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INTRODUCTION
NAUSILEX TABLET is a combination of Doxylamine and Pyridoxine which belongs to the group of medicines called Anti-emetics and Vitamin B Complex respectively. It is used in pregnant women to treat nausea and vomiting (morning sickness) when changes in diet or other non-medical treatments does not provide adequate response.
Doxylamine is an antihistamine. It blocks the actions of certain chemicals in the body that causes nausea and vomiting. Pyridoxine is a vitamin B supplement. It supplements our body with necessary vitamins that is required for proper foetal growth and development. Collectively, they both reduce nausea and vomiting during pregnancy while replacing the lost nutrients.
Take NAUSILEX TABLET as advised by your physician. NAUSILEX TABLET cannot cure vomiting caused due to pregnancy. It can only manage the symptoms for a short period. Therefore, continue to take NAUSILEX TABLET as advised by the physician to achieve better results. NAUSILEX TABLET can be used in all trimesters of pregnancy.
Before taking NAUSILEX TABLET inform your doctor if you have asthma or any stomach problems. You must also inform your doctor if you have any problems in your bladder. Consult your doctor before taking NAUSILEX TABLET if you are breastfeeding.
NAUSILEX TABLET may make you feel dizzy or drowsy and therefore be cautious while you drive or handle any heavy tools or machines. Other most common side effects of NAUSILEX TABLET are headache, stomach pain and trouble sleeping.
USES OF NAUSILEX TABLET
- Treats morning sickness (nausea and vomiting) during pregnancy
HOW NAUSILEX TABLET WORKS
NAUSILEX TABLET prevents nausea and vomiting in pregnant women where doxylamine acts by blocking the actions of a certain chemicals (histamine) in the body that causes nausea and vomiting and pyridoxine acts by replacing the lost nutrients in the body. Collectively they reduce morning sickness during pregnancy while replacing the lost nutrients.
DIRECTIONS FOR USE
Take NAUSILEX TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. NAUSILEX TABLET must be taken on an empty stomach. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition. Do not stop taking NAUSILEX TABLET unless your doctor tells you to stop, as it may make the nausea and vomiting to reoccur.
SIDE EFFECTS OF NAUSILEX TABLET
COMMON
- feeling sleepy, dizzy or tired
- dryness of mouth
RARE
Stop taking NAUSILEX TABLET and contact your doctor immediately if you experience any of the following side effects such as:
- signs of allergic reactions (such as skin rash, itching, swelling of the face, lips, mouth, tongue, or throat causing difficulty in swallowing or breathing)
HOW TO MANAGE SIDE EFFECTS
Dizziness Or Drowsiness
Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your condition did not improve.
WARNING & PRECAUTIONS
PREGNANCY
SafeNAUSILEX TABLET is intended for use in pregnant women. However, consult your doctor before taking.
BREASTFEEDING
ContraindicatedNAUSILEX TABLET is not recommended for use in breast-feeding women as it may pass through breast milk. Therefore, consult your doctor before taking it.
DRIVING AND USING MACHINES
Use with CautionDo not drive or handle any heavy tools or machines if you experience dizziness, drowsiness, or blurred vision after taking NAUSILEX TABLET.
ALCOHOL
Consult your doctorAvoid consumption of alcohol while undergoing treatment with NAUSILEX TABLET.
ALLERGY
ContraindicatedDo not take NAUSILEX TABLET if you are allergic to pyridoxine, doxylamine or to any other antihistamines (such as diphenhydramine).
LUNGS
Use with CautionNAUSILEX TABLET should be used with caution in patients who have or ever had asthma. Therefore, consult your doctor before taking it.
USE IN PEDIATRICS
ContraindicatedNAUSILEX TABLET is not intended for use in children and adolescents (below18 years). Therefore, consult your doctor before taking it.
OTHERS
Before taking NAUSILEX TABLET, inform your doctor if you:
- have or every had glaucoma
- have or every had ulcers in the stomach
- have or every had blockage in the gut, between stomach and small intestine
- have or every had blockage in the urinary bladder
- have hyperemesis gravidarum (a condition which causes severe nausea and vomiting which is uncontrollable)
- are going to have a urine test
INTERACTIONS
A. Drug - Drug interactions:
Before taking NAUSILEX TABLET, inform your doctor if you are taking any of the following medicines such as:
- linezolid (an antibiotic medicine used to treat bacterial infections)
- medicines used to treat parkinson’s disease (Ex. levodopa)
- methylene blue (used to treat blood disorder)
- medicines used to treat conditions such as disorders in bowel, bladder or
respiratory systems (Ex. solifenacin, scopolamine, ipratropium) - medicines used to treat depression or other mental illness (Ex. sertraline, citalopram, escitalopram, selegiline, rasagiline)
- medicine used to reduce anxiety and to induce sleep (Ex. alprazolam, lorazepam, zolpidem, triazolam)
- medicines used to treat allergies (Ex. cetirizine, montelukast, fexofenadine)
- anaesthetics medicines used before surgeries for sedation (Ex. etomidate, sevoflurane, isoflurane)
- medicines used to relive severe pain (Ex. fentanyl, codeine, paracetamol, ibuprofen)
- cough medicine (Ex. dextromethorphan)
- vitamin B supplements
B. Drug-Food interactions
Avoid taking NAUSILEX TABLET with food as it may delay the absorption of NAUSILEX TABLET.
