Navidoxine is indicated for:

1. the treatment of pregnancy nausea and vomiting.
2. adult and adolescent over 12 years old, for the prevention and symptomatic treatment of nausea, vomiting and dizziness associated with travel sickness (motion sickness).
3. Management of vertigo associated with diseases affecting the vestibular system.

Since drowsiness may, on occasion, occur with use of Navidoxine, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery. Patients should avoid alcoholic beverages while taking this drug. Navidoxine should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland.

Composition

Each Navidoxine tablet contains:

• 25 mg Meclozine Hydrochloride.
• 50 mg Vitamin B6 ( Pyridoxine) Hydrochloride.

Is Navidoxine safe in pregnancy?

Navidoxine, is one of the most commonly used medications for NVPs ((nausea and vomiting in pregnancy). Navidoxine is generally considered safe to be use in pregnancy. Navidoxine, should be used in pregnant women only if absolutely necessary, and duration should be as short as possible and dosage should not exceed two tablets per day.

Navidoxine for Early Pregnancy Nausea and Vomiting

Nausea and vomiting are common symptoms experienced by 50– 90% of women in early pregnancy. ‘Morning sickness’ is a misnomer frequently used to describe nausea and vomiting in pregnancy (NVP), although the symptoms may persist the whole day and/or night.

Pregnant women experience these symptoms mainly in the first trimester between 6 and 12 weeks of gestation, few of them continue till 20 weeks of gestation while in few others it continues throughout the pregnancy.

The problem peaks at 9-week gestation, and approximately 60% of NVPs resolve by the end of first trimester. In a very small minority of these patients, the symptoms become severe leading to dehydration, weight loss, excessive vomiting, and mandate hospital admission; this condition is known as Hyperemesis Gravidarum.

Hyperemesis Gravidarum (HG)

HG defined, based on the symptoms, vomiting exceeding three times a day with significant ketonuria or weight loss more than or equal to 5% of pre pregnancy weight, electrolytic imbalance or fluid depletion, and onset occurs at 4 to 8 weeks of pregnancy till 14 to 16 weeks.

Nausea and vomiting in pregnancy is of multifarious etiology (fluctuating levels of progesterone, estrogens, Thyroid Stimulating Hormone (TSH), slow peristaltic movement of Gastrointestinal (GI) tract); however, the exact mechanism remains still unclear.

Both patients and healthcare practitioners often fear the use of antiemetic medications in pregnancy due to the potential risk to fetus and mother. The manifestation of nausea and vomiting in pregnancy is different among each woman, so its management should be tailored similarly.

An early treatment of nausea and vomiting is important and beneficial since it prevents a more severe form of occurring, or a possible hospitalization, and prevents both emotional and psychological problems.

It is very important for the women and the healthcare providers to understand that a safe and effective NVP treatment benefits both fetus and mother, thus all the treatment options should be open and considered.

Nonetheless, given the widespread prevalence of nausea and vomiting, its adverse effects and effects on psychological conditions of pregnant women, it is necessary to be treated effectively and safely during embryonic and fetal developmental stages.

Does Pyridoxine effective in treating Nausea and Vomiting?

Pyridoxine is a water-soluble vitamin and is a very essential coenzyme for folate metabolism pathway; the drug was first licensed for the use of NVP in 1942.

Pyridoxine was clinically proved to be efficacious in two different trials that showed significant reduction severity of nausea with a very little effect on the episodes of vomiting.

The first trial showed that it is efficacious only in severe form of nausea and vomiting, and concluded; pyridoxine is more effective in relieving the severity of nausea with less significance to episodes of vomiting.

The second trial with larger population and adequate settings revealed it to be efficacious in both mild and moderate forms of NVPs (nausea and vomiting in pregnancy). Pyridoxine can be used alone or in combination with other antiemetic’s (Meclozine HCL) in the treatment of NVPs (nausea and vomiting in pregnancy).

Does Meclozine used to treat Nausea and Vomiting?

A pooled data from seven randomized clinical trials have confirmed that antihistamines (including Meclozine) significantly reduce nausea and vomiting in pregnancy. Meclozine is known to have a sedative effect, and thus many women show discomfort in taking these medications throughout the day.

Meclozine is one of the most commonly used antihistamine for NVPs ((nausea and vomiting in pregnancy). Meclozine is generally considered safe to be use in pregnancy.

Navidoxine Dosage

• For the control of vertigo associated with diseases affecting the vestibular system, the recommended dose is 1 to 4 Navidoxine tablets daily, in divided dosage, depending upon clinical response.
• For Motion Sickness: The initial dose is 1 – 2 tablets to be taken one hour prior to embarkation for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.
• For nausea and vomiting in pregnancy: Navidoxine, should be used in pregnant women only if absolutely necessary, and duration should be as short as possible and dosage should not exceed two tablets per day.

Warnings and Precautions

1. Navidoxine should be used with caution in patients suffering from: bladder outflow obstruction, glaucoma, pyloric stenosis, impaired gastric and intestinal motility, myasthenia gravis, dementia. Asthma.
2. Patients suffering from epilepsy and patients with severe renal impairment should use this product with caution.
3. The concomitant use of alcohol and Navidoxine should be avoided.
4. The potentiating action of Meclozine hydrochloride must be considered when it is used simultaneously with other central nervous system depressant drugs, with drugs having anticholinergic properties, or with MAO inhibitors.
5. Meclozine hydrochloride treatment should be stopped four days before allergy testing to avoid effects on the test results.
6. Long-term use of large doses of pyridoxine is associated with the development of severe peripheral neuropathies; the dose at which these occur is controversial.

Adverse Reactions

Undesirable effects are mostly related to CNS depressant or paradoxical CNS stimulation effects, to anticholinergic properties, or to hypersensitivity reactions of Meclozine hydrochloride.

The most common adverse effect of Meclozine hydrochloride is drowsiness or sedation. Dry mouth is a frequent adverse effect. Blurred vision, nausea and vomiting occur rarely.

Others include: anaphylactic shock, anorexia, appetite increased, anxiety, euphoric mood, excitability, hallucinations, insomnia, psychotic disorder, dizziness, sedation, somnolence, headache, paraesthesia, movement disorders (including Parkinsonism), peripheral neuropathy, diplopia, vision blurred, tinnitus, vertigo, palpitations, tachycardia, hypotension, dry throat, nasal dryness, dry mouth, nausea, vomiting, abdominal pain, constipation, diarrhoea, rash, urticaria, dysuria, polyuria, fatigue, weakness, weight increased after long-term use of large doses of pyridoxine.

Interactions

1. Dosage adjustments may be necessary, in case of concomitant use of alcohol and CNS depressants with Meclozine hydrochloride as the depressant action of these drugs or of Meclozine may increase.
2. The potentiating action of Meclozine hydrochloride must be considered, and dosage should be adapted on an individual basis, while Meclozine is co-administered with anticholinergics, other drugs with anticholinergic effects or MAO inhibitors.
3. Although, no in vitro and no in vivo interaction studies have been performed with Meclozine, there is a potential risk for interaction when Meclozine is administered to patients on drugs known to be inducers or inhibitors of liver enzymes.
4. Pyridoxine reduces the effects of levodopa. This effect does not occur if a dopa decarboxylase inhibitor is also given.
5. Pyridoxine reduces the activity of altretamine. It has also been reported to decrease serum concentrations of phenobarbital and phenytoin.

Belgian Chemical Union – UCB, the company that owns the production and marketing rights for NAVIDOXIN, is a multinational biopharmaceutical production company headquartered in Brussels, Belgium.

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