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1. Name Of The Medicinal Product

Hyperbaric Bupivacaine Hydrochloride Injection 0.5% W/V.

2. Qualitative And Quantitative Composition

Each ml contains bupivacaine hydrochloride 5.28mg equivalent to anhydrous bupivacaine hydrochloride 5mg.

3. Pharmaceutical Form

Solution for Injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Spinal anaesthesia for surgery (urological and lower limb surgery lasting 2-3 hours and abdominal surgery lasting 45-60 minutes).

4.2 Posology And Method Of Administration

Route of administration: for injection into the spinal subarachnoid space.

The following recommended doses should be regarded as a guide for use in the average adult:

Spinal anaesthesia for surgery: Adults only: 2 - 4ml (10 - 20mg bupivacaine hydrochloride anhydrous). Pregnant women: 2 - 2.5 ml (10 - 12.5mg bupivacaine hydrochloride anhydrous).

The spread of anaesthesia obtained with hyperbaric bupivacaine solution 0.5% w/v depends on several factors, including the volume administered and the position of the patient during and after the injection. When injected at the L3 - L4 intervertebral space with the patient in the sitting position, a dose of 3ml spreads to the T7 – T10 spinal segments. If the patient receives the injection in the horizontal position and is then turned supine, the blockade spreads to the T4 - T7 spinal segments. It should be noted that the level of spinal anaesthesia achieved with any local anaesthetic can be unpredictable in a given patient. The effects of injecting volumes in excess of 4ml have not been studied and such volumes cannot, therefore, be recommended.

4.3 Contraindications

Known hypersensitivity to local an

Helixate NexGen 1000 IU powder and solvent for solution for injection

Recombinant coagulation factor VIII (octocog alfa)

Read all of this leaflet carefully before you start using this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or your pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

  • 1. What Helixate NexGen 1000 IU is and what it is used for
  • 2. Before you use Helixate NexGen 1000 IU
  • 3. How to use Helixate NexGen 1000 IU
  • 4. Possible side effects
  • 5. How to store Helixate NexGen 1000 IU
  • 6. Further information

WHAT Helixate NexGen 1000 IU IS AND WHAT IT IS USED FOR

Helixate NexGen 1000 IU belongs to a pharmacotherapeutic group called blood coagulation Factor VIII (ATC-Code B02B D02).

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.

One vial with powder for solution for injection nominally contains 1000 IU octocog alfa (IU equals International Units). After reconstitution with the appropriate volume of solvent (water for injections),

1. Name Of The Medicinal Product

Hytrin BPH 10mg Tablets

2. Qualitative And Quantitative Composition

    mg/tablet
Active: Terazosin

as monohydrochloride dihydrate

10.0

3. Pharmaceutical Form

Tablet

4. Clinical Particulars

4.1 Therapeutic Indications

Orally administered Hytrin BPH is indicated as a therapy for the symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia (BPH). Terazosin is a selective post synaptic alpha-1-adrenoreceptor antagonist. Antagonism of alpha-1-receptors on prostatic and urethral smooth muscle has been shown to improve urinary tract flow and relieve the urinary obstruction caused by BPH.

4.2 Posology And Method Of Administration

Adults Only:

The dose of terazosin should be adjusted according to the patient's response. The following is a guide to administration:

Initial dose

1 mg before bedtime is the starting dose for all patients and should not be exceeded. Strict compliance with this recommendation should be observed to minimise acute first-dose hypotensive episodes.

Subsequent dose

The dose may be increased by approximately doubling at weekly or bi-weekly intervals to achieve the desired reduction in symptoms. The maintenance dose is usually 5 to 10mg on

1. Name Of The Medicinal Product

HYDRALAZINE TABLETS BP 25mg

2. Qualitative And Quantitative Composition

Each tablet contains 25mg Hydralazine Hydrochloride.

For excipients, see 6.1.

3. Pharmaceutical Form

Film-coated tablet.

Ivory, circular, biconvex film-coated tablets impressed “C” on one face and the identifying letters “HY” on the reverse.

