Introduction About GRAVEMIN TABLET

GRAVEMIN 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 manage nausea and vomiting (morning sickness) when changes in diet or other non-medical managements 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 GRAVEMIN TABLET as advised by your physician. GRAVEMIN TABLET cannot manage vomiting caused due to pregnancy. It can only manage the symptoms for a short period. Therefore, continue to take GRAVEMIN TABLET as advised by the physician to achieve better results. GRAVEMIN TABLET can be used in all trimesters of pregnancy.

Before taking GRAVEMIN 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 GRAVEMIN TABLET if you are breastfeeding.

GRAVEMIN 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 GRAVEMIN TABLET are headache, stomach pain and trouble sleeping.

Uses Of GRAVEMIN TABLET

• Manage morning sickness (nausea and vomiting) during pregnancy

How GRAVEMIN TABLET Works

GRAVEMIN TABLET manages 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.

How to use GRAVEMIN TABLET

Take GRAVEMIN TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. GRAVEMIN 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 GRAVEMIN TABLET unless your doctor tells you to stop, as it may make the nausea and vomiting to reoccur.

Side Effects Of GRAVEMIN TABLET

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

Safe

GRAVEMIN TABLET is intended for use in pregnant women. However, consult your doctor before taking.

Breastfeeding

Contraindicated

GRAVEMIN 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 Caution

Do not drive or handle any heavy tools or machines if you experience dizziness, drowsiness, or blurred vision after taking GRAVEMIN TABLET.

Alcohol

Consult your doctor

Avoid consumption of alcohol while undergoing management with GRAVEMIN TABLET.

Allergy

Contraindicated

Do not take GRAVEMIN TABLET if you are allergic to pyridoxine, doxylamine or to any other antihistamines (such as diphenhydramine).

Lungs

Use with Caution

GRAVEMIN TABLET should be used with caution in patients who have or ever had asthma. Therefore, consult your doctor before taking it.

Use In Pediatrics

Contraindicated

GRAVEMIN TABLET is not intended for use in children and adolescents (below18 years). Therefore, consult your doctor before taking it.

Interactions

A. Drug - Drug interactions:

Before taking GRAVEMIN TABLET, inform your doctor if you are taking any of the following medicines such as:

• linezolid (an antibiotic medicine used to manage bacterial infections)
• medicines used to manage parkinson’s disease (Ex. levodopa)
• methylene blue (used to manage blood disorder)
• medicines used to manage conditions such as disorders in bowel, bladder or
  respiratory systems (Ex. solifenacin, scopolamine, ipratropium)
• medicines used to manage 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 manage 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 GRAVEMIN TABLET with food as it may delay the absorption of GRAVEMIN TABLET.

Overdosage:

If you or anyone else accidentally took more GRAVEMIN 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

More Information

• Keep GRAVEMIN TABLET out of reach of children
• Store GRAVEMIN TABLET at room temperature

FAQs About GRAVEMIN TABLET

Q: Will the use of GRAVEMIN TABLET affect the growth of foetus?

A: No. GRAVEMIN 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 GRAVEMIN TABLET. However, consult your doctor before taking.

Q: Is GRAVEMIN TABLET addictive?

A: No. GRAVEMIN TABLET does not cause addiction. However, take GRAVEMIN TABLET only as advised by your doctor. Continue to take GRAVEMIN TABLET as instructed by your doctor as premature discontinuation may cause the symptoms to reoccur.

Q: How long will it take for GRAVEMIN TABLET to stop vomiting?

A: GRAVEMIN TABLET may reduce vomiting within 5-7 hours of administration. However, it may take around few weeks (2 weeks) for GRAVEMIN TABLET show improvement in your overall health condition. Therefore, continue to take GRAVEMIN TABLET regularly as instructed by the doctor. GRAVEMIN TABLET cannot manage vomiting caused due to pregnancy. It can only manage the symptoms for a short period.

Q: Will taking a higher dose of GRAVEMIN TABLET be more effective?

A: No. Do not take a high dose of GRAVEMIN 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 GRAVEMIN TABLET to manage nausea without consulting doctor?

A: No. Do not take GRAVEMIN TABLET to manage nausea without consulting a doctor. Although the use of GRAVEMIN 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 GRAVEMIN TABLET. Therefore, always consult your doctor before taking GRAVEMIN TABLET.

Q: Can GRAVEMIN TABLET be used in non-pregnant individuals?

A: GRAVEMIN TABLET is intended for use only in pregnant women. There is no adequate information about use of GRAVEMIN 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 GRAVEMIN TABLET than recommended by the physician?

A: No. Take GRAVEMIN 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 GRAVEMIN TABLET?

A: Take GRAVEMIN TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. GRAVEMIN TABLET should be taken on an empty stomach. GRAVEMIN TABLET works faster when taken 4-6 hours before having food. Do not stop taking GRAVEMIN TABLET unless your doctor tells you to stop, as it may make the symptoms to reappear.

Q: Can I give GRAVEMIN TABLET to my child suffering from nausea and vomiting?

A: No. Do not give GRAVEMIN TABLET to children, as there is no proper information regarding the use of GRAVEMIN TABLET this medicine in children. Therefore, consult your doctor before taking it.

Q: Can I stop taking GRAVEMIN TABLET once my symptom subsides?

A: No. Do not stop taking GRAVEMIN TABLET without consulting your doctor. If you stop taking GRAVEMIN TABLET suddenly your symptoms may reappear. If you any doubts regarding the use of GRAVEMIN 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

Reviewed By Dr. Sankara Babu Gorle - MBBS, MD(Pharmacology) View profile

Last updated on 21 Mar 2023 | 06:56 PM(IST)