Chemical formula: C₁₅H₁₅ClN₂O₄S Molecular mass: 354.81 g/mol
There is no experience with the use of xipamide during pregnancy. In animal studies, reproduction toxic effects occurred.
Thiazide diuretics pass the placenta and may lead to electrolyte changes, hypoglycaemia as well as to haemolytic anaemia and thrombocytopenia in the unborn or newborn child. There is no data available on the transplacental passage of xipamide.
Due to their pharmacological properties, diuretics like xipamide are contraindicated during pregnancy in principle. Moreover, diuretics are not to be used under any circumstances for treatment of pregnancy-related oedemas and physiological oedemas, particularly since with these substances foetoplacental ischaemia may occur with the risk of foetal growth disturbances.
Thiazides and related diuretics should not be used to treat hypertension. They may cause neonatal thrombocytopenia, bone marrow suppression, jaundice, electrolyte disturbances, and hypoglycaemia; placental perfusion may also be reduced. Stimulation of labour, uterine inertia, and meconium staining have also been reported.
Since it is unknown whether xipamide passes into human breast milk, xipamide is contraindicated during lactation period.
Xipamide may cause dizziness and electrolyte disturbances which may affect the patient’s concentration or alertness, and may affect their ability to safely drive or operate machinery. This particularly applies at initiation of treatment or changes to the dose. If affected, patients should not drive or operate machinery.
With thiazide diuretics and drugs related to these including xipamide, the following undesirable effects may occur. Regarding clinical and chemical parameters the majority of undesirable effects are dose-dependent
In case of excessive diuresis, haemoconcentration may occur as a result of hypovolaemia as well as convulsions, somnolence, confusional state and circulatory collapse in rare cases.
Rarely, anaphylactoid reactions may occur.
A latent diabetes mellitus may manifest. In patients with diabetes mellitus, glucose levels may be increased.
With high dosages the risk of thrombosis and embolism is increased, particularly with previous existing venous disorders.
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/l0), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports, not known (cannot be estimated from the available data).
Very rare: Thrombocytopenia, leukopenia, agranulocytosis, aplastic anaemia (discontinuation of therapy)
Rare: Hyperlipidaemia
Common: Lethargy, anxiety, agitation
Common: Headache, dizziness, dry mouth, fatigue, sweating
Rare: Minor visual disturbances, aggravation of existing myopia (discontinuation of therapy)
Common: Palpitation
Common: Orthostatic hypotension
Common: Upper abdominal discomfort, cramping abdominal pain, diarrhoea, constipation
Rare: Haemorrhagic pancreatitis (discontinuation of therapy)
Rare: Acute cholecystitis in case or pre-existing cholelithiasis (discontinuation of therapy)
Very rare: Jaundice (icterus)
Uncommon: Photosensitivity reactions
Rare: Allergic skin reactions (pruritus, erythema, urticarial) (discontinuation of therapy)
Common: Muscle spasms/cramps
Very common: Hypokalaemia which may become apparent with symptoms such as nausea, vomiting, ECG changes, increased sensitivity to glycosides, arrhythmia or hypotonia of the skeletal muscles.
Common: Disturbances in the electrolytes and water balance, such as dehydration, hyponatraemia, hypomagnesaemia, hypochloremic alkalosis. Reversible increase in nitrogenous, urinary excreted substances (urea, creatinine), particularly at the beginning of treatment. Increase in serum uric acid level and triggering acute gouty arthritis in predisposed patients.
Very rare: Acute interstitial nephritis.
Therapy should be discontinued in case of:
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