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Introduction About PROTHIADEN 50MG TABLET
PROTHIADEN 50MG TABLET contains Dosulepin which belongs to the group of medicines called Antidepressants. It is used in the management of depression (mood disorder causing persistent feeling of sadness and loss of interest) and also helps to reduce the feelings of anxiety (intense, excessive, persistent worry and fear about everyday situations), this medicine is used only when other medicines are not suitable.
PROTHIADEN 50MG TABLET is not recommended for use in patients with liver problems, irregular heartbeat or any other heart problems, mania (feeling over excited with unusual behaviour), glaucoma (increased pressure in eye), prostate problems and fits. Before taking PROTHIADEN 50MG TABLET inform your doctor if you have any planned surgeries (such as dental or general surgery), intolerance to certain sugars and thyroid problems. Avoid consumption of alcohol during management with PROTHIADEN 50MG TABLET as it can make the drowsiness worse.
PROTHIADEN 50MG TABLET should be used in pregnant and breast-feeding women only if clearly advised by the doctor. It is not recommended for use in children and adolescents (below the age of 18 years) and it should be used with caution in elderly patients due to increased risk of certain side effects. The most common side effects of taking PROTHIADEN 50MG TABLET are dry mouth, blurred vision, dizziness, constipation, sedation and difficulty in passing urine. Consult with your doctor if any of the side effect worsens.
Uses Of PROTHIADEN 50MG TABLET
It is used to:
- manage depression
- reduce feelings of anxiety
How PROTHIADEN 50MG TABLET Works
PROTHIADEN 50MG TABLET acts on central nervous system (CNS) which works by enhancing the activity of certain neurotransmitters (such as serotonin and noradrenaline) in the brain. It also works by stopping the reabsorption of neurotransmitters into the nerve cells in the brain. Thus, results in prolonging their effects and helps to relieve depression and lighten the mood.
How to use PROTHIADEN 50MG TABLET
Take PROTHIADEN 50MG TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
Side Effects Of PROTHIADEN 50MG TABLET
Common
- dry mouth
- blurred vision
- heartbeat changes
- dizziness
- constipation
- sedation
- difficulty in passing urine
Uncommon
- severe allergic reaction
- severe low blood pressure
- increased sweating
- tiredness or sleepiness
- confusion and hallucination (strange vision or sounds)
- tremors
- changes in libido (sex drive)
Rare
- severe mood changes such as extreme excitability
Stop taking PROTHIADEN 50MG TABLET and inform your doctor immediately if you experience any of the following side effects:
- skin rash or difficulty in breathing
- self-harming thoughts
- bone marrow depression or reduction in some blood cells (signs include unusual bruising, abnormal bleeding, mouth ulcers, sore throat and fever)
- liver problems associated with yellowing of the skin and eyes (jaundice)
- convulsions
- irregular heartbeat
How To Manage Side Effects
Constipation
Try to eat more high-fiber foods such as fresh fruit, vegetables, cereals, and drink plenty of water. Try doing exercise regularly (going for a daily walk or run). If this does not help, inform your doctor for receiving alternate management for constipation.
Dizziness Or Drowsiness
Lie down until dizziness is gone, then get up slowly. Move slowly and carefully, do not hurry. Get adequate rest. Drink plenty of water and other fluids. Avoid coffee, cigarettes, alcohol, and drugs. Consult your doctor if the symptom gets worse.
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. Consult your doctor if the symptom does not improve.
Warning & Precautions
Pregnancy
Monitoring requiredPROTHIADEN 50MG TABLET should be used in pregnant women only if clearly advised by your doctor. Consult your doctor before taking it.
Breastfeeding
Monitoring requiredPROTHIADEN 50MG TABLET should be used in breastfeeding women only if clearly advised by your doctor. Consult your doctor before taking the medicine.
Driving and Using Machines
Use with CautionDo not drive or use machines if you feel drowsy after taking PROTHIADEN 50MG TABLET. Consult your doctor for advice.
Alcohol
Consult your doctorAvoid consumption of alcohol during management with PROTHIADEN 50MG TABLET as it can make the feeling of drowsiness worse.
Liver
ContraindicatedPROTHIADEN 50MG TABLET is not recommended for use in patients with liver problems. Consult your doctor before taking PROTHIADEN 50MG TABLET.
Allergy
ContraindicatedDo not take PROTHIADEN 50MG TABLET if you are allergic to Dosulepin or any other ingredients of this medicine.
Heart Disease
ContraindicatedPROTHIADEN 50MG TABLET is not recommended for use in patients with irregular heartbeat or any other heart problems. Consult your doctor before taking PROTHIADEN 50MG TABLET.
Use In Pediatrics
ContraindicatedPROTHIADEN 50MG TABLET is not recommended for use in children and adolescents (under 18 years of age). Consult child’s doctor for advice.
Use In Geriatrics
Use with CautionPROTHIADEN 50MG TABLET should be used with caution in elderly patients due to increased risk of side effects such as agitation, confusion and light headedness. Consult your doctor before taking PROTHIADEN 50MG TABLET.
