Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets)

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

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.

Doxinate Tablets and Doxinate-OD Tablets are
manufactured by Svizera Health Remedies Private
Limited, India. (A Division of Maneesh Pharmaceuticals
Ltd.)

Chemical Structure - Doxylamine Succinate

Chemical Structure - Pyridoxine Hydrochloride

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.

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.
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Recommended Adult Dosage
For most patients, the starting dose of Doxinate Tablets (Generic
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.

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.

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.

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 .

Warnings
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
Phencyclidine Phosphate (PCP):
There have been reports of false positive urine screening tests for
Methadone, Opiates, and PCP with doxylamine Succinate/Pyridoxine
Hydrochloride use.

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.

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

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

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.

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.

Doxinate Tablets (Generic Doxylamine Succinate
and Pyridoxine Hydrochloride Tablets) are
manufactured by Svizera Health Remedies Private
Limited, India (A Division of Maneesh
Pharmaceuticals Ltd.).

Doxinate Tablets (Generic Doxylamine Succinate and Pyridoxine Hydrochloride Tablets)

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