Losartan-Comp 50/12.5 mg Oral Tablets – 50mg Losartan/12.5mg Hydrochlorothiazide

Don’t use during pregnancy as it may cause injury or death to the developing fetus.

Composition

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

Therapeutic indications

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.

Losartan Hydrochlorothiazide Combination Anti-hypertensive
Losartan Hydrochlorothiazide Combination Anti-hypertensive
Losartan-Comp, usually taken once daily with or without food. If this medication causes you to urinate more frequently, it is best to take it at least 6 hours before your bedtime to prevent having to get up to urinate.

Is it better to take Losartan-Comp at night or morning?

Take Losartan-Comp tablets once a day. Your doctor may suggest that you take your first dose before breakfast, because it can make you urinate more frequently. As a general guidline, you can take Losartan-Comp at any time of day. But try to take it at the same time every day.

How long does it take for Losartan-Comp to lower blood pressure?

Losartan-Comp usually takes 3 to 6 weeks to see the full effects of this medication.

Undesirable effects

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:

Hepato-biliary disorders

  • 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

Psychiatric disorders

  • 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

Eye disorders

Uncommon: Blurred vision, burning/stinging in the eye, conjunctivitis, decrease in visual acuity

Ear and labyrinth disorders

Uncommon: Vertigo, tinnitus

Cardiac disorders

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)

Vascular disorders

  • 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.

Gastrointestinal disorders

  • Common: Abdominal pain, nausea, diarrhoea, dyspepsia.
  • Uncommon: Constipation, dental pain, dry mouth, flatulence, gastritis, vomiting, constipation
  • Not Known: Pancreatitis

Hepato-biliary disorders

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

General disorders 

  • Common: Asthenia, fatigue, chest pain
  • Uncommon: Facial oedema, oedma, fever Not known: flu-like symptoms, malaise

Investigations

  • 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
Losartan potassium & Hydrochlorothiazide combination
Losartan potassium & Hydrochlorothiazide combination

Referances

Losartan potassium & Hydrochlorothiazide combination – EN – PIL.

Losartan potassium & Hydrochlorothiazide combination – AR – PIL.

Product ATC code: C09DA01 – Product of: PHAROPHARMA – Egypt