Side effects of Romapal in details
The administration of Perindopril (Romapal) inhibits the renin-angiotensin-aldosterone axis and tends to reduce the potassium loss caused by Indapamide (Romapal). Two percent (2%) of the patients on treatment with Romapal 2.5 mg/0.625 mg, 4% of the patients on treatment with Romapal 5 mg/1.25 mg and 6% of the patients on treatment with Romapal 10 mg/2.5 mg experience hypokalaemia (potassium level <3.4 micromol/L).
The following undesirable effects could be observed during treatment and ranked under the following frequency: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).
Blood and the Lymphatic System Disorders: Very Rare: Thrombocytopenia, leucopenia/neutropenia, agranulocytosis, aplastic anaemia, haemolytic anaemia. Anaemia has been reported with ACE inhibitors in specific circumstances (patients who have had kidney transplants, patients undergoing haemodialysis).
Psychiatric Disorders: Uncommon: Mood or sleep disturbances.
Nervous System Disorders: Common: Paraesthesia, headache, dizziness, vertigo. Very Rare: Confusion.
Eye Disorders: Common: Vision disturbance.
Ear and Labyrinth Disorders: Common: Tinnitus.
Vascular Disorders: Common: Hypotension whether orthostatic or not.
Cardiac Disorders: Very Rare: Arrhythmia including bradycardia, ventricular tachycardia, atrial fibrillation, angina pectoris and myocardial infarction possibly secondary to excessive hypotension in high-risk patients.
Respiratory, Thoracic and Mediastinal Disorders: Common: A dry cough has been reported with the use of ACE inhibitors. It is characterised by its persistence and by its disappearance when treatment is withdrawn. An iatrogenic aetiology should be considered in the presence of this symptom. Dypsnoea. Uncommon: Bronchospasm. Very Rare: Eosinophilic pneumonia, rhinitis.
Gastrointestinal Disorders: Common: Constipation, dry mouth, nausea, vomiting, abdominal pain, dysgeusia, dyspepsia, diarrhoea, epigastric pain, anorexia, abdominal pains, taste disturbance. Very Rare: Pancreatitis.
Hepato-Biliary Disorders: Very Rare: Hepatitis either cytolytic or cholestatic. Not known: In case of hepatic insufficiency, there is a possibility of onset of hepatic encephalopathy.
Skin and Subcutaneous Tissue Disorders: Common: Rash, pruritus, maculopapular eruptions. Uncommon: Angioedema of face, extremities, lips, mucous membranes, tongue, glottis and/or larynx, urticaria. Hypersensitivity reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions. Purpura, possible aggravation of preexisting acute disseminated lupus erythematosus. Very Rare: Erythema multiforme, toxic epidermic necrolysis, Stevens-Johnson syndrome. Cases of photosensitivity reactions have been reported.
Musculoskeletal, Connective Tissue and Bone Disorders: Common: Muscle cramps.
Renal and Urinary Disorders: Uncommon: Renal insufficiency. Very Rare: Acute renal failure.
Reproductive System and Breast Disorders: Uncommon: Impotence.
General Disorders and Administration Site Conditions: Common: Asthenia. Uncommon: Sweating.
Investigations: Potassium depletion with particularly serious reduction in levels of potassium in some at risk populations. Reduced sodium levels with hypovolaemia causing dehydration and orthostatic hypotension. Increase in uric acid levels and in blood glucose levels during treatment. Slight increase in urea and in plasma creatinine levels, reversible when treatment is stopped. This increase is more frequent in cases of renal artery stenosis, arterial hypertension treated with diuretics, renal insufficiency. Increased levels of potassium, usually transitory. Rare: Raised plasma calcium levels.
Romapal contraindications
Linked to Perindopril (Romapal): Hypersensitivity to Perindopril (Romapal) or to any other ACE inhibitor; history of angioedema (Quincke's oedema) associated with previous ACE inhibitor therapy; hereditary/idiopathic angioedema; bilateral or unilateral renal artery stenosis.
