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XONVEA PR is a brand name for Doxylamine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Xonvea PR is indicated for the symptomatic treatment of nausea and vomiting of pregnancy (NVP) in pregnant women ≥18 years who do not respond to conservative management (i.e., lifestyle and diet change). Limitations of use: The combination doxylamine/pyridoxine has not been studied in case of hyperemesis gravidarum…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The recommended starting dose of Xonvea PR is one tablet (20mg/20mg) at bedtime on Day 1 and on Day 2. If symptoms are not adequately controlled on Day 2, the dose can be increased on Day 3 to one additional tablet (20mg/20mg) in the morning and one tablet (20mg/20mg) at bedtime (for a total of two tablets per day).
The maximum recommended dose is two tablets daily, one in the morning and one at bedtime (for a maximum daily dose of 40mg/40mg). Xonvea PR should be taken as a daily prescription and not on an as needed basis. Continued need for Xonvea PR should be reassessed as the pregnancy progresses.
Some women may achieve symptom control at intermediatory doses of 30mg/30mg. This dose is not achievable with Xonvea PR 20mg/20mg. Other formulations of doxylamine hydrogen succinate/pyridoxine hydrochloride are available which provide for greater flexibility to dose adjust according to severity of symptoms.
With Xonvea PR 20mg/20mg prolonged-release tablet formulation, the maximum daily recommended dosing of 40mg/40mg consists of only two tablets daily. To prevent a sudden return of nausea and vomiting of pregnancy symptoms, a gradual tapering dose of Xonvea PR is recommended at the time of discontinuation.
Hepatic impairment No pharmacokinetic studies have been conducted in hepatic impaired patients. 4). Renal impairment No pharmacokinetic studies have been conducted in renal impaired patients. 4). 1). Method of administration Oral use. 5).
tablets should be swallowed whole and should not be crushed, split or chewed to preserve the gastro-resistant properties.
a. Summary of the safety profile Adverse event information is derived from clinical trials and worldwide post- marketing experience. There has been a vast clinical experience regarding the use of the Xonvea PR combination (doxylamine hydrogen succinate and pyridoxine hydrochloride).
The most frequently reported adverse reaction (≥5% and exceeding the rate in placebo) was somnolence in a double-blind, randomised, placebo-controlled trial of 15 days duration, including 261 women with nausea and vomiting of pregnancy (128 treated with placebo and 133 with doxylamine hydrogen succinate/pyridoxine hydrochloride) b.
Tabulated list of adverse reactions The following listing of adverse reactions is based on clinical trial experience and/or post-marketing use, with this medicine and other similar medicine containing the same active ingredients. Undesirable effects are displayed by MedDRA System Organ Classes and use the following conventions for frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to < 1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports. Consequently, the frequency of these adverse events is qualified as "not known". System Organ Class Undesirable Effect Frequency Blood and lymphatic system disorders haemolytic anaemia Rare Immune system disorders hypersensitivity Not known confusional state Uncommon agitation Rare Psychiatric disorders anxiety, disorientation, insomnia, irritability, nightmares Not known somnolence Very common dizziness Common tremor, seizure Rare Nervous system disorders headache, migraines, paresthesia, psychomotor hyperactivity Not known diplopia, glaucoma UncommonEye disorders vision blurred, visual impairment Not known tinnitus UncommonEar and labyrinth disorders vertigo Not known Cardiac disorders palpitation, tachycardia Not known Vascular disorders orthostatic hypotension Uncommon increased bronchial secretion CommonRespiratory, thoracic and mediastinal disorders dyspnoea Not known dry mouth Common nausea, vomiting Uncommon Gastrointestinal disorders abdominal distention, abdominal pain, constipation, diarrhoea Not known photosensitivity reaction UncommonSkin and subcutaneous tissue disorders hyperhidrosis, pruritus, rash, rash maculo-papular Not known Renal and urinary disorders dysuria, urinary retention Not known fatigue Common asthenia, oedema peripheral Uncommon General disorders and administration site conditions chest discomfort, malaise Not known c.
8). 5). This medicinal product has anticholinergic properties and, therefore, should be used with caution in patients with: increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and bladder-neck obstruction as the anticholinergic effects of this medicinal product may worsen these conditions.
This medicinal product should also be used with caution in patients with asthma or other breathing disorders, such as chronic bronchitis and pulmonary emphysema. It has been demonstrated that antihistamines reduce the volume of bronchial secretions and increase their viscosity, thereby making bronchial expectoration more difficult.
This may result in respiratory obstruction, which may worsen these conditions. As such, care should be taken in these patients. This medicinal product should be used with caution in patients with hepatic or renal impairment. No data are available.
However, the metabolism of doxylamine and pyridoxine may theoretically be reduced in the presence of hepatic impairment. Also, there could be a theoretical metabolite accumulation in the presence of renal impairment. Xonvea PR contains pyridoxine hydrochloride, a vitamin B6 analog, therefore additional levels from diet and vitamin B6 supplements should be assessed.
The combination doxylamine/pyridoxine has not been studied in cases of hyperemesis gravidarum; therefore, caution should be taken. These patients should be treated by a specialist. 1).
Photosensitivity reactions:
Although not noted with doxylamine, an increased sensitivity of the skin to sunlight, with photodermatitis, has been observed with some antihistamines; thus, sunbathing should be avoided during treatment.
Ototoxic medications:
Sedating antihistamines of the ethanolamine class, like doxylamine, could mask the warning signs of damage caused by ototoxic drugs such as antibacterial aminoglycosides, carboplatin, cisplatin, chloroquine and erythromycin, among others.
1. 5). Porphyria.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5). 5). Possible adverse anticholinergic effects associated with the use of antihistamines as a class in general include: dryness of mouth, nose and throat; dysuria; urinary retention; vertigo, visual disturbances, blurred vision, diplopia, tinnitus; acute labyrinthitis; insomnia; tremors, nervousness; irritability; and facial dyskinesia.
Tightness of chest, thickening of bronchial secretions, wheezing, nasal stuffiness, sweating, chills, early menses, toxic psychosis, headache, faintness and paresthesia have occurred. Rarely, agranulocytosis, haemolytic anaemia, leukopenia, thrombocytopenia, and pancytopenia have been reported in a few patients receiving some antihistamines.
Increased appetite and/or weight gain also occurred in patients receiving antihistamines. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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Care should be taken in epileptic patients as antihistamines have occasionally been associated with paradoxical hyperexcitability reactions, even at therapeutic doses. Due to decreased sweating caused by anticholinergic effects, antihistamines may aggravate symptoms of dehydration and heat stroke.
Special precautions should be adopted in patients with long QT syndrome, as several antihistamines may prolong the mentioned QT interval, although this effect has not been observed specifically with doxylamine at therapeutic dose. The suitability of treating patients with hypokalemia or other electrolyte disturbances must be evaluated.
The risk of abuse and drug dependence of doxylamine is low. 5). Interference with allergy skin testing Antihistamines may suppress the cutaneous histamine response to allergen extracts and should be stopped several days before skin testing.
This medicinal product contains Allura Red AC aluminium lake (E129), an azo colouring agent, which may cause allergic reactions. This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.