Doxinate Tablets (Generic Doxylamine and Pyridoxine Tablets)

1. Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) © The Swiss Pharmacy

2. Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) Doxinate (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) is a fixed dose combination drug product of Doxylamine Succinate, an antihistamine, and Pyridoxine Hydrochloride, a Vitamin B6 analog, which is used to treat nausea and vomiting in pregnant women (also called morning sickness) whose symptoms have not been relieved by other treatments. This medicine is also prescribed for the temporary use in the relief of insomnia. © The Swiss Pharmacy

3. Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) Doxinate Tablets and Doxinate-OD Tablets are manufactured by Svizera Health Remedies Private Limited, India. (A Division of Maneesh Pharmaceuticals Ltd.) © The Swiss Pharmacy

4. Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) Chemical Structure - Doxylamine Succinate © The Swiss Pharmacy

5. Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) Chemical Structure - Pyridoxine Hydrochloride © The Swiss Pharmacy

6. Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) The active ingredient contained in Doxinate tablets are Doxylamine Succinate and Pyridoxine Hydrochloride. Each enteric coated tablet of Doxinate contains Doxylamine Succinate 10 mg and Pyridoxine Hydrochloride 10 mg whereas each enteric coated tablet of Doxinate OD contains 20 mg of Doxylamine Succinate and 20 mg of Pyridoxine Hydrochloride. © The Swiss Pharmacy

7. Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) Uses of Doxinate 10mg and 20mg Tablets: This combination medication Doxinate (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) is used to prevent or reduce nausea and vomiting caused by pregnancy. Decreasing nausea and vomiting may improve your health and nutrition during pregnancy. Doxylamine Succinate and Pyridoxine Hydrochloride tablets have not been studied in women with hyperemesis gravidarum. Doxylamine is an antihistamine that is thought to work by affecting certain natural substances (acetylcholine, serotonin) in your body or by acting directly on certain parts of the brain. Pyridoxine is a B vitamin that is important for good health. Most people get enough pyridoxine in their diet, but certain health conditions (such as pregnancy, poor diet, alcoholism) can result in a lack of this vitamin. This medicine is also used for short-term management of insomnia, particularly in individuals who have difficulty falling asleep. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html © The Swiss Pharmacy

8. Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) Recommended Adult Dosage For most patients, the starting dose of Doxinate Tablets Doxylamine and Pyridoxine Tablets) is one tablet orally at bedtime (Day 1). If this dose adequately controls symptoms the next day, continue taking one tablet daily at bedtime only. However, if symptoms persist on Day 2, increase the daily dose to one tablet in the morning and one tablet at bedtime. The maximum recommended dose is two tablets per day, one in the morning and one at bedtime. Doxinate Tablets (Generic URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html © The Swiss Pharmacy

9. Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) Contraindications ➔Doxinate tablets are contraindicated in patients with a known hypersensitivity to Doxylamine Succinate, Pyridoxine Hydrochloride, other ethanolamine derivative antihistamines or any component of the tablets. ➔Monoamine oxidase (MAO) inhibitors intensify and prolong the adverse central nervous system effects of Doxinate. Administration of Doxinate with Monoamine oxidase (MAO) inhibitors is contraindicated. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html © The Swiss Pharmacy

10. Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) Storage Instructions Doxinate Tablets (Generic Doxylamine and Pyridoxine Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html © The Swiss Pharmacy

11. Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) Warnings Activities requiring mental alertness: Avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using Doxinate Tablets until cleared to do so by a healthcare provider. Central nervous system (CNS) depressants: Concurrent use with alcohol or other CNS depressants is not recommended. Anticholinergic actions: Use with caution in patients with increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and urinary bladder-neck obstruction. Interference with urine drug screen: Doxinate Tablets may interfere with urine screening for methadone, opiates and PCP . URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html © The Swiss Pharmacy

12. Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) Warnings Concomitant Medical Conditions: Concomitant Medical Conditions: Doxinate has anticholinergic properties and, therefore, should be used with caution in women with asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction or urinary bladder-neck obstruction. Interference with Urine Screen for Methadone, Opiates and Interference with Urine Screen for Methadone, Opiates and Phencyclidine Phosphate (PCP): Phencyclidine Phosphate (PCP): There have been reports of false positive urine screening tests for Methadone, Opiates, and PCP with doxylamine Succinate/Pyridoxine Hydrochloride use. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html © The Swiss Pharmacy

13. Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) Possible Side Effects Most common Doxylamine Succinate and Pyridoxine Hydrochloride Tablets (Doxinate) side effects that occurred with an incidence rate of greater than or equal to 5% and exceeded the incidence for placebo are: Somnolence. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html © The Swiss Pharmacy

14. Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) Possible Side Effects The following side effects, listed alphabetically, have been identified during post-approval use of the combination of 10 mg Doxylamine Succinate and 10 mg Pyridoxine Hydrochloride (Doxinate Tablets): Cardiac disorders: dyspnea, palpitation, tachycardia Ear and labyrinth disorders: vertigo Eye disorders: vision blurred, visual disturbances Gastrointestinal disorders: abdominal distension, abdominal pain, constipation, diarrhea General disorders and administration site conditions: chest discomfort, fatigue, irritability, malaise URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html © The Swiss Pharmacy

15. Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) Possible Side Effects The following side effects, listed alphabetically, have been identified during post-approval use of the combination of 10 mg Doxylamine Succinate and 10 mg Pyridoxine Hydrochloride (Doxinate Tablets): Immune system disorders: hypersensitivity Nervous system disorders: dizziness, headache, migraines, paresthesia, psychomotor hyperactivity Psychiatric disorders: anxiety, disorientation, insomnia, nightmares Renal and urinary disorders: dysuria, urinary retention Skin and subcutaneous tissue disorders: hyperhidrosis, pruritus, rash, rash maculo-papular URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html © The Swiss Pharmacy

16. Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) Doxinate Tablets Overdosage Signs and symptoms of Doxylamine Succinate and Pyridoxine Hydrochloride Tablets (Doxinate) overdose may include restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion and tachycardia. At toxic doses, Doxylamine exhibits anticholinergic effects, including seizures, rhabdomyolysis, acute renal failure and death. In case treatment for Doxinate overdose is needed, it consists of gastric lavage or activated charcoal, whole bowel irrigation and symptomatic treatment. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html © The Swiss Pharmacy

17. Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) Doxinate Tablets During Pregnancy Doxylamine Succinate has been classified by the US FDA as Pregnancy Category B. Pyridoxine Hydrochloride has been classified by the US FDA as Pregnancy Category A. Doxylamine Succinate and Pyridoxine Hydrochloride (Doxinate Tablets)is intended for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. No increased risk for congenital malformations has been reported in epidemiologic studies in pregnant women. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html © The Swiss Pharmacy

18. Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) Doxinate Tablets Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets) are manufactured by Svizera Health Remedies Private Limited, India (A Division of Maneesh Pharmaceuticals Ltd.). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9689_Doxinate-Tablets.html © The Swiss Pharmacy