4. Clinical Particulars

4.1 Therapeutic Indications

Hydralazine is indicated for:

1) Moderate to severe hypertension (in conjunction with a beta-adrenoceptor blocking agent or diuretic) and hypertensive crisis.

2) The management of moderate to severe congestive cardiac failure (reduces afterload), where optimal doses of diuretics and cardiac glycosides prove insufficient. In patients with high left ventricular filling pressure, it is recommended to combine hydralazine with a nitrate.

4.2 Posology And Method Of Administration

For oral administration.

Adults: Dosage should not be increased beyond 100mg daily without first checking the patient's acetylator status.

Hypertension: The dose should be adjusted to the individual requirements of the patient. Treatment should begin with low doses of hydralazine which, depending on the patient's response, should be increased stepwise to achieve optimal therapeutic effect whilst keeping unwanted effects to a minimum. Initially 25mg twice daily. This can be increased gradually to a dose not exceeding 200mg daily.

Chronic congestive heart failure: Treatment with hydralazine should always be initiated in hospital, where the patient's individual haemodynamic values can be reliably determined with the help of invasive monitoring. It shou

1. Name Of The Medicinal Product

Hypnomidate® 2 mg/ml Injection

2. Qualitative And Quantitative Composition

Each ml of Hypnomidate contains etomidate 2 mg.

3. Pharmaceutical Form

Solution for injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Hypnomidate is an intravenous induction agent of anaesthesia.

4.2 Posology And Method Of Administration

For intravenous administration.

Hypnomidate should be injected slowly by the intravenous route.

The product must only be used by physicians trained in endotracheal intubation. Equipment for artificial respiration must be available.

Adults and children:

A dose of 0.3 mg/kg bodyweight given intravenously at induction of anaesthesia, gives sleep lasting from 4 to 5 minutes.

Dosage should be adjusted to the individual patient response and to clinical effects.

In children under 15 years the dosage may need to be increased: a supplementary dose of up to 30% of the normal dose for adults is sometimes necessary to obtain the same depth and duration of sleep as obtained in adults.

Elderly:

A dose of 0.15-0.2 mg/kg bodyweight should be given and the dose should be further adjusted according to the individual patient response and to clinical effects (see Section 4.4 Special Warnings and Precautions for Use).

Since Hypnomidate has no analgesic action, appropriate analgesics should be used in procedures involving painful stimuli.

Hypnosis can be prolonged by additional injections of Hypnomidate.

Do not exceed a total dose of 30 ml (3 ampoules).

1. Name Of The Medicinal Product

Hydromol Cream.

2. Qualitative And Quantitative Composition

Sodium Pyrrolidone Carboxylate 2.5%.

Excipients: Cetomacrogol emulsifying wax contains cetostearyl alcohol.

For full list of excipients see Section 6.1.

3. Pharmaceutical Form

Hydromol Cream is a soft, white, oil-in-water cream which can be massaged easily into the skin.

4. Clinical Particulars

4.1 Therapeutic Indications

Any condition in which “dry skin” is a feature, including all forms of dermatitis/eczema and all degrees of ichthyosis and senile pruritus.

4.2 Posology And Method Of Administration

Route of administration

For topical use only.

Adults, Children and the Elderly:

Apply liberally to the affected area and massage well into the skin. Hydromol Cream may be used as often as required.

Hydromol Cream is especially beneficial when used immediately after washing or bathing, when the resultant warmth of the skin enhances absorption.

4.3 Contraindications

There are no contra-indications except true hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

The formulation is not designed for use as a diluent.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Hydromol Cream is not contra-indicated in pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

1. Name Of The Medicinal Product

HumaJect S (Soluble)

(Soluble insulin injection)

100IU/ml solution for injection

HumaJect M3 (Mixture 3)

 

(Biphasic isophane insulin injection-30% soluble insulin/70% isophane insulin)

100IU/ml suspension for injection

2. Qualitative And Quantitative Composition

Active Ingredient

Human insulin

(recombinant DNA origin)

Quantity per ml

100IU

For excipients, see 6.1.

