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Introduction About THEMIDOL 50MG INJECTION
THEMIDOL 50MG INJECTION contains Tramadol which belongs to the group of medicines called Opioids. It is used in the management of moderate to severe pain.
THEMIDOL 50MG INJECTION is not recommended for use in patients with seizures (fits) which are not controlled by the management, who have consumed alcohol, withdrawal symptoms caused by opiates (morphine-like medicines).
Before receiving THEMIDOL 50MG INJECTION, inform your doctor if you had or have a head injury, breathing difficulties, severe liver or kidney problems, feeling of faint, are in a shocking state (sign may be cold sweat), addicted to alcohol or certain medicines (such as opioids), previously suffered from withdrawal symptoms while stop taking drugs or alcohol (signs include agitation, anxiety, shaking or sweating), adrenal insufficiency and seizures (fits).
THEMIDOL 50MG INJECTION is not recommended for use in pregnant and breastfeeding women. THEMIDOL 50MG INJECTION is not recommended for use in children (below 12 years of age) and in children with breathing problems. It should be cautiously used among elderly patients (aged 75 years and above).
The most common side effects of receiving THEMIDOL 50MG INJECTION are fatigue, vomiting, headache, dry mouth and constipation. Inform your doctor if any of the side effects worsen.
Uses Of THEMIDOL 50MG INJECTION
- Manage moderate to severe pain
How THEMIDOL 50MG INJECTION Works
THEMIDOL 50MG INJECTION inhibits the reuptake of the natural neurotransmitters (norepinephrine and serotonin) and binds weakly to certain receptors (μ-opioid), blocking the transmission of pain signals to the brain. Thus, it reduces moderate to severe pain by acting on specific nerve cells of the spinal cord and the brain.
How to use THEMIDOL 50MG INJECTION
THEMIDOL 50MG INJECTION will be given to you only by a doctor or a nurse into a vein as a slow intravenous infusion or into the muscle as intramuscular injection. Your doctor will decide the correct dose and duration for you depending on your age, body weight and disease condition.
Side Effects Of THEMIDOL 50MG INJECTION
Common
- fatigue, sweating
- vomiting, headache
- constipation
- dry mouth
- somnolence (feeling of sleepiness, drowsy or low in energy)
Uncommon
- effects on the heart and blood circulation (pounding of the heart, fast heartbeat, feeling faint or collapsing during an upright position or under physical strain)
- retching (urge to be sick)
- trouble stomach (such as a feeling of pressure in the stomach, bloating and diarrhoea)
- skin reactions (such as rash and itching)
Rare
- slow heart rate elevated blood pressure
- changes in appetite
- abnormal sensations (such as itching, tingling and numbness)
- trembling, epileptic fits, muscle twitches, uncoordinated movement
- transient syncope (loss of consciousness), speech abnormalities
- hallucinations, sleep disorders, delirium, anxiety and nightmares
- mood changes (mostly high spirits, occasionally irritated mood)
- changes in activity (such as slowing down or increasing in activity)
- decreased cognitive and secondary perception (changes in senses and recognition which lead to errors in judgment)
- muscle weakness
- blurred vision, dilated pupils
- pain and difficulties in passing urine or low urine output
Inform your doctor immediately if you experience any of the following side effects while receiving THEMIDOL 50MG INJECTION:
- slow or shallow breathing, confusion, sleepiness, small pupils, severe nausea and or constipation, constipation and lack of appetite
- serotonin syndrome (signs include agitation, hallucination, coma, fever, increase in heart rate, unstable blood pressure, involuntary twitching, muscular rigidity, lack of coordination, nausea, vomiting and diarrhoea)
- difficulty breathing, rash or itchy skin, swollen face or tongue or difficulty in swallowing
- sleep-related breathing disorders or hypoxemia (signs include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintaining sleep or excessive drowsiness during the day)
How To Manage Side Effects
Vomiting:
Stick to simple meals while receiving this medicine. Avoid eating oily rich, fried or spicy foods. Do not lie down or sleep immediately after eating. Inform your doctor if the symptom does not improve.
Constipation:
Try to eat more high-fibre foods such as fresh fruit, vegetables, cereals, and drink plenty of water. If this does not help, inform your doctor to receive alternate management for constipation.
Headache:
Drink an ample amount of water and avoid skipping meals. Get adequate rest. Try to be relaxed and stress-free. Apply pain relieving balm on your forehead if necessary. Inform your doctor if the symptom does not improve.
Dry mouth:
Sip water regularly and other sugar-free liquids. Do not use mouthwashes that contain alcohol because they can make your mouth dry, use mouthwash that is used only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco products. Inform your doctor if the symptom does not improve.
Warning & Precautions
Pregnancy
THEMIDOL 50MG INJECTION is not recommended for use in pregnant women or women planning to have a baby because the baby may become dependent and may show withdrawal symptoms after the birth. Consult your doctor before receiving THEMIDOL 50MG INJECTION.
Breastfeeding
THEMIDOL 50MG INJECTION is not recommended for use in breastfeeding women as it may pass through the breast milk and will affect the baby. Consult your doctor before receiving THEMIDOL 50MG INJECTION.
Driving and Using Machines
Do not drive or operate any machines if you experience drowsiness, dizziness, blurred vision or impaired reaction after receiving THEMIDOL 50MG INJECTION.
Alcohol
Do not consume alcohol while receiving THEMIDOL 50MG INJECTION as it may increase the effects of this medicine.
Kidney
THEMIDOL 50MG INJECTION should be used with caution in patients with kidney problems. Consult your doctor before receiving THEMIDOL 50MG INJECTION.
Liver
THEMIDOL 50MG INJECTION should be used with caution in patients with severe liver problems. Consult your doctor before receiving THEMIDOL 50MG INJECTION.
