PREZEN Tablet

Nausea and vomiting of pregnancy. Morning Sickness. Temporary use in the relief of insomnia.

Posology and route administration

Usual Dosage Oral: Adults: 2 tablets at bedtime; In severe cases or in cases with nausea/vomiting during the day, dosage may be increased by 1 tablet in the morning and/or afternoon.

Main dose should be taken at bedtime to provide relief in the early morning hours.

Hypersensitivity to Doxylamine. Pyridoxine and other ethanolamine derivative antihistamines or to any other ingredient in the product.

Adverse Reactions Frequency not defined.

Cardiovascular; Palpitations, tachycardia.

Central nervous system: Dizziness, disorientation, drowsiness, headache, paradoxical CNS stimulation, vertigo.

Genitourinary: Dysuria, urinary retention.

Gastrointestinal: Anorexia, dry mucous membranes, diarrhea, constipation, epigastric pain, xerostomia.

Ocular: Blurred vision, diplopia.

A common side-effect of doxylamine succinate is sedation. Other side-effects include gastro-intestinal disturbances, headache, blurred vision, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of the mouth, tightness of the chest, and tingling, heaviness and weakness of the hands. Symptoms of stimulation in adults include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions. Large doses may precipitate fits in epileptics. Allergy and anaphylaxis may occur. Blood dyscrasias including agranulocytosis and haemolytic anaemia may occur. Doxylamine succinate has anticholinergic properties and should be used with care in conditions such as glaucoma and prostatic hypertrophy. The effects of atropine and tricyclic antidepressants may be enhanced by doxylamine succinate. Doxylamine succinate may mask the warning symptoms of damage caused by ototoxic drugs and may affect the metabolism of drugs in the liver. Doxylamine succinate may enhance the sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers.

Anticholinergic agents: Central and/or peripheral anticholinergic syndrome can occur when administered with narcotic analgesics, phenothiazines and other antipsychotics (especially with high anticholinergic activity), tricyclic antidepressants, quinidine and some other antiarrhythmics, and antihistamines. Cholinergic agents: Drugs with high anticholinergic activity may antagonize the therapeutic effect of cholinergic agents: includes donepezil, rivastigmine, and tacrine. CNS depressants: Sedative effects may be additive with CNS depressants; includes ethanol, benzodiazepines, barbiturates, narcotic analgesics, and other sedative agents; monitor for increased effect.

Food Interaction: See the package insert about the details.

Pregnancy category A: Drugs that have been taken by a large number pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

Pregnancy Implications Doxylamine has been approved for use in pregnancy-associated nausea and vomiting.

May cause drowsiness; patient should avoid tasks requiring alertness (e.g. driving, operating machinery) until effects are known, Sedative effects of CNS depressants or ethanol are potentiated. Use with caution in patients with angle-closure glaucoma, pyloroduodenal obstruction (including stenotic peptic ulcer), urinary tract obstruction (including bladder neck obstruction and symptomatic prostatic hyperplasia), hyperthyroidism, increased intraocular pressure, and cardiovascular disease (including hypertension and tachycardia). Caution should be taken if taken with alcohol. Due to the anticholinergic properties of antihistamines, caution should be used when Prezen is taken concurrently with other medications. Caution should be taken by those with narrow angle or open-angle glaucoma, urinary retention, prostate enlargement, pyloroduodenal obstruction, epilepsy or severe cardiovascular disorders. Doxylamine may suppress positive skin test results.

For the treatment of Nausea and Vomiting of Pregnancy and is available to patients in suffering from this disorder of pregnancy. Doxylamine succinate is an ethanolamine derivative antihistamine. Because of its sedative effect, it is used for the temporary relief of sleeplessness. The drug is also used in combination with antitussives and decongestants for the temporary relief of cold and cough symptoms. It is not structurally related to the cyclic antidepressants. It is an antihistamine with hypnotic, anticholinergic, antimuscarinic and local anaesthetic effects.