|Don’t use during pregnancy as it may cause injury or death to the developing fetus.|
Each tablet of Losartan-Comp contains: Active ingredients:
- Losartan potassium 50mg
- Hydrochlorothiazide 12.5mg
Inactive ingredients: Microcrystalline cellulose PH 101, Maize starch, dibasic calcium phosphate dihydrate, Croscarmellose sodium, Pregelatinized starch, Magnesium stearate.
Pharmaceutical form: Tablets
Losartan potassium/Hydrochlorothiazide (Losartan-Comp) is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on Losartan or hydrochlorothiazide.
Posology and method of administration
Hypertension: Losartan-Comp (Losartan potassium/Hydrochlorothiazide) is not for use as initial therapy, but in patients whose blood pressure is not adequately controlled by Losartan potassium or hydrochlorothiazide alone.
Dose titration with the individual components (Losartan potassium/Hydrochlorothiazide) is recommended.
When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled.
The usual maintenance dose of Losartan Potassium/Hydrochlorothiazide is one tablet of Losartan Potassium/Hydrochlorothiazide 50 mg/12.5 mg (Losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily.
Use in patients with renal impairment and haemodialysis patients: No initial dosage adjustment is necessary in patients with moderate renal impairment (ie, creatinine clearance 30-50 ml/min).
Losartan and Hydrochlorothiazide tablets are not recommended for haemodialysis patients. Losartan/Hydrochlorothiazide tablets must not be used in patients with severe renal impairment (ie, creatinine clearance <30ml/min).
Use in patients with intravascular volume deplation: Volume and/or sodium depletion should be corrected prior to administration of Losartan/Hydrochlorothiazide tablets.
Use in patients with hepatic impairment: Losartan/Hydrochlorothiazide is contraindicated in patients with severe hepatic impairment.
Older people: Dosage adjustment is not usually necessary for the older people.
Method of administration
For oral administration.
Losartan-Comp may be administered with other antihypertensive agents.
Losartan-Comp tablets should be swallowed whole with a glass of water .
Losartan-Comp may be administered with or without food.
Paediatric population and adolescents (< 18 years): There is no experience in children and adolescents. Therefore, Losartan/hydrochlorothiazide should not be administered to children and adolescents.
When is the best time of day to take Losartan-Comp?
Is it better to take Losartan-Comp at night or morning?
How long does it take for Losartan-Comp to lower blood pressure?
The adverse events below are classified where appropriate by system organ class and frequency according to the following convention:
- 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)
In clinical trials with Losartan potassium salt and hydrochlorothiazide, no adverse events peculiar to this combination of substances were observed. The adverse events were restricted to those which were formerly observed with Losartan potassium salt and/or hydrochlorothiazide.
In controlled clinical trials for essential hypertension, dizziness was the only adverse experience reported by patients treated with Losartan potassium/Hydrochlorothiazide.
Next to these effects, there are further adverse reactions reported after the introduction of the product to the market as follows:
- Rare: Hepatitis Investigations
- Rare: Hyperkalaemia, elevation of ALT
The adverse reactions that have been seen with one of the individual components and may be potential adverse events with Losartan potassium/hydrochlorothiazide are the following:
The following adverse reactions have been reported for Losartan in clinical studies and in post-marketing experience
Blood and lymphatic system disorders
- Uncommon: Anaemia, Henoch-Schönlein purpura, ecchymosis, haemolysis
- Not known: Thrombocytopenia
Immune system disorders
Rare: Hypersensitivity: anaphylactic reactions, angiooedema including swelling of the larynx and glottis causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue in some of these patients anglooedema had been reported in the past in connection with the administration of other medicines, Including ACE inhibitors.
Metabolism and nutrition disorders
Uncommon: Anorexia, gout
- Common: Insomnia
- Uncommon: Anxiety, anxiety disorder, panic disorder, confusion, depression, abnormal dreams, sleep disorder, somnolence, memory impairment
Nervous system disorders
- Common: Headache, dizziness
- Uncommon: Nervousness, paraesthesia, peripheral neuropathy, tremor, migraine, syncope
- Not known: Dysgeusia
Uncommon: Blurred vision, burning/stinging in the eye, conjunctivitis, decrease in visual acuity
Ear and labyrinth disorders
Uncommon: Vertigo, tinnitus
Uncommon: Hypotension, orthostatic hypotension, sternalgia, angina pectoris, grade II-AV block, cerebrovascular event, myocardial infarction, palpitation, arrhythmias (atrial fibrillations, sinus bradycardia, tachycardia, ventricular tachycardia, ventricular fibrillation)
- Uncommon: Vasculitis
- Not known: Dose-related orthostatic effects
Respiratory, thoracic and mediastinal disorders
Common Cough upper respiratory infection, nasal congestion, sinusitis, sinus disorder.
Uncommon: Pharyngeal discomfort, pharyngitis, laryngitis, dyspnoea, bronchitis, epistaxis, rhinitis, respiratory congestion.
- Common: Abdominal pain, nausea, diarrhoea, dyspepsia.
- Uncommon: Constipation, dental pain, dry mouth, flatulence, gastritis, vomiting, constipation
- Not Known: Pancreatitis
Not known: Liver function abnormalities.
Skin and subcutaneous tissue disorders
Uncommon: Alopecia, dermatitis, dry skin, erythema, flushing, photosensitivity, pruritus, rash, urticaria, sweating
Musculoskeletal and connective tissue disorders
- Common Muscle cramp, back pain, leg pain, myalgia
- Uncommon: Arm pain, joint swelling, knee pain, musculoskeletal pain, shoulder pain, stiffness, arthralgia, arthritis, coxalgia, fibromyalgia, muscle weakness
- Not known: Rhabdomyolysis
Renal and urinary disorders
- Common: Renal impairment, renal failure
- Uncommon: Nocturia, urinary frequency, urinary tract infection
Reproductive system and breast disorders
Uncommon: Decreased libido, erectile dysfunction/impotence
- Common: Asthenia, fatigue, chest pain
- Uncommon: Facial oedema, oedma, fever Not known: flu-like symptoms, malaise
- Common: Hyperkalaemia, mild reduction of haematocrit and haemoglobin, hypoglycaemia
- Uncommon: Mild increase in urea and creatinine serum levels
- Very rare: Increase in hepatic enzymes and bilirubin.
- Not Known: Hyponatraemia
Product ATC code: C09DA01 – Product of: PHAROPHARMA – Egypt