Overdosage:
If you or anyone else accidentally took more NAUSILEX TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose might include restlessness,
dry mouth, dilated pupils (blurred vision), dizziness, sleepiness, vertigo (spinning sensation), confusion and increased heartbeat, seizures or severe muscle pain or weakness.
SYNOPSIS
| Drug | : | Doxylamine, Pyridoxine |
| Pharmacological Category | : | Anti-emetics, Vitamin B Complex |
| Therapeutic Indication | : | Morning Sickness |
| Dosage Forms | : | Tablet, Capsule |
MORE INFORMATION
- Keep NAUSILEX TABLET out of reach of children
- Store NAUSILEX TABLET at room temperature
FAQs ABOUT NAUSILEX TABLET
Q: Will the use of NAUSILEX TABLET affect the growth of foetus?
A: No. NAUSILEX TABLET is generally safe and well tolerated. It does not affect the growth of foetus. There is no evidence reported for foetal abnormalities in pregnant women taking NAUSILEX TABLET. However, consult your doctor before taking.
Q: Is NAUSILEX TABLET addictive?
A: No. NAUSILEX TABLET does not cause addiction. However, take NAUSILEX TABLET only as advised by your doctor. Continue to take NAUSILEX TABLET as instructed by your doctor as premature discontinuation may cause the symptoms to reoccur.
Q: How long will it take for NAUSILEX TABLET to stop vomiting?
A: NAUSILEX TABLET may reduce vomiting within 5-7 hours of administration. However, it may take around few weeks (2 weeks) for NAUSILEX TABLET show improvement in your overall health condition. Therefore, continue to take NAUSILEX TABLET regularly as instructed by the doctor. NAUSILEX TABLET cannot cure vomiting caused due to pregnancy. It can only manage the symptoms for a short period.
Q: Will taking a higher dose of NAUSILEX TABLET be more effective?
A: No. Do not take a high dose of NAUSILEX TABLET without consulting your doctor as it may lead to toxicity. If the prescribed dose, does not provide you with adequate results, consult your doctor for advice. Your doctor would evaluate your health condition and suggest a suitable dose for you.
Q: Can I take NAUSILEX TABLET to treat nausea without consulting doctor?
A: No. Do not take NAUSILEX TABLET to treat nausea without consulting a doctor. Although the use of NAUSILEX TABLET is safe, proper evaluation of pre-existing disease conditions such as presence of asthma, stomach problems or glaucoma should be considered prior to the use of NAUSILEX TABLET. Therefore, always consult your doctor before taking NAUSILEX TABLET.
Q: Can NAUSILEX TABLET be used in non-pregnant individuals?
A: NAUSILEX TABLET is intended for use only in pregnant women. There is no adequate information about use of NAUSILEX TABLET in non-pregnant individuals. If you are not pregnant and wish to stop nausea and vomiting, choose over the counter anti-emetics or consult your doctor for a suitable therapy.
Q: Can I increase the daily dose of NAUSILEX TABLET than recommended by the physician?
A: No. Take NAUSILEX TABLET only as directed by your physician. Do not increase the number of doses without consulting your doctor, as it may lead to toxicity.
Q: When and how should I take NAUSILEX TABLET?
A: Take NAUSILEX TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. NAUSILEX TABLET should be taken on an empty stomach. NAUSILEX TABLET works faster when taken 4-6 hours before having food. Do not stop taking NAUSILEX TABLET unless your doctor tells you to stop, as it may make the symptoms to reappear.
Q: Can I give NAUSILEX TABLET to my child suffering from nausea and vomiting?
A: No. Do not give NAUSILEX TABLET to children, as there is no proper information regarding the use of NAUSILEX TABLET this medicine in children. Therefore, consult your doctor before taking it.
Q: Can I stop taking NAUSILEX TABLET once my symptom subsides?
A: No. Do not stop taking NAUSILEX TABLET without consulting your doctor. If you stop taking NAUSILEX TABLET suddenly your symptoms may reappear. If you any doubts regarding the use of NAUSILEX TABLET kindly consult your doctor immediately.
REFERENCES
1. K.D. Tripathi, Antiemetic, Prokinetic and digestant drugs. Essentials of pharmacology. Seventh Edition. 2013. Page – 663.
2. Cada, D. J., Demaris, K., Levien, T. L., & Baker, D. E. Doxylamine succinate/pyridoxine hydrochloride. NCBI. PMC US National Library of Medicine, National Institute of Health. October 2013. [Accessed on 6th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3857125/
3. Koren G, Clark S, Hankins GD, Caritis SN, Umans JG, Miodovnik M, Mattison DR, Matok I. Maternal safety of the delayed release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo-controlled trial. BMC Pregnancy Childbirth. NCBI, PMC US National Library of Medicine, National Institute of Health. March 2015. [Accessed on 6th May 2022] https://pubmed.ncbi.nlm.nih.gov/25884778/
4. Duchesnay USA, Inc U.S. Food & Drug Administration [Revised in November 2016] [Accessed on 6th May 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209661lbl.pdf
5. Elara Pharma services Europe Limited. Health Products Regulatory Authority. [Revised in January 2020] [Accessed on 6th May 2022] https://www.hpra.ie/img/uploaded/swedocuments/e1d5eb8d-a06b-4bc9-b0e1-e2f769bf7dd2.pdf
6. Svizera health care. Doxinate OD. Doxylamine/pyridoxine. 2020. [Accessed on 22nd June 2022] https://www.doxinate.com/doxinateod
AUTHOR DETAILS
Written By Srilekha. R, B.Pharm
Last updated on 21 Mar 2023 | 06:56 PM(IST)
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