Dicliz Plus

• Approved Indications:
• Treatment of nausea and vomiting during pregnancy (NVP), commonly referred to as morning sickness.
• Management of mild to moderate nausea and vomiting in early pregnancy when dietary and lifestyle modifications are insufficient.
• Off-label/Clinically Accepted Uses:
• Adjunct treatment in hyperemesis gravidarum under specialist supervision.
• Occasionally used for nausea associated with other causes, though primarily indicated for pregnancy-related symptoms.

• Adults (including pregnant women):
• Initial dose: 10 mg pyridoxine hydrochloride plus 10 mg doxylamine succinate orally at bedtime.
• If symptoms persist, dosage may be increased up to a maximum of 4 doses daily, typically divided as 2 tablets at bedtime and 1 tablet in the morning and afternoon.
• Pediatrics:
• Not recommended for children.
• Elderly:
• Use with caution due to increased sensitivity to sedative effects; no formal dose adjustments established.
• Special Populations:
• Renal or hepatic impairment: Use with caution; no specific dose adjustments.
• Route: Oral administration, preferably with water.
• Duration: Usually limited to the first trimester or until symptoms resolve.

Pyridoxine hydrochloride (Vitamin B6) serves as a coenzyme in numerous enzymatic reactions, including amino acid metabolism and neurotransmitter synthesis, which may help reduce nausea through modulation of central nervous pathways. Doxylamine succinate is a first-generation antihistamine that blocks H1 histamine receptors and exerts anticholinergic and sedative effects, decreasing vestibular stimulation and vomiting reflexes in the central nervous system, thereby alleviating nausea and vomiting.

• Absorption: Both components are well absorbed orally.
• Distribution: Pyridoxine is widely distributed in body tissues; doxylamine readily crosses the blood-brain barrier, contributing to central nervous system effects.
• Metabolism: Pyridoxine is metabolized in the liver to its active form, pyridoxal 5’-phosphate; doxylamine undergoes hepatic metabolism primarily via CYP2D6 and CYP1A2 isoenzymes.
• Elimination: Pyridoxine metabolites are excreted renally as pyridoxic acid; doxylamine and metabolites are eliminated via renal and biliary routes.
• Half-life: Pyridoxine approximately 15–20 days; doxylamine approximately 10 hours.
• Onset of action: Symptomatic relief usually begins within a few days of treatment initiation.

• Pregnancy:
• Pyridoxine classified as FDA Pregnancy Category A (no risk demonstrated).
• Doxylamine classified as Category B (no evidence of risk in humans).
• Considered safe and effective for use in pregnancy at recommended doses.
• Lactation:
• Pyridoxine is excreted in breast milk in small amounts and considered safe.
• Doxylamine is also excreted into breast milk; caution is advised due to potential sedative effects in nursing infants.

• Antiemetic combination
• Pyridoxine: Vitamin B6 supplement
• Doxylamine: First-generation H1 antihistamine with sedative and anticholinergic properties

• Hypersensitivity to pyridoxine hydrochloride, doxylamine succinate, or any component of the formulation.
• Concomitant use with monoamine oxidase inhibitors (MAOIs).
• Known severe hepatic or renal impairment (use with caution).
• Patients with narrow-angle glaucoma or urinary retention due to prostatic hypertrophy (because of anticholinergic effects).

• Use caution in patients with respiratory conditions such as asthma or chronic obstructive pulmonary disease due to possible respiratory depression.
• May cause significant drowsiness; patients should avoid driving or operating machinery.
• Additive sedation may occur with concomitant use of alcohol or CNS depressants.
• Monitor for allergic reactions or signs of severe skin reactions.
• Avoid abrupt discontinuation after prolonged use.

• Common:
• Drowsiness, dizziness, dry mouth, headache, fatigue.
• Gastrointestinal discomfort such as nausea or constipation.
• Serious (rare):
• Hypersensitivity reactions including rash, urticaria, and angioedema.
• Central nervous system effects like confusion or hallucinations, especially in elderly or sensitive individuals.
• Side effects are generally mild, dose-dependent, and reversible upon discontinuation.

• Increased sedation with alcohol, benzodiazepines, opioids, and other CNS depressants.
• Additive anticholinergic effects with tricyclic antidepressants, antipsychotics, or other anticholinergic drugs.
• Doxylamine metabolism may be affected by CYP2D6 or CYP1A2 inhibitors or inducers, altering drug levels.
• No significant drug-food interactions reported.

• Recommended as first-line pharmacologic treatment for nausea and vomiting of pregnancy by professional guidelines (e.g., ACOG).
• Emphasis on safe use at recommended doses with avoidance of unnecessary prolonged therapy.
• No recent major safety warnings or dosing changes.

• Store at 20°C to 25°C (68°F to 77°F), protected from moisture and light.
• Keep in tightly closed containers.
• Keep out of reach of children.