Others
PROTHIADEN 50MG TABLET is not recommended for use if you:
- have mania (feeling over excited with unusual behaviour)
- have glaucoma (increased pressure in eye)
- have fits (epilepsy)
- have prostate problems (difficulty in passing urine)
Before taking PROTHIADEN 50MG TABLET inform your doctor if you:
- have any planned surgeries (general or dental surgery)
- have thyroid problems
- are intolerant to certain sugars
Interactions
A. Drug-Drug Interactions:
Before taking PROTHIADEN 50MG TABLET inform your doctor if you are taking any of the following medicines:
- medicines used to manage depression such as selective serotonin reuptake inhibitor (SSRIs) (Ex. citalopram, fluoxetine) and mono-amine oxidase inhibitor (MAOI) (Ex. isocarboxazid, phenelzine)
- medicines used to manage underactive thyroid (Ex. Levothyroxine)
- medicines used to manage epilepsy (Ex. phenobarbitone), insomnia (Ex. amylobarbitone) and behavioural problems (Ex. methylphenidate)
- medicine containing an opioid (Ex. codeine, morphine, dihydrocodeine, co-proxamol and co-dydramol) (used to manage pain)
- medicines used to manage heart problems and asthma (also as cough and cold remedies), sympathomimetic agents (Ex. ephedrine, pseudoephedrine, adrenaline and noradrenaline)
- medicines used to manage high blood pressure (Ex. guanethidine) and regulate heartbeat (Ex. sotalol)
- terfenadine, astemizole (used to manage hay fever or allergy)
- halofantrine (used to manage malaria)
Overdosage:
If you or anyone else accidentally takes too much of PROTHIADEN 50MG TABLET, consult your doctor immediately or visit the nearby hospital as it may seriously harm you and cause life-threatening problems.
Synopsis
| Drug | : | Dosulepin |
| Pharmacological Category | : | Tricyclic Antidepressants |
| Therapeutic Indication | : | Depression, Anxiety |
| Dosage Forms | : | Tablet |
More Information
Storage
- Keep PROTHIADEN 50MG TABLET out of reach of children
- Store at room temperature
FAQs About PROTHIADEN 50MG TABLET
Q: What is PROTHIADEN 50MG TABLET and why it is given?
A: PROTHIADEN 50MG TABLET contains Dosulepin which belongs to the group of medicines called Antidepressants. It is used in the management of depression and also helps to reduce the feelings of anxiety.
Q: Can I stop taking PROTHIADEN 50MG TABLET on my own?
A: No. You should not stop taking PROTHIADEN 50MG TABLET suddenly on your own without the advice of your doctor. Your doctor may gradually withdraw the dose in case of stopping the medicine. If you stop taking PROTHIADEN 50MG TABLET suddenly you may experience some withdrawal symptoms like irritability, insomnia and excessive perspiration (sweating).
Q: Is PROTHIADEN 50MG TABLET safe to use in pregnant and breast-feeding women?
A: PROTHIADEN 50MG TABLET should be used in pregnant and breast-feeding women only if clearly advised by the doctor. Consult your doctor before taking PROTHIADEN 50MG TABLET if you are pregnant or planning to get pregnant or breast-feeding your child.
Q: Can I drive or operate heavy machines after taking PROTHIADEN 50MG TABLET?
A: PROTHIADEN 50MG TABLET may cause drowsiness. Therefore, it is not advisable to drive or use machineries and tools until you feel normal again. Consult your doctor for advice before taking PROTHIADEN 50MG TABLET.
Q: Can PROTHIADEN 50MG TABLET be used in elderly patients?
A: PROTHIADEN 50MG TABLET should be used with caution in elderly patients due to increased risk of side effects such as agitation, confusion and light headedness. Consult your doctor before taking it.
References
1. KD. Tripathi. Antidepressant and Antianxiety Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page-459.
2. T Nakagawa, K Ukai, S Kubo. Antidepressive effects of the stereoisomer cis-dosulepin hydrochloride. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. January 1993 [Accessed on 14th June 2022] https://pubmed.ncbi.nlm.nih.gov/8447840/
3. P Zusky, T C Manschreck, C Blanchard, J Rosenbaum, C Elliot, P Lou. Dosulepin hydrochloride: management efficacy and safety. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. October 1986. [Accessed on 14th June 2022] https://pubmed.ncbi.nlm.nih.gov/3531188/
4. Dosulepin. NIH National Library of Medicine, National center for biotechnology information. Pubchem. [Revised in September 2022] [Accessed on 14th June 2022] https://pubchem.ncbi.nlm.nih.gov/compound/Dosulepin#section=Mechanism-of-Action
5. Teva Pharmaceuticals Works Pvt Ltd. Dosulepin. [Revised in March 2021]. [Accessed on 14th June 2022] https://products.tevauk.com/mediafile/id/50662.pdf
6. Teofarma S.r.l. Health Products Regulatory Authority (HPRA). [Revised in July 2020] [Accessed on 14th June 2022] https://www.hpra.ie/img/uploaded/swedocuments/0cc11c1c-a57e-470f-a788-57d351b29341.pdf