Allergy
Do not receive THEMIDOL 50MG INJECTION if you are allergic to Tramadol or any other ingredients of this medicine.
Others
THEMIDOL 50MG INJECTION is not recommended for use if you:
- have epilepsy (fits) which is not properly controlled by the management
- have withdrawal symptoms caused by opiates (morphine-like medicines)
Before receiving THEMIDOL 50MG INJECTION, inform your doctor if you:
- have a head injury or breathing difficulties
- have a feeling of fainting
- are in a shocking state (cold sweat may be a sign)
- are addicted to certain medicines (such as opioids or prescription medicines) and alcohol
- tend to develop fits
- have a history of suffering from withdrawal symptoms such as agitation, anxiety, shaking or sweating (when stopped taking drugs or alcohol)
- have signs of adrenal insufficiency (low levels of cortisol) such as extreme fatigue, lack of appetite, severe abdominal pain, nausea, vomiting or low blood pressure
Use in paediatrics:
THEMIDOL 50MG INJECTION is not recommended for use in children (under 12 years of age). It is also not recommended for children having breathing problems because the toxicity of this medicine will be worse in these children. Consult your child’s doctor for advice before administration of THEMIDOL 50MG INJECTION to your child.
Use in geriatrics:
THEMIDOL 50MG INJECTION should be used with caution in elderly patients (aged above 75 years). Consult your doctor before receiving THEMIDOL 50MG INJECTION
Interactions
A. Drug - Drug interactions:
Before receiving THEMIDOL 50MG INJECTION, inform your doctor if you are taking any of the following medicines:
- benzodiazepines (medicines used to manage anxiety or sleep problems) Ex. diazepam, lorazepam
- anticoagulants (medicines used to manage or manage blood clots) Ex. warfarin
- carbamazepine (used to manage fits)
- ondansetron (used to manage or manage nausea)
- monoamine oxidase inhibitors (medicines used to manage depression) Ex. moclobemide, phenelzine and selegiline (used to manage Parkinson's disease)
- other medicines used to manage pain (Ex. pentazocine, buprenorphine, morphine, codeine)
Overdosage:
THEMIDOL 50MG INJECTION will be administered to you only by a physician or a nurse in a hospital, and so it is unlikely to receive an overdose. However, consult your physician if you experience any unusual symptoms. Overdosage symptoms of THEMIDOL 50MG INJECTION are excessive constriction of the pupil of the eye, vomiting, cardiovascular collapse, consciousness disorders up to coma, convulsions, respiratory depression up to respiratory arrest and serotonin syndrome (a serious drug reaction).
Synopsis
| Drug | : | Tramadol |
| Pharmacological Category | : | Opioids |
| Therapeutic Indication | : | Moderate to severe pain |
| Dosage Forms | : | Injection, Tablet, Capsule, Suppositories |
More Information
- Store at room temperature
FAQs About THEMIDOL 50MG INJECTION
Does THEMIDOL 50MG INJECTION cause withdrawal symptoms?
Yes, if you stop receiving THEMIDOL 50MG INJECTION suddenly you may experience withdrawal symptoms (such as restlessness, sleeping difficulties, irritability, agitation, anxiety, palpitations, increased blood pressure, nausea and vomiting, shaking, shivering or sweating. Your doctor will determine the appropriate duration of management and safely stop the management when it is not necessary by gradually reducing the dose.
What are the common side effects of receiving THEMIDOL 50MG INJECTION?
The most common side effects of receiving THEMIDOL 50MG INJECTION are fatigue, vomiting, headache, sweating, dry mouth, somnolence (feeling of sleepiness, drowsy or low in energy) and constipation. Inform your doctor if any of the side effects worsens
Is THEMIDOL 50MG INJECTION safe to use in children?
THEMIDOL 50MG INJECTION is not recommended for use in children (under 12 years of age). It is also not recommended for children having breathing problems because the toxicity of this medicine will be worse in these children. Consult your child’s doctor for advice before administration of THEMIDOL 50MG INJECTION to your child.
Is THEMIDOL 50MG INJECTION safe during breastfeeding?
THEMIDOL 50MG INJECTION is not recommended for use in breastfeeding women as it may pass through the breast milk and will affect the baby. Consult your doctor before receiving THEMIDOL 50MG INJECTION
Can THEMIDOL 50MG INJECTION be used in patients with kidney problems?
THEMIDOL 50MG INJECTION should be used with caution in patients with kidney problems. Your doctor may adjust the dose depending on kidney function. Consult your doctor for advice before receiving THEMIDOL 50MG INJECTION
References
1. KD Tripathi MD. Drugs acting on Central nervous system. Essentials of Medical Pharmacology. Eighth Edition, 2019. Page -504
2. Minkowitz H, Leiman D, Lu L, Reines S, Ryan M, Harnett M, Singla N. IV Tramadol A New Treatment Option for Management of Post-Operative Pain in the US: An Open-Label, Single-Arm, Safety Trial Including Various Types of Surgery. NIH National Library of Medicine, National centre for biotechnology information. Pubmed Central. 2020 [Accessed on 14th September 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7250287/
3. Avenue Therapeutics. Tramadol Infusion-Post operative pain safety study. Clinical trial.gov. 2017[Revised in August 2018] [Accessed on 14th September 2022] https://clinicaltrials.gov/ProvidedDocs/08/NCT03395808/Prot_000.pdf
4. Siegfried Hameln GmbH. Electronic Medicines Compendium (EMC). [Revised in January 2022] [Accessed on 14th September 2022] https://www.medicines.org.uk/emc/files/pil.3420.pdf
Useful Diagnostic Tests
- Kidney function test
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