3. Pharmaceutical Form

A solution or suspension for injection in a prefilled/disposable pen injector containing a 3ml cartridge. HumaJect delivers up to 96 units per dose in increments of 2 units.

Humulin Soluble is a sterile, clear, colourless, aqueous solution of human insulin adjusted to a pH range of 7.0 to 7.8.

Humulin Soluble is a rapidly acting insulin preparation.

Humulin Mixture 3 is a sterile suspension of human insulin in the proportion of 30% soluble insulin to 70% isopha

1. Name Of The Medicinal Product

HALDOL® decanoate 50 mg/ml

HALDOL® decanoate 100 mg/ml

2. Qualitative And Quantitative Composition

HALDOL® decanoate 50 mg/ml

Haloperidol decanoate 70.52 mg, equivalent to 50 mg haloperidol base, per millilitre.

HALDOL® decanoate 100 mg/ml

Haloperidol decanoate 141.04 mg, equivalent to 100 mg haloperidol base, per millilitre.

3. Pharmaceutical Form

Straw-coloured viscous solution for intramuscular injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Haldol decanoate is indicated for long term maintenance treatment where a neuroleptic is required; for example in schizophrenia, other psychoses (especially paranoid), and other mental or behavioural problems where maintenance treatment is clearly indicated.

4.2 Posology And Method Of Administration

By intramuscular administration.

Haldol decanoate is for use in adults only and has been formulated to provide one month's therapy for most patients following a single deep intramuscular injection in the gluteal region. Haldol decanoate must not be administered intravenously.

Since individual response to neuroleptic drugs is variable, dosage should be individually determined and is best initiated and titrated under close clinical supervision.

The size of the initial dose will depend on both the severity of the symptomatology and the amount of oral medication required to maintain the patient before starting depot treatment. Haldol decanoate injection should be used at the minimum dose that is clinically effective.

An initial dose of 50 mg every four weeks is recommended, increasing if nece

1. Name Of The Medicinal Product

Hypurin® Bovine Isophane

2. Qualitative And Quantitative Composition

Crystalline Insulin Ph Eur (Bovine) 100 IU/ml.Isophane Insulin Injection Ph Eur (Bovine)

For excipients, see 6.1

3. Pharmaceutical Form

Suspension for injection.

A white suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

The treatment of insulin dependent diabetes mellitus.

May be used for diabetics requiring a depot insulin of medium duration. Where a more rapid, intense onset is desirable it may be mixed with Hypurin Neutral.

4.2 Posology And Method Of Administration

To be determined by the physician according to the needs of the patient.

Usually administered subcutaneously but where necessary it may be given intramuscularly in which case onset is more rapid and overall duration shorter. It should not be given intravenously. Onset of action occurs within 2 hours after subcutaneous injection with an overall duration of 18-24 hours. Maximum effect is exerted between 612 hours.

4.3 Contraindications

Hypoglycaemia.

Hypersensitivity to insulin or to any of the excipients.

4.4 Special Warnings And Precautions For Use

In no circumstances must Hypurin® Bovine Isophane be given intravenously.

Hypoglycaemia: Susceptibility to hypoglycaemia may be increased by an inaccurate or excessive dosage of insulin, the omission of a meal by the patient or increased physical activity. Correct insulin administration and awareness of the symptoms of hypoglycaemia are essential to reduce the risk of hypoglycaemia (see section 4.9).

Blood or urinary glucose concentrations should be monito

1. Name Of The Medicinal Product

Herpid.

2. Qualitative And Quantitative Composition

A clear, colourless solution containing idoxuridine BP 5% in dimethyl sulfoxide.

3. Pharmaceutical Form

Topical Solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Cutaneous herpes simplex and herpes zoster (shingles).

4.2 Posology And Method Of Administration

Administration: Herpid should be painted on the lesions and their erythematous bases four times daily for four days.