Linked to Indapamide (Romapal): Hypersensitivity to Indapamide (Romapal) or to any other sulphonamides; severe renal impairment (creatinine clearance <30 mL/min); hepatic encephalopathy; severe hepatic impairment; hypokalaemia.
As a general rule, Indapamide (Romapal) is inadvisable in combination with non-antiarrhythmic agents causing Torsades de pointes.
Linked to Romapal: Hypersensitivity to any of the excipients of Romapal.
Linked to Romapal 10 mg/2.5 mg: Severe and moderate renal impairment (creatinine clearance <60 mL/min)
Due to the lack of sufficient therapeutic experience, Romapal should not be used in dialysis patients; patients with untreated decompensated heart failure.
Excipients: Romapal should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Renal Impairment: Romapal 5 mg/1.25 mg: In cases of severe renal impairment (creatinine clearance <30 mL/min), treatment is contraindicated. Romapal 10 mg/2.5 mg: In cases of severe and moderate renal impairment (creatinine clearance <60 mL/min), treatment is contraindicated.
In certain hypertensive patients without preexisting apparent renal lesions and for whom renal blood tests show functional renal insufficiency, treatment should be stopped and possibly restarted either at a low dose or with 1 constituent only.
In these patients, usual medical follow-up will include frequent monitoring of potassium and creatinine, after 2 weeks of treatment and then every 2 months during therapeutic stability period. Renal failure has been reported mainly in patients with severe heart failure or underlying renal failure including renal artery stenosis.
The Romapal is usually not recommended in case of bilateral renal artery stenosis or a single functioning kidney.
Use in pregnancy & lactation: As this combination includes an ACE inhibitor, Romapal is contraindicated during pregnancy and lactation.
ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.
Use of Perindopril (Romapal) is not recommended during breastfeeding.
Linked to Perindopril (Romapal): Appropriate and well-controlled studies have not been done in humans. ACE inhibitors cross the placenta and can cause foetal and neonatal morbidity and mortality when administered to pregnant women.
Foetal exposure to ACE inhibitors during the 2nd and 3rd trimesters has been associated with neonatal hypotension, renal failure, face or skull deformities and/or death. Maternal oligohydramnios has also been reported reflecting decreasing renal function in the foetus. Limb contractures, craniofacial deformities, hypoplastic lung development and intrauterine growth retardation have been reported in association with oligohydramnios. Infants exposed in utero to ACE inhibitors should be closely observed for hypotension, oliguria and hyperkalaemia. Oliguria should be treated with support of blood pressure and renal perfusion.
Intrauterine growth retardation, prematurity, patent ductus arteriosus and foetal death have also been reported but it is not clear whether they are related to the ACE inhibition or the underlying maternal disease. It is not known whether exposure limited to the 1st trimester can adversely affect foetal outcome. Women who become pregnant while receiving an ACE inhibitor should be informed of the potential hazard to the foetus.
ACE inhibitors may be excreted in breast milk and their effect on the nursing infant has not been determined. It is recommended that lactating mothers should not breastfeed while taking ACE inhibitors.
Linked to Indapamide (Romapal): As a general rule, the administration of diuretics should be avoided in pregnant women and should never be given as treatment for physiological oedema (and therefore, do not require treatment) of pregnancy. Diuretics may lead to foeto-placental ischaemia, with a risk of impaired foetal growth.
Nonetheless, diuretics remain an essential part of the treatment of oedema from cardiac, hepatic and renal origin arising in pregnant women.
Indapamide (Romapal) is excreted in small quantities in breast milk. Nonetheless, it should not be used in breastfeeding period due to: The decrease and even suppression of the milk secretion; its adverse reactions in particular biological (potassium levels); its belonging to the sulphonamide group with the risks of allergy and nuclear icterus.
Use in children and adolescents: Romapal should not be used in children and adolescents as the efficacy and tolerability of Perindopril (Romapal) in children and adolescents, alone or in combination, have not been established.
References
- DailyMed. "INDAPAMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DTP/NCI. "indapamide: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "Indapamide: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
