Product image of Navalem (Doxylamine Hydrogen Succinate, Pyridoxine Hydrochloride) supplied by GNH India

Navalem

Active Ingredient:
Doxylamine Hydrogen Succinate, Pyridoxine Hydrochloride
Origin:
EU

Navalem (Doxylamine Hydrogen Succinate, Pyridoxine Hydrochloride)

Doxylamine hydrogen succinate, the active ingredient in Navalem, is an H1‑antihistamine presented as an oral formulation for oral use. It is combined with pyridoxine hydrochloride (vitamin B6) and is employed to relieve nausea and vomiting, particularly the nausea of early pregnancy.

GNH India supplies Navalem as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The product conforms to EU standards and is manufactured under strict quality controls.

Manufacturer / TM Owner

Italfarmaco S.A.

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Indications & Clinical Uses

Navalem, containing doxylamine and pyridoxine, is used in the management of nausea and vomiting related to pregnancy.

  • Nausea and vomiting of pregnancy (morning sickness): reduces frequency and severity of symptoms.
  • Hyperemesis gravidarum: provides symptomatic relief when conventional measures are insufficient.
  • Early‑gestation nausea: alleviates discomfort during the first trimester.

How It Works

  • Doxylamine hydrogen succinate blocks H1 histamine receptors in the central nervous system, diminishing vestibular stimulation that contributes to nausea. Pyridoxine hydrochloride serves as a cofactor in neurotransmitter synthesis, enhancing the anti‑emetic effect. The combined action reduces the chemoreceptor trigger zone response, leading to decreased nausea and vomiting.

Side Effects

Common Side Effects

  • Drowsiness: feeling unusually sleepy or fatigued.
  • Dry mouth: reduced salivation causing throat discomfort.
  • Constipation: infrequent or hard stools.
  • Blurred vision: temporary visual disturbances.
  • Urinary retention: difficulty emptying the bladder.

Serious or Rare Side Effects

  • Anaphylactic reaction: severe allergic response requiring emergency care.
  • Stevens‑Johnson syndrome: rare skin disorder with blistering.
  • Cardiac arrhythmia: irregular heart rhythm.
  • Hepatic injury: signs of liver dysfunction.
  • Seizures: uncontrolled electrical activity in the brain.

Precautions & Warnings

Navalem should be used with caution in specific populations and situations.

  • Pregnancy: consult a healthcare professional before initiating therapy.
  • Breastfeeding: assess risk versus benefit with a clinician.
  • Elderly patients: monitor for increased sedation and anticholinergic effects.
  • Concomitant CNS depressants: avoid additive sedation and respiratory depression.
  • Operating machinery: do not drive or use heavy equipment until individual response is known.
  • Store at ambient temperature: keep below 25 °C in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Navalem may interact with other medicines; some combinations require avoidance while others need monitoring.

Major Interactions (Avoid)

  • Alcohol: additive central nervous system depression.
  • Opioid analgesics: heightened sedation and respiratory depression.
  • Other antihistamines: increased anticholinergic burden.
  • Sedative hypnotics: risk of profound drowsiness.

Moderate Interactions (Monitor Closely)

  • Anticholinergic drugs (e.g., atropine): may exacerbate dry mouth and urinary retention.
  • Tricyclic antidepressants: potential for enhanced anticholinergic effects.
  • Antacids: could affect absorption of the active ingredients.

Frequently Asked Questions

Navalem is an oral medication that combines doxylamine, an H1‑antihistamine, with pyridoxine (vitamin B6). It is primarily prescribed to treat nausea and vomiting associated with early pregnancy, including morning sickness and, in more severe cases, hyperemesis gravidarum.

Doxylamine hydrogen succinate blocks H1 histamine receptors in the brain, reducing vestibular stimulation that can trigger nausea. When paired with pyridoxine, which supports neurotransmitter synthesis, the combination enhances the anti‑emetic effect, helping to control vomiting episodes.

The specific dose of Navalem is determined by the prescribing clinician based on the patient’s condition, severity of symptoms, and individual response. Patients should follow the dosage instructions provided by their healthcare professional and not adjust the dose on their own.

Navalem is frequently used for nausea in pregnancy, but safety must be evaluated by a healthcare provider. While doxylamine has a long history of use in pregnancy, pyridoxine is a vitamin. Breastfeeding mothers should discuss potential risks and benefits with their clinician.

To place an order, submit an enquiry on the Navalem product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Navalem’s combination of an antihistamine and vitamin B6 offers a dual mechanism that can be more effective for pregnancy‑related nausea than single‑agent antihistamines alone. Compared with metoclopramide or ondansetron, it generally has a milder side‑effect profile but may cause more sedation.

Navalem should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture and direct sunlight, and ensure the container is tightly closed to maintain stability.

Navalem is taken orally, usually with a glass of water. The tablet should be swallowed whole and not chewed or crushed unless directed otherwise by a healthcare professional.

Serious risks, though rare, include severe allergic reactions such as anaphylaxis, skin conditions like Stevens‑Johnson syndrome, cardiac arrhythmias, hepatic injury, and seizures. Patients should seek immediate medical attention if they experience symptoms such as rash, difficulty breathing, irregular heartbeat, jaundice, or convulsions.

Navalem is contraindicated in individuals with known hypersensitivity to doxylamine, pyridoxine, or any excipients in the formulation. It should also be avoided in patients with severe hepatic impairment, uncontrolled narrow‑angle glaucoma, or those taking medications that could cause dangerous additive sedation.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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