Adults and children over 12 years:

Treatment should start as soon as the condition has been diagnosed, ideally within two or three days after the rash appears. Good results are less likely if treatment is not started within seven days.

Children under 12 years:

The use of Herpid in children with malignant disease might be justified but, although not a contra-indication, its use in children under the age of 12 years is not recommended.

No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.

4.3 Contraindications

Known hypersensitivity to either idoxuridine or dimethyl sulfoxide.

Dermographia.

4.4 Special Warnings And Precautions For Use

Herpid in the eye causes stinging: treat by washing out with water. The dimethyl sulfoxide in Herpid may be irritant to the skin.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Since the solvent in Herp

Harmogen 1.5mg Tablets

estropipate

Pharmacia logo

What is this leaflet about?

This leaflet is a summary of the information about your Harmogen tablets. Please read this leaflet before you start taking your tablets. If there is anything you do not understand or if you want to know more, ask your own doctor or pharmacist (chemist).

This medicine has been prescribed for you personally. You should not give it to others as it may harm them, even if their symptoms are the same as yours.

In this leaflet:

  • 1. What Harmogen 1.5 mg Tablets are and what they are used for.
  • 2. Before you use Harmogen 1.5 mg.
  • 3. When to use Harmogen 1.5 mg.
  • 4. Using Harmogen 1.5 mg.
  • 5. Possible side-effects.
  • 6. Reasons to stop using Harmogen 1.5 mg.
  • 7. Storing Harmogen 1.5 mg.
  • 8. Further information.

The name of your medicine is Harmogen 1.5 mg Tablets (Harmogen).

Your Harmogen tablets contain 1.5 mg Estropipate USP (piperazine estrone sulphate), equivalent to 0.93 mg estrone. The estropipate is the active ingredient.

There are also inactive ingredients in the tablet. These are: lactose, dibasic potassium phosphate, tromethamine, hydroxypropyl cellulose, sodium starch glycollate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, h

1. Name Of The Medicinal Product

HAYMINE TABLETS

2. Qualitative And Quantitative Composition

Each tablet contains:

Chlorphenamine maleate Ph.Eur. 10 mg

Ephedrine hydrochloride Ph.Eur. 15mg

3. Pharmaceutical Form

Sustained release tablet

4. Clinical Particulars

4.1 Therapeutic Indications

Relief of symptoms caused by allergic conditions such as hay fever, allergic rhinitis, perennial rhinitis, urticaria etc., which are responsive to antihistamine.

4.2 Posology And Method Of Administration

Adults, elderly and children over 12 years of age:

One or two tablets daily. One tablet should be taken in the morning on rising and a further tablet may be taken at night if required.

Children under 12 years of age:

Not recommended.

Method of administration - oral use.

4.3 Contraindications

Coronary thrombosis, hypertension, thyrotoxicosis and those on treatment with monoamine oxidase inhibitors.

4.4 Special Warnings And Precautions For Use

Tablets should be swallowed whole and not sucked or chewed. Do not exceed the stated dose. Asthmatics should consult their doctor before using this product. May cause drowsiness, if affected do not drive or operate machinery. Avoid alcoholic drink.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Alcoholic drinks and certain other central nervous system depressants can potentiate any sedative effect.

4.6 Pregnancy And Lactation

Contra-indicated.

4.7 Effects On Ability To

Helixate NexGen 500 IU powder and solvent for solution for injection

Recombinant coagulation factor VIII (octocog alfa)

Read all of this leaflet carefully before you start using this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or your pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

  • 1. What Helixate NexGen 500 IU is and what it is used for
  • 2. Before you use Helixate NexGen 500 IU
  • 3. How to use Helixate NexGen 500 IU
  • 4. Possible side effects
  • 5. How to store Helixate NexGen 500 IU
  • 6. Further information

WHAT Helixate NexGen 500 IU IS AND WHAT IT IS USED FOR

Helixate NexGen 500 IU belongs to a pharmacotherapeutic group called blood coagulation Factor VIII (ATC-Code B02B D02).

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.

