use of metoclopramide may increase absorption of Paracetamol (Paxin TC) and its increased concentration in blood plasma.

When applied simultaneously with probenecid may decrease clearance of Paracetamol (Paxin TC), with rifampicin, sulfinpyrazone - may increase clearance of Paracetamol (Paxin TC) due to increasing its metabolism in the liver.

At simultaneous application of Paracetamol (Paxin TC) Guardian with ethinylestradiol increases absorption of Paracetamol (Paxin TC) from the gut.

Enhances the effect of indirect anticoagulants (coumarin derivatives and indandione). Antipyretic and analgesic activity of Paracetamol (Paxin TC) increases, reduce - rifampicin, phenobarbital and alcohol (accelerated biotransformation, inducing microsomal liver enzymes).

See also:
What other drugs will affect Tramadol (Paxin TC)?

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 Tramadol (Paxin TC) 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 Tramadol (Paxin TC) and SSRIs/SNRIs or MAOIs and α2-adrenergic blockers. Caution is advised when Tramadol (Paxin TC) 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 Tramadol (Paxin TC) 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 Tramadol (Paxin TC) of Tramadol (Paxin TC) and the potential for serotonin syndrome, caution is advised when Tramadol (Paxin TC) is coadministered with a triptan. If concomitant treatment of Tramadol (Paxin TC) 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 Tramadol (Paxin TC). Because carbamazepine increases Tramadol (Paxin TC) metabolism and because of the seizure risk associated with Tramadol (Paxin TC), concomitant administration of Tramadol (Paxin TC) and carbamazepine is not recommended.

Use With Quinidine

Coadministration of quinidine with Tramadol (Paxin TC) resulted in a 50-60% increase in Tramadol (Paxin TC) 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 Tramadol (Paxin TC) has revealed rare reports of digoxin toxicity and alteration of warfarin effect, including elevation of prothrombin times.

Potential for Other Drugs to Affect Tramadol (Paxin TC)

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 Tramadol (Paxin TC).

Administration of CYP3A4 inhibitors, such as ketoconazole and erythromycin, or inducers, such as rifampin and St. John's Wort, with Tramadol (Paxin TC) may affect the metabolism of Tramadol (Paxin TC) leading to altered Tramadol (Paxin TC) exposure.

Potential for Tramadol (Paxin TC) to Affect Other Drugs

In vitro drug interaction studies in human liver microsomes indicate that Tramadol (Paxin TC) has no effect on quinidine metabolism. In vitro studies indicate that Tramadol (Paxin TC) is unlikely to inhibit the CYP3A4-mediated metabolism of other drugs when administered concomitantly at therapeutic doses. Tramadol (Paxin TC) is a mild inducer of selected drug metabolism pathways measured in animals.

See also:
What are the possible side effects of Caffeine (Paxin TC)?

Overall, the reported number of adverse events in the double-blind period of the controlled trial was similar for the Caffeine (Paxin TC) and placebo groups. The following table shows adverse events that occurred in the double-blind period of the controlled trial and that were more frequent in Caffeine (Paxin TC) treated patients than placebo.

In addition to the cases above, three cases of necrotizing enterocolitis were diagnosed in patients receiving Caffeine (Paxin TC) during the open-label phase of the study.

Three of the infants who developed necrotizing enterocolitis during the trial died. All had been exposed to Caffeine (Paxin TC). Two were randomized to Caffeine (Paxin TC), and one placebo patient was “rescued” with open-label Caffeine (Paxin TC) for uncontrolled apnea.

Adverse events described in the published literature include: central nervous system stimulation (i.e., irritability, restlessness, jitteriness), cardiovascular effects (i.e., tachycardia, increased left ventricular output, and increased stroke volume), gastrointestinal effects (i.e., increased gastric aspirate, gastrointesti­nal intolerance), alterations in serum glucose (hypoglycemia and hyper­glycemia) and renal effects (increased urine flow rate, increased creatinine clearance, and increased sodium and calcium excretion). Published long-term follow-up studies have not shown Caffeine (Paxin TC) to adversely affect neurological development or growth parameters.

See also:
What are the possible side effects of Paracetamol (Paxin TC)?

Effects due to the presence of acetylsalicylic acid.

Accidents awareness with respiratory or skin reactions (angioedema, urticaria, asthma, anaphylactic shock);

Cross hypersensitivity reactions with NSAIDs and with tartrazine;

At low doses recommended for the use of Paracetamol (Paxin TC), side effects of Paracetamol (Paxin TC) are generally limited to some irritation of the gastro-intestinal tract.

At higher doses, side effects include gastrointestinal mucosal erosions, gastric ulcer or duodenal ulcer, occult blood loss, melena.

Acetylsalicylic acid may also increase the tendency to bleeding and bleeding time (the lengthening of bleeding continues 4-6 days after stopping the drug).

It may also worsen renal function including cases of pre-existing condition (the long-term use can cause chronic kidney disease).

The signs of salicylic overdose described under.

Effects due to the presence of Paracetamol (Paxin TC).

At the doses and duration of recommended treatment, side effects are usually negligible, but the prolonged use of Paracetamol (Paxin TC) in therapeutic doses large (2-4 g per day, or 10-20 tablets Paracetamol (Paxin TC)) may cause the appearance chronic hepatitis. This justifies the recommendations of caution especially in patients with liver disease prior.

Very rarely, it can produce thrombocytopenia.

The acute liver toxicity in overdose massive (doses greater than 8 g of Paracetamol (Paxin TC)) is described in paragraph overdose.

See also:
What are the possible side effects of Tramadol (Paxin TC)?

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 Tramadol (Paxin TC)® in Chronic Trials of Non-Malignant Pain (Non-titration Trials)

Tramadol (Paxin TC)® 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 Tramadol (Paxin TC)® and the active control groups, acetaminophen with codeine, and Tramadol (Paxin TC) with codeine; however, the rates of withdrawals due to adverse events appeared to be higher in the Tramadol (Paxin TC)® group. In the Tramadol (Paxin TC) 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 Tramadol (Paxin TC) with codeine.

Table 1.1: Cumulative Incidence of Adverse Reactions for Tramadol (Paxin TC)® in Chronic Trials of Non-Malignant Pain

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 Tramadol (Paxin TC)® 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 Tramadol (Paxin TC)® during clinical trials and/or reported in post-marketing experience. A causal relationship between Tramadol (Paxin TC)® 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 Tramadol (Paxin TC) Hydrochloride

Adverse events which have been reported with the use of Tramadol (Paxin TC) 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 Tramadol (Paxin TC) 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 Tramadol (Paxin TC) when used concomitantly with other serotonergic agents such as SSRIs and MAOIs. Post-marketing experience with the use of Tramadol (Paxin TC)-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 Tramadol (Paxin TC), mostly in patients with pre-disposing risk factors, including diabetes, elderly and renal insufficiency. Caution should be exercised when prescribing Tramadol (Paxin TC) to diabetic patients. More frequent monitoring of blood glucose levels may be appropriate, including at initiation or dose increase.

Drug Abuse, Addiction And Dependence

Tramadol (Paxin TC) 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. Tramadol (Paxin TC) is associated with craving and tolerance development.

A Risk Management program to support the safe and effective use of Tramadol (Paxin TC)® has been established. The following are considered to be the essential components of the Risk Management program:

1. Commitment to not emphasize or highlight the scheduling status of Tramadol (Paxin TC)® (i.e., not listed under a schedule to the CDSA) in its advertising or promotional activities.
2. Inclusion of a PAAB-approved fair balance statement in all Tramadol (Paxin TC)® advertising and promotional materials.
3. Assurance that health-care education activities on pain management with Tramadol (Paxin TC)® 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 Tramadol (Paxin TC)® 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 Tramadol (Paxin TC)® 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.