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INTRODUCTION
DROTIN PLUS TABLET is a combination of Drotaverine and Paracetamol which belongs to the group of medicines called Anti-spasmodic agents and Analgesics & Antipyretics respectively. It is used to treat and relieve pain due to irritable bowel syndrome, menstrual cramps, cervical spasm during labour, headache, chest pain, gallstones pain and pain in renal colic. This medicine also treats spasm or twitches of the smooth muscles in the stomach and heart.
DROTIN PLUS TABLET is not recommended for use in patients with severe liver or kidney disease and heart disease. Contact your doctor before taking. Before taking DROTIN PLUS TABLET inform your doctor if you have lung, liver or kidney disease or heart disease. Contact your doctor before taking. DROTIN PLUS TABLET should be used with caution in pregnant and breastfeeding women. Contact your doctor before taking.
DROTIN PLUS TABLET is not recommended for use in children under 10 years of age. Contact your doctor before taking. DROTIN PLUS TABLET should be used with caution in elderly patients aged 65 years or above. Contact your doctor before taking. The most common side effects of this medicine are dry mouth, dizziness, nausea and vomiting, fluctuating pulse rate, headache and skin reactions. Contact your doctor if any of the side effects worsen.
USES OF DROTIN PLUS TABLET
It is used to treat and relieve pain due to:
- irritable bowel syndrome
- menstrual periods
- cervical spasm during labour
- headache
- chest pain
- gallstones and renal colic
It also treats spasm or twitches of the smooth muscles in the stomach and heart.
HOW DROTIN PLUS TABLET WORKS
DROTIN PLUS TABLET helps to treat pain, where Drotaverine works by inhibiting phosphodiesterase 4 (an enzyme responsible for the degradation of cyclic adenosine monophosphate CAMP), inhibition of PDE4 leads to elevated levels of CAMP and reduced calcium uptake by the cells, leading to smooth muscle relaxation. Paracetamol relieves pain by reducing the production of prostaglandins in the brain and spinal cord. Prostaglandins are produced by the body in response to injury and certain diseases.
DIRECTIONS FOR USE
Take DROTIN PLUS TABLET as advised by your physician. Swallow this medicine as whole with a glass of water and do not crush or chew the medicine. Your doctor will decide the right dose depends on your age, body weight and disease condition.
SIDE EFFECTS OF DROTIN PLUS TABLET
COMMON
- dry mouth
- dizziness
- nausea and vomiting
- fluctuating pulse rate
- headache
- skin reactions
RARE
- blood platelet disorders
- abnormal formation of blood cell in bone marrow
- depression
- confusion
- hallucinations
- tremor
- headache
- disturbed vision
- oedema
- pain in abdomen, bleeding from stomach or intestines
- diarrhoea
- dizziness
- fever, sedation
Stop taking DROTIN PLUS TABLET and contact your physician immediately if you experience any of the following side effects:
- severe allergic reactions such as rash, itching, sweating, hives, red patches on skin, swelling of the face, lips, tongue or throat causing difficulty in breathing
- liver disease such as jaundice (yellowish discolouration of the skin and whites of eyes), hepatic necrosis or liver failure
HOW TO MANAGE SIDE EFFECTS
Diarrhea
Drink lots of fluids, such as water or fruit juices to keep you hydrated. Do not take any medicine on your own for treating diarrhoea. Contact your doctor if the symptom did not improve.
Dizziness Or Drowsiness
Try to rest and relax. Get enough sleep. Avoid driving or operate any machines while you are feeling dizzy. Do not consume alcohol, as it can aggravate your dizziness. Contact your doctor if the symptom did not improve.
Headache
Rest and relax. Drink plenty of fluids such as water or electrolytes and apply a pain-relieving balm on the head if necessary. Do not consume alcohol. Contact your doctor if the symptom did not improve.
Nausea And Vomiting
Take this medicine with, or just after meals. Stick to simple meals. Avoid eating oily or spicy foods.
Stomach Pain
Try to rest and relax. Eat small meals but take frequently. Keep a heat pad on your stomach. Contact your doctor if the symptom did not improve.
WARNING & PRECAUTIONS
PREGNANCY
Use with CautionDROTIN PLUS TABLET should be used with caution in pregnancy. Contact your doctor before taking.
BREASTFEEDING
Use with CautionDROTIN PLUS TABLET should be used with caution in breastfeeding. Contact your doctor before taking it.
ALCOHOL
Consult your doctorAvoid consumption of alcohol while taking DROTIN PLUS TABLET as it increases the risk of liver damage.
KIDNEY
ContraindicatedDROTIN PLUS TABLET is not recommended for use in patients with severe kidney disease. Contact your doctor before taking.
LIVER
Consult your doctorDROTIN PLUS TABLET is not recommended for use in patients with severe liver disease and should be used with caution in liver disease (including Gilbert’s syndrome or hepatitis). Contact your doctor before taking.
ALLERGY
ContraindicatedDo not take DROTIN PLUS TABLET if you are allergic to Drotaverine, Paracetamol or to other ingredients of this medicine.
LUNGS
Use with CautionDROTIN PLUS TABLET should be used with caution in patients with lung diseases such as asthma. Contact your doctor before taking.
HEART DISEASE
ContraindicatedDROTIN PLUS TABLET is not recommended for use in patients with severe heart diseases. Contact your doctor before taking.
USE IN PEDIATRICS
Consult your doctorYour doctor will prescribe the right dose depends on your child’s age, body weight and disease condition. Contact your doctor before taking DROTIN PLUS TABLET.