One vial with powder for solution for injection nominally contains 500 IU octocog alfa (IU equals International Units). After reconstitution with the appropriate volume of solvent (water for injections), each via

1. Name Of The Medicinal Product

Herceptin

2. Qualitative And Quantitative Composition

One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures.

The reconstituted Herceptin solution contains 21 mg/ml of trastuzumab.

For a full list of excipients, (see section 6.1).

3. Pharmaceutical Form

Powder for concentrate for solution for infusion.

Herceptin is a white to pale yellow lyophilised powder.

4. Clinical Particulars

4.1 Therapeutic Indications

Breast Cancer

Metastatic Breast Cancer (MBC)

Herceptin is indicated for the treatment of patients with HER2 positive metastatic breast cancer:

- as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.

- in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.

- in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.

- in combination with an aromatase inhibitor for the treatment of postmenopausal patie

1. Name Of The Medicinal Product

HYDREX®, CLEAR CHLORHEXIDINE GLUCONATE 0.5% W/V IN 70% V/V DEB.

2. Qualitative And Quantitative Composition

Chlorhexidine Gluconate Solution 20% BP (Ph Eur) – 2.5% v/v

3. Pharmaceutical Form

Liquid

4. Clinical Particulars

4.1 Therapeutic Indications

This product is for pre-operative skin disinfection prior to minor surgical procedures

4.2 Posology And Method Of Administration

This product is applied topically.

4.3 Contraindications

i) Do not use in patients who are hypersensitive to chlorhexidine.

ii) Do not use in contact with eyes, brain, meninges, middle ear or external ear with a perforated tympanic membrane.

iii) Do not inject.

iv) Do not use in body cavities.

v) When use is to be followed by diathermy do not allow pooling of the fluid to occur and ensure that the skin and surrounding drapes are dry.

4.4 Special Warnings And Precautions For Use

i) Precautions:- irritant skin reaction and generated allergic reactions to chlorhexidine have been reported.

ii) Accidental ingestion:- chlorhexidine is poorly absorbed orally. Treat with gastric lavage using milk, egg white, gelatin or mild soap. Employ supportive measures as appropriate.

iii) Accidental intravenous infusion - blood transfusion may be necessary to counteract haemolysis.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated

4.6 Pregnancy And Lactation

None stated

4.7 Effects On Ability To Drive And Use Machines

None stated

1. Name Of The Medicinal Product

Hypurin® Bovine Neutral

2. Qualitative And Quantitative Composition

Crystalline Insulin Ph Eur (Bovine) 100IU/ml.

Neutral Insulin Injection Ph Eur (Bovine)

For excipients, see 6.1

3. Pharmaceutical Form

Solution for injection

A clear, colourless solution

4. Clinical Particulars

4.1 Therapeutic Indications

The treatment of insulin dependent diabetes mellitus.

May be used for diabetics who require an insulin of prompt onset and short duration. It is a suitable preparation for admixture with longer acting insulins. It is particularly useful where intermittent, short term or emergency therapy is required, during initial stabilisation and in the treatment of labile diabetes.

4.2 Posology And Method Of Administration

To be determined by the physician according to the needs of the patient.

Usually administered subcutaneously but where necessary it may be given intramuscularly or intravenously. After subcutaneous injection onset of action occurs within 30-60 minutes with an overall duration of 6-8 hours. Maximum effect is exerted over the mid-range.

4.3 Contraindications

Hypoglycaemia.

Hypersensitivity to insulin or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Hypoglycaemia: Susceptibility to hypoglycaemia may be increased by an inaccurate or excessive dosage of insulin, the omission of a meal by the patient or increased physical activity. Correct insulin administration and awareness of the symptoms of hypoglycaemia are essential to reduce the risk of hypoglycaemia (see section 4.9).

Blood or urinary glucose c

Hygroton Tablets 50 mg

chlortalidone

Read all of this leaflet carefully before you start taking this medicine

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.

The information in this leaflet has been divided into the following sections:

  • 1. What Hygroton is and what it is taken for
  • 2. Check before you take Hygroton
  • 3. How to take Hygroton
  • 4. Possible side effects
  • 5. How to store Hygroton
  • 6. Further information

What Hygroton is and what it is taken for

Hygroton belongs to a group of medicines called thiazide diuretics.

Thiazide diuretics help to reduce the amount of water in your body. They do this by increasing the amount of water that you pass as urine. They are sometimes called 'water tablets'.

Hygroton is used to:

  • treat high blood pressure (hypertension)
  • treat heart failure
  • help reduce the flui

1. Name Of The Medicinal Product

Hepsera 10 mg tablets

2. Qualitative And Quantitative Composition

Each tablet contains 10 mg adefovir dipivoxil.

Excipient(s):

Each tablet contains 113 mg lactose monohydrate.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablet.

White to off

4. Clinical Particulars

4.1 Therapeutic Indications

Hepsera is indicated for the treatment of chronic hepatitis B in adults with:

• compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis

• decompensated liver disease.

4.2 Posology And Method Of Administration

Therapy should be initiated by a physician experienced in the management of chronic hepatitis B.

Adults: The recommended dose of Hepsera is 10 mg (one tablet) once daily taken orally with or without food.

Higher doses must not be administered.

The optimum duration of treatment is unknown. The relationship between treatment response and long

Patients should be monitored every six months for hepatitis B biochemical, virological and serological markers.

Treatment discontinuation may be considered as follows:

- In HBeAg positive patients without cirrhosis, treatment should be administered for at least 6

- In HBeAg negative patients without cirrhosis, treatment should be administered at least until HBs seroconversion or there is evidence of loss of efficacy. With prolonged treatment for more than 2 years, regular re

1. Name Of The Medicinal Product

Hytrin Tablets 5mg

Terazosin Tablets 5mg

2. Qualitative And Quantitative Composition

    mg/tablet
Active: Terazosin

as monohydrochloride dihydrate

5.0

3. Pharmaceutical Form

Tan, round, flat bevelled tablets embossed with logo and triangular facets on one face and plain on the other.

4. Clinical Particulars

4.1 Therapeutic Indications

Orally administered Hytrin is indicated in the treatment of mild to moderate hypertension. It may be used in combination with thiazide diuretics and/or other antihypertensive drugs or as sole therapy where other agents are inappropriate or ineffective. The hypotensive effect is most pronounced on the diastolic pressure. Although the exact mechanism of the hypotensive action of terazosin is not established, the relaxation of peripheral blood vessels appears to be produced mainly by competitive antagonism of post-synaptic alpha1 - adrenoceptors. Hytrin usually produces an initial gradual decrease in blood pressure followed by a sustained antihypertensive action.

Orally administered Hytrin is also indicated as a therapy for the symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia (BPH). Terazosin is a selective post synaptic alpha-1 -adrenoreceptor antagonist. Antagonism of alpha-i -receptors on prostatic and urethral smooth muscle has been shown to improve urinary tract

1. Name Of The Medicinal Product

Hytrin Tablets 5mg

Terazosin Tablets 5mg

2. Qualitative And Quantitative Composition

 

 

mg/tablet

Active:

Terazosin 5.0

as monohydrochloride dihydrate

2.0

3. Pharmaceutical Form

Tan, round, flat bevelled tablets embossed with logo and triangular facets on one face and plain on the other.

4. Clinical Particulars

4.1 Therapeutic Indications

Orally administered Hytrin is indicated in the treatment of mild to moderate hypertension. It may be used in combination with thiazide diuretics and/or other antihypertensive drugs or as sole therapy where other agents are inappropriate or ineffective. The hypotensive effect is most pronounced on the diastolic pressure. Although the exact mechanism of the hypotensive action of terazosin is not established, the relaxation of peripheral blood vessels appears to be produced mainly by competitive antagonism of post-synaptic alpha1 - adrenoceptors. Hytrin usually produces an initial gradual decrease in blood pressure followed by a sustained antihypertensive action.

Orally administered Hytrin is also indica