Cosmos Pharmaceutical Limited | CARDITAN®
Cosmos Limited is one of the leading manufacturers of pharmaceutical products in Kenya and East Africa. Through our specialized Human Health and Animal Health.
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CARDITAN®

CLINICAL PHARMACOLOGY:
Losartan is an angiotensin II receptor antagonist with antihypertensive activity due mainly to selective blockade of AT1 receptors and the consequent reduced pressor effect of angiotensin II.

Pharmacokinetics:

Losartan is readily absorbed from the gastrointestinal tract after oral doses, but undergoes substantial first-pass metabolism resulting in a systemic bioavailability of about 33%. It is metabolised  to an active carboxylic acid metabolite E-3174 (EXP-3174), which has greater pharmacological activity than losartan; some inactive metabolites are also formed. Metabolism is primarily by cytochrome P450 isoenzymes CYP2C9 and CYP3A4. Peak plasma concentrations of losartan and E-3174 occur about 1 hour and 3 to 4 hours, respectively, after an oral dose. Both Losartan and E-3174 are more than 98% bound to plasma proteins. Losartan is excreted in the urine, and in the faeces via bile, as unchanged drug and metabolites. About 4% of an oral dose is excreted unchanged in urine and about 6% is excreted in urine as the active metabolite. The terminal elimination half-lives of losartan and E-3174 are about 1.5 to 2.5 hours and 3 to 9 hours, respectively.

USES:

It is used in the management of hypertension particularly in patients who develop cough with ACE inhibitors and to reduce the risk of stroke in patient with left ventricular hypertrophy, and in the treatment of diabetic nephropathy. It has also been tried in heart failure and in myocardial infarction.

DOSAGE AND ADMINISTRATION:

Losartan is given by mouth as the potassium salt. The maximum hypotensive effect is achieved in about 3 to 6 weeks after initiating treatment.
In hypertension the usual dose is 50mg once daily. The dose may be increased, if necessary, to 100mg daily as a single dose or in two divided doses. An initial dose of 25mg once daily should be given to patients with intravascular fluid depletion, and is recommended in the elderly over 75 years of age. Similar reductions may be appropriate in patients with hepatic or renal impairment. Children aged 6 years or over with hypertension may be given an initial dose of 700 micrograms/kg once daily, with a maximum of 50mg, adjusted according to response.
In diabetic nephropathy Losartan is given in an initial dose of 50mg once daily, increased to 100 mg once daily  depending on the blood pressure.

CARDITAN® TABLETS
CONTRA-INDICATIONS AND  WARNINGS:
Precautions:

Losartan is contra-indicated in pregnancy. It should be used with caution in patients with renal artery stenosis. Losartan is excreted in  urine and in bile and reduced doses may therefore be required in patients with renal impairment and should be considered in patients with hepatic impairment. Patients with volume depletion (for example those who have received high-dose diuretic therapy) may experience hypotension; volume depletion should be corrected before starting therapy, or a low initial dose should be used. Since hyperkalaemia may occur, serum-potassium concentrations should be monitored, especially in the elderly and patients with renal impairment, and the concomitant use of potassium-sparing diuretics should generally be avoided.
Adverse Effects:

Adverse effects of losartan have been reported to be usually mild and transient , and include dizziness, headache, and dose-related orthostatic hypotension.

Hypotension may occur particularly in patients with volume depletion. Impaired renal function  and, rarely, rash, urticaria, pruritus, angioedema, and raised liver enzyme values may occur. Hyperkalaemia, myalgia, and arthralgia have been reported. Losartan appears less likely than ACE inhibitors to cause cough. Other adverse effects that have been reported with angiotensin II receptor antagonists include respiratory-tract disorders, back pain, gastrointestinal disturbances, fatigue, and neutropenia.

Interactions:

The antihypertensive effects of losartan may be potentiated by drugs or other agents that lower blood pressure. An additive hyperkalaemic effect is possible with potassium supplements, potassium-sparing diuretics, or other drugs that can cause hyperkalaemia; losartan and potassium-sparing diuretics should not generally be given together. Losartan and some other angiotensin II receptor antagonists are metabolised by cytochrome P450 isoenzymes and interactions may occur with drugs that affect these enzymes.

PHARMACEUTICAL PRECAUTIONS:

Store in a dry place below 25ºC.  Protect from light.  Keep all medicines out of the  reach of children.

LEGAL CATEGORY:
Prescription Only Medicine (POM)
®Regd. TM                                                                                        Ref. No.: INS244/10.08

IMAGES
  • CARDITAN®50 Tablets F/C

    PresentationCarditan® Tablets 50mg: White, circular, biconvex film coated tablet embossed 'C' on one side and a breakline on the other side. Each film coated tablet contains: Losartan Potassium USP 50mg. Pack size - 28's (2x14's)

  • CARDITAN®AM Tablets

    PresentationLOSARTAN POTASSIUM / AMLODIPINE Tablets 50:5mg. Pack size - 28's (2x14's)

  • CARDITAN®H Tablets

    PresentationCarditan® Tablets 50mg: White, circular, biconvex film coated tablet embossed 'C' on one side and a breakline on the other side. Each film coated tablet contains: Losartan Potassium USP 50mg. Pack size - 28's (2x14's)