Tramal 50mg Capsule 10 ‘S

Description

About

{{Product}} is a synthetic opioid analog that produces pain suppression at the Central Nervous System (CNS) level. {{Product}} is clinically prescribed to reduce moderate to severe pain in adults. It modifies the pain perception and response in the brain by acting as an agonist to the opioid receptors involved in analgesia. 

{{Product}} is also known to act as a serotonin reuptake inhibitor (SNRI) which makes it a potential agent to cause withdrawal symptoms in those who stop using it abruptly. This means that it also has anxiolytic and antidepressant effects to some extent so that Tramal 50mg Capsule 10 ‘S is an effective drug to be given to individuals who are suffering from depression and anxiety associated with pain. 

Long-term use of Tramal 50mg Capsule 10 ‘S is associated with addiction that can lead to overdose and toxicity, especially when it is used along with other opioid analgesics and antidepressants. There is also a risk of serious breathing problems along with sleep apnea. That’s why the usual practice is to initiate the therapy with the least possible dose for the shortest possible time. 

{{Product}} also acts on certain pain modulators and inflammatory markers. This suggests that Tramal 50mg Capsule 10 ‘S has a broad spectrum of acting as a potent pain-killer which is why it is an effective supportive therapy in the management of neuropathic pain, osteoarthritic pain, fibromyalgia (muscular pain that involves whole-body), back pain, labor & post-operative pain, and pain associated with tumors. 

Indications

{{Product}} is indicated for the management of moderate to severe pain in adults which could be chronic to severe. The extended-release formulation of Tramal 50mg Capsule 10 ‘S is used for long-term pain management. However, an immediate-release form is given for short-term pain management. 

How Does Tramal 50mg Capsule 10 ‘S Work

{{Product}} produces inhibitory effects on the ascending pain pathways by binding to the opioid mu receptors partially (agonistic effect) at the CNS level. {{Product}} also weakly inhibits serotonin and norepinephrine reuptake. These neurotransmitters are involved in descending pain perception and Tramal 50mg Capsule 10 ‘S makes them available to produce descending pain modulation. This way, {[product}} works in synergism with the central nervous system for the modulation of pain perception and response. 

{{Product}] also produces analgesic effects by affecting other pain modulators in the CNS and markers of the inflammation involved in immune responses such as Prostaglandins E2, Cytokines, and Glial cells. This action aids in multiple clinical manifestations which require pain management as a supportive treatment such as osteoarthritis, labor, and post-operative pain. 

How To Use Tramal 50mg Capsule 10 ‘S

{{Product}} should be taken orally (by mouth) with water irrespective of the meal. 

Dosage

Form and strength

• 50mg capsule 
• 100mg tablet
• 100mg injection (100mg/2ml)

Adult Dose

Immediate Release {{Product}}

Chronic Pain 

25mg once daily is the initial dose to be taken every morning. The dose can be increased to 50 mg once daily taken every 3 days and from 50 to 100mg taken every 6 hours as per the treatment response. 

Acute Pain 

50-100mg 6 hourly can be administered for acute pain. The progression of treatment depends upon the clinical response to the dose.

The dose should not be exceeded more than 400mg per day in both cases. The need to continue the treatment is decided after close monitoring of withdrawal symptoms. 

Extended-release (Capsule)

{{Product}} is usually given for round-the-clock treatment as 100mg once daily. The dose can be modified to 100mg per day every 5 days, and should not be exceeded more than 300mg each day. 

Pediatric Dose

{{Product}} should not be given to children below 12 years of age. 

Pregnancy And Lactation 

{{Product}} is contraindicated to be used in pregnancy as it may cause withdrawal symptoms in the neonate. It may also cause respiratory depression in infants if administered to the mother during labor. {{Product}} should not be taken by breastfeeding mothers as well as its active metabolite releases in breast milk and may harm the neonate. 

Contraindications

The use of Tramal 50mg Capsule 10 ‘S is contraindicated in the following scenarios:

• If you are sensitive to opioids, the active ingredients, the excipients used in the formulation of Tramal 50mg Capsule 10 ‘S. 
• If you have known or suspected obstruction in the G.I tract which may or may not be associated with gastrointestinal bleeding. 
• If you are taking Monoamine oxidase inhibitors (MAOIs) such as Isocarboxazid and Phenelzine, or have taken in the last 14 days. 
• Children under 12 years of age or children under 18 who have undergone surgery to rem tonsils or adenoids.  
• Severe or acute bronchial asthma, breathing problems, or respiratory depression.
• If you are taking sedatives such as sleeping pills, tranquilizers, or alcohol. 

Precautions

{{Product}} should be taken with caution under the following circumstances:

• Taking higher doses than recommended increases the risk of seizures, especially in people who are on opioids or antidepressants. 
• {{Product}} should be avoided use in individuals who have suicidal tendencies or are prone to addiction. 
• {{Product}} is known to develop an addiction. Its misuse may be fatal due to urge, leading to overdose and ultimately death due to respiratory depression. 
• Newborns may suffer froovem life-threatening withdrawal symptoms if Tramal 50mg Capsule 10 ‘S is administered during pregnancy. 
• Intake of alcohol during the treatment with Tramal 50mg Capsule 10 ‘S enhances slow breathing rate and hence causes fatal side effects. So consumption of alcohol or other sedatives should be strictly avoided. 
• If you feel extreme fatigue, loss of appetite, abdominal pain accompanied by nausea and vomiting, and low blood pressure; you should talk to your doctor as this may suspect adrenal insufficiency. 
• {{Product}} can cause sleep-related breathing problems such as sleep apnea in which there is a breathing pause during sleep. It may also cause sleep hypoxemia in which the oxygen levels in the blood go low. If you feel symptoms like shortness of breath, waking up from a deep sleep due to a breathing problem, or disturbed sleeping patterns, you should immediately tell your doctor who might proceed with dose reduction or pausing the treatment. 

Interactions With Other Medications

{{Product}} is known to have interaction with some medications. Concomitant administration of them should be avoided:

• Alvimopan 
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline

Except for Alvimopan (compete for the receptor site), all other agents increase serotonin levels in the CNS and hence may put the patient at risk of Serotonin Syndrome. 

Other agents that should be avoided during the treatment with Tramal 50mg Capsule 10 ‘S are:

• Duloxetine
• Venlafaxine
• Monoamine oxidase inhibitors (Phenelzine, Isocarboxazid)
• Opioids (Buprenorphine, Nalbuphine)
• Ondansetron
• Narcotics (Codeine, Morphine)
• Benzodiazepines (Alprazolam, diazepam)
• Antiplatelets (Warferin) 
• Tricyclic Antidepressants (Amitriptyline 
• Ketoconazole
• Theophylline

Adverse Effects

Common Adverse Effects

• Drowsiness
• Nausea
• Headache
• Constipation
• Dry mouth 
• Sweating 

Potential Adverse Effects 

{{Product}} has the potential to cause:

• Rapid breathing (to cope with shortness of breath)
• Increased heart rate
• Low blood pressure in the upright position
• G.I irritation 
• Serotonin syndrome
• Respiratory depression in children 
• Sleep apnea 
• Sleep-related hypoxemia 
• Withdrawal symptoms (anxiety, agitation, restlessness, tremor, and GI irritation)
• Seizures

Rare Adverse Effects

• Slow heart rhythms 
• Tingling sensations on the skin
• Muscle weakness
• Dilation of Pupils and blurred vision 
• Allergic reactions such as angioedema and urticaria
• Nightmares and sleep disturbances

How To Cope With Some Of The Adverse Effects

• Constipation – Drink a good amount of water and consume a diet rich in fiber such as green leafy vegetables, bananas, and oranges. Exercise daily and start using mild laxatives at bedtime, which act as stool softeners. 
• Drowsiness –  Avoid usage of caffeine, alcohol, and drugs that make you feel drowsy. Lifting heavy machinery and driving should also be avoided until you get back to normal. 
• Sleep apnea – Do not sleep in a supine position (on your back). Instead, sleeping on one side f your body can help you breathe normally during sleep. Use a humidifier in your room to retain moisture in the air and have surroundings to breathe easily. This should be followed by smoking or tobacco cessation. 
• Dry Mouth – Drink lots of water to stay hydrated, avoid medications that may cause dry mouth, use a mouthwash that is free of alcohol, and take sugarless candies and gum to increase salivation. 

Key Facts About Tramal 50mg Capsule 10 ‘S

• {{Product}} is indicated for the treatment of moderate to severe pain for acute and chronic management and works as an opioid analgesic as well as SNRI (Serotonin-norepinephrine reuptake inhibitor).
• {{Product}} is an analog of codeine and morphine and produces similar effects of analgesia. 
• {{Product}} has the potential to cause breathing difficulties as side effects, especially in children, that’s why it is contraindicated in children below 12 years of age. 
• {{Product}} is associated with withdrawal symptoms like other SNRIs, so dose progression and cessation should be followed by careful monitoring.

FAQs

• WHAT IS THE ONSET OF {{PRODUCT}}’S ACTION?

{{Product}} starts producing an analgesic effect within one hour of swallowing. 

• FOR HOW LONG DOES {{PRODUCT}} REMAIN EFFECTIVE?

The duration of action of Tramal 50mg Capsule 10 ‘S is 9 hours.

• CAN I CONSUME ALCOHOL DURING THE TREATMENT?

You should not consume alcohol during or after a certain period of treatment as it may make you feel drowsy and enhance the chances of developing side effects such as breathing difficulty. 

• DOES {{PRODUCT}} CAUSE WITHDRAWAL SYMPTOMS?

{{Product}} tends to develop withdrawal symptoms in you as it centrally acts on the nervous system. You should not stop using it abruptly or should not deviate from the dosing schedule set by the prescriber. 

• IS {{PRODUCT}} SAFE TO USE IN PREGNANCY?    

The product should be avoided in pregnancy as it may develop withdrawal symptoms in the neonate.                                                                             

• CAN A BREASTFEEDING MOTHER TAKE {{PRODUCT}}?

 There is a risk of exposure of the infant to serious side effects associated with the use of Tramal 50mg Capsule 10 ‘S. So it should not be given to a breastfeeding mother as its active metabolite is secreted in breast milk.

• WHEN WILL I GET RID OF THE WITHDRAWAL SYMPTOMS? 

Withdrawal symptoms may appear after 2 to 24 hours of the last dose. If the withdrawal symptoms are left untreated, they may persist for about 4 to 10 days. You should not suddenly stop taking Tramal 50mg Capsule 10 ‘S to avoid withdrawal symptoms. 

• HOW TO STORE {{PRODUCT}}?

{{Product}} can be stored at room temperature, below 30ºC. Protect it from direct sunlight and moisture. 

• WHAT TO DO IF I MISS THE DOSE?

{{Product}} is taken for pain management and usually taken once daily. But if you miss the dose, take it whenever you remember throughout the day. 

• WHAT TO DO IN CASE OF OVERDOSE?

The caregiver should look for breathing difficulties in case of overdose. Performing CPR (Cardiopulmonary Resuscitation) is helpful until the patient doesn’t get medical help. Naloxone is an active agent that reverses the effect of an opioid overdose. The medical practitioners give Naloxone as an antidote to Tramal 50mg Capsule 10 ‘S toxicity.