USE IN GERIATRICS
Use with CautionDROTIN PLUS TABLET should be used with caution in elderly patients (aged 65 years or above). Contact your doctor before taking.
OTHERS
DROTIN PLUS TABLET is not recommended for use if you have:
- porphyria
Before taking DROTIN PLUS TABLET, inform your doctor if you:
- are dehydrated
- have impaired nutritional state
- have haemolytic anaemia
- have deficiency of glucose- 6-phosphatedehydrogenase
- have serious infection
- have metabolic acidosis
INTERACTIONS
A. Drug-Drug interactions:
Inform your physician, if you are taking:
- chloramphenicol (medicines used to treat infections)
- metoclopramide or domperidone (medicines used to treat nausea and vomiting)
- cholestyramine (medicines used to lower high cholesterol levels)
- probenecid (medicines used to treat gout)
- warfarin (medicines used to treat blood clots)
- salicylamide (medicines used to treat fever and pain)
- lamotrigine, phenytoin (medicines used to treat epilepsy)
- barbiturates or carbamazepine (medicines used to treat mental disorders and epilepsy)
- rifampicin, isoniazid (medicines used to treat bacterial infections like tuberculosis)
- St John’s wort (herbal medicine used for depression)
- imatinib (medicine used to treat leukaemia and some stomach tumours)
- levodopa (medicines used to treat Parkinson’s disease)
Overdosage:
If you or anyone else accidentally took too much of this medicine, consult your doctor immediately. Symptoms of overdose are nausea, vomiting, loss of appetite, paleness and abdominal pain or liver damage.
SYNOPSIS
| Drug | : | Drotaverine, Paracetamol |
| Pharmacological Category | : | Phosphodiesterase 4 inhibitors, Analgesics |
| Therapeutic Indication | : | Pain |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep out of reach of children
- Store DROTIN PLUS TABLET below 25°C
FAQs ABOUT DROTIN PLUS TABLET
Q: For what conditions DROTIN PLUS TABLET is used?
A: DROTIN PLUS TABLET is used to treat and relieve pain due to irritable bowel syndrome, menstrual cramps, cervical spasm during labour, headache, chest pain, gallstones pain and pain in renal colic. This medicine also treats spasm or twitches of the smooth muscles in the stomach and heart.
Q: What are the side effects of taking DROTIN PLUS TABLET?
A: The most common side effects of this medicine are nausea, vomiting, dry mouth and vertigo. Contact your doctor if any of the symptoms worsen.
Q: How DROTIN PLUS TABLET works?
A: DROTIN PLUS TABLET helps to treat pain, where Drotaverine works by inhibiting phosphodiesterase 4 (an enzyme responsible for the degradation of cyclic adenosine monophosphate CAMP), inhibition of PDE4 leads to elevated levels of CAMP and reduced calcium uptake by the cells, leading to smooth muscle relaxation. Paracetamol relieves pain by reducing the production of prostaglandins in the brain and spinal cord. Prostaglandins are produced by the body in response to injury and certain diseases.
Q: Can I drink alcohol while using DROTIN PLUS TABLET?
A: No. Avoid consumption of alcohol while taking DROTIN PLUS TABLET as it increases the risk of liver injury.
Q: Can I use DROTIN PLUS TABLET in children?
A: Your doctor will prescribe the right dose depends on your child’s age, body weight and disease condition. Contact your doctor before taking DROTIN PLUS TABLET.
REFERENCES
1. K.D. Tripathi. Drugs acting on the ANS & NSAIDs and Antipyretic- Analgesics. Essentials of medical pharmacology. Seventh edition. 2013. Page- 118, 207.
2. Narang S, Koli J. Uses of Drotaverine hydrochloride and Paracetamol. Journal of Gastroenterology and Hepatology. December 2018. [Accessed on 13th June 2022] https://pubmed.ncbi.nlm.nih.gov/29968385/
3. Bethesda (MD). Levamisole. National Institute of Health. NLM. National Centre for Biotechnology Information. PubChem Compound Summary. 2004. [Accessed on 13th June 2022] https://pubchem.ncbi.nlm.nih.gov/compound/1712095#section=Top
4. Balkan Pharma. Health Products Regulatory Authority (HPRA). [Revised in June 2019] [Accessed on 13th June 2022] https://www.hpra.ie/img/uploaded/swedocuments/2b04cfdb-8571-4543-a4c9-b1380e0a92c3.pdf
5. Accord, Barnstaple. Electronic Medicines Compendium (EMC). [Revised in November 2021] [Accessed on 13th June 2022] https://www.medicines.org.uk/emc/files/pil.5916.pdf
6. Drotaverine and Paracetamol. Tanishq Life care. [Accessed on 13th June 2022] http://india.tanishqlifecare.com/latest-update/drotaverine-80-mg-/8855
7. Drotaverine and Paracetamol. Mims.com. [Accessed on 13th June 2022] https://www.mims.com/malaysia/drug/info/drotaverine?mtype=generic
8. Drotaverine and Paracetamol. West-Coast Pharmaceuticals Ltd. [Accessed on 13th June 2022] https://westcoastin.com/product/spascol-drotaverine-hydrochloride-paracetamol-80-mg-500-mg/
USEFUL DIAGNOSTIC TESTS
- Complete blood count
- Prothrombin time
AUTHOR DETAILS
Written By Dr. Janet.C, Pharm.D
Last updated on 18 Feb 2023 | 06:04 PM(IST)
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