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What is Prostif and what is it used for?

Prostif contains Finasteride 5 mg in tablet form. s a drug for the treatment of Benign Prostatic Hyperplasia (BPH) commonly known as enlarged prostate the condition in which size of prostate glands increases in middle-aged and old aged man.

It is proven to improve the symptoms associated with BPH such as difficulties related to urination such as getting up during the night to urinate, hesitation at the start of urination, and decreased urinary flow.

How does it work?

Prostif belongs to the group of medicines, called 5-alpha reductase inhibitors. They act by reducing the size of the prostate gland in men. Prostif is used in the treatment and control of benign enlargement of the prostate (benign prostatic hyperplasia – BPH). It causes regression of the enlarged prostate, improves urinary flow and symptoms caused by BPH, and reduces the risk of acute urinary retention and the need for surgery.

How to take Prostif?

The recommended dose is one tablet orally once a day. It can be taken with or without food.

Although early improvement may be seen, treatment for at least six months may be necessary to assess whether a beneficial response has been achieved. Your doctor will tell you how long you should continue to take Prostif. Do not interrupt treatment early or the symptoms may come back.

What if you miss a dose?

If you forget to take a dose of Prostif, you can take it as soon as you remember unless it is almost time for the next dose, in which case you should continue with your medication as prescribed. Do not take a double dose to make up for a forgotten dose.

                                                                                            

What to do in case of overdose?

If you take more Prostif than you should or if children have been taken medicine by accident please notify your doctor or pharmacist immediately.

What do you need to know before you take Prostif?

Do not take Prostif:

·         If you have ever had an allergic reaction to a medicine.

·         If you are a woman or anyone aged under 18 years

Talk to your doctor or pharmacist before taking Prostif:

·         if you have a large amount of residual urine and/or severely reduced urinary flow. If this is the case, you should be closely monitored for narrowing of the urinary tract.

·         if you have a Prostate Specific Antigen test. Tell your doctor that you are taking Prostif. Prostif can affect the blood levels of the substance being tested, Prostate Specific Antigen (PSA).

·         if your sexual partner is or may potentially be pregnant, you should avoid exposing her to your semen which could contain a tiny amount of the drug and may affect the normal development of the baby’s sex organs.

Consult your doctor if any of the above applies to you now or in the past.

Prostif and other medications

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Prostif (Finasteride) does not usually affect other medicines.

Pregnancy and breast-feeding

Pregnancy

Prostif should not be taken by women who are pregnant or may become pregnant. They should not handle broken or crushed Prostif tablets. If Prostif (finasteride) is absorbed through the skin or taken by mouth by a woman pregnant with a male fetus, the child may be born with malformed genital organs. When the patient’s sexual partner is or may become pregnant, the patient should either avoid exposure of his partner to semen (e.g. by use of a condom) or discontinue treatment with Prostif.

Breast-feeding

Prostif should not be administered by lactating mothers.

Driving and using machines

As far as is known, Prostif has no influence on the ability to drive or operate machinery.

Prostif and special population

Patients with impaired liver function

There is no experience of the use of Prostif (Finasteride 5 mg) in patients with restricted liver function.

Patients with impaired kidney function

No dosage adjustment is required. The use of Prostif (Finasteride 5 mg) in patients who have to undergo hemodialysis has not been investigated to date.

Elderly

No dosage adjustment is required. Please speak to your doctor or pharmacist if you feel that the effect of Prostif (Finasteride 5 mg) is too strong or too weak.

What are the possible side effects?

Common side-effects (these affect less than 1 in 10 men)

What can I do if I experience this?

Reduced desire to have sex, inability to get an erection, breast tenderness

If any of these become troublesome, speak with your doctor

 

Important: If you develop any pain or lumps in your breast area, or any discharge from your nipples, you should tell your doctor. This is because there have been a few rare reports of breast cancer in men taking 5-alpha reductase inhibitors like finasteride.

Mechanism of action:

Prostif works by forming a stable complex with the enzyme Type II 5a-reductase which results in inhibition of the enzyme Type II 5a-reductase is the enzyme necessary for peripheral conversion of testosterone to 5α-dihydrotestosterone (DHT) which is responsible for stimulation of prostatic growth. Hence inhibition of Type II 5a-reductase results in blockage of formation of DHT consequently decreasing its serum and tissue DHT concentrations by approximately 20-30% after continued therapy of more than 6 months.

Pharmacokinetic properties:

Absorption: It is well absorbed following oral administration. In healthy male subjects receiving oral finasteride, the mean oral bioavailability was 63% for 5 mg finasteride. It is reported that food intake does not affect the oral bioavailability of the drug. The peak plasma concentrations (Cmax) averaged 37 ng/mL (range, 27-49 ng/mL) reached 1-2 hours post administration.

Volume of distribution: The volume of distribution is 76 L at steady state, ranging from 44 to 96 L. Finasteride has been shown to cross the blood brain barrier but does not appear to distribute preferentially to the CSF.

Protein Binding: Approximately 90% of circulating finasteride is bound to plasma proteins.

Metabolism: Finasteride undergoes extensive hepatic metabolism predominantly mediated by the cytochrome P450 3A4 (CYP3A4) enzyme to form the t-butyl side chain monohydroxylated and monocarboxylic acid metabolites. Theses metabolites retain less than 20% of the pharmacological activity of the parent compound.

Excretion: In healthy subjects, about 32-46% of total oral dose of finasteride was excreted in the urine in the form of metabolites while about 51-64% of the dose was excreted in the feces. In patients with renal impairment, the extent of urinary excretion of finasteride is expected to be decreased while the fecal excretion is increased.

Elimination Half-life: The mean elimination half-life in plasma was 6 hours ranging from 3 to 16 hours. In elderly patients over the age of 70 years, the half-life is prolonged to 8 hours

 

Clearance: In healthy young subjects (n=15), the mean plasma clearance of finasteride was 165 mL/min with the range between 70 and 279